Safety first: the EU’s General Product Safety Regulation is now in force

Insight

22.01.2025

The new General Product Safety Regulation (GPSR) marks a significant change to the product safety regime across the EU. As of 13 December 2024, all businesses selling products into the EU and Northern Ireland are required to comply with its new product safety rules, even if those businesses are not physically based in the EU.

The GPSR repeals and replaces the EU’s existing product safety framework – the General Product Safety Directive 2021 (GPSD). The GPSD is over 20 years old, and there have been significant developments (ie new technologies) and changes to the market (ie online marketplace selling) since it was originally enacted into law. The GPSR is therefore aimed at filling those gaps by bringing product safety rules up to date.

As the GPSR is an EU Regulation, it will apply across all of the EU without individual member states having to introduce national legislation in order to give effect to the new rules. It is also important to note that the GPSR applies to retailers, manufacturers of products, importers, and distributors, as well as online marketplaces that supply goods on the EU market, which greatly expands upon the scope of the existing product safety framework.

What are the new rules?

The new product safety requirements in the GPSR are fairly expansive, and at the time of writing, the EU has not released any official guidance on the GPSR. Here is a summary of some of the core rules:

The new general safety requirement contains a general obligation for businesses to only place “safe products” on the market. “Safe products” are defined as products which, under normal or reasonably foreseeable conditions of use, do not present any risk or only the minimum risks compatible with the product’s use. In order to assess whether a product meets the general safety requirements, the GPSR outlines a number of factors that should be taken into consideration, including: (i) the characteristics of the product, including its design, packaging, and instructions; (ii) the presentation of the product, including the labelling; and (iii) the categories of consumers using the product.
The GPSR creates different product safety rules for each business within the supply chain, namely product manufacturers, manufacturers’ authorised representatives, importers, distributors, and providers of online marketplaces. This includes enhanced information requirements to ensure product safety, both before and after a product is placed on the market. For example, pursuant to Article 9, product manufacturers are required to perform a thorough risk analysis before a product is placed on the market and compile technical documentation based on that risk assessment detailing the product’s design, safety features, and associated risks. Manufacturers are also required to take the necessary corrective measures required to address any product safety concerns and inform affected consumers of any issues accordingly.
There is a requirement to designate a responsible person who is established within the EU for all products which are sold into the EU. This responsible person could be a manufacturer, importer, or other authorised representative, and serves as the primary point of contact for regulators in relation to applicable products. The responsible person is also required to verify that the product complies with the technical documentation and contains the necessary information required by the GPSR.
The GPSR also includes a number of enhanced accident reporting and product safety recall requirements. It establishes protocols for product recalls, including the use of a standardised recall template provided by the European Commission. In the event of a recall, affected consumers must also be offered an effective, cost-free and timely remedy, which includes the provision of at least two remedial options (repair, replacement or an adequate refund).

What can we do to comply?

If UK businesses are selling products into the EU and are still in the dark about what they should do to comply with the new rules, we recommend taking the following steps towards compliance:

Assess: As a first step, UK businesses will need to assess which products are required to comply with the new rules. In short, the GPSR applies to all products which are intended for consumers, or which are likely, under reasonably foreseeable conditions, to be used by consumers (even if they were not actually intended for them), except if they are expressly excluded from scope or covered by existing EU safety rules. It is also important to keep in mind that the GPSR includes a transitional period, although the effects of this are relatively limited in practice. Our view is that new product units which are sold within the EU after 13 December 2024 are caught within scope of the GPSR, even if the product unit is part of a product line which was first placed on the market before 13 December 2024.
Review: Businesses should review existing arrangements with the other ‘economic operators’ in its supply chain. If necessary, it may be appropriate to include contractual arrangements which allocate responsibility for certain aspects GPSR compliance. Businesses should also review their internal product safety process to ensure that they have the required procedures and documents in place to comply with the new rules. This will include building in time to conduct through product safety risk analyses and having the necessary procedures in place to adequately address any product safety issues. In particular, businesses should familiarise themselves with the new EU's Safety Gate Portal as it is now the mandatory channel for reporting product recalls and accidents.
Implement: Once a business has identified: (i) what products are within scope; and (ii) what changes need to be made in order to comply with the new rules, it will need to implement the necessary changes. This will involve designating a responsible person, undertaking and documenting the required risk analysis for its in-scope products, and updating the required technical documentation, products, product labels and online product listings (including by taking advice on translations as appropriate). This may involve a wholesale review of the internal processes to build in a “product safety by design” approach where possible.

This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.