KANBrief 4/23
As of 13 December 2024, the Product Safety Regulation (EU) 2023/988 of 10 May 2023 will replace the existing Product Safety Directive 2001/95/EC. As a regulation, it applies directly in all Member States without having to be transposed into national law.
The Product Safety Regulation is based on the New Legislative Framework (comprising Regulation (EC) No. 765/2008, Decision No. 768/2008 and Regulation (EU) 2019/1020), which harmonizes market surveillance, accreditation, conformity assessment and CE marking for products. The enacting terms, which include procedures and catalogues of obligations, have grown significantly. The core of European product safety law nevertheless remains unchanged.
Although Article 2 of the Product Safety Regulation appears at first glance to suggest otherwise, the Regulation’s scope is no different from that of the Directive. Its declared aim is to guarantee a high level of consumer protection and to implement the border-free Single Market. Definitions of terms such as risk, importer and fulfilment service provider, which have long been established in European product law, have now been included for the first time, however. Definitions of various standardization terms such as European standard and European standardisation organisation have also been included. They make reference to the definitions of the European Standardisation Regulation and thus ensure clarity for application of the regulation. All economic operators are now explicitly obliged to place or make available on the market only products that are safe. This was not previously the case. As before, a product is any item intended for consumers, or likely to be used by them under reasonably foreseeable conditions.
The safety assessment procedure has not changed significantly. However, the new Articles 6 to 8 of the Product Safety Regulation govern this procedure in much greater detail. The presumption of conformity in Article 7 (1) is decisive in the first instance. This states that a product is presumed safe if it conforms to the relevant European standards the references of which have been published in the Official Journal, or in the absence of such standards, to national statutory requirements, provided that these are in compliance with EU law. For the purposes of harmonization, the European Commission is empowered to determine, by means of implementing acts, what specific safety requirements are to be governed by European standards.
In addition, Article 6 lists numerous aspects to be included in the assessment procedure. Cybersecurity features of a product that are necessary to protect it against external influences are significant, for example. To these are added evolving, learning and predictive functions of the product, i.e. artificial intelligence. Finally, should the presumption of conformity not apply, provision remains for secondary codes to be taken into account in accordance with Article 8.
It is evident from the length of Chapter III of the Product Safety Regulation that the European legislator was keen to produce a conclusive regulation. As before, the obligations under product safety legislation are linked to the economic operator’s relationship to the product. As a result, the obligations are addressed in the first instance to the manufacturer of a product. However, a manufacturer is also deemed to be any party selling a product under its own name or trademark. The new Regulation sets out in legislation for the first time that any party substantially modifying a product is also deemed to be a manufacturer; in addition, “substantial modification” is now defined.
The status of the authorised representative, which is familiar from the Market Surveillance Regulation, is now also regulated; however, the authorised representative’s role is modified by the addition of obligations such as review of the technical documentation. Manufactures must notify the competent authorities of any accidents caused by one of their products. Importers and distributors must report such information to the manufacturer.
All economic operators must put internal processes in place to ensure that their obligations are met (Article 14). For certain products and product categories, the Commission may set up a traceability system for the collection and storage of data “enabling the identification of the product, its components or of the economic operators involved in its supply chain”. Although these internal conformity assessment obligations already existed, they were not placed as strongly in the focus of market surveillance, and reinforce the impression that the European legislator is increasingly focusing on systems and not solely on the legal compliance of products.
Any party distributing a product by distance sales must provide contact details of the manufacturer or party responsible for the product, a picture of it and all necessary warning and safety information. The new obligations for providers of online marketplaces under Article 22 of the Product Safety Regulation are governed in detail in 12 paragraphs. They include, for example, the designation of points of contact for market surveillance authorities and consumers, arrangements concerning notifying orders, product safety recalls and obligations to cooperate.
Market surveillance is based on Regulation (EU) 2019/1020, parts of which are declared applicable. Member States continue to report unsafe products through the Safety Gate rapid alert system (formerly RAPEX). The Safety Business Gateway is also being set up, which is intended to facilitate communication between economic operators and online marketplace providers on the one hand and market surveillance authorities and consumers on the other.
Cooperation among market surveillance authorities in Europe and between them and the Commission is to be stepped up. A consumer safety network is to be set up for communication and coordination with the authorities. Coordinated measures are also planned for checks of specific products or product categories. Where risks to the safety and health of consumers emanate from a product, the Commission may also take measures in the form of implementing acts, including prohibitions on placing on the market. It may do so on its own initiative or in response to an initiative by a Member State.
Philipp Reusch
Lawyer; partner and founder of reuschlaw
p.reusch@reuschlaw.de