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Operational guidelines (Member State level)
New RAPEX guidelines
On 16 December 2009, the Commission adopted Decision 2010/15/EU laying down the new guidelines for the management of the
"RAPEX" system and of the notification procedure established under Article 11 of the General Product Safety Directive.
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Reason for change
Both, RAPEX and Article 11 notification procedures have proven to be reliable systems that are recognised worldwide. In the sixth year since the adoption of the previous RAPEX guidelines (Commission Decision 2004/418/EC), the total number of submitted notifications has more than quadrupled (to 1993) and is still growing.
The new RAPEX guidelines were adopted, so that:
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a) they could reflect and allow the RAPEX Network to respond to the changes in the product safety environment and to the new challenges (such as, the need to increase the traceability of dangerous products, including by providing more detailed and precise information about dangerous products notified via RAPEX and the need to strengthen and broaden cooperation between market surveillance and customs authorities);
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b) RAPEX and Article 11 notification procedure could be adjusted to best practices worked out over the years by the Member States and the Commission RAPEX Team to ensure even more efficient and effective operation of the two notification procedures;
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c) the need to further unify the operation of the two notification procedures in the Member States by introducing more precise and comprehensible regulation of different aspects of the procedures and by including provisions governing new aspects which have not been yet regulated (such as confidentiality rules).
Content of the new guidelines
The Decision 2010/15/EU replaces the Commission Decision 2004/418/EC. The new guidelines precisely and comprehensibly:
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(a) identify the scope of the RAPEX system and Article 11 notification procedure;
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(b) clarify the notification criteria (including definitions of products and measures covered by and excluded from the notification procedures, redefined concept of the "cross-border effect", clearer provisions on the risk assessment);
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(c) define various stages and aspects of the notification and reaction procedures (such as the classification of notifications, content of notifications and reactions, the examination and validation of notifications and reactions by the Commission, follow up to notifications);
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(d) regulate aspects of the procedures which so far have not been subject to specific regulations, including permanent withdrawal of notifications from the system, temporary removal of notifications from the RAPEX website and confidentiality rules;
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(e) define the new risk assessment method that was developed by a dedicated working group of Member State experts and is recommended to all national authorities to assess the safety of consumer products.
Text of the new guidelines
The new guidelines (text available in 22 official languages of the EU):
Use of Guidelines for notifications based on Regulation (EC) No 765/2008
Since guidelines were written before 1 January 2010 they refer explicitly only to notifications based on the General Product Safety Directive. Nevertheless they are the main reference also for notifications based on Regulation (EC) No 765/2008 (see Article 22(4) therein).
Links
To check most recent RAPEX notifications, please click here.
You can also search for specific RAPEX notifications
To check contact details of the RAPEX Contact Points, please click here (the National Contact Points, Updated 13-05-2013).
Privacy Statement concerning the National Contact Points.
RAG Application
The "RAG Application" has been established to support the use of the RAPEX risk assessment guidelines when assessing the risks of non-food consumer products under the General Product Safety Directive.
The application is web-based and directly accessible (no login required), it saves data only on the user's local hard disk. Users are thus free to use the application as it fits their needs. - Of course suggestions for improvement are always welcome (see link under the application's About).
It is highly recommended that users make themselves familiar with the RAPEX risk assessment guidelines before using the application; the guidelines are accessible under the application's Help. The Help also describes how to use the application, including brief summary references to the guidelines.
To access the "RAG Application", click here.
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