Navigating the EU's new GPSR: what manufacturers and importers of products need to know

The EU's General Product Safety Regulation (GPSR) (Regulation (EU) 2023/988) came into force on 12 June 2023 and will be applicable to businesses later this year from 13 December.

Under the GPSR, a manufacturer is defined as someone who manufactures a product or has a product designed or manufactured, and markets that product under that person’s name or trademark. An importer is someone who is established within the EU who places a product from a third country onto the EU market.

Broadly speaking, these roles are equivalent to the role of a "producer" roles under now defunct General Product Safety Directive (GPSD) (Directive 2001/95/EC).

While the GSPR is a piece of EU law and won't apply directly to the UK, manufacturers and importers should be mindful that the UK is also planning to review its product safety regime. Based on initial feedback, it is evident that industry stakeholders are keen for an UK system that is closely aligned to the EU's – and the GPSR is a helpful indicator of the similar requirements that may also soon apply to the UK. 

Wider 'safety' considerations

A fundamental requirement of the GPSR is that products need to be safe when they are placed on the market and that they should remain safe throughout their lifespan.

Safe products are those that present the minimum possible risks compatible with their use, bearing in mind various factors, including relevant technical standards, guidance, the "state of the art" and reasonable consumer expectations.

Manufacturers and Importers of products that have digital elements should pay particular attention to this ongoing requirement. For example, consider whether your products have appropriate cybersecurity features to protect against external influences. Ensuing a product is safe from this perspective might include introducing features to protect against misuse of or interference with a product's connective functions. Additionally, consideration should be given to how the risk profiles of products with evolving, learning and predictive functionalities may also change during the product lifespan.

Risk analysis and technical documentation

Ongoing risk analysis and technical documentation will be required for all products. The GPSR creates an obligation for manufacturers to carry out risk analysis and prepare technical documentation for every product.

At a minimum, this should contain a general description of the product and essential characteristics relevant for assessing that product's safety, but should also set out any technical standards the product has been tested against to ensure its safety and the other steps taken to eliminate or mitigate potential risks.

These technical files must be kept up to date (for products that have evolving functionalities, this will mean ongoing risk analysis, to reflect these changes) and documents must be retained for at least ten years after a product has been placed on the market. These technical files must also be available and produced to regulators upon request.

These obligations are not limited to manufacturers. Importers are required to hold a copy of the technical documentation for each product they place on the EU market.

Updated packaging and labelling requirements

There are significant updates to product packaging and labelling requirements which manufacturers and importers should familiarise themselves with. For example, it is now a specific requirement under the GPSR for all products to bear a serial number (or equivalent), which is easily visible and legible for consumers, to facilitate product identification and traceability.

Note that, despite QR codes increasing in popularity, electronic labelling is still not permitted as a direct alternative to physical labelling.

Osborne Clarke comment

It has been over 20 years since the GPSD (the existing EU framework for product safety) was introduced, and the GPSR now takes into account the rapid growth of digital products. Manufacturers and importers of products with digital elements should, therefore, take particular care to consider the potential scope and changing risks of their product throughout its lifecycle including through updates and monitoring capabilities.  

With the GPSR's requirements applicable from 13 December, now is the time for manufacturers and importers of products to familiarise themselves with the new or changing obligations and ensure that there is sufficient time to implement any required changes into new product lines, etc. before the deadline.

This is the first in our series of Insights on what businesses need to know about the new EU General Product Safety Regulation. Please also keep an eye out for other Insights as part of this series that will provide more detailed coverage of obligations for online marketplaces and the changing rules for product recalls, or check our dedicated webpage for all our resources.