Changes through the new Product Safety Regulation

On 13 December 2024, the new EU General Product Safety Regulation (GPSR) replaced the outdated General Product Safety Directive (GPSD). The revised GPSR sets comprehensive safety standards for products available in the European market, irrespective of their origin and distribution channels. The changes will impact products made available on the European market from 13 December 2024, while those already on the market before this date are exempt from the new obligations. It encompasses all consumer products on the EU market, including used and repaired items, with the exception of certain, explicitly excluded groups of products, including medicinal products, food, feed, living plants and animals and plant protection products. The regulation also covers products primarily meant for industrial use if they enter the consumer market and are likely to be used by consumers under reasonably foreseeable conditions. 

For companies operating within or trading with the EU, understanding the intricate details of these new rules is crucial. The GPSR not only bolsters the enforcement of safety standards but also enhances the efficiency of market surveillance authorities and refines the recall procedures for hazardous non-food products.

Key changes

• Expansion of scope: Fulfilment service providers are now included among the economic operators, albeit without specific obligations imposed exclusively on them. The GPSR also extends obligations to online marketplace providers and online interfaces. Moreover, under Article 13 of the GPSR, any person significantly altering a product’s safety attributes is also considered the manufacturer, responsible for assessing and managing new risks arising from such changes (with the resulting obligations listed in the third bullet below). In addition, products are considered as “placed on the market” when offered for distance selling, leading to an earlier application of regulatory duties compared to the old regime. In alignment with the EU Market Surveillance Regulation, a responsible party residing in the EU is necessary for a product to be marketed. 
• Tightened safety criteria: The core principle remains that only safe products can be placed on the European market. However, the GPSR tightens safety criteria to account for various factors such as the impact of other products, cybersecurity features, and predictive functions like AI elements, along with product presentation and the potential to mislead consumers and appeal to children.
• More stringent obligations for manufacturers: Manufacturers must conduct internal risk analyses for all products and retain the related technical documentation for at least 10 years. Another pivotal change is the codification of “significant alteration”, whereby any party that makes substantial changes to a product, physically or digitally, assumes the role and responsibilities of a manufacturer, necessitating a new risk assessment. Generally, it is also the manufacturer’s responsibility to promptly report serious accidents related to product safety to authorities via the Safety Business Gateway to ensure swift and coordinated measures.
  
  In addition, manufacturers outside of the EU who market their products online are confronted with stricter labelling requirements such as the requirement to indicate the name and contact details of a responsible person within the EU on the product or an accompanying document.
• Information obligation: The GPSR also mandates extended information obligations for all economic operators in distance selling. At the stage of product offering, they must provide detailed information such as manufacturer and EU economic operator identification, product images, and warnings or safety information. Online marketplace providers are further obligated to fulfil networked safety responsibilities by establishing a central contact point for market surveillance authorities and meeting comprehensive reporting and collaboration obligations. This means, in effect, that market surveillance authorities will use private entities to enforce the Regulation. In light of the overwhelming demands on many market surveillance authorities, this could become an effective enforcement tool. 
• New system for recalls: Besides the obligations of individual economic operators, the system of product recalls also becomes more complex, requiring that affected consumers are directly, swiftly, and clearly informed about safety recalls or warnings by economic operators and marketplace providers. Despite criticism from some economic sectors, a product safety remedy right is introduced, obliging operators to offer consumers two remedies free of charge for product safety recalls, such as repair, replacement with a safe product, or a refund equal to the consumer’s purchase price.

Practical impact

The GPSR’s expansion of the criteria to assess a product’s safety requires manufacturers to carefully consider their existing product portfolio as they cannot rely on a prior safety assessment conducted under the existing GPSD and the corresponding national implementation acts, as the application of the GPSR is tied to the individual product with a clear cut off date on 13 December 2024.

In addition, traceability of the product is key not only for manufacturers with regard to product recalls. Online marketplace providers are made responsible for product safety for the first time. This is particularly important in case of a product recall or safety warning where it is expected that online marketplace providers use the consumer data they have collected to contact the consumers concerned. If it is not possible to reach all consumers, they might even be obliged to issue a mass media announcement. Considering the massive increase of online shopping over the last years, online marketplace providers will play a decisive role under the new regime and adherence to both product safety obligations as well as the online marketplace providers’ terms and conditions will become even more important. 

The increased documentation requirements and rules on document retention become especially important in light of the new Product Liability Directive (read more here). As the latter contains a provision on disclosure requirements and a presumption of liability in cases of failure to produce the relevant documents, it will be decisive to ensure internal protocols on document retention reflect the new regime. 

Lastly, the requirements to provide for at least two of the three remedies in case of a product recall will ultimately affect the pricing of the product, as well as the costs associated with product liability and recall insurances.