The EU General Product Safety Regulation (GPSR) comes into force on 13 December 2024, replacing the General Product Safety Directive in EU member states, signals a major change in EU product safety regulation.
The GPSR introduces stricter requirements and more obligations for manufacturers, importers, distributors, and online marketplaces. The GPSR aims to address the challenges posed by new technologies and the growth of e-commerce.
For businesses operating in or selling into the EU market, understanding and preparing for these changes is crucial to ensure compliance and avoid potential penalties. In this guide, we highlight the steps which businesses, particularly non-EU based businesses, will need to consider as the deadline for compliance approaches.
The GPSR will govern the safety of consumer products or products which are likely to be used by consumers even if not intended for them. It will apply to products to the extent that there are no other EU laws which regulate their safety.
While the GPSR will take effect on 13 December, individual product units (as opposed to whole product lines) already lawfully placed on the market prior to 13 December in accordance with the current General Product Safety Directive regime, can remain on the market.
The question of whether or not a particular product unit has been 'placed on the market' is not always straightforward, often requiring a case-by-case assessment. However, there are established principles which can be applied and doing so correctly can avoid the need for time consuming and costly conformance exercises to bring products into line with GPSR requirements.
The GPSR imposes obligations at various levels of the supply chain and upon a range of economic operators. While non-EU businesses may consider that they aren’t at direct risk of enforcement action, other EU-based entities in the supply chain, such as importers and distributors, will want to ensure that both they and the products they are supplying are in compliance with the GPSR.
As a result, non-EU-based entities – particularly non-EU manufacturers – will, even if only as a condition of market access for their products, need to ensure that their products meet GPSR requirements. Contractual arrangements underpinning a supply chain may allocate responsibilities and require certain steps to be taken by non-EU businesses to assist EU-based economic operators. A failure to do so could expose non-EU businesses to the risk of contractual claims.
Products covered by the GPSR will only be able to be placed on the EU market where there is an economic operator, such as importer or distributor, established in the EU that assumes responsibility for certain product safety-related tasks.
Particularly in the case of non-EU businesses selling directly to consumers in the EU, businesses may need to consider appointing an EU-based authorised representative to satisfy this requirement.
The GPSR requires that products bear certain specific markings including a type, batch or serial number or other element enabling the identification of the product, that they include contact information and that they are accompanied by clear instructions and safety information in relevant languages. There are exemptions that can apply in certain circumstances.
Before placing their products on the market, manufacturers are required to undertake an internal risk analysis and draw up technical documentation for their products. The technical documentation – which needs to both be kept up-to-date and retained for 10 years – should contain an analysis of product risks and the measures adopted to either eliminate or, where elimination is not possible, mitigate those risks.
The GPSR requires that economic operators only supply 'safe' products. The GPSR includes a list of factors that should be taken into account when assessing whether a product is a safe product. These include a number of new factors, including:
For products made available online or through other forms of distance selling, businesses must ensure that, when those products are offered for sale, the following information is provided:
Manufacturers are required to provide consumers with the ability – such as a contact phone number, an email address or a dedicated page on their website – to submit complaints and report accidents or safety-related issues. EU-based importers are required to verify that appropriate communication channels have been put in place by the product's manufacturer and, if not, the importer will have to put them in place itself.
Manufacturers must investigate complaints and accident reports to determine whether their products present a safety risk. They are required to maintain a register of these complaints and accident reports as well as of product recalls and any corrective measures undertaken. EU-based importers are required to inform manufacturers of any comparable investigations which they undertake.
Manufacturers are required to ensure that other supply-chain participants, including providers of online marketplaces, are kept informed about known safety issues affecting their products.
Manufacturers should be prepared to promptly report occurrences that have led to death or 'serious adverse effects' on an individual's health and safety, including injuries, illnesses and chronic health effects. If the manufacturer isn’t based in the EU, this responsibility falls to their designated representative in the EU who has knowledge of the accident.
The GPSR introduces new requirements for product recalls and corrective measures, including:
Non-EU entities should familiarise themselves with the EU's Safety Gate portal, as it will become the mandatory channel for reporting product recalls and accidents.
For further information or advice, please contact the business risk and regulation team.
