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, and repealing Council Decision 93/465/EEC
(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,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
Whereas:
(1)
On 7 May 2003 the Commission issued a Communication to the Council and the European Parliament entitled ‘Enhancing the Implementation of the New Approach Directives’. In its Resolution of 10 November 2003 (3), the Council acknowledged the importance of the New Approach as an appropriate and efficient regulatory model allowing technological innovation and enhancing the competitiveness of European industry, and confirmed the necessity of extending the application of its principles to new areas, while recognising the need for a clearer framework for conformity assessment, accreditation and market surveillance.
(2)
This Decision 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. This Decision therefore constitutes a general framework of a horizontal nature for future legislation harmonising the conditions for the marketing of products and a reference text for existing legislation.
(3)
This Decision provides, in the form of reference provisions, definitions and general obligations for economic operators and a range of conformity assessment procedures from which the legislator can select as appropriate. It also lays down rules for CE marking. Furthermore, reference provisions are provided as regards the requirements for conformity assessment bodies to be notified to the Commission as competent to carry out the relevant conformity assessment procedures and as regards the notification procedures. In addition, this Decision includes reference provisions concerning procedures for dealing with products presenting a risk in order to ensure the safety of the market place.
(4)
Whenever legislation is drawn up which concerns a product already subject to other Community acts, those acts must be taken into account to ensure the consistency of all legislation concerning the same product.
(5)
However, the specificities of sectoral needs may provide grounds for recourse to other regulatory solutions. In particular, that is the case where there are specific, comprehensive legal systems already in place in a sector, as for example in the fields of feed and food, cosmetic and tobacco products, common market organisations for agricultural products, plant health and plant protection, human blood and tissues, medicinal products for human and veterinary use and chemicals, or where sectoral needs require specific adaptation of the common principles and reference provisions, as for example in the fields of medical devices, construction products and marine equipment. Such adaptations may also be related to the modules set out in Annex II.
(6)
Whenever legislation is drawn up, the legislator may depart, totally or partially, from the common principles and reference provisions laid down in this Decision on account of the specificities of the sector concerned. Any such departure should be justified.
(7)
Although the incorporation of the provisions of this Decision in future legislative acts cannot be required by law, the co-legislators adopting this Decision have entered into a clear political commitment which they should respect in any legislative act falling within the scope of this Decision.
(8)
Specific product legislation should, wherever possible, avoid going into technical detail but should limit itself to the expression of essential requirements. Such legislation should, where appropriate, have recourse to harmonised standards adopted in accordance with 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 (4) for the purpose of expressing detailed technical specifications. This Decision builds on and complements the standardisation system provided for by that Directive. However, where health and safety, the protection of consumers or of the environment, other aspects of public interest, or clarity and practicability so require, detailed technical specifications may be set out in the legislation concerned.
(9)
The presumption of conformity to a legal provision conferred by conformity to a harmonised standard should enhance recourse to compliance with harmonised standards.
(10)
It should be possible for Member States or the Commission to object in cases in which a harmonised standard does not entirely satisfy the requirements of Community harmonisation legislation. The Commission should be able to decide not to publish such a standard. To that end, the Commission should, in such manner as appropriate, consult sectoral representatives and Member States before the Committee set up by Article 5 of Directive 98/34/EC delivers its opinion.
(11)
The essential requirements should be worded precisely enough to create legally binding obligations. They should be formulated so as to make it possible to assess conformity with them even in the absence of harmonised standards or where the manufacturer chooses not to apply a harmonised standard. The degree of detail of the wording will depend on the characteristics of each sector.
(12)
The successful accomplishment of the required conformity assessment procedure enables economic operators to demonstrate and the competent authorities to ensure that products made available on the market conform to the requirements applicable.
(13)
The modules for the conformity assessment procedures to be used in the Community harmonisation legislation were initially set out in 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 (5). This Decision replaces that Decision.
(14)
It is necessary to offer a choice of clear, transparent and coherent conformity assessment procedures, restricting the possible variants. This Decision provides for a menu of modules, enabling the legislator to choose a procedure from the least to the most stringent, in proportion to the level of risk involved and the level of safety required.
