Home › Blog › Regulation (Eu) 2023/988 Of The European Parliament And of The Council of 10 May 2023 on General Product Safety

Regulation (Eu) 2023/988 Of The European Parliament And of The Council of 10 May 2023 on General Product Safety

Regulation (Eu) 2023/988 Of The European Parliament And of The Council of 10 May 2023 on General Product Safety
19 May 2024  |  François Ponthieu, Alicia Dode

GENERAL PRESENTATION

  1. In view of its entry into force on December 13, 2024, it is appropriate to take a look at the new General Product Safety Regulation (« GPSR ») which replaces the General Product Safety Directive[1] and the one concerning products which, appearing to be other than they are, endanger the health or safety of consumers[2].
  2. The GPSR is a new legal instrument aimed at modernizing the European Union’s (« EU ») general framework for product safety. It responds to the new challenges posed by increasing digitization and the development of new technologies in this field, in particular the rise of online sales.
    Its goal is to ensure that all the consumer products on the EU market are “safe”, meaning they “[do] not present any risk or only the minimum risks compatible with [their] use, considered acceptable and consistent with a high level of protection of the health and safety of consumers”, as defined in article 3 (2) of the GPSR.
  3. The GPSR applies to new, used, repaired or reconditioned non-food products, whether sold offline or online. It covers risks not specifically regulated by other EU legislation.
  4. Like all European regulations, the GPSR is a legal act, mandatory in all its provisions, which is binding on all subjects of law. Contrary to directives, which delegate the choice of means and must be transposed into the national law of each member state, the GPSR is directly applicable in all member states; it sets an objective (products safety, therefore), but also the means to achieve it.

Among these means, it seems essential to mention:

I – PRODUCT SAFETY ASSESSMENT

  1. According to article 6, paragraph 1, of the GPSR, when assessing the safety of a product, various elements must be taken into account, such as its characteristics, its effect on other products, the effect that other products could have on it, its presentation and labelling, the categories of consumers who use it, its appearance and finally, when its nature requires it, its cybersecurity features and its functionalities.
  2. In addition, article 8 of the Regulation lists additional elements that may be taken into account when assessing the safety of a product, for example “the state of the art and technology, including the opinion of recognised scientific bodies and expert committees” (point (g), paragraph 1).

It is up to the various economic operators concerned to assess the safety of the products they sell.

II – OBLIGATIONS OF THE VARIOUS ECONOMIC OPERATORS

II. 1. Manufacturers

  1. The manufacturer is defined in article 3 (8) of the GPSR as “any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under that person’s name or trademark”.
  2. To ensure compliance with the general safety obligation laid down in Article 5 of the GPSR, article 9 of this text lists the different obligations imposed on manufacturers.

8.1. One of the most significant obligations is for manufacturers to produce “an internal risk analysis and draw up technical documentation containing at least a general description of the product and its essential characteristics relevant for assessing its safety”, in accordance with paragraph 2 of the aforementioned article.

This documentation must be up to date and kept “at the disposal of the market surveillance authorities for a period of 10 years after the product has been placed on the market”, as specified in paragraph 3 of article 9 of the Regulation.

8.2. Manufacturers are also obliged to ensure that the products they sell in the EU market comply with labelling requirements.

8.2.1. As mentioned in point 5 above, labelling is one of the elements used to assess product safety; it must therefore provide a range of information.

8.2.2. Article 9, paragraph 5, of the GPSR stipulates that “manufacturers shall ensure that their products bear a type, batch or serial number or other element enabling the

identification of the product and which is easily visible and legible for consumers, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product”.

8.2.3. Paragraph 6 of the aforementioned article goes on to state that “manufacturers shall indicate their name, their registered trade name or registered trade mark, their postal and electronic address and, where different, the postal or electronic address of the single contact point at which they can be contacted. That information shall be placed on the product or, where that is not possible, on its packaging or in a document accompanying the product”.

