The General Product Safety Regulation (GPSR) is the new Regulation for the Safety of products which do not fall into the scope of other regulations or directives. The GPSR enters into force on 13 December in the European Union and brings new requirements for non-food products, whether sold online or through traditional channels.
One of the requirements set by the GPSR is the compilation of a technical file.
Content overview of general products’ technical documentation
For GPSR compliance, manufacturers should have in place a technical documentation for the products they intend to place on the EU market. The technical documentation should contain the necessary information to declare and determine if the product can be considered as “safe” according to the GPSR.
Generally, a complete technical file should include at least the following:
- Labels and, if applicable, Instructions for Use (IFUs)
- A general description of the product and its essential characteristics.
- An analysis of possible risks that users might encounter while using the product and solutions adopted to eliminate or mitigate them, and the reports that can prove this, if any risks are identified.
- A list of relevant European standards, which were followed for the manufacture of the product, if any.
- Testing performed and toxicological assessment, if any.
However, it is essential to assess the necessary documentation product-by-product.
To ensure regulatory compliance, it is crucial to keep technical documentation updated and accessible for market surveillance authorities for 10 years after the product’s market release, making it available upon request.
Responsible Person for GPSR compliance
The way of designating a Responsible Person may have different scenarios. EU-based manufacturers act as Responsible Peron by default, while importers act as Responsible Person when the manufacturer is based outside of the Union market. When non-EU manufacturers do not have an importer, e.g., when they sell their products online, the EU based fulfilment service provider acts as Responsible Person. In all scenarios, all manufacturers can appoint an Authorised Representative that acts as Responsible Person.
The Responsible Person shall check if the product complies with the requirements of the Regulation before its placement on the market, verifying that all the documents necessary are available and keeping at disposal the updated technical documentation. The Responsible Person’s details must be displayed on the product, their packaging, or on a document accompanying the product.
Do you need a Responsible Person for your general products? Contact us here or send an email to prodlaw@obelis.net for more information.
References:
EUR-Lex (2024). Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC. Retrieved on 14/10/2024.
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