(15)
For the purposes of ensuring inter-sectoral coherence and avoiding ad-hoc variants, it is desirable that the procedures which are to be used in sectoral legislation be chosen from among the modules, in accordance with the general criteria set out.
(16)
In the past, legislation on the free movement of goods has used a set of terms partly without defining them and guidelines for explanation and interpretation have consequently been necessary. Where legal definitions have been introduced they differ to some extent in their wording and sometimes in their meaning, which gives rise to difficulties in their interpretation and correct implementation. This Decision therefore introduces clear definitions of certain fundamental concepts.
(17)
Products that are placed on the Community market should comply with the relevant applicable Community legislation, and economic operators should be responsible for the compliance of products, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of public interests, such as health and safety, and the protection of consumers and of the environment, and to guarantee fair competition on the Community market.
(18)
All economic operators are expected to act responsibly and in full accordance with the legal requirements applicable when placing or making products available on the market.
(19)
All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they make available on the market only products which are in conformity with the applicable legislation. This Decision provides a clear and proportionate distribution of obligations which correspond to the role of each operator in the supply and distribution process.
(20)
As certain tasks can be executed only by the manufacturer, it is necessary to distinguish clearly between the manufacturer and operators further down the distribution chain. It is also necessary to distinguish clearly between the importer and the distributor, as the importer introduces products from third countries to the Community market. The importer has thus to make sure that those products comply with the applicable Community requirements.
(21)
The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the complete conformity assessment procedure. Conformity assessment should therefore remain the obligation of the manufacturer alone.
(22)
It is necessary to ensure that products from third countries entering the Community market comply with all applicable Community requirements, and in particular that appropriate 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 applicable requirements and that they do not place on the market products which do not comply with such requirements or present a risk. For the same reason, 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 supervisory authorities.
(23)
The distributor makes a product available on the market after it has been placed on the market by the manufacturer or the importer and must act with due care to ensure that its handling of the product does not adversely affect the compliance of the product. Both importers and distributors are expected to act with due care in relation to the requirements applicable when placing or making products available on the market.
(24)
Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (6) applies, inter alia, to products not in conformity with Community harmonisation legislation. Manufacturers and importers who have placed non-compliant products on the Community market are liable for damages under that Directive.
(25)
When placing a product on the market, every importer should indicate on the product his name and the 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.
(26)
Any economic operator that either places a product on the market under his own name or trademark or modifies a product in such a way that compliance with applicable requirements may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.
(27)
Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by national authorities, and should be prepared to participate actively, providing the competent authorities with all necessary information relating to the product concerned.
(28)
Ensuring traceability of a product throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities' task of tracing economic operators who made non-compliant products available on the market.
(29)
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 of the European Parliament and the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (7). Rules governing the affixing of the CE marking, to be applied in Community harmonisation legislation providing for the use of that marking, should be laid down in this Decision.
(30)
The CE marking should be the only marking of conformity indicating that a product is in conformity with Community harmonisation legislation. However, other markings may be used as long as they contribute to the improvement of consumer protection and are not covered by Community harmonisation legislation.
(31)
It is crucial to make clear to both manufacturers and users that by affixing the CE marking to a product the manufacturer declares that the product is in conformity with all applicable requirements and that he takes full responsibility therefor.
(32)
In order better to evaluate the effectiveness of the CE marking and to define strategies aimed at preventing abuse, the Commission should monitor its implementation and report thereon to the European Parliament.
(33)
The CE marking can be of value only if its affixing respects the conditions laid down in Community law. Member States should, therefore, ensure proper enforcement of those conditions and pursue violations and abuse of the CE marking by legal or other appropriate means.
(34)
Member States are responsible for ensuring strong and efficient market surveillance on their territories and should allocate sufficient powers and resources to their market surveillance authorities.
(35)
For the purpose of raising awareness regarding the CE marking, the Commission should launch an information campaign targeted primarily at economic operators, consumer and sectoral organisations and sales personnel, which are the most appropriate channels for conveying information to consumers.
