Regulation (EU) 2023/988

The Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety (GPSR) is a European regulation on consumer protection. It replaces Directive 2001/95/EC on general product safety. The regulation is intended to ensure that products placed on the market in the European internal market do not endanger the health and safety of consumers through a high level of consumer protection.

Scope

The regulation applies to products placed on the market or made available in the EU. If certain other harmonized legal provisions apply to these products, they are fully or partially exempt from certain obligations, such as the assessment through an internal risk analysis. Some categories of products, like medicinal products, are complety exempt.

The scope of the regulation includes economic operators such as fulfillment service providers and online marketplace operators.

Economic Operators

The GPSR establishes in §3(13) the following roles for economic operators:

• Manufacturer
• Authorised representative
• Importer
• Distributor
• Fulfillment service provider

Manufacturers may name an authorised representative in the European Union as a contact point for market surveillance authorities.

Safety Business Gateway

The regulation strenghtens product vigilance through reporting obligations, and establishes the "Safety Business Gateway" als central reporting point for unsafe products. The GPSR includes reporting obligations for economic operators in the event of accidents (serious incidents) involving a product that result in death or health impairment. Article 20 of the regulation stipulates that importers and distributors must inform the product's manufacturer, who then submits a report on a dangerous product through the Safety Business Gateway portal.

Risk Analysis and Safety Assessment

To confirm compliance with the general safety requirement under Section 5 of the GPSR ("Economic operators shall place or make available on the market only safe products."), manufacturers are obligated to assess the safety of the product as part of an internal risk analysis. To make this possible, economic operators need internal product safety procedures that enable them to comply with the relevant requirements of this Regulation (that is, to conduct risk management). Various aspects, such as the product's characteristics, composition or packaging, or its interaction with other products, are evaluated. Relevant European standards, for example, may be used for this assessment. The internal risk analysis and the list of any relevant European standards part of the technical documentation for a product.

Distance Sales

The GPSR also includes provisions for distance selling that apply to online providers. These providers must register on the Safety Gate portal. Online providers of products covered by the GPSR are also required to fulfill information obligations for consumers. According to Article 19 of the regulation, details about the manufacturer (name or trade name) or the EU-authorized representative of the manufacturer, as well as product identification information (including a product image) and any warnings or safety information about the product, must be provided on the offering website (online interface). Article 22 additionally names specific obligations of providers of online marketplaces that are related to product safety and information.

Transition Provisions

This regulation applies to all products within its scope that are placed on the market from December 13, 2024. The making available on the market of products covered by Directive 2001/95/EC, which comply with that directive and were placed on the market before December 13, 2024, shall not be impeded by EU Member States.