The new Regulation (EU) 2023/988 (hereinafter referred to as EU ProdSV) was published in the EU Official Journal on May 23rd 2023, following a surprisingly swift legislative process. As an EU regulation, it will apply directly in all member states from December 13th 2024 and will replace the Product Safety Directive 2001/95/EC.
The scope of application remains limited to products "intended for consumers or likely to be used by consumers under reasonably foreseeable conditions, even if not intended for consumers" (cf. Art 3 No. 1 EU-ProdSV).
New safety requirements arise with regard to the advancing digitalization and networking of products in the Internet of Things (IOT), for example, from Art. 6 (1) g) EU ProdSV. According to this, a product can only be classified as safe if it has the "necessary cybersecurity features" to protect the product from external influences, including malicious third parties, insofar as such an influence could have an impact on the safety of the product, including a possible failure of the connection.
Manufacturers (cf. Art. 9 EU ProdSV) and importers (Art. 11 EU ProdSV) are subject to new obligations:
- Obligation to carry out internal risk analyses and to prepare technical documentation for the non-harmonized product area.
- In addition to the postal address, an electronic (e-mail) address must also be indicated on the product in the future
- Obligation to set up complaint facilities for consumers via publicly accessible communication channels (e.g. telephone numbers, e-mail addresses or website)
- Notification and information obligations regarding "dangerous" products to market surveillance authorities and consumers.
In this context, there is a particular need to adapt risk management and information processes within the company.
Another focus is on online trade. Here, the EU ProdSV requires the provision of specific information about products sold online, namely, in addition to a picture of the respective product, the manufacturer and product labeling as well as all necessary safety information required for the safe use of the product. In addition, online marketplaces must set up a central contact point for market surveillance authorities and consumers, for example, with regard to product safety issues, and must also register with the Safety Gate portal (Art. 22 EU ProdSV).
It is recommended that you already prepare for the new product safety regulations and adapt your company's processes. We would be happy to advise or support you in this – simply contact us!
