2024 was a particularly eventful year in terms of European regulations on consumer goods. Besides the adoption of several important regulations, like the New Directive on liability for defective products (Directive (EU) 2024/2853) of 23 October 2024 or the Regulation laying down harmonised rules on artificial intelligence (Regulation (EU) 2024/1689) of 13 June 2024, the Regulation on general product safety of 10 May 2023 (Regulation (EU) 2023/988, hereinafter ,"the Regulation") came into effect on 13 December 2024. This Regulation repeals Directive 2001/95/EC (hereinafter, "the Directive" and applies to products placed on the European market since 13 December 2024.
Contrary to other regulations on which we recently commented1 , this Regulation might be less innovative, but is nevertheless still crucial. Therefore, an exhaustive and practical presentation is required for companies to fully understand the extent of their obligations.
This Regulation hence ought to be examined in three steps:
- The first step will explain the scope of application of the Regulation as well as its main purpose, which is to guarantee the general safety of products placed on the European market (1);
- The second step will detail the main obligations of all economic operators who can place a product on the market or make a product available on the market (2); and
- The third step will present the different powers and obligations in terms of market surveillance, for member States, national and European authorities, as well as consumer rights, notably in the event of a product recall (3).
1. PURPOSE: GENERAL SAFETY OF PRODUCTS
Article 5 of the Regulation indicates that: "Economic operators shall place or make available on the market only safe products".
As a reminder, a "safe product" is defined as: "any product which, under normal or reasonably foreseeable conditions of use, including the actual duration of use, does not present any risk or only the minimum risks compatible with the product's use, considered acceptable and consistent with a high level of protection of the health and safety of consumers".
A dangerous product is an "unsafe" product.
Therefore, the main purpose of this Regulation is to ensure that all products placed on the European market comply with the "essential safety rules" applicable to all consumer goods2 (1.2). However, this implies that the Regulation be subsidiary to other more specific texts, which also lay down rules on the safety of products to which they apply (1.1).
1.1 A subsidiary scope of application
Article 2.1 of the Regulation explains that it is applicable only in the absence of more specific European texts that would specifically govern some types of products.
Therefore, the provisions of the Regulation are only applicable to products placed on the European market that would not already fall under the scope of application of a specific European text, or to the risks that are not covered, for these products, by special texts.
The purpose of the Regulation is to bring a general framework for the safety of the products on the European market, without prejudice to more detailed and specific rules.
For instance, when a product is governed by another European text and complies with the safety provisions stated in that text, the product will be considered "safe" within the meaning of the Regulation (Article 7). This is the direct expression of the general and subsidiary application of the Regulation.
Furthermore, the Regulation complements the Regulation on market surveillance and compliance of products of 20 June 2019 (Regulation EU 2019/1020) (hereinafter, the "Regulation on Market Surveillance").
Consequently, the Regulation has a general and subsidiary scope and defines the minimum standard that should be applicable for the safety of products in the European Union (EU).
1.2 An updated minimum standard to assess the safety of products
This standard is defined in Article 6 of the Regulation, which lists the elements that notably contribute to the assessment of the safety of products.
First of all, it ought to be noted that the Regulation is aligned with other European texts on the safety of products but was not harmonised or made consistent with these different applicable texts.
Indeed, the Regulation is characterised by the objective of adapting to new technologies by including new products and developing the assessment criteria of their safety.
Article 3.1 defines the term "product" as: "any item, whether or not it is interconnected to other items, supplied or made available, whether for consideration or not, including in the context of providing a service, which is intended for consumers or is likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them".
And Article 6 notably specifies that: "When assessing whether a product is a safe product, the following aspects in particular shall be taken into account:
(a) [...];
(b) the effect on other products, where it is reasonably foreseeable that the product will be used with other products, including the interconnection of those products;
(c) the effect that other products might have on the product to be assessed, where it is reasonably foreseeable that other products will be used with that product, including the effect of non-embedded items that are meant to determine, change or complete the way the product to be assessed works, which has to be taken into consideration when assessing the safety of the product to be assessed;
[...]
(g) when required by the nature of the product, the appropriate cybersecurity features necessary to protect the product against external influences, including malicious third parties, where such an influence might have an impact on the safety of the product, including the possible loss of interconnection;
(h) when required by the nature of the product, the evolving, learning and predictive functionalities of the product.
These new criteria show the objective of the Regulation to take into account technological and technical progress regarding consumer goods, and to be in line with the general dynamic of revising European laws3.
Then, Article 6 also defines other more regular criteria such as the product's characteristics of the product, its presentation, or appearance, as well as the categories of consumers using the product, etc.
However, in comparison to the Directive4, the Regulation also modernises these criteria. In particular, regarding the categories of consumers using the product, the Regulation now takes into consideration persons with disabilities as well as gender differences to assess health and safety risks for consumers (Article 6.e). We also notice the reinforced protection of children, particularly when a product not initially designed to be used by children might have an appearance similar to a product that is generally used by children (Article 6.f.ii).
When the product is not considered safe pursuant to Article 7, i.e. when the product is not subject to the safety standards set by another more specific text, other international or national standards can be taken into account to assess the safety of the product (Article 8), including, for instance, voluntary certification schemes, codes of good practice, the current state of the art and technology, etc.
Lastly, still with the aim of modernising the law, it is interesting to note that the Regulation also takes into account the influence of online selling on the principle of making products available on the European market (Article 4). Making a product available is defined as the "supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge".
