The Directive aims at ensuring that products placed on the market are safe. It applies to all the products which are intended for consumers or likely to be used by consumers even if not intended for them, and are supplied or made available, whether for consideration or not, in the course of a commercial activity, and whether new, used or reconditioned.
Remark: This Directive has been repealed by Regulation (EU) 2023/988 general product safety. Member States may not impede the making available on the market of products covered by Directive 2001/95/EC which are in conformity with that Directive and which are or were placed on the market before 13 December 2024.
The Directive defines the legal terms "product", "safe product", "dangerous product", "serious risk", "producer", "distributor", "recall" and "withdrawal".
A "safe product" is a product which, under normal or reasonably foreseeable conditions of use including duration and, where applicable, putting into service, installation and maintenance requirements, does not present any risk or only the minimum risks compatible with the product's use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons, taking into account in particular its characteristics, package and presentation, special groups of consumers (elderly or young people) and effects on other products.
It is the producer's responsibility to place only safe products on the market. Producers shall provide consumers with the relevant information to enable them to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use. The producer has to take precautionary measures against these risks which can be information for consumers, recall of products or withdrawal products from the market.
If producers or distributors become aware that a product is dangerous, they must inform national authorities and cooperate with them.
Member States shall ensure that producers and distributors comply with their obligations under this Directive in such a way that products placed on the market are safe. They shall establish or nominate authorities competent to monitor the compliance of products with the general safety requirements.
The Directive establishes RAPEX (Rapid Exchange of Information System): when a product is considered to be dangerous, the competent national authority takes appropriate action to eliminate the risk and informs the European Commission about the risks and the measures taken. The European Commission informs the National Contact Points of all other EU countries. The European Commission publishes on the internet overviews of dangerous products and the measures taken to eliminate the risks.
Each of the Directive's 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.
Annex I: Requirements concerning information on products that do not comply with the general safety requirement to be provided to the competent authorities by producers and distributors
Annex II: Procedures for the application of RAPEX and guidelines for notifications
See also:Regulation 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.