S tefano S oro European Commission Health and Consumer Protection DG OBLIGATION OF PRODUCERS AND DISTRIBUTORS TO NOTIFY DANGEROUS PRODUCTS

Objectives :  Important element of the market surveillance  Enable the competent authorities of the Member States to: - provide assistance - monitor measures adopted by economic operators - assess whether other similar product should be subject to controls  RAPEX system

Legal base :  General Product Safety Directive 2001/95/EC - Article 5 (3) - Annex I  Guidelines for the notification of dangerous products to the national authorities of the Member States by producers and distributors.

 Consumer product  No specific similar obligation in the Community legislation  Product is on the market  Economic operator has an evidence that the product is dangerous  Risks are such that the product cannot remain on the market and preventive actions should be taken Notification criteria :

Important aspects - WHO ? : Obligation applies to producers and distributors : - the manufacturer of the product when he is established in the EU, - the manufacturer’s representative if the manufacturer is not established in the EU, - importer if there is no manufacturer’s representative established in the EU, - other professionals in the supply chain…

Important aspects - WHAT? : Data transmitted – details of: - authorities and companies receiving the form - producer/distributor submitting the form - product involved - risks posed by the product - actions taken to eliminate the risks - other companies in the supply chain holding affected products

Important aspects – HOW? : Cooperation between economic operators and the national authorities of the Member States based on TRUST.

Business Application :  Objective: - To simplify the practical application of the economic operators’ obligation to notify dangerous product  Cooperation with stakeholders: - Consultations with business and the national authorities of the Member States

Business Application: The state of play:  In production February 2007  Information on the Commission’s website!

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THANK YOU VERY MUCH FOR YOUR ATTENTION. Stefano Soro Head of Unit Product and Service Safety Health and Consumer Protection Directorate General European Commission Office B232 06/116, 1049 Brussels, Belgium