ATEX Directive

DIRECTIVE 2014/34/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 26 February 2014

on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1)

Directive 94/9/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres (3) has been substantially amended (4). Since further amendments are to be made, that Directive should be recast in the interests of clarity.

(2)

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (5) lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking.

(3)

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products (6) lays down common principles and reference provisions intended to apply across sectoral legislation in order to provide a coherent basis for revision or recasts of that legislation. Directive 94/9/EC should be adapted to that Decision.

(4)

This Directive covers products which are new to the Union market when they are placed on the market; that is to say they are either new products made by a manufacturer established in the Union or products, whether new or second-hand, imported from a third country.

(5)

This Directive should apply to all forms of supply, including distance selling.

(6)

It is the duty of Member States to protect, on their territory, the health and safety of persons, especially workers, and, where appropriate, domestic animals and property, especially against the hazards resulting from the use of equipment and systems providing protection against potentially explosive atmospheres.

(7)

Directive 94/9/EC has made positive steps towards effective protection against explosion hazards for both mining and surface equipment. Those two groups of equipment are used in a large number of commercial and industrial sectors and possess considerable economic significance.

(8)

Compliance with the health and safety requirements is essential in order to ensure the safety of equipment and protective systems. Those requirements should be subdivided into general and additional requirements which need to be met by equipment and protective systems. In particular, the additional requirements should take account of existing or potential hazards. Equipment and protective systems should, therefore, meet at least one of those requirements where this is necessary for their proper functioning or is to apply to their intended use. The notion of intended use is of prime importance for the explosion-proofing of equipment and protective systems. It is essential that manufacturers supply full information. Specific, clear marking of equipment and protective systems, stating their use in a potentially explosive atmosphere, should also be necessary.

(9)

Compliance with the essential health and safety requirements laid down in this Directive should be imperative in order to ensure the safety of equipment and protective systems. For the implementation of those requirements, both the technology obtained at the time of manufacture and overriding technical and economic requirements should be taken into account.

(10)

Economic operators should be responsible for the compliance of products with this Directive, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of health and safety of persons, especially workers, and, where appropriate, protection of domestic animals and property, and to guarantee fair competition on the Union market.

(11)

All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they only make available on the market products which are in conformity with this Directive. It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain.

(12)

In order to facilitate communication between economic operators, market surveillance authorities and consumers, Member States should encourage economic operators to include a website address in addition to the postal address.

(13)

The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure. Conformity assessment should therefore remain solely the obligation of the manufacturer.

(14)

It is necessary to ensure that products from third countries entering the Union market comply with this Directive, and in particular that appropriate conformity assessment procedures have been carried out by manufacturers with regard to those products. Provision should therefore be made for importers to make sure that the products they place on the market comply with the requirements of this Directive and that they do not place on the market products which do not comply with such requirements or present a risk. Provision should also be made for importers to make sure that conformity assessment procedures have been carried out and that product marking and documentation drawn up by manufacturers are available for inspection by the competent national authorities.

(15)

When placing a product on the market, every importer should indicate on the product his name, registered trade name or registered trade mark and the postal address at which he can be contacted. Exceptions should be provided for in cases where the size or nature of the product does not allow it. This includes cases where the importer would have to open the packaging to put his name and address on the product.

(16)

The distributor makes a product available on the market after it has been placed on the market by the manufacturer or the importer and should act with due care to ensure that its handling of the product does not adversely affect the compliance of the product.

(17)

Any economic operator that either places a product on the market under his own name or trade mark or modifies a product in such a way that compliance with this Directive may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.

(18)

Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by the competent national authorities, and should be prepared to participate actively, providing those authorities with all necessary information relating to the product concerned.

(19)

Ensuring traceability of a product throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates the market surveillance authorities’ task of tracing economic operators who made non-compliant products available on the market. When keeping the information required under this Directive for the identification of other economic operators, economic operators should not be required to update such information in respect of other economic operators who have either supplied them with a product or to whom they have supplied a product.

(20)

This Directive should be limited to the expression of the essential health and safety requirements. In order to facilitate conformity assessment with those requirements it is necessary to provide for a presumption of conformity for products which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European Standardisation (7) for the purpose of expressing detailed technical specifications of those requirements.

(21)

Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised standards where those standards do not entirely satisfy the requirements of this Directive.

(22)

In order to enable economic operators to demonstrate and the competent authorities to ensure that products made available on the market conform to the essential health and safety requirements it is necessary to provide for conformity assessment procedures. Decision No 768/2008/EC establishes modules for conformity assessment procedures, which include procedures from the least to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-sectoral coherence and to avoid ad-hoc variants, conformity assessment procedures should be chosen from among those modules.

(23)

Manufacturers should draw up an EU declaration of conformity to provide information required under this Directive on the conformity of a product with the requirements of this Directive and of other relevant Union harmonisation legislation.

(24)

To ensure effective access to information for market surveillance purposes, the information required to identify all applicable Union acts should be available in a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity.

(25)

The CE marking, indicating the conformity of a product, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking are set out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking should be laid down in this Directive.

(26)

Certain conformity assessment procedures set out in this Directive require the intervention of conformity assessment bodies, which are notified by the Member States to the Commission.

(27)

Experience has shown that the criteria set out in Directive 94/9/EC that conformity assessment bodies have to fulfil to be notified to the Commission are not sufficient to ensure a uniformly high level of performance of notified bodies throughout the Union. It is, however, essential that all notified bodies perform their functions to the same level and under conditions of fair competition. That requires the setting of obligatory requirements for conformity assessment bodies wishing to be notified in order to provide conformity assessment services.

(28)

If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards, it should be presumed to comply with the corresponding requirements set out in this Directive

(29)

In order to ensure a consistent level of quality in the performance of conformity assessment, it is also necessary to set requirements for notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies.

(30)

The system set out in this Directive should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should also be used for the purposes of notification.

(31)

Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates of conformity, should be considered by the national public authorities throughout the Union as the preferred means of demonstrating the technical competence of conformity assessment bodies. However, national authorities may consider that they possess the appropriate means of carrying out that evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements.

(32)

Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for the products to be placed on the Union market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified and the monitoring of bodies already notified cover also activities carried out by subcontractors and subsidiaries.

(33)

It is necessary to increase the efficiency and transparency of the notification procedure and, in particular, to adapt it to new technologies so as to enable online notification.

(34)

Since notified bodies may offer their services throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies.

(35)

In the interests of competitiveness, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved through appropriate coordination and cooperation between notified bodies.

(36)

Member States should take all appropriate measures to ensure that products covered by this Directive may be placed on the market only if, when properly stored and used for their intended purpose, or under conditions of use which can be reasonably foreseen, they do not endanger the health and safety of persons. Products covered by this Directive should be considered as non-compliant with the essential health and safety requirements laid down in this Directive only under conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behaviour.

(37)

In order to ensure legal certainty, it is necessary to clarify that rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to products covered by this Directive. This Directive should not prevent Member States from choosing the competent authorities to carry out those tasks.

(38)

Directive 94/9/EC already provides for a safeguard procedure which is necessary to allow the possibility for contesting the conformity of a product. In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard procedure, with a view to making it more efficient and drawing on the expertise available in Member States.

(39)

The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to products presenting a risk to the health or safety of persons, especially workers, or to domestic animals or property. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an earlier stage in respect of such products.

(40)

Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, no further involvement of the Commission should be required, except where non-compliance can be attributed to shortcomings of a harmonised standard.

(41)

In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (8).

(42)

The advisory procedure should be used for the adoption of implementing acts requesting the notifying Member State to take the necessary corrective measures in respect of notified bodies that do not meet or no longer meet the requirements for their notification.

(43)

The examination procedure should be used for the adoption of implementing acts with respect to compliant products which present a risk to the health or safety of persons or to other aspects of public interest protection.

(44)

The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to compliant products which present a risk to the health or safety of persons or to domestic animals or property, imperative grounds of urgency so require.

(45)

In line with established practice, the committee set up by this Directive can play a useful role in examining matters concerning the application of this Directive raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.

(46)

When matters relating to this Directive, other than its implementation or infringements, are being examined, i.e. in a Commission expert group, the European Parliament should in line with existing practice receive full information and documentation and, where appropriate, an invitation to attend such meetings.

(47)

The Commission should, by means of implementing acts and, given their special nature, acting without the application of Regulation (EU) No 182/2011, determine whether measures taken by Member States in respect of non-compliant products are justified or not.

(48)

Member States should lay down rules on penalties applicable to infringements of the provisions of national law adopted pursuant to this Directive and ensure that those rules are enforced. The penalties provided for should be effective, proportionate and dissuasive.

(49)

It is necessary to provide for reasonable transitional arrangements that allow the making available on the market and putting into service, without the need to comply with further product requirements, of products that have already been placed on the market in accordance with Directive 94/9/EC before the date for application of national measures transposing this Directive. Distributors should therefore be able to supply products that have been placed on the market, namely stock that is already in the distribution chain, before the date of application of national measures transposing this Directive.

(50)

Since the objective of this Directive, namely to ensure that products on the market fulfil the requirements providing for a high level of protection of health and safety of persons, especially workers, and, where appropriate, protection of domestic animals and property, while guaranteeing the functioning of the internal market, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

(51)

The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive amendment as compared to the earlier Directive. The obligation to transpose the provisions which are unchanged arises under the earlier Directive.

(52)

This Directive should be without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and the dates of application of the Directive set out in Annex XI, Part B,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER 1

GENERAL PROVISIONS

Article 1

Scope

1.   This Directive shall apply to the following, hereinafter referred to as ‘products’:

(a)

equipment and protective systems intended for use in potentially explosive atmospheres;

(b)

safety devices, controlling devices and regulating devices intended for use outside potentially explosive atmospheres but required for or contributing to the safe functioning of equipment and protective systems with respect to the risks of explosion;

(c)

components intended to be incorporated into equipment and protective systems referred to in point (a).

2.   This Directive shall not apply to:

(a)

medical devices intended for use in a medical environment;

(b)

equipment and protective systems where the explosion hazard results exclusively from the presence of explosive substances or unstable chemical substances;

(c)

equipment intended for use in domestic and non-commercial environments where potentially explosive atmospheres may only rarely be created, solely as a result of the accidental leakage of fuel gas;

(d)

personal protective equipment covered by Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (9);

(e)

seagoing vessels and mobile offshore units together with equipment on board such vessels or units;

(f)

means of transport, i.e. vehicles and their trailers intended solely for transporting passengers by air or by road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, by public road or rail networks or by water. Vehicles intended for use in a potentially explosive atmosphere shall not be excluded from the scope of this Directive;

(g)

the equipment covered by point (b) of Article 346(1) of the Treaty on the Functioning of the European Union.

Article 2

Definitions

For the purposes of this Directive, the following definitions shall apply:

(1)

‘equipment’ means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy and/or the processing of material and which are capable of causing an explosion through their own potential sources of ignition;

(2)

‘protective systems’ means devices other than components of equipment which are intended to halt incipient explosions immediately and/or to limit the effective range of an explosion and which are separately made available on the market for use as autonomous systems;

(3)

‘components’ means any item essential to the safe functioning of equipment and protective systems but with no autonomous function;

(4)

‘explosive atmosphere’ means a mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture;

(5)

‘potentially explosive atmosphere’ means an atmosphere which could become explosive due to local and operational conditions;

(6)

‘equipment-group I’ means equipment intended for use in underground parts of mines, and in those parts of surface installations of such mines, liable to be endangered by firedamp and/or combustible dust, comprising equipment categories M 1 and M 2 as set out in Annex I;

(7)

‘equipment-group II’ means equipment intended for use in other places liable to be endangered by explosive atmospheres, comprising equipment categories 1, 2 and 3 as set out in Annex I;

(8)

‘equipment category’ means the classification of equipment, within each equipment-group, specified in Annex I, determining the requisite level of protection to be ensured;

(9)

‘intended use’ means the use of a product prescribed by the manufacturer by assigning the equipment to a particular equipment-group and category or by providing all the information which is required for the safe functioning of a protective system, device or component;

(10)

‘making available on the market’ means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

(11)

‘placing on the market’means the first making available of a product on the Union market;

(12)

‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trade mark or uses it for his own purposes;

(13)

‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;

(14)

‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market;

(15)

‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

(16)

‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

(17)

‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a product;

(18)

‘harmonised standard’ means harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;

(19)

‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;

(20)

‘national accreditation body’ means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;

(21)

‘conformity assessment’ means the process demonstrating whether the essential health and safety requirements of this Directive relating to a product have been fulfilled;

(22)

‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

(23)

‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the end-user;

(24)

‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market;

(25)

‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;

(26)

‘CE marking’ means a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.

Article 3

Making available on the market and putting into service

1.   Member States shall take all appropriate measures to ensure that products may be made available on the market and put into service only if, when properly installed and maintained and used in accordance with their intended use, they comply with this Directive.

2.   This Directive shall not affect Member States’ entitlement to lay down such requirements as they may deem necessary to ensure that persons and, in particular, workers are protected when using relevant products provided that this does not mean that such products are modified in a way not specified in this Directive.

3.   At trade fairs, exhibitions and demonstrations, Member States shall not prevent the showing of products which do not comply with this Directive, provided that a visible sign clearly indicates that such products do not comply with this Directive and that they are not for sale until they have been brought into conformity by the manufacturer. During demonstrations, adequate safety measures shall be taken to ensure the protection of persons.

Article 4

Essential health and safety requirements

Products shall meet the essential health and safety requirements set out in Annex II which apply to them, account being taken of their intended use.

Article 5

Free movement

Member States shall not prohibit, restrict or impede the making available on the market and putting into service in their territory of products which comply with this Directive.

CHAPTER 2

OBLIGATIONS OF ECONOMIC OPERATORS

Article 6

Obligations of manufacturers

1.   When placing their products on the market or using them for their own purposes, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential health and safety requirements set out in Annex II.

2.   Manufacturers shall draw up the technical documentation referred to in Annexes III to IX and carry out the relevant conformity assessment procedure referred to in Article 13 or have it carried out.

Where compliance of a product, other than a component, with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.

Where compliance of a component with the applicable requirements has been demonstrated by the relevant conformity assessment procedure, manufacturers shall draw up a written attestation of conformity as referred to in Article 13(3).

Manufacturers shall ensure that each product is accompanied by a copy of the EU declaration of conformity or of the attestation of conformity, as appropriate. However, where a large number of products are delivered to a single user, the batch or consignment concerned may be accompanied by a single copy.

3.   Manufacturers shall keep the technical documentation and the EU declaration of conformity or, where applicable, the attestation of conformity for 10 years after the product has been placed on the market.

4.   Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Directive. Changes in a product design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which conformity of a product is declared shall be adequately taken into account.

When deemed appropriate with regard to the risks presented by a product, manufacturers shall, to protect the health and safety of end-users, carry out sample testing of products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep distributors informed of any such monitoring.

5.   Manufacturers shall ensure that products which they have placed on the market bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product.

6.   Manufacturers shall ensure that products, other than components, which they have placed on the market bear the specific marking of explosion protection and, where applicable, the other markings and information referred to in point 1.0.5 of Annex II.

7.   Manufacturers shall indicate, on the product, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the product. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and market surveillance authorities.

8.   Manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by end-users, as determined by the Member State concerned. Such instructions and safety information, as well as any labelling, shall be clear, understandable and intelligible.

9.   Manufacturers who consider or have reason to believe that a product which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the product available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

10.   Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the product with this Directive, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.

Article 7

Authorised representatives

1.   A manufacturer may, by a written mandate, appoint an authorised representative.

The obligations laid down in Article 6(1) and the obligation to draw up technical documentation referred to in Article 6(2) shall not form part of the authorised representative’s mandate.

2.   An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

(a)

keep the EU declaration of conformity or, where applicable, the attestation of conformity and the technical documentation at the disposal of national market surveillance authorities for 10 years after the product has been placed on the market;

(b)

further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product;

(c)

cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by products covered by the authorised representative’s mandate.

Article 8

Obligations of importers

1.   Importers shall place only compliant products on the market.

2.   Before placing a product on the market importers shall ensure that the appropriate conformity assessment procedure referred to in Article 13 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the product bears the CE marking, where applicable, is accompanied by the EU declaration of conformity or the attestation of conformity and the required documents, and that the manufacturer has complied with the requirements set out in Article 6(5), (6) and (7).

Where an importer considers or has reason to believe that a product is not in conformity with the essential health and safety requirements set out in Annex II, he shall not place the product on the market until it has been brought into conformity. Furthermore, where the product presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect.

3.   Importers shall indicate on the product their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the product. The contact details shall be in a language easily understood by end-users and market surveillance authorities.

4.   Importers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by end-users, as determined by the Member State concerned.

5.   Importers shall ensure that, while a product is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential health and safety requirements set out in Annex II.

6.   When deemed appropriate with regard to the risks presented by a product, importers shall, to protect the health and safety of end-users, carry out sample testing of products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep distributors informed of any such monitoring.

7.   Importers who consider or have reason to believe that a product which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, importers shall immediately inform the competent national authorities of the Member States in which they made the product available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

8.   Importers shall, for 10 years after the product has been placed on the market, keep a copy of the EU declaration of conformity or, where applicable, of the attestation of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

9.   Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of a product in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.

Article 9

Obligations of distributors

1.   When making a product available on the market distributors shall act with due care in relation to the requirements of this Directive.

2.   Before making a product available on the market distributors shall verify that the product bears the CE marking, where applicable, that it is accompanied by the EU declaration of conformity or the attestation of conformity and the required documents and by instructions and safety information, in a language which can be easily understood by end-users in the Member State in which the product is to be made available on the market, and that the manufacturer and the importer have complied with the requirements set out in Article 6(5), (6) and (7) and Article 8(3) respectively.

Where a distributor considers or has reason to believe that a product is not in conformity with the essential health and safety requirements set out in Annex II, he shall not make the product available on the market until it has been brought into conformity. Furthermore, where the product presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.

3.   Distributors shall ensure that, while a product is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential health and safety requirements set out in Annex II.

4.   Distributors who consider or have reason to believe that a product which they have made available on the market is not in conformity with this Directive shall make sure that the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore, where the product presents a risk, distributors shall immediately inform the competent national authorities of the Member States in which they made the product available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

5.   Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of a product. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have made available on the market.

Article 10

Cases in which obligations of manufacturers apply to importers and distributors

An importer or distributor shall be considered a manufacturer for the purposes of this Directive and he shall be subject to the obligations of the manufacturer under Article 6, where he places a product on the market under his name or trade mark or modifies a product already placed on the market in such a way that compliance with this Directive may be affected.

Article 11

Identification of economic operators

Economic operators shall, on request, identify the following to the market surveillance authorities:

(a)

any economic operator who has supplied them with a product;

(b)

any economic operator to whom they have supplied a product.

Economic operators shall be able to present the information referred to in the first paragraph for 10 years after they have been supplied with the product and for 10 years after they have supplied the product.

CHAPTER 3

CONFORMITY OF THE PRODUCT

Article 12

Presumption of conformity of products

1.   Products which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential health and safety requirements set out in Annex II covered by those standards or parts thereof.

2.   In the absence of harmonised standards, Member States shall take any steps which they deem necessary to bring to the attention of the parties concerned the existing national standards and technical specifications regarded as important or relevant to the proper implementation of the essential health and safety requirements set out in Annex II.

Article 13

Conformity assessment procedures

1.   The procedures to be followed for assessing the conformity of equipment and, where necessary, the devices referred to in point (b) of Article 1(1) shall be as follows:

(a)

for equipment-groups I and II, equipment-categories M 1 and 1, the EU-type examination set out in Annex III, in conjunction with either of the following:

—

conformity to type based on quality assurance of the production process set out in Annex IV,

—

conformity to type based on product verification set out in Annex V;

(b)

for equipment-groups I and II, equipment categories M 2 and 2:

(i)

in the case of internal combustion engines and electrical equipment in these groups and categories, the EU-type examination set out in Annex III, in conjunction with either of the following:

—

conformity to type based on internal production control plus supervised product testing set out in Annex VI,

—

conformity to type based on product quality assurance set out in Annex VII;

(ii)

in the case of other equipment in these groups and categories, internal production control set out in Annex VIII and the communication of the technical documentation provided for in Annex VIII, point 2, to a notified body, which shall acknowledge receipt of it as soon as possible and shall retain it;

(c)

for equipment-group II, equipment category 3, internal production control set out in Annex VIII;

(d)

for equipment-groups I and II, in addition to the procedures referred to in points (a), (b) and (c) of this paragraph, conformity based on unit verification set out in Annex IX may also be followed.

2.   The procedure referred to in point (a) or (d) of paragraph 1 shall be used for conformity assessment of protective systems.

3.   The procedures referred to in paragraph 1 shall be applied in respect of components with the exception of the affixing of the CE marking and the drawing up of the EU declaration of conformity. A written attestation of conformity shall be issued by the manufacturer, declaring the conformity of the components with the applicable provisions of this Directive and stating their characteristics and how they must be incorporated into equipment or protective systems to assist compliance with the essential health and safety requirements set out in Annex II applicable to finished equipment or protective systems.

4.   With regard to the safety aspects referred to in point 1.2.7 of Annex II, in addition to the conformity assessment procedures referred to in paragraphs 1 and 2, the procedure referred to in Annex VIII may also be followed.

5.   By derogation from paragraphs 1, 2 and 4, the competent authorities may, on a duly justified request, authorise the placing on the market and putting into service on the territory of the Member State concerned of the products other than components in respect of which the procedures referred to in paragraphs 1, 2 and 4 have not been applied and the use of which is in the interests of protection.

6.   Documents and correspondence relating to the conformity assessment procedures referred to in paragraphs 1 to 4 shall be drawn up in a language, determined by the Member State concerned.

Article 14

EU declaration of conformity

1.   The EU declaration of conformity shall state that the fulfilment of the essential health and safety requirements set out in Annex II has been demonstrated.

2.   The EU declaration of conformity shall have the model structure set out in Annex X, shall contain the elements specified in the relevant conformity assessment procedures set out in Annexes III to IX and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the product is placed or made available on the market.

3.   Where a product is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned, including their publication references.

4.   By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the product with the requirements laid down in this Directive.

Article 15

General principles of the CE marking

The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

Article 16

Rules and conditions for affixing the CE marking and other markings

1.   The CE marking shall be affixed visibly, legibly and indelibly to the product or to its data plate. Where that is not possible or not warranted on account of the nature of the product, it shall be affixed to the packaging and to the accompanying documents.

2.   The CE marking shall be affixed before the product is placed on the market.

3.   The CE marking shall be followed by the identification number of the notified body, where that body is involved in the production control phase.

The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.

4.   The CE marking and, where applicable, the identification number of the notified body shall be followed by the specific marking of explosion protection

Image 1
, the symbols of the equipment-group and category and, where applicable, the other markings and information referred to in point 1.0.5 of Annex II.

 

5.   The CE marking and the markings, symbols and information referred to in paragraph 4, and, where applicable, the identification number of the notified body, may be followed by any other mark indicating a special risk or use.

Products that are designed for a particular explosive atmosphere shall be marked accordingly.

6.   Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.

CHAPTER 4

NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Article 17

Notification

Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Directive.

Article 18

Notifying authorities

1.   Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with the provisions of Article 23.

2.   Member States may decide that the assessment and monitoring referred to in paragraph 1 is to be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.

3.   Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 19. In addition it shall have arrangements to cover liabilities arising out of its activities.

4.   The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.

Article 19

Requirements relating to notifying authorities

1.   A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.

2.   A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.

3.   A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment.

4.   A notifying authority shall not offer or provide any activities that conformity assessment bodies perform or consultancy services on a commercial or competitive basis.

5.   A notifying authority shall safeguard the confidentiality of the information it obtains.

6.   A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.

Article 20

Information obligation on notifying authorities

Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.

The Commission shall make that information publicly available.

Article 21

Requirements relating to notified bodies

1.   For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.

2.   A conformity assessment body shall be established under the national law of a Member State and have legal personality.

3.   A conformity assessment body shall be a third-party body independent of the organisation or the product it assesses.

A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.

4.   A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products which they assess, nor the representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of such products for personal purposes.

A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those products, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.

Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

5.   Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

6.   A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annexes III to VII and Annex IX and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.

At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:

(a)

personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

(b)

descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;

(c)

procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.

A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.

7.   The personnel responsible for carrying out conformity assessment tasks shall have the following:

(a)

sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

(b)

satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

(c)

appropriate knowledge and understanding of the essential health and safety requirements set out in Annex II, of the applicable harmonised standards, of the relevant provisions of Union harmonisation legislation and of national legislation;

(d)

the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

8.   The impartiality of the conformity assessment bodies, their top level management, and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.

The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.

9.   Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.

10.   The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annexes III to VII and Annex IX or any provision of national law giving effect to it, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.

11.   Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under the relevant Union harmonisation legislation and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

Article 22

Presumption of conformity of notified bodies

Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 21 in so far as the applicable harmonised standards cover those requirements.

Article 23

Subsidiaries of and subcontracting by notified bodies

1.   Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 21 and shall inform the notifying authority accordingly.

2.   Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

3.   Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.

4.   Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annexes III to VII and Annex IX.

Article 24

Application for notification

1.   A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established.

2.   The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the product or products for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 21.

3.   Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 21.

Article 25

Notification procedure

1.   Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 21.

2.   They shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.

3.   The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and the product or products concerned and the relevant attestation of competence.

4.   Where a notification is not based on an accreditation certificate as referred to in Article 24(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body’s competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 21.

5.   The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used.

Only such a body shall be considered a notified body for the purposes of this Directive.

6.   The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification.

Article 26

Identification numbers and lists of notified bodies

1.   The Commission shall assign an identification number to a notified body.

It shall assign a single such number even where the body is notified under several Union acts.

2.   The Commission shall make publicly available the list of the bodies notified under this Directive, including the identification numbers that have been assigned to them and the activities for which they have been notified.

The Commission shall ensure that the list is kept up to date.

Article 27

Changes to notifications

1.   Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 21, or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.

2.   In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.

Article 28

Challenge of the competence of notified bodies

1.   The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.

2.   The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned.

3.   The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.

4.   Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requesting the notifying Member State to take the necessary corrective measures, including withdrawal of notification if necessary.

That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 39(2).

Article 29

Operational obligations of notified bodies

1.   Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annexes III to VII and Annex IX.

2.   Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators. Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.

In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the product with the requirements of this Directive.

3.   Where a notified body finds that the essential health and safety requirements set out in Annex II or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a certificate of conformity.

4.   Where, in the course of the monitoring of conformity following the issue of a certificate, a notified body finds that a product no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate if necessary.

5.   Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates, as appropriate.

Article 30

Appeal against decisions of notified bodies

Member States shall ensure that an appeal procedure against decisions of the notified bodies is available.

Article 31

Information obligation on notified bodies

1.   Notified bodies shall inform the notifying authority of the following:

(a)

any refusal, restriction, suspension or withdrawal of a certificate;

(b)

any circumstances affecting the scope of or conditions for notification;

(c)

any request for information which they have received from market surveillance authorities regarding conformity assessment activities;

(d)

on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.

2.   Notified bodies shall provide the other bodies notified under this Directive carrying out similar conformity assessment activities covering the same products with relevant information on issues relating to negative and, on request, positive conformity assessment results.

Article 32

Exchange of experience

The Commission shall provide for the organisation of exchange of experience between the Member States’ national authorities responsible for notification policy.

Article 33

Coordination of notified bodies

The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Directive are put in place and properly operated in the form of a sectoral group of notified bodies.

Member States shall ensure that the bodies notified by them participate in the work of that group, directly or by means of designated representatives.

CHAPTER 5

UNION MARKET SURVEILLANCE, CONTROL OF PRODUCTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE

Article 34

Union market surveillance and control of products entering the Union market

Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to products covered by Article 1 of this Directive.

Article 35

Procedure for dealing with products presenting a risk at national level

1.   Where the market surveillance authorities of one Member State have sufficient reason to believe that a product presents a risk to the health or safety of persons or to domestic animals or property, they shall carry out an evaluation in relation to the product concerned covering all relevant requirements laid down in this Directive. The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose.

Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the product does not comply with the requirements laid down in this Directive, they shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the product into compliance with those requirements, to withdraw the product from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.

The market surveillance authorities shall inform the relevant notified body accordingly.

Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.

2.   Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.

3.   The economic operator shall ensure that all appropriate corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Union.

4.   Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the products being made available on their national market, to withdraw the product from that market or to recall it.

The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.

5.   The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant product, the origin of the product, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either of the following:

(a)

failure of the product to meet requirements relating to the health or safety of persons or to the protection of domestic animals or property; or

(b)

shortcomings in the harmonised standards referred to in Article 12 conferring a presumption of conformity.

6.   Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the product concerned, and, in the event of disagreement with the adopted national measure, of their objections.

7.   Where, within three months of receipt of the information referred to in the second subparagraph of paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.

8.   Member States shall ensure that appropriate restrictive measures, such as withdrawal of the product from the market, are taken in respect of the product concerned without delay.

Article 36

Union safeguard procedure

1.   Where, on completion of the procedure set out in Article 35(3) and (4), objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not.

The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the relevant economic operator or operators.

2.   If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant product is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned shall withdraw that measure.

3.   Where the national measure is considered justified and the non-compliance of the product is attributed to shortcomings in the harmonised standards referred to in point (b) of Article 35(5) of this Directive, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.

Article 37

Compliant products which present a risk

1.   Where, having carried out an evaluation under Article 35(1), a Member State finds that although a product is in compliance with this Directive, it presents a risk to the health or safety of persons or to domestic animals or property, it shall require the relevant economic operator to take all appropriate measures to ensure that the product concerned, when placed on the market, no longer presents that risk, to withdraw the product from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe.

2.   The economic operator shall ensure that corrective action is taken in respect of all the products concerned that he has made available on the market throughout the Union.

3.   The Member State shall immediately inform the Commission and the other Member States. That information shall include all available details, in particular the data necessary for the identification of the product concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.

4.   The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide by means of implementing acts whether the national measure is justified or not, and where necessary, propose appropriate measures.

The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 39(3).

On duly justified imperative grounds of urgency relating to the protection of health and safety of persons or to the protection of domestic animals or property, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 39(4).

5.   The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.

Article 38

Formal non-compliance

1.   Without prejudice to Article 35, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:

(a)

the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 16 of this Directive;

(b)

the CE marking, where required, has not been affixed;

(c)

the specific marking of explosion protection

Image 2
, the symbols of the equipment-group and category and, where applicable, the other markings and information have been affixed in violation of point 1.0.5 of Annex II or have not been affixed;

 

(d)

the identification number of the notified body, where that body is involved in the production control phase, has been affixed in violation of Article 16 or has not been affixed;

(e)

the EU declaration of conformity or the attestation of conformity, as appropriate, does not accompany the product;

(f)

the EU declaration of conformity or, where required, the attestation of conformity has not been drawn up correctly;

(g)

technical documentation is either not available or not complete;

(h)

the information referred to in Article 6(7) or 8(3) is absent, false or incomplete;

(i)

any other administrative requirement provided for in Article 6 or 8 is not fulfilled.

2.   Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or ensure that it is recalled or withdrawn from the market.

CHAPTER 6

COMMITTEE, TRANSITIONAL AND FINAL PROVISIONS

Article 39

Committee procedure

1.   The Commission shall be assisted by the Committee on equipment and protective systems intended for use in potentially explosive atmospheres. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.   Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

3.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

4.   Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

5.   The committee shall be consulted by the Commission on any matter for which consultation of sectoral experts is required by Regulation (EU) No 1025/2012 or by any other Union legislation.

The committee may furthermore examine any other matter concerning the application of this Directive raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.

Article 40

Penalties

Member States shall lay down rules on penalties applicable to infringements by economic operators of the provisions of national law adopted pursuant to this Directive and shall take all measures necessary to ensure that they are enforced. Such rules may include criminal penalties for serious infringements.

The penalties provided for shall be effective, proportionate and dissuasive.

Article 41

Transitional provisions

1.   Member States shall not impede the making available on the market or the putting into service of products covered by Directive 94/9/EC which are in conformity with that Directive and which were placed on the market before 20 April 2016.

2.   Certificates issued under Directive 94/9/EC shall be valid under this Directive.

Article 42

Transposition

1.   Member States shall adopt and publish by 19 April 2016 the laws, regulations and administrative provisions necessary to comply with Article 1, points 2 and 8 to 26 of Article 2, Article 3, Articles 5 to 41 and Annexes III to X. They shall forthwith communicate the text of those measures to the Commission.

They shall apply those measures from 20 April 2016.

When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 43

Repeal

Directive 94/9/EC, as amended by the Regulations listed in Annex XI, Part A, is repealed with effect from 20 April 2016, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and the dates of application of the Directive set out in Annex XI, Part B.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex XII.

Article 44

Entry into force and application

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Points 1 and 3 to 7 of Article 2, Article 4 and Annexes I, II, XI and XII shall apply from 20 April 2016.

Article 45

Addressees

This Directive is addressed to the Member States.

Done at Strasbourg, 26 February 2014.

For the European Parliament

The President

M. SCHULZ

For the Council

The President

D. KOURKOULAS

(1)   OJ C 181, 21.6.2012, p. 105.

(2)  Position of the European Parliament of 5 February 2014 (not yet published in the Official Journal) and decision of the Council of 20 February 2014.

(3)   OJ L 100, 19.4.1994, p. 1.

(4)  See Annex XI, Part A.

(5)   OJ L 218, 13.8.2008, p. 30.

(6)   OJ L 218, 13.8.2008, p. 82.

(7)   OJ L 316, 14.11.2012, p. 12.

(8)   OJ L 55, 28.2.2011, p. 13.

(9)   OJ L 399, 30.12.1989, p. 18.

ANNEX I

CRITERIA DETERMINING THE CLASSIFICATION OF EQUIPMENT-GROUPS INTO CATEGORIES

1.   Equipment-group I

 

(a)

 Equipment category M 1 comprises equipment designed and, where necessary, equipped with additional special means of protection to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a very high level of protection.

Equipment in this category is intended for use in underground parts of mines as well as those parts of surface installations of such mines endangered by firedamp and/or combustible dust.

Equipment in this category is required to remain functional, even in the event of rare incidents relating to equipment, with an explosive atmosphere present, and is characterised by means of protection such that:

—

either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection,

—

or the requisite level of protection is assured in the event of two faults occurring independently of each other.

Equipment in this category must comply with the supplementary requirements referred to in point 2.0.1 of Annex II.
 

(b)

 Equipment category M 2 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a high level of protection.

Equipment in this category is intended for use in underground parts of mines as well as those parts of surface installations of such mines likely to be endangered by firedamp and/or combustible dust.

This equipment is intended to be de-energised in the event of an explosive atmosphere.

The means of protection relating to equipment in this category assure the requisite level of protection during normal operation and also in the case of more severe operating conditions, in particular those arising from rough handling and changing environmental conditions.

Equipment in this category must comply with the supplementary requirements referred to in point 2.0.2 of Annex II.

2.   Equipment-group II

 

(a)

 Equipment category 1 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a very high level of protection.

Equipment in this category is intended for use in areas in which explosive atmospheres caused by mixtures of air and gases, vapours or mists or by air/dust mixtures are present continuously, for long periods or frequently.

Equipment in this category must ensure the requisite level of protection, even in the event of rare incidents relating to equipment, and is characterised by means of protection such that:

—

either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection,

—

or the requisite level of protection is assured in the event of two faults occurring independently of each other.

Equipment in this category must comply with the supplementary requirements referred to in point 2.1 of Annex II.
 

(b)

 Equipment category 2 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and of ensuring a high level of protection.

Equipment in this category is intended for use in areas in which explosive atmospheres caused by gases, vapours, mists or air/dust mixtures are likely to occur occasionally.

The means of protection relating to equipment in this category ensure the requisite level of protection, even in the event of frequently occurring disturbances or equipment faults which normally have to be taken into account.

Equipment in this category must comply with the supplementary requirements referred to in point 2.2 of Annex II.
 

(c)

 Equipment category 3 comprises equipment designed to be capable of functioning in conformity with the operating parameters established by the manufacturer and ensuring a normal level of protection.

Equipment in this category is intended for use in areas in which explosive atmospheres caused by gases, vapours, mists, or air/dust mixtures are unlikely to occur or, if they do occur, are likely to do so only infrequently and for a short period only.

Equipment in this category ensures the requisite level of protection during normal operation.

Equipment in this category must comply with the supplementary requirements referred to in point 2.3 of Annex II.

ANNEX II

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE DESIGN AND CONSTRUCTION OF EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES

Preliminary observations

 

A.

 Technological knowledge, which can change rapidly, must be taken into account as far as possible and be utilised immediately.
 

B.

 For the devices referred to in point (b) of Article 1(1), the essential health and safety requirements shall apply only in so far as they are necessary for the safe and reliable functioning and operation of those devices with respect to the risks of explosion.

1.   Common requirements for Equipment and protective systems

1.0.   General requirements

1.0.1.   Principles of integrated explosion safety

Equipment and protective systems intended for use in potentially explosive atmospheres must be designed from the point of view of integrated explosion safety.

In this connection, the manufacturer must take measures:

—

above all, if possible, to prevent the formation of explosive atmospheres which may be produced or released by equipment and by protective systems themselves,

—

to prevent the ignition of explosive atmospheres, taking into account the nature of every electrical and non-electrical source of ignition,

—

should an explosion nevertheless occur which could directly or indirectly endanger persons and, as the case may be, domestic animals or property, to halt it immediately and/or to limit the range of explosion flames and explosion pressures to a sufficient level of safety.

1.0.2.   Equipment and protective systems must be designed and manufactured after due analysis of possible operating faults in order as far as possible to preclude dangerous situations.

Any misuse which can reasonably be anticipated must be taken into account.

1.0.3.   Special checking and maintenance conditions

Equipment and protective systems subject to special checking and maintenance conditions must be designed and constructed with such conditions in mind.

1.0.4.   Surrounding area conditions

Equipment and protective systems must be so designed and constructed as to be capable of coping with actual or foreseeable surrounding area conditions.

1.0.5.   Marking

All equipment and protective systems must be marked legibly and indelibly with the following minimum particulars:

—

name, registered trade name or registered trade mark, and address of the manufacturer,

—

CE marking (see Annex II to Regulation (EC) No 765/2008),

—

designation of series or type,

—

batch or serial number, if any,

—

year of construction,

—

the specific marking of explosion protection

Image 3
followed by the symbol of the equipment-group and category,

 

—

for equipment-group II, the letter ‘G’ (concerning explosive atmospheres caused by gases, vapours or mists),

and/or

—

the letter ‘D’ (concerning explosive atmospheres caused by dust).

Furthermore, where necessary, they must also be marked with all information essential to their safe use.

1.0.6.   Instructions

(a)

All equipment and protective systems must be accompanied by instructions, including at least the following particulars:

—

a recapitulation of the information with which the equipment or protective system is marked, except for the batch or serial number (see point 1.0.5), together with any appropriate additional information to facilitate maintenance (e.g. address of the repairer, etc.);

—

instructions for safe:

—

putting into service,

—

use,

—

assembling and dismantling,

—

maintenance (servicing and emergency repair),

—

installation,

—

adjustment;

—

where necessary, an indication of the danger areas in front of pressure-relief devices;

—

where necessary, training instructions;

—

details which allow a decision to be taken beyond any doubt as to whether an item of equipment in a specific category or a protective system can be used safely in the intended area under the expected operating conditions;

—

electrical and pressure parameters, maximum surface temperatures and other limit values;

—

where necessary, special conditions of use, including particulars of possible misuse which experience has shown might occur;

—

where necessary, the essential characteristics of tools which may be fitted to the equipment or protective system.

(b)

The instructions must contain the drawings and diagrams necessary for the putting into service, maintenance, inspection, checking of correct operation and, where appropriate, repair of the equipment or protective system, together with all useful instructions, in particular with regard to safety.

(c)

Literature describing the equipment or protective system must not contradict the instructions with regard to safety aspects.

1.1.   Selection of materials

1.1.1.   The materials used for the construction of equipment and protective systems must not trigger off an explosion, taking into account foreseeable operational stresses.

1.1.2.   Within the limits of the operating conditions laid down by the manufacturer, it must not be possible for a reaction to take place between the materials used and the constituents of the potentially explosive atmosphere which could impair explosion protection.

1.1.3.   Materials must be so selected that predictable changes in their characteristics and their compatibility in combination with other materials will not lead to a reduction in the protection afforded; in particular, due account must be taken of the material’s corrosion and wear resistance, electrical conductivity, mechanical strength, ageing resistance and the effects of temperature variations.

1.2.   Design and construction

1.2.1.   Equipment and protective systems must be designed and constructed with due regard to technological knowledge of explosion protection so that they can be safely operated throughout their foreseeable lifetime.

1.2.2.   Components to be incorporated into or used as replacements in equipment and protective systems must be so designed and constructed that they function safely for their intended purpose of explosion protection when they are installed in accordance with the manufacturer’s instructions.

1.2.3.   Enclosed structures and prevention of leaks

Equipment which may release flammable gases or dusts must wherever possible employ enclosed structures only.

If equipment contains openings or non-tight joints, these must as far as possible be designed in such a way that releases of gases or dusts cannot give rise to explosive atmospheres outside the equipment.

Points where materials are introduced or drawn off must, as far as possible, be designed and equipped so as to limit releases of flammable materials during filling or draining.

1.2.4.   Dust deposits

Equipment and protective systems which are intended to be used in areas exposed to dust must be so designed that deposit dust on their surfaces is not ignited.

In general, dust deposits must be limited where possible. Equipment and protective systems must be easily cleanable.

The surface temperatures of equipment parts must be kept well below the glow temperature of the deposit dust.

The thickness of deposit dust must be taken into consideration and, if appropriate, means must be taken to limit the temperature in order to prevent a heat build up.

1.2.5.   Additional means of protection

Equipment and protective systems which may be exposed to certain types of external stresses must be equipped, where necessary, with additional means of protection.

Equipment must withstand relevant stresses, without adverse effect on explosion protection.

1.2.6.   Safe opening

If equipment and protective systems are in a housing or a locked container forming part of the explosion protection itself, it must be possible to open such housing or container only with a special tool or by means of appropriate protection measures.

1.2.7.   Protection against other hazards

Equipment and protective systems must be so designed and manufactured as to:

(a)

avoid physical injury or other harm which might be caused by direct or indirect contact;

(b)

assure that surface temperatures of accessible parts or radiation which would cause a danger, are not produced;

(c)

eliminate non-electrical dangers which are revealed by experience;

(d)

assure that foreseeable conditions of overload do not give rise to dangerous situations.

Where, for equipment and protective systems, the risks referred to in this point are wholly or partly covered by other Union legislation, this Directive shall not apply or shall cease to apply in the case of such equipment and protective systems and of such risks upon application of that specific Union legislation.

1.2.8.   Overloading of equipment

Dangerous overloading of equipment must be prevented at the design stage by means of integrated measurement, regulation and control devices, such as over-current cut-off switches, temperature limiters, differential pressure switches, flowmeters, time-lag relays, overspeed monitors and/or similar types of monitoring devices.

1.2.9.   Flameproof enclosure systems

If parts which can ignite an explosive atmosphere are placed in an enclosure, measures must be taken to ensure that the enclosure withstands the pressure developed during an internal explosion of an explosive mixture and prevents the transmission of the explosion to the explosive atmosphere surrounding the enclosure.

1.3.   Potential ignition sources

1.3.1.   Hazards arising from different ignition sources

Potential ignition sources such as sparks, flames, electric arcs, high surface temperatures, acoustic energy, optical radiation, electromagnetic waves and other ignition sources must not occur.

1.3.2.   Hazards arising from static electricity

Electrostatic charges capable of resulting in dangerous discharges must be prevented by means of appropriate measures.

1.3.3.   Hazards arising from stray electric and leakage currents

Stray electric and leakage currents in conductive equipment parts which could result in, for example, the occurrence of dangerous corrosion, overheating of surfaces or sparks capable of provoking an ignition must be prevented.

1.3.4.   Hazards arising from overheating

Overheating caused by friction or impacts occurring, for example, between materials and parts in contact with each other while rotating or through the intrusion of foreign bodies must, as far as possible, be prevented at the design stage.

1.3.5.   Hazards arising from pressure compensation operations

Equipment and protective systems must be so designed or fitted with integrated measuring, control and regulation devices that pressure compensations arising from them do not generate shock waves or compressions which may cause ignition.

