Legal act:
Regulation (EU) 2023/988
Directive 2001/95/EC (until 12/12/2024)

Consolidated act:
01/01/2010 of Directive 2001/95/EC

Article 1 - Objective - Scope – Definitions

1. The purpose of this Directive is to ensure that products placed on the market are safe.
2. This Directive shall apply to all the products defined in Article 2 (a). Each of its provisions shall apply in so far as there are no specific provisions with the same objective in rules of Community law governing the safety of the products concerned. Where products are subject to specific safety requirements imposed by Community legislation, this Directive shall apply only to the aspects and risks or categories of risks not covered by those requirements. This means that:
   1. Articles 2(b) and (c), 3 and 4 shall not apply to those products insofar as concerns the risks or categories of risks covered by the specific legislation;
   2. Articles 5 to 18 shall apply except where there are specific provisions governing the aspects covered by the said Articles with the same objective.

Article 3 - General safety requirement, conformity assessment criteria and European standards

1. Producers shall be obliged to place only safe products on the market.
2. A product shall be deemed safe, as far as the aspects covered by the relevant national legislation are concerned, when, in the absence of specific Community provisions governing the safety of the product in question, it conforms to the specific rules of national law of the Member State in whose territory the product is marketed, such rules being drawn up in conformity with the Treaty, and in particular Articles 28 and 30 thereof, and laying down the health and safety requirements which the product must satisfy in order to be marketed. A product shall be presumed safe as far as the risks and risk categories covered by relevant national standards are concerned when it conforms to voluntary national standards transposing European standards, the references of which have been published by the Commission in the Official Journal of the European Communities in accordance with Article 4. The Member States shall publish the references of such national standards.
3. In circumstances other than those referred to in paragraph 2, the conformity of a product to the general safety requirement shall be assessed by taking into account the following elements in particular, where they exist:
   1. voluntary national standards transposing relevant European standards other than those referred to in paragraph 2;
   2. the standards drawn up in the Member State in which the product is marketed;
   3. Commission recommendations setting guidelines on product safety assessment;
   4. product safety codes of good practice in force in the sector concerned;
   5. the state of the art and technology;
   6. reasonable consumer expectations concerning safety.
4. Conformity of a product with the criteria designed to ensure the general safety requirement, in particular the provisions mentioned in paragraphs 2 or 3, shall not bar the competent authorities of the Member States from taking appropriate measures to impose restrictions on its being placed on the market or to require its withdrawal from the market or recall where there is evidence that, despite such conformity, it is dangerous.