legislation-profile

General Product Safety Directive

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety

Scope

The purpose of this Directive is to ensure that products placed on the market are safe. (Art.1) It shall apply to all the products defined in the Article 2 (a) of the Directive. More specifically, a 'product' shall mean any product-including in the context of providing a service-which is intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them, and is supplied or made available, whether for consideration or not, in the course of a commercial activity, and whether new, used or reconditioned. It applies to substances and mixtures. Businesses should inform consumers of any risks associated with the products they supply. They also have to make sure any dangerous products present on the market can be traced so they can be removed to avoid any risks to consumers. The Directive complements sector specific legislation such as specific rules that apply to toys, electrical and electronic goods, cosmetics, chemicals and other specific product groups. It does not cover pharmaceuticals, medical devices or food, which fall under separate legislation.

Exemptions

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. (Art. 2)

Regulatory activities

Producers are required to place only safe products on the market. Industry compliance with the Directive is ensured through the MS national legislation and enforcement activities. In this context, no industry-specific submission system is defined. Where specific national rules do not exist, the safety of a product should be assessed in accordance with European standards, Community technical specifications, code of good practice, the state of the art and the expectations of consumers. In addition to the basic requirement to place only safe products on the market, producers must inform consumers of the risks associated with the products they supply, and take appropriate measures to prevent such risks.

Relevant product types

No reference data

Reference documents

Yes Decision 1999/468/EC Directive 85/374/EEC Directive 98/34/EC Directive 75/319/EEC Directive 81/851/EEC Decision 2010/15/EU Regulation (EEC) No 793/93 Directive 67/548/EEC

Obligations based on CLP hazard class

Yes Within the context of RAPEX, and specifically Annex II (i.e., Procedures for the Application of RAPEX and Guidelines for Notifications) of GPSD, Member States notifying under Article 12 shall provide all available details. This includes communicating the anticipated effects of the measure on consumer health and safety together with the assessment of the risk carried out in accordance with the general principles for the risk evaluation of chemical substances as referred to in Article 10(4) of Regulation (EEC) No 793/93 in the case of an existing substance or in Article 3(2) of Directive 67/548/EEC in the case of a new substance. Note that Regulation 793/93/EEC and Directive 67/548/EEC are part of the EU's previous chemicals management framework.

Obligations based on properties of concerns

No

EU-level occupational exposure limits

No provision

EU-level emission limit values

No provision

Substance-centric data source(s) at the EU level

The General Product Safety Directive (GPSD) provides for an alert system, known as the Community Rapid Information System (RAPEX), which ensures that the relevant authorities are rapidly informed of dangerous products. Commission Decision 2010/15/EU establishes guidelines for the management of RAPEX, including the notification procedure for MS authorities as per Article 11 of GPSD. Note: GPSD, Chapter V (Exchanges of information and rapid intervention situations - Art. 12), and Annex II (Procedures for the Application of RAPEX and Guidelines for Notifications) The Rapid Alert System (RAPEX) enables quick exchange of information between 31 European countries and the European Commission about dangerous non-food products posing a risk to health and safety of consumers.

Industry submission system in place

No electronic system in place that should be used by the industry for submission of information.

Format for industry submission

Not applicable

Owner

DG JUST (Unit JUST.E4 Product Safety and Rapid Alert System)

Update process

DG JUST (Unit JUST.E4 Product Safety and Rapid Alert System)

Amendments

REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 REGULATION (EC) No 596/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 June 2009

Categories Display