WRITTEN QUESTION E-1698/99

by Erik Meijer (GUE/NGL) to the Commission

(29 September 1999)

Subject: Adverse effects of replacing national quality marks with 'self-certification' by manufacturers on the basis of Conformité Européenne

1. Can the Commission confirm that introduction of the CE (Conformité Européenne) marking for consumer goods and professional equipment enables manufacturers to decide independently whether their products satisfy the requirements for safety, quality, energy-efficiency and protection of the environment, in contrast to the system currently existing in the various Member States where a product can only be marketed if a quality mark has been supplied by a body designated by the national authority, such as KEMA in the Netherlands?

2. In what way will the Commission verify the extent to which products covered by the European directives on CE marking actually comply with the requirements laid down in those directives?

3. Will the Commission check whether the system of self-verification (with manufacturers and importers themselves being responsible for ensuring that new products meet the requirements of the CE directives) will lead to the requirements being circumvented? If so, how? If not, is it prepared to submit to Parliament without delay a proposal for effective monitoring?

4. Can the Commission confirm that the regional offices of the Dutch Labour Inspectorate and Commodity Inspectorate and comparable bodies in the other Member States do not have the power to request technical files from manufacturers or to consult a notified body in another Member State? If so, what does this mean in terms of effectiveness of compliance with the directives?

5. In how many cases did the notified bodies of the individual Member States request technical files on products because they suspected that a product bearing an EC sticker did not satisfy the basic requirements of the relevant CE directives?

6. Is the Commission aware that an investigation conducted by the Commodity Inspectorate in The Hague in 1998 into the safety of grinding machines, drill presses and bandsaws found that 90 % of the items inspected failed to comply with the European directive on machinery and none complied with the Dutch legal requirements?

7. Can the Commission provide a breakdown of its current and planned activities to provide national authorities, research bodies and the public with a rapid and satisfactory source of information on whether products actually satisfy the essential requirements of the relevant CE directives?

8. What is the Commission planning to do to compile statistics on the effects of the CE and, subsequently, to ensure that standards do not fall for consumers, professional users or the environment?

Answer given by Mr Liikanen on behalf of the Commission

(12 November 1999)

1. The CE marking is affixed to products covered by New Approach Directives(1), on the responsibility of the producer, his authorised representative in the Community or the person responsible of placing the product on the Community market, as an indication that the essential requirements of relevant directives have been met and that the conformity assessment procedures laid down in those directives have been complied with. These conformity assessment procedures vary according to the nature of the risks and products concerned. In many cases, third party tests and certificates are required. All the procedures have been established on the basis of a high level of protection. Further, while some Member States may have used quality marks for some products before the adoption of Community measures, this was not a universal practice. In consequence, the Commission cannot agree with the statement of the Honourable Member.

2. and 3. Ensuring compliance by those who place products on the Community market is a responsibility of the Member States. The Commission's concern is to ensure that the Member States carry out this obligation. The recent programme of mutual joint visits, which ended with a seminar in Brussels in September 1999, promoted the exchange of understanding and best practice. It is an example of the way in which this responsibility is being executed.

4. Community law requires the manufacturer, his authorised representative or the person responsible for placing the product on the market (in certain cases the person having the documentation) must be established in the Community and to retain the technical documentation, on the basis of which conformity to New Approach Directives has been established, and to keep it at the disposal of the national authorities. This documentation includes all specific information for verification of conformity with the safety requirements, which may include any certificates and test reports provided by notified bodies in connection with establishment of conformity. The Commission considers that this should contribute to effective market surveillance.

5. Where a manufacturer requests a notified body to carry out conformity assessment procedures required under New Approach Directives, these are done on the basis inter alia, of technical documentation provided by the manufacturer. It is not the function of notified bodies to carry out autonomous market surveillance activities, which are the prerogative of national authorities.

6. The Commission is not aware of survey results of the type referred to by the Honourable Member.

7. The identification of defective products is a matter for the Member States. The Commission, through administrative co-operation, safeguard and, for consumer goods presenting severe and immediate hazards, RAPEX procedures, assists with the distribution of information concerning defective products which have been identified by Member State authorities, where problems have not been satisfactorily resolved. The medical devices vigilance system monitors serious incidents involving medical devices, whether rectified or not.

8. Monitoring of injuries, with a view to reducing their incidence has in the past been carried out under the European home and leisure accident surveillance system (Ehlass). The Community action programme on injury prevention in the framework of action in the field of public health(2) will reinforce and develop this, helping identify any areas where deficiencies in product safety may contribute to accidents. As has been made clear above, the Commission does not share the view of the Honourable Member that the use of the CE marking reduces safety standards. It believes that the reverse is the case, due to the application of uniformly high levels of protection to products placed on the internal market.

(1) OJ C 136, 4.6.1985; OJ L 220, 30.8.1993; OJ L 282, 17.11.1993.

(2) Parliament and Council Decision 372/99/EC of 8 February 1999 adopting a programme of Community action on injury prevention in the field of public health (1999-2003), OJ L 46, 20.2.1999.