Today we will focus on European legislation, specifically the regulation of the sale of products, which is newly regulated in the General Product Safety Regulation (the Regulation). The Regulation is effective from 13. 12. 2024 , it is still a relatively new legislation, which many market operators may not have adequately experienced yet. Until the Regulation came into force, general product safety was only partially regulated at EU level and at Directive level. The adoption of the Regulation therefore brings about a rather fundamental change. It can be said that the adoption of the Regulation is part of a longer-term trend in the development of EU legislation, which is moving from directives to regulations. On the one hand, this brings the possibility of a better orientation in the law across countries (the Regulations apply equally to all Member States), on the other hand, this trend brings less sovereignty for the national states and less possibility to regulate the area at least to some extent individually. However, a broader analysis of EU legislative developments is beyond the scope of this article.
The Regulation aims, as its name suggests, to make products safer on the European market. All products sold within the Union that do not have their own specific legislation are subject to regulation. The Regulation therefore does not cover , for example, medicines, medical devices, animal feed, toys, antiques, etc. These exceptions are set out in Article 2 of the Regulation. Other products are covered, regardless of whether they are sold as new, used, repaired or modified, and regardless of whether they are sold in bricks-and-mortar shops or e.g. on e-shops or online marketplaces. It is therefore a subsidiary regulation for any products not covered by a specific regulation.
The Regulation is designed to impose obligations on operators in the supply chain to ensure the safety of products. Most of the obligations in this respect fall on the manufacturer (as the entity that primarily places the product on the market), while other entities (importers, distributors) have in particular the obligation to check that the safety verification has been properly carried out by the manufacturer, as well as some sub-obligations (e.g. information obligation).
A manufacturer within the meaning of the Regulation is a person who manufactures or markets a product under his own name or trademark.
The basic obligations of the manufacturer under the Regulation include placing only safe products on the market. This is to be achieved through the obligation to carry out internal risk analyses and to produce appropriate technical documentation on product safety. In addition, the manufacturer must also ensure that consumers are sufficiently informed, such as by accurately identifying the product (including batch or serial number, instructions for use, if required, etc.) or by providing its identification data. Other obligations on the manufacturer include the obligation to keep records of complaints received or to follow procedures in the event of the placing on the market of a dangerous product, which include informing consumers or the supervisory authority.
The obligations of importers and distributors then include in particular checking that the safety assessment of the product (risk analysis, technical documentation) has been properly carried out by the manufacturer and only in this case to resell the product. They must also supply their identification data with the product, ensure appropriate transport and storage conditions and, where applicable, fulfil their information obligations towards consumers or the supervisory authority.
Finally, the Regulation contains partial obligations for specific entities (e.g. operators of online marketplaces).
Overall, this is a fairly complex piece of legislation that sets out the obligations of a number of entities. It is a piece of legislation that is still in its infancy, and the various mechanisms in practice have yet to evolve. However, it is necessary that the obliged entities are well acquainted with all the partial obligations under the Regulation, because in case of their violation there are quite severe sanctions, the upper limit of which is in the order of units or in some cases even tens of millions of CZK.
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This article is for informational purposes only and does not constitute legal advice or guidance for any particular case.