Product Safety in the European Union
Jan 20, 2010 QuickCounsel Download PDF
By ACC and Phillip Turner
Introduction: The E.U.’s Revised GPSD
The General Product Safety Directive (GPSD) aims at ensuring that only safe consumer products are sold in the E.U. Its objectives are to protect consumer health and safety and to ensure the proper functioning of the internal market. The current General Product Safety Directive (“GPSD”)(Directive 2001/95/EC) came into force in 2004, replacing the earlier GPSD (Directive 92/59/EEC). Under the GPSD, producers of products intended for use by consumers have a general duty to place only “safe” products on the market. The GPSD also puts in place a system of notification (rapid alert system, or “RAPEX”) by Member States to the E.C. Commission and other Member States.
Scope of the GPSD
The GPSD applies only to consumer products placed into the E.U. marketplace. Consumer products covered under the GPSD must be:
This means, for example, that products intended for professional use but which consumers foreseeably might use, are considered consumer products. The GPSD also applies to products provided in the context of some services (e.g., machine rental) but not others that are more indirect (e.g., escalators in shopping centers).
The GPSD partially applies to consumer products that are treated more comprehensively under E.U. sector or product-specific Directives. Whether a product covered by specific provisions of other Directives still may be subject to the GPSD is ambiguous. The determination can only be made on a case-by-case basis.
Obligations of Producers/Distributors Under the GPSD
The GPSD is designed to ensure that consumer products distributed within the EU are safe. Manufacturers have a general duty to place only safe products on the market. All producers or distributors of consumer products must take steps to:
Product Safety Reporting Requirements
In the U.S., the Consumer Product Safety Act (CPSA) does not require importers, manufacturers, distributors, and retailers of consumer products to report product risks to individual state authorities. This is a significant contrast to the situation in the E.U., where reports of product safety issues initially go to Member State authorities. Under Article 5(3) of the GPSD, producers and distributors must immediately inform their individual Member State authorities, not the EC directly, when they know, or ought to know, that a product they placed on the market poses risks to the consumer that are incompatible with general safety requirements or when they have taken any actions to prevent risks to the consumer regarding a particular product.
There are two significant substantive differences between the GPSD and CPSC reporting requirements. The GPSD does not specially require producers or distributors to report product-related choking incidents involving children, or lawsuits involving consumer products. Moreover, unlike the CPSA and its implementing regulations, the GPSD itself does not prescribe detailed guidance on when to report or impose specific penalties for failure to comply with Article 5(3). The GPSD does, however, provide that Member States must adopt rules on penalties applicable to infringements, and that penalties must be “effective, proportionate, and dissuasive.” Member States will determine their own individual penalties for failing to report.
Producers and distributors should be familiar with the individual laws of Member States and published industry safety standards on product safety. Under Article 3 of the GPSD, products are deemed safe if they comply with Member States’ product safety laws. Products are presumed safe if they comply with voluntary national standards for product safety.
Rapid Exchange System for Sharing Information
The GPSD establishes a special rapid exchange system (“RAPEX”) for sharing information between the Member States and the Commission on measures and actions taken with regard to product safety. Member states evaluate the information provided by producers or distributors to determine if there is a serious risk to consumers. If so, they are required to notify the Commission of any voluntary measures taken by the manufacturer or distributor. Member States are expected to supply the following information (and thus companies should be prepared to provide it):
Guidelines for RAPEX notifications identify a conceptual approach that may be used by enforcement officials to determine if a specific hazardous situation constitutes a serious risk under the GPSD. It involves first categorizing the severity of the hazard as “slight,” “serious,” or “very serious,” and then evaluating the probability of an adverse impact on health and safety. The assessment of the risk level must be adjusted based on whether or not the consumer product will be used by “vulnerable people” (e.g., children and the elderly). Under the RAPEX system, Member States must notify the Commission “as soon as possible” (within 10 days) of decisions or measures relating to products presenting a serious risk to consumers.
When a consumer product sold both in the E.U. and the U.S. is subject to a RAPEX notification because of a safety problem in the E.U., chances are that the manufacturer will have information requiring a report to the CPSC before the RAPEX notification occurs. Consequently, E.U obligations and actions taken within the E.U. under the RAPEX system must be a consideration for U.S. manufacturers operating under the GPSD.
The RAPEX system has some parallels to Consumer Product Safety Commission (CPSC) procedures in the U.S., but there are significant differences between the U.S. and the E.U. regulatory structure and enforcement authority. (For example, there is the need for companies to be cognizant of regulatory obligations under Member State law.) Any national measures restricting unsafe products—or requiring a product recall—must be reported by Member States to the Commission. Several product categories, like pharmaceuticals, certain medical devices, and food and feed products, are not included at all under the RAPEX system.
In today’s business environment, consumer product manufacturers must comply with the product safety regulations and reporting requirements of the regions in which they are selling their products, and should adopt regulatory compliance and risk management strategies reflecting those requirements. As a practical matter, the U.S. requirements are more stringent in both application and enforcement, but care must be taken to understand and comply with both U.S. and E.U. requirements.
Additional ACC Resources
Requirements to Sell, Manufacture or Commercialize Transgenics, Insecticides, Pesticides, Herbicides and Rodenticides Global Practice Guide
ACC Resource Library - Primer
ACC Resource Library - Article
ACC Resource Library - ACC Docket
ACC Resource Library - Article
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