1.4.   Hazards arising from external effects

1.4.1.   Equipment and protective systems must be so designed and constructed as to be capable of performing their intended function in full safety, even in changing environmental conditions and in the presence of extraneous voltages, humidity, vibrations, contamination and other external effects, taking into account the limits of the operating conditions established by the manufacturer.

1.4.2.   Equipment parts used must be appropriate to the intended mechanical and thermal stresses and capable of withstanding attack by existing or foreseeable aggressive substances.

1.5.   Requirements in respect of safety-related devices

1.5.1.   Safety devices must function independently of any measurement and/or control devices required for operation.

As far as possible, failure of a safety device must be detected sufficiently rapidly by appropriate technical means to ensure that there is only very little likelihood that dangerous situations will occur.

The fail-safe principle is to be applied in general.

Safety-related switching must in general directly actuate the relevant control devices without intermediate software command.

1.5.2.   In the event of a safety device failure, equipment and/or protective systems shall, wherever possible, be secured.

1.5.3.   Emergency stop controls of safety devices must, as far as possible, be fitted with restart lockouts. A new start command may take effect on normal operation only after the restart lockouts have been intentionally reset.

1.5.4.   Control and display units

Where control and display units are used, they must be designed in accordance with ergonomic principles in order to achieve the highest possible level of operating safety with regard to the risk of explosion.

1.5.5.   Requirements in respect of devices with a measuring function for explosion protection

In so far as they relate to equipment used in explosive atmospheres, devices with a measuring function must be designed and constructed so that they can cope with foreseeable operating requirements and special conditions of use.

1.5.6.   Where necessary, it must be possible to check the reading accuracy and serviceability of devices with a measuring function.

1.5.7.   The design of devices with a measuring function must incorporate a safety factor which ensures that the alarm threshold lies far enough outside the explosion and/or ignition limits of the atmospheres to be registered, taking into account, in particular, the operating conditions of the installation and possible aberrations in the measuring system.

1.5.8.   Risks arising from software

In the design of software-controlled equipment, protective systems and safety devices, special account must be taken of the risks arising from faults in the programme.

1.6.   Integration of safety requirements relating to the system

1.6.1.   Manual override must be possible in order to shut down the equipment and protective systems incorporated within automatic processes which deviate from the intended operating conditions, provided that this does not compromise safety.

1.6.2.   When the emergency shutdown system is actuated, accumulated energy must be dispersed as quickly and as safely as possible or isolated so that it no longer constitutes a hazard.

This does not apply to electrochemically-stored energy.

1.6.3.   Hazards arising from power failure

Where equipment and protective systems can give rise to a spread of additional risks in the event of a power failure, it must be possible to maintain them in a safe state of operation independently of the rest of the installation.

1.6.4.   Hazards arising from connections

Equipment and protective systems must be fitted with suitable cable and conduit entries.

When equipment and protective systems are intended for use in combination with other equipment and protective systems, the interface must be safe.

1.6.5.   Placing of warning devices as parts of equipment

Where equipment or protective systems are fitted with detection or alarm devices for monitoring the occurrence of explosive atmospheres, the necessary instructions must be provided to enable them to be provided at the appropriate places.

2.   Supplementary requirements in respect of equipment

2.0.   Requirements applicable to equipment in equipment-group I

2.0.1.   Requirements applicable to equipment category M 1 of equipment-group I

 

2.0.1.1.

 Equipment must be so designed and constructed that sources of ignition do not become active, even in the event of rare incidents relating to equipment.

Equipment must be equipped with means of protection such that:

—

either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection,

—

or, the requisite level of protection is ensured in the event of two faults occurring independently of each other.

Where necessary, equipment must be equipped with additional special means of protection.

It must remain functional with an explosive atmosphere present.
 

2.0.1.2.

 Where necessary, equipment must be so constructed that no dust can penetrate it.
 

2.0.1.3.

 The surface temperatures of equipment parts must be kept clearly below the ignition temperature of the foreseeable air/dust mixtures in order to prevent the ignition of suspended dust.
 

2.0.1.4.

 Equipment must be so designed that the opening of equipment parts which may be sources of ignition is possible only under non-active or intrinsically safe conditions. Where it is not possible to render equipment non-active, the manufacturer must affix a warning label to the opening part of the equipment.

If necessary, equipment must be fitted with appropriate additional interlocking systems.

2.0.2.   Requirements applicable to equipment category M 2 of equipment-group I

 

2.0.2.1.

 Equipment must be equipped with means of protection ensuring that sources of ignition do not become active during normal operation, even under more severe operating conditions, in particular those arising from rough handling and changing environmental conditions.

The equipment is intended to be de-energised in the event of an explosive atmosphere.
 

2.0.2.2.

 Equipment must be so designed that the opening of equipment parts which may be sources of ignition is possible only under non-active conditions or via appropriate interlocking systems. Where it is not possible to render equipment non-active, the manufacturer must affix a warning label to the opening part of the equipment.
 

2.0.2.3.

 The requirements regarding explosion hazards arising from dust applicable to equipment category M 1 must be applied.

2.1.   Requirements applicable to equipment category 1 of equipment-group II

2.1.1.   Explosive atmospheres caused by gases, vapours or mists

 

2.1.1.1.

 Equipment must be so designed and constructed that sources of ignition do not become active, even in event of rare incidents relating to equipment.

It must be equipped with means of protection such that:

—

either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection,

—

or, the requisite level of protection is ensured in the event of two faults occurring independently of each other.
 

2.1.1.2.

 For equipment with surfaces which may heat up, measures must be taken to ensure that the stated maximum surface temperatures are not exceeded even in the most unfavourable circumstances.

Temperature rises caused by heat build-ups and chemical reactions must also be taken into account.
 

2.1.1.3.

 Equipment must be so designed that the opening of equipment parts which might be sources of ignition is possible only under non-active or intrinsically safe conditions. Where it is not possible to render equipment non-active, the manufacturer must affix a warning label to the opening part of the equipment.

If necessary, equipment must be fitted with appropriate additional interlocking systems.

2.1.2.   Explosive atmospheres caused by air/dust mixtures

 

2.1.2.1.

 Equipment must be so designed and constructed that ignition of air/dust mixtures does not occur even in the event of rare incidents relating to equipment.

It must be equipped with means of protection such that

—

either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection,

—

or, the requisite level of protection is ensured in the event of two faults occurring independently of each other.
 

2.1.2.2.

 Where necessary, equipment must be so designed that dust can enter or escape from the equipment only at specifically designated points.

This requirement must also be met by cable entries and connecting pieces.
 

2.1.2.3.

 The surface temperatures of equipment parts must be kept well below the ignition temperature of the foreseeable air/dust mixtures in order to prevent the ignition of suspended dust.
 

2.1.2.4.

 With regard to the safe opening of equipment parts, requirement 2.1.1.3 applies.

2.2.   Requirements applicable to equipment category 2 of equipment-group II

2.2.1.   Explosive atmospheres caused by gases, vapours or mists

 

2.2.1.1.

 Equipment must be so designed and constructed as to prevent ignition sources arising, even in the event of frequently occurring disturbances or equipment operating faults, which normally have to be taken into account.
 

2.2.1.2.

 Equipment parts must be so designed and constructed that their stated surface temperatures are not exceeded, even in the case of risks arising from abnormal situations anticipated by the manufacturer.
 

2.2.1.3.

 Equipment must be so designed that the opening of equipment parts which might be sources of ignition is possible only under non-active conditions or via appropriate interlocking systems. Where it is not possible to render equipment non-active, the manufacturer must affix a warning label to the opening part of the equipment.

2.2.2.   Explosive atmospheres caused by air/dust mixtures

 

2.2.2.1.

 Equipment must be designed and constructed so that ignition of air/dust mixtures is prevented, even in the event of frequently occurring disturbances or equipment operating faults which normally have to be taken into account.
 

2.2.2.2.

 With regard to surface temperatures, requirement 2.1.2.3 applies.
 

2.2.2.3.

 With regard to protection against dust, requirement 2.1.2.2 applies.
 

2.2.2.4.

 With regard to the safe opening of equipment parts, requirement 2.2.1.3 applies.

2.3.   Requirements applicable to equipment category 3 of equipment-group II

2.3.1.   Explosive atmospheres caused by gases, vapours or mists

 

2.3.1.1.

 Equipment must be so designed and constructed as to prevent foreseeable ignition sources which can occur during normal operation.
 

2.3.1.2.

 Surface temperatures must not exceed the stated maximum surface temperatures under intended operating conditions. Higher temperatures in exceptional circumstances may be allowed only if the manufacturer adopts special additional protective measures.

2.3.2.   Explosive atmospheres caused by air/dust mixtures

 

2.3.2.1.

 Equipment must be so designed and constructed that air/dust mixtures cannot be ignited by foreseeable ignition sources likely to exist during normal operation.
 

2.3.2.2.

 With regard to surface temperatures, requirement 2.1.2.3 applies.
 

2.3.2.3.

 Equipment, including cable entries and connecting pieces, must be so constructed that, taking into account the size of its particles, dust can neither develop explosive mixtures with air nor form dangerous accumulations inside the equipment.

3.   Supplementary requirements in respect of protective systems

3.0.   General requirements

3.0.1.   Protective systems must be dimensioned in such a way as to reduce the effects of an explosion to a sufficient level of safety.

3.0.2.   Protective systems must be designed and capable of being positioned in such a way that explosions are prevented from spreading through dangerous chain reactions or flashover and incipient explosions do not become detonations.

3.0.3.   In the event of a power failure, protective systems must retain their capacity to function for a period sufficient to avoid a dangerous situation.

3.0.4.   Protective systems must not fail due to outside interference.

3.1.   Planning and design

3.1.1.   Characteristics of materials

With regard to the characteristics of materials, the maximum pressure and temperature to be taken into consideration at the planning stage are the expected pressure during an explosion occurring under extreme operating conditions and the anticipated heating effect of the flame.

3.1.2.   Protective systems designed to resist or contain explosions must be capable of withstanding the shock wave produced without losing system integrity.

3.1.3.   Accessories connected to protective systems must be capable of withstanding the expected maximum explosion pressure without losing their capacity to function.

3.1.4.   The reactions caused by pressure in peripheral equipment and connected pipe-work must be taken into consideration in the planning and design of protective systems.

3.1.5.   Pressure-relief systems

If it is likely that stresses on protective systems will exceed their structural strength, provision must be made in the design for suitable pressure-relief devices which do not endanger persons in the vicinity.

3.1.6.   Explosion suppression systems

Explosion suppression systems must be so planned and designed that they react to an incipient explosion at the earliest possible stage in the event of an incident and counteract it to best effect, with due regard to the maximum rate of pressure increase and the maximum explosion pressure.

3.1.7.   Explosion decoupling systems

Decoupling systems intended to disconnect specific equipment as swiftly as possible in the event of incipient explosions by means of appropriate devices must be planned and designed so as to remain proof against the transmission of internal ignition and to retain their mechanical strength under operating conditions.

3.1.8.   Protective systems must be capable of being integrated into a circuit with a suitable alarm threshold so that, if necessary, there is cessation of product feed and output and shutdown of equipment parts which can no longer function safely.

ANNEX III

MODULE B:   EU-TYPE EXAMINATION

 

1.

 EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of a product and verifies and attests that the technical design of the product meets the requirements of this Directive that apply to it.
 

2.

 EU-type examination shall be carried out with the examination of a specimen, representative of the production envisaged, of the complete product (production type).
 

3.

 The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.

The application shall include:

(a)

the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

(b)

a written declaration that the same application has not been lodged with any other notified body,

(c)

the technical documentation. The technical documentation shall make it possible to assess the product’s conformity with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements:

(i)

a general description of the product,

(ii)

conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

(iii)

descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

(iv)

a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

(v)

results of design calculations made, examinations carried out, etc., and

(vi)

test reports,

(d)

the specimens representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme.
 

4.

 The notified body shall:

4.1.

examine the technical documentation, verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications;

4.2.

carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards, these have been applied correctly;

4.3.

carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential health and safety requirements of this Directive;

4.4.

agree with the manufacturer on a location where the examinations and tests will be carried out.
 

5.

 The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
 

6.

 Where the type meets the requirements of this Directive that apply to the product concerned, the notified body shall issue an EU-type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The EU-type examination certificate may have one or more annexes attached.

The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control.

Where the type does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
 

7.

 The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the product with the essential health and safety requirements of this Directive or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.
 

8.

 Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate.
 

9.

 The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market.
 

10.

 The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.

ANNEX IV

MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

1.   Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.

2.   Manufacturing

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the products concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.

3.   Quality system

 

3.1.

 The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.

The application shall include:

(a)

the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

(b)

a written declaration that the same application has not been lodged with any other notified body,

(c)

all relevant information for the product category envisaged,

(d)

the documentation concerning the quality system,

(e)

the technical documentation of the approved type and a copy of the EU-type examination certificate.
 

3.2.

 The quality system shall ensure that the products are in conformity with the type described in the EU-type examination certificate and comply with the requirements of this Directive that apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

(a)

the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,

(b)

the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

(c)

the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

(d)

the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc., and

(e)

the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
 

3.3.

 The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.1(e) to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.
 

3.4.

 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.
 

3.5.

 The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4.   Surveillance under the responsibility of the notified body

 

4.1.

 The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
 

4.2.

 The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

(a)

the quality system documentation,

(b)

the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
 

4.3.

 The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.
 

4.4.

 In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

5.   CE marking, EU declaration of conformity and attestation of conformity

 

5.1.

 The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual product other than a component that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
 

5.2.

 The manufacturer shall draw up a written EU declaration of conformity for each product model, other than a component and keep it at the disposal of the national authorities for 10 years after the product other than a component has been placed on the market. The EU declaration of conformity shall identify such product model for which it has been drawn up.

A copy of the EU declaration of conformity shall accompany every product, other than a component.
 

5.3.

 The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

6.   The manufacturer shall, for a period ending 10 years after the product has been placed on the market, keep at the disposal of the national authorities:

(a)

the documentation referred to in point 3.1,

(b)

the information relating to the change referred to in point 3.5, as approved,

(c)

the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.

7.   Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.

8.   Authorised representative

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

ANNEX V

MODULE F:   CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION

1.   Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5 and ensures and declares on his sole responsibility that the products concerned, which have been subject to the provisions of point 3, are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.

2.   Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.

3.   Verification

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the products with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.

The examinations and tests to check the conformity of the products with the appropriate requirements shall be carried out by examination and testing of every product as specified in point 4.

4.   Verification of conformity by examination and testing of every product

 

4.1.

 All products shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify conformity with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.

In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.
 

4.2.

 The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the product has been placed on the market.

5.   CE marking, EU declaration of conformity and attestation of conformity

 

5.1.

 The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3, the latter’s identification number to each individual product other than a component that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
 

5.2.

 The manufacturer shall draw up a written EU declaration of conformity for each product model other than a component and keep it at the disposal of the national authorities, for 10 years after the product, other than a component, has been placed on the market. The EU declaration of conformity shall identify such product model for which it has been drawn up.

A copy of the EU declaration of conformity shall accompany every product other than a component.

If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the products other than components.
 

5.3.

 The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

6.   If the notified body agrees and under its responsibility, the manufacturer may affix the notified body’s identification number to the products during the manufacturing process.

7.   Authorised representative

The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer’s obligations set out in point 2.

ANNEX VI

MODULE C1:   CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING

1.   Conformity to type based on internal production control plus supervised product testing is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.

2.   Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.

3.   Product checks

For each individual product manufactured one or more tests on one or more specific aspects of the product shall be carried out by the manufacturer or on his behalf, in order to verify conformity with the type described in the EU-type examination certificate and with the corresponding requirements of this Directive. The tests shall be carried out under the responsibility of a notified body, chosen by the manufacturer.

The manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.

4.   CE marking, EU declaration of conformity and attestation of conformity

 

4.1.

 The manufacturer shall affix the CE marking to each individual product other than a component that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
 

4.2.

 The manufacturer shall draw up a written EU declaration of conformity for a product model other than a component and keep it at the disposal of the national authorities for 10 years after the product, other than a component has been placed on the market. The EU declaration of conformity shall identify such product model for which it has been drawn up.

A copy of the EU declaration of conformity shall accompany every product, other than a component.
 

4.3.

 The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

5.   Authorised representative

The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

ANNEX VII

MODULE E:   CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE

1.   Conformity to type based on product quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.

2.   Manufacturing

The manufacturer shall operate an approved quality system for final product inspection and testing of the products concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.

3.   Quality system

 

3.1.

 The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.

The application shall include:

(a)

the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

(b)

a written declaration that the same application has not been lodged with any other notified body,

(c)

all relevant information for the product category envisaged,

(d)

the documentation concerning the quality system, and

(e)

the technical documentation of the approved type and a copy of the EU-type examination certificate.
 

3.2.

 The quality system shall ensure compliance of the products with the type described in the EU-type examination certificate and with the applicable requirements of this Directive.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

(a)

the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,

(b)

the examinations and tests that will be carried out after manufacture,

(c)

the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.,

(d)

the means of monitoring the effective operation of the quality system.
 

3.3.

 The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.1(e) in order to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.
 

3.4.

 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.
 

3.5.

 The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4.   Surveillance under the responsibility of the notified body

 

4.1.

 The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
 

4.2.

 The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

(a)

the quality system documentation,

(b)

the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
 

4.3.

 The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.
 

4.4.

 In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

5.   CE marking, EU declaration of conformity and attestation of conformity

 

5.1.

 The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual product other than a component that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
 

5.2.

 The manufacturer shall draw up a written EU declaration of conformity for each product model, other than a component and keep it at the disposal of the national authorities for 10 years after the product other than a component has been placed on the market. The EU declaration of conformity shall identify such product model for which it has been drawn up.

A copy of the EU declaration of conformity shall accompany every product other than a component.
 

5.3.

 The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

6.   The manufacturer shall, for a period ending 10 years after the product has been placed on the market, keep at the disposal of the national authorities:

(a)

the documentation referred to in point 3.1,

(b)

the information relating to the change referred to in point 3.5, as approved,

(c)

the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.

7.   Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.

8.   Authorised representative

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

ANNEX VIII

MODULE A:   INTERNAL PRODUCTION CONTROL

1.   Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned satisfy the requirements of this Directive that apply to them.

2.   Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product’s conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).

The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements:

(a)

a general description of the product,

(b)

conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.

(c)

descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

(d)

a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

(e)

results of design calculations made, examinations carried out, etc., and

(f)

test reports.

3.   Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of this Directive that apply to them.

4.   CE marking, EU declaration of conformity and attestation of conformity

 

4.1.

 The manufacturer shall affix the CE marking to each individual product other than a component that satisfies the applicable requirements of this Directive.
 

4.2.

 The manufacturer shall draw up a written EU declaration of conformity for a product model other than a component and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product, other than a component, has been placed on the market. The EU declaration of conformity shall identify such product model for which it has been drawn up.

A copy of the EU declaration of conformity shall accompany every product other than a component.
 

4.3.

 The manufacturer shall draw up a written attestation of conformity for each component model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

5.   Authorised representative

The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

ANNEX IX

MODULE G:   CONFORMITY BASED ON UNIT VERIFICATION

1.   Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 5, and ensures and declares on his sole responsibility that the product concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of this Directive that apply to it.

2.   Technical documentation

 

2.1.

 The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 4. The documentation shall make it possible to assess the product’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements:

(a)

a general description of the product,

(b)

conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

(c)

descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

(d)

a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

(e)

results of design calculations made, examinations carried out, etc., and

(f)

test reports.
 

2.2.

 The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the product has been placed on the market.

3.   Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with the applicable requirements of this Directive.

4.   Verification

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the product with the applicable requirements of this Directive, or have them carried out. In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out.

The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved product, or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the product has been placed on the market.

5.   CE marking, EU declaration of conformity and attestation of conformity

 

5.1.

 The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 4, the latter’s identification number to each product other than a component that satisfies the applicable requirements of this Directive.
 

5.2.

 The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for 10 years after the product, other than a component has been placed on the market. The EU declaration of conformity shall identify such product for which it has been drawn up.

A copy of the EU declaration of conformity shall accompany every product, other than a component.
 

5.3.

 The manufacturer shall draw up a written attestation of conformity and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

6.   Authorised representative

The manufacturer’s obligations set out in points 2.2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

ANNEX X

EU DECLARATION OF CONFORMITY (No XXXX) (1)

 

1.

 Product model/product (product, type, batch or serial number):
 

2.

 Name and address of the manufacturer and, where applicable, his authorised representative:
 

3.

 This declaration of conformity is issued under the sole responsibility of the manufacturer.
 

4.

 Object of the declaration (identification of product allowing traceability; it may, where necessary for the identification of the product, include an image):
 

5.

 The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:
 

6.

 References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared:
 

7.

 Where applicable, the notified body … (name, number) performed … (description of intervention) and issued the certificate:
 

8.

 Additional information:

Signed for and on behalf of:

(place and date of issue):

(name, function) (signature):

(1)  It is optional for the manufacturer to assign a number to the declaration of conformity.

ANNEX XI

PART A

Repealed Directive with list of the successive amendments thereto

(referred to in Article 43)

Directive 94/9/EC of the European Parliament and of the Council

(OJ L 100, 19.4.1994, p. 1).

 

Regulation (EC) No 1882/2003 of the European Parliament and of the Council

(OJ L 284, 31.10.2003, p. 1).

Only point 8 of Annex I

Regulation (EU) No 1025/2012 of the European Parliament and of the Council

(OJ L 316, 14.11.2012, p. 12).

Only point (c) of Article 26(1)

PART B

Time limits for transposition into national law and dates of application

(referred to in Article 43)

Directive

Time limit for transposition

Date of application

94/9/EC

1 September 1995

1 March 1996

ANNEX XII

CORRELATION TABLE

Directive 94/9/EC

This Directive

Article 1(1)

Article 1(1)(a)

Article 1(2)

Article 1(1)(b)

—

Article 1(1)(c)

Article 1(3)

Article 2(1) to (9)

—

Article 2(10) to (26)

Article 1(4)

Article 1(2)

Article 2

Article 3

Article 3

Article 4

Article 4

Article 5

Article 5(1), first subparagraph

—

Article 5(1), second subparagraph

Article 12(2)

Article 5(2)

Article 12(1)

Article 5(3)

—

—

Articles 6 to 11

—

—

Article 6(1) and (2)

—

Article 6(3)

Article 39(1) to (4)

—

Article 39(5), first subparagraph

Article 6(4)

Article 39(5), second subparagraph

Article 7

—

Article 8(1) to (6)

Article 13(1) to (6)

Article 8(7)

—

—

Articles 14 and 15

Article 9

—

Article 10(1)

—

Article 10(2)

Article 16(1)

Article 10(3)

—

—

Article 16(2) to (6)

—

Articles 17 to 33

Article 11

—

—

Articles 34 to 38

Articles 12 and 13

—

—

Article 40

—

Article 41(1)

Article 14(1)

—

Article 14(2)

Article 41(2)

Article 14(3)

—

Article 15(1)

Article 42(1)

Article 15(2)

—

—

Article 42(2)

—

Articles 43 and 44

Article 16

Article 45

Annexes I to IX

Annexes I to IX

Annex X

—

Annex XI

—

—

Annex X

—

Annex XI

—

Annex XII

STATEMENT OF THE EUROPEAN PARLIAMENT

The European Parliament considers that only when and insofar as implementing acts in the sense of Regulation (EU) No 182/2011 are discussed in meetings of committees, can the latter be considered as ‘comitology committees’ within the meaning of Annex I to the Framework Agreement on the relations between the European Parliament and the European Commission. Meetings of committees thus fall within the scope of point 15 of the Framework Agreement when and insofar as other issues are discussed.

Machinery Directive

DIRECTIVE 2006/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 17 May 2006

on machinery, and amending Directive 95/16/EC (recast)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Economic and Social Committee (2),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),

Whereas:

(1)

Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery (4) codified Directive 89/392/EEC (5). Now that new substantial amendments are being made to Directive 98/37/EC, it is desirable, in order to clarify matters, that that Directive should be recast.

(2)

The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the Community economy. The social cost of the large number of accidents caused directly by the use of machinery can be reduced by inherently safe design and construction of machinery and by proper installation and maintenance.

(3)

Member States are responsible for ensuring the health and safety on their territory of persons, in particular of workers and consumers and, where appropriate, of domestic animals and goods, notably in relation to the risks arising out of the use of machinery.

(4)

In order to ensure legal certainty for users, the scope of this Directive and the concepts relating to its application should be defined as precisely as possible.

(5)

The Member States' mandatory provisions governing construction site hoists intended for lifting persons or persons and goods, which are often supplemented by de facto compulsory technical specifications and/or by voluntary standards, do not necessarily lead to different levels of health and safety but, because of their disparities, do nevertheless constitute barriers to trade within the Community. Moreover, the national systems for the conformity assessment and certification of these machines diverge considerably. It is therefore desirable not to exclude from the scope of this Directive construction site hoists intended for lifting persons or persons and goods.

(6)

It is appropriate to exclude from the scope of this Directive weapons, including firearms, that are subject to Council Directive 91/477/EEC of 18 June 1991 on control of the acquisition and possession of weapons (6); the exclusion of firearms should not apply to portable cartridge-operated fixing and other impact machinery designed for industrial or technical purposes only. It is necessary to provide for transitional arrangements enabling Member States to authorise the placing on the market and putting into service of such machinery manufactured in accordance with national provisions in force upon adoption of this Directive, including those implementing the Convention of 1 July 1969 on the Reciprocal Recognition of Proofmarks on Small Arms. Such transitional arrangements will also enable the European standardisation organisations to draft standards ensuring the safety level based on the state of the art.

(7)

This Directive does not apply to the lifting of persons by means of machines not designed for the lifting of persons. However, this does not affect the right of Member States to take national measures, in accordance with the Treaty, with respect to such machines, with a view to implementing Council Directive 89/655/EEC of 30 November 1989 concerning the minimum safety and health requirements for the use of work equipment by workers at work (second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (7).

(8)

In relation to agricultural and forestry tractors, the provisions of this Directive concerning the risks currently not covered by Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units (8) should no longer apply when such risks are covered by Directive 2003/37/EC.

(9)

Market surveillance is an essential instrument inasmuch as it ensures the proper and uniform application of Directives. It is therefore appropriate to put in place the legal framework within which market surveillance can proceed harmoniously.

(10)

Member States are responsible for ensuring that this Directive is effectively enforced on their territory and that the safety of the machinery concerned is, as far as possible, improved in accordance with its provisions. Member States should ensure their capacity to carry out effective market surveillance, taking account of guidelines developed by the Commission, in order to achieve the proper and uniform application of this Directive.

(11)

In the context of market surveillance, a clear distinction should be established between the disputing of a harmonised standard conferring a presumption of conformity on machinery and the safeguard clause relating to machinery.

(12)

The putting into service of machinery within the meaning of this Directive can relate only to the use of the machinery itself for its intended purpose or for a purpose which can reasonably be foreseen. This does not preclude the laying down of conditions of use external to the machinery, provided that it is not thereby modified in a way not specified in this Directive.

(13)

It is also necessary to provide for an adequate mechanism allowing for the adoption of specific measures at Community level requiring Member States to prohibit or restrict the placing on the market of certain types of machinery presenting the same risks to the health and safety of persons either due to shortcomings in the relevant harmonised standard(s) or by virtue of their technical characteristics, or to make such machinery subject to special conditions. In order to ensure the appropriate assessment of the need for such measures, they should be taken by the Commission, assisted by a committee, in the light of consultations with the Member States and other interested parties. Since such measures are not directly applicable to economic operators, Member States should take all necessary measures for their implementation.

(14)

The essential health and safety requirements should be satisfied in order to ensure that machinery is safe; these requirements should be applied with discernment to take account of the state of the art at the time of construction and of technical and economic requirements.

(15)

Where the machinery may be used by a consumer, that is to say, a non-professional operator, the manufacturer should take account of this in the design and construction. The same applies where a machine is normally used to provide a service to a consumer.

(16)

Although the requirements of this Directive do not apply to partly completed machinery in their entirety, it is nevertheless important that the free movement of such machinery be guaranteed by means of a specific procedure.

(17)

For trade fairs, exhibitions and such like, it should be possible to exhibit machinery which does not satisfy the requirements of this Directive. However, interested parties should be properly informed that the machinery does not conform and cannot be purchased in that condition.

(18)

This Directive defines only the essential health and safety requirements of general application, supplemented by a number of more specific requirements for certain categories of machinery. In order to help manufacturers to prove conformity to these essential requirements, and to allow inspection of conformity to the essential requirements, it is desirable to have standards that are harmonised at Community level for the prevention of risks arising out of the design and construction of machinery. These standards are drawn up by private-law bodies and should retain their non-binding status.

(19)

In view of the nature of the risks involved in the use of machinery covered by this Directive, procedures for assessing conformity to the essential health and safety requirements should be established. These procedures should be devised in the light of the extent of the danger inherent in such machinery. Consequently, each category of machinery should have its appropriate procedure in conformity with Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives (9), taking account of the nature of the verification required for such machinery.

(20)

Manufacturers should retain full responsibility for certifying the conformity of their machinery to the provisions of this Directive. Nevertheless, for certain types of machinery having a higher risk factor, a stricter certification procedure is desirable.

(21)

The CE marking should be fully recognised as being the only marking which guarantees that machinery conforms to the requirements of this Directive. All other markings which are likely to mislead third parties as to the meaning or the form of the CE marking, or both, should be prohibited.

(22)

In order to ensure the same quality for the CE marking and the manufacturer's mark, it is important that they be affixed according to the same techniques. In order to avoid confusion between any CE markings which might appear on certain components and the CE marking corresponding to the machinery, it is important that the latter marking be affixed alongside the name of the person who has taken responsibility for it, namely the manufacturer or his authorised representative.

(23)

The manufacturer or his authorised representative should also ensure that a risk assessment is carried out for the machinery which he wishes to place on the market. For this purpose, he should determine which are the essential health and safety requirements applicable to his machinery and in respect of which he must take measures.

(24)

It is essential that, before drawing up the EC declaration of conformity, the manufacturer or his authorised representative established in the Community should prepare a technical construction file. However, it is not essential that all documentation should be permanently available in material form, but it must be possible to make it available on request. It need not include detailed plans of subassemblies used for the manufacture of machinery, unless knowledge of such plans is essential in order to ascertain conformity with the essential health and safety requirements.

(25)

The addressees of any decision taken under this Directive should be informed of the reasons for such a decision and of the legal remedies open to them.

(26)

Member States should provide for penalties applicable to infringements of the provisions of this Directive. Those penalties should be effective, proportionate and dissuasive.

(27)

The application of this Directive to a number of machines intended for lifting persons requires a better delimitation of the products covered by this Directive with respect to those covered by Directive 95/16/EC of the European Parliament and of the Council of 29 June 1995 on the approximation of the laws of the Member States relating to lifts (10). A redefinition of the scope of the latter Directive is thus deemed necessary. Directive 95/16/EC should therefore be amended accordingly.

(28)

Since the objective of this Directive, namely, to lay down the essential health and safety requirements in relation to design and manufacture in order to improve the safety of machinery placed on the market, cannot be sufficiently achieved by the Member States and can be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

(29)

In accordance with point 34 of the Interinstitutional Agreement on better law-making (11), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

(30)

The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (12),

HAS ADOPTED THIS DIRECTIVE:

Article 1

Scope

1.   This Directive applies to the following products:

(a)

machinery;

(b)

interchangeable equipment;

(c)

safety components;

(d)

lifting accessories;

(e)

chains, ropes and webbing;

(f)

removable mechanical transmission devices;

(g)

partly completed machinery.

2.   The following are excluded from the scope of this Directive:

(a)

safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery;

(b)

specific equipment for use in fairgrounds and/or amusement parks;

(c)

machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity;

(d)

weapons, including firearms;

(e)

the following means of transport:

—

agricultural and forestry tractors for the risks covered by Directive 2003/37/EC, with the exclusion of machinery mounted on these vehicles,

—

motor vehicles and their trailers covered by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (13), with the exclusion of machinery mounted on these vehicles,

—

vehicles covered by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles (14), with the exclusion of machinery mounted on these vehicles,

—

motor vehicles exclusively intended for competition, and

—

means of transport by air, on water and on rail networks with the exclusion of machinery mounted on these means of transport;

(f)

seagoing vessels and mobile offshore units and machinery installed on board such vessels and/or units;

(g)

machinery specially designed and constructed for military or police purposes;

(h)

machinery specially designed and constructed for research purposes for temporary use in laboratories;

(i)

mine winding gear;

(j)

machinery intended to move performers during artistic performances;

(k)

electrical and electronic products falling within the following areas, insofar as they are covered by Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (15):

—

household appliances intended for domestic use,

—

audio and video equipment,

—

information technology equipment,

—

ordinary office machinery,

—

low-voltage switchgear and control gear,

—

electric motors;

(l)

the following types of high-voltage electrical equipment:

—

switch gear and control gear,

—

transformers.

Article 2

Definitions

For the purposes of this Directive, ‘machinery’ designates the products listed in Article 1(1)(a) to (f).

The following definitions shall apply:

(a)

‘machinery’ means:

—

an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application,

—

an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion,

—

an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure,

—

assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,

—

an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort;

(b)

‘interchangeable equipment’ means a device which, after the putting into service of machinery or of a tractor, is assembled with that machinery or tractor by the operator himself in order to change its function or attribute a new function, in so far as this equipment is not a tool;

(c)

‘safety component’ means a component:

—

which serves to fulfil a safety function,

—

which is independently placed on the market,

—

the failure and/or malfunction of which endangers the safety of persons, and

—

which is not necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function.

An indicative list of safety components is set out in Annex V, which may be updated in accordance with Article 8(1)(a);

(d)

‘lifting accessory’ means a component or equipment not attached to the lifting machinery, allowing the load to be held, which is placed between the machinery and the load or on the load itself, or which is intended to constitute an integral part of the load and which is independently placed on the market; slings and their components are also regarded as lifting accessories;

(e)

‘chains, ropes and webbing’ means chains, ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;

(f)

‘removable mechanical transmission device’ means a removable component for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing. When it is placed on the market with the guard it shall be regarded as one product;

(g)

‘partly completed machinery’ means an assembly which is almost machinery but which cannot in itself perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies;

(h)

‘placing on the market’ means making available for the first time in the Community machinery or partly completed machinery with a view to distribution or use, whether for reward or free of charge;

(i)

‘manufacturer’ means any natural or legal person who designs and/or manufactures machinery or partly completed machinery covered by this Directive and is responsible for the conformity of the machinery or the partly completed machinery with this Directive with a view to its being placed on the market, under his own name or trademark or for his own use. In the absence of a manufacturer as defined above, any natural or legal person who places on the market or puts into service machinery or partly completed machinery covered by this Directive shall be considered a manufacturer;

(j)

‘authorised representative’ means any natural or legal person established in the Community who has received a written mandate from the manufacturer to perform on his behalf all or part of the obligations and formalities connected with this Directive;

(k)

‘putting into service’ means the first use, for its intended purpose, in the Community, of machinery covered by this Directive;

(l)

‘harmonised standard’ means a non-binding technical specification adopted by a standardisation body, namely the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) or the European Telecommunications Standards Institute (ETSI), on the basis of a remit issued by the Commission in accordance with the procedures laid down in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (16).

Article 3

Specific Directives

Where, for machinery, the hazards referred to in Annex I are wholly or partly covered more specifically by other Community Directives, this Directive shall not apply, or shall cease to apply, to that machinery in respect of such hazards from the date of implementation of those other Directives.

Article 4

Market surveillance

1.   Member States shall take all appropriate measures to ensure that machinery may be placed on the market and/or put into service only if it satisfies the relevant provisions of this Directive and does not endanger the health and safety of persons and, where appropriate, domestic animals or property, when properly installed and maintained and used for its intended purpose or under conditions which can reasonably be foreseen.

2.   Member States shall take all appropriate measures to ensure that partly completed machinery can be placed on the market only if it satisfies the relevant provisions of this Directive.

3.   Member States shall institute or appoint the competent authorities to monitor the conformity of machinery and partly completed machinery with the provisions set out in paragraphs 1 and 2.

4.   Member States shall define the tasks, organisation and powers of the competent authorities referred to in paragraph 3 and shall notify the Commission and other Member States thereof and also of any subsequent amendment.

Article 5

Placing on the market and putting into service

1.   Before placing machinery on the market and/or putting it into service, the manufacturer or his authorised representative shall:

(a)

ensure that it satisfies the relevant essential health and safety requirements set out in Annex I;

(b)

ensure that the technical file referred to in Annex VII, part A is available;

(c)

provide, in particular, the necessary information, such as instructions;

(d)

carry out the appropriate procedures for assessing conformity in accordance with Article 12;

(e)

draw up the EC declaration of conformity in accordance with Annex II, part 1, Section A and ensure that it accompanies the machinery;

(f)

affix the CE marking in accordance with Article 16.

2.   Before placing partly completed machinery on the market, the manufacturer or his authorised representative shall ensure that the procedure referred to in Article 13 has been completed.

3.   For the purposes of the procedures referred to in Article 12, the manufacturer or his authorised representative shall have, or shall have access to, the necessary means of ensuring that the machinery satisfies the essential health and safety requirements set out in Annex I.

4.   Where machinery is also the subject of other Directives relating to other aspects and providing for the affixing of the CE marking, the marking shall indicate that the machinery also conforms to the provisions of those other Directives.

However, where one or more of those Directives allow the manufacturer or his authorised representative to choose, during a transitional period, the system to be applied, the CE marking shall indicate conformity only to the provisions of those Directives applied by the manufacturer or his authorised representative. Particulars of the Directives applied, as published in the Official Journal of the European Union, shall be given on the EC declaration of conformity.

Article 6

Freedom of movement

1.   Member States shall not prohibit, restrict or impede the placing on the market and/or putting into service in their territory of machinery which complies with this Directive.

2.   Member States shall not prohibit, restrict or impede the placing on the market of partly completed machinery where the manufacturer or his authorised representative makes a declaration of incorporation, referred to in Annex II, part 1, Section B, stating that it is to be incorporated into machinery or assembled with other partly completed machinery to form machinery.

3.   At trade fairs, exhibitions, demonstrations, and such like, Member States shall not prevent the showing of machinery or partly completed machinery which does not conform to this Directive, provided that a visible sign clearly indicates that it does not conform and that it will not be made available until it has been brought into conformity. Furthermore, during demonstrations of such non-conforming machinery or partly completed machinery, adequate safety measures shall be taken to ensure the protection of persons.

Article 7

Presumption of conformity and harmonised standards

1.   Member States shall regard machinery bearing the CE marking and accompanied by the EC declaration of conformity, the content of which is set out in Annex II, part 1, Section A, as complying with the provisions of this Directive.

2.   Machinery manufactured in conformity with a harmonised standard, the references to which have been published in the Official Journal of the European Union, shall be presumed to comply with the essential health and safety requirements covered by such a harmonised standard.

3.   The Commission shall publish in the Official Journal of the European Union the references of the harmonised standards.

4.   Member States shall take the appropriate measures to enable the social partners to have an influence at national level on the process of preparing and monitoring the harmonised standards.

Article 8

Specific measures

1.   The Commission, acting in accordance with the procedure referred to in Article 22(3), may take any appropriate measure to implement the provisions relating to the following points:

(a)

updating of the indicative list of safety components in Annex V referred to in point (c) in Article 2;

(b)

restriction of the placing on the market of machinery referred to in Article 9.

2.   The Commission, acting in accordance with the procedure referred to in Article 22(2), may take any appropriate measure connected with the implementation and practical application of this Directive, including measures necessary to ensure cooperation of Member States with each other and with the Commission, as provided for in Article 19(1).

Article 9

Specific measures to deal with potentially hazardous machinery

1.   When, in accordance with the procedure referred to in Article 10, the Commission considers that a harmonised standard does not entirely satisfy the essential health and safety requirements which it covers and which are set out in Annex I, the Commission may, in accordance with paragraph 3 of this Article, take measures requiring Member States to prohibit or restrict the placing on the market of machinery with technical characteristics presenting risks due to the shortcomings in the standard or to make such machinery subject to special conditions.

When, in accordance with the procedure referred to in Article 11, the Commission considers that a measure taken by a Member State is justified, the Commission may, in accordance with paragraph 3 of this Article, take measures requiring Member States to prohibit or restrict the placing on the market of machinery presenting the same risk by virtue of its technical characteristics or to make such machinery subject to special conditions.

2.   Any Member State may request the Commission to examine the need for the adoption of the measures referred to in paragraph 1.

3.   In the cases referred to in paragraph 1, the Commission shall consult the Member States and other interested parties indicating the measures it intends to take, in order to ensure, at Community level, a high level of protection of the health and safety of persons.

Taking due account of the results of this consultation, it shall adopt the necessary measures in accordance with the procedure referred to in Article 22(3).

Article 10

Procedure for disputing a harmonised standard

Where a Member State or the Commission considers that a harmonised standard does not entirely satisfy the essential health and safety requirements which it covers and which are set out in Annex I, the Commission or the Member State shall bring the matter before the committee set up by Directive 98/34/EC, setting out the reasons therefor. The committee shall deliver an opinion without delay. In the light of the committee's opinion, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in the Official Journal of the European Union.

Article 11

Safeguard clause

1.   Where a Member State ascertains that machinery covered by this Directive, bearing the CE marking, accompanied by the EC declaration of conformity and used in accordance with its intended purpose or under conditions which can reasonably be foreseen, is liable to compromise the health and safety of persons and, where appropriate, domestic animals or property, it shall take all appropriate measures to withdraw such machinery from the market, to prohibit the placing on the market and/or putting into service of such machinery or to restrict free movement thereof.

2.   The Member State shall immediately inform the Commission and the other Member States of any such measure, indicating the reasons for its decision and, in particular, whether the non-conformity is due to:

(a)

failure to satisfy the essential requirements referred to in Article 5(1)(a);

(b)

incorrect application of the harmonised standards referred to in Article 7(2);

(c)

shortcomings in the harmonised standards themselves referred to in Article 7(2).

3.   The Commission shall enter into consultation with the parties concerned without delay.

The Commission shall consider, after this consultation, whether or not the measures taken by the Member State are justified, and it shall communicate its decision to the Member State which took the initiative, the other Member States, and the manufacturer or his authorised representative.

4.   Where the measures referred to in paragraph 1 are based on a shortcoming in the harmonised standards and if the Member State which instigated the measures maintains its position, the Commission or the Member State shall initiate the procedure referred to in Article 10.

5.   Where machinery does not conform and bears the CE marking, the competent Member State shall take appropriate action against whomsoever has affixed the marking and shall so inform the Commission. The Commission shall inform the other Member States.

6.   The Commission shall ensure that Member States are kept informed of the progress and outcome of the procedure.

Article 12

Procedures for assessing the conformity of machinery

1.   The manufacturer or his authorised representative shall, in order to certify the conformity of machinery with the provisions of this Directive, apply one of the procedures for assessment of conformity described in paragraphs 2, 3 and 4.

2.   Where the machinery is not referred to in Annex IV, the manufacturer or his authorised representative shall apply the procedure for assessment of conformity with internal checks on the manufacture of machinery provided for in Annex VIII.

3.   Where the machinery is referred to in Annex IV and manufactured in accordance with the harmonised standards referred to in Article 7(2), and provided that those standards cover all of the relevant essential health and safety requirements, the manufacturer or his authorised representative shall apply one of the following procedures:

(a)

the procedure for assessment of conformity with internal checks on the manufacture of machinery, provided for in Annex VIII;

(b)

the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3;

(c)

the full quality assurance procedure provided for in Annex X.

4.   Where the machinery is referred to in Annex IV and has not been manufactured in accordance with the harmonised standards referred to in Article 7(2), or only partly in accordance with such standards, or if the harmonised standards do not cover all the relevant essential health and safety requirements or if no harmonised standards exist for the machinery in question, the manufacturer or his authorised representative shall apply one of the following procedures:

(a)

the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3;

(b)

the full quality assurance procedure provided for in Annex X.

Article 13

Procedure for partly completed machinery

1.   The manufacturer of partly completed machinery or his authorised representative shall, before placing it on the market, ensure that:

(a)

the relevant technical documentation described in Annex VII, part B is prepared;

(b)

assembly instructions described in Annex VI are prepared;

(c)

a declaration of incorporation described in Annex II, part 1, Section B has been drawn up.

2.   The assembly instructions and the declaration of incorporation shall accompany the partly completed machinery until it is incorporated into the final machinery and shall then form part of the technical file for that machinery.