8.2.4. The next paragraph of the same article indicates that “manufacturers shall ensure that their product is accompanied by clear instructions and safety information in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available on the market”.

These provisions, with which all manufacturers are required to comply, are aimed at ensuring:

8.3. If a manufacturer considers that one of the products he has placed on the market is dangerous, in other words that it is not « safe » because it does not meet the requirements set out in the aforementioned definition in article 3 (2) of the Regulation, he is obliged to follow the procedure described in article 9, paragraph 8, of the GPSR.

This procedure involves taking “the corrective measures necessary to bring in an effective manner the product into conformity” and informing consumers, as well as market surveillance authorities, of the risks incurred by making the dangerous product available on this market.

8.4. Paragraphs 11 and 12 of article 9 of the GPSR oblige manufacturers to provide the public with “communication channels” to enable consumers to “submit complaints”, which manufacturers must keep in “an internal register”.

II. 2. Authorised representatives

  1. The authorised representative is defined in article 3 (9) of the GPSR as “any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on that manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under this Regulation”.
  2. According to article 10 of the GPSR, authorised representatives must be designated by a written mandate and must carry out the tasks mentioned in this document received by a manufacturer. They have to provide evidence that a product is safe to any market surveillance authority that requests it, to inform the manufacturer if they consider a product to be unsafe, and to inform and cooperate with the competent national authorities in the event of action being taken to try to eliminate the risks associated with the products covered by their mandate.

Practice will probably show that authorised representatives will be tasked above all with representing companies based outside the EU.

II.3. Importers

  1. “Any natural or legal person established within the Union who places a product from a third country on the Union market” can be qualified as an importer, in accordance with the definition set out in article 3 (10) of the GPSR.
  2. The main obligation of importers (apart from perhaps acting as authorized representatives) is to check that the product to be placed on the market complies with the general safety requirement, and that the manufacturer of the product in question has carried out:
  1. Furthermore, article 11 of the Regulation lists a number of additional obligations with which importers are required to comply, such as cooperating with market surveillance authorities and the manufacturer, or checking the availability of communication channels for consumers.

II.4. Distributors

  1. The distributor is defined in article 3 (11) of the GPSR as “any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market”.
  2. The main obligation of distributors (in addition to perhaps acting as authorized representatives) is to ensure that the manufacturer or importer of the product to be made available on the market has:
  1. Moreover, article 12 of the Regulation lists additional obligations with which distributors are required to comply. For example, in accordance with paragraph 2 of the aforementioned article, they must ensure that “storage or transport conditions” of products for which they are responsible do not compromise their safety.

II.5. Obligations of all economic operators

  1. Under articles 14 and 15 of the GPSR, all economic operators must have internal product safety processes in place and cooperate with market surveillance authorities. This obligation of cooperate results in traceability requirements. Indeed, according to the terms of article 15, paragraph 3, of the GPSR, market surveillance authorities may require economic operators to provide information concerning “any economic operator who has supplied them with the product, or with a part, a component or any software embedded into the product”, as well as “any economic operator to whom they have supplied the product”.

In addition, article 18 of the Regulation sets out specific traceability requirements for certain products likely to present a serious risk to consumer health and safety.

  1. Insofar as any product covered by the GPSR can only be placed on the market if there is an economic operator established in the EU who is responsible for the tasks mentioned in paragraph 3 of article 4 of Regulation (EU) 2019/1020[3], the appointment of a “responsible person for products placed on the Union market” (to use the terms of article 16 of the GPSR) is necessary for economic operators established outside the EU who sell their products on the Union market. It seems to follow from the GPSR that this responsible person can be, in particular, the authorised representative whose functions have been recalled above – but also any other economic operator, and for example the importer.
  2. In case of distance selling or accidents related to safety of products, economic operators are subject to various specific information obligations, in accordance with articles 19 and 20 of the GPSR.

