Product safety under close scrutiny
Article written by Christelle Guyot and Valérie Le Couedic
Manufacturers’ obligations regarding product safety are defined in France mainly by Article L421-3 of the Consumer Code, which stipulates that products and services must, under normal conditions of use or other conditions reasonably foreseeable by the professional, offer the safety that can legitimately be expected and not harm people’s health.
This provision is in line with European directives on general product safety, in particular Directive 2001/95/EC.
Changes have been made at European level with Regulation 2023/988 on general product safety (GSP), adopted on 10 May 2023 and which came into force on 13 December 2024. This new regulation aims to modernise and strengthen the European regulatory framework for product safety, taking into account market developments, in particular the rise of e-commerce and the development of new technologies such as artificial intelligence and connected objects. It was necessary to take into account new risks to product safety related to “remote” transformations or modifications after marketing (updates, evolving functions, cyber attacks, etc.). These elements must therefore be fully integrated into the risk analyses carried out by manufacturers.
- Risk analysis
One of the key points of Regulation 2023/988 is the obligation for professionals (manufacturers, importers or sellers) to carry out a risk assessment for each type of product. This assessment must identify and prevent potential risks associated with the use of the products. It must conclude either that there is no danger or that risk mitigation measures need to be put in place, for example in a user manual or in the form of a warning.
Professionals must also cooperate with the authorities to eliminate the risks posed by products.
Professionals must provide information enabling the traceability of products, such as the type, batch or serial number, as well as the name or company name of the manufacturer.
The obligation to retain documents is 10 years for design and 5 years for risk management.
Internal processes must also be formalised, in particular to ensure that adequate procedures are in place in the event of product recalls.
- European “Safety Gate” portal
The European rapid alert system for dangerous non-food products, known as RAPEX, has been renamed “Safety Gate”.
This system, which has been in place since 2003, enables the rapid exchange of information between 31 countries (the EU countries, Norway, Iceland and Liechtenstein) and the European Commission on dangerous non-food products that pose a risk to the health and safety of consumers, and on the measures taken by these countries to eliminate this risk.
This portal has been improved to enhance the effectiveness of product recalls and the dissemination of information. It comprises three main elements:
- a rapid alert system for dangerous products,
- a point of access for market surveillance authorities,
- an access point for consumers and professionals.
- Use of the portal by professionals
European Regulation 2023/988 now requires professionals (manufacturers, importers or sellers) to notify the competent authorities of any danger associated with the use of their product via the Safety Business Gate portal.
It is therefore no longer the responsibility of the authorities to feed information into the portal (formerly Rapex), but directly that of the professionals concerned.
The Safety Business Gateway allows professionals to:
- Notify corrective measures taken regarding dangerous products (e.g. withdrawal, recall, destruction).
- Inform market surveillance authorities and consumers of the existence of dangerous products or accidents.
- Collaborate with national authorities to ensure the safety of products placed on the market.
- This portal also allows European consumers to directly report dangerous products.
- Link with French law
European Regulation 2023/988 was transposed into national law by the Act of 22 April 2024 on various provisions for adaptation to European Union law (DDADUE). This law provides for tougher penalties for product recalls, with sentences of up to five years’ imprisonment and a fine of €600,000, which may be increased to 10% of the average annual turnover of the operator concerned.
In France, since April 2021, professionals have been required to report product recalls carried out in France on the RappelConso website. They must therefore also report on the European Safety Business Gate platform. This dual reporting allows:
For French consumers: Access detailed and localised information on recalled products.
European authorities: Receive technical notifications to coordinate safety actions at EU level.
RappelConso thus serves as a national public information platform, while Safety Gate facilitates coordination between market surveillance authorities at European level.
In summary, European Regulation 2023/988 introduces significant changes in product safety, with a particular focus on risk analysis and the use of the Safety Business Gate portal by professionals to report dangerous products, in addition to RappelConso in France.
These measures aim to improve optimal consumer protection and ensure fair competition for businesses in the European market.
Are you interested in this topic and would like to find out more?
EURO-SYMBIOSE offers a one-day training course on product safety: Risk Management and Legal Responsibilities #16.
We can also assist you with the practical implementation of these measures in your company.
📞 Our teams are at your service to meet your needs:
France: +33 (0)2 51 13 13 00 – service.clients@euro-symbiose.fr
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