Article 14

Notified bodies

1.   Member States shall notify the Commission and the other Member States of the bodies which they have appointed to carry out the assessment of conformity for placing on the market referred to in Article 12(3) and (4), together with the specific conformity assessment procedures and categories of machinery for which these bodies have been appointed and the identification numbers assigned to them beforehand by the Commission. Member States shall notify the Commission and other Member States of any subsequent amendment.

2.   The Member States shall ensure that the notified bodies are monitored regularly to check that they comply at all times with the criteria set out in Annex XI. The notified body shall provide all relevant information on request, including budgetary documents, to enable the Member States to ensure that the requirements of Annex XI are met.

3.   Member States shall apply the criteria set out in Annex XI in assessing the bodies to be notified and the bodies already notified.

4.   The Commission shall publish in the Official Journal of the European Union, for information, a list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.

5.   Bodies meeting the assessment criteria laid down in the relevant harmonised standards, the references of which shall be published in the Official Journal of the European Union, shall be presumed to fulfil the relevant criteria.

6.   If a notified body finds that relevant requirements of this Directive have not been met or are no longer met by the manufacturer or that an EC type-examination certificate or the approval of a quality assurance system should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate or the approval issued or place restrictions on it, giving detailed reasons, unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer. In the event of suspension or withdrawal of the certificate or the approval or of any restriction placed on it, or in cases where intervention by the competent authority may prove necessary, the notified body shall inform the competent authority pursuant to Article 4. The Member State shall inform the other Member States and the Commission without delay. An appeal procedure shall be available.

7.   The Commission shall provide for the organisation of an exchange of experience between the authorities responsible for appointment, notification and monitoring of notified bodies in the Member States, and the notified bodies, in order to coordinate the uniform application of this Directive.

8.   A Member State which has notified a body shall immediately withdraw its notification if it finds:

(a)

that the body no longer meets the criteria set out in Annex XI; or

(b)

that the body seriously fails to fulfil its responsibilities.

The Member State shall immediately inform the Commission and the other Member States accordingly.

Article 15

Installation and use of machinery

This Directive shall not affect Member States' entitlement to lay down, in due observance of Community law, such requirements as they may deem necessary to ensure that persons, and in particular workers, are protected when using machinery, provided that this does not mean that such machinery is modified in a way not specified in this Directive.

Article 16

CE marking

1.   The CE conformity marking shall consist of the initials ‘CE’ as shown in Annex III.

2.   The CE marking shall be affixed to the machinery visibly, legibly and indelibly in accordance with Annex III.

3.   The affixing on machinery of markings, signs and inscriptions which are likely to mislead third parties as to the meaning or form of the CE marking, or both, shall be prohibited. Any other marking may be affixed to the machinery provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.

Article 17

Non-conformity of marking

1.   Member States shall consider the following marking not to conform:

(a)

the affixing of the CE marking pursuant to this Directive on products not covered by this Directive;

(b)

the absence of the CE marking and/or the absence of the EC declaration of conformity for machinery;

(c)

the affixing on machinery of a marking, other than the CE marking, which is prohibited under Article 16(3).

2.   Where a Member State ascertains that marking does not conform to the relevant provisions of this Directive, the manufacturer or his authorised representative shall be obliged to make the product conform and to put an end to the infringement under conditions fixed by that Member State.

3.   Where non-conformity persists, the Member State shall take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market in accordance with the procedure laid down in Article 11.

Article 18

Confidentiality

1.   Without prejudice to existing national provisions and practices in the area of confidentiality, Members States shall ensure that all parties and persons concerned by the application of this Directive are required to treat as confidential information obtained in the execution of their tasks. More particularly business, professional and trade secrets shall be treated as confidential, unless the divulging of such information is necessary in order to protect the health and safety of persons.

2.   The provisions of paragraph 1 shall not affect the obligations of the Member States and the notified bodies with regard to mutual exchange of information and the issuing of warnings.

3.   Any decisions taken by the Member States and by the Commission in accordance with Articles 9 and 11 shall be published.

Article 19

Cooperation between Member States

1.   Member States shall take the appropriate measures to ensure that the competent authorities referred to in Article 4(3) cooperate with each other and with the Commission and transmit to each other the information necessary to enable this Directive to be applied uniformly.

2.   The Commission shall provide for the organisation of an exchange of experience between the competent authorities responsible for market surveillance in order to coordinate the uniform application of this Directive.

Article 20

Legal remedies

Any measure taken pursuant to this Directive which restricts the placing on the market and/or putting into service of any machinery covered by this Directive shall state the exact grounds on which it is based. Such a measure shall be notified as soon as possible to the party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in the Member State concerned and of the time limits to which such remedies are subject.

Article 21

Dissemination of information

The Commission shall take the necessary measures for appropriate information concerning the implementation of this Directive to be made available.

Article 22

Committee

1.   The Commission shall be assisted by a committee, hereinafter referred to as the ‘Committee’.

2.   Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

3.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

4.   The Committee shall adopt its rules of procedure.

Article 23

Penalties

Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 29 June 2008 and shall notify it without delay of any subsequent amendment affecting them.

Article 24

Amendment of Directive 95/16/EC

Directive 95/16/EC is hereby amended as follows:

1.

in Article 1, paragraphs 2 and 3 shall be replaced by the following:

2.    ‘For the purposes of this Directive, “lift” shall mean a lifting appliance serving specific levels, having a carrier moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal, intended for the transport of:

—

persons,

—

persons and goods,

—

goods alone if the carrier is accessible, that is to say a person may enter it without difficulty, and fitted with controls situated inside the carrier or within reach of a person inside the carrier.

Lifting appliances moving along a fixed course even where they do not move along guides which are rigid shall be considered as lifts falling within the scope of this Directive.

A “carrier” means a part of the lift by which persons and/or goods are supported in order to be lifted or lowered.

3.   This Directive shall not apply to:

—

lifting appliances whose speed is not greater than 0,15 m/s,

—

construction site hoists,

—

cableways, including funicular railways,

—

lifts specially designed and constructed for military or police purposes,

—

lifting appliances from which work can be carried out,

—

mine winding gear,

—

lifting appliances intended for lifting performers during artistic performances,

—

lifting appliances fitted in means of transport,

—

lifting appliances connected to machinery and intended exclusively for access to workstations including maintenance and inspection points on the machinery,

—

rack and pinion trains,

—

escalators and mechanical walkways.’;

2.

in Annex I, point 1.2 shall be replaced by the following:

1.2.   ‘Carrier

The carrier of each lift must be a car. This car must be designed and constructed to offer the space and strength corresponding to the maximum number of persons and the rated load of the lift set by the installer.

Where the lift is intended for the transport of persons, and where its dimensions permit, the car must be designed and constructed in such a way that its structural features do not obstruct or impede access and use by disabled persons and so as to allow any appropriate adjustments intended to facilitate its use by them.’

Article 25

Repeal

Directive 98/37/EC is hereby repealed.

References made to the repealed Directive shall be construed as being made to this Directive and should be read in accordance with the correlation table in Annex XII.

Article 26

Transposition

1.   Member States shall adopt and publish the provisions necessary to comply with this Directive by 29 June 2008 at the latest. They shall forthwith inform the Commission thereof.

They shall apply those provisions with effect from 29 December 2009.

When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive, together with a table showing how the provisions of this Directive correspond to the national provisions adopted.

Article 27

Derogation

Until 29 June 2011 Member States may allow the placing on the market and the putting into service of portable cartridge-operated fixing and other impact machinery which are in conformity with the national provisions in force upon adoption of this Directive.

Article 28

Entry into force

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 29

Addressees

This Directive is addressed to the Member States.

Done at Strasbourg, 17 May 2006.

For the European Parliament

The President

J. BORRELL FONTELLES

For the Council

The President

H. WINKLER

(1)   OJ C 154 E, 29.5.2001, p. 164.

(2)   OJ C 311, 7.11.2001, p. 1.

(3)  Opinion of the European Parliament of 4 July 2002 (OJ C 271 E, 12.11.2003, p. 491), Council Common Position of 18 July 2005 (OJ C 251 E, 11.10.2005, p. 1) and Position of the European Parliament of 15 December 2005 (not yet published in the Official Journal). Council Decision of 25 April 2006.

(4)   OJ L 207, 23.7.1998, p. 1. Directive as amended by Directive 98/79/EC (OJ L 331, 7.12.1998, p. 1).

(5)  Council Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery (OJ L 183, 29.6.1989, p. 9).

(6)   OJ L 256, 13.9.1991, p. 51.

(7)   OJ L 393, 30.12.1989, p. 13. Directive as last amended by Directive 2001/45/EC of the European Parliament and of the Council (OJ L 195, 19.7.2001, p. 46).

(8)   OJ L 171, 9.7.2003, p. 1. Directive as last amended by Commission Directive 2005/67/EC (OJ L 273, 19.10.2005, p. 17).

(9)   OJ L 220, 30.8.1993, p. 23.

(10)   OJ L 213, 7.9.1995, p. 1. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

(11)   OJ C 321, 31.12.2003, p. 1.

(12)   OJ L 184, 17.7.1999, p. 23.

(13)   OJ L 42, 23.2.1970, p. 1. Directive as last amended by Commission Directive 2006/28/EC (OJ L 65, 7.3.2006, p. 27).

(14)   OJ L 124, 9.5.2002, p. 1. Directive as last amended by Commission Directive 2005/30/EC (OJ L 106, 27.4.2005, p. 17).

(15)   OJ L 77, 26.3.1973, p. 29. Directive as amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1).

(16)   OJ L 204, 21.7.1998, p. 37. Directive as last amended by the 2003 Act of Accession.

ANNEX I

Essential health and safety requirements relating to the the design and construction of machinery

GENERAL PRINCIPLES

 

1.

 The manufacturer of machinery or his authorised representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment.

By the iterative process of risk assessment and risk reduction referred to above, the manufacturer or his authorised representative shall:

—

determine the limits of the machinery, which include the intended use and any reasonably foreseeable misuse thereof,

—

identify the hazards that can be generated by the machinery and the associated hazardous situations,

—

estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence,

—

evaluate the risks, with a view to determining whether risk reduction is required, in accordance with the objective of this Directive,

—

eliminate the hazards or reduce the risks associated with these hazards by application of protective measures, in the order of priority established in section 1.1.2(b).
 

2.

 The obligations laid down by the essential health and safety requirements only apply when the corresponding hazard exists for the machinery in question when it is used under the conditions foreseen by the manufacturer or his authorised representative or in foreseeable abnormal situations. In any event, the principles of safety integration referred to in section 1.1.2 and the obligations concerning marking of machinery and instructions referred to in sections 1.7.3 and 1.7.4 apply.
 

3.

 The essential health and safety requirements laid down in this Annex are mandatory; However, taking into account the state of the art, it may not be possible to meet the objectives set by them. In that event, the machinery must, as far as possible, be designed and constructed with the purpose of approaching these objectives.
 

4.

 This Annex is organised in several parts. The first one has a general scope and is applicable to all kinds of machinery. The other parts refer to certain kinds of more specific hazards. Nevertheless, it is essential to examine the whole of this Annex in order to be sure of meeting all the relevant essential requirements. When machinery is being designed, the requirements of the general part and the requirements of one or more of the other parts shall be taken into account, depending on the results of the risk assessment carried out in accordance with point 1 of these General Principles.

1.   ESSENTIAL HEALTH AND SAFETY REQUIREMENTS

1.1.   GENERAL REMARKS

1.1.1.   Definitions

For the purpose of this Annex:

(a)

‘hazard’ means a potential source of injury or damage to health;

(b)

‘danger zone’ means any zone within and/or around machinery in which a person is subject to a risk to his health or safety;

(c)

‘exposed person’ means any person wholly or partially in a danger zone;

(d)

‘operator’ means the person or persons installing, operating, adjusting, maintaining, cleaning, repairing or moving machinery;

(e)

‘risk’ means a combination of the probability and the degree of an injury or damage to health that can arise in a hazardous situation;

(f)

‘guard’ means a part of the machinery used specifically to provide protection by means of a physical barrier;

(g)

‘protective device’ means a device (other than a guard) which reduces the risk, either alone or in conjunction with a guard;

(h)

‘intended use’ means the use of machinery in accordance with the information provided in the instructions for use;

(i)

‘reasonably foreseeable misuse’ means the use of machinery in a way not intended in the instructions for use, but which may result from readily predictable human behaviour.

1.1.2.   Principles of safety integration

(a)

Machinery must be designed and constructed so that it is fitted for its function, and can be operated, adjusted and maintained without putting persons at risk when these operations are carried out under the conditions foreseen but also taking into account any reasonably foreseeable misuse thereof.

The aim of measures taken must be to eliminate any risk throughout the foreseeable lifetime of the machinery including the phases of transport, assembly, dismantling, disabling and scrapping.

(b)

In selecting the most appropriate methods, the manufacturer or his authorised representative must apply the following principles, in the order given:

—

eliminate or reduce risks as far as possible (inherently safe machinery design and construction),

—

take the necessary protective measures in relation to risks that cannot be eliminated,

—

inform users of the residual risks due to any shortcomings of the protective measures adopted, indicate whether any particular training is required and specify any need to provide personal protective equipment.

(c)

When designing and constructing machinery and when drafting the instructions, the manufacturer or his authorised representative must envisage not only the intended use of the machinery but also any reasonably foreseeable misuse thereof.

The machinery must be designed and constructed in such a way as to prevent abnormal use if such use would engender a risk. Where appropriate, the instructions must draw the user's attention to ways — which experience has shown might occur — in which the machinery should not be used.

(d)

Machinery must be designed and constructed to take account of the constraints to which the operator is subject as a result of the necessary or foreseeable use of personal protective equipment.

(e)

Machinery must be supplied with all the special equipment and accessories essential to enable it to be adjusted, maintained and used safely.

1.1.3.   Materials and products

The materials used to construct machinery or products used or created during its use must not endanger persons' safety or health. In particular, where fluids are used, machinery must be designed and constructed to prevent risks due to filling, use, recovery or draining.

1.1.4.   Lighting

Machinery must be supplied with integral lighting suitable for the operations concerned where the absence thereof is likely to cause a risk despite ambient lighting of normal intensity.

Machinery must be designed and constructed so that there is no area of shadow likely to cause nuisance, that there is no irritating dazzle and that there are no dangerous stroboscopic effects on moving parts due to the lighting.

Internal parts requiring frequent inspection and adjustment, and maintenance areas must be provided with appropriate lighting.

1.1.5.   Design of machinery to facilitate its handling

Machinery, or each component part thereof, must:

—

be capable of being handled and transported safely,

—

be packaged or designed so that it can be stored safely and without damage.

During the transportation of the machinery and/or its component parts, there must be no possibility of sudden movements or of hazards due to instability as long as the machinery and/or its component parts are handled in accordance with the instructions.

Where the weight, size or shape of machinery or its various component parts prevents them from being moved by hand, the machinery or each component part must:

—

either be fitted with attachments for lifting gear, or

—

be designed so that it can be fitted with such attachments, or

—

be shaped in such a way that standard lifting gear can easily be attached.

Where machinery or one of its component parts is to be moved by hand, it must:

—

either be easily moveable, or

—

be equipped for picking up and moving safely.

Special arrangements must be made for the handling of tools and/or machinery parts which, even if lightweight, could be hazardous.

1.1.6.   Ergonomics

Under the intended conditions of use, the discomfort, fatigue and physical and psychological stress faced by the operator must be reduced to the minimum possible, taking into account ergonomic principles such as:

—

allowing for the variability of the operator's physical dimensions, strength and stamina,

—

providing enough space for movements of the parts of the operator's body,

—

avoiding a machine-determined work rate,

—

avoiding monitoring that requires lengthy concentration,

—

adapting the man/machinery interface to the foreseeable characteristics of the operators.

1.1.7.   Operating positions

The operating position must be designed and constructed in such a way as to avoid any risk due to exhaust gases and/or lack of oxygen.

If the machinery is intended to be used in a hazardous environment presenting risks to the health and safety of the operator or if the machinery itself gives rise to a hazardous environment, adequate means must be provided to ensure that the operator has good working conditions and is protected against any foreseeable hazards.

Where appropriate, the operating position must be fitted with an adequate cabin designed, constructed and/or equipped to fulfil the above requirements. The exit must allow rapid evacuation. Moreover, when applicable, an emergency exit must be provided in a direction which is different from the usual exit.

1.1.8.   Seating

Where appropriate and where the working conditions so permit, work stations constituting an integral part of the machinery must be designed for the installation of seats.

If the operator is intended to sit during operation and the operating position is an integral part of the machinery, the seat must be provided with the machinery.

The operator's seat must enable him to maintain a stable position. Furthermore, the seat and its distance from the control devices must be capable of being adapted to the operator.

If the machinery is subject to vibrations, the seat must be designed and constructed in such a way as to reduce the vibrations transmitted to the operator to the lowest level that is reasonably possible. The seat mountings must withstand all stresses to which they can be subjected. Where there is no floor beneath the feet of the operator, footrests covered with a slip-resistant material must be provided.

1.2.   CONTROL SYSTEMS

1.2.1.   Safety and reliability of control systems

Control systems must be designed and constructed in such a way as to prevent hazardous situations from arising. Above all, they must be designed and constructed in such a way that:

—

they can withstand the intended operating stresses and external influences,

—

a fault in the hardware or the software of the control system does not lead to hazardous situations,

—

errors in the control system logic do not lead to hazardous situations,

—

reasonably foreseeable human error during operation does not lead to hazardous situations.

Particular attention must be given to the following points:

—

the machinery must not start unexpectedly,

—

the parameters of the machinery must not change in an uncontrolled way, where such change may lead to hazardous situations,

—

the machinery must not be prevented from stopping if the stop command has already been given,

—

no moving part of the machinery or piece held by the machinery must fall or be ejected,

—

automatic or manual stopping of the moving parts, whatever they may be, must be unimpeded,

—

the protective devices must remain fully effective or give a stop command,

—

the safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery and/or partly completed machinery.

For cable-less control, an automatic stop must be activated when correct control signals are not received, including loss of communication.

1.2.2.   Control devices

Control devices must be:

—

clearly visible and identifiable, using pictograms where appropriate,

—

positioned in such a way as to be safely operated without hesitation or loss of time and without ambiguity,

—

designed in such a way that the movement of the control device is consistent with its effect,

—

located outside the danger zones, except where necessary for certain control devices such as an emergency stop or a teach pendant,

—

positioned in such a way that their operation cannot cause additional risk,

—

designed or protected in such a way that the desired effect, where a hazard is involved, can only be achieved by a deliberate action,

—

made in such a way as to withstand foreseeable forces; particular attention must be paid to emergency stop devices liable to be subjected to considerable forces.

Where a control device is designed and constructed to perform several different actions, namely where there is no one-to-one correspondence, the action to be performed must be clearly displayed and subject to confirmation, where necessary.

Control devices must be so arranged that their layout, travel and resistance to operation are compatible with the action to be performed, taking account of ergonomic principles.

Machinery must be fitted with indicators as required for safe operation. The operator must be able to read them from the control position.

From each control position, the operator must be able to ensure that no-one is in the danger zones, or the control system must be designed and constructed in such a way that starting is prevented while someone is in the danger zone.

If neither of these possibilities is applicable, before the machinery starts, an acoustic and/or visual warning signal must be given. The exposed persons must have time to leave the danger zone or prevent the machinery starting up.

If necessary, means must be provided to ensure that the machinery can be controlled only from control positions located in one or more predetermined zones or locations.

Where there is more than one control position, the control system must be designed in such a way that the use of one of them precludes the use of the others, except for stop controls and emergency stops.

When machinery has two or more operating positions, each position must be provided with all the required control devices without the operators hindering or putting each other into a hazardous situation.

1.2.3.   Starting

It must be possible to start machinery only by voluntary actuation of a control device provided for the purpose.

The same requirement applies:

—

when restarting the machinery after a stoppage, whatever the cause,

—

when effecting a significant change in the operating conditions.

However, the restarting of the machinery or a change in operating conditions may be effected by voluntary actuation of a device other than the control device provided for the purpose, on condition that this does not lead to a hazardous situation.

For machinery functioning in automatic mode, the starting of the machinery, restarting after a stoppage, or a change in operating conditions may be possible without intervention, provided this does not lead to a hazardous situation.

Where machinery has several starting control devices and the operators can therefore put each other in danger, additional devices must be fitted to rule out such risks. If safety requires that starting and/or stopping must be performed in a specific sequence, there must be devices which ensure that these operations are performed in the correct order.

1.2.4.   Stopping

1.2.4.1.   Normal stop

Machinery must be fitted with a control device whereby the machinery can be brought safely to a complete stop.

Each workstation must be fitted with a control device to stop some or all of the functions of the machinery, depending on the existing hazards, so that the machinery is rendered safe.

The machinery's stop control must have priority over the start controls.

Once the machinery or its hazardous functions have stopped, the energy supply to the actuators concerned must be cut off.

1.2.4.2.   Operational stop

Where, for operational reasons, a stop control that does not cut off the energy supply to the actuators is required, the stop condition must be monitored and maintained.

1.2.4.3.   Emergency stop

Machinery must be fitted with one or more emergency stop devices to enable actual or impending danger to be averted.

The following exceptions apply:

—

machinery in which an emergency stop device would not lessen the risk, either because it would not reduce the stopping time or because it would not enable the special measures required to deal with the risk to be taken,

—

portable hand-held and/or hand-guided machinery.

The device must:

—

have clearly identifiable, clearly visible and quickly accessible control devices,

—

stop the hazardous process as quickly as possible, without creating additional risks,

—

where necessary, trigger or permit the triggering of certain safeguard movements.

Once active operation of the emergency stop device has ceased following a stop command, that command must be sustained by engagement of the emergency stop device until that engagement is specifically overridden; it must not be possible to engage the device without triggering a stop command; it must be possible to disengage the device only by an appropriate operation, and disengaging the device must not restart the machinery but only permit restarting.

The emergency stop function must be available and operational at all times, regardless of the operating mode.

Emergency stop devices must be a back-up to other safeguarding measures and not a substitute for them.

1.2.4.4.   Assembly of machinery

In the case of machinery or parts of machinery designed to work together, the machinery must be designed and constructed in such a way that the stop controls, including the emergency stop devices, can stop not only the machinery itself but also all related equipment, if its continued operation may be dangerous.

1.2.5.   Selection of control or operating modes

The control or operating mode selected must override all other control or operating modes, with the exception of the emergency stop.

If machinery has been designed and constructed to allow its use in several control or operating modes requiring different protective measures and/or work procedures, it must be fitted with a mode selector which can be locked in each position. Each position of the selector must be clearly identifiable and must correspond to a single operating or control mode.

The selector may be replaced by another selection method which restricts the use of certain functions of the machinery to certain categories of operator.

If, for certain operations, the machinery must be able to operate with a guard displaced or removed and/or a protective device disabled, the control or operating mode selector must simultaneously:

—

disable all other control or operating modes,

—

permit operation of hazardous functions only by control devices requiring sustained action,

—

permit the operation of hazardous functions only in reduced risk conditions while preventing hazards from linked sequences,

—

prevent any operation of hazardous functions by voluntary or involuntary action on the machine's sensors.

If these four conditions cannot be fulfilled simultaneously, the control or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zone.

In addition, the operator must be able to control operation of the parts he is working on from the adjustment point.

1.2.6.   Failure of the power supply

The interruption, the re-establishment after an interruption or the fluctuation in whatever manner of the power supply to the machinery must not lead to dangerous situations.

Particular attention must be given to the following points:

—

the machinery must not start unexpectedly,

—

the parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situations,

—

the machinery must not be prevented from stopping if the command has already been given,

—

no moving part of the machinery or piece held by the machinery must fall or be ejected,

—

automatic or manual stopping of the moving parts, whatever they may be, must be unimpeded,

—

the protective devices must remain fully effective or give a stop command.

1.3.   PROTECTION AGAINST MECHANICAL HAZARDS

1.3.1.   Risk of loss of stability

Machinery and its components and fittings must be stable enough to avoid overturning, falling or uncontrolled movements during transportation, assembly, dismantling and any other action involving the machinery.

If the shape of the machinery itself or its intended installation does not offer sufficient stability, appropriate means of anchorage must be incorporated and indicated in the instructions.

1.3.2.   Risk of break-up during operation

The various parts of machinery and their linkages must be able to withstand the stresses to which they are subject when used.

The durability of the materials used must be adequate for the nature of the working environment foreseen by the manufacturer or his authorised representative, in particular as regards the phenomena of fatigue, ageing, corrosion and abrasion.

The instructions must indicate the type and frequency of inspections and maintenance required for safety reasons. They must, where appropriate, indicate the parts subject to wear and the criteria for replacement.

Where a risk of rupture or disintegration remains despite the measures taken, the parts concerned must be mounted, positioned and/or guarded in such a way that any fragments will be contained, preventing hazardous situations.

Both rigid and flexible pipes carrying fluids, particularly those under high pressure, must be able to withstand the foreseen internal and external stresses and must be firmly attached and/or protected to ensure that no risk is posed by a rupture.

Where the material to be processed is fed to the tool automatically, the following conditions must be fulfilled to avoid risks to persons:

—

when the workpiece comes into contact with the tool, the latter must have attained its normal working condition,

—

when the tool starts and/or stops (intentionally or accidentally), the feed movement and the tool movement must be coordinated.

1.3.3.   Risks due to falling or ejected objects

Precautions must be taken to prevent risks from falling or ejected objects.

1.3.4.   Risks due to surfaces, edges or angles

Insofar as their purpose allows, accessible parts of the machinery must have no sharp edges, no sharp angles and no rough surfaces likely to cause injury.

1.3.5.   Risks related to combined machinery

Where the machinery is intended to carry out several different operations with manual removal of the piece between each operation (combined machinery), it must be designed and constructed in such a way as to enable each element to be used separately without the other elements constituting a risk for exposed persons.

For this purpose, it must be possible to start and stop separately any elements that are not protected.

1.3.6.   Risks related to variations in operating conditions

Where the machinery performs operations under different conditions of use, it must be designed and constructed in such a way that selection and adjustment of these conditions can be carried out safely and reliably.

1.3.7.   Risks related to moving parts

The moving parts of machinery must be designed and constructed in such a way as to prevent risks of contact which could lead to accidents or must, where risks persist, be fitted with guards or protective devices.

All necessary steps must be taken to prevent accidental blockage of moving parts involved in the work. In cases where, despite the precautions taken, a blockage is likely to occur, the necessary specific protective devices and tools must, when appropriate, be provided to enable the equipment to be safely unblocked.

The instructions and, where possible, a sign on the machinery shall identify these specific protective devices and how they are to be used.

1.3.8.   Choice of protection against risks arising from moving parts

Guards or protective devices designed to protect against risks arising from moving parts must be selected on the basis of the type of risk. The following guidelines must be used to help to make the choice.

1.3.8.1.   Moving transmission parts

Guards designed to protect persons against the hazards generated by moving transmission parts must be:

—

either fixed guards as referred to in section 1.4.2.1, or

—

interlocking movable guards as referred to in section 1.4.2.2.

Interlocking movable guards should be used where frequent access is envisaged.

1.3.8.2.   Moving parts involved in the process

Guards or protective devices designed to protect persons against the hazards generated by moving parts involved in the process must be:

—

either fixed guards as referred to in section 1.4.2.1, or

—

interlocking movable guards as referred to in section 1.4.2.2, or

—

protective devices as referred to in section 1.4.3, or

—

a combination of the above.

However, when certain moving parts directly involved in the process cannot be made completely inaccessible during operation owing to operations requiring operator intervention, such parts must be fitted with:

—

fixed guards or interlocking movable guards preventing access to those sections of the parts that are not used in the work, and

—

adjustable guards as referred to in section 1.4.2.3 restricting access to those sections of the moving parts where access is necessary.

1.3.9.   Risks of uncontrolled movements

When a part of the machinery has been stopped, any drift away from the stopping position, for whatever reason other than action on the control devices, must be prevented or must be such that it does not present a hazard.

1.4.   REQUIRED CHARACTERISTICS OF GUARDS AND PROTECTIVE DEVICES

1.4.1.   General requirements

Guards and protective devices must:

—

be of robust construction,

—

be securely held in place,

—

not give rise to any additional hazard,

—

not be easy to by-pass or render non-operational,

—

be located at an adequate distance from the danger zone,

—

cause minimum obstruction to the view of the production process, and

—

enable essential work to be carried out on the installation and/or replacement of tools and for maintenance purposes by restricting access exclusively to the area where the work has to be done, if possible without the guard having to be removed or the protective device having to be disabled.

In addition, guards must, where possible, protect against the ejection or falling of materials or objects and against emissions generated by the machinery.

1.4.2.   Special requirements for guards

1.4.2.1.   Fixed guards

Fixed guards must be fixed by systems that can be opened or removed only with tools.

Their fixing systems must remain attached to the guards or to the machinery when the guards are removed.

Where possible, guards must be incapable of remaining in place without their fixings.

1.4.2.2.   Interlocking movable guards

Interlocking movable guards must:

—

as far as possible remain attached to the machinery when open,

—

be designed and constructed in such a way that they can be adjusted only by means of an intentional action.

Interlocking movable guards must be associated with an interlocking device that:

—

prevents the start of hazardous machinery functions until they are closed and

—

gives a stop command whenever they are no longer closed.

Where it is possible for an operator to reach the danger zone before the risk due to the hazardous machinery functions has ceased, movable guards must be associated with a guard locking device in addition to an interlocking device that:

—

prevents the start of hazardous machinery functions until the guard is closed and locked, and

—

keeps the guard closed and locked until the risk of injury from the hazardous machinery functions has ceased.

Interlocking movable guards must be designed in such a way that the absence or failure of one of their components prevents starting or stops the hazardous machinery functions.

1.4.2.3.   Adjustable guards restricting access

Adjustable guards restricting access to those areas of the moving parts strictly necessary for the work must be:

—

adjustable manually or automatically, depending on the type of work involved, and

—

readily adjustable without the use of tools.

1.4.3.   Special requirements for protective devices

Protective devices must be designed and incorporated into the control system in such a way that:

—

moving parts cannot start up while they are within the operator's reach,

—

persons cannot reach moving parts while the parts are moving, and

—

the absence or failure of one of their components prevents starting or stops the moving parts.

Protective devices must be adjustable only by means of an intentional action.

1.5.   RISKS DUE TO OTHER HAZARDS

1.5.1.   Electricity supply

Where machinery has an electricity supply, it must be designed, constructed and equipped in such a way that all hazards of an electrical nature are or can be prevented.

The safety objectives set out in Directive 73/23/EEC shall apply to machinery. However, the obligations concerning conformity assessment and the placing on the market and/or putting into service of machinery with regard to electrical hazards are governed solely by this Directive.

1.5.2.   Static electricity

Machinery must be designed and constructed to prevent or limit the build-up of potentially dangerous electrostatic charges and/or be fitted with a discharging system.

1.5.3.   Energy supply other than electricity

Where machinery is powered by source of energy other than electricity, it must be so designed, constructed and equipped as to avoid all potential risks associated with such sources of energy.

1.5.4.   Errors of fitting

Errors likely to be made when fitting or refitting certain parts which could be a source of risk must be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings. The same information must be given on moving parts and/or their housings where the direction of movement needs to be known in order to avoid a risk.

Where necessary, the instructions must give further information on these risks.

Where a faulty connection can be the source of risk, incorrect connections must be made impossible by design or, failing this, by information given on the elements to be connected and, where appropriate, on the means of connection.

1.5.5.   Extreme temperatures

Steps must be taken to eliminate any risk of injury arising from contact with or proximity to machinery parts or materials at high or very low temperatures.

The necessary steps must also be taken to avoid or protect against the risk of hot or very cold material being ejected.

1.5.6.   Fire

Machinery must be designed and constructed in such a way as to avoid any risk of fire or overheating posed by the machinery itself or by gases, liquids, dust, vapours or other substances produced or used by the machinery.

1.5.7.   Explosion

Machinery must be designed and constructed in such a way as to avoid any risk of explosion posed by the machinery itself or by gases, liquids, dust, vapours or other substances produced or used by the machinery.

Machinery must comply, as far as the risk of explosion due to its use in a potentially explosive atmosphere is concerned, with the provisions of the specific Community Directives.

1.5.8.   Noise

Machinery must be designed and constructed in such a way that risks resulting from the emission of airborne noise are reduced to the lowest level, taking account of technical progress and the availability of means of reducing noise, in particular at source.

The level of noise emission may be assessed with reference to comparative emission data for similar machinery.

1.5.9.   Vibrations

Machinery must be designed and constructed in such a way that risks resulting from vibrations produced by the machinery are reduced to the lowest level, taking account of technical progress and the availability of means of reducing vibration, in particular at source.

The level of vibration emission may be assessed with reference to comparative emission data for similar machinery.

1.5.10.   Radiation

Undesirable radiation emissions from the machinery must be eliminated or be reduced to levels that do not have adverse effects on persons.

Any functional ionising radiation emissions must be limited to the lowest level which is sufficient for the proper functioning of the machinery during setting, operation and cleaning. Where a risk exists, the necessary protective measures must be taken.

Any functional non-ionising radiation emissions during setting, operation and cleaning must be limited to levels that do not have adverse effects on persons.

1.5.11.   External radiation

Machinery must be designed and constructed in such a way that external radiation does not interfere with its operation.

1.5.12.   Laser radiation

Where laser equipment is used, the following should be taken into account:

—

laser equipment on machinery must be designed and constructed in such a way as to prevent any accidental radiation,

—

laser equipment on machinery must be protected in such a way that effective radiation, radiation produced by reflection or diffusion and secondary radiation do not damage health,

—

optical equipment for the observation or adjustment of laser equipment on machinery must be such that no health risk is created by laser radiation.

1.5.13.   Emissions of hazardous materials and substances

Machinery must be designed and constructed in such a way that risks of inhalation, ingestion, contact with the skin, eyes and mucous membranes and penetration through the skin of hazardous materials and substances which it produces can be avoided.

Where a hazard cannot be eliminated, the machinery must be so equipped that hazardous materials and substances can be contained, evacuated, precipitated by water spraying, filtered or treated by another equally effective method.

Where the process is not totally enclosed during normal operation of the machinery, the devices for containment and/or evacuation must be situated in such a way as to have the maximum effect.

1.5.14.   Risk of being trapped in a machine

Machinery must be designed, constructed or fitted with a means of preventing a person from being enclosed within it or, if that is impossible, with a means of summoning help.

1.5.15.   Risk of slipping, tripping or falling

Parts of the machinery where persons are liable to move about or stand must be designed and constructed in such a way as to prevent persons slipping, tripping or falling on or off these parts.

Where appropriate, these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stability.

1.5.16.   Lightning

Machinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earth.

1.6.   MAINTENANCE

1.6.1.   Machinery maintenance

Adjustment and maintenance points must be located outside danger zones. It must be possible to carry out adjustment, maintenance, repair, cleaning and servicing operations while machinery is at a standstill.

If one or more of the above conditions cannot be satisfied for technical reasons, measures must be taken to ensure that these operations can be carried out safely (see section 1.2.5).

In the case of automated machinery and, where necessary, other machinery, a connecting device for mounting diagnostic fault-finding equipment must be provided.

Automated machinery components which have to be changed frequently must be capable of being removed and replaced easily and safely. Access to the components must enable these tasks to be carried out with the necessary technical means in accordance with a specified operating method.

1.6.2.   Access to operating positions and servicing points

Machinery must be designed and constructed in such a way as to allow access in safety to all areas where intervention is necessary during operation, adjustment and maintenance of the machinery.

1.6.3.   Isolation of energy sources

Machinery must be fitted with means to isolate it from all energy sources. Such isolators must be clearly identified. They must be capable of being locked if reconnection could endanger persons. Isolators must also be capable of being locked where an operator is unable, from any of the points to which he has access, to check that the energy is still cut off.

In the case of machinery capable of being plugged into an electricity supply, removal of the plug is sufficient, provided that the operator can check from any of the points to which he has access that the plug remains removed.

After the energy is cut off, it must be possible to dissipate normally any energy remaining or stored in the circuits of the machinery without risk to persons.

As an exception to the requirement laid down in the previous paragraphs, certain circuits may remain connected to their energy sources in order, for example, to hold parts, to protect information, to light interiors, etc. In this case, special steps must be taken to ensure operator safety.

1.6.4.   Operator intervention

Machinery must be so designed, constructed and equipped that the need for operator intervention is limited. If operator intervention cannot be avoided, it must be possible to carry it out easily and safely.

1.6.5.   Cleaning of internal parts

The machinery must be designed and constructed in such a way that it is possible to clean internal parts which have contained dangerous substances or preparations without entering them; any necessary unblocking must also be possible from the outside. If it is impossible to avoid entering the machinery, it must be designed and constructed in such a way as to allow cleaning to take place safely.

1.7.   INFORMATION

1.7.1.   Information and warnings on the machinery

Information and warnings on the machinery should preferably be provided in the form of readily understandable symbols or pictograms. Any written or verbal information and warnings must be expressed in an official Community language or languages, which may be determined in accordance with the Treaty by the Member State in which the machinery is placed on the market and/or put into service and may be accompanied, on request, by versions in any other official Community language or languages understood by the operators.

1.7.1.1.   Information and information devices

The information needed to control machinery must be provided in a form that is unambiguous and easily understood. It must not be excessive to the extent of overloading the operator.

Visual display units or any other interactive means of communication between the operator and the machine must be easily understood and easy to use.

1.7.1.2.   Warning devices

Where the health and safety of persons may be endangered by a fault in the operation of unsupervised machinery, the machinery must be equipped in such a way as to give an appropriate acoustic or light signal as a warning.

Where machinery is equipped with warning devices these must be unambiguous and easily perceived. The operator must have facilities to check the operation of such warning devices at all times.

The requirements of the specific Community Directives concerning colours and safety signals must be complied with.

1.7.2.   Warning of residual risks

Where risks remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted, the necessary warnings, including warning devices, must be provided.

1.7.3.   Marking of machinery

All machinery must be marked visibly, legibly and indelibly with the following minimum particulars:

—

the business name and full address of the manufacturer and, where applicable, his authorised representative,

—

designation of the machinery,

—

the CE Marking (see Annex III),

—

designation of series or type,

—

serial number, if any,

—

the year of construction, that is the year in which the manufacturing process is completed.

It is prohibited to pre-date or post-date the machinery when affixing the CE marking.

Furthermore, machinery designed and constructed for use in a potentially explosive atmosphere must be marked accordingly.

Machinery must also bear full information relevant to its type and essential for safe use. Such information is subject to the requirements set out in section 1.7.1.

Where a machine part must be handled during use with lifting equipment, its mass must be indicated legibly, indelibly and unambiguously.

1.7.4.   Instructions

All machinery must be accompanied by instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service.

The instructions accompanying the machinery must be either ‘Original instructions’ or a ‘Translation of the original instructions’, in which case the translation must be accompanied by the original instructions.

By way of exception, the maintenance instructions intended for use by specialised personnel mandated by the manufacturer or his authorised representative may be supplied in only one Community language which the specialised personnel understand.

The instructions must be drafted in accordance with the principles set out below.

1.7.4.1.   General principles for the drafting of instructions

(a)

The instructions must be drafted in one or more official Community languages. The words ‘Original instructions’ must appear on the language version(s) verified by the manufacturer or his authorised representative.

(b)

Where no ‘Original instructions’ exist in the official language(s) of the country where the machinery is to be used, a translation into that/those language(s) must be provided by the manufacturer or his authorised representative or by the person bringing the machinery into the language area in question. The translations must bear the words ‘Translation of the original instructions’.

(c)

The contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereof.

(d)

In the case of machinery intended for use by non-professional operators, the wording and layout of the instructions for use must take into account the level of general education and acumen that can reasonably be expected from such operators.

1.7.4.2.   Contents of the instructions

Each instruction manual must contain, where applicable, at least the following information:

(a)

the business name and full address of the manufacturer and of his authorised representative;

(b)

the designation of the machinery as marked on the machinery itself, except for the serial number (see section 1.7.3);

(c)

the EC declaration of conformity, or a document setting out the contents of the EC declaration of conformity, showing the particulars of the machinery, not necessarily including the serial number and the signature;

(d)

a general description of the machinery;

(e)

the drawings, diagrams, descriptions and explanations necessary for the use, maintenance and repair of the machinery and for checking its correct functioning;

(f)

a description of the workstation(s) likely to be occupied by operators;

(g)

a description of the intended use of the machinery;

(h)

warnings concerning ways in which the machinery must not be used that experience has shown might occur;

(i)

assembly, installation and connection instructions, including drawings, diagrams and the means of attachment and the designation of the chassis or installation on which the machinery is to be mounted;

(j)

instructions relating to installation and assembly for reducing noise or vibration;

(k)

instructions for the putting into service and use of the machinery and, if necessary, instructions for the training of operators;

(l)

information about the residual risks that remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted;

(m)

instructions on the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided;

(n)

the essential characteristics of tools which may be fitted to the machinery;

(o)

the conditions in which the machinery meets the requirement of stability during use, transportation, assembly, dismantling when out of service, testing or foreseeable breakdowns;

(p)

instructions with a view to ensuring that transport, handling and storage operations can be made safely, giving the mass of the machinery and of its various parts where these are regularly to be transported separately;

(q)

the operating method to be followed in the event of accident or breakdown; if a blockage is likely to occur, the operating method to be followed so as to enable the equipment to be safely unblocked;

(r)

the description of the adjustment and maintenance operations that should be carried out by the user and the preventive maintenance measures that should be observed;

(s)

instructions designed to enable adjustment and maintenance to be carried out safely, including the protective measures that should be taken during these operations;

(t)

the specifications of the spare parts to be used, when these affect the health and safety of operators;

(u)

the following information on airborne noise emissions:

—

the A-weighted emission sound pressure level at workstations, where this exceeds 70 dB(A); where this level does not exceed 70 dB(A), this fact must be indicated,

—

the peak C-weighted instantaneous sound pressure value at workstations, where this exceeds 63 Pa (130 dB in relation to 20 μPa),

—

the A-weighted sound power level emitted by the machinery, where the A-weighted emission sound pressure level at workstations exceeds 80 dB(A).

These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced.

In the case of very large machinery, instead of the A-weighted sound power level, the A-weighted emission sound pressure levels at specified positions around the machinery may be indicated.

Where the harmonised standards are not applied, sound levels must be measured using the most appropriate method for the machinery. Whenever sound emission values are indicated the uncertainties surrounding these values must be specified. The operating conditions of the machinery during measurement and the measuring methods used must be described.

Where the workstation(s) are undefined or cannot be defined, A-weighted sound pressure levels must be measured at a distance of 1 metre from the surface of the machinery and at a height of 1,6 metres from the floor or access platform. The position and value of the maximum sound pressure must be indicated.

Where specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels, those Directives must be applied and the corresponding provisions of this section shall not apply;

(v)

where machinery is likely to emit non-ionising radiation which may cause harm to persons, in particular persons with active or non-active implantable medical devices, information concerning the radiation emitted for the operator and exposed persons.

1.7.4.3.   Sales literature

Sales literature describing the machinery must not contradict the instructions as regards health and safety aspects. Sales literature describing the performance characteristics of machinery must contain the same information on emissions as is contained in the instructions.

2.   SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR CERTAIN CATEGORIES OF MACHINERY

Foodstuffs machinery, machinery for cosmetics or pharmaceutical products, hand-held and/or hand-guided machinery, portable fixing and other impact machinery, machinery for working wood and material with similar physical characteristics must meet all the essential health and safety requirements described in this chapter (see General Principles, point 4).

2.1.   FOODSTUFFS MACHINERY AND MACHINERY FOR COSMETICS OR PHARMACEUTICAL PRODUCTS

2.1.1.   General

Machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products must be designed and constructed in such a way as to avoid any risk of infection, sickness or contagion.

The following requirements must be observed:

(a)

materials in contact with, or intended to come into contact with, foodstuffs or cosmetics or pharmaceutical products must satisfy the conditions set down in the relevant Directives. The machinery must be designed and constructed in such a way that these materials can be cleaned before each use. Where this is not possible disposable parts must be used;

(b)

all surfaces in contact with foodstuffs or cosmetics or pharmaceutical products, other than surfaces of disposable parts, must:

—

be smooth and have neither ridges nor crevices which could harbour organic materials. The same applies to their joinings,

—

be designed and constructed in such a way as to reduce the projections, edges and recesses of assemblies to a minimum,

—

be easily cleaned and disinfected, where necessary after removing easily dismantled parts; the inside surfaces must have curves with a radius sufficient to allow thorough cleaning;

(c)

it must be possible for liquids, gases and aerosols deriving from foodstuffs, cosmetics or pharmaceutical products as well as from cleaning, disinfecting and rinsing fluids to be completely discharged from the machinery (if possible, in a ‘cleaning’ position);

(d)

machinery must be designed and constructed in such a way as to prevent any substances or living creatures, in particular insects, from entering, or any organic matter from accumulating in, areas that cannot be cleaned;

(e)

machinery must be designed and constructed in such a way that no ancillary substances hazardous to health, including the lubricants used, can come into contact with foodstuffs, cosmetics or pharmaceutical products. Where necessary, machinery must be designed and constructed in such a way that continuing compliance with this requirement can be checked.