(36)
In certain circumstances the conformity assessment procedures prescribed by the applicable legislation require the intervention of conformity assessment bodies, which are notified by the Member States to the Commission.
(37)
Experience has shown that the criteria set out in sectoral legislation which 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 Community. 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.
(38)
In order to ensure a consistent level of quality in the performance of conformity assessment it is necessary not only to consolidate the requirements that conformity assessment bodies wishing to be notified must fulfil, but also, in parallel, to set requirements that notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies must fulfil.
(39)
The system set out in this Decision is 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, its use should also be encouraged for the purposes of notification.
(40)
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 the relevant sectoral legislation.
(41)
Where Community harmonisation legislation provides for the selection of conformity assessment bodies for its implementation, transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in conformity certificates, should be considered by the national public authorities throughout the Community the preferred means of demonstrating the technical competence of those bodies. However, national authorities may consider that they possess the appropriate means of carrying out this 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.
(42)
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 Community 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.
(43)
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.
(44)
Since notified bodies may offer their services throughout the Community, 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.
(45)
In the interests of competitiveness, it is crucial that notified bodies apply the modules 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 modules must be ensured. That can best be achieved through appropriate coordination and cooperation between notified bodies.
(46)
To ensure the proper functioning of the certification process, certain procedures, such as exchanges of experience and information between notified bodies and notifying authorities and between notified bodies, should be consolidated.
(47)
Community harmonisation legislation already provides for a safeguard procedure which applies only in the event of disagreement between Member States over measures taken by a Member State. In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard clause procedure, with a view to making it more efficient and drawing on the expertise available in Member States.
(48)
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 and safety of persons or to other aspects of public interest protection. 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.
(49)
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.
(50)
Community legislation should take account of the specific situation of small and medium-sized enterprises as regards administrative burdens. However, rather than providing for general exceptions and derogations for such enterprises, which might imply that they or their products are second-rate or sub-quality and which might result in a complex legal situation for the national market surveillance authorities to supervise, Community legislation should provide for the situation of such enterprises to be taken into account in setting the rules for the selection and implementation of the most appropriate conformity assessment procedures and concerning the obligations placed on conformity assessment bodies to operate in a proportionate manner in relation to the size of undertakings and to the small serial or non-serial nature of the production concerned. This Decision provides the legislator with the flexibility necessary to take account of such a situation, without creating unnecessary specific and inappropriate solutions for small and medium-sized enterprises, and without compromising the protection of public interests.
(51)
This Decision establishes provisions for conformity assessment bodies to perform their functions, while taking into consideration the specific situation of small and medium-sized enterprises and respecting the degree of rigour and level of protection required for products to comply with the legislative instruments applicable to them.
(52)
Within one year of the publication of this Decision in the Official Journal of the European Union, the Commission should present an in-depth analysis in the field of consumer safety markings, followed by legislative proposals if necessary,
HAVE DECIDED AS FOLLOWS:
Article 1
General principles
1. Products placed on the Community market shall comply with all applicable legislation.
2. When placing products on the Community market, economic operators shall, in relation to their respective roles in the supply chain, be responsible for the compliance of their products with all applicable legislation.
3. Economic operators shall be responsible for ensuring that all information they provide with regard to their products is accurate, complete and in compliance with Community rules applicable.
Article 2
Subject matter and scope
This Decision sets out the common framework of general principles and reference provisions for the drawing up of Community legislation harmonising the conditions for the marketing of products (Community harmonisation legislation).
Community harmonisation legislation shall have recourse to the general principles set out in this Decision and to the relevant reference provisions of Annexes I, II and III. However, Community legislation may depart from those general principles and reference provisions if that is appropriate on account of the specificities of the sector concerned, especially if comprehensive legal systems are already in place.
Article 3
Level of protection of public interests
1. As regards the protection of public interests, Community harmonisation legislation shall restrict itself to setting out the essential requirements determining the level of such protection and shall express those requirements in terms of the results to be achieved.
Where recourse to essential requirements is not possible or not appropriate, in view of the objective of ensuring the adequate protection of consumers, public health and the environment or other aspects of public interest protection, detailed specifications may be set out in the Community harmonisation legislation concerned.
