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European overview

Alison Newstead

Shook Hardy & Bacon LLP

Tuesday 19 November 2019


The success of the European market has led to increasing numbers of products moving freely across European borders. The result of this free movement is that the same products (and their inherent safety risks) are commonly found in many jurisdictions. A pan-European structure therefore needs to be in place to effectively manage any product safety issues that may arise.

The aim of European product safety legislation is to ensure that a consistent approach to the regulation of product safety issues is adopted across the EU. A uniform approach facilitates the smooth running of cross-border commercial activities and gives assurance to community citizens that effective measures are in place to ensure that the products they use in their daily lives are safe.

Laws governing product recall in Europe

In Europe, the laws governing the safety requirements that consumer (non-food) products must meet and the corrective action that needs to be taken by producers (and others) when a product poses a safety risk are set out in the General Product Safety Directive 2001/95/EC (GPSD). These requirements are implemented in each member state by way of national laws.

The main obligations prescribed by the GPSD are monitored and enforced by competent national authorities. However, there is an important overarching supervisory function played by the European Commission, which ensures that information obtained regarding unsafe products is disseminated quickly and efficiently throughout the EU.

The obligations set out in the GPSD apply to products intended for, or likely to be used by, consumers. Other similar regulatory regimes are in place for food products, pharmaceuticals and medical devices. In addition, Regulation (EC) No. 765/2008 on accreditation and market surveillance contains extra provisions that apply to professional products covered by EU harmonisation legislation (eg, machinery, electrical goods). This means that member states – through their market surveillance authorities – should have powers not only to restrict the sale of non-compliant products but to order their recall as well. Thus recall powers are not limited to consumer products and may extend to products used for business purposes if they are subject to EU harmonised requirements. This European overview deals primarily with the current regime as it applies to non-food consumer products.

The current EU legislative framework was due to be revised in 2015 in response to the proposals set out in the European Commission’s Product Safety and Market Surveillance Package, adopted in February 2013. The initial expected implementation date of 2015 was not achieved and, as at September 2019, ‘country of origin’ issues have still to be overcome. The Package, if implemented, will see the replacement of the GPSD with a new Regulation on Consumer Product Safety (COM (2013) 78) and the introduction of a Regulation on the Market Surveillance of Products (COM (2013) 75). If implemented in their current draft form, these Regulations will have significant practical implications for those who manufacture, distribute or sell products within the EU. In particular, there will be additional obligations with regard to labelling, preparation of risk assessments, extended obligations to manufacturers, importers and retailers regarding notification of risks, penalties that are linked to the size of the business, increased scope of market surveillance provisions and additional obligations on national authorities with regard to investigations, in addition to explicit powers regarding recall.

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