2.1.2.   Instructions

The instructions for foodstuffs machinery and machinery for use with cosmetics or pharmaceutical products must indicate recommended products and methods for cleaning, disinfecting and rinsing, not only for easily accessible areas but also for areas to which access is impossible or inadvisable.

2.2.   PORTABLE HAND-HELD AND/OR HAND-GUIDED MACHINERY

2.2.1.   General

Portable hand-held and/or hand-guided machinery must:

—

depending on the type of machinery, have a supporting surface of sufficient size and have a sufficient number of handles and supports of an appropriate size, arranged in such a way as to ensure the stability of the machinery under the intended operating conditions,

—

except where technically impossible, or where there is an independent control device, in the case of handles which cannot be released in complete safety, be fitted with manual start and stop control devices arranged in such a way that the operator can operate them without releasing the handles,

—

present no risks of accidental starting and/or continued operation after the operator has released the handles. Equivalent steps must be taken if this requirement is not technically feasible,

—

permit, where necessary, visual observation of the danger zone and of the action of the tool with the material being processed.

The handles of portable machinery must be designed and constructed in such a way as to make starting and stopping straightforward.

2.2.1.1.   Instructions

The instructions must give the following information concerning vibrations transmitted by portable hand-held and hand-guided machinery:

—

the vibration total value to which the hand-arm system is subjected, if it exceeds 2,5 m/s2. Where this value does not exceed 2,5 m/s2, this must be mentioned,

—

the uncertainty of measurement.

These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced.

If harmonised standards are not applied, the vibration data must be measured using the most appropriate measurement code for the machinery.

The operating conditions during measurement and the methods used for measurement, or the reference of the harmonised standard applied, must be specified.

2.2.2.   Portable fixing and other impact machinery

2.2.2.1.   General

Portable fixing and other impact machinery must be designed and constructed in such a way that:

—

energy is transmitted to the impacted element by the intermediary component that does not leave the device,

—

an enabling device prevents impact unless the machinery is positioned correctly with adequate pressure on the base material,

—

involuntary triggering is prevented; where necessary, an appropriate sequence of actions on the enabling device and the control device must be required to trigger an impact,

—

accidental triggering is prevented during handling or in case of shock,

—

loading and unloading operations can be carried out easily and safely.

Where necessary, it must be possible to fit the device with splinter guard(s) and the appropriate guard(s) must be provided by the manufacturer of the machinery.

2.2.2.2.   Instructions

The instructions must give the necessary information regarding:

—

the accessories and interchangeable equipment that can be used with the machinery,

—

the suitable fixing or other impacted elements to be used with the machinery,

—

where appropriate, the suitable cartridges to be used.

2.3.   MACHINERY FOR WORKING WOOD AND MATERIAL WITH SIMILAR PHYSICAL CHARACTERISTICS

Machinery for working wood and materials with similar physical characteristics must comply with the following requirements:

(a)

the machinery must be designed, constructed or equipped in such a way that the piece being machined can be placed and guided in safety; where the piece is hand-held on a work-bench, the latter must be sufficiently stable during the work and must not impede the movement of the piece;

(b)

where the machinery is likely to be used in conditions involving the risk of ejection of workpieces or parts of them, it must be designed, constructed, or equipped in such a way as to prevent such ejection, or, if this is not possible, so that the ejection does not engender risks for the operator and/or exposed persons;

(c)

the machinery must be equipped with an automatic brake that stops the tool in a sufficiently short time if there is a risk of contact with the tool whilst it runs down;

(d)

where the tool is incorporated into a non-fully automated machine, the latter must be designed and constructed in such a way as to eliminate or reduce the risk of accidental injury.

3.   SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET HAZARDS DUE TO THE MOBILITY OF MACHINERY

Machinery presenting hazards due to its mobility must meet all the essential health and safety requirements described in this chapter (see General Principles, point 4).

3.1.   GENERAL

3.1.1.   Definitions

(a)

‘Machinery presenting hazards due to its mobility’ means

—

machinery the operation of which requires either mobility while working, or continuous or semi-continuous movement between a succession of fixed working locations, or

—

machinery which is operated without being moved, but which may be equipped in such a way as to enable it to be moved more easily from one place to another.

(b)

‘Driver’ means an operator responsible for the movement of a machine. The driver may be transported by the machinery or may be on foot, accompanying the machinery, or may guide the machinery by remote control.

3.2.   WORK POSITIONS

3.2.1.   Driving position

Visibility from the driving position must be such that the driver can, in complete safety for himself and the exposed persons, operate the machinery and its tools in their foreseeable conditions of use. Where necessary, appropriate devices must be provided to remedy hazards due to inadequate direct vision.

Machinery on which the driver is transported must be designed and constructed in such a way that, from the driving positions, there is no risk to the driver from inadvertent contact with the wheels and tracks.

The driving position of ride-on drivers must be designed and constructed in such a way that a driver's cab may be fitted, provided this does not increase the risk and there is room for it. The cab must incorporate a place for the instructions needed for the driver.

3.2.2.   Seating

Where there is a risk that operators or other persons transported by the machinery may be crushed between parts of the machinery and the ground should the machinery roll or tip over, in particular for machinery equipped with a protective structure referred to in section 3.4.3 or 3.4.4, their seats must be designed or equipped with a restraint system so as to keep the persons in their seats, without restricting movements necessary for operations or movements relative to the structure caused by the suspension of the seats. Such restraint systems should not be fitted if they increase the risk.

3.2.3.   Positions for other persons

If the conditions of use provide that persons other than the driver may occasionally or regularly be transported by the machinery or work on it, appropriate positions must be provided which enable them to be transported or to work on it without risk.

The second and third paragraphs of section 3.2.1 also apply to the places provided for persons other than the driver.

3.3.   CONTROL SYSTEMS

If necessary, steps must be taken to prevent unauthorised use of controls.

In the case of remote controls, each control unit must clearly identify the machinery to be controlled from that unit.

The remote control system must be designed and constructed in such a way as to affect only:

—

the machinery in question,

—

the functions in question.

Remote controlled machinery must be designed and constructed in such a way that it will respond only to signals from the intended control units.

3.3.1.   Control devices

The driver must be able to actuate all control devices required to operate the machinery from the driving position, except for functions which can be safely actuated only by using control devices located elsewhere. These functions include, in particular, those for which operators other than the driver are responsible or for which the driver has to leave the driving position in order to control them safely.

Where there are pedals, they must be so designed, constructed and fitted as to allow safe operation by the driver with the minimum risk of incorrect operation. They must have a slip-resistant surface and be easy to clean.

Where their operation can lead to hazards, notably dangerous movements, the control devices, except for those with preset positions, must return to the neutral position as soon as they are released by the operator.

In the case of wheeled machinery, the steering system must be designed and constructed in such a way as to reduce the force of sudden movements of the steering wheel or the steering lever caused by shocks to the guide wheels.

Any control that locks the differential must be so designed and arranged that it allows the differential to be unlocked when the machinery is moving.

The sixth paragraph of section 1.2.2, concerning acoustic and/or visual warning signals, applies only in the case of reversing.

3.3.2.   Starting/moving

All travel movements of self-propelled machinery with a ride-on driver must be possible only if the driver is at the controls.

Where, for operating purposes, machinery is fitted with devices which exceed its normal clearance zone (e.g. stabilisers, jib, etc.), the driver must be provided with the means of checking easily, before moving the machinery, that such devices are in a particular position which allows safe movement.

This also applies to all other parts which, to allow safe movement, have to be in particular positions, locked if necessary.

Where it does not give rise to other risks, movement of the machinery must depend on safe positioning of the aforementioned parts.

It must not be possible for unintentional movement of the machinery to occur while the engine is being started.

3.3.3.   Travelling function

Without prejudice to road traffic regulations, self-propelled machinery and its trailers must meet the requirements for slowing down, stopping, braking and immobilisation so as to ensure safety under all the operating, load, speed, ground and gradient conditions allowed for.

The driver must be able to slow down and stop self-propelled machinery by means of a main device. Where safety so requires, in the event of a failure of the main device, or in the absence of the energy supply needed to actuate the main device, an emergency device with a fully independent and easily accessible control device must be provided for slowing down and stopping.

Where safety so requires, a parking device must be provided to render stationary machinery immobile. This device may be combined with one of the devices referred to in the second paragraph, provided that it is purely mechanical.

Remote-controlled machinery must be equipped with devices for stopping operation automatically and immediately and for preventing potentially dangerous operation in the following situations:

—

if the driver loses control,

—

if it receives a stop signal,

—

if a fault is detected in a safety-related part of the system,

—

if no validation signal is detected within a specified time.

Section 1.2.4 does not apply to the travelling function.

3.3.4.   Movement of pedestrian-controlled machinery

Movement of pedestrian-controlled self-propelled machinery must be possible only through sustained action on the relevant control device by the driver. In particular, it must not be possible for movement to occur while the engine is being started.

The control systems for pedestrian-controlled machinery must be designed in such a way as to minimise the risks arising from inadvertent movement of the machine towards the driver, in particular:

—

crushing,

—

injury from rotating tools.

The speed of travel of the machinery must be compatible with the pace of a driver on foot.

In the case of machinery on which a rotary tool may be fitted, it must not be possible to actuate the tool when the reverse control is engaged, except where the movement of the machinery results from movement of the tool. In the latter case, the reversing speed must be such that it does not endanger the driver.

3.3.5.   Control circuit failure

A failure in the power supply to the power-assisted steering, where fitted, must not prevent machinery from being steered during the time required to stop it.

3.4.   PROTECTION AGAINST MECHANICAL HAZARDS

3.4.1.   Uncontrolled movements

Machinery must be designed, constructed and where appropriate placed on its mobile support in such a way as to ensure that, when moved, uncontrolled oscillations of its centre of gravity do not affect its stability or exert excessive strain on its structure.

3.4.2.   Moving transmission parts

By way of exception to section 1.3.8.1, in the case of engines, moveable guards preventing access to the moving parts in the engine compartment need not have interlocking devices if they have to be opened either by the use of a tool or key or by a control located in the driving position, providing the latter is in a fully enclosed cab with a lock to prevent unauthorised access.

3.4.3.   Roll-over and tip-over

Where, in the case of self-propelled machinery with a ride-on driver, operator(s) or other person(s), there is a risk of rolling or tipping over, the machinery must be fitted with an appropriate protective structure, unless this increases the risk.

This structure must be such that in the event of rolling or tipping over it affords the ride-on person(s) an adequate deflection-limiting volume.

In order to verify that the structure complies with the requirement laid down in the second paragraph, the manufacturer or his authorised representative must, for each type of structure concerned, perform appropriate tests or have such tests performed.

3.4.4.   Falling objects

Where, in the case of self-propelled machinery with a ride-on driver, operator(s) or other person(s), there is a risk due to falling objects or material, the machinery must be designed and constructed in such a way as to take account of this risk and fitted, if its size allows, with an appropriate protective structure.

This structure must be such that, in the event of falling objects or material, it guarantees the ride-on person(s) an adequate deflection-limiting volume.

In order to verify that the structure complies with the requirement laid down in the second paragraph, the manufacturer or his authorised representative must, for each type of structure concerned, perform appropriate tests or have such tests performed.

3.4.5.   Means of access

Handholds and steps must be designed, constructed and arranged in such a way that the operators use them instinctively and do not use the control devices to assist access.

3.4.6.   Towing devices

All machinery used to tow or to be towed must be fitted with towing or coupling devices designed, constructed and arranged in such a way as to ensure easy and secure connection and disconnection and to prevent accidental disconnection during use.

Insofar as the tow bar load so requires, such machinery must be equipped with a support with a bearing surface suited to the load and the ground.

3.4.7.   Transmission of power between self-propelled machinery (or tractor) and recipient machinery

Removable mechanical transmission devices linking self-propelled machinery (or a tractor) to the first fixed bearing of recipient machinery must be designed and constructed in such a way that any part that moves during operation is protected over its whole length.

On the side of the self-propelled machinery (or tractor), the power take-off to which the removable mechanical transmission device is attached must be protected either by a guard fixed and linked to the self-propelled machinery (or tractor) or by any other device offering equivalent protection.

It must be possible to open this guard for access to the removable transmission device. Once it is in place, there must be enough room to prevent the drive shaft damaging the guard when the machinery (or the tractor) is moving.

On the recipient machinery side, the input shaft must be enclosed in a protective casing fixed to the machinery.

Torque limiters or freewheels may be fitted to universal joint transmissions only on the side adjoining the driven machinery. The removable mechanical transmission device must be marked accordingly.

All recipient machinery, the operation of which requires a removable mechanical transmission device to connect it to self-propelled machinery (or a tractor), must have a system for attaching the removable mechanical transmission device so that, when the machinery is uncoupled, the removable mechanical transmission device and its guard are not damaged by contact with the ground or part of the machinery.

The outside parts of the guard must be so designed, constructed and arranged that they cannot turn with the removable mechanical transmission device. The guard must cover the transmission to the ends of the inner jaws in the case of simple universal joints and at least to the centre of the outer joint or joints in the case of wide-angle universal joints.

If means of access to working positions are provided near to the removable mechanical transmission device, they must be designed and constructed in such a way that the shaft guards cannot be used as steps, unless designed and constructed for that purpose.

3.5.   PROTECTION AGAINST OTHER HAZARDS

3.5.1.   Batteries

The battery housing must be designed and constructed in such a way as to prevent the electrolyte being ejected on to the operator in the event of rollover or tipover and to avoid the accumulation of vapours in places occupied by operators.

Machinery must be designed and constructed in such a way that the battery can be disconnected with the aid of an easily accessible device provided for that purpose.

3.5.2.   Fire

Depending on the hazards anticipated by the manufacturer, machinery must, where its size permits:

—

either allow easily accessible fire extinguishers to be fitted, or

—

be provided with built-in extinguisher systems.

3.5.3.   Emissions of hazardous substances

The second and third paragraphs of section 1.5.13 do not apply where the main function of the machinery is the spraying of products. However, the operator must be protected against the risk of exposure to such hazardous emissions.

3.6.   INFORMATION AND INDICATIONS

3.6.1.   Signs, signals and warnings

All machinery must have signs and/or instruction plates concerning use, adjustment and maintenance, wherever necessary, so as to ensure the health and safety of persons. They must be chosen, designed and constructed in such a way as to be clearly visible and indelible.

Without prejudice to the provisions of road traffic regulations, machinery with a ride-on driver must have the following equipment:

—

an acoustic warning device to alert persons,

—

a system of light signals relevant to the intended conditions of use; the latter requirement does not apply to machinery intended solely for underground working and having no electrical power,

—

where necessary, there must be an appropriate connection between a trailer and the machinery for the operation of signals.

Remote-controlled machinery which, under normal conditions of use, exposes persons to the risk of impact or crushing must be fitted with appropriate means to signal its movements or with means to protect persons against such risks. The same applies to machinery which involves, when in use, the constant repetition of a forward and backward movement on a single axis where the area to the rear of the machine is not directly visible to the driver.

Machinery must be constructed in such a way that the warning and signalling devices cannot be disabled unintentionally. Where it is essential for safety, such devices must be provided with the means to check that they are in good working order and their failure must be made apparent to the operator.

Where the movement of machinery or its tools is particularly hazardous, signs on the machinery must be provided to warn against approaching the machinery while it is working; the signs must be legible at a sufficient distance to ensure the safety of persons who have to be in the vicinity.

3.6.2.   Marking

The following must be shown legibly and indelibly on all machinery:

—

nominal power expressed in kilowatts (kW),

—

mass of the most usual configuration, in kilograms (kg);

and, where appropriate:

—

maximum drawbar pull provided for at the coupling hook, in Newtons (N),

—

maximum vertical load provided for on the coupling hook, in Newtons (N).

3.6.3.   Instructions

3.6.3.1.   Vibrations

The instructions must give the following information concerning vibrations transmitted by the machinery to the hand-arm system or to the whole body:

—

the vibration total value to which the hand-arm system is subjected, if it exceeds 2,5 m/s2. Where this value does not exceed 2,5 m/s2, this must be mentioned,

—

the highest root mean square value of weighted acceleration to which the whole body is subjected, if it exceeds 0,5 m/s2. Where this value does not exceed 0,5 m/s2, this must be mentioned,

—

the uncertainty of measurement.

These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced.

Where harmonised standards are not applied, the vibration must be measured using the most appropriate measurement code for the machinery concerned.

The operating conditions during measurement and the measurement codes used must be described.

3.6.3.2.   Multiple uses

The instructions for machinery allowing several uses depending on the equipment used and the instructions for the interchangeable equipment must contain the information necessary for safe assembly and use of the basic machinery and the interchangeable equipment that can be fitted.

4.   SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET HAZARDS DUE TO LIFTING OPERATIONS

Machinery presenting hazards due to lifting operations must meet all the relevant essential health and safety requirements described in this chapter (see General Principles, point 4).

4.1.   GENERAL

4.1.1.   Definitions

(a)

‘Lifting operation’ means a movement of unit loads consisting of goods and/or persons necessitating, at a given moment, a change of level.

(b)

‘Guided load’ means a load where the total movement is made along rigid or flexible guides whose position is determined by fixed points.

(c)

‘Working coefficient’ means the arithmetic ratio between the load guaranteed by the manufacturer or his authorised representative up to which a component is able to hold it and the maximum working load marked on the component.

(d)

‘Test coefficient’ means the arithmetic ratio between the load used to carry out the static or dynamic tests on lifting machinery or a lifting accessory and the maximum working load marked on the lifting machinery or lifting accessory.

(e)

‘Static test’ means the test during which lifting machinery or a lifting accessory is first inspected and subjected to a force corresponding to the maximum working load multiplied by the appropriate static test coefficient and then re-inspected once the said load has been released to ensure that no damage has occurred.

(f)

‘Dynamic test’ means the test during which lifting machinery is operated in all its possible configurations at the maximum working load multiplied by the appropriate dynamic test coefficient with account being taken of the dynamic behaviour of the lifting machinery in order to check that it functions properly.

(g)

‘Carrier’ means a part of the machinery on or in which persons and/or goods are supported in order to be lifted.

4.1.2.   Protection against mechanical hazards

4.1.2.1.   Risks due to lack of stability

Machinery must be designed and constructed in such a way that the stability required by section 1.3.1 is maintained both in service and out of service, including all stages of transportation, assembly and dismantling, during foreseeable component failures and also during the tests carried out in accordance with the instruction handbook. To that end, the manufacturer or his authorised representative must use the appropriate verification methods.

4.1.2.2.   Machinery running on guide rails and rail tracks

Machinery must be provided with devices which act on the guide rails or tracks to prevent derailment.

If, despite such devices, there remains a risk of derailment or of failure of a rail or of a running component, devices must be provided which prevent the equipment, component or load from falling or the machinery from overturning.

4.1.2.3.   Mechanical strength

Machinery, lifting accessories and their components must be capable of withstanding the stresses to which they are subjected, both in and, where applicable, out of use, under the installation and operating conditions provided for and in all relevant configurations, with due regard, where appropriate, to the effects of atmospheric factors and forces exerted by persons. This requirement must also be satisfied during transport, assembly and dismantling.

Machinery and lifting accessories must be designed and constructed in such a way as to prevent failure from fatigue and wear, taking due account of their intended use.

The materials used must be chosen on the basis of the intended working environments, with particular regard to corrosion, abrasion, impacts, extreme temperatures, fatigue, brittleness and ageing.

Machinery and lifting accessories must be designed and constructed in such a way as to withstand the overload in the static tests without permanent deformation or patent defect. Strength calculations must take account of the value of the static test coefficient chosen to guarantee an adequate level of safety. That coefficient has, as a general rule, the following values:

(a)

manually-operated machinery and lifting accessories: 1,5;

(b)

other machinery: 1,25.

Machinery must be designed and constructed in such a way as to undergo, without failure, the dynamic tests carried out using the maximum working load multiplied by the dynamic test coefficient. This dynamic test coefficient is chosen so as to guarantee an adequate level of safety: the coefficient is, as a general rule, equal to 1,1. As a general rule, the tests will be performed at the nominal speeds provided for. Should the control circuit of the machinery allow for a number of simultaneous movements, the tests must be carried out under the least favourable conditions, as a general rule by combining the movements concerned.

4.1.2.4.   Pulleys, drums, wheels, ropes and chains

Pulleys, drums and wheels must have a diameter commensurate with the size of the ropes or chains with which they can be fitted.

Drums and wheels must be designed, constructed and installed in such a way that the ropes or chains with which they are equipped can be wound without coming off.

Ropes used directly for lifting or supporting the load must not include any splicing other than at their ends. Splicings are, however, tolerated in installations which are intended by design to be modified regularly according to needs of use.

Complete ropes and their endings must have a working coefficient chosen in such a way as to guarantee an adequate level of safety. As a general rule, this coefficient is equal to 5.

Lifting chains must have a working coefficient chosen in such a way as to guarantee an adequate level of safety. As a general rule, this coefficient is equal to 4.

In order to verify that an adequate working coefficient has been attained, the manufacturer or his authorised representative must, for each type of chain and rope used directly for lifting the load and for the rope ends, perform the appropriate tests or have such tests performed.

4.1.2.5.   Lifting accessories and their components

Lifting accessories and their components must be sized with due regard to fatigue and ageing processes for a number of operating cycles consistent with their expected life-span as specified in the operating conditions for a given application.

Moreover:

(a)

the working coefficient of wire-rope/rope-end combinations must be chosen in such a way as to guarantee an adequate level of safety; this coefficient is, as a general rule, equal to 5. Ropes must not comprise any splices or loops other than at their ends;

(b)

where chains with welded links are used, they must be of the short-link type. The working coefficient of chains must be chosen in such a way as to guarantee an adequate level of safety; this coefficient is, as a general rule, equal to 4;

(c)

the working coefficient for textile ropes or slings is dependent on the material, method of manufacture, dimensions and use. This coefficient must be chosen in such a way as to guarantee an adequate level of safety; it is, as a general rule, equal to 7, provided the materials used are shown to be of very good quality and the method of manufacture is appropriate to the intended use. Should this not be the case, the coefficient is, as a general rule, set at a higher level in order to secure an equivalent level of safety. Textile ropes and slings must not include any knots, connections or splicing other than at the ends of the sling, except in the case of an endless sling;

(d)

all metallic components making up, or used with, a sling must have a working coefficient chosen in such a way as to guarantee an adequate level of safety; this coefficient is, as a general rule, equal to 4;

(e)

the maximum working load of a multilegged sling is determined on the basis of the working coefficient of the weakest leg, the number of legs and a reduction factor which depends on the slinging configuration;

(f)

in order to verify that an adequate working coefficient has been attained, the manufacturer or his authorised representative must, for each type of component referred to in (a), (b), (c) and (d), perform the appropriate tests or have such tests performed.

4.1.2.6.   Control of movements

Devices for controlling movements must act in such a way that the machinery on which they are installed is kept safe.

(a)

Machinery must be designed and constructed or fitted with devices in such a way that the amplitude of movement of its components is kept within the specified limits. The operation of such devices must, where appropriate, be preceded by a warning.

(b)

Where several fixed or rail-mounted machines can be manoeuvred simultaneously in the same place, with risks of collision, such machinery must be designed and constructed in such a way as to make it possible to fit systems enabling these risks to be avoided.

(c)

Machinery must be designed and constructed in such a way that the loads cannot creep dangerously or fall freely and unexpectedly, even in the event of partial or total failure of the power supply or when the operator stops operating the machine.

(d)

It must not be possible, under normal operating conditions, to lower the load solely by friction brake, except in the case of machinery whose function requires it to operate in that way.

(e)

Holding devices must be designed and constructed in such a way that inadvertent dropping of the loads is avoided.

4.1.2.7.   Movements of loads during handling

The operating position of machinery must be located in such a way as to ensure the widest possible view of trajectories of the moving parts, in order to avoid possible collisions with persons, equipment or other machinery which might be manoeuvring at the same time and liable to constitute a hazard.

Machinery with guided loads must be designed and constructed in such a way as to prevent persons from being injured by movement of the load, the carrier or the counterweights, if any.

4.1.2.8.   Machinery serving fixed landings

4.1.2.8.1.   Movements of the carrier

The movement of the carrier of machinery serving fixed landings must be rigidly guided to and at the landings. Scissor systems are also regarded as rigid guidance.

4.1.2.8.2.   Access to the carrier

Where persons have access to the carrier, the machinery must be designed and constructed in such a way as to ensure that the carrier remains stationary during access, in particular while it is being loaded or unloaded.

The machinery must be designed and constructed in such a way as to ensure that the difference in level between the carrier and the landing being served does not create a risk of tripping.

4.1.2.8.3.   Risks due to contact with the moving carrier

Where necessary in order to fulfil the requirement expressed in the second paragraph of section 4.1.2.7, the travel zone must be rendered inaccessible during normal operation.

When, during inspection or maintenance, there is a risk that persons situated under or above the carrier may be crushed between the carrier and any fixed parts, sufficient free space must be provided either by means of physical refuges or by means of mechanical devices blocking the movement of the carrier.

4.1.2.8.4.   Risk due to the load falling off the carrier

Where there is a risk due to the load falling off the carrier, the machinery must be designed and constructed in such a way as to prevent this risk.

4.1.2.8.5.   Landings

Risks due to contact of persons at landings with the moving carrier or other moving parts must be prevented.

Where there is a risk due to persons falling into the travel zone when the carrier is not present at the landings, guards must be fitted in order to prevent this risk. Such guards must not open in the direction of the travel zone. They must be fitted with an interlocking device controlled by the position of the carrier that prevents:

—

hazardous movements of the carrier until the guards are closed and locked,

—

hazardous opening of a guard until the carrier has stopped at the corresponding landing.

4.1.3.   Fitness for purpose

When lifting machinery or lifting accessories are placed on the market or are first put into service, the manufacturer or his authorised representative must ensure, by taking appropriate measures or having them taken, that the machinery or the lifting accessories which are ready for use — whether manually or power-operated — can fulfil their specified functions safely.

The static and dynamic tests referred to in section 4.1.2.3 must be performed on all lifting machinery ready to be put into service.

Where the machinery cannot be assembled in the manufacturer's premises or in the premises of his authorised representative, the appropriate measures must be taken at the place of use. Otherwise, the measures may be taken either in the manufacturer's premises or at the place of use.

4.2.   REQUIREMENTS FOR MACHINERY WHOSE POWER SOURCE IS OTHER THAN MANUAL EFFORT

4.2.1.   Control of movements

Hold-to-run control devices must be used to control the movements of the machinery or its equipment. However, for partial or complete movements in which there is no risk of the load or the machinery colliding, the said devices may be replaced by control devices authorising automatic stops at pre-selected positions without the operator holding a hold-to-run control device.

4.2.2.   Loading control

Machinery with a maximum working load of not less than 1 000 kilograms or an overturning moment of not less than 40 000 Nm must be fitted with devices to warn the driver and prevent dangerous movements in the event:

—

of overloading, either as a result of the maximum working load or the maximum working moment due to the load being exceeded, or

—

of the overturning moment being exceeded.

4.2.3.   Installations guided by ropes

Rope carriers, tractors or tractor carriers must be held by counterweights or by a device allowing permanent control of the tension.

4.3.   INFORMATION AND MARKINGS

4.3.1.   Chains, ropes and webbing

Each length of lifting chain, rope or webbing not forming part of an assembly must bear a mark or, where this is not possible, a plate or irremovable ring bearing the name and address of the manufacturer or his authorised representative and the identifying reference of the relevant certificate.

The certificate mentioned above must show at least the following information:

(a)

the name and address of the manufacturer and, if appropriate, his authorised representative;

(b)

a description of the chain or rope which includes:

—

its nominal size,

—

its construction,

—

the material from which it is made, and

—

any special metallurgical treatment applied to the material;

(c)

the test method used;

(d)

the maximum load to which the chain or rope should be subjected in service. A range of values may be given on the basis of the intended applications.

4.3.2.   Lifting accessories

Lifting accessories must show the following particulars:

—

identification of the material where this information is needed for safe use,

—

the maximum working load.

In the case of lifting accessories on which marking is physically impossible, the particulars referred to in the first paragraph must be displayed on a plate or other equivalent means and securely affixed to the accessory.

The particulars must be legible and located in a place where they are not liable to disappear as a result of wear or jeopardise the strength of the accessory.

4.3.3.   Lifting machinery

The maximum working load must be prominently marked on the machinery. This marking must be legible, indelible and in an un-coded form.

Where the maximum working load depends on the configuration of the machinery, each operating position must be provided with a load plate indicating, preferably in diagrammatic form or by means of tables, the working load permitted for each configuration.

Machinery intended for lifting goods only, equipped with a carrier which allows access to persons, must bear a clear and indelible warning prohibiting the lifting of persons. This warning must be visible at each place where access is possible.

4.4.   INSTRUCTIONS

4.4.1.   Lifting accessories

Each lifting accessory or each commercially indivisible batch of lifting accessories must be accompanied by instructions setting out at least the following particulars:

(a)

the intended use;

(b)

the limits of use (particularly for lifting accessories such as magnetic or vacuum pads which do not fully comply with section 4.1.2.6(e));

(c)

instructions for assembly, use and maintenance;

(d)

the static test coefficient used.

4.4.2.   Lifting machinery

Lifting machinery must be accompanied by instructions containing information on:

(a)

the technical characteristics of the machinery, and in particular:

—

the maximum working load and, where appropriate, a copy of the load plate or load table described in the second paragraph of section 4.3.3,

—

the reactions at the supports or anchors and, where appropriate, characteristics of the tracks,

—

where appropriate, the definition and the means of installation of the ballast;

(b)

the contents of the logbook, if the latter is not supplied with the machinery;

(c)

advice for use, particularly to offset the lack of direct vision of the load by the operator;

(d)

where appropriate, a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representative;

(e)

for machinery which is not assembled on the premises of the manufacturer in the form in which it is to be used, the necessary instructions for performing the measures referred to in section 4.1.3 before it is first put into service.

5.   SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR MACHINERY INTENDED FOR UNDERGROUND WORK

Machinery intended for underground work must meet all the essential health and safety requirements described in this chapter (see General Principles, point 4).

5.1.   RISKS DUE TO LACK OF STABILITY

Powered roof supports must be designed and constructed in such a way as to maintain a given direction when moving and not slip before and while they come under load and after the load has been removed. They must be equipped with anchorages for the top plates of the individual hydraulic props.

5.2.   MOVEMENT

Powered roof supports must allow for unhindered movement of persons.

5.3.   CONTROL DEVICES

The accelerator and brake controls for movement of machinery running on rails must be hand-operated. However, enabling devices may be foot-operated.

The control devices of powered roof supports must be designed and positioned in such a way that, during displacement operations, operators are sheltered by a support in place. The control devices must be protected against any accidental release.

5.4.   STOPPING

Self-propelled machinery running on rails for use in underground work must be equipped with an enabling device acting on the circuit controlling the movement of the machinery such that movement is stopped if the driver is no longer in control of the movement.

5.5.   FIRE

The second indent of section 3.5.2 is mandatory in respect of machinery which comprises highly flammable parts.

The braking system of machinery intended for use in underground workings must be designed and constructed in such a way that it does not produce sparks or cause fires.

Machinery with internal combustion engines for use in underground workings must be fitted only with engines using fuel with a low vaporising pressure and which exclude any spark of electrical origin.

5.6.   EXHAUST EMISSIONS

Exhaust emissions from internal combustion engines must not be discharged upwards.

6.   SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR MACHINERY PRESENTING PARTICULAR HAZARDS DUE TO THE LIFTING OF PERSONS

Machinery presenting hazards due to the lifting of persons must meet all the relevant essential health and safety requirements described in this chapter (see General Principles, point 4).

6.1.   GENERAL

6.1.1.   Mechanical strength

The carrier, including any trapdoors, must be designed and constructed in such a way as to offer the space and strength corresponding to the maximum number of persons permitted on the carrier and the maximum working load.

The working coefficients for components set out in sections 4.1.2.4 and 4.1.2.5 are inadequate for machinery intended for the lifting of persons and must, as a general rule, be doubled. Machinery intended for lifting persons or persons and goods must be fitted with a suspension or supporting system for the carrier designed and constructed in such a way as to ensure an adequate overall level of safety and to prevent the risk of the carrier falling.

If ropes or chains are used to suspend the carrier, as a general rule, at least two independent ropes or chains are required, each with its own anchorage.

6.1.2.   Loading control for machinery moved by power other than human strength

The requirements of section 4.2.2 apply regardless of the maximum working load and overturning moment, unless the manufacturer can demonstrate that there is no risk of overloading or overturning.

6.2.   CONTROL DEVICES

Where safety requirements do not impose other solutions, the carrier must, as a general rule, be designed and constructed in such a way that persons in the carrier have means of controlling upward and downward movements and, if appropriate, other movements of the carrier.

In operation, those control devices must override any other devices controlling the same movement with the exception of emergency stop devices.

The control devices for these movements must be of the hold-to-run type except where the carrier itself is completely enclosed.

6.3.   RISKS TO PERSONS IN OR ON THE CARRIER

6.3.1.   Risks due to movements of the carrier

Machinery for lifting persons must be designed, constructed or equipped in such a way that the acceleration or deceleration of the carrier does not engender risks for persons.

6.3.2.   Risk of persons falling from the carrier

The carrier must not tilt to an extent which creates a risk of the occupants falling, including when the machinery and carrier are moving.

Where the carrier is designed as a work station, provision must be made to ensure stability and to prevent hazardous movements.

If the measures referred to in section 1.5.15 are not adequate, carriers must be fitted with a sufficient number of suitable anchorage points for the number of persons permitted on the carrier. The anchorage points must be strong enough for the use of personal protective equipment against falls from a height.

Any trapdoor in floors or ceilings or side doors must be designed and constructed in such a way as to prevent inadvertent opening and must open in a direction that obviates any risk of falling, should they open unexpectedly.

6.3.3.   Risk due to objects falling on the carrier

Where there is a risk of objects falling on the carrier and endangering persons, the carrier must be equipped with a protective roof.

6.4.   MACHINERY SERVING FIXED LANDINGS

6.4.1.   Risks to persons in or on the carrier

The carrier must be designed and constructed in such a way as to prevent risks due to contact between persons and/or objects in or on the carrier with any fixed or moving elements. Where necessary in order to fulfil this requirement, the carrier itself must be completely enclosed with doors fitted with an interlocking device that prevents hazardous movements of the carrier unless the doors are closed. The doors must remain closed if the carrier stops between landings where there is a risk of falling from the carrier.

The machinery must be designed, constructed and, where necessary, equipped with devices in such a way as to prevent uncontrolled upward or downward movement of the carrier. These devices must be able to stop the carrier at its maximum working load and at the foreseeable maximum speed.

The stopping action must not cause deceleration harmful to the occupants, whatever the load conditions.

6.4.2.   Controls at landings

Controls, other than those for emergency use, at landings must not initiate movements of the carrier when:

—

the control devices in the carrier are being operated,

—

the carrier is not at a landing.

6.4.3.   Access to the carrier

The guards at the landings and on the carrier must be designed and constructed in such a way as to ensure safe transfer to and from the carrier, taking into consideration the foreseeable range of goods and persons to be lifted.

6.5.   MARKINGS

The carrier must bear the information necessary to ensure safety including:

—

the number of persons permitted on the carrier,

—

the maximum working load.

ANNEX II

Declarations

1.   CONTENT

A.   EC DECLARATION OF CONFORMITY OF THE MACHINERY

This declaration and translations thereof must be drawn up under the same conditions as the instructions (see Annex I, section 1.7.4.1(a) and (b)), and must be typewritten or else handwritten in capital letters.

This declaration relates exclusively to the machinery in the state in which it was placed on the market, and excludes components which are added and/or operations carried out subsequently by the final user.

The EC declaration of conformity must contain the following particulars:

1.

business name and full address of the manufacturer and, where appropriate, his authorised representative;

2.

name and address of the person authorised to compile the technical file, who must be established in the Community;

3.

description and identification of the machinery, including generic denomination, function, model, type, serial number and commercial name;

4.

a sentence expressly declaring that the machinery fulfils all the relevant provisions of this Directive and where appropriate, a similar sentence declaring the conformity with other Directives and/or relevant provisions with which the machinery complies. These references must be those of the texts published in the Official Journal of the European Union;

5.

where appropriate, the name, address and identification number of the notified body which carried out the EC type-examination referred to in Annex IX and the number of the EC type-examination certificate;

6.

where appropriate, the name, address and identification number of the notified body which approved the full quality assurance system referred to in Annex X;

7.

where appropriate, a reference to the harmonised standards used, as referred to in Article 7(2);

8.

where appropriate, the reference to other technical standards and specifications used;

9.

the place and date of the declaration;

10.

the identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or his authorised representative.

B.   DECLARATION OF INCORPORATION OF PARTLY COMPLETED MACHINERY

This declaration and translations thereof must be drawn up under the same conditions as the instructions (see Annex 1, section 1.7.4.1(a) and (b)), and must be typewritten or else handwritten in capital letters.

The declaration of incorporation must contain the following particulars:

1.

business name and full address of the manufacturer of the partly completed machinery and, where appropriate, his authorised representative;

2.

name and address of the person authorised to compile the relevant technical documentation, who must be established in the Community;

3.

description and identification of the partly completed machinery including generic denomination, function, model, type, serial number and commercial name;

4.

a sentence declaring which essential requirements of this Directive are applied and fulfilled and that the relevant technical documentation is compiled in accordance with part B of Annex VII, and, where appropriate, a sentence declaring the conformity of the partly completed machinery with other relevant Directives. These references must be those of the texts published in the Official Journal of the European Union;

5.

an undertaking to transmit, in response to a reasoned request by the national authorities, relevant information on the partly completed machinery. This shall include the method of transmission and shall be without prejudice to the intellectual property rights of the manufacturer of the partly completed machinery;

6.

a statement that the partly completed machinery must not be put into service until the final machinery into which it is to be incorporated has been declared in conformity with the provisions of this Directive, where appropriate;

7.

the place and date of the declaration;

8.

the identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or his authorised representative.

2.   CUSTODY

The manufacturer of machinery or his authorised representative shall keep the original EC declaration of conformity for a period of at least 10 years from the last date of manufacture of the machinery.

The manufacturer of partly completed machinery or his authorised representative shall keep the original declaration of incorporation for a period of at least 10 years from the last date of manufacture of the partly completed machinery.

ANNEX III

CE marking

The CE conformity marking shall consist of the initials ‘CE’ taking the following form:

Image 1

If the CE marking is reduced or enlarged the proportions shown in the above drawing must be respected.

The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm. The minimum dimension may be waived for small-scale machinery.

The CE marking must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative, using the same technique.

Where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied, the CE marking must be followed by the identification number of the notified body.

ANNEX IV

Categories of machinery to which one of the procedures referred to in Article 12(3) and (4) must be applied

1.   

Circular saws (single- or multi-blade) for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:

1.1.

sawing machinery with fixed blade(s) during cutting, having a fixed bed or support with manual feed of the workpiece or with a demountable power feed;

1.2.

sawing machinery with fixed blade(s) during cutting, having a manually operated reciprocating saw-bench or carriage;

1.3

sawing machinery with fixed blade(s) during cutting, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading;

1.4.

sawing machinery with movable blade(s) during cutting, having mechanical movement of the blade, with manual loading and/or unloading.

2.   

Hand-fed surface planing machinery for woodworking.

3.   

Thicknessers for one-side dressing having a built-in mechanical feed device, with manual loading and/or unloading for woodworking.

4.   

Band-saws with manual loading and/or unloading for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:

4.1.

sawing machinery with fixed blade(s) during cutting, having a fixed or reciprocating-movement bed or support for the workpiece;

4.2.

sawing machinery with blade(s) assembled on a carriage with reciprocating motion.

5.   

Combined machinery of the types referred to in points 1 to 4 and in point 7 for working with wood and material with similar physical characteristics.

6.   

Hand-fed tenoning machinery with several tool holders for woodworking.

7.   

Hand-fed vertical spindle moulding machinery for working with wood and material with similar physical characteristics.

8.   

Portable chainsaws for woodworking.

9.   

Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s.

10.   

Injection or compression plastics-moulding machinery with manual loading or unloading.

11.   

Injection or compression rubber-moulding machinery with manual loading or unloading.

12.   

Machinery for underground working of the following types:

12.1.

locomotives and brake-vans;

12.2.

hydraulic-powered roof supports.

13.   

Manually loaded trucks for the collection of household refuse incorporating a compression mechanism.

14.   

Removable mechanical transmission devices including their guards.

15.   

Guards for removable mechanical transmission devices.

16.   

Vehicle servicing lifts.

17.   

Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than three metres.

18.   

Portable cartridge-operated fixing and other impact machinery.

19.   

Protective devices designed to detect the presence of persons.

20.   

Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9, 10 and 11.

21.   

Logic units to ensure safety functions.

22.   

Roll-over protective structures (ROPS).

23.   

Falling-object protective structures (FOPS).

ANNEX V

Indicative list of the safety components referred to in Article 2(c)

1.   

Guards for removable mechanical transmission devices.

2.   

Protective devices designed to detect the presence of persons.

3.   

Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in items 9, 10 and 11 of Annex IV.

4.   

Logic units to ensure safety functions.

5.   

Valves with additional means for failure detection intended for the control of dangerous movements on machinery.

6.   

Extraction systems for machinery emissions.

7.   

Guards and protective devices designed to protect persons against moving parts involved in the process on the machinery.

8.   

Monitoring devices for loading and movement control in lifting machinery.

9.   

Restraint systems to keep persons on their seats.

10.   

Emergency stop devices.

11.   

Discharging systems to prevent the build-up of potentially dangerous electrostatic charges.

12.   

Energy limiters and relief devices referred to in sections 1.5.7, 3.4.7 and 4.1.2.6 of Annex I.

13.   

Systems and devices to reduce the emission of noise and vibrations.

14.   

Roll-over protective structures (ROPS).

15.   

Falling-object protective structures (FOPS).

16.   

Two-hand control devices.

17.   

Components for machinery designed for lifting and/or lowering persons between different landings and included in the following list:

(a)

devices for locking landing doors;

(b)

devices to prevent the load-carrying unit from falling or unchecked upwards movement;

(c)

overspeed limitation devices;

(d)

energy-accumulating shock absorbers,

—

non-linear, or

—

with damping of the return movement;

(e)

energy-dissipating shock absorbers;

(f)

safety devices fitted to jacks of hydraulic power circuits where these are used as devices to prevent falls;

(g)

electric safety devices in the form of safety switches containing electronic components.

ANNEX VI

Assembly instructions for partly completed machinery

The assembly instructions for partly completed machinery must contain a description of the conditions which must be met with a view to correct incorporation in the final machinery, so as not to compromise safety and health.

The assembly instructions must be written in an official Community language acceptable to the manufacturer of the machinery in which the partly completed machinery will be assembled, or to his authorised representative.

ANNEX VII

A.   Technical file for machinery

This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the requirements of this Directive. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages, except for the instructions for the machinery, for which the special provisions of Annex I, section 1.7.4.1 apply.

 

1.

 The technical file shall comprise the following:

(a)

a construction file including:

—

a general description of the machinery,

—

the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery,

—

full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements,

—

the documentation on risk assessment demonstrating the procedure followed, including:

(i)

a list of the essential health and safety requirements which apply to the machinery,

(ii)

the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery,

—

the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards,

—

any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative,

—

a copy of the instructions for the machinery,

—

where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery,

—

where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery,

—

a copy of the EC declaration of conformity;

(b)

for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of this Directive.

The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file.
 

2.

 The technical file referred to in point 1 must be made available to the competent authorities of the Member States for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced.

The technical file does not have to be located in the territory of the Community, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity.

The technical file does not have to include detailed plans or any other specific information as regards the sub-assemblies used for the manufacture of the machinery unless a knowledge of them is essential for verification of conformity with the essential health and safety requirements.
 

