In May 2023, the EU published the new General Product Safety Regulation (GPSR) 2023/988 in the Official Journal of the European Union. After an 18-month transition period, the regulation will replace Directive 2001/95/EC from 13 December 2024 and come into force directly in all EU member states.
The EU Product Safety Regulation aims to ensure that only safe products continue to be placed on the market in the EU. Due to increasing digitalisation and growing online trade, additional requirements have been introduced compared to Directive 2001/95/EC.
Scope of validity of the EU Product Safety Regulation
The regulation applies to all products that are placed or made available on the market in the EU, unless specific EU regulations such as CE directives govern product safety. Medicinal products, foodstuffs and animal feed, live plants and animals, plant protection products, means of transport and aircraft as well as antiques are excluded.
Extension of the personal scope of application
Fulfilment service providers and providers of online marketplaces have been newly included in the regulation as economic operators. These actors have specific obligations, such as ensuring the traceability and safety of products.
Evaluation of product safety
Article 6 of the EU product Safety Regulation sets out new criteria for the safety assessment of products, including product characteristics, interactions with other products, the presentation of the product, cybersecurity features and predictive functions.
New obligations for manufacturers
Manufacturers must now carry out a risk analysis for each product and draw up technical documentation that must be kept for at least ten years. These obligations supplement the requirements already contained in Directive 2001/95/EC.
Significant change to a product
The term "substantial modification" has been included in the regulation. Any person who modifies a product in such a way that it affects product safety is now considered a manufacturer. Such changes can be of a physical or digital nature and must be covered by a new risk assessment.
Traceability systems
For certain products that pose a serious risk to health and safety, the Commission may introduce a traceability system. This system requires the collection and storage of data to identify the product and the actors involved in the supply chain.
Obligations in distance selling
Economic operators offering products online must ensure that their offers contain certain information, such as the name of the manufacturer, its contact information and warnings and safety information in a language easily understood by consumers.
Notification of accidents
Manufacturers are obliged to immediately report accidents caused by their products to the competent authorities via the Safety Business Gateway. Importers and distributors must inform the manufacturer if they become aware of an accident caused by a product they have supplied.
Obligations of online marketplaces
Providers of online marketplaces must register with the Safety Gate portal and ensure that internal product safety procedures are in place. In the event of a recall, all affected consumers must be notified and personal data may be used for recalls and safety alerts.
Remedial measures for product safety recalls
In the event of a recall, economic operators must offer consumers an effective, free and timely remedy, including repair, replacement or refund of the purchase price.
Regulation 2023/988 significantly expands the requirements for product safety and specifically addresses the challenges of the digital age and online trade in order to further ensure the protection of consumers in the EU.
Lawyer for commercial law
Find out about the legal provisions in good time!
Lawyer Dr Simon Harald Baier will be happy to advise you on questions of product safety and the specific requirements of the GPSR.
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