Decision 2019/417 - Guidelines for the management of the EU Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system (notified under document C(2018) 7334) - Main contents
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Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system (notified under document C(2018) 7334)| Legal instrument | Decision |
|---|---|
| Number legal act | Decision 2019/417 |
| CELEX number i | 32019D0417 |
| Document | 08-11-2018; Date of adoption |
|---|---|
| Publication in Official Journal | 15-03-2019; OJ L 73 p. 121-187 |
| Effect | 12-11-2018; Takes effect Date notif. |
| End of validity | 31-12-9999 |
| Notification | 12-11-2018 |
15.3.2019 |
EN |
Official Journal of the European Union |
L 73/121 |
COMMISSION IMPLEMENTING DECISION (EU) 2019/417
of 8 November 2018
laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system
(notified under document C(2018) 7334)
THE EUROPEAN COMMISSION,
Having regard 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,
Having regard to 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 on the marketing of products and repealing Regulation (EEC) No 339/93 (2),
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 European Union Rapid Information System (‘RAPEX’) for the rapid exchange of information between the Member States and the Commission on measures and action taken on products posing a serious risk to the health and safety of consumers. |
(2) |
Point 8 of Annex II to Directive 2001/95/EC requires the guidelines to be regularly updated in the light of new developments and experience. Commission Decision 2010/15/EU (3) was the first and only update of the guidelines. |
(3) |
In view of new developments and in order to ensure more efficient and effective notification procedures in line with best practice, a further update of the guidelines is required. |
(4) |
Terminology and references have become obsolete as has the means of communication between the Commission and the Member States authorities and between the authorities themselves. |
(5) |
New tools that have been developed over the last years for the proper functioning of RAPEX (wiki's, interface between RAPEX and other market surveillance systems) have to be taken into consideration in the guidelines. |
(6) |
Criteria for the RAPEX notification, following the new developments, have become unclear and need to be clarified. |
(7) |
Cross-border online sales of goods have increased. This development needs to be reflected in the notification techniques as well as in the follow-up instruments to be used. |
(8) |
Regulation (EC) No 765/2008 extends the application of RAPEX provided for in Article 12 of Directive 2001/95/EC also to products covered by that legislation. Extending the application of RAPEX raises some issues that need to be clarified in the guidelines. |
(9) |
Regulation (EC) No 765/2008 applies to consumer products and to professional products such as some medical devices. That Regulation covers a broader scope of risks, other than those related to the health and safety of consumers, such as security and environmental risks. Therefore, a risk can concern not only consumers but also an indeterminate group of people referred to as ‘end-users’. |
(10) |
Article 22 of Regulation (EC) No 765/2008 provides therefore that measures taken against products presenting a serious risk to health and safety or other relevant public interests should be notified via RAPEX. |
(11) |
Directive 2001/95/EC and Regulation (EC) No 765/2008 are complementary and provide a system to improve the safety of non-food products. |
(12) |
RAPEX helps to prevent and restrict the supply of products posing a serious risk to health and safety or, in the case of products covered by Regulation (EC) No 765/2008, also to other relevant... |
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