COMMISSION DECISION
of 16 December 2009
laying down guidelines for the management of the Community Rapid Information System ‘RAPEX’ established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive)
(notified under document C(2009) 9843)
(2010/15/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on European Union and to the Treaty on the Functioning of the European Union,
Having regard to Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (1), and in particular the third subparagraph of Article 11(1) and point 8 of Annex II thereof,
After consulting the Advisory Committee set up by Article 15 of Directive 2001/95/EC,
Whereas:
(1)
Article 12 of Directive 2001/95/EC establishes a Community Rapid Information System ‘RAPEX’ for the rapid exchange of information between the Member States and the Commission on measures and action taken in relation to products posing a serious risk to the health and safety of consumers.
(2)
RAPEX helps to prevent and restrict the supply of products posing a serious risk to consumer health and safety, and facilitates the monitoring of the effectiveness and consistency of market surveillance and enforcement activities in the Member States. It provides a basis for identifying the need for action at Community level and makes for consistent enforcement of EC product safety requirements and hence the smooth functioning of the internal market.
(3)
The notification procedure established under Article 11 of Directive 2001/95/EC provides for an exchange of information between the Member States and the Commission on measures adopted in relation to products posing a non-serious risk to the health and safety of consumers.
(4)
Notifications submitted under Article 11 of Directive 2001/95/EC help to ensure a consistent, high level of consumer health and to preserve the unity of the internal market.
(5)
In order to facilitate the operation of RAPEX and the notification procedure under Article 11 of Directive 2001/95/EC, the Commission should draw up guidelines to regulate various aspects of these notification procedures and, in particular, to establish the content of notifications. These should include a standard notification form, criteria for notifications involving risks that do not or cannot go beyond the territory of the Member State and criteria for the classification of notifications according to the degree of urgency. The guidelines should also lay down operating arrangements, including deadlines for the various steps of the notification procedures.
(6)
To ensure that RAPEX and notification procedure under Article 11 of Directive 2001/95/EC are properly applied, the guidelines should also set out a risk assessment method and, in particular, specific criteria for identifying serious risks.
(7)
On 29 April 2004, the Commission adopted Decision 2004/418/EC laying down guidelines for the management of the Community Rapid Information System (RAPEX) and for notifications presented in accordance with Article 11 of Directive 2001/95/EC (2). Point 8 of Annex II to Directive 2001/95/EC and Chapter 1.2 of the guidelines set out in the Annex to Decision 2004/418/EC require the guidelines to be regularly updated in the light of new developments and experience.
(8)
In the fifth year since the adoption of Decision 2004/418/EC, the total number of notifications submitted under RAPEX and the notification procedure under Article 11 of Directive 2001/95/EC has quadrupled and is still growing. Market surveillance authorities have enhanced their enforcement actions (including their participation in joint market surveillance projects) and national authorities in charge of external border controls have became more actively involved in product safety activities.
(9)
In view of these developments, and in order to ensure more efficient and effective notification procedures in line with best practice, it is necessary to update the guidelines.
(10)
The main objective of this Decision is to lay down new guidelines that establish the scope of RAPEX and of the notification procedure under Article 11 of Directive 2001/95/EC more clearly, identify the notification criteria and regulate various aspects of the notification and reaction procedures, such as the scope of data provided by the Member States, confidentiality rules, withdrawal of notifications, follow-up action to notifications and organisational aspects.
(11)
In the light of the provisions of point 2 in Annex II to Directive 2001/95/EC, the new guidelines include improved risk assessment guidelines for consumer products which specify the criteria for identifying serious risks.
(12)
The structure and content of the new guidelines allow them to be adapted, if and as appropriate, to include provisions relating to the notification procedure established under Article 22 of Regulation (EC) 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 and repealing Regulation (EEC) No 339/93 (3) which will use RAPEX to exchange information and to the safeguard procedure notifications, for example regarding toys.
(13)
The guidelines are addressed to all authorities of the Member States acting in the consumer product safety area and participating in the RAPEX network pursuant to Directive 2001/95/EC, including market surveillance authorities responsible for monitoring the compliance of consumer products with safety requirements and authorities in charge of external border controls. The Commission should use the guidelines as a reference for managing RAPEX and the notification procedure under Article 11 of Directive 2001/95/EC,
HAS ADOPTED THIS DECISION:
Article 1
The guidelines for the management of the Community Rapid Information System ‘RAPEX’ established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC are set out in the Annex to this Decision.
Article 2
Decision 2004/418/EC is repealed.
Article 3
This Decision is addressed to the Member States.
Done at Brussels, 16 December 2009.