September 24, 2021

Volume XI, Number 267

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Towards a GPS Regulation

On 30 June 2021, the European Commission published the outcome of its public consultation and finally approved proposed text for a revision of the General Product Safety Directives (GSPD). The proposal’s aim is to repeal the two existing Directives, 87/357/EEC and 2001/95/EC, and form an EU Regulation directly applicable to all EU Member States. The new Regulation will govern rules that will make sure both harmonized products (bearing the CE mark) and unharmonized products (except for foods which are covered by another piece of existing legislation and procedures) are not presenting any unacceptable harm to consumers (i.e., that they are considered “safe” according to their intended conditions of use).

Specific objectives are:

  1. to address emerging issues related to e-commerce and use of new information technologies and online sales;

  2. to ensure better enforcement of the rules and a more efficient and even market surveillance;

  3. to simplify the “standardization” process;

  4. to improve several aspects related to the recall of products already in the hands of consumers which could present undue dangers during their normal intended conditions of use (i.e., the current RAPEX system transformed into a unique “Safety Gate” to offer a better coherence with the Information and Communication System on Market Surveillance (ICSMS) national contact points).

The COM proposal, which is part of an overall package defining the “New Consumer” and related to protection rules, is open to a final round public consultation until September 8Further information on the text of the proposed Regulation is available here.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 197
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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