From December 13, 2024, companies must implement the new EU Product Safety Regulation, which has been in force since May 10, 2023. It replaces the previous EU Product Safety Directive from 2001 and the national implementing legislation based on it. The regulation now contains EU-wide, directly applicable rules for the safety of consumer products. It thus follows the same path of harmonization as the EU Battery Regulation, for example. The obligations for companies have been expanded and specified, for example with regard to risk analysis and internal procedures to ensure product safety. The regulation also takes new technologies and sales models into account. For example, specific obligations for fulfillment service providers and providers of online marketplaces are regulated. The aim of the regulation is to ensure that only safe consumer products are placed on the market or made available on the market.
The General Product Safety Regulation (GPSR), as the regulation is called in English, applies to all consumer products unless there are special regulations for them. Medicinal products, foodstuffs and animal feed, live animals and plants, animal products, plant protection products, means of transport, aircraft and antiques are otherwise exempt.
A manufacturer within the meaning of the GPSR is any natural or legal person who manufactures a product or has a product designed or manufactured and markets this product in their own name or under their own trademark. A manufacturer is also considered to be anyone who significantly modifies a product and the modification also affects the safety of the product. In addition, so-called quasi-manufacturers who market a product under their own name or trademark are also covered.
Manufacturer labeling
The previous obligations regarding the manufacturer labeling of products have been expanded. One of the new requirements is that an email address or website address must also be provided.
Risk analysis and technical documentation
Before placing consumer products on the market, manufacturers must carry out an internal risk analysis and prepare technical documentation on the product and its essential safety characteristics. The technical documentation must be kept and updated for ten years. The assessment aspects for the safety of products have been adapted to current developments and expanded to include cybersecurity features and evolving, learning and predictive functions (AI).
Communication channels and notification obligations
Manufacturers must also set up publicly accessible communication channels for consumer complaints and the reporting of accidents or safety problems. They must investigate incoming reports. The complaint channels must also be accessible to people with disabilities. If a manufacturer receives information about hazards in connection with its product, it must investigate these and take the necessary corrective measures, including product recalls. They must inform the market surveillance authorities of all member states in which the product is marketed via the Safety Business Gateway. The manufacturer must also report accidents in connection with the product there.
Manufacturers may mandate natural or legal persons in writing to perform certain tasks on their behalf with regard to the fulfillment of the manufacturer’s obligations under this Regulation. This is particularly relevant in view of the fact that an economic operator established in the Union must be responsible for each product covered by the Regulation. Otherwise, the product may not be placed on the market. Such a necessary responsible economic operator may also be an authorized representative, for example for a manufacturer established in a third country. In future, specific obligations of the manufacturer to be defined in the mandate can be transferred to the authorized representative. Its minimum legal obligations include the transmission of information and documents to prove the safety of the product and cooperation in risk elimination at the request of a market surveillance authority, informing the manufacturer about potentially dangerous products and informing the competent national authorities about measures to eliminate the risks via the safety business gateway.
The duties of the importer have also been extended. An importer is any natural or legal person established in the EU who places a product from a third country on the market in the Union. The importer must ensure that the manufacturer carries out a risk analysis, prepares technical documentation and has fulfilled the product and manufacturer labeling obligations. In addition, the importer also has his own labeling obligations, which apply in addition to the manufacturer’s labeling. If the product is a dangerous product, the importer must immediately inform the manufacturer and the market surveillance authorities via the Safety Business Gateway. If it is suspected that the product does not comply with the GPSR, the importer must not place it on the market. He must also keep the technical documentation and, if necessary, provide a risk analysis. The importer must also check the manufacturer’s communication channels. If necessary, he sets up his own. Complaints must be investigated independently.
For retailers, the previous obligations essentially remain the same: They may only make products available on the market if they can guarantee conformity with the Product Safety Regulation. In particular, they must check: the type, batch or serial number, the manufacturer’s labeling and the accompanying safety information. If there is reason to believe that a product does not comply with labeling obligations or instruction or safety information obligations or that it is a dangerous product, retailers must inform the manufacturer or importer immediately and ensure corrective measures are taken. Dealers must also report accidents there. They are also responsible for informing the market surveillance authorities via the Safety Business Gateway.
Providers of online marketplaces are also subject to their own obligations with regard to product safety, in addition to and in addition to the requirements of the Digital Services Act. They must first designate a central contact point with which they can register with the Safety Gate Portal, among other things, and through which consumers can reach them. They must process product safety notifications immediately. Market surveillance authorities can instruct providers of online marketplaces to take information on dangerous products offline. Online marketplaces must be designed in such a way that product providers can store the information on manufacturer labeling there. They have a duty to cooperate in the event of product recalls.
All economic operators, i.e. manufacturers, distributors, authorized representatives, importers and fulfillment service providers, must ensure from 13 December 2024 that they have internal procedures in place to ensure product safety that enable them to meet the requirements of the GPSR. In future, providers of online marketplaces will also have to ensure that they have implemented internal procedures to ensure product safety. Until now, the establishment of preventive product compliance processes was part of the general company organizational obligations. Now the processes are also enshrined in special legislation. The design and implementation of appropriate product compliance processes and a product compliance management system will therefore become even more relevant.
The Product Safety Regulation sets out new requirements for the recall of products, the design of the recall notice and the minimum remedies to be offered to consumers in the event of a recall. All economic operators are obliged to collect customer data. If not all customers can be reached, all economic operators must publish clear and visible recall notices or safety warnings. They should use all available channels to achieve the greatest possible reach.
Finally, specific requirements for product offers made online or via other forms of distance selling also apply to all economic operators. For example, the offer must include details of the manufacturer and contact details, product identification information including an image and any warnings and safety information.
The new GPSR rules will apply from December 13, 2024 for all products placed on the market from this date. For products previously placed on the market under the previous legal situation, the old legal situation is likely to continue to apply for reasons of legitimate expectations.
From a consumer perspective, the new regulations will help to continue to ensure a high level of safety for consumer products. In general, the position of consumers will be strengthened by, for example, increased information and labeling obligations, complaint options and new requirements for remedial measures in the event of a product safety recall. From the perspective of the affected economic operators and providers of online marketplaces, the obligations will be significantly expanded both in relation to the pre-market phase and the post-market phase. In particular, the obligation to establish internal procedures to ensure product safety, which now applies across the board to all economic operators, i.e. manufacturers, authorized representatives, importers, distributors and fulfillment service providers, emphatically underpins the need for appropriate and systematic product compliance management.
Partner
Co-Head of General Business and Commercial Law
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tuhlig@kpmg-law.com
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