Yet, the Regulation considers that "products offered for sale online or through other means of distance sales shall be deemed to be made available on the market if the offer is targeted at consumers in the Union. An offer for sale shall be considered to be targeted at consumers in the Union if the relevant economic operator directs, by any means, its activities to one or more Member States". Surprisingly, the Regulation here refers to a principle of private international law that is applicable to conflicts of laws and jurisdiction5. This concept should hence be construed in line with the other European texts that are using it, although its assessment is rather complex and usually casuistic.
Any product placed on the European market and covered by the Regulation should therefore present the minimum level of safety which assessment is possible pursuant to Article 6, on the basis of modernised criteria to take into consideration recent technological progress and guarantee consistency with the revision of other important European texts applicable to the products
2. ECONOMIC OPERATORS' OBLIGATIONS
In addition to laying down essential and minimum rules applicable to product safety on the European market, the Regulation also covers the obligations of the entire distribution chain, unlike the Directive that only dedicated referred to "producers" and "distributors". This is consistent with the objectives of harmonising legislation in the EU.
First of all, the Regulation establishes that there must be, in the EU territory, an economic operator responsible for the general safety of the products for such products to be placed on the European market (Article 16). This person can be the manufacturer, importer or distributor of the product (Article 3.13).
Therefore, in accordance with the Regulation on market surveillance (Article 4.3), this Regulation provides that any person responsible for the declaration of conformity, as well as cooperating with and informing competent authorities regarding the conformity of products, is defined as the economic operator responsible for the general safety of the products placed on the market. They must notably ensure that the product is complies with its technical documentation and that instructions and safety information are available. They are hence not responsible for all the obligations applicable to all economic operators, but are the main interlocutor in the EU to guarantee the safety of the products placed on the market. Each economic operator has their own obligations.
The identification information of the economic operator defined above must appear on the product, its packaging or, failing such, in the documentation provided with the product (Article 16.3).
The Regulation hence provides for specific obligations for each level of the products' distribution chain: from the manufacturer to the provider of online marketplace (2.1), as well as general obligations that are equally applicable to all economic operators (2.2).
2.1 Specific obligations for each level of the distribution chain
The Regulation provides for the obligations applicable to the manufacturers (a), importers (b), distributors (c) as well as providers of online marketplaces (d).
a) The manufacturer
The manufacturer is defined 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" (Article 3.8). Their obligations are defined in Article 9.
The manufacturer can appoint an authorised representative to represent them in the EU and transfer all or part of their obligations (Article 10).
Any person who substantially modifies the product, after it was placed on the market, is considered as the manufacturer of a new product and is subject to the obligations applicable to the manufacturer as of the substantial modification (Article 13). A substantial modification is a modification that has an impact on the safety of the product, either due to the creation of a new hazard or the increase of the level of risk, and that changes the product in a manner that was not foreseen in the initial assessment of the risks. The modifications must not have been made by the consumers themselves for their own use.
The manufacturer's essential obligation is to design and place on the market products that are safe, within the meaning of Article 5. The manufacturer must notably carry out an internal analysis of the risks of the product and then establish technical documentation containing at least a general description of the product and its essential characteristics relevant for assessing its safety by the other levels of the distribution chain, the case arising (Article 9.2). They must keep this technical documentation for 10 years from the date when the product was placed on the market, and make it available for the surveillance authority.
This obligation did not exist in the former system of the Directive (Article 5).
The manufacturer must also indicate their name on the product, the packaging or, failing such, in the documentation provided with the product (Article 9.6).
They must also ensure that the product is provided with clear instructions and safety information for the consumer, unless they consider that it is not required to guarantee the safe use of the product by the consumer (Article 9.7). These instructions must be written in a language that can be easily understood by the consumer depending on the Member State in which the product is made available on the market.
It ought to be noted that the information that needs to be communicated to the consumer by the manufacturer can also be transmitted in a digital format via electronic technical solutions that are clearly identifiable on the product (e.g. a QR code6 ). This digital format alone is not sufficient, but it could allow the manufacturer to only provide key elements or to shorten the information on the product/packaging and invite the consumer to refer to an external digital link for further details. It will be interesting to see how this option will be applied.
Once the product is placed on the market, the manufacturer must still meet several obligations. For instance, the manufacturer must ensure that the products placed on the market remain safe. They provide consumers with communication channels enabling them to share their complaints regarding the safety of the product (Article 9.11). The manufacturer must record all the complaints received and their answers within an internal register (Article 9.12).
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Footnotes
1 See our article on New Directive (EU) 2024/2853 of 23 October 2024 on liability for defective products: https://www.signaturelitigation.com/wp-content/ uploads/2024/09/Whats-likely-to-come_-v.04.pdf.
2 Nevertheless, some products are excluded from the scope of application of the Regulation (Article 2.2), including medicinal products; food; living plants and animals; plant protection products; etc.
3 See our article on New Directive (EU) 2024/2853 of 23 October 2024 on liability for defective products [https://www.signaturelitigation.com/wp-content/ uploads/2024/09/Whats-likely-to-come_-v.04.pdf].
4 See Article 2 (b) of the Directive.
5 See Article 17 of Regulation (EU) 1215/2012 of 12 December 2012, called "Brussels I bis", and Article 6 of Regulation 539/2008 of 17 June 2008, called "Rome I".
6 See Recital 32 of the Regulation
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.