3.

 Failure to present the technical file in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the essential health and safety requirements.

B.   Relevant technical documentation for partly completed machinery

This part describes the procedure for compiling relevant technical documentation. The documentation must show which requirements of this Directive are applied and fulfilled. It must cover the design, manufacture and operation of the partly completed machinery to the extent necessary for the assessment of conformity with the essential health and safety requirements applied. The documentation must be compiled in one or more official Community languages.

It shall comprise the following:

(a)

a construction file including:

—

the overall drawing of the partly completed machinery and drawings of the control circuits,

—

full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the partly completed machinery with the applied essential health and safety requirements,

—

the risk assessment documentation showing the procedure followed, including:

(i)

a list of the essential health and safety requirements applied and fulfilled,

(ii)

the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, where appropriate, the indication of the residual risks,

(iii)

the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards,

(iv)

any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative,

(v)

a copy of the assembly instructions for the partly completed machinery;

(b)

for series manufacture, the internal measures that will be implemented to ensure that the partly completed machinery remains in conformity with the essential health and safety requirements applied.

The manufacturer must carry out necessary research and tests on components, fittings or the partly completed machinery to determine whether by its design or construction it is capable of being assembled and used safely. The relevant reports and results shall be included in the technical file.

The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to the competent authorities of the Member States. It does not have to be located in the territory of the Community, nor does it have to be permanently available in material form. It must be capable of being assembled and presented to the relevant authority by the person designated in the declaration for incorporation.

Failure to present the relevant technical documentation in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the partly completed machinery with the essential health and safety requirements applied and attested.

ANNEX VIII

Assessment of conformity with internal checks on the manufacture of machinery

1.   

This Annex describes the procedure by which the manufacturer or his authorised representative, who carries out the obligations laid down in points 2 and 3, ensures and declares that the machinery concerned satisfies the relevant requirements of this Directive.

2.   

For each representative type of the series in question, the manufacturer or his authorised representative shall draw up the technical file referred to in Annex VII, part A.

3.   

The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured machinery with the technical file referred to in Annex VII, part A, and with the requirements of this Directive.

ANNEX IX

EC type-examination

EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative model of machinery referred to in Annex IV (hereafter named the type) satisfies the provisions of this Directive.

1.   

The manufacturer or his authorised representative must, for each type, draw up the technical file referred to in Annex VII, part A.

2.   

For each type, the application for an EC type-examination shall be submitted by the manufacturer or his authorised representative to a notified body of his choice.

The application shall include:

—

the name and address of the manufacturer and, where appropriate, his authorised representative,

—

a written declaration that the application has not been submitted to another notified body,

—

the technical file.

Moreover, the applicant shall place at the disposal of the notified body a sample of the type. The notified body may ask for further samples if the test programme so requires.

3.   

The notified body shall:

3.1.

examine the technical file, check that the type was manufactured in accordance with it and establish which elements have been designed in accordance with the relevant provisions of the standards referred to in Article 7(2), and those elements whose design is not based on the relevant provisions of those standards;

3.2.

carry out or have carried out appropriate inspections, measurements and tests to ascertain whether the solutions adopted satisfy the essential health and safety requirements of this Directive, where the standards referred to in Article 7(2) were not applied;

3.3.

where harmonised standards referred to in Article 7(2) were used, carry out or have carried out appropriate inspections, measurements and tests to verify that those standards were actually applied;

3.4.

agree with the applicant as to the place where the check that the type was manufactured in accordance with the examined technical file and the necessary inspections, measurements and tests will be carried out.

4.   

If the type satisfies the provisions of this Directive, the notified body shall issue the applicant with an EC type-examination certificate. The certificate shall include the name and address of the manufacturer and his authorised representative, the data necessary for identifying the approved type, the conclusions of the examination and the conditions to which its issue may be subject.

The manufacturer and the notified body shall retain a copy of this certificate, the technical file and all relevant documents for a period of 15 years from the date of issue of the certificate.

5.   

If the type does not satisfy the provisions of this Directive, the notified body shall refuse to issue the applicant with an EC type-examination certificate, giving detailed reasons for its refusal. It shall inform the applicant, the other notified bodies and the Member State which notified it. An appeal procedure must be available.

6.   

The applicant shall inform the notified body which retains the technical file relating to the EC type-examination certificate of all modifications to the approved type. The notified body shall examine these modifications and shall then either confirm the validity of the existing EC type-examination certificate or issue a new one if the modifications are liable to compromise conformity with the essential health and safety requirements or the intended working conditions of the type.

7.   

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC type-examination certificates. On reasoned request, the Commission and the Member States may obtain a copy of the technical file and the results of the examinations carried out by the notified body.

8.   

Files and correspondence referring to the EC type-examination procedures shall be written in the official Community language(s) of the Member State where the notified body is established or in any other official Community language acceptable to the notified body.

9.   

Validity of the EC type-examination certificate

9.1.   

The notified body has the ongoing responsibility of ensuring that the EC type-examination certificate remains valid. It shall inform the manufacturer of any major changes which would have an implication on the validity of the certificate. The notified body shall withdraw certificates which are no longer valid.

9.2.   

The manufacturer of the machinery concerned has the ongoing responsibility of ensuring that the said machinery meets the corresponding state of the art.

9.3.   

The manufacturer shall request from the notified body the review of the validity of the EC type-examination certificate every five years.

If the notified body finds that the certificate remains valid, taking into account the state of the art, it shall renew the certificate for a further five years.

The manufacturer and the notified body shall retain a copy of this certificate, of the technical file and of all the relevant documents for a period of 15 years from the date of issue of the certificate.

9.4.   

In the event that the validity of the EC-type examination certificate is not renewed, the manufacturer shall cease the placing on the market of the machinery concerned.

ANNEX X

Full quality assurance

This Annex describes the conformity assessment of machinery referred to in Annex IV, manufactured using a full quality assurance system, and the procedure whereby a notified body assesses and approves the quality system and monitors its application.

1.   

The manufacturer must operate an approved quality system for design, manufacture, final inspection and testing, as specified in point 2, and shall be subject to the surveillance referred to in point 3.

2.   

Quality system

2.1.   

The manufacturer or his authorised representative shall lodge an application for assessment of his quality system to a notified body of his choice.

The application shall contain:

—

the name and address of the manufacturer and, where appropriate, his authorised representative,

—

the places of design, manufacture, inspection, testing and storage of the machinery,

—

the technical file described in Annex VII, Part A, for one model of each category of machinery referred to in Annex IV which he intends to manufacture,

—

the documentation on the quality system,

—

a written declaration that the application has not been submitted to another notified body.

2.2.   

The quality system must ensure conformity of the machinery with the provisions of this Directive. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner, in the form of measures, procedures and written instructions. The documentation on the quality system must permit a uniform interpretation of the procedural and quality measures, such as quality programmes, plans, manuals and records.

It must contain, in particular, an adequate description of:

—

the quality objectives, the organisational structure, and the responsibilities and powers of the management with regard to the design and quality of the machinery,

—

the technical design specifications, including standards that will be applied and, where the standards referred to in Article 7(2) are not applied in full, the means that will be used to ensure that the essential health and safety requirements of this Directive are fulfilled,

—

the design inspection and design verification techniques, processes and systematic actions that will be used when designing machinery covered by this Directive,

—

the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

—

the inspections and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

—

the quality records, such as inspection reports and test data, calibration data, and reports on the qualifications of the personnel concerned,

—

the means of monitoring the achievement of the required design and quality of the machinery, as well as the effective operation of the quality system.

2.3.   

The notified body shall assess the quality system to determine whether it satisfies the requirements of point 2.2.

The elements of the quality system which conform to the relevant harmonised standard shall be presumed to conform to the corresponding requirements referred to in point 2.2.

The team of auditors must have at least one member who is experienced in the assessment of the technology of the machinery. The assessment procedure shall include an inspection to be carried out at the manufacturer's premises. During the assessment, the team of auditors shall carry out a review of the technical files referred to in point 2.1, second paragraph, third indent to ensure their compliance with the relevant health and safety requirements.

The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. An appeal procedure must be available.

2.4.   

The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to ensure that it remains appropriate and effective.

The manufacturer or his authorised representative shall inform the notified body which approved the quality system of any planned change to it.

The notified body shall evaluate the proposed changes and decide whether the modified quality assurance system will continue to satisfy the requirements referred to in point 2.2, or whether a re-assessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

3.   

Surveillance under the responsibility of the notified body

3.1.   

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

3.2.   

The manufacturer shall, for inspection purposes, allow the notified body access to the places of design, manufacture, inspection, testing and storage, and shall provide it with all necessary information, such as:

—

the documentation concerning the quality system,

—

the quality records provided for in that part of the quality system concerned with design, such as the results of analyses, calculations, tests, etc.,

—

the quality records provided for in that part of the quality system concerned with manufacture, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.

3.3.   

The notified body shall conduct periodic audits to make sure that the manufacturer is maintaining and applying the quality system; it shall provide the manufacturer with an audit report. The frequency of the periodic audits shall be such that a full reassessment is carried out every three years.

3.4.   

Moreover, the notified body may pay the manufacturer unannounced visits. The need for these additional visits and their frequency will be determined on the basis of a visit monitoring system managed by the notified body. In particular, the following factors will be taken into account in the visits monitoring system:

—

the results of previous surveillance visits,

—

the need to monitor remedial measures,

—

where appropriate, special conditions attaching to approval of the system,

—

significant modifications in the organisation of the manufacturing process, measures or techniques.

On the occasion of such visits, the notified body may, if necessary, carry out tests or have them carried out in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if a test was carried out, with a test report.

4.   

The manufacturer or his authorised representative shall keep available for the national authorities, for a period of ten years from the last date of manufacture:

—

the documentation referred to in point 2.1,

—

the decisions and reports of the notified body referred to in point 2.4, third and fourth subparagraphs, and in points 3.3 and 3.4.

ANNEX XI

Minimum criteria to be taken into account by Member States for the notification of bodies

1.   

The body, its director and the staff responsible for carrying out the verification tests shall not be the designer, manufacturer, supplier or installer of machines which they inspect, nor the authorised representative of any of these parties. They shall not become involved, either directly or as authorised representatives, in the design, construction, marketing or maintenance of the machines. This does not preclude the possibility of exchanges of technical information between the manufacturer and the body.

2.   

The body and its staff shall carry out the verification tests with the highest degree of professional integrity and technical competence and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of the inspection, especially from persons or groups of persons with an interest in the result of verifications.

3.   

For each category of machinery for which it is notified, the body must possess personnel with technical knowledge and sufficient and appropriate experience to perform a conformity assessment. It must have the means necessary to complete the technical and administrative tasks connected with implementation of the checks in an appropriate manner; it must also have access to the equipment necessary for the exceptional checks.

4.   

The staff responsible for inspection shall have:

—

sound technical and vocational training,

—

satisfactory knowledge of the requirements of the tests they carry out and adequate experience of such tests,

—

the ability to draw up the certificates, records and reports required to authenticate the performance of the tests.

5.   

The impartiality of inspection staff shall be guaranteed. Their remuneration shall not depend on the number of tests carried out or on the results of such tests.

6.   

The body shall take out liability insurance unless its liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the tests.

7.   

The staff of the body shall be bound to observe professional secrecy with regard to all information obtained in carrying out its tasks (except vis-à-vis the competent administrative authorities of the State in which its activities are carried out) under this Directive or any provision of national law giving effect to it.

8.   

Notified bodies shall participate in coordination activities. They shall also take part directly or be represented in European standardisation, or ensure that they know the situation in respect of relevant standards.

9.   

Member States may take all necessary measures they regard as necessary in order to ensure that, in the event of cessation of the activities of a notified body, the files of its customers are sent to another body or are made available to the Member State which has notified it.

ANNEX XII

Correlation table (1)

Directive 98/37/EC

This Directive

Article 1(1)

Article 1(1)

Article 1(2)(a)

Article 2(a) and (b)

Article 1(2)(b)

Article 2(c)

Article 1(3)

Article 1(2)

Article 1(4)

Article 3

Article 1(5)

—

Article 2(1)

Article 4(1)

Article 2(2)

Article 15

Article 2(3)

Article 6(3)

Article 3

Article 5(1)(a)

Article 4(1)

Article 6(1)

Article 4(2), first subparagraph

Article 6(2)

Article 4(2), second subparagraph

—

Article 4(3)

—

Article 5(1), first subparagraph

Article 7(1)

Article 5(1), second subparagraph

—

Article 5(2), first subparagraph

Article 7(2) and (3)

Article 5(2), last subparagraph

—

Article 5(3)

Article 7(4)

Article 6(1)

Article 10

Article 6(2)

Article 22

Article 7(1)

Article 11(1) and (2)

Article 7(2)

Article 11(3) and (4)

Article 7(3)

Article 11(4)

Article 7(4)

Article 11(5)

Article 8(1), first subparagraph

Article 5(1)(e) and Article 12(1)

Article 8(1), second subparagraph

Article 5(1)(f)

Article 8(2)(a)

Article 12(2)

Article 8(2)(b)

Article 12(4)

Article 8(2)(c)

Article 12(3)

Article 8(3)

—

Article 8(4)

—

Article 8(5)

—

Article 8(6)

Article 5(4)

Article 8(7)

—

Article 8(8)

—

Article 9(1), first subparagraph

Article 14(1)

Article 9(1), second subparagraph

Article 14(4)

Article 9(2)

Article 14(3) and (5)

Article 9(3)

Article 14(8)

Article 10(1 to 3)

Article 16(1) to (3)

Article 10(4)

Article 17

Article 11

Article 20

Article 12

Article 21

Article 13(1)

Article 26(2)

Article 13(2)

—

Article 14

—

Article 15

Article 28

Article 16

Article 29

Annex I — Preliminary observation 1

Annex I — General Principles point 2

Annex I — Preliminary observation 2

Annex I — General Principles point 3

Annex I — Preliminary observation 3

Annex I — General Principles point 4

Annex I, Part 1

Annex I, Part 1

Annex I, Section 1.1.

Annex I, Section 1.1.

Annex I, Section 1.1.1.

Annex I, Section 1.1.1.

Annex I, Section 1.1.2.

Annex I, Section 1.1.2.

Annex I, Section 1.1.2(d)

Annex I, Section 1.1.6.

Annex I, Section 1.1.3.

Annex I, Section 1.1.3.

Annex I, Section 1.1.4.

Annex I, Section 1.1.4.

Annex I, Section 1.1.5.

Annex I, Section 1.1.5.

Annex I, Section 1.2.

Annex I, Section 1.2.

Annex I, Section 1.2.1.

Annex I, Section 1.2.1.

Annex I, Section 1.2.2.

Annex I, Section 1.2.2.

Annex I, Section 1.2.3.

Annex I, Section 1.2.3.

Annex I, Section 1.2.4.

Annex I, Section 1.2.4.

Annex I, Section 1.2.4., paragraphs 1 to 3

Annex I, Section 1.2.4.1.

Annex I, Section 1.2.4., paragraphs 4 to 6

Annex I, Section 1.2.4.3.

Annex I, Section 1.2.4., paragraph 7

Annex I, Section 1.2.4.4.

Annex I, Section 1.2.5.

Annex I, Section 1.2.5.

Annex I, Section 1.2.6.

Annex I, Section 1.2.6.

Annex I, Section 1.2.7.

Annex I, Section 1.2.1.

Annex I, Section 1.2.8.

Annex I, Section 1.1.6.

Annex I, Section 1.3

Annex I, Section 1.3

Annex I, Section 1.3.1.

Annex I, Section 1.3.1.

Annex I, Section 1.3.2.

Annex I, Section 1.3.2.

Annex I, Section 1.3.3.

Annex I, Section 1.3.3.

Annex I, Section 1.3.4.

Annex I, Section 1.3.4.

Annex I, Section 1.3.5.

Annex I, Section 1.3.5.

Annex I, Section 1.3.6.

Annex I, Section 1.3.6.

Annex I, Section 1.3.7.

Annex I, Section 1.3.7.

Annex I, Section 1.3.8

Annex I, Section 1.3.8.

Annex I, Section 1.3.8 A

Annex I, Section 1.3.8.1.

Annex I, Section 1.3.8 B

Annex I, Section 1.3.8.2.

Annex I, Section 1.4.

Annex I, Section 1.4.

Annex I, Section 1.4.1.

Annex I, Section 1.4.1.

Annex I, Section 1.4.2.

Annex I, Section 1.4.2.

Annex I, Section 1.4.2.1.

Annex I, Section 1.4.2.1.

Annex I, Section 1.4.2.2.

Annex I, Section 1.4.2.2.

Annex I, Section 1.4.2.3.

Annex I, Section 1.4.2.3.

Annex I, Section 1.4.3.

Annex I, Section 1.4.3.

Annex I, Section 1.5.

Annex I, Section 1.5.

Annex I, Section 1.5.1.

Annex I, Section 1.5.1.

Annex I, Section 1.5.2.

Annex I, Section 1.5.2.

Annex I, Section 1.5.3.

Annex I, Section 1.5.3.

Annex I, Section 1.5.4.

Annex I, Section 1.5.4.

Annex I, Section 1.5.5.

Annex I, Section 1.5.5.

Annex I, Section 1.5.6.

Annex I, Section 1.5.6.

Annex I, Section 1.5.7.

Annex I, Section 1.5.7.

Annex I, Section 1.5.8.

Annex I, Section 1.5.8.

Annex I, Section 1.5.9.

Annex I, Section 1.5.9.

Annex I, Section 1.5.10.

Annex I, Section 1.5.10.

Annex I, Section 1.5.11.

Annex I, Section 1.5.11.

Annex I, Section 1.5.12.

Annex I, Section 1.5.12.

Annex I, Section 1.5.13.

Annex I, Section 1.5.13.

Annex I, Section 1.5.14.

Annex I, Section 1.5.14.

Annex I, Section 1.5.15.

Annex I, Section 1.5.15.

Annex I, Section 1.6.

Annex I, Section 1.6.

Annex I, Section 1.6.1.

Annex I, Section 1.6.1.

Annex I, Section 1.6.2.

Annex I, Section 1.6.2.

Annex I, Section 1.6.3.

Annex I, Section 1.6.3.

Annex I, Section 1.6.4.

Annex I, Section 1.6.4.

Annex I, Section 1.6.5.

Annex I, Section 1.6.5.

Annex I, Section 1.7.

Annex I, Section 1.7.

Annex I, Section 1.7.0.

Annex I, Section 1.7.1.1.

Annex I, Section 1.7.1.

Annex I, Section 1.7.1.2.

Annex I, Section 1.7.2.

Annex I, Section 1.7.2.

Annex I, Section 1.7.3.

Annex I, Section 1.7.3.

Annex I, Section 1.7.4.

Annex I, Section 1.7.4.

Annex I, Section 1.7.4.(b) and (h)

Annex I, Section 1.7.4.1.

Annex I, Section 1.7.4.(a) and (c) and (e) to (g)

Annex I, Section 1.7.4.2.

Annex I, Section 1.7.4.(d)

Annex I, Section 1.7.4.3.

Annex I, Part 2

Annex I, Part 2

Annex I, Section 2.1.

Annex I, Section 2.1.

Annex I, Section 2.1., paragraph 1

Annex I, Section 2.1.1.

Annex I, Section 2.1., paragraph 2

Annex I, Section 2.1.2.

Annex I, Section 2.2.

Annex I, Section 2.2.

Annex I, Section 2.2., paragraph 1

Annex I, Section 2.2.1.

Annex I, Section 2.2., paragraph 2

Annex I, Section 2.2.1.1.

Annex I, Section 2.3.

Annex I, Section 2.3.

Annex I, Part 3

Annex I, Part 3

Annex I, Section 3.1.

Annex I, Section 3.1.

Annex I, Section 3.1.1.

Annex I, Section 3.1.1.

Annex I, Section 3.1.2.

Annex I, Section 1.1.4.

Annex I, Section 3.1.3.

Annex I, Section 1.1.5.

Annex I, Section 3.2.

Annex I, Section 3.2.

Annex I, Section 3.2.1.

Annex I, Section 1.1.7. and 3.2.1.

Annex I, Section 3.2.2.

Annex I, Sections 1.1.8. and 3.2.2.

Annex I, Section 3.2.3.

Annex I, Section 3.2.3.

Annex I, Section 3.3.

Annex I, Section 3.3.

Annex I, Section 3.3.1.

Annex I, Section 3.3.1.

Annex I, Section 3.3.2.

Annex I, Section 3.3.2.

Annex I, Section 3.3.3.

Annex I, Section 3.3.3.

Annex I, Section 3.3.4.

Annex I, Section 3.3.4.

Annex I, Section 3.3.5.

Annex I, Section 3.3.5.

Annex I, Section 3.4.

Annex I, Section 3.4.

Annex I, Section 3.4.1., paragraph 1

Annex I, Section 1.3.9.

Annex I, Section 3.4.1., paragraph 2

Annex I, Section 3.4.1.

Annex I, Section 3.4.2.

Annex I, Section 1.3.2.

Annex I, Section 3.4.3.

Annex I, Section 3.4.3.

Annex I, Section 3.4.4.

Annex I, Section 3.4.4.

Annex I, Section 3.4.5.

Annex I, Section 3.4.5.

Annex I, Section 3.4.6.

Annex I, Section 3.4.6.

Annex I, Section 3.4.7.

Annex I, Section 3.4.7.

Annex I, Section 3.4.8.

Annex I, Section 3.4.2.

Annex I, Section 3.5.

Annex I, Section 3.5.

Annex I, Section 3.5.1.

Annex I, Section 3.5.1.

Annex I, Section 3.5.2.

Annex I, Section 3.5.2.

Annex I, Section 3.5.3.

Annex I, Section 3.5.3.

Annex I, Section 3.6.

Annex I, Section 3.6.

Annex I, Section 3.6.1.

Annex I, Section 3.6.1.

Annex I, Section 3.6.2.

Annex I, Section 3.6.2.

Annex I, Section 3.6.3.

Annex I, Section 3.6.3.

Annex I, Section 3.6.3(a)

Annex I, Section 3.6.3.1.

Annex I, Section 3.6.3(b)

Annex I, Section 3.6.3.2.

Annex I, Part 4

Annex I, Part 4

Annex I, Section 4.1.

Annex I, Section 4.1.

Annex I, Section 4.1.1.

Annex I, Section 4.1.1.

Annex I, Section 4.1.2.

Annex I, Section 4.1.2.

Annex I, Section 4.1.2.1.

Annex I, Section 4.1.2.1.

Annex I, Section 4.1.2.2.

Annex I, Section 4.1.2.2.

Annex I, Section 4.1.2.3.

Annex I, Section 4.1.2.3.

Annex I, Section 4.1.2.4.

Annex I, Section 4.1.2.4.

Annex I, Section 4.1.2.5.

Annex I, Section 4.1.2.5.

Annex I, Section 4.1.2.6.

Annex I, Section 4.1.2.6.

Annex I, Section 4.1.2.7.

Annex I, Section 4.1.2.7.

Annex I, Section 4.1.2.8.

Annex I, Section 1.5.16.

Annex I, Section 4.2.

Annex I, Section 4.2.

Annex I, Section 4.2.1.

—

Annex I, Section 4.2.1.1.

Annex I, Section 1.1.7.

Annex I, Section 4.2.1.2.

Annex I, Section 1.1.8.

Annex I, Section 4.2.1.3.

Annex I, Section 4.2.1.

Annex I, Section 4.2.1.4.

Annex I, Section 4.2.2.

Annex I, Section 4.2.2.

Annex I, Section 4.2.3.

Annex I, Section 4.2.3.

Annex I, Sections 4.1.2.7. and 4.1.2.8.2.

Annex I, Section 4.2.4.

Annex I, Section 4.1.3.

Annex I, Section 4.3.

Annex I, Section 4.3.

Annex I, Section 4.3.1.

Annex I, Section 4.3.1.

Annex I, Section 4.3.2.

Annex I, Section 4.3.2.

Annex I, Section 4.3.3.

Annex I, Section 4.3.3.

Annex I, Section 4.4.

Annex I, Section 4.4.

Annex I, Section 4.4.1.

Annex I, Section 4.4.1.

Annex I, Section 4.4.2.

Annex I, Section 4.4.2.

Annex I, Part 5

Annex I, Part 5

Annex I, Section 5.1.

Annex I, Section 5.1.

Annex I, Section 5.2.

Annex I, Section 5.2.

Annex I, Section 5.3.

—

Annex I, Section 5.4.

Annex I, Section 5.3.

Annex I, Section 5.5.

Annex I, Section 5.4.

Annex I, Section 5.6.

Annex I, Section 5.5.

Annex I, Section 5.7.

Annex I, Section 5.6.

Annex I, Part 6

Annex I, Part 6

Annex I, Section 6.1.

Annex I, Section 6.1.

Annex I, Section 6.1.1.

Annex I, Section 4.1.1.(g)

Annex I, Section 6.1.2.

Annex I, Section 6.1.1.

Annex I, Section 6.1.3.

Annex I, Section 6.1.2.

Annex I, Section 6.2.

Annex I, Section 6.2.

Annex I, Section 6.2.1.

Annex I, Section 6.2.

Annex I, Section 6.2.2.

Annex I, Section 6.2.

Annex I, Section 6.2.3.

Annex I, Section 6.3.1.

Annex I, Section 6.3.

Annex I, Section 6.3.2.

Annex I, Section 6.3.1.

Annex I, Section 6.3.2., paragraph 3

Annex I, Section 6.3.2.

Annex I, Section 6.3.2., paragraph 4

Annex I, Section 6.3.3.

Annex I, Section 6.3.2., paragraph 1

Annex I, Section 6.4.1.

Annex I, Sections 4.1.2.1., 4.1.2.3. and 6.1.1.

Annex I, Section 6.4.2.

Annex I, Section 6.3.1.

Annex I, Section 6.5.

Annex I, Section 6.5.

Annex II, Parts A and B

Annex II, Part 1,Section A

Annex II, Part C

—

Annex III

Annex III

Annex IV.A.1 (1.1. to 1.4)

Annex IV.1 (1.1. to 1.4)

Annex IV.A.2

Annex IV.2

Annex IV.A.3

Annex IV.3

Annex IV.A.4

Annex IV.4 (4.1 and 4.2)

Annex IV.A.5

Annex IV.5

Annex IV.A.6

Annex IV.6

Annex IV.A.7

Annex IV.7

Annex IV.A.8

Annex IV.8

Annex IV.A.9

Annex IV.9

Annex IV.A.10

Annex IV.10

Annex IV.A.11

Annex IV.11

Annex IV.A.12 (first and second indent)

Annex IV.12 (12.1 and 12.2)

Annex IV.A.12 (third indent)

—

Annex IV.A.13

Annex IV.13

Annex IV.A.14, first part

Annex IV.15

Annex IV.A.14, second part

Annex IV.14

Annex IV.A.15

Annex IV.16

Annex IV.A.16

Annex IV.17

Annex IV.A.17

—

Annex IV.B.1

Annex IV.19

Annex IV.B.2

Annex IV.21

Annex IV.B.3

Annex IV.20

Annex IV.B.4

Annex IV.22

Annex IV.B.5

Annex IV.23

Annex V, Section 1

—

Annex V, Section 2

—

Annex V, Section 3, first subparagraph, point (a)

Annex VII, Part A, Section 1, first subparagraph, point (a)

Annex V, Section 3, first subparagraph, point (b)

Annex VII, Part A, Section 1, first subparagraph, point (b)

Annex V, Section 3, second subparagraph

Annex VII, Part A, Section 1, second subparagraph

Annex V, Section 3, third subparagraph

Annex VII, Part A, Section 3

Annex V, Section 4(a)

Annex VII, Part A. Section 2, second and third subparagraphs

Annex V, Section 4 (b)

Annex VII, Part A. Section 2, first subparagraph

Annex V, Section 4(c)

Annex VII, Part A, Introduction

Annex VI, Section 1

Annex IX, Introduction

Annex VI, Section 2

Annex IX, Sections 1 and 2

Annex VI, Section 3

Annex IX, Section 3

Annex VI, Section 4, first subparagraph

Annex IX, Section 4, first subparagraph

Annex VI, Section 4, second subparagraph

Annex IX, Section 7

Annex VI, Section 5

Annex IX, Section 6

Annex VI, Section 6, first sentence

Annex IX, Section 5

Annex VI, Section 6, second and third sentences

Article 14(6)

Annex VI, Section 7

Annex IX, Section 8

Annex VII, Section 1

Annex XI, Section 1

Annex VII, Section 2

Annex XI, Section 2

Annex VII, Section 3

Annex XI, Section 3

Annex VII, Section 4

Annex XI, Section 4

Annex VII, Section 5

Annex XI, Section 5

Annex VII, Section 6

Annex XI, Section 6

Annex VII, Section 7

Annex XI, Section 7

Annex VIII

—

Annex IX

—

(1)  This table indicates the relation between parts of Directive 98/37/EC and the parts of this Directive that deal with the same subject. However, the content of the correlated parts is not necessarily identical.

The EU Medical Device Regulation 2017/745 (MDR) succeeds the EU Medical Device Directive 93/42/EEC (MDD)

What is the MDD to MDR transition period, and to whom does it apply?
    Class III custom-made implantable devices – deadline May 26, 2026.
    Class III and class IIb implantable devices – deadline December 31, 2027.
    Class IIb, IIa, and class I sterile/measuring devices – deadline December 31, 2028.

COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185

of 23 November 2017

on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (1), and in particular Articles 39(10) and 42(13) thereof,

Having regard to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (2), and in particular Articles 35(10) and 38(13) thereof,

Whereas:

(1)

Conformity assessment of medical devices under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 may require involvement of conformity assessment bodies. Only conformity assessment bodies that have been designated under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 may carry out such assessment and only for the activities related to the types of devices concerned. In order to enable specifying the scope of the designation of conformity assessment bodies notified under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 it is necessary to draw up list of codes and corresponding types of devices.

(2)

The lists of codes and corresponding types of devices should take into account various device types which can be characterised by design and intended purpose, manufacturing processes and technologies used, such as sterilisation and the use of nanomaterials. The lists of codes should provide for a multi-dimensional typology of devices which ensures that conformity assessment bodies designated as notified bodies are fully competent for the devices they are required to assess.

(3)

In accordance with Article 42(3) of Regulation (EU) 2017/745 and Article 38(3) of Regulation (EU) 2017/746, when notifying the Commission and the other Member States of the conformity assessment bodies they have designated Member States are to clearly specify, using the codes, the scope of the designation indicating the conformity assessment activities and the types of devices which the notified body is authorised to assess. In order to facilitate such notification and the assessment of the application for designation referred to in Article 38 of Regulation (EU) 2017/745 and Article 34 of Regulation (EU) 2017/746, conformity assessment bodies should use the lists of codes and corresponding types of devices set out in this Regulation when applying for designation.

(4)

Experience shows that conformity assessment bodies applying for designation in the field of in vitro diagnostic medical devices also apply for designation for medical devices under Regulation (EU) 2017/745. It is therefore appropriate, for reasons of user-friendliness, to include the lists of codes for Regulation (EU) 2017/745 and for Regulation (EU) 2017/746 in one Implementing Regulation.

(5)

As of 26 November 2017, conformity assessment bodies may submit an application for designation as a notified body under Regulation (EU) 2017/745 and Regulation (EU) 2017/746. In order to enable the conformity assessment bodies to use the codes laid down in this Regulation in the application for designation, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union.

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Committee on Medical Devices,

HAS ADOPTED THIS REGULATION:

Article 1

List of codes

1.   The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 is set out in Annex I to this Regulation.

2.   The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of in vitro diagnostic medical devices under Regulation (EU) 2017/746 is set out in Annex II to this Regulation.

Article 2

Application for designation

Conformity assessment bodies shall use the lists of codes and corresponding types of devices set out in Annexes I and II to this Regulation when specifying the types of devices in the application for designation referred to in Article 38 of Regulation (EU) 2017/745 and Article 34 of Regulation (EU) 2017/746.

Article 3

Entry into force

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 23 November 2017.

For the Commission

The President

Jean-Claude JUNCKER

(1)   OJ L 117, 5.5.2017, p. 1.

(2)   OJ L 117, 5.5.2017, p. 176.

ANNEX I

The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745

I.   CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE

A.   Active devices

1.   Active implantable devices

MDA CODE

Active implantable devices

MDA 0101

Active implantable devices for stimulation/inhibition/monitoring

MDA 0102

Active implantable devices delivering drugs or other substances

MDA 0103

Active implantable devices supporting or replacing organ functions

MDA 0104

Active implantable devices utilising radiation and other active implantable devices

2.   Active non-implantable devices for imaging, monitoring and/or diagnosis

MDA CODE

Active non-implantable devices for imaging, monitoring and/or diagnosis

MDA 0201

Active non-implantable imaging devices utilising ionizing radiation

MDA 0202

Active non-implantable imaging devices utilising non-ionizing radiation

MDA 0203

Active non-implantable devices for monitoring of vital physiological parameters

MDA 0204

Other active non-implantable devices for monitoring and/or diagnosis

3.   Active non-implantable therapeutic devices and general active non-implantable devices

MDA CODE

Active non-implantable therapeutic devices and general active non-implantable devices

MDA 0301

Active non-implantable devices utilising ionizing radiation

MDA 0302

Active non-implantable devices utilising non-ionizing radiation

MDA 0303

Active non-implantable devices utilising hyperthermia/hypothermia

MDA 0304

Active non-implantable devices for shock-wave therapy (lithotripsy)

MDA 0305

Active non-implantable devices for stimulation or inhibition

MDA 0306

Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis

MDA 0307

Active non-implantable respiratory devices

MDA 0308

Active non-implantable devices for wound and skin care

MDA 0309

Active non-implantable ophthalmologic devices

MDA 0310

Active non-implantable devices for ear, nose and throat

MDA 0311

Active non-implantable dental devices

MDA 0312

Other active non-implantable surgical devices

MDA 0313

Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport

MDA 0314

Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)

MDA 0315

Software

MDA 0316

Medical gas supply systems and parts thereof

MDA 0317

Active non-implantable devices for cleaning, disinfection and sterilisation

MDA 0318

Other active non-implantable devices

B.   Non-active devices

1.   Non-active implants and long term surgically invasive devices

MDN CODE

Non-active implants and long term surgically invasive devices

MDN 1101

Non-active cardiovascular, vascular and neurovascular implants

MDN 1102

Non-active osteo- and orthopaedic implants

MDN 1103

Non-active dental implants and dental materials

MDN 1104

Non-active soft tissue and other implants

2.   Non-active non-implantable devices

MDN CODE

Non-active non-implantable devices

MDN 1201

Non-active non-implantable devices for anaesthesia, emergency and intensive care

MDN 1202

Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis

MDN 1203

Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools

MDN 1204

Non-active non-implantable devices for wound and skin care

MDN 1205

Non-active non-implantable orthopaedic and rehabilitation devices

MDN 1206

Non-active non-implantable ophthalmologic devices

MDN 1207

Non-active non-implantable diagnostic devices

MDN 1208

Non-active non-implantable instruments

MDN 1209

Non-active non-implantable dental materials

MDN 1210

Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases

MDN 1211

Non-active non-implantable devices for disinfecting, cleaning and rinsing

MDN 1212

Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)

MDN 1213

Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route

MDN 1214

General non-active non-implantable devices used in health care and other non-active non-implantable devices

II.   HORIZONTAL CODES

1.   Devices with specific characteristics

MDS CODE

Devices with specific characteristics

MDS 1001

Devices incorporating medicinal substances

MDS 1002

Devices manufactured utilising tissues or cells of human origin, or their derivatives

MDS 1003

Devices manufactured utilising tissues or cells of animal origin, or their derivatives

MDS 1004

Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (1)

MDS 1005

Devices in sterile condition

MDS 1006

Reusable surgical instruments

MDS 1007

Devices incorporating or consisting of nanomaterial

MDS 1008

Devices utilising biologically active coatings and/or materials or being wholly or mainly absorbed or locally dispersed in the human body or are intended to undergo a chemical change in the body

MDS 1009

Devices incorporating software/utilising software/controlled by software, including devices intended for controlling, monitoring or directly influencing the performance of active or active implantable devices

MDS 1010

Devices with a measuring function

MDS 1011

Devices in systems or procedure packs

MDS 1012

Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745

MDS 1013

Class III custom-made implantable devices

MDS 1014

Devices incorporating as an integral part an in vitro diagnostic device

2.   Devices for which specific technologies or processes are used

MDT CODE

Devices for which specific technologies or processes are used

MDT 2001

Devices manufactured using metal processing

MDT 2002

Devices manufactured using plastic processing

MDT 2003

Devices manufactured using non-metal mineral processing (e.g. glass, ceramics)

MDT 2004

Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)

MDT 2005

Devices manufactured using biotechnology

MDT 2006

Devices manufactured using chemical processing

MDT 2007

Devices which require knowledge regarding the production of pharmaceuticals

MDT 2008

Devices manufactured in clean rooms and associated controlled environments

MDT 2009

Devices manufactured using processing of materials of human, animal, or microbial origin

MDT 2010

Devices manufactured using electronic components including communication devices

MDT 2011

Devices which require packaging, including labelling

MDT 2012

Devices which require installation, refurbishment

MDT 2013

Devices which have undergone reprocessing

(1)  Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) (OJ L 157, 9.6.2006, p. 24).

ANNEX II

The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of in vitro diagnostic medical devices under Regulation (EU) 2017/746

I.   CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE

1.   Devices intended to be used for blood grouping

IVR CODE

Devices intended to be used to determine markers of the specific blood grouping systems to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration

IVR 0101

Devices intended to determine markers of the ABO system [A (ABO1), B (ABO2), AB (ABO3)]

IVR 0102

Devices intended to determine markers of the Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]

IVR 0103

Devices intended to determine markers of the Kell system [Kel1 (K)]

IVR 0104

Devices intended to determine markers of the Kidd system [JK1 (Jka), JK2 (Jkb)]

IVR 0105

Devices intended to determine markers of the Duffy system [FY1 (Fya), FY2 (Fyb)]

 

Other devices intended to be used for blood grouping

IVR 0106

Other devices intended to be used for blood grouping

2.   Devices intended to be used for tissue typing

IVR CODE

Devices intended to be used for tissue typing

IVR 0201

Devices intended to be used for tissue typing (HLA A, B, DR) to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration

IVR 0202

Other devices intended to be used for tissue typing

3.   Devices intended to be used for markers of cancer and non-malignant tumours

IVR CODE

Devices intended to be used for markers of cancer and non-malignant tumours except devices for human genetic testing

IVR 0301

Devices intended to be used in screening, diagnosis, staging or monitoring of cancer

IVR 0302

Other devices intended to be used for markers of cancer and non-malignant tumours

4.   Devices intended to be used for human genetic testing

IVR CODE

Devices intended to be used for human genetic testing

IVR 0401

Devices intended to be used in screening/confirmation of congenital/inherited disorders

IVR 0402

Devices intended to be used to predict genetic disease/disorder risk and prognosis

IVR 0403

Other devices intended to be used for human genetic testing

5.   Devices intended to be used to determine markers of infections/immune status

IVR CODE

Devices intended to be used for the screening, confirmation, identification of infectious agents or determination of immune status

IVR 0501

Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents

IVR 0502

Devices intended to be used to detect the presence of, or exposure to transmissible agents in blood, blood components, cells, tissues or organs, or in any of their derivatives, to assess their suitability for transfusion, transplantation or cell administration

IVR 0503

Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents

IVR 0504

Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging

IVR 0505

Devices intended to be used to grow/isolate/identify and handle infectious agents

IVR 0506

Other devices intended to be used to determine markers of infections/immune status

6.   Devices intended to be used for non-infectious pathologies, physiological markers, disorders/impairments (except human genetic testing), and therapeutic measures

IVR CODE

Devices intended to be used for a specific disease

IVR 0601

Devices intended to be used for screening/confirmation of specific disorders/impairments

IVR 0602

Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease

IVR 0603

Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances

IVR 0604

Other devices intended to be used for a specific disease

 

Devices intended to be used to define or monitor physiological status and therapeutic measures

IVR 0605

Devices intended to be used for monitoring of levels of medicinal products, substances or biological components

IVR 0606

Devices intended to be used for non-infectious disease staging

IVR 0607

Devices intended to be used for detection of pregnancy or fertility testing

IVR 0608

Devices intended to be used for screening, determination or monitoring of physiological markers

IVR 0609

Other devices intended to be used to define or monitor physiological status and therapeutic measures

7.   Devices which are controls without a quantitative or qualitative assigned value

IVR CODE

Controls without a quantitative or qualitative assigned value

IVR 0701

Devices which are controls without a quantitative assigned value

IVR 0702

Devices which are controls without a qualitative assigned value

8.   Class A devices in sterile condition

IVR CODE

Class A devices in sterile condition

IVR 0801

Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746

IVR 0802

Instruments intended specifically to be used for in vitro diagnostic procedures referred to in point 2.5 (rule 5), under b), of Annex VIII to Regulation (EU) 2017/746

IVR 0803

Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746

II.   HORIZONTAL CODES

1.   In vitro diagnostic devices with specific characteristics

IVS CODE

In vitro diagnostic devices with specific characteristics

IVS 1001

Devices intended to be used for near-patient testing

IVS 1002

Devices intended to be used for self-testing

IVS 1003

Devices intended to be used as companion diagnostics

IVS 1004

Devices manufactured utilising tissues or cells of human origin, or their derivatives

IVS 1005

Devices in sterile condition

IVS 1006

Calibrators (point 1.5 of Annex VIII to Regulation (EU) 2017/746)

IVS 1007

Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes (point 1.6 of Annex VIII to Regulation (EU) 2017/746)

IVS 1008

Instruments, equipment, systems or apparatus

IVS 1009

Software that are devices in themselves including software apps, software for data analysis, and for defining or monitoring therapeutic measures

IVS 1010

Devices incorporating software/utilising software/controlled by software

2.   In vitro diagnostic devices for which specific technologies are used

IVT CODE

In vitro diagnostic devices for which specific technologies are used

IVT 2001

In vitro diagnostic devices manufactured using metal processing

IVT 2002

In vitro diagnostic devices manufactured using plastic processing

IVT 2003

In vitro diagnostic devices manufactured using non-metal mineral processing (e.g. glass, ceramics)

IVT 2004

In vitro diagnostic devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)

IVT 2005

In vitro diagnostic devices manufactured using biotechnology

IVT 2006

In vitro diagnostic devices manufactured using chemical processing

IVT 2007

In vitro diagnostic devices which require knowledge regarding the production of pharmaceuticals

IVT 2008

In vitro diagnostic devices manufactured in clean rooms and associated controlled environments

IVT 2009

In vitro diagnostic devices manufactured using processing of materials of human, animal or microbial origin

IVT 2010

In vitro diagnostic devices manufactured using electronic components including communication devices

IVT 2011

In vitro diagnostic devices which require packaging, including labelling

3.   In vitro diagnostic devices which require specific knowledge in examination procedures for the purpose of product verification

IVP CODE

In vitro diagnostic devices which require specific knowledge in examination procedures

IVP 3001

In vitro diagnostic devices which require knowledge regarding agglutination tests

IVP 3002

In vitro diagnostic devices which require knowledge regarding biochemistry

IVP 3003

In vitro diagnostic devices which require knowledge regarding chromatography

IVP 3004

In vitro diagnostic devices which require knowledge regarding chromosomal analysis

IVP 3005

In vitro diagnostic devices which require knowledge regarding coagulometry

IVP 3006

In vitro diagnostic devices which require knowledge regarding flow cytometry

IVP 3007

In vitro diagnostic devices which require knowledge regarding immunoassays

IVP 3008

In vitro diagnostic devices which require knowledge regarding lysis based testing

IVP 3009

In vitro diagnostic devices which require knowledge regarding measurement of radioactivity

IVP 3010

In vitro diagnostic devices which require knowledge regarding microscopy

IVP 3011

In vitro diagnostic devices which require knowledge regarding molecular biological testing including nucleic acid assays and next generation sequencing (NGS)

IVP 3012

In vitro diagnostic devices which require knowledge regarding physical chemistry including electrochemistry

IVP 3013

In vitro diagnostic devices which require knowledge regarding spectroscopy

IVP 3014

In vitro diagnostic devices which require knowledge regarding tests of cell function

4.   In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification

IVD CODE

In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification

IVD 4001

In vitro diagnostic devices which require knowledge regarding bacteriology

IVD 4002

In vitro diagnostic devices which require knowledge regarding clinical chemistry/biochemistry

IVD 4003

In vitro diagnostic devices which require knowledge regarding detection of transmissible agents (without organisms or viruses)