III- OBLIGATIONS OF PROVIDERS OF ONLINE MARKETPLACES

  1. The provider of an online marketplace is defined in article 3 (14) of the GPSR as being “a provider of an intermediary service using an online interface which allows consumers to conclude distance contracts with traders for the sale of products”.
  2. Article 22 of the Regulation lists a number of specific obligations that providers of online marketplaces must comply with to ensure product safety.

These obligations include the designation of “a single point of contact allowing for direct communication, by electronic means, with Member States’ market surveillance authorities”, the implementation of “internal processes”, the processing of “the notices related to product safety issues […] offered for sale online through their services”, the provision of a wide range of informations, and the suspension of “the provision of their services to traders that frequently offer products which are non-compliant with this Regulation”.

  1. The providers of online marketplaces are the subject of an entire chapter of the GPSR (chapter IV), demonstrating a strong desire to ensure the safety of products sold online.

IV – DEVELOPMENT OF A RAPID INFORMATION EXCHANGE SYSTEM

  1. The GPSR allows the establishment of a system for the rapid exchange of information between the various economic players in order to guarantee more effective surveillance of Union market; this system is composed of several tools.

23.1. A « Safety Gate Rapid Alert System » enables the exchange between member states of corrective measures taken concerning dangerous products.

This system allows almost immediate notification of products considered to present a serious risk to consumer health and safety, which must be carried out “within four working days after the corrective measure is taken” to meet the objective of rapidity, as specified in article 26, paragraph 4, of the GPSR.

23.2. A « Safety Business Gateway » enables economic operators and providers of online marketplaces to provide surveillance authorities and consumers with information on hazardous products and accidents via an Internet portal.

Notification of accidents related to product safety must be made “without undue delay from the moment [of knowledge of] the accident, to the competent authorities of the Member State where the accident has occurred” (in the words of article 20 of the RSGP).

23.3. A « Safety Gate Portal » offers free access to information for the general public.

This tool also provides consumers with a way of lodging complaints when they believe that a product could present a risk to the health and safety of its users, in accordance with article 34, paragraph 3, of the GPSR.

  1. Article 30 of the Regulation describes the functioning of the « Consumer Safety Network » and states that the aim of this European network is ”to serve as a platform for structured coordination and cooperation between authorities of the Member States and the Commission in enhancing product safety in the Union”.

V – IMPROVING RECALL PROCEDURES FOR DANGEROUS PRODUCTS

  1. A recall procedure consists of asking consumers to return a product that proves to be dangerous.
  2. In order to inform all consumers in possession of a recall product, economic operators and providers of online marketplaces must provide direct notification without undue delay, as stipulated in article 35, paragraph 1, of the GPSR.
    The personal data collected may be used to achieve this direct contact, as long as it is used for this single purpose.
  3. A recall notice is a written document designed to inform consumers about a product recall. This written document must respect certain requirements, listed in article 36 of the Regulation, for the recall to be effective.
    The Commission is making a model recall notice available to economic operators to facilitate the drafting of such a document.
  4. Economic operators responsible for a recall product for safety reasons must offer affected consumers “an effective, cost-free and timely remedy”, in accordance with article 37, paragraph 1, of the GPSR.
    The consumer must then be able to choose between at least two of the following solutions:

***

In conclusion, to ensure that all non-food products on the Union market are safe, the GPSR, while setting out elements for assessing product safety and developing a rapid information exchange system, also imposes numerous obligations on the various economic operators, including the implementation of effective recalls.

Under article 44 of the Regulation, it is up to the member states to establish a system of “effective, proportionate and dissuasive” sanctions in the event of infringement of the GPSR’s provisions.

However, economic operators still have several months to ensure their compliance with the GPSR, which will only become applicable from December 13, 2024.

*

[1] DIRECTIVE 2001/95/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 3 December 2001

[2] DIRECTIVE 87/357/EEC OF THE COUNCIL of 25 June 1987

[3] REGULATION (EU) 2019/1020 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019