The new General Product Safety Regulation (EU) 2023/988 came into force on December 13, 2024, replacing Directive 2001/95/EC.

The reform applies to products placed on the market from December 13, 2024.

A product is considered to be “placed on the market” when it is made available for the first time on the European Union market, either when it is sold after manufacture or when it is imported. This situation arises, for example, when a manufacturer transfers a product to a distributor for the first time. It is important to note that this notion applies to each individual product, whether mass-produced or single unit, and not to a reference or model as a whole.

What are the European Commission’s objectives for this reform?

In the age of the digital economy, the European Commission’s ambition is to adapt the legal framework to products derived from new technologies, such as connected objects and artificial intelligence, as well as to marketplaces. It is also seeking to enhance the effectiveness of market surveillance and product recall procedures.

What’s at stake for your company?

In view of the recent publication of the new directive on product liability on November 18, it is imperative for companies to protect themselves against any liability in this area. They must also redouble their vigilance with regard to the criminal liability of the legal entity and/or its director, particularly when the product defect causes serious damage (injury or death). In this context, protecting your company’s image and that of your brands is also a major challenge.

Finally, companies now risk being penalized under the new article L.452-5-1 of the Consumer Code introduced by the RSGP. This penalizes non-compliance with withdrawal and recall procedures, as well as failure to inform consumers and the authorities. It provides for a fine of €600,000 and 5 years’ imprisonment, with a possible increase of up to 10% of average annual sales, proportional to the benefits derived from the offence.

So, to avoid these risks, it’s essential to put in place strict product compliance and monitoring measures.

What is a safe product?

A product is safe within the meaning of the RSGP when, under normal or reasonably foreseeable conditions of use, it presents no or only minimal risk to consumers.

The RSGP provides for a presumption of conformity when products comply with European standards, or in the absence of such standards, when they comply with the national requirements of the Member State in which they are placed on the market.

What are the main new features of the RSGP?

  • Replacement of the notions of “producers” and “distributors” by “economic operators”.

The RSGP introduces the notion of “economic operator” to better identify the various parties involved in the supply chain. The following are thus designated as economic operators: manufacturers, agents, importers, distributors, order fulfillment service providers and any other natural or legal persons subject to obligations linked to manufacturing products or making them available on the market.

  • Reinforced traceability requirements

The RSGP introduces a specific traceability system for products likely to present a serious risk, i.e. where the product is deemed to require rapid intervention by market surveillance authorities. This system is based on the collection and storage of data, including by electronic means, to identify the product, its components and the economic operators involved in its supply chain. It also provides for the display of such data.

  • New criteria for assessing product safety

The Regulation introduces new criteria to be taken into account when assessing product safety:

  • When a non-food product can be mistaken by a child for a foodstuff due to its characteristics (shape, color, packaging, etc.), increasing the risk of it being put in the mouth or ingested.
  • When a product intended for adults can be used by children due to its design, packaging or appearance.
  • The appropriate cybersecurity features needed to protect the product from external influences, where these could have an influence on the product’s safety.
  • The product’s evolutionary, learning and predictive functionalities.

 

  • Clarification of the obligation for companies to report accidents to the competent authorities

In the event of an accident, the economic operator concerned is obliged to notify the competent authorities of the Member State where the accident occurred via the Safety Business Gateway system, without undue delay from the moment he becomes aware of the accident. The RSGP specifies the information relating to the products and the degree of seriousness of the accident that must be included in the notification.

  • Reinforcement of market surveillance rules

This reinforcement is reflected in the use and exchange of information via the Safety Gate Early Warning System, intended for consumers, and the Safety Business Gateway, reserved for companies. Vertical obligations are also imposed on economic operators, who must cooperate with market surveillance authorities. These authorities may request product information from economic operators at any time, ranging from technical documentation to information on product traceability over a period of 6 to 10 years.

  • More effective recall/withdrawal procedures

The RSGP specifies how consumers are to be informed, depending on their ability to be identified. This includes direct notification obligations using data collected from consumers, as well as the dissemination of recall notices or safety warnings via all available communication networks. The European Commission has also taken the initiative of developing a model recall notice (Implementing Regulation 2024/1435 of May 24, 2024).

  • Modernization of the Safety Gate/Safety Business Gateway alert system

Formerly known as RAPEX, the European alert notification system Safety Gate and the Safety Business Gateway access portal have been modernized by the Commission to simplify the notification of dangerous products to the authorities and improve information exchange. The RSGP announces forthcoming changes to the system, to be implemented by Commission implementing acts and delegated acts. Stay tuned!

  • Specific provisions for online sales and marketplaces

With regard to online sales, the RSGP focuses primarily on the obligation for economic operators to provide certain information on their online product offers. For marketplaces, new obligations are introduced, such as using their status as a digital platform to pass on information to consumers when a product is recalled. This includes the need to directly contact all purchasers of the product concerned and publish details of the recall on their website.

Elsa Rodrigues, partner, and Carla Moussay, associate, from our Litigation Department, offer training courses tailored to your business.