IVD 4004

In vitro diagnostic devices which require knowledge regarding genetics

IVD 4005

In vitro diagnostic devices which require knowledge regarding haematology/haemostasis, including coagulation disorders

IVD 4006

In vitro diagnostic devices which require knowledge regarding histocompatibility and immunogenetics

IVD 4007

In vitro diagnostic devices which require knowledge regarding immunohistochemistry/histology

IVD 4008

In vitro diagnostic devices which require knowledge regarding immunology

IVD 4009

In vitro diagnostic devices which require knowledge regarding molecular biology/diagnostics

IVD 4010

In vitro diagnostic devices which require knowledge regarding mycology

IVD 4011

In vitro diagnostic devices which require knowledge regarding parasitology

IVD 4012

In vitro diagnostic devices which require knowledge regarding virology

Pressure Equipment Directive

Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment

Official Journal L 181 , 09/07/1997 P. 0001 - 0055

DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,

Having regard to the proposals from the Commission (1),

Having regard to the Opinion of the Economic and Social Committee (2),

Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), in the light of the joint text approved by the Conciliation Committee on 4 February 1997,

1. Whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;

2. Whereas there are differences in the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety and protection of health of persons and, where appropriate, domestic animals or property, where pressure equipment not covered by present Community legislation is concerned; whereas the certification and inspection procedures for such equipment differ from one Member State to another; whereas such disparities may well constitute barriers to trade within the Community;

3. Whereas the harmonization of national legislation is the only means of removing these barriers to free trade; whereas this objective cannot be achieved satisfactorily by the individual Member States; whereas this Directive only lays down indispensable requirements for the free circulation of the equipment to which it is applicable;

4. Whereas equipment subject to a pressure of not more than 0,5 bar does not pose a significant hazard due to pressure; whereas there should not therefore be any obstacle to its free movement within the Community; whereas this Directive applies to equipment subject to a maximum allowable pressure PS exceeding 0,5 bar;

5. Whereas this Directive relates also to assemblies composed of several pieces of pressure equipment assembled to constitute an integrated and functional whole; whereas these assemblies may range from simple assemblies such as pressure cookers to complex assemblies such as watertube boilers; whereas, if the manufacturer of an assembly intends it to be placed on the market and put into service as an assembly - and not in the form of its constituent non-assembled elements - that assembly must conform to this Directive; whereas, on the other hand, this Directive does not cover the assembly of pressure equipment on the site and under the responsibility of the user, as in the case of industrial installations;

6. Whereas this Directive harmonizes national provisions on hazards due to pressure; whereas the other hazards which this equipment may present accordingly may fall within the scope of other Directives dealing with such hazards; whereas, however, pressure equipment may be included among products covered by other Directives based on Article 100a of the Treaty; whereas the provisions laid down in some of those Directives deal with the hazard due to pressure; whereas those provisions are considered adequate to provide appropriate protection where the hazard due to pressure associated with such equipment remains small; whereas, therefore, there are grounds for excluding such equipment from the scope of this Directive;

7. Whereas, for pressure equipment covered by international Conventions, transport and pressure hazards are due to be dealt with as soon as possible by forthcoming Community Directives based on such Conventions or by supplements to existing Directives; whereas such equipment is accordingly excluded from the scope of this Directive;

8. Whereas certain types of pressure equipment, although subject to a maximum allowable pressure PS higher than 0,5 bar, do not present any significant hazard due to pressure, and therefore the freedom of movement of such equipment in the Community should not be hindered if it has been legally manufactured or placed on the market in a Member State; whereas it is not necessary in order to ensure free movement of such equipment to include it in the scope of this Directive; whereas consequently it is expressly excluded from its scope;

9. Whereas other pressure equipment subject to a maximum allowable pressure higher than 0,5 bar and presenting a significant hazard due to pressure, but in respect of which free movement and an appropriate level of safety are guaranteed, is excluded from the scope of this Directive; whereas such exclusions should, however, be regularly reviewed in order to ascertain whether it is necessary to take action at Union level;

10. Whereas regulations to remove technical barriers to trade must follow the new approach provided for in the Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards (4), which requires a definition of the essential requirements regarding safety and other requirements of society without reducing existing, justified levels of protection within the Member States; whereas that Resolution provides that a very large number of products be covered by a single Directive in order to avoid frequent amendments and the proliferation of Directives;

11. Whereas the existing Community Directives on the approximation of the laws of the Member States relating to pressure equipment have made positive steps towards removing barriers to trade in this area; whereas those Directives cover that sector only to a minor extent; whereas Council Directive 87/404/EEC of 25 June 1987 on the harmonization of the laws of the Member States relating to simple pressure vessels (5) is the first case of application of the new approach to the sector of pressure equipment; whereas the present Directive will not apply to the area covered by Directive 87/404/EEC; whereas, no later than three years after the present Directive enters into force, a review will be carried out of the application of Directive 87/404/EEC in order to ascertain the need for the integration thereof into the present Directive;

12. Whereas the framework Directive, Council Directive 76/767/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to common provisions for pressure vessels and methods for inspecting them (6) is optional; whereas it provides for a procedure for the bilateral recognition of testing and certification of pressure equipment which did not operate satisfactorily and which therefore must be replaced by effective Community measures;

13. Whereas the scope of this Directive must be based on a general definition of the term 'pressure equipment` so as to allow for the technical development of products;

14. Whereas compliance with the essential safety requirements is necessary in order to ensure the safety of pressure equipment; whereas those requirements have been subdivided into general and specific requirements which must be met by pressure equipment; whereas in particular the specific requirements are intended to take account of particular types of pressure equipment; whereas certain types of pressure equipment in categories III and IV must be subject to a final assessment comprising final inspection and proof tests;

15. Whereas Member States should be in a position to allow the showing at trade fairs of pressure equipment which is not yet in conformity with the requirements of this Directive; whereas, during demonstrations, appropriate safety measures must be taken in accordance with the general safety rules of the Member State concerned to ensure the safety of persons;

16. Whereas in order to ease the task of demonstrating compliance with the essential requirements, standards harmonized at European level are useful, especially with regard to the design, manufacture and testing of pressure equipment, compliance with which enables a product to be presumed to meet the said essential requirements; whereas standards harmonized at European level are drawn up by private bodies and must retain their non-mandatory status; whereas, for this purpose, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as being the bodies that are competent to adopt harmonized standards that follow the general guidelines for cooperation between the Commission and those two bodies signed on 13 November 1984;

17. Whereas, for the purposes of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted by one or other of those bodies, or by both, at the request of the Commission pursuant to Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (7) and in accordance with the general guidelines referred to above; whereas, in relation to standardization, it would be advisable for the Commission to be assisted by the Committee set up pursuant to Directive 83/189/EEC; whereas the Committee will, if necessary, consult technical experts;

18. Whereas manufacturing of pressure equipment calls for the utilization of safe materials; whereas in the absence of harmonized standards it is useful to define the characteristics of the materials intended for repeated use; whereas this definition is established by European approvals for materials, such approvals being issued by one of the notified bodies specifically designated for that task; whereas the materials conforming to the European approvals shall be presumed to satisfy the essential requirements of this Directive;

19. Whereas, in view of the nature of the hazards involved in the use of pressure equipment it is necessary to establish procedures for assessing compliance with the basic requirements of the Directives; whereas these procedures must be devised in the light of the level of danger which is inherent in the pressure equipment; whereas, therefore, for each category of pressure equipment there must be an adequate procedure or a choice between different procedures of equivalent stringency; whereas the procedures adopted are as required by Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization Directives (8); whereas the details added to these procedures are justified by the nature of the verification required for pressure equipment;

20. Whereas Member States should be in a position to authorize user inspectorates to carry out certain tasks for conformity assessment in the framework of this Directive; whereas for that purpose this Directive sets out criteria for the authorization of user inspectorates by Member States;

21. Whereas, under the conditions laid down by this Directive, certain procedures for conformity assessment may require each item to be inspected and tested by a notified body or a user inspectorate as part of the final assessment of the pressure equipment; whereas in other cases provision should be made to ensure that the final assessment may be monitored by a notified body by means of unexpected visits;

22. Whereas pressure equipment will, as a general rule, bear the CE marking affixed either by the manufacturer or by his authorized representative established within the Community; whereas the CE marking means that the pressure equipment complies with the provisions of this Directive and those of other applicable Community directives on CE marking; whereas for pressure equipment defined in this Directive which presents only a minor pressure hazard and for which certification procedures are therefore not justified, the CE marking will not be affixed;

23. Whereas it is appropriate that the Member States, as provided for by Article 100a of the Treaty, may take provisional measures to limit or prohibit the placing on the market, putting into service and use of pressure equipment in cases where it presents a particular risk to the safety of persons and, where appropriate, domestic animals or property, provided that the measures are subject to a Community control procedure;

24. Whereas the addressees of any decision taken under this Directive must be aware of the reasons behind that decision and the means of appeal open to them;

25. Whereas it is necessary to lay down a transitional arrangement enabling pressure equipment manufactured in compliance with the national regulations in force on the date of entry into force of this Directive to be marketed and put into service;

26. Whereas the requirements laid down in the Annexes should be made as clear as possible so as to allow all users, including small and medium-sized enterprises (SMEs), to comply with them easily;

27. Whereas an agreement on a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was reached on 20 December 1994 (9),

HAVE ADOPTED THIS DIRECTIVE:

 Article 1 Scope and definitions

1. This Directive applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0,5 bar.

2. For the purposes of this Directive:

2.1. 'Pressure equipment` means vessels, piping, safety accessories and pressure accessories.

Where applicable, pressure equipment includes elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, lifting lugs, etc.

2.1.1. 'Vessel` means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment. A vessel may be composed of more than one chamber.

2.1.2. 'Piping` means piping components intended for the transport of fluids, when connected together for integration into a pressure system. Piping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate. Heat exchangers consisting of pipes for the purpose of cooling or heating air shall be considered as piping.

2.1.3. 'Safety accessories` means devices designed to protect pressure equipment against the allowable limits being exceeded. Such devices include:

- devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS), and

- limiting devices, which either activate the means for correction or provide for shutdown or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and 'safety related measurement control and regulation (SRMCR)` devices.

2.1.4. 'Pressure accessories` means devices with an operational function and having pressure-bearing housings.

2.1.5. 'Assemblies` means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole.

2.2. 'Pressure` means pressure relative to atmospheric pressure, i.e. gauge pressure. As a consequence, vacuum is designated by a negative value.

2.3. 'Maximum allowable pressure PS` means the maximum pressure for which the equipment is designed, as specified by the manufacturer.

It is defined at a location specified by the manufacturer. This must be the location of connection of protective and/or limiting devices or the top of equipment or if not appropriate any point specified.

2.4. 'Maximum/minimum allowable temperature TS` means the maximum/minimum temperatures for which the equipment is designed, as specified by the manufacturer.

2.5. 'Volume (V)` means the internal volume of a chamber, including the volume of nozzles to the first connection or weld and excluding the volume of permanent internal parts.

2.6. 'Nominal size (DN)` means a numerical designation of size which is common to all components in a piping system other than components indicated by outside diameters or by thread size. It is a convenient round number for reference purposes and is only loosely related to manufacturing dimensions. The nominal size is designated by DN followed by a number.

2.7. 'Fluids` means gases, liquids and vapours in pure phase as well as mixtures thereof. A fluid may contain a suspension of solids.

2.8. 'Permanent joints` means joints which cannot be disconnected except by destructive methods.

2.9. 'European approval for materials` means a technical document defining the characteristics of materials intended for repeated use in the manufacture of pressure equipment which are not covered by any harmonized standard.

3. The following are excluded from the scope of this Directive:

3.1. pipelines comprising piping or a system of piping designed for the conveyance of any fluid or substance to or from an installation (onshore or offshore) starting from and including the last isolation device located within the confines of the installation, including all the annexed equipment designed specifically for pipelines. This exclusion does not apply to standard pressure equipment such as may be found in pressure reduction stations or compression stations;

3.2. networks for the supply, distribution and discharge of water and associated equipment and headraces such as penstocks, pressure tunnels, pressure shafts for hydroelectric installations and their related specific accessories;

3.3. equipment covered by Directive 87/404/EEC on simple pressure vessels;

3.4. equipment covered by Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (10);

3.5. equipment intended for the functioning of vehicles defined by the following Directives and their Annexes:

- Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (11),

- Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors (12),

- Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two or three-wheel motor vehicles (13);

3.6. equipment classified as no higher than category I under Article 9 of this Directive and covered by one of the following Directives:

- Council Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery (14),

- European Parliament and Council Directive 95/16/EC of 29 June 1995 on the approximation of the laws of the Member States relating to lifts (15),

- Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits (16),

- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (17),

- Council Directive 90/396/EEC of 29 June 1990 on the approximation of the laws of the Member States relating to appliances burning gaseous fuels (18),

- Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres (19);

3.7. equipment covered by Article 223 (1) (b) of the Treaty;

3.8. items specifically designed for nuclear use, failure of which may cause an emission of radioactivity;

3.9. well-control equipment used in the petroleum, gas or geothermal exploration and extraction industry and in underground storage which is intended to contain and/or control well pressure. This comprises the wellhead (Christmas tree), the blow out preventers (BOP), the piping manifolds and all their equipment upstream;

3.10. equipment comprising casings or machinery where the dimensioning, choice of material and manufacturing rules are based primarily on requirements for sufficient strength, rigidity and stability to meet the static and dynamic operational effects or other operational characteristics and for which pressure is not a significant design factor. Such equipment may include:

- engines including turbines and internal combustion engines,

- steam engines, gas/steam turbines, turbo-generators, compressors, pumps and actuating devices;

3.11. blast furnaces including the furnace cooling system, hot-blast recuperators, dust extractors and blast-furnace exhaust-gas scrubbers and direct reducing cupolas, including the furnace cooling, gas converters and pans for melting, re-melting, de-gassing and casting of steel and non-ferrous metals;

3.12. enclosures for high-voltage electrical equipment such as switchgear, control gear, transformers, and rotating machines;

3.13. pressurized pipes for the containment of transmission systems, e.g. for electrical power and telephone cables;

3.14. ships, rockets, aircraft and mobile off-shore units, as well as equipment specifically intended for installation on board or the propulsion thereof;

3.15. pressure equipment consisting of a flexible casing, e.g. tyres, air cushions, balls used for play, inflatable craft, and other similar pressure equipment;

3.16. exhaust and inlet silencers;

3.17. bottles or cans for carbonated drinks for final consumption;

3.18. vessels designed for the transport and distribution of drinks having a PS 7V of not more than 500 bar 7L and a maximum allowable pressure not exceeding 7 bar;

3.19. equipment covered by the ADR (20), the RID (21), the IMDG (22) and the ICAO Convention (23);

3.20. radiators and pipes in warm water heating systems;

3.21. vessels designed to contain liquids with a gas pressure above the liquid of not more than 0,5 bar.

 

Article 2 Market surveillance

1. Member States shall take all appropriate measures to ensure that the pressure equipment and the assemblies referred to in Article 1 may be placed on the market and put into serive only if, when properly installed and maintained and used for their intended purpose, they do not endanger the health and safety of persons and, where appropriate, domestic animals or property.

2. The provisions of this Directive shall not affect Member States' entitlement to lay down, with due regard to the provisions of the Treaty, such requirements as they may deem necessary to ensure that persons and, in particular, workers are protected during use of the pressure equipment or assemblies in question provided that this does not mean modifications to such equipment or assemblies in a way not specified in this Directive.

3. At trade fairs, exhibitions, demonstrations, etc., Member States shall not prevent the showing of pressure equipment or assemblies as defined in Article 1 not in conformity with the provisions of this Directive, provided that a visible sign clearly indicates their non-conformity and their non-availability for sale until brought into conformity by the manufacturer or by his authorized representative established within the Community. During demonstrations, appropriate safety measures shall be taken in accordance with any requirements laid down by the competent authority of the Member State concerned in order to ensure the safety of persons.

 Article 3 Technical requirements

1. The pressure equipment referred to in 1.1, 1.2, 1.3 and 1.4 must satisfy the essential requirements set out in Annex I:

1.1. Vessels, except those referred to in 1.2 for:

(a) gases, liquefied gases, gases dissolved under pressure, vapours and also those liquids whose vapour pressure at the maximum allowable temperature is greater than 0,5 bar above normal atmospheric pressure, (1 013 mbar) within the following limits:

- for fluids in Group 1 with a volume greater than 1 L and a product of PS and V greater than 25 bar 7L, or with a pressure PS greater than 200 bar (Annex II, table 1),

- for fluids in Group 2, with a volume greater than 1 L and a product of PS and V is greater than 50 bar 7L, or with a pressure PS greater than 1 000 bar, and all portable extinguishers and bottles for breathing apparatus (Annex II, table 2);

(b) liquids having a vapour pressure at the maximum allowable temperature of not more than 0,5 bar above normal atmospheric pressure (1 013 mbar) within the following limits:

- for fluids in Group 1 with a volume greater than 1 L and a product of PS and V greater than 200 bar 7L, or with a pressure PS greater than 500 bar (Annex II, table 3),

- for fluids in Group 2 with a pressure PS greater than 10 bar and a product of PS and V greater than 10 000 bar 7L, or with a pressure PS greater than 1 000 bar (Annex II, table 4).

1.2. Fired or otherwise heated pressure equipment with the risk of overheating intended for generation of steam or super-heated water at temperatures higher than 100 °C having a volume greater than 2L, and all pressure cookers (Annex II, table 5).

1.3. Piping intended for:

(a) gases, liquified gases, gases dissolved under pressure, vapours and those liquids whose vapour pressure at the maximum allowable temperature is greater than 0,5 bar above normal atmospheric pressure (1 013 mbar) within the following limits:

- for fluids in Group 1 with a DN greater than 25 (Annex II, table 6),

- for fluids in Group 2 with a DN greater than 32 and a product of PS and DN greater than 1 000 bar (Annex II, table 7);

(b) liquids having a vapour pressure at the maximum allowable temperature of not more than 0,5 bar above normal atmospheric pressure (1 013 mbar), within the following limits:

- for fluids in Group 1 with a DN greater than 25 and a product of PS and DN greater than 2 000 bar (Annex II, table 8),

- for fluids in Group 2 with a PS greater than 10 bar, a DN greater than 200 and a product of PS and DN greater than 5 000 bar (Annex II, table 9).

1.4. Safety and pressure accessories intended for equipment covered by 1.1, 1.2 and 1.3 including where such equipment is incorporated into an assembly.

2. The assemblies defined in Article 1, section 2.1.5, which include at least one item of pressure equipment covered by section 1 of this Article and which are listed in 2.1, 2.2 and 2.3 of this Article must satisfy the essential requirements set out in Annex I.

2.1. Assemblies intended for generating steam or superheated water at a temperature higher than 100 °C comprising at least one item of fired or otherwise heated pressure equipment presenting a risk of overheating.

2.2. Assemblies other than those referred to in 2.1, if the manufacturer intends them to be placed on the market and put into service as assemblies.

2.3. By way of derogation from the introductory paragraph to this section, assemblies intended for generating warm water at temperatures not greater than 110 °C which are manually fed with solid fuels and have a PS 7V greater than 50 bar 7L must comply with the essential requirements referred to in 2.10, 2.11, 3.4, 5 (a) and 5 (d) of Annex I.

3. Pressure equipment and/or assemblies below or equal to the limits in sections 1.1, 1.2 and 1.3 and section 2 respectively must be designed and manufactured in accordance with the sound engineering practice of a Member State in order to ensure safe use. Pressure equipment and/or assemblies must be accompanied by adequate instructions for use and must bear markings to permit identification of the manufacturer or of his authorized representative established within the Community. Such equipment and/or assemblies must not bear the CE marking referred to in Article 15.

 Article 4 Free movement

1.1. Member States shall not, on grounds of the hazards due to pressure, prohibit, restrict or impede the placing on the market or putting into service under the conditions specified by the manufacturer of pressure equipment or assemblies referred to in Article 1 which comply with this Directive and bear the CE marking indicating that they have undergone conformity assessment in accordance with Article 10.

1.2. Member States shall not, on grounds of the hazards due to pressure, prohibit, restrict or impede the placing on the market or putting into service of pressure equipment or assemblies which comply with Article 3 (3).

2. Member States may require, to the extent that it is needed for safe and correct use of pressure equipment and assemblies, the information referred to in Annex I sections 3.3 and 3.4 to be provided in the official language(s) of the Community which may be determined in accordance with the Treaty by the Member State in which the equipment or assembly reaches the final user.

 Article 5 Presumption of conformity

1. Member States shall regard pressure equipment and assemblies bearing the CE marking provided for in Article 15 and the EC declaration of conformity provided for in Annex VII as conforming to all the provisions of this Directive, including the conformity assessment provided for in Article 10.

2. Pressure equipment and assemblies which conform to the national standards transposing the harmonized standards the reference numbers of which have been published in the Official Journal of the European Communities shall be presumed to conform to the essential requirements referred to in Article 3. Member States shall publish the reference numbers of the national standards referred to above.

3. Member States shall ensure that appropriate measures are taken to enable both sides of industry to have an input at national level in the process of preparing and monitoring the harmonized standards.

 Article 6 Committee on technical standards and regulations

Where a Member State or the Commission considers that the standards referred to in Article 5 (2) do not entirely meet the essential requirements referred to in Article 3, the Member State concerned or the Commission shall inform the Standing Committee set up by Article 5 of Directive 83/189/EEC giving the reasons therefor. The Committee shall issue an opinion as a matter of urgency.

Taking into account the Committee's opinion, the Commission shall notify the Member States as to whether or not those standards should be withdrawn from the publications referred to in Article 5 (2).

 Article 7 Committee on Pressure Equipment

1. The Commission may take any appropriate measure to implement the following provisions:

Where a Member State considers that, for very serious safety reasons,

- an item or family of pressure equipment referred to in Article 3 (3) should be subject to the requirements of Article 3 (1), or

- an assembly or family of assemblies referred to in Article 3 (3) should be subject to the requirements of Article 3 (2), or

- an item or family of pressure equipment should be classified, by way of derogation from the requirements of Annex II, in another category,

it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures. Those measures shall be adopted in accordance with the procedure laid down in paragraph 3.

2. The Commission shall be assisted by a Standing Committee, hereafter referred to as 'the Committee`, composed of representatives appointed by the Member States and chaired by a representative of the Commission.

The Committee shall draw up its own rules of procedure.

3. The representative of the Commission shall submit to the Committee a draft of the measures to be taken pursuant to paragraph 1. The Committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.

The opinion shall be record in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.

The Commission shall take the utmost account of the opinion delivered by the Committee. It shall inform the Committee of the manner in which its opinion has been taken into account.

4. The Committee may furthermore examine any other matter relating to the implementation and practical application of this Directive and raised by its chairman either on his own initiative or at the request of a Member State.

 Article 8 Safeguard clause

1. Where a Member State ascertains that pressure equipment or assemblies referred to in Article 1, bearing the CE marking and used in accordance with their intended use are liable to endanger the safety of persons and, where appropriate, domestic animals or property, it shall take all appropriate measures to withdraw such equipment or assemblies from the market, prohibit the placing on the market, putting into service or use thereof, or restrict free movement thereof.

The Member State shall immediately inform the Commission of any such measure, indicating the reasons for its decision and, in particular, whether non-conformity is due to:

(a) failure to satisfy the essential requirements referred to in Article 3;

(b) incorrect application of the standards referred to in Article 5 (2);

(c) shortcomings in the standards referred to in Article 5 (2);

(d) shortcomings in the European approval of pressure equipment materials as referred to in Article 11.

2. The Commission shall enter into consultation with the parties concerned without delay. Where the Commission considers, after this consultation, that the measure is justified, it shall immediately so inform the Member State which took the initiative and the other Member States.

Where the Commission considers, after this consultation, that the measure is unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer, or his authorized representative established within the Community. Where the decision referred to in paragraph 1 is based on a shortcoming in the standards or in European approvals for materials and where the Member State at the origin of the decision maintains its position the Commission shall immediately inform the Committee referred to in Article 6 in order to initiate the procedure referred to in the first paragraph of Article 6.

3. Where pressure equipment or an assembly which does not comply bears the CE marking, the competent Member State shall take appropriate action against the person(s) having affixed the CE marking and shall so inform the Commission and the other Member States.

4. The Commission shall ensure that the Member Sates are kept informed of the progress and outcome of this procedure.

 

Article 9 Classification of pressure equipment

1. Pressure equipment referred to in Article 3 (1) shall be classified by category in accordance with Annex II, according to ascending level of hazard.

For the purposes of such classification fluids shall be divided into two groups in accordance with 2.1 and 2.2.

2.1. Group 1 comprises dangerous fluids. A dangerous fluid is a substance or preparation covered by the definitions in Article 2 (2) of Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (24).

Group 1 comprises fluids defined as:

- explosive,

- extremely flammable,

- highly flammable,

- flammable (where the maximum allowable temperature is above flashpoint),

- very toxic,

- toxic,

- oxidizing.

2.2. Group 2 comprises all other fluids not referred to in 2.1.

3. Where a vessel is composed of a number of chambers, it shall be classified in the highest category applicable to the individual chambers. Where a chamber contains several fluids, classification shall be on the basis of the fluid which requires the highest category.

 

Article 10 Conformity assessment

1.1. Before placing pressure equipment on the market, the manufacturer shall subject each item of equipment to one of the conformity assessment procedures described in Annex III, according to the conditions given in this Article.

1.2. The conformity assessment procedures to be applied to an item of pressure equipment with a view to affixing the CE marking shall be determined by the category, as defined in Article 9, in which the equipment is classified.

1.3. The conformity assessment procedures to be applied for the various categories are as follows:

- category I

Module A

- category II

Module A1

Module D1

Module E1

- category III

Module B1 + D

Module B1 + F

Module B + E

Module B + C1

Module H

- category IV

Module B + D

Module B + F

Module G

Module H1

1.4. Pressure equipment shall be subjected to one of the conformity assessment procedures which may be chosen by the manufacturer among those laid down for the category in which it is classified. The manufacturer may also choose to apply one of the procedures which apply to a higher category, if available.

1.5. In the framework of quality assurance procedures for equipment in categories III and IV referred to in Article 3, section 1.1 (a), section 1.1 (b) first indent and section 1.2, the notified body shall, when performing unexpected visits, take a sample of equipment from the manufacturing or storage premises in order to perform, or have performed, the final assessment as referred to in Annex I, section 3.2.2. To this end, the manufacturer shall inform the notified body of the intended schedule of production. The notified body shall carry out at least two visits during the first year of manufacturing. The frequency of subsequent visits shall be determined by the notified body on the basis of the criteria set out in section 4.4 of the relevant modules.

1.6. In the case of one-off production of vessels and equipment in Category III referred to in Article 3, section 1.2 under the module H procedure, the notified body shall perform or have performed the final assessment, as referred to in Annex I, section 3.2.2, for each unit. To this end, the manufacturer shall communicate the intended schedule of production to the notified body.

2. Assemblies referred to in Article 3 (2) shall be subjected to a global conformity assessment procedure comprising:

(a) assessment of each item of pressure equipment making up the assembly and referred to in Article 3 (1) which has not been previously subjected to a conformity assessment procedure and to a separate CE marking; the assessment procedure shall be determined by the category of each item of equipment;

(b) the assessment of the integration of the various components of the assembly as referred to in sections 2.3, 2.8 and 2.9 of Annex I which shall be determined by the highest category applicable to the equipment concerned other than that applicable to any safety accessories;

(c) the assessment of the protection of an assembly against exceeding the permissible operating limits as referred to in sections 2.10 and 3.2.3 of Annex I shall be conducted in the light of the highest category applicable to the items of equipment to be protected.

3. By way of derogation from paragraphs 1 and 2, the competent authorities may, where justified, allow the placing on the market and putting into service in the territory of the Member State concerned of individual pressure equipment items and assemblies referred to in Article 1 (2), in respect of which the procedures referred to in paragraphs 1 and 2 of this Article have not been applied and the use of which is in the interests of experimentation.

4. Records and correspondence relating to conformity assessment shall be drawn up in the official language(s) of the Community which may be determined in accordance with the Treaty by the Member State where the body responsible for carrying out these procedures is established, or in a language accepted by that body.

 

Article 11 European approval for materials

1. European approval for materials, as defined in Article 1, section 2.9, shall be issued at the request of one or more manufacturers of materials or equipment, by one of the notified bodies referred to in Article 12 specifically designated for that task. The notified body shall determine and perform, or arrange for the performance of, the appropriate inspections and tests to certify the conformity of the types of material with the corresponding requirements of this Directive; in the case of materials recognized as being safe to use before 29 November 1999, the notified body shall take account of the existing data when certifying such conformity.

2. Before issuing European approval for materials, the notified body shall inform the Member States and the Commission by sending them the appropriate information. Within three months, a Member State or the Commission may refer the matter to the Standing Committee set up by Article 5 of Directive 83/189/EEC, giving its reasons. In that case, the Committee shall issue an opinion as a matter of urgency.

The notified body shall issue the European approval for materials taking into account, where appropriate, the opinion of the Committee and the comments submitted.

3. A copy of the European approval for pressure equipment materials shall be sent to the Member States, the notified bodies and the Commission. The Commission shall publish and keep up to date a list of European approvals for materials in the Official Journal of the European Communities.

4. The materials used for the manufacture of pressure equipment conforming with European approvals for materials, the references of which have been published in the Official Journal of the European Communities, shall be presumed to conform to the applicable essential requirements of Annex I.

5. The notified body which issued the European approval for pressure equipment materials shall withdraw that approval if it finds that it should not have been issued for if the type of materials is covered by a harmonized standard. It shall immediately inform the other Member States, the notified bodies and the Commission of any withdrawal of an approval.

 

Article 12 Notified bodies

1. Member States shall notify the Commission and the other Member States of the bodies which they have appointed to carry out the procedures referred to in Article 10 and Article 11, together with the specific tasks which those bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.

The Commission shall publish in the Official Journal of the European Communities a list of the notified bodies, with their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.

2. Member States shall apply the criteria set out in Annex IV for the designation of bodies. Bodies meeting the criteria laid down in the relevant harmonized standards shall be presumed to fulfil the corresponding criteria in Annex IV.

3. A Member State which has notified a body must withdraw such notification if it finds that the body no longer meets the criteria referred to in paragraph 2.

It shall forthwith inform the other Member States and the Commission of any such withdrawal of a notification.

 

Article 13 Recognized third-party organizations

1. Member States shall notify the Commission and the other Member States of the third-party organizations which they have recognized for the purposes of the tasks referred to in Annex I, sections 3.2.2 and 3.1.3.

The Commission shall publish in the Official Journal of the European Communities a list of the recognized organizations with the tasks for which they have been recognized. The Commission shall ensure that this list is kept up to date.

2. Member States shall apply the criteria set out in Annex IV for the recognition of organizations. Organizations meeting the criteria laid down in the relevant harmonized standards shall be presumed to fulfil the corresponding criteria in Annex IV.

3. A Member State which has recognized an organization must withdraw such recognition if it finds that the organization no longer meets the criteria referred to in paragraph 2.

It shall forthwith inform the other Member States and the Commission of any such withdrawal of a recognition.

 Article 14 User inspectorates

1. By way of derogation from the provisions relating to the tasks carried out by the notified bodies, Member States may authorize in their territory the placing on the market, and the putting into service by users, of pressure equipment or assemblies referred to in Article 1 of which conformity with the essential requirements has been assessed by a user inspectorate designated in accordance with the criteria referred to in paragraph 8.

2. When a Member State has designated a user inspectorate in accordance with the criteria set out in this Article, it may not, on grounds of the hazards due to pressure, prohibit, restrict or impede the placing on the market or putting into service under the conditions provided for in this Article of pressure equipment or assemblies the conformity of which has been assessed by a user inspectorate designated by another Member State in accordance with the criteria set out in this Article.

3. Pressure equipment and assemblies the conformity of which has been assessed by a user inspectorate shall not bear the CE marking.

4. The pressure equipment and assemblies referred to may be used only in establishments operated by the group of which the inspectorate is part. The group shall apply a common safety policy as regards the technical specifications for the design, manufacture, inspection, maintenance and use of pressure equipment and assemblies.

5. The user inspectorates shall act exclusively for the group of which they are part.

6. The conformity assessment procedures applicable by user inspectorates shall be modules A1, C1, F and G, as described in Annex III.

7. Member States shall inform the other Member States and the Commission which user inspectorates they have authorized, the tasks for which they have been designated and, for each inspectorate, a list of the establishments satisfying the provisions of paragraph 4.

8. In designating the user inspectorates, the Member States shall apply the criteria listed in Annex V and ensure that the group of which the inspectorate is part applies the criteria referred to in the second sentence of paragraph 4.

9. A Member State that has authorized a user inspectorate shall withdraw that authorization if it finds that the user inspectorate no longer meets the criteria referred to in paragraph 8. It shall inform the other Member States and the Commission thereof.

10. The effects of this Article shall be monitored by the Commission and evaluated three years after the date specified in Article 20 (3). To this end, Member States shall forward to the Commission any useful information on the implementation of this Article. If necessary the evaluation shall be accompanied by a proposal for amendment of the Directive.

 Article 15 CE marking

1. The CE marking consists of the initials 'CE` in accordance with the model in Annex VI.

The CE marking shall be accompanied by the identification number, as referred to in Article 12 (1), of the notified body involved at the production control phase.

2. The CE marking shall be affixed in a visible, easily legible and indelible fashion to each

- item of pressure equipment referred to in Article 3 (1), or

- assembly referred to in Article 3 (2)

which is complete or is in a state permitting final assessment as described in section 3.2 of Annex I.

3. It is not necessary for the CE marking to be affixed to each individual item of pressure equipment making up an assembly as referred to in Article 3 (2). Individual items of pressure equipment already bearing the CE marking when incorporated into the assembly shall continue to bear that marking.

4. Where the pressure equipment or assembly is subject to other Directives covering other aspects which provide for the affixing of the CE marking, the latter shall indicate that the pressure equipment or assembly in question is also presumed to conform to the provisions of those other Directives.

However, should one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate conformity only with the Directives applied by the manufacturer. In this case, the particulars of the said Directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the Directives and accompanying the pressure equipment or assembly.

5. The affixing of markings on pressure equipment or assemblies which are likely to mislead third parties as to the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to pressure equipment or assemblies provided that the visibility and legibility of the CE marking is not thereby reduced.

 

Article 16 Unduly affixed CE marking

Without prejudice to Article 8:

(a) where a Member State establishes that the CE marking has been affixed unduly, the manufacturer, or his authorized representative established within the Community, shall be obliged to make the product conform as regards the provisions concerning the CE marking and to end the infringement under the conditions imposed by the Member State;

(b) should non-conformity persist, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 8.

 

Article 17

Member States shall take appropriate measures in order to encourage the authorities responsible for implementing this Directive to cooperate with each other and provide each other and the Commission with information in order to assist the functioning of this Directive.

 

Article 18 Decisions entailing refusal or restriction

Any decision taken pursuant to this Directive which restricts the placing on the market and the putting into service or requires the withdrawal from the market of pressure equipment or assemblies shall state the exact grounds on which it is based. Such decision shall be notified forthwith to the party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in the Member State concerned and of the time limits to which such remedies are subject.

 Article 19 Repeal

Article 22 of Directive 76/767/EEC shall cease to apply as from 29 November 1999 in respect of pressure equipment and assemblies covered by this Directive.

 Article 20 Transposition and transitional provisions

1. Before 29 May 1999 Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.

When Member States adopt the measures referred to in the first subparagraph, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

Member States shall apply such provisions as from 29 November 1999.

2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.

3. Member States must permit the placing on the market of pressure equipment and assemblies which comply with the regulations in force in their territory at the date of application of this Directive until 29 May 2002, and permit such equipment and assemblies to be put into service beyond that date.

 Article 21 Addressees of the Directive

This Directive is addressed to the Member States.

 Done at Brussels, 29 May 1997.

For the European Parliament

The President

J. M. GIL-ROBLES

For the Council

The President

A. JORRITSMA LEBBINK

 (1) OJ No C 246, 9. 9. 1993, p. 1 and OJ No C 207, 27. 7. 1994, p. 5.

(2) OJ No C 52, 19. 2. 1994, p. 10.

(3) Opinion of the European Parliament of 19 April 1994 (OJ No C 128, 9. 5. 1994, p. 61), common position of the Council of 29 March 1996 (OJ No C 147, 21. 5. 1996, p. 1), Decision of the European Parliament of 17 July 1996 (OJ No C 261, 9. 9. 1996, p. 68). Council Decision of 17 April 1997.

(4) OJ No C 136, 4. 6. 1985, p. 1.

(5) OJ No L 220, 8. 8. 1987, p. 48. Directive as last amended by Directive 93/68/EEC (OJ No L 220, 30. 8. 1993, p. 1).

(6) OJ No L 262, 27. 9. 1976, p. 153. Directive as last amended by the 1994 Act of Accession.

(7) OJ No L 109, 26. 4. 1983, p. 8. Directive at last amended by the 1994 Act of Accession.

(8) OJ No L 220, 30. 8. 1993, p. 23.

(9) OJ No C 102, 4. 4. 1996, p. 1.

(10) OJ No L 147, 9. 6. 1975, p. 40. Directive as last amended by Commission Directive 94/1/EC (OJ No L 23, 28. 1. 1994, p. 28).

(11) OJ No L 42, 23. 2. 1970, p. 1. Directive as last amended by Commission Directive 95/54/EC (OJ No L 266, 8. 11. 1995, p. 1).

(12) OJ No L 84, 28. 3. 1974, p. 10. Directive as last amended by the 1994 Act of Accession.

(13) OJ No L 225, 10. 8. 1992, p. 72. Directive as last amended by the 1994 Act of Accession.

(14) OJ No L 183, 29. 6. 1989, p. 9. Directive as last amended by Directive 93/68/EEC (OJ No L 220, 30. 8. 1993, p. 1).

(15) OJ No L 213, 7. 9. 1995, p. 1.

(16) OJ No L 77, 26. 3. 1973, p. 29. Directive as last amended by Directive 93/68/EEC (OJ No L 220, 30. 8. 1993, p. 1).

(17) OJ No L 169, 12. 7. 1993, p. 1.

(18) OJ No L 196, 26. 7. 1990, p. 15. Directive as last amended by Directive 93/68/EEC (OJ No L 220, 30. 8. 1993, p. 1).

(19) OJ No L 100, 19. 4. 1994, p. 1.

(20) ADR = European Agreement concerning the International Carriage of Dangerous Goods by Road.

(21) RID = Regulations concerning the International Carriage of Dangerous Goods by Rail.

(22) IMDG = International Maritime Dangerous Goods Code.

(23) ICAO = International Civil Aviation Organization.

(24) OJ No 196, 16. 8. 1967, p. 1. Directive as last amended by Commission Directive 94/69/EC (OJ No L 381, 31. 12. 1994, p. 1).

 

 

 

ANNEX I

 

ESSENTIAL SAFETY REQUIREMENTS

 

PRELIMINARY OBSERVATIONS

1. The obligations arising from the essential requirements listed in this Annex for pressure equipment also apply to assemblies where the corresponding hazard exists.

2. The essential requirements laid down in the Directive are compulsory. The obligations laid down in these essential requirements apply only if the corresponding hazard exists for the pressure equipment in question when it is used under conditions which are reasonably foreseeable by the manufacturer.

3. The manufacturer is under an obligation to analyse the hazards in order to identify those which apply to his equipment on account of pressure; he must then design and construct it taking account of his analysis.

4. The essential requirements are to be interpreted and applied in such a way as to take account of the state of the art and current practice at the time of design and manufacture as well as of technical and economic considerations which are consistent with a high degree of health and safety protection.

 

1. GENERAL

1.1. Pressure equipment must be designed, manufactured and checked, and if applicable equipped and installed, in such a way as to ensure its safety when put into service in accordance with the manufacturer's instructions, or in reasonably foreseeable conditions.

1.2. In choosing the most appropriate solutions, the manufacturer must apply the principles set out below in the following order:

- eliminate or reduce hazards as far as is reasonably practicable,

- apply appropriate protection measures against hazards which cannot be eliminated,

- where appropriate, inform users of residual hazards and indicate whether it is necessary to take appropriate special measures to reduce the risks at the time of installation and/or use.

1.3. Where the potential for misuse is known or can be clearly foreseen, the pressure equipment must be designed to prevent danger from such misuse or, if that is not possible, adequate warning given that the pressure equipment must not be used in that way.

 

2. DESIGN

2.1. General

The pressure equipment must be properly designed taking all relevant factors into account in order to ensure that the equipment will be safe throughout its intended life.

The design must incorporate appropriate safety coefficients using comprehensive methods which are known to incorporate adequate safety margins against all relevant failure modes in a consistent manner.

2.2. Design for adequate strength

2.2.1. The pressure equipment must be designed for loadings appropriate to its intended use and other reasonably foreseeable operating conditions. In particular, the following factors must be taken into account:

- internal/external pressure,

- ambient and operational temperatures,

- static pressure and mass of contents in operating and test conditions,

- traffic, wind, earthquake loading,

- reaction forces and moments which result from the supports, attachments, piping, etc.,

- corrosion and erosion, fatigue, etc.,

- decomposition of unstable fluids.

Various loadings which can occur at the same time must be considered, taking into account the probability of their simultaneous occurrence.

2.2.2. Design for adequate strength must be based on:

- as a general rule, a calculation method, as described in 2.2.3, and supplemented if necessary by an experimental design method as described in 2.2.4, or

- an experimental design method without calculation, as described in 2.2.4, when the product of the maximum allowable pressure PS and the volume V is less than 6 000 bar 7L or the product PS 7DN less than 3 000 bar.

2.2.3. Calculation method

(a) Pressure containment and other loading aspects

The allowable stresses for pressure equipment must be limited having regard to reasonably foreseeable failure modes under operating conditions. To this end, safety factors must be applied to eliminate fully any uncertainty arising out of manufacture, actual operational conditions, stresses, calculation models and the properties and behaviour of the material.

These calculation methods must provide sufficient safety margins consistent, where applicable, with the requirements of section 7.

The requirements set out above may be met by applying one of the following methods, as appropriate, if necessary as a supplement to or in combination with another method:

- design by formula,

- design by analysis,

- design by fracture mechanics;

(b) Resistance

Appropriate design calculations must be used to establish the resistance of the pressure equipment concerned.

In particular:

- the calculation pressures must not be less than the maximum allowable pressures and take into account static head and dynamic fluid pressures and the decomposition of unstable fluids. Where a vessel is separated into individual pressure-containing chambers, the partition wall must be designed on the basis of the highest possible chamber pressure relative to the lowest pressure possible in the adjoining chamber,

- the calculation temperatures must allow for appropriate safety margins,

- the design must take appropriate account of all possible combinations of temperature and pressure which might arise under reasonably foreseeable operating conditions for the equipment,

- the maximum stresses and peak stress concentrations must be kept within safe limits,

- the calculation for pressure containment must utilize the values appropriate to the properties of the material, based on documented data, having regard to the provisions set out in section 4 together with appropriate safety factors. Material characteristics to be considered, where applicable, include:

- yield strength, 0,2 % or 1,0 % proof strength as appropriate at calculation temperature,

- tensile strength,

- time-dependent strength, i.e. creep strength,

- fatigue data,

- Young's modulus (modulus of elasticity),

- appropriate amount of plastic strain,

- impact strength,

- fracture toughness,

- appropriate joint factors must be applied to the material properties depending, for example, on the type of non-destructive testing, the materials joined and the operating conditions envisaged,

- the design must take appropriate account of all reasonably foreseeable degradation mechanisms (e.g. corrosion, creep, fatigue) commensurate with the intended use of the equipment. Attention must be drawn, in the instructions referred to in section 3.4, to particular features of the design which are relevant to the life of the equipment, for example:

- for creep: design hours of operation at specified temperatures,

- for fatigue: design number of cycles at specified stress levels,

- for corrosion: design corrosion allowance;

(c) Stability aspects

Where the calculated thickness does not allow for adequate structural stability, the necessary measures must be taken to remedy the situation taking into account the risks from transport and handling.

2.2.4. Experimental design method

The design of the equipment may be validated, in all or in part, by an appropriate test programme carried out on a sample representative of the equipment or the category of equipment.

The test programme must be clearly defined prior to testing and accepted by the notified body responsible for the design conformity assessment module, where it exists.

This programme must define test conditions and criteria for acceptance or refusal. The actual values of the essential dimensions and characteristics of the materials which constitute the equipment tested shall be measured before the test.