2. Where Community harmonisation legislation sets out essential requirements, it shall provide for recourse to be had to harmonised standards, adopted in accordance with Directive 98/34/EC, which shall express those requirements in technical terms and which shall, alone or in conjunction with other harmonised standards, provide for the presumption of conformity with those requirements, while maintaining the possibility of setting the level of protection by other means.
Article 4
Conformity assessment procedures
1. Where Community harmonisation legislation requires conformity assessment to be performed in respect of a particular product, the procedures which are to be used shall be chosen from among the modules set out and specified in Annex II, in accordance with the following criteria:
(a)
whether the module concerned is appropriate to the type of product;
(b)
the nature of the risks entailed by the product and the extent to which conformity assessment corresponds to the type and degree of risk;
(c)
where third party involvement is mandatory, the need for the manufacturer to have a choice between quality assurance and product certification modules set out in Annex II;
(d)
the need to avoid imposing modules which would be too burdensome in relation to the risks covered by the legislation concerned.
2. Where a product is subject to several Community acts within the scope of this Decision, consistency among conformity assessment procedures shall be ensured by the legislator.
3. The modules referred to in paragraph 1 shall be applied as appropriate to the product concerned and in accordance with the instructions set out in those modules.
4. For custom-made products and small series production, the technical and administrative conditions relating to conformity assessment procedures shall be alleviated.
5. When applying the modules referred to in paragraph 1, and wherever applicable and relevant, the legislative instrument may:
(a)
regarding technical documentation, require information additional to that which is already stipulated in the modules;
(b)
regarding the time for which the manufacturer and/or notified body are obliged to keep any kind of documentation, alter the period stipulated in the modules;
(c)
specify the manufacturer's choice as to whether the tests are carried out either by an accredited in-house body or under the responsibility of a notified body chosen by the manufacturer;
(d)
where product verification is performed, specify the manufacturer's choice as to whether the examinations and tests to check the conformity of the products with the appropriate requirements will be carried out, by examination and testing of every product, or by examination and testing of the products on a statistical basis;
(e)
provide for the EC-type examination certificate to have a period of validity;
(f)
regarding the EC-type examination certificate, specify relevant information relating to conformity assessment and in-service control to be included in it or its annexes;
(g)
provide for different arrangements regarding the obligations of the notified body to inform its notifying authorities;
(h)
if the notified body carries out periodic audits, specify their frequency.
6. When applying the modules referred to in paragraph 1, and wherever applicable and relevant, the legislative instrument shall:
(a)
where product checks and/or verification are performed, determine the products concerned, the appropriate tests, the adequate sampling schemes, the operational characteristics of the statistical method to be applied and the corresponding action to be taken by the notified body and/or the manufacturer;
(b)
where EC-type examination is performed, determine the appropriate manner (design type, production type, design and production type) and the specimens required.
7. An appeal procedure against decisions of the notified body shall be available.
Article 5
EC declaration of conformity
Where Community harmonisation legislation requires a statement by the manufacturer that fulfilment of the requirements relating to a product has been demonstrated (EC declaration of conformity), the legislation shall provide that a single declaration shall be drawn up in respect of all Community acts applicable to the product containing all information required for the identification of Community harmonisation legislation to which the declaration relates, and giving the publication references of the acts concerned.
Article 6
Conformity assessment
1. Where Community harmonisation legislation requires conformity assessment, it may provide for that assessment to be carried out by public authorities, manufacturers or notified bodies.
2. Where Community harmonisation legislation provides for conformity assessment to be carried out by public authorities, the legislation shall provide that the conformity assessment bodies on which those authorities rely for technical assessments must comply with the same criteria as those set out in this Decision for notified bodies.
Article 7
Reference provisions
The reference provisions for Community harmonisation legislation for products shall be as set out in Annex I.
Article 8
Repeal
Decision 93/465/EEC is hereby repealed.
References to the repealed Decision shall be construed as references to this Decision.
Done at Strasbourg, 9 July 2008.