Where appropriate, during tests, it must be possible to observe the critical zones of the pressure equipment with adequate instrumentation capable of registering strains and stresses with sufficient precision.

The test programme must include:

(a) A pressure strength test, the purpose of which is to check that, at a pressure with a defined safety margin in relation to the maximum allowable pressure, the equipment does not exhibit significant leaks or deformation exceeding a determined threshold.

The test pressure must be determined on the basis of the differences between the values of the geometrical and material characteristics measures under test conditions and the values used for design purposes; it must take into account the differences between the test and design temperatures;

(b) where the risk of creep or fatigue exists, appropriate tests determined on the basis of the service conditions laid down for the equipment, for instance hold time at specified temperatures, number of cycles at specified stress-levels, etc.;

(c) where necessary, additional tests concerning other factors referred to in 2.2.1 such as corrosion, external damage, etc.

2.3. Provisions to ensure safe handling and operation

The method of operation specified for pressure equipment must be such as to preclude any reasonably foreseeable risk in operation of the equipment. Particular attention must be paid, where appropriate, to:

- closures and openings,

- dangerous discharge of pressure relief blow-off,

- devices to prevent physical access whilst pressure or a vacuum exists,

- surface temperature taking into consideration the intended use,

- decomposition of unstable fluids.

In particular, pressure equipment fitted with an access door must be equipped with an automatic or manual device enabling the user easily to ascertain that the opening will not present any hazard. Furthermore, where the opening can be operated quickly, the pressure equipment must be fitted with a device to prevent it being opened whenever the pressure or temperature of the fluid presents a hazard.

2.4. Means of examination

(a) Pressure equipment must be designed and constructed so that all necessary examinations to ensure safety can be carried out;

(b) Means of determining the internal condition of the equipment must be available, where it is necessary to ensure the continued safety of the equipment, such as access openings allowing physical access to the inside of the pressure equipment so that appropriate examinations can be carried out safely and ergonomically;

(c) Other means of ensuring the safe condition of the pressure equipment may be applied:

- where it is too small for physical internal access, or

- where opening the pressure equipment would adversely affect the inside, or

- where the substance contained has been shown not to be harmful to the material from which the pressure equipment is made and no other internal degradation mechanisms are reasonably foreseeable.

2.5. Means of draining and venting

Adequate means must be provided for the draining and venting of pressure equipment where necessary:

- to avoid harmful effects such as water hammer, vacuum collapse, corrosion and uncontrolled chemical reactions. All stages of operation and testing, particularly pressure testing, must be considered,

- to permit cleaning, inspection and maintenance in a safe manner.

2.6. Corrosion or other chemical attack

Where necessary, adequate allowance or protection against corrosion or other chemical attack must be provided, taking due account of the intended and reasonably foreseeable use.

2.7. Wear

Where severe conditions of erosion or abrasion may arise, adequate measures must be taken to:

- minimize that effect by appropriate design, e.g. additional material thickness, or by the use of liners or cladding materials,

- permit replacement of parts which are most affected,

- draw attention, in the instructions referred to in 3.4, to measures necessary for continued safe use.

2.8. Assemblies

Assemblies must be so designed that:

- the components to be assembled together are suitable and reliable for their duty,

- all the components are properly integrated and assembled in an appropriate manner.

2.9. Provisions for filling and discharge

Where appropriate, the pressure equipment must be so designed and provided with accessories, or provision made for their fitting, as to ensure safe filling and discharge in particular with respect to hazards such as:

(a) on filling:

- overfilling or overpressurization having regard in particular to the filling ratio and to vapour pressure at the reference temperature,

- instability of the pressure equipment;

(b) on discharge: the uncontrolled release of the pressurized fluid;

(c) on filling or discharge: unsafe connection and disconnection.

2.10. Protection against exceeding the allowable limits of pressure equipment

Where, under reasonably foreseeable conditions, the allowable limits could be exceeded, the pressure equipment must be fitted with, or provision made for the fitting of, suitable protective devices, unless the equipment is intended to be protected by other protective devices within an assembly.

The suitable device or combination of such devices must be determined on the basis of the particular characteristics of the equipment or assembly.

Suitable protective devices and combinations thereof comprise:

(a) safety accessories as defined in Article 1, section 2.1.3,

(b) where appropriate, adequate monitoring devices such as indicators and/or alarms which enable adequate action to be taken either automatically or manually to keep the pressure equipment within the allowable limits.

2.11. Safety accessories

2.11.1. Safety accessories must:

- be so designed and constructed as to be reliable and suitable for their intended duty and take into account the maintenance and testing requirements of the devices, where applicable,

- be independent of other functions, unless their safety function cannot be affected by such other functions,

- comply with appropriate design principles in order to obtain suitable and reliable protection. These principles include, in particular, fail-safe modes, redundancy, diversity and self-diagnosis.

2.11.2. Pressure limiting devices

These devices must be so designed that the pressure will not permanently exceed the maximum allowable pressure PS; however a short duration pressure surge in keeping with the specifications laid down in 7.3 is allowable, where appropriate.

2.11.3. Temperature monitoring devices

These devices must have an adequate response time on safety grounds, consistent with the measurement function.

2.12. External fire

Where necessary, pressure equipment must be so designed and, where appropriate, fitted with suitable accessories, or provision made for their fitting, to meet damage-limitation requirements in the event of external fire, having particular regard to its intended use.

 

3. MANUFACTURING

3.1. Manufacturing procedures

The manufacturer must ensure the competent execution of the provisions set out at the design stage by applying the appropriate techniques and relevant procedures, especially with a view to the aspects set out below.

3.1.1. Preparation of the component parts

Preparation of the component parts (e.g. forming and chamfering) must not give rise to defects or cracks or changes in the mechanical characteristics likely to be detrimental to the safety of the pressure equipment.

3.1.2. Permanent joining

Permanent joints and adjacent zones must be free of any surface or internal defects detrimental to the safety of the equipment.

The properties of permanent joints must meet the minimum properties specified for the materials to be joined unless other relevant property values are specifically taken into account in the design calculations.

For pressure equipment, permanent joining of components which contribute to the pressure resistance of equipment and components which are directly attached to them must be carried out by suitably qualified personnel according to suitable operating procedures.

For pressure equipment in categories II, III and IV, operating procedures and personnel must be approved by a competent third party which, at the manufacturer's discretion, may be:

- a notified body,

- a third-party organization recognized by a Member State as provided for in Article 13.

To carry out these approvals the third party must perform examinations and tests as set out in the appropriate harmonized standards or equivalent examinations and tests or must have them performed.

3.1.3. Non-destructive tests

For pressure equipment, non-destructive tests of permanent joints must be carried out by suitable qualified personnel. For pressure equipment in categories III and IV, the personnel must be approved by a third-party organization recognized by a Member State pursuant to Article 13.

3.1.4. Heat treatment

Where there is a risk that the manufacturing process will change the material properties to an extent which would impair the safety of the pressure equipment, suitable heat treatment must be applied at the appropriate stage of manufacture.

3.1.5. Traceability

Suitable procedures must be established and maintained for identifying the material making up the components of the equipment which contribute to pressure resistance by suitable means from receipt, through production, up to the final test of the manufactured pressure equipment.

3.2. Final assessment

Pressure equipment must be subjected to final assessment as described below.

3.2.1. Final inspection

Pressure equipment must undergo a final inspection to assess visually and by examination of the accompanying documents compliance with the requirements of the Directive. Test carried out during manufacture may be taken into account. As far as is necessary on safety grounds, the final inspection must be carried out internally and externally on every part of the equipment, where appropriate in the course of manufacture (e.g. where examination during the final inspection is no longer possible).

3.2.2. Proof test

Final assessment of pressure equipment must include a test for the pressure containment aspect, which will normally take the form of a hydrostatic pressure test at a pressure at least equal, where appropriate, to the value laid down in 7.4.

For category I series-produced pressure equipment, this test may be performed on a statistical basis.

Where the hydrostatic pressure test is harmful or impractical, other tests of a recognized value may be carried out. For tests other than the hydrostatic pressure test, additional measures, such as non-destructive tests or other methods of equivalent validity, must be applied before those tests are carried out.

3.2.3. Inspection of safety devices

For assemblies, the final assessment must also include a check of the safety devices intended to check full compliance with the requirements referred to in 2.10.

3.3. Marking and labelling

In addition to the CE marking referred to in Article 15, the following information must be provided:

(a) for all pressure equipment:

- the name and address or other means of identification of the manufacturer and, where appropriate, of his authorized representative established within the Community,

- the year of manufacture,

- identification of the pressure equipment according to its nature, such as type, series or batch identification and serial number,

- essential maximum/minimum allowable limits;

(b) depending on the type of pressure equipment, further information necessary for safe installation, operation or use and, where applicable, maintenance and periodic inspection such as:

- the volume V of the pressure equipment in L,

- the nominal size for piping DN,

- the test pressure PT applied in bar and date,

- safety device set pressure in bar,

- output of the pressure equipment in kW,

- supply voltage in V (volts),

- intended use,

- filling ratio kg/L,

- maximum filling mass in kg,

- tare mass in kg,

- the product group;

(c) where necessary, warnings fixed to the pressure equipment drawing attention to misuse which experience has shown might occur.

The CE marking and the required information must be given on the pressure equipment or on a dataplate firmly attached to it, with the following exceptions:

- where applicable, appropriate documentation may be used to avoid repetitive marking of individual parts such as piping components, intended for the same assembly. This applies to CE marking and other marking and labelling referred to in this Annex;

- where the pressure equipment is too small, e.g. accessories, the information referred to in (b) may be given on a label attached to that pressure equipment;

- labelling or other adequate means may be used for the mass to be filled and the warnings referred to in (c), provided it remains legible for the appropriate period of time.

3.4. Operating instructions

(a) When pressure equipment is placed on the market, it must be accompanied, as far as relevant, with instructions for the user, containing all the necessary safety information relating to:

- mounting including assembling of different pieces of pressure equipment,

- putting into service,

- use,

- maintenance including checks by the user;

(b) Instructions must cover information affixed to the pressure equipment in accordance with 3.3, with the exception of serial identification, and must be accompanied, where appropriate, by the technical documents, drawings and diagrams necessary for a full understanding of these instructions;

(c) If appropriate, these instructions must also refer to hazards arising from misuse in accordance with 1.3 and particular features of the design in accordance with 2.2.3.

 

4. MATERIALS

Materials used for the manufacture of pressure equipment must be suitable for such application during the scheduled lifetime unless replacement is foreseen.

Welding consumables and other joining materials need fulfil only the relevant requirements of 4.1, 4.2 (a) and the first paragraph of 4.3, in an appropriate way, both individually and in a joined structure.

4.1. Materials for pressurized parts must:

(a) have appropriate properties for all operating conditions which are reasonably foreseeable and for all test conditions, and in particular they should be sufficiently ductile and tough. Where appropriate, the characteristics of the materials must comply with the requirements of 7.5. Moreover, due care should be exercised in particular in selecting materials in order to prevent brittle-type fracture where necessary; where for specific reasons brittle material has to be used appropriate measures must be taken;

(b) be sufficiently chemically resistant to the fluid contained in the pressure equipment; the chemical and physical properties necessary for operational safety must not be significantly affected within the scheduled lifetime of the equipment;

(c) not be significantly affected by ageing;

(d) be suitable for the intended processing procedures;

(e) be selected in order to avoid significant undesirable effects when the various materials are put together.

4.2. (a) The pressure equipment manufacturer must define in an appropriate manner the values necessary for the design calculations referred to in 2.2.3 and the essential characteristics of the materials and their treatment referred to in 4.1;

(b) the manufacturer must provide in his technical documentation elements relating to compliance with the materials specifications of the Directive in one of the following forms:

- by using materials which comply with harmonized standards,

- by using materials covered by a European approval of pressure equipment materials in accordance with Article 11,

- by a particular material appraisal;

(c) for pressure equipment in categories III and IV, particular appraisal as referred to in the third indent of (b) must be performed by the notified body in charge of conformity assessment procedures for the pressure equipment.

4.3. The equipment manufacturer must take appropriate measures to ensure that the material used conforms with the required specification. In particular, documentation prepared by the material manufacturer affirming compliance with a specification must be obtained for all materials.

For the main pressure-bearing parts of equipment in categories II, III and IV, this must take the form of a certificate of specific product control.

Where a material manufacturer has an appropriate quality-assurance system, certified by a competent body established within the Community and having undergone a specific assessment for materials, certificates issued by the manufacturer are presumed to certify conformity with the relevant requirements of this section.

 

 

SPECIFIC PRESSURE EQUIPMENT REQUIREMENTS

In addition to the applicable requirements of sections 1 to 4, the following requirements apply to the pressure equipment covered by sections 5 and 6.

 

5. FIRED OR OTHERWISE HEATED PRESSURE EQUIPMENT WITH A RISK OF OVERHEATING AS REFERRED TO IN ARTICLE 3 (1)

This pressure equipment includes:

- steam and hot-water generators as referred to in Article 3, section 1.2, such as fired steam and hot-water boilers, superheaters and reheaters, waste-heat boilers, waste incineration boilers, electrode or immersion-type electrically heated boilers, pressure cookers, together with their accessories and where applicable their systems for treatment of feedwater and for fuel supply, and

- process-heating equipment for other than steam and hot water generation falling under Article 3, section 1.1, such as heaters for chemical and other similar processes and pressurized food-processing equipment.

This pressure equipment must be calculated, designed and constructed so as to avoid to minimize risks of a significant loss of containment from overheating. In particular it must be ensured, where applicable, that:

(a) appropriate means of protection are provided to restrict operating parameters such as heat input, heat take-off and, where applicable, fluid level so as to avoid any risk of local and general overheating,

(b) sampling points are provided where required to allow evaluation of the properties of the fluid so as to avoid risks related to deposits and/or corrosion,

(c) adequate provisions are made to eliminate risks of damage from deposits,

(d) means of safe removal of residual heat after shutdown are provided,

(e) steps are taken to avoid a dangerous accumulation of ignitable mixtures of combustible substances and air, or flame blowback.

 

6. PIPING AS REFERRED TO IN ARTICLE 3, SECTION 1.3

Design and construction must ensure:

(a) that the risk of overstressing from inadmissible free movement or excessive forces being produced, e.g. on flanges, connections, bellows or hoses, is adequately controlled by means such as support, constraint, anchoring, alignment and pre-tension;

(b) that where there is a possibility of condensation occurring inside pipes for gaseous fluids, means are provided for drainage and removal of deposits from low areas to avoid damage from water hammer or corrosion;

(c) that due consideration is given to the potential damage from turbulence and formation of vortices; the relevant parts of 2.7 are applicable;

(d) that due consideration is given to the risk of fatigue due to vibrations in pipes;

(e) that, where fluids of Group 1 are contained in the piping, appropriate means are provided to isolate 'take-off` pipes the size of which represents a significant risk;

(f) that the risk of inadvertent discharge is minimized; the take-off points must be clearly marked on the permanent side, indicating the fluid contained;

(g) that the position and route of underground piping is at least recorded in the technical documentation to facilitate safe maintenance, inspection or repair.

 

7. SPECIFIC QUANTITATIVE REQUIREMENTS FOR CERTAIN PRESSURE EQUIPMENT

The following provisions apply as a general rule. However, where they are not applied, including in cases where materials are not specifically referred to and no harmonized standards are applied, the manufacturer must demonstrate that appropriate measures have been taken to achieve an equivalent overall level of safety.

This section is an integral part of Annex I. The provisions laid down in this section supplement the essential requirements of sections 1 to 6 for the pressure equipment to which they apply.

7.1. Allowable stresses

7.1.1. Symbols

Re/t , yield limit, indicates the value at the calculation temperature of:

- the upper flow limit for a material presenting upper and lower flow limits,

- the 1,0 % proof strength of austenitic steel and non-alloyed aluminium,

- the 0,2 % proof strength in other cases.

Rm/20 indicates the minimum value of the ultimate strength 20 °C.

Rm/t designates the ultimate strength at the calculation temperature.

7.1.2. The permissible general membrane stress for predominantly static loads and for temperatures outside the range in which creep is significant must not exceed the smaller of the following values, according to the material used:

- in the case of ferritic steel including normalized (normalized rolled) steel and excluding fine-grained steel and specially heat-treated steel, 2/3 of Re/t and 5/12 of Rm/20 ;

- in the case of austenitic steel:

- if its elongation after rupture exceeds 30 %, 2/3 of Re/t

- or, alternatively, and if its elongation after rupture exceeds 35 %, 5/6 of Re/t and 1/3 of Rm/t ;

- in the case of non-alloy or low-alloy cast steel, 10/19 of Re/t and 1/3 of Rm/20 ;

- in the case of aluminium, 2/3 of Re/t ;

- in the case of aluminium alloys excluding precipitation hardening alloys 2/3 of Re/t and 5/12 of Rm/20 .

7.2. Joint coefficients

For welded joints, the joint coefficient must not exceed the following values:

- for equipment subject to destructive and non-destructive tests which confirm that the whole series of joints show no significant defects: 1,

- for equipment subject to random non-destructive testing: 0,85,

- for equipment not subject to non-destructive testing other than visual inspection: 0,7.

If necessary, the type of stress and the mechanical and technological properties of the joint must also be taken into account.

7.3. Pressure limiting devices, particularly for pressure vessels

The momentary pressure surge referred to in 2.11.2 must be kept to 10 % of the maximum allowable pressure.

7.4. Hydrostatic test pressure

For pressure vessels, the hydrostatic test pressure referred to in 3.2.2 must be no less than:

- that corresponding to the maximum loading to which the pressure equipment may be subject in service taking into account its maximum allowable pressure and its maximum allowable temperature, multiplied by the coefficient 1,25, or

- the maximum allowable pressure multiplied by the coefficient 1,43, whichever is the greater.

7.5. Material characteristics

Unless other values are required in accordance with other criteria that must be taken into account, a steel is considered as sufficiently ductile to satisfy 4.1 (a) if, in a tensile test carried out by a standard procedure, its elongation after rupture is no less than 14 % and its bending rupture energy measured on an ISO V test-piece is no less than 27 J, at a temperature not greater than 20 °C but not higher than the lowest scheduled operating temperature.

 

 

 

 

ANNEX II

 

CONFORMITY ASSESSMENT TABLES

1. The references in the tables to categories of modules are the following:

I = Module A

II = Module A1, D1, E1

III = Modules B1 + D, B1 + F, B + E, B + C1, H

IV = Modules B + D, B + F, G, H1

2. The safety accessories defined in Article 1, Section 2.1.3, and referred to in Article 3, Section 1.4, are classified in category IV. However, by way of exception, safety accessories manufactured for specific equipment may be classified in the same category as the equipment they protect.

3. The pressure accessories defined in Article 1, Section 2.1.4, and referred to in Article 3, Section 1.4, are classified on the basis of:

- their maximum allowable pressure PS, and

- their volume V or their nominal size DN, as appropriate, and

- the group of fluids for which they are intended,

and the appropriate table for vessels or piping is to be used to determine the conformity assessment category.

Where both the volume and the nominal size are considered appropriate in the second indent, the pressure accessory must be classified in the highest category.

4. The demarcation lines in the following conformity assessment tables indicate the upper limit for each category.

>REFERENCE TO A GRAPHIC>

 

Table 1 Vessels referred to in Article 3, Section 1.1 (a), first indent

>START OF GRAPHIC>

 

Exceptionally, vessels intended to contain an unstable gas and falling within categories I or II on the basis of table 1 must be classified in category III.>END OF GRAPHIC>

>REFERENCE TO A GRAPHIC>

 

Table 2 Vessels referred to in Article 3, Section 1.1 (a), second indent

>START OF GRAPHIC>

 

Exceptionally, portable extinguishers and bottles for breathing equipment must be classified at least in category III.>END OF GRAPHIC>

>REFERENCE TO A GRAPHIC>

 

Table 3 Vessels referred to in Article 3, Section 1.1 (b), first indent

>START OF GRAPHIC>

>END OF GRAPHIC>

>REFERENCE TO A GRAPHIC>

 

Table 4 Vessels referred to in Article 3, Section 1.1 (b), second indent

>START OF GRAPHIC>

 

Exceptionally, assemblies intended for generating warm water as referred to in Article 3, Section 2.3, must be subject either to an EC design examination (Module B1) with respect to their conformity with the essential requirements referred to in Sections 2.10, 2.11, 3.4, 5 (a) and 5 (d) of Annex I, or to full quality assurance (Module H).>END OF GRAPHIC>

>REFERENCE TO A GRAPHIC>

 

Table 5 Pressure equipment referred to in Article 3, Section 1.2

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Exceptionally, the design of pressure-cookers must be subject to a conformity assessment procedure equivalent to at least one of the category III modules.>END OF GRAPHIC>

>REFERENCE TO A GRAPHIC>

 

Table 6 Piping referred to in Article 3, Section 1.3 (a), first indent

>START OF GRAPHIC>

 

Exceptionally, piping intended for unstable gases and falling within categories I or II on the basis of Table 6 must be classified in category III.>END OF GRAPHIC>

>REFERENCE TO A GRAPHIC>

 

Table 7 Piping referred to in Article 3, Section 1.3 (a), second indent

>START OF GRAPHIC>

 

Exceptionally, all piping containing fluids at a temperature greater than 350 °C and falling within category II on the basis of Table 7 must be classified in category III.>END OF GRAPHIC>

>REFERENCE TO A GRAPHIC>

 

Table 8 Piping referred to in Article 3, Section 1.3 (b), first indent

>START OF GRAPHIC>

>END OF GRAPHIC>

>REFERENCE TO A GRAPHIC>

 

Table 9 Piping referred to in Article 3, Section 1.3 (b), second indent

>START OF GRAPHIC>

>END OF GRAPHIC>

 

 

 

ANNEX III

 

CONFORMITY ASSESSMENT PROCEDURES

The obligations arising from the provisions on pressure equipment in this Annex also apply to assemblies.

 

Module A (internal production control)

1. This module describes the procedure whereby the manufacturer or his authorized representative established within the Community who carries out the obligations laid down in section 2 ensures and declares that pressure equipment satisfies the requirements of the Directive which apply to it. The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity.

2. The manufacturer must draw up the technical documentation described in section 3 and either the manufacturer or his authorized representative established within the Community must keep it at the disposal of the relevant national authorities for inspection purposes for a period of ten years after the last of the pressure equipment has been manufactured.

Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the pressure equipment on the Community market.

3. The technical documentation must enable an assessment to be made of the conformity of the pressure equipment with the requirements of the Directive which apply to it. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the pressure equipment and contain:

- a general description of the pressure equipment,

- conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the pressure equipment,

- a list of the standards referred to in Article 5, applied in full or in part, and a description of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports.

4. The manufacturer, or his authorized representative established within the Community, must keep a copy of the declaration of conformity with the technical documentation.

5. The manufacturer must take all measures necessary to ensure that the manfacturing process requires the manufactured pressure equipment to comply with the technical documentation referred to in section 2 and with the requirements of the Directive which apply to it.

 

Module A1 (internal manufacturing checks with monitoring of the final assessment)

In addition to the requirements of module A, the following applies.

Final assessment must be performed by the manufacturer and monitored by means of unexpected visits by a notified body chosen by the manufacturer.

During such visits, the notified body must:

- establish that the manufacturer actually performs final assessment in accordance with section 3.2 of Annex I,

- take samples of pressure equipment at the manufacturing or storage premises in order to conduct checks. The notified body assesses the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of the final assessment of the pressure equipment samples.

Should one or more of the items of pressure equipment not conform, the notified body must take appropriate measures.

On the responsibility of the notified body, the manufacturer must affix the former's identification number on each item of pressure equipment.

 

Module B (EC type-examination)

1. This module describes the part of the procedure by which a notified body ascertains and attests that a representative example of the production in question meets the provisions of the Directive which apply to it.

2. The application for EC type-examination must be lodged by the manufacturer or by his authorized representative established within the Community with a single notified body of his choice.

The application must include:

- the name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address as well,

- a written declaration that the same application has not been lodged with any other notified body,

- the technical documentation described in section 3.

The applicant must place at the disposal of the notified body a representative example of the production envisaged, hereinafter called 'type`. The notified body may request further examples should the test programme so require.

A type may cover several versions of pressure equipment provided that the differences between the versions do not affect the level of safety.

3. The technical documentation must enable an assessment to be made of the conformity of the pressure equipment with the requirements of the Directive which apply to it. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the pressure equipment and contain:

- a general description of the type,

- conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the pressure equipment,

- a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports,

- information concerning the tests provided for in manufacture,

- information concerning the qualifications or approvals required under sections 3.1.2 and 3.1.3 of Annex I.

4. The notified body must:

4.1. examine the technical documentation, verify that the type has been manufactured in conformity with it and identify the components designed in accordance with the relevant provisions of the standards referred to in Article 5, as well as those designed without applying the provisions of those standards.

In particular, the notified body must:

- examine the technical documentation with respect to the design and the manufacturing procedures,

- assess the materials used where these are not in conformity with the relevant harmonized standards or with a European approval for pressure equipment materials, and check the certificate issued by the material manufacturer in accordance with section 4.3 of Annex I,

- approve the procedures for the permanent joining of pressure equipment parts, or check that they have been previously approved in accordance with section 3.1.2 of Annex I,

- verify that the personnel undertaking the permanent joining of pressure equipment parts and the non-destructive tests are qualified or approved in accordance with sections 3.1.2 or 3.1.3 of Annex I.

4.2. perform or have performed the appropriate examinations and necessary tests to establish whether the solutions adopted by the manufacturer meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied.

4.3. perform or have performed the appropriate examinations and necessary tests to establish whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied.

4.4. agree with the applicant the location where the examinations and necessary tests are to be carried out.

5. Where the type satisfies the provisions of the Directive which apply to it, the notified body must issue an EC type-examination certificate to the applicant. The certificate, which should be valid for ten years and be renewable, must contain the name and address of the manufacturer, the conclusions of the examination and the necessary data for identification of the approved type.

A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body.

If the notified body refuses to issue an EC type-examination certificate to the manufacturer or to his authorized representative established within the Community, that body must provide detailed reasons for such refusal. Provision must be made for an appeals procedure.

6. The applicant must inform the notified body that holds the technical documentation concerning the EC type-examination certificate of all modifications to the approved pressure equipment; these are subject to additional approval where they may affect conformity with the essential requirements or the prescribed conditions for use of the pressure equipment. This additional approval must be given in the form of an addition to the original EC type-examination certificate.

7. Each notified body must communicate to the Member States the relevant information concerning EC type-examination certificates which it has withdrawn, and, on request, those it has issued.

Each notified body must also communicate to the other notified bodies the relevant information concerning the EC type-examination certificates it has withdrawn or refused.

8. The other notified bodies may receive copies of the EC type-examination certificates and/or their additions. The annexes to the certificates must be held at the disposal of the other notified bodies.

9. The manufacturer, or his authorized representative established within the Community, must keep with the technical documentation copies of EC type-examination certificates and their additions for a period of ten years after the last of the pressure equipment has been manufactured.

Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market.

 

Module B1 (EC design-examination)

1. This module describes the part of the procedure whereby a notified body ascertains and attests that the design of an item of pressure equipment meets the provisions of the Directive which apply to it.

The experimental design method provided for in section 2.2.4 of Annex I may not be used in the context of this module.

2. The manufacturer, or his authorized representative established within the Community, must lodge an application for EC design examination with a single notified body.

The application must include:

- the name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address as well,

- a written declaration that the same application has not been lodged with any other notified body,

- the technical documentation described in section 3.

The application may cover several versions of the pressure equipment provided that the differences between the versions do not affect the level of safety.

3. The technical documentation must enable an assessment to be made of the conformity of the pressure equipment with the requirements of the Directive which apply to it. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the pressure equipment and contain:

- a general description of the pressure equipment,

- conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the pressure equipment,

- a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,

- the necessary supporting evidence for the adequacy of the design solution, in particular where the standards referred to in Article 5 have not been applied in full; this supporting evidence must include the results of tests carried out by the appropriate laboratory of the manufacturer or on his behalf,

- results of design calculations made, examinations carried out, etc.,

- information regarding the qualifications or approvals required under sections 3.1.2 and 3.1.3 of Annex I.

4. The notified body must:

4.1. examine the technical documentation and identify the components which have been designed in accordance with the relevant provisions of the standards referred to in Article 5, as well as those which have been designed without applying the relevant provisions of those standards.

In particular, the notified body must:

- assess the materials where these are not in conformity with the relevant harmonized standards or with a European approval for pressure equipment materials,

- approve the procedures for the permanent joining of pressure equipment parts, or check that they have been previously approved in accordance with section 3.1.2 of Annex I,

- verify that the personnel undertaking the permanent joining of pressure equipment parts and the non-destructive tests are qualified or approved in accordance with sections 3.1.2 and 3.1.3 of Annex I.

4.2. perform the necessary examinations to establish whether the solutions adopted by the manufacturer meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied.

4.3. perform the necessary examinations to establish whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied.

5. Where the design meets the provisions of the Directive which apply to it, the notified body must issue an EC design-examination certificate to the applicant. The certificate must contain the name and address of the applicant, the conclusions of the examination, conditions for its validity and the necessary data for identification of the approved design.

A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body.

If the notified body refuses to issue an EC design-examination certificate to the manufacturer or to his authorized representative established within the Community, that body must provide detailed reasons for such refusal. Provision must be made for an appeals procedure.

6. The applicant must inform the notified body that holds the technical documentation concerning the EC design-examination certificate of all modifications to the approved design; these are subject to additional approval where such changes may affect the conformity of the pressure equipment with the essential requirements of the Directive or the prescribed conditions for use of the equipment. This additional approval must be given in the form of an addition to the original EC design-examination certificate.

7. Each notified body must communicate to the Member States the relevant information concerning EC design-examination certificates which it has withdrawn, and, on request, those it has issued.

Each notified body must also communicate to the other notified bodies the relevant information concerning the EC design-examination certificates it has withdrawn or refused.

8. The other notified bodies may on request obtain the relevant information concerning:

- the EC design-examination certificates and additions granted,

- the EC design-examination certificates and additions withdrawn.

9. The manufacturer, or his authorized representative established within the Community, must keep with the technical documentation referred to in section 3 copies of EC design-examination certificates and their additions for a period of ten years after the last of the pressure equipment has been manufactured.

Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market.

 

Module C1 (conformity to type)

1. This module describes that part of the procedure whereby the manufacturer, or his authorized representative established within the Community, ensures and declares that pressure equipment is in conformity with the type as described in the EC type-examination certificate and satisfies the requirements of the Directive which apply to it. The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity.

2. The manufacturer must take all measures necessary to ensure that the manufacturing process requires the manufactured pressure equipment to comply with the type as described in the EC type-examination certificate and with the requirements of the Directive which apply to it.

3. The manufacturer, or his authorized representative established within the Community, must keep a copy of the declaration of conformity for a period of ten years after the last of the pressure equipment has been manufactured.

Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the pressure equipment on the Community market.

4. Final assessment must be subject to monitoring in the form of unexpected visits by a notified body chosen by the manufacturer.

During such visits, the notified body must:

- establish that the manufacturer actually performs final assessment in accordance with section 3.2 of Annex I,

- take samples of pressure equipment at the manufacturing or storage premises in order to conduct checks. The notified body must assess the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of final assessment on the pressure equipment samples.

Should one or more of the items of pressure equipment not conform, the notified body must take appropriate measures.

On the responsibility of the notified body, the manufacturer must affix the former's identification number on each item of pressure equipment.

 

Module D (production quality assurance)

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of section 2 ensures and declares that the pressure equipment concerned is in conformity with the type described in the EC type-examination certificate or EC design-examination certificate and satisfies the requirements of the Directive which apply to it. The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity. The CE marking must be accompanied by the identification number of the notified body responsible for surveillance as specified in section 4.

2. The manufacturer must operate an approved quality system for production, final inspection and testing as specified in section 3 and be subject to surveillance as specified in section 4.

3. Quality system

3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice.

The application must include:

- all relevant information on the pressure equipment concerned,

- the documentation concerning the quality system,

- the technical documentation for the approved type and a copy of the EC type-examination certificate or EC design-examination certificate.

3.2. The quality system must ensure compliance of the pressure equipment with the type described in the EC type-examination certificate or EC design-examination certificate and with the requirements of the Directive which apply to it.

All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

It must contain in particular an adequate description of:

- the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,

- the manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with section 3.1.2 of Annex I,

- the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

- the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the joining of parts and the non-destructive tests in accordance with sections 3.1.2 and 3.1.3 of Annex I,

- the means of monitoring the achievement of the required quality and the effective operation of the quality system.

3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 3.2. The elements of the quality system which conform to the relevant harmonized standard are presumed to comply with the corresponding requirements referred to in 3.2.

The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. Provision must be made for an appeals procedure.

3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to ensure that it remains satisfactory and efficient.

The manufacturer, or his authorized representative established within the Community, must inform the notified body that has approved the quality system of any intended adjustment to the quality system.

The notified body must assess the proposed changes and decide whether the amended quality system will still satisfy the requirements referred to in 3.2 or whether a reassessment is required.

It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2. The manufacturer must allow the notified body access for inspection purposes to the locations of manufacture, inspection, testing and storage and provide it with all necessary information, in particular:

- the quality system documentation,

- the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

4.3. The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years.

4.4. In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:

- the category of the equipment,

- the results of previous surveillance visits,

- the need to follow up corrective action,

- special conditions linked to the approval of the system, where applicable,

- significant changes in manufacturing organization, policy or techniques.

During such visits the notified body may, if necessary, carry out or have carried out tests to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

5. The manufacturer must, for a period of ten years after the last of the pressure equipment has been manufactured, hold at the disposal of the national authorities:

- the documentation referred to in the second indent of 3.1;

- the adjustments referred to in the second paragraph of 3.4;

- the decisions and reports from the notified body which are referred to in the last paragraph of 3.3, the last paragraph of 3.4, and in 4.3 and 4.4.

6. Each notified body must communicate to the Member States the relevant information concerning the quality system approvals which it has withdrawn, and, on request, those it has issued.

Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.

 

Module D1 (production quality assurance)

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of section 3 ensures and declares that the items of pressure equipment concerned satisfy the requirements of the Directive which apply to them. The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity. The CE marking must be accompanied by the identification number of the notified body responsible for surveillance as specified in section 5.

2. The manufacturer must draw up the technical documentation described below.

The technical documentation must enable an assessment to be made of the conformity of the pressure equipment with the requirements of the Directive which apply to it. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the pressure equipment and contain:

- a general description of the pressure equipment,

- conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the pressure equipment,

- a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports.

3. The manufacturer must operate an approved quality system for production, final inspection and testing as specified in section 4 and be subject to surveillance as specified in section 5.

4. Quality system

4.1. The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice.

The application must include:

- all relevant information on the pressure equipment concerned,

- the documentation concerning the quality system.

4.2. The quality system must ensure compliance of the pressure equipment with the requirements of the Directive which apply to it.

All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

It must contain in particular an adequate description of:

- the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,

- the manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with section 3.1.2 of Annex I,

- the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

- the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts in accordance with section 3.1.2 of Annex I,

- the means of monitoring the achievement of the required quality and the effective operation of the quality system.

4.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 4.2. The elements of the quality system which conform to the relevant harmonized standard are presumed to comply with the corresponding requirements referred to in 4.2.

The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. Provision must be made for an appeals procedure.

4.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to ensure that it remains satisfactory and efficient.

The manufacturer, or his authorized representative established within the Community, must inform the notified body that has approved the quality system of any intended adjustment to the quality system.

The notified body must assess the proposed changes and decide whether the amended quality system will still satisfy the requirements referred to in 4.2 or whether a reassessment is required.

If must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

5. Surveillance under the responsibility of the notified body

5.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

5.2. The manufacturer must allow the notified body access for inspection purposes to the locations of manufacture, inspection, testing and storage and provide it with all necessary information, in particular:

- the quality system documentation,

- the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

5.3. The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years.

5.4. In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:

- the category of the equipment,

- the results of previous surveillance visits,

- the need to follow up corrective action,

- special conditions linked to the approval of the system, where applicable,

- significant changes in manufacturing organization, policy or techniques.

During such visits the notified body may, if necessary, carry out or have carried out tests to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

6. The manufacturer must, for a period of ten years after the last of the pressure equipment has been manufactured, hold at the disposal of the national authorities:

- the technical documentation referred to in section 2,

- the documention referred to in the second indent of 4.1,

- the adjustments referred to in the second paragraph of 4.4,

- the decisions and reports from the notified body which are referred to in the last paragraph of 4.3, the last paragraph of 4.4, and in 5.3 and 5.4.

7. Each notified body must communicate to the Member States the relevant information concerning the quality system approvals which it has withdrawn, and, on request, those it has issued.

Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.

 

Module E (product quality assurance)

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of section 2 ensures and declares that the pressure equipment is in conformity with the type as described in the EC type-examination certificate and satisfies the requirements of the Directive which apply to it. The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each product and draw up a written declaration of conformity. The CE marking must be accompanied by the identification number of the notified body responsible for surveillance as specified in section 4.

2. The manufacturer must operate an approved quality system for the final pressure equipment inspection and testing as specified in section 3 and be subject to surveillance as specified in section 4.

3. Quality system

3.1. The manufacturer must lodge an application for assessment of his quality system for the pressure equipment with a notified body of his choice.

The application must include:

- all relevant information on the pressure equipment concerned,

- the documentation concerning the quality system,

- the technical documentation for the approved type and a copy of the EC type-examination certificate.

3.2. Under the quality system, each item of pressure equipment must be examined and appropriate tests as set out in the relevant standard(s) referred to in Article 5, or equivalent tests, particularly final assessment as referred to in section 3.2 of Annex I, must be carried out in order to ensure its conformity with the requirements of the Directive which apply to it. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

It must contain in particular an adequate description of:

- the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,

- the examinations and tests to be carried out after manufacture,

- the means of monitoring the effective operation of the quality system,

- the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with sections 3.1.2 and 3.1.3 of Annex I.

3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 3.2. The elements of the quality system which conform to the relevant harmonized standard are presumed to comply with the corresponding requirements referred to in 3.2.

The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

3.4. The manufacturer must undertake to discharge the obligations arising from the quality system as approved and to ensure that it remains satisfactory and efficient.

The manufacturer, or his authorized representative established within the Community, must inform the notified body which has approved the quality system of any intended adjustment to the quality system.

The notified body must assess the proposed changes and decide whether the modified quality system will still satisfy the requirements referred to in 3.2 or whether a reassessment is required.

It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2. The manufacturer must allow the notified body access for inspection purposes to the locations of inspection, testing and storage and provide it with all necessary information, in particular:

- the quality system documentation,

- the technical documentation,

- the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

4.3. The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years.

4.4. In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:

- the category of the equipment,

- the results of previous surveillance visits,

- the need to follow up corrective action,

- special conditions linked to the approval of the system, where applicable,

- significant changes in manufacturing organization, policy or techniques.

During such visits, the notified body may, if necessary, carry out or have carried out tests to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

5. The manufacturer must, for a period of ten years after the last of the pressure equipment has been manufactured, hold at the disposal of the national authorities:

- the documentation referred to in the second indent of 3.1,

- the adjustments referred to in the second paragraph of 3.4,

- the decisions and reports from the notified body which are referred to in the last paragraph of 3.3, the last paragraph of 3.4, and in 4.3 and 4.4.

6. Each notified body must communicate to the Member States the relevant information concerning the quality system approvals which it has withdrawn and, on request, those it has issued.

Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.

 

Module E1 (product quality assurance)

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of section 3 ensures and declares that the pressure equipment satisfies the requirements of the Directive which apply to it. The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity. The CE marking must be accompanied by the identification number of the notified body responsible for surveillance as specified in section 5.

2. The manufacturer must draw up the technical documentation described below.

The technical documentation must enable an assessment to be made of the conformity of the pressure equipment with the requirements of the Directive which apply to it. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the pressure equipment and contain:

- a general description of the pressure equipment,

- conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the pressure equipment,

- a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports.

3. The manufacturer must operate an approved quality system for the final pressure equipment inspection and testing as specified in section 4 and be subject to surveillance as specified in section 5.

4. Quality system

4.1. The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice.

The application must include:

- all relevant information on the pressure equipment concerned,

- the documentation concerning the quality system.

4.2. Under the quality system, each item of pressure equipment must be examined and appropriate tests as set out in the relevant standard(s) referred to in Article 5, or equivalent tests, and particularly final assessment as referred to in section 3.2 of Annex I, must be carried out in order to ensure its conformity with the requirements of the Directive which apply to it. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

It must contain in particular an adequate description of:

- the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,

- the procedures used for the permanent joining of parts as approved in accordance with section 3.1.2 of Annex I,

- the examinations and tests to be carried out after manufacture,

- the means of monitoring the effective operation of the quality system,

- the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts in accordance with section 3.1.2 of Annex I.

4.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 4.2. The elements of the quality system which conform to the relevant harmonized standard are presumed to comply with the corresponding requirements referred to in 4.2.

The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. Provision must be made for an appeals procedure.

4.4. The manufacturer must undertake to discharge the obligations arising from the quality system as approved and to ensure that it remains satisfactory and efficient.

The manufacturer, or his authorized representative established within the Community, must inform the notified body which has approved the quality system of any intended adjustment to the quality system.

The notified body must assess the proposed changes and decide whether the modified quality system will still satisfy the requirements referred to in 4.2 or whether a reassessment is required.

It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

5. Surveillance under the responsibility of the notified body

5.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

5.2. The manufacturer must allow the notified body access for inspection purposes to the locations of inspection, testing and storage and provide it with all necessary information, in particular:

- the quality system documentation,

- the technical documentation,

- the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

5.3. The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years.

5.4. In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:

- the category of the equipment,

- the results of previous surveillance visits,

- the need to follow up corrective action,

- special conditions linked to the approval of the system, where applicable,

- significant changes in manufacturing organization, policy or techniques.

During such visits the notified body may, if necessary, carry out or have carried out tests to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

6. The manufacturer must, for a period of ten years after the last of the pressure equipment has been manufactured, keep at the disposal of the national authorities:

- the technical documentation referred to in section 2,

- the documentation referred to in the second indent of 4.1,

- the adjustments referred to in the second paragraph of 4.4,

- the decisions and reports from the notified body which are referred to in the last paragraph of 4.3, the last paragraph of 4.4 and in 5.3 and 5.4.

7. Each notified body must communicate to the Member States the relevant information concerning the quality system approvals which it has withdrawn and, on request, those is has issued.

Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.

 

Module F (product verification)

1. This module describes the procedure whereby a manufacturer, or his authorized representative established within the Community, ensures and declares that the pressure equipment subject to the provisions of section 3 is in conformity with the type described:

- in the EC type-examination certificate, or

- in the EC design-examination certificate

and satisfies the requirements of the Directive which apply to it.

2. The manufacturer must take all measures necessary to ensure that the manufacturing process requires the pressure equipment to comply with the type described

- in the EC type-examination certificate, or

- in the EC design-examination certificate

and with the requirements of the Directive which apply to it.

The manufacturer, or his authorized representative established within the Community, must affix the CE marking to all pressure equipment and draw up a declaration of conformity.

3. The notified body must perform the appropriate examinations and tests in order to check the conformity of the pressure equipment with the relevant requirements of the Directive by examining and testing every product in accordance with section 4.

The manufacturer, or his authorized representative established within the Community, must keep a copy of the declaration of conformity for a period of ten years after the last of the pressure equipment has been manufactured.

4. Verification by examination and testing of each item of pressure equipment

4.1. Each item of pressure equipment must be individually examined and must undergo appropriate examinations and tests as set out in the relevant standard(s) referred to in Article 5 or equivalent examinations and tests in order to verify that it conforms to the type and the requirements of the Directive which apply to it.

In particular, the notified body must:

- verify that the personnel undertaking the permanent joining of parts and the non-destructive tests are qualified or approved in accordance with sections 3.1.2 and 3.1.3 of Annex I,

- verify the certificate issued by the materials manufacturer in accordance with section 4.3 of Annex I,

- carry out or have carried out the final inspection and proof test referred to in section 3.2 of Annex I and examine the safety devices, if applicable.

4.2. The notified body must affix its identification number or have it affixed to each item of pressure equipment and draw up a written certificate of conformity relating to the tests carried out.

4.3. The manufacturer, or his authorized representative established within the Community, must ensure that the certificates of conformity issued by the notified body can be made available on request.

 

Module G (EC unit verification)

1. This module describes the procedure whereby the manufacturer ensures and declares that pressure equipment which has been issued with the certificate referred to in section 4.1 satisfies the requirements of the Directive which apply to it. The manufacturer must affix the CE marking to the pressure equipment and draw up a declaration of conformity.

2. The manufacturer must apply to a notified body of his choice for unit verification.

The application must contain:

- the name and address of the manufacturer and the location of the pressure equipment,

- a written declaration to the effect that a similar application has not been lodged with another notified body,

- technical documentation.

3. The technical documentation must enable the conformity of the pressure equipment with the requirements of the Directive which apply to it to be assessed and the design, manufacture and operation of the pressure equipment to be understood.

The technical documentation must contain:

- a general description of the pressure equipment,

- conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the pressure equipment,

- a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports,

- appropriate details relating to the approval of the manufacturing and test procedures and of the qualifications or approvals of the personnel concerned in accordance with sections 3.1.2 and 3.1.3 of Annex I.

4. The notified body must examine the design and construction of each item of pressure equipment and during manufacture perform appropriate tests as set out in the relevant standard(s) referred to in Article 5 of the Directive, or equivalent examinations and tests, to ensure its conformity with the requirements of the Directive which apply to it.

In particular the notified body must:

- examine the technical documentation with respect to the design and the manufacturing procedures,

- assess the materials used where these are not in conformity with the relevant harmonized standards or with a European approval for pressure equipment materials, and check the certificate issued by the material manufacturer in accordance with section 4.3 of Annex I,

- approve the procedures for the permanent joining of parts or check that they have been previously approved in accordance with section 3.1.2 of Annex I,

- verify the qualifications or approvals required under sections 3.1.2 and 3.1.3 of Annex I,

- carry out the final inspection referred to in section 3.2.1 of Annex I, perform or have performed the proof test referred to in section 3.2.2 of Annex I, and examine the safety devices, if applicable.

4.1. The notified body must affix its identification number or have it affixed to the pressure equipment and draw up a certificate of conformity for the tests carried out. This certificate must be kept for a period of ten years.

4.2. The manufacturer, or his authorized representative established within the Community, must ensure that the declaration of conformity and certificate of conformity issued by the notified body can be made available on request.

 

Module H (full quality assurance)

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of section 2 ensures and declares that the pressure equipment in question satisfies the requirements of the Directive which apply to it. The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity. The CE marking must be accompanied by the identification number of the notified body responsible for surveillance as specified in section 4.

2. The manufacturer must implement an approved quality system for design, manufacture, final inspection and testing as specified in section 3 and be subject to surveillance as specified in section 4.

3. Quality system

3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice.

The application must include:

- all relevant information concerning the pressure equipment in question,

- the documentation concerning the quality system.

3.2. The quality system must ensure compliance of the pressure equipment with the requirements of the Directive which apply to it.

All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the procedural and quality measures such as programmes, plans, manuals and records.

It must contain in particular an adequate description of:

- the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the design and to product quality,

- the technical design specifications, including standards, that will be applied and, where the standards referred to in Article 5 are not applied in full, the means that will be used to ensure that the essential requirements of the Directive which apply to the pressure equipment will be met,

- the design control and design verification techniques, processes and systematic measures that will be used when designing the pressure equipment, particularly with regard to materials in accordance with section 4 of Annex I,

- the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used, particularly the procedures for the permanent joining of parts as approved in accordance with section 3.1.2 of Annex I,

- the examinations and tests to be carried out before, during, and after manufacture, and the frequency with which they will be carried out,

- the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with sections 3.1.2 and 3.1.3 of Annex I,

- the means of monitoring the achievement of the required pressure equipment design and quality and the effective operation of the quality system.

3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 3.2. The elements of the quality system which conform to the relevant harmonized standard are presumed to comply with the corresponding requirements referred to in 3.2.

The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. Provision must be made for an appeals procedure.

3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to ensure that it remains satisfactory and efficient.

The manufacturer, or his authorized representative established within the Community, must inform the notified body that has approved the quality system of any intended adjustment to the quality system.

The notified body must assess the proposed changes and decide whether the modified quality system will still satisfy the requirements referred to in 3.2 or whether a reassessment is required.

It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

4.1. The purpose of this surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2. The manufacturer must allow the notified body access for inspection purposes to the locations of design, manufacture, inspection, testing and storage and provide it with all necessary information, in particular:

- the quality system documentation,

- the quality records provided for in the design part of the quality system, such as results of analyses, calculations, tests, etc.,

- the quality records provided for in the manufacturing part of the quality system, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

4.3. The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years.

4.4. In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:

- the category of the equipment,

- the results of previous surveillance visits,

- the need to follow up corrective action,

- special conditions linked to the approval of the system, where applicable,

- significant changes in manufacturing organization, policy or techniques.

During such visits the notified body may, if necessary, carry out or have carried out tests to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

5. The manufacturer must, for a period of ten years after the last of the pressure equipment has been manufactured, keep at the disposal of the national authorities:

- the documentation referred to in the second indent of the second subparagraph of 3.1;

- the adjustments referred to in the second subparagraph of 3.4;

- the decisions and reports from the notified body which are referred to in the last subparagraph of 3.3, the last subparagraph of 3.4, and in 4.3 and 4.4.

6. Each notified body must communicate to the Member States the relevant information concerning the quality system approvals which it has withdrawn, and, on request, those it has issued.

Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.

 

Module H1 (full quality assurance with design examination and special surveillance of the final assessment)

1. In addition to the requirements of module H, the following apply:

(a) the manufacturer must lodge an application for examination of the design with the notified body;

(b) the application must enable the design, manufacture and operation of the pressure equipment to be understood, and enable conformity with the relevant requirements of the Directive to be assessed.

It must include:

- the technical design specifications, including standards, which have been applied,

- the necessary supporting evidence for their adequacy, in particular where the standards referred to in Article 5 have not been applied in full. This supporting evidence must include the results of tests carried out by the appropriate laboratory of the manufacturer or on his behalf;

(c) the notified body must examine the application and where the design meets the provisions of the Directive which apply to it issue an EC design-examination certificate to the applicant. The certificate must contain the conclusions of the examination, the conditions for its validity, the necessary data for identification of the approved design and, if relevant, a description of the functioning of the pressure equipment or accessories;

(d) the applicant must inform the notified body that has issued the EC design-examination certificate of all modifications to the approved design. Modifications to the approved design must receive additional approval from the notified body that issued the EC design-examination certificate where they may affect conformity with the essential requirements of the Directive or the prescribed conditions for use of the pressure equipment. This additional approval must be given in the form of an addition to the original EC design-examination certificate;

(e) each notified body must also communicate to the other notified bodies the relevant information concerning the EC design-examination certificates it has withdrawn or refused.

2. Final assessment as referred to in section 3.2 of Annex I is subject to increased surveillance in the form of unexpected visits by the notified body. In the course of such visits, the notified body must conduct examinations on the pressure equipment.

 ANNEX IV

 MINIMUM CRITERIA TO BE MET WHEN DESIGNATING THE NOTIFIED BODIES REFERRED TO IN ARTICLE 12 AND THE RECOGNIZED THIRD-PARTY ORGANIZATIONS REFERRED TO IN ARTICLE 13

1. The body, its director and the personnel responsible for carrying out the assessment and verification operations may not be the designer, manufacturer, supplier, installer or user of the pressure equipment or assemblies which that body inspects, nor the authorized representative of any of those parties. They may not become directly involved in the design, construction, marketing or maintenance of the pressure equipment or assemblies, nor represent the parties engaged in these activities. This does not preclude the possibility of exchanges of technical information between the manufacturer of pressure equipment or assemblies and the notified body.

2. The body and its personnel must carry out the assessments and verifications with the highest degree of professional integrity and technical competence and must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection, especially from persons or groups of persons with an interest in the results of verifications.

3. The body must have at its disposal the necessary personnel and possess the necessary facilities to enable it to perform properly the technical and administrative tasks connected with the inspection and surveillance operations, it must also have access to the equipment required to perform special verifications.

4. The personnel responsible for inspection must have:

- sound technical and vocational training,

- satisfactory knowledge of the requirements of the inspections they carry out and adequate experience of such operations,

- the ability required to draw up the certificates, records and reports to demonstrate that the inspections have been carried out.

5. The impartiality of the inspection personnel must be guaranteed. Their remuneration must not depend on the number of inspections carried out, nor on the results of such inspections.

6. The body must take out liability insurance unless its liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the inspections.

7. The personnel of the body must observe professional secrecy with regard to all information gained in carrying out their tasks (except vis-à-vis the competent administrative authorities of the State in which their activities are carried out) under the Directive or any provision of national law giving effect to it.

 ANNEX V

 CRITERIA TO BE MET WHEN AUTHORIZING USER INSPECTORATES REFERRED TO IN ARTICLE 14

1. The user inspectorate must be organizationally identifiable and have reporting methods within the group of which it is part which ensure and demonstrate its impartiality. It must not be responsible for the design, manufacture, supply, installation, operation or maintenance of the pressure equipment or assemblies, and must not engage in any activities that might conflict with its independence of judgment and integrity in relation to its inspection activities.

2. The user inspectorate and its personnel must carry out the assessments and verifications with the highest degree of professional integrity and technical competence and must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection, especially from persons or groups of persons with an interest in the results of verifications.

3. The user inspectorate must have at its disposal the necessary personnel and possess the necessary facilities to enable it to perform properly the technical and administrative tasks connected with the inspection and surveillance operations; it must also have access to the equipment required to perform special verifications.

4. The personnel responsible for inspection must have:

- sound technical and vocational training,

- satisfactory knowledge of the requirements of the inspections they carry out and adequate experience of such operations,

- the ability required to draw up the certificates, records and reports to demonstrate that the inspections have been carried out.

5. The impartiality of inspection personnel must be guaranteed. Their remuneration must not depend on the number of inspections carried out, nor on the results of such inspections.

6. The user inspectorate must have adequate liability insurance unless liability is assumed by the group of which it is part.

7. The personnel of the user inspectorate must observe professional secrecy with regard to all information gained in carrying out their tasks (except vis-à-vis the competent administrative authorities of the State in which their activities are carried out) under the Directive or any provision of national law giving effect to it.

ANNEX VI

CE MARKING

The CE marking consists of the initials 'CE` taking the following form:

>REFERENCE TO A GRAPHIC>

If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.

The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm.

 ANNEX VII

 DECLARATION OF CONFORMITY

The EC declaration of conformity must contain the following particulars:

- name and address of the manufacturer or of his authorized representative established within the Community,

- description of the pressure equipment or assembly,

- conformity assessment procedure followed,

- in the case of assemblies, description of the pressure equipment constituting the assembly, and the conformity assessment procedures followed,

- where appropriate, name and address of the notified body which carried out the inspection,

- where appropriate, a reference to the EC type-examination certificate, EC design-examination certificate or EC certificate of conformity,

- where appropriate, name and address of the notified body monitoring the manufacturer's quality assurance system,

- where appropriate, the references of the harmonized standards applied,

- where appropriate, other technical standards and specifications used,

- where appropriate, the references of the other Community Directives applied,

- particulars of the signatory authorized to sign the legally binding declaration for the manufacturer or his authorized representative established within the Community.

Construction Products Directive
Repealed by Construction Products Regulation (EU) No 305/2011

Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products

Official Journal L 040 , 11/02/1989 P. 0012 - 0026
Finnish special edition: Chapter 13 Volume 17 P. 0185
Swedish special edition: Chapter 13 Volume 17 P. 0185

 

COUNCIL DIRECTIVE of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States (89/106/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,

Having regard to the proposal from the Commission (1),

In cooperation with the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

Whereas Member States are responsible for ensuring that building and civil engineering works on their territory are designed and executed in a way that does not endanger the safety of persons, domestic animals and property, while respecting other essential requirements in the interests of general well-being;

Whereas Member States have provisions, including requirements, relating not only to building safety but also to health, durability, energy economy, protection of the environment, aspects of economy, and other aspects important in the public interest;

Whereas these requirements, which are often the subject of national provisions laid down by law, regulation or administrative action, have a direct influence on the nature of construction products employed and are reflected in national product standards, technical approvals and other technical specifications and provisions which, by their disparity, hinder trade within the Community;

Whereas paragraph 71 of the White Paper on completing the internal market, approved by the European Council in June 1985, states that, within the general policy, particular emphasis will be placed on certain sectors, including construction; whereas the removal of technical barriers in the construction field, to the extent that they cannot be removed by mutual recognition of equivalence among all the Member States, should follow the new approach set out in the Council resolution of 7 May 1985 (4) which calls for the definition of essential requirements on safety and other aspects which are important for the general well-being, without reducing the existing and justified levels of protection in the Member States;

Whereas the essential requirements constitute both the general and specific criteria with which construction works must comply; whereas such requirements are to be understood as requiring that the said works conform with an appropriate degree of reliability with one, some or all of these requirements when and where this is laid down in regulations;

Whereas, as a basis for the harmonized standards or other technical specifications at European level and for the drawing up or granting of European technical approval, interpretative documents will be established in order to give concrete form to the essential requirements at a technical level;

Whereas these essential requirements provide the basis for the preparation of harmonized standards at European level for construction products; whereas, in order to achieve the greatest possible advantage for a single internal market,to afford access to that market for as many mannifacturers as possible, to ensure the greatest possible degree of market transparency and to create the conditions for a harmonized system of general rules in the construction industry, harmonized standards should be established as far as, and as quickly as, possible; whereas these standards are drawn up by private bodies and must remain non-mandatory texts; whereas, for that purpose, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the competent bodies for the adoption of harmonized standards in accordance with the general guidelines for cooperation between the Commission and those two bodies signed on 13 November 1984; whereas, for the purposes of this Directive, a harmonized standard is a technical specification (European standard or harmonized document) adopted by one or both of those bodies upon a mandate given by the Commission in accordance with the provisions of Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (5);

Whereas the special nature of construction products requires the precise formulation of these harmonized standards; whereas it is therefore necessary to draw up interpretative documents in order to establish links between mandates for standards and the essential requirements; whereas harmonized standards, expressed as far as possible in terms of product performance, take account of these interpretative documents, which shall be drawn up in cooperation with the Member States;

Whereas performance levels and requirements to be fulfilled by products in future in the Member States shall be laid down in classes in the interpretative documents and in the harmonized technical specifications in order to take account of different levels of essential requirements for certain works and of different conditions prevailing in the Member States;

Whereas harmonized standards should include classifications that allow construction products which meet the essential requirements and which are produced and used lawfully in accordance with technical traditions warranted by local climatological and other conditions to continue to be placed on the market;

Whereas a product is presumed fit for use if it conforms to a harmonized standard, a European technical approval or a non-harmonized technical specification recognized at Community level; whereas, in cases where products are of little importance with respect to the essential requirements and where they deviate from existing technical specifications, their fitness for use can be certified by recourse to an approved body;

Whereas products thus considered fit for use are easily recognizable by the EC mark; whereas they must be allowed free movement and free use for their intended purpose throughout the Community;

Whereas, in the case of products where European standards cannot be produced or foreseen within a reasonable period of time or of products which deviate substantially from a standard, the fitness for use of such products may be proved by recourse to European technical approvals on the basis of common guidelines; whereas the common guidelines for the granting of European technical approvals will be adopted on the basis of the interpretative documents;

Whereas, in the absence of harmonized standards and European technical approvals, national or other non-harmonized technical specifications may be recognized as providing a suitable basis for a presumption that the essential requirements are met;

Whereas it is necessary to ensure the conformity of products with harmonized standards and with non-harmonized technical specifications recognized at European level by means of procedures of production control by manufacturers and of supervision, testing assessment and certification by independent qualified third parties, or by the manufacturer himself;

Whereas a special procedure should be provided as an interim measure for products where standards or technical approvals recognized at European level do not yet exist; whereas this procedure should facilitate recognition of the results of tests performed in another Member State according to the technical requirements of the Member State of destination;

Whereas a Standing Committee on Construction should be set up comprising experts designated by Member States to assist the Commission on questions arising from the implementation and practical application of this Directive;

Whereas the responsibility of Member States for safety, health and other matters covered by the essential requirements on their territory should be recognized in a safeguard clause providing for appropriate protective measures,

HAS ADOPTED THIS DIRECTIVE:

CHAPTER I

Field of application - Definitions - Requirements Technical specifications - Free movement of goods

Article 1

1. This Directive shall apply to construction products in so far as the essential requirements in respect of construction works under Article 3 (1) relate to them

2. For the purposes of this Directive, 'construction product' means any product which is produced for incorporation in a permanent manner in construction works, including both buildings and civil engineering works.

'Construction Products' are hereinafter referred to as 'products'; construction works including both buildings and civil engineering works are hereinafter referred to as 'works'.

Article 2

1. Member States shall take all necessary measures to ensure that the products referred to in Article 1, which are intended for use in works, may be placed on the market only if they are fit for this intended use, that is to say they have such characteristics that the works in which they are to be incorporated, assembled, applied or installed, can, if properly designed and built, satisfy the essential requirements referred to in Article 3 when and where such works are subject to regulations containing such requirements.

2. When products are subject to other Community directives with regard to other aspects, the EC conformity mark, hereinafter referred to as the 'EG mark', referred to in Article 4 (2) shall indicate in these cases that the requirements of those other directives have also been complied with.

3. When a future directive concerns mainly other aspects and only to a minor extent the essential requirements of this Directive, that subsequent directive shall contain provisions ensuring that it also covers the requirements of this Directive.

4. This Directive shall not affect the right of Member States to specify - with due observance of the provisions of the Treaty - the requirements they deem necessary to ensure that workers are protected when using products, provided it does not mean the products are modified in a way unspecified in this Directive

Article 3

1. The essential requirements applicable to works which may influence the technical characteristics of a product are set out in terms of objectives in Annex I. One, some or all of these requirements may apply; they shall be satisfied during an economically reasonable working life.

2. In order to take account of possible differences in geographical or climatic conditions or in ways of life as well as different levels of protection that may prevail at national, regional or local level, each essential requirement may give rise to the establishment of classes in the documents referred to in paragraph 3 and the technical specifications referred to in Article 4 for the requirement to be respected.

3. The essential requirements shall be given concrete form in documents (interpretative documents) for the creation of the necessary links between the essential requirements laid down in paragraph 1 and the standardization mandates, mandates for guidelines for European technical approval or the recognition of other technical specifications within the meaning of Articles 4 and 5.

Article 4

1. Standards and technical approvals shall, for the purposes of ehis Directive, be referred to as 'technical specifications'

For the purposes of this Directive, harmonized standards shall be the technical specifications adopted by CEN, Cenelec or both, on mandates given by the Commission in conformity with Directive 83/189/EEC on the basis of an opinion given by the Committee referred to in Article 19 and in accordance with the general provisions concerning cooperation between the Commission and these two bodies signed on 13 November 1984.

2. Member States shall presume that the products are fit for their intended use if they enable works in which they are employed, provided the latter are properly designed and built, to satisfy the essential requirements referred to in Article 3, and those products bear the EC mark. The EC mark shall indicate:

(a) that they comply with the relevant national standards transposing the harmonized standards, references to which have been published in the Official Journal of the European Countries. Member States shall publish the references of these national standards:

(b) that they comply with a European technical approval, delivered according to the procedure of Chapter III, or

(c) that they comply with the national technical specifications referred to in paragraph 3 in as much as harmonized specifications do not exist; a list of these national specifications shall be drawn up according to the procedure in Article 5 (2).

3. Member States may communicate to the Commission the texts of their national technical specifications which they regard as complying with the essential requirements referred to in Article 3. The Commission shall forward these national technical specifications forthwith to the other Member States. In accordance with the procedure provided for in Article 5 (2), it shall notify the Member States of those national technical specificationsion respect of which there is presumption of conformity with the essential requirements referred to in Article 3.

This procedure will be initiated and managed by the Commission in consultation with the committee referred to in Article 19

Member States shall publish the references to these technical specifications. The Commission shall also publish them in the Official Journal of the European Countries

4. Where a manufacturer, or his agent, established in the Community, has not applied, or has applied only in part, the existing technical specifications referred to in paragraph 2, which require, according to the criteria set out in Article 13 (4), the product to be submitted for a declaration of conformity as defined in Annex III (2) (ii), second and third possibilities, the corresponding decisions under Article 13 (4) and Annex III shall apply and such a product's fitness for use within the meaning of Article 2 (1) shall be established in accordance with the procedure set out in Annex III (2) (ii), second possibility.

5. The Commission, in consultation with the committee referred to in Article 19, shall draw up, manage and revise periodically a list of products which play a minor part with respect to health and safety and in respect of which a declaration of compliance with the 'acknowledged rule of technology', issued by the manufacturer, will authorize such products to be placed on the market.

6. The EC mark signifies that products satisfy the requirements of paragraphs 2 and 4 of this Article. It is for the manufacturer, or his agent established in the Community, to take responsibility for affixing the EC mark on the product itself, on a label attached to it, on its packaging, or on the accompanying commercial documents.

The model of the EC mark and conditions of its use are given in Annex III.

Products referred to in paragraph 5 shall not bear the EC mark.

Article 5

1. Where a Member State or the Commission is of the opinion that the harmonized standards or European technical approvals referred to in Article 4 (2), points (a) and (b), or the mandates referred to in Chapter II, do not satisfy the provisions of Articles 2 and 3, that Member State or the Commission shall notify the committee referred to in Article 19, setting out its reasons. The committee shall deliver an urgent opinion.

In the light of the opinion of the committee, and after consuItation with the committee set up under Directive 83/189/EEC where it concerns harmonized standards, the Commission shall inform Member States if the standards or approvals concerned should be withdrawn in the publications referred to in Article 7 (3).

2. On reception of the communication referred to in Article 4 (3), the Commission shall consult the committee referred to in Article 19. In the light of the opinion of the committee, the Commission shall notify Member States whether the technical specification in question should benefit from the presumption of conformity and, if so, publish a reference to it in the Official Journal of the European Countries.

If the Commission or a Member State believes that a technical specification no longer fulfills the conditions necessary for presumption of conformity with the provisions of Articles 2 and 3, the Commission shall consult the committee referred to in Article 19. In the light of the opinion of the said committee, the Commission shall notify the Member States whether the national technical specification in question should continue to benefit from presumption of conformity, and, if not, whether the reference to it referred to in Article 4 (3) should be withdrawn.

Article 6

1. Member States shall not impede the free movement, placing on the market or use in their territory of products which satisfy the provisions of this Directive

Member States shall ensure that the use of such products, for the purpose for which they were intended, shall not be impeded by rules or conditions imposed by public bodies or private bodies acting as a public undertaking or acting as a public body on the basis of a monopoly position.

2. Member States shall, however, allow products not covered by Article 4 (2)to be placed on the market in their territory if they satisfy national provisions consistent with the Treaty until the European technical specifications referred to in Chapters II and III provide otherwise. The Commission and the committee referred to in Article 19 will monitor and review the development of the European technical specifications on a regular basis.

3. If the relevant European technical specifications, either themselves or on the basis of the interpretative documents referred to in Article 3 (3), distinguish between different classes corresponding to different performance levels, Member States may determine the performance levels also to be observed in their territory only within the classifications adopted at Community level and only subject to the use of all or some classes or one class.

CHAPTER II

Harmonized standards

Article 7

1. In order to ensure the quality of harmonized standards for products, the standards shall be established by the European standards organizations on the basis of mandates given by the Commission in accordance with the procedure laid down in Directive 83/189/EEC and, after consulting the committee referred to in Article 19, in accordance with the general provisions concerning cooperation between the Commission and these bodies signed on 13 November 1984.

2. The resulting standards shall be expressed as far as practicable in product performance terms, having regard to the interpretative documents.

3. Once the standards have been established by the European standards organizations, the Commission shall publish the references of the standards in the 'C' series of the Official Official Journal of the European Countries.

CHAPTER III

European technical approval

Article 8

1. European technical approval is a favourable technical assessment of the fitness for use of a product for an intended use, based on fulfilment of the essential requirements for building works for which the product is us2. European technical approval may be granted to:

(a) products for which there is neither a harmonized standard, nor a recognized national standard, nor a mandate for a harmonized standard, and for which the Commission, after consulting the committee referred to in Article 19, considers that a standard could not, or not yet, be elaborated; and

(b) products which differ significantly from harmonized or recognized national standards.

Even in the case where a mandate for a harmonized standard has been issued, the provisions referred to in (a) do not exclude the granting of European technical approval for products for which guidelines for such approval exist. This shall apply until the entry into force of the harmonized standard in the Member States.

3. In special cases, the Commission may, as a derogation from paragraph 2 (a), authorize the issue of European technical approval, after consulting the committee referred to in Article 19, for products for which there is a mandate for a harmonized standard, or for which the Commission has established that a harmonized standard can be elaborated. The authorization shall be valid for a fixed period.

4. European technical approval shall in general be issued for a five-year period. This period may be extended

Article 9

1. European technical approval for a product shall be based on examinations, tests and an assessment on the basis of the interpretative documents referred to in Article 3 (3) and of the guidelines referred to in Article 11 for this product or the corresponding family of products.

2. Where guidelines referred to in Article 11 do not or not yet exist, European technical approval may be issued by reference to the relevant essential requirements and the interpretative documents where the assessment of the product is adopted by the approval bodies acting jointly in the organization referred to in Annex II. If the approval bodies cannot agree, the matter shall be referred to the committee referred to in Article 19.

3. The European technical approval for a product shall be issued in a Member State in accordance with the procedure laid down in Annex II at the request of the manufacturer or his agent established in the Community.

Article 10

1. Each Member State shall notify the other Member States and the Commission of the names and addresses of the bodies which it has authorized to issue European technical approvals.

2. The approval bodies must satisfy the requirements of chis Directive and in particular must be able:

- to assess the fitness for use of new products on the basis of scientific and practical knowledge,

- to take impartial decisions in relation to the interests of the manufacturers concerned or their agents, and

- to collate the contributions of all the interested parties in a balanced assessment.

3. The list of approval bodies which are competent to issue European technical approvals, as well as any amendments to that list, shall be published in the'G' series of the Official Official Journal of the European Countries.

Article 11

1. The Commission shall, after consulting the committee referred to in Article 19, issue mandates for establishing guidelines for European technical approval for a product or family of products to the organization of approval bodies designated by the Member States.

2. The guidelines for European technical approval for a product or family of products should contain the following, in particular:

(a) a list of the relevant interpretative documents referred to in Article 3 (3);

(b) specific requirements for the products within the meaning of the essential requirements referred to in Article 3 (1);

(c) the test procedures;

(d) method of assessing and judging the resuIts of the tests;

(e) the inspection and conformity procedures which must correspond to Articles 13, 14 and 15;

(f) the period of validity of the European technical approval.

3. The guidelines for European technical approval shall, after consultation with the committee referred to in Article 19, be published by the Member States in their official language or languages.

CHAPTER IV

Interpretative documents

Article 12

1. The Commission shall, after consulting the committee referred to in Article 19, instruct technical committees in which the Member States participate to draw up the interpretative documents referred to in Article 3 (3).

2. The interpretative documents shall:

(a) give concrete form to the essential requirements laid down in Article 3 and in Annex I by harmonizing the terminology and the technical bases and indicating classes or levels for each requirement where necessary and where the state of scientific and technical knowledge so permits;

(b) indicate methods of correlating these classes or levels of requirement with the technical specifications referred to in Article 4, for example, methods of calculation and of proof, technical rules for project design, etc.;

(c) serve as a reference for the establishment of harmonized standards and guidelines for European technical approval and for recognition of national technical specifications in accordance with Article 4 (3).

3. The Commission shall publish the interpretative documents in the 'G' series of the Official Official Journal of the European Countries after Soliciting the opinion of the committee referred to in Article 19.

CHAPTER V

Attestation of conformity

Article 13

1. The manufacturer, or his agent established in the Community, shall be responsible for the attestation that products are in conformity with the requirements of a technical specification within the meaning of Article 4.

2. Products that are the subject of an attestation of conformity shall benefit from the presumption of conformity with technical specifications within the meaning of Article 4. Conformity shall be established by means of testing or other evidence on the basis of the technical specifications in accordance with Annex III.

3. The attestation of conformity of a product is dependention:

(a) the manufacturer having a factory production control system to ensure that production conforms with the relevant technical specifications; or

(b) for particular products indicated in the relevant technical specifications, in addition to a factory production control system, an approved certification body being involved in assessment and surveillance of the production control or of the product itself.

4. The choice of the procedure within the meaning of paragraph 3 for a given product or family of products shall be specified by the Commission, after consultation of the committee referred to in Article 19, according to:

(a) the importance of the part played by the product with respect to the essential requirements, in particular those relating to health and safety;

(b) the nature of the product;

(c) the effect of the variability of the product's characteristics on its serviceability;

(d) the susceptibility to defects in the product manufacture;

in accordance with the particulars set out in Annex III.

In each case, the least onerous possible procedure consistent with safety shall be chosen.

The procedure thus determined shall be indicated in the mandates and in the technical specifications or in the publication thereof.

5. In the case of individual (and non-series) production, a declaration of conformity in accordance with Annex III (2) (ii), third possibility, shall suffice, unless otherwise provided by the technical specifications for products which have particularly important implications for health and safety.

Article 14

1. In accordance with Annex III, the procedures described shall lead:

(a) in the case of Article 13 (3) (a), to the production of a declaration of conformity for a product by the manufacturer, or his agent established in the Community; or

(b) in the case of Article 13 (3) (b), to the issue by an approved certification body of a certificate of conformity for a system of production control and surveillance or for the product itself.

Detailed rules for the implementation of the procedures of attestation of conformity are given in Annex III.

2. The manufacturer's declaration of conformity or the certificate of conformity shall entitle the manufacturer, or his agent established in the Community, to affix the corresponding EC mark on the product itself, on a label attached to it, on its packaging or on the accompanying commercial documents. The model of the EC mark and the rules for its use in respect of each of the procedures of attestation of conformity are given in Annex III.

Article 15

1. Member States shall ensure that the EC mark is correctly used.

2. Where it is established that the EC mark has been affixed to a product which does not satisfy, or no longer satisfies, this Directive, the Member State in which conformity was attested shall ensure that, if necessary, the use of the EC mark is forbidden and unsold products are withdrawn, or marks obliterated, until such time as the product concerned is brought back to conformity

The Member State concerned shall immediately inform the other Member States and the Commission, giving all the qualitative and quantitative details necessary to identify the product which does not conform.

3. Member States shall ensure that the affixing to products or their packing of marks which are likely to be confused with the EC mark shall be prohibited.

CHAPTER VI

Special procedures

Article 16

1. In the absence of technical specifications, as defined in Article 4, for any given product, the Member State of destination shall, on request in individual cases, consider the product to be in conformity with the national provisions in force if they have satisfied tests and inspections carried out by an approved body in the producing Member State according to the methods in force in the Member State of destination or recognized as equivalent by that Member State.

2. The producing Member State shall inform the Member State of destination, in accordance with whose provisions the tests and inspections are to be carried out, of the body it intends to approve for this purpose. The Member State of destination and the producing Member State shall provide each other with all necessary information. On conclusion of this exchange of information the producing Member State shall approve the body thus designated. If a Member State has misgivings, it shall substantiate its position and inform the Commission.

3. Member States shall ensure that the designated bodies afford one another all necessary assistance.

4. Where a Member State establishes that an approved body is not carrying out the tests and inspections properly in conformity with its national provisions, it shall notify the Member State in which the body is approved thereof. That Member State shall inform the notifying Member State.

within a reasonable time limit of what action has been taken. If the notifying Member State does not consider the action taken to be sufficient, it may prohibit the placing on the market and use of the product in question or make it subject to special conditions. It shall inform the other Member State and the Commission thereof.

Article 17

Member States of destination shall attach the same value to reports and attestations of conformity issued in the producing Member State in accordance with the procedure referred to in Article l6, as they do to their own corresponding national documents.

CHAPTER VII

Approved bodies

Article 18

1. Each Member State shall forward to the Commission a list of names and addresses of certification bodies, inspection bodies and testing laboratories which have been designated by that Member State for tasks to be carried out for the purposes of technical approvals, conformity certifications, inspections and tests according to this Directive.

2. Certification bodies, inspection bodies and testing laboratories shall comply with the criteria laid down in Annex IV.

3. Member States shall indicate the products which fall within the competence of the bodies and laboratories referred to in paragraph 1 and the nature of the tasks to be assigned to them.

CHAPTER VIII

Standing Committee on Construction

Article 19

1. A Standing Committee on Construction is hereby set up

2. The committee shall be made up of representatives appointed by the Member States. It shall be chaired by a representative of the Commission. Each Member State shall appoint two representatives. The representatives may be accompanied by experts.

3. The committee shall draw up its own rules of procedure.

Article 20

1. The committee referred to in Article 19 may, at the request of its chairman or a Member State, examine any question posed by the implementation and the practical application of this Directive.

2. The provisions necessary for:

(a) the establishment of classes of requirements in so far as they are not included in the interpretative documents and the establishment of the procedure for attesting conformity in mandates for standards pursuant to Article 7 (1) and guidelines for approvals pursuant to Article 11 (1);

(b) the giving of instructions for the drawing-up of interpretative documents pursuant to Article 12 (1) and decisions on interpretative documents pursuant to Article 12 (3);

(c) the recognition of national technical specifications in accordance with Article 4 (3);

shall be adopted in accordance with the procedure laid down in paragraphs 3 and 4.

3. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.

4. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee

If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by qualified majority.

If, within three months of the proposal being submitted to it, the Council has not acted, the proposed measures shall be adopted by the Commission.

CHAPTER IX

Safeguard clause

Article 21

1. Where a Member State ascertains that a product declared to be in conformity with the terms of this Directive.

does not comply with Articles 2 and 3, it shall take all appropriate measures to withdraw those products from the market, prohibit the placing thereof on the market or restrict free movement thereof.

The Member State concerned shall immediately inform the Commission of any such measure, indicating the reasons for its decision, and in particular whether non-conformity is due to:

(a) failure to comply with Articles 2 and 3, where the product does not meet the technical specifications referred to in Article 4;

(b) incorrect application of the technical specifications referred to in Article 4;

(c) shortcomings in the technical specifications referred to in Article 4 themselves

2. The Commission shall carry out a consultation of the parties concerned as soon as possible. Where the Commission finds, after this consultation, that the action is justified, it shall immediately so inform the Member State that took the action as well as the other Member States.

3. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards or technical specifications, the Commission, after consulting the parties concerned, shall bring the matter before the committee referred to in Article 19, as well as the committee set up under Directive 83/189/EEC in the case of shortcomings in a harmonized standard, within two months if the Member State which has taken the measures intends to uphold them, and shall start the procedures referred to in Article 5 (2).

4. The Member State concerned shall take appropriate action against whomsoever made the declaration of conformity and shall inform the Commission and the other Member States thereof.

5. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.

CHAPTER X

Final provisions

Article 22

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive within 30 months of its notification (6). They shall forthwith inform the Commission thereof.

2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.

Article 23

At the latest by 31 December 1993, the Commission, in consultation with the committee referred to in Article 19, shall re-examine the practicability of the procedures laid down by this Directive and, where necessary, submit proposals for appropriate amendments.

Article 24

This Directive is addressed to the Member States.

Done at Brussels, 21 December 1988.

For the Council

The President

V. PAPANDREOU

(1) OJ N° C 93, 6. 4. 1987, p. 1.

(2) OJ N° C 305, 16. 11. 1987, p. 74 and OJ N° C 326, 19. 12. 1988.

(3) OJ N° C 95, 11. 4. 1988, p. 29.

(4) OJ N° C 136, 4. 6. 1985, p. 1.

(5) OJ N° L 109, 26. 4. 1983, p. 8

(6) This Directive was notified to the Member States on 27 December 1988.

ANNEX I

ESSENTIAL REQUIREMENTS

The products must be suitable for construction works which (as a whole and in their separate parts) are fit for their intended use, account being taken of economy, and in this connection satisfy the following essential requirements where the works are subject to regulations containing such requirements. Such requirements must, subject to normal maintenance, be satisfied for an economically reasonable working life. The requirements generally concern actions which are forseeable.

1. Mechanical resistance and stability

The construction works must be designed and built in such a way that the loadings that are liable to act on it during its constructions and use will not lead to any of the following:

(a) collapse of the whole or part of the work:

(b) major deformations to an inadmissible degree;

(c) damage to other parts of the works or to fittings or installed equipment as a result of major deformation of the load-bearing construction;

(d) damage by an event to an extent disproportionate to the original cause.

2. Safety in case of fire

The construction works must be designed and built in such a way that in the event of an outbreak of fire:

- the load-bearing capacity of the construction can be assumed for a specific period of time,

- the generation and spread of fire and smoke within the works are limited,

- the spread of the fire to neighbouring construction works is limited,

- the safety of rescue teams is taken into consideration.

3. Hygiene, health and the environment

The construction work must be designed and built in such a way that it will not be a threat to the hygiene or health of the occupants or neighbours, in particular as a result of any of the following:

- the giving-off of toxic gas,

- the presence of dangerous particles or gases in the air,

- the emission of dangerous radiation,

- pollution or poisoning of the water or soil,

- faulty elimination of waste water, smoke, solid or liquid wastes,

- the Presence of damp in parts of the works or on surfaces within the works

4. Safety in use

The construction work must be designed and built in such a way that it does not present unacceptable risks of accidents in service or in operation such as slipping, falling, collision, burns, electrocution, injury from explosion.

5. Protection against noise

The construction works must be designed and built in such a way that noise perceived by the occupants or people nearby is kept down to a level that will not threaten their health and will allow them to sleep, rest and work in satisfactory conditions.

6. Energy economy and heat retention

The construction works and its heating, cooling and ventilation installations must be designed and built in such a way that the amount of energy required in use shall be low, having regard to the climatic conditions of the location and the occupants.

ANNEX II

EUROPEAN TECHNICAL APPROVAL

1. A request for approval may be made by a manufacturer, or his agent established in the Community, only to a single body authorized for this Purpose.

2. The approval bodies designated by the Member States form an organization. In the performance of its duties, this organization is obliged to work in close coordination with the Commission, which shall consult the committee referred to in Article 19 of the Directive on important matters. Where a Member State has designated more than one approval body, the Member State shall be responsible for coordinating such bodies; it shall also designate the body which shall be spokesman in the organization.

3. The common procedural rules for making the request, the preparation and the granting of approvals are drawn up by the organization comprising the designated approval bodies. The common procedural rules are adopted by the Commission on the basis of the opinion of the committee in accordance with Article 20.

4. In the framework of the organization comprising them, the approval bodies shall afford each other all necessary support. This organization is also responsible for coordination on specific questions of technical approval. If necessary, the organization shall establish sub-groups for this purpose.

5. The European technical approvals are published by the approval bodies, which notify all other approved bodies. At the request of an authorized approval body, a complete set of supporting documents for an approval which has been granted is to be forwarded to the latter for information.

6. The costs arising from the European technical approval procedure shall be paid by the applicant in accordance with national rules.

ANNEX III

ATTESTATION OF CONFORMITY WITH TECHNICAL SPECIFICATIONS 1. METHODS OF CONTROL OF CONFORMITY

When the procedures for aetestation of conformity of a product with technical specifications pursuant to Article 13 are being determined, the following methods of control of conformity shall be used; the choice and combination of methods for any given system shall depend on requirements for the particular product or group of products according to the criteria indicated in Article 13 (3) and (4);

(a) initial type-testing of the product by the manufacturer or an approved body;

(b) testing of samples taken at the factory in accordance with a prescribed test plan by the manufacturer or an approved body;

(c) audit-testing of samples taken at the factory, on the open market or on a construction site by the manufacturer or an approved body;

(d) testing of samples from a batch which is ready for delivery, or has been delivered, by the manufacturer or an approved body;

(e) factory production control;

(f) initial inspection of factory and of factoty production control by an approved body;

(g) continuous surveillance, judgement and assessment of factory production control by an approved body.

In the Directive, factory production control means the permanent internal control of production exercised by the manufacturer. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic mannter in the form of written policies and procedures. This production control system documentation shall ensure a common understanding of quality assurance and enable the achievement of the required product characteristics and the effective operation of the production control system to be checked.

2. SYSTEMS OF CONFORMITY ATTESTATION

preference is given to application of the following systems of conformity attestation

(i) Certification of the conformity of the product by an approved certification body on the basis of: (a) (tasks for the manufacturer)

(1) factory production control;

(2) further testing of samples taken at the factory by the manufacturer in accordance with a prescribed test plan; (b) (tasks for the approved body)

(3) initial type-testing of the product;

(4) intitial inspection of factory and of factory production control;

(S) continnious surveillance, assessment and approval of factory production control;

(6) possibly, audit-testing of samples taken at the factory, on the market or on the construction site.

(ii) Declaration of conformity of the product by the manufacturer on the basis of:

First possibility:

(a) (tasks for the manufacturer)

(1) initial type-testing of the product;

(2) factory production control;

(3) possibly, testing of samples taken at the faccory in accordance with a prescribed test plan;

(b) (tasks for the approved body)

(4) certification of factory production control on the basis of:

- initial inspection of factory and of factory production control,

- possibly, continuous surveillance, assessment and approval of factory production control.

Second possibility:

(1) initial type-testing of the product by an approved laboratory; (2) factory production control

Third possibility:

(a) initial type-testirtg by the manufacturer; (b) factory production control

3. BODIES INVOLVED IN THE ATTESTATION OF CONFORMITY

With respect to the function of the bodies involved in the attestation of conformity, distinction shall be made between

(i) certification body, which means an impartial body, governmental or non-governmental, possessing the necessary competence and responsibility to carry out conformity certification according to given rules of procedure and management;

(ii) inspection body, which means an impartial body having the organization, staffing, competence and integrity to perform according to specified criteria functions such as assessing, recommending for acceptance and subsequent audit of manufacturers' quality control operations, and selection and evaluation of products on site or in factories or elsewhere, according to specific criteria;

(iii) testing laboratory, which means alaboratory which measures,examines,tests,calibrates or otherwise determines the chatacteristics or performance of materials or products

In case (i) and (ii) (first possibility) of paragraph 2, the three functions 3 (i) to (iii) may be performed by one and the same body or by different bodies, in which case the inspection body and/or the testing laboratory involved in the attestation of conformity carries out its function on behalf of the certification body.

For the criteria concerning the competence, impartiality and integrity of certification bodies, inspection bodies and testing laboratories, see Annex IV.

4. EC CONFORMITY MARK, EC CERTIFICATE OF CONFORMITY, EC DECLARATION OF CONFORMITY

4.1. EC conformity mark

The EC conformity mark shall consist of the symbol CE as given below.

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It shall be accompanied by:

- the name or identifying mark of the producer, and, where appropriate:

- inditations -tn identify the characteristics of the product, where appropriate to technical specifications,

- the last two digits of the year of manufacture,

- the identification symbol of the inspection body involved,

- the number of the EC certificate of conformity.

4.2. EC certificate of conformity

The EC certificate of conformity shall contain in particular:

- name and address of the certification body,

- name and address of the manufacturer or his agent established in the Community,

- description of the product (type, identification, use...),

- provisions to which the product conforms,

- particular conditions applicable to the use of the product,

- the certificate's number,

- conditions and period of validity of the certificate, where applicable,

- name of, and position held by, the person empowered to sign the certificate.

4.3. EC declaration of conformity

The EC declaration of conformity shall contain in particular:

- name and address of the manufacturer or his agent established in the Community,

- description of the product (type, identification, use...),

- provision to which the product conforms,

- particular conditions applicable to the use of the product,

- name and address of the approved body, where applicable,

- name of, and position held by, the person empowered to sign the declaratinn on behalf of the manufacturer or of his authorized representative.

4.4. The certificate and declaration of conformity shall be presented in the official language or languages of the Member State in which the product is to be used.

ANNEX IV

APPROVAL OF TESTING LABORATORIES, INSPECTION BODIES AND CERTIFIGATION BODIES

The testing laboratories, the inspection bodies and the certification bodies designated by the Member States must fulfil the following minimum conditions:

l. availability of personnel and of the necessary means and equipment;

2. technical competence and professionalintegrity of personnel;

3. impartiality, in carrying out the tests, preparing the reports, issuing the certificates and performing the surveillance provided for in the Directive, of staff and technical personnel in relation to allcircles, groups or persons directly or indirectly concerned with construction products;

4. maintenance of professional secrecy by personnei:

5. subscription of a civil liability insurance unless that liability is covered by the State under nationallaw

Fulfilment of the conditions under 1 and 2 shall be verified at intervals by the competent authorities of Member States.

 

 

  1. LVD
  2. EMC