In recent years, there have been a number of amendments to product safety legislation in the EU. For example, as recently as 18 November 2024, the Directive on Liability for Defective Goods was published.
On 12 June 2023, Regulation (EU) 2023/988 on general product safety (hereinafter referred to as the “Regulation”) was published. This Regulation replaces the General Product Safety Directive (Directive 2001/95/EC) (hereinafter referred to as the “Directive”), which required that only safe products be placed on the market. This review was carried out to respond to developments related to new technologies and online sales. The Regulation will apply from December 13, 2024 (article 52 of the Regulation). We will now introduce the content of the Regulation, focusing on the important changes brought about by the Directive.
It is important to note the change of the form of Directive to Regulation aimed at ensuring consistency with the legal framework for market surveillance of products that fall within the scope of EU-harmonised legislation, and at reducing the regulatory burden by ensuring the consistent application of product safety regulations within the EU.
I.- Scope of application for products
The Regulation applies to products that are placed or made available on the market insofar as there are no specific provisions with the same objective under Union law which regulate the safety of the products concerned (article 2.1 of the Regulation).
However, the Regulation does not apply to medicinal products for human or veterinary use, foodstuffs, animal feed, living plants and animals, animal by-products and derived products, plant protection products, equipment related to transport services, aircraft, and antiques (article 2.2 of the Regulation).
II.- Non-EEA operators
The Regulation imposes obligations on the manufacturer, the authorised representative, the importer and on the distributor (hereinafter collectively referred to as “economic operator”). It is important to note that these obligations apply even if a manufacturer located outside the EEA places products on the EEA market. In addition, in order to place a product covered by the Regulation on the market, there must be a person who falls under the category of economic operator established in the Union (article 16 of the Regulation).
II.- Aspects for assessing the safety of products
As with the Directive, the Regulation states that economic operators shall only place on the market or make available those products which are safe (article 5 of the Regulation).
However, the Regulation now specifies the aspects to be taken into account when assessing whether a product is safe (article 6.1 of the Regulation), which were not specified in the Directive. These aspects are: (a) the characteristics of the product; (b) the effect on other products; (c) the effect that other products might have on the product under assessment; (d) the presentation of the product; (e) the categories of customers using the product; (f) the appearance of the product; (g) cybersecurity features; and (h) the evolving, learning and predictive functionalities of the product.
III.- Distance sales
A new obligation has been introduced for distance sales.
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 (article 4 of the Regulation).
Article 19 of the Directive states that when an economic operator makes products available on the market online or through other means of distance sales, in the offer of those products at least the following information shall be clearly and visibly indicated:
(a) the name, registered trade name or registered trademark of the manufacturer, as well as the postal and e-mail address at which they can be contacted;
(b) where the manufacturer is not established in the Union, the name, postal and e-mail address of the responsible person within the meaning of article 16(1) of the Regulation or article 4(1) of Regulation (EU) 2019/1020;
(c) information allowing for the identification of the product, including a picture of it, its type and any other product identifier; and
(d) any warning or safety information to be affixed to the product or to the packaging or included in an accompanying document in accordance with the Regulation or the applicable Union harmonisation legislation 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.
IV.- Obligation of notification in the case of accidents related to the safety of products
Article 20 of the Regulation states that the manufacturer shall ensure that, through the Safety Business Gateway, an accident caused by a product placed or made available on the market is notified, without undue delay from the moment it knows about the accident, to the competent authorities of the Member State where the accident has occurred. The notification shall include the type and identification number of the product, as well as the circumstances of the accident, if known. The manufacturer shall notify, upon request, the competent authorities of any other relevant information.
Importers and distributors which have knowledge of an accident caused by a product that they placed or made available on the market shall, without undue delay, inform the relevant manufacturer thereof. The manufacturer shall carry out the notification in accordance with the foregoing, or instruct the importer or one of the distributors to make the notification.
Where the manufacturer of the product is not established in the Union, the responsible person who has knowledge of an accident shall ensure that the notification is made.
At this stage of the imminent application of the Regulation, operators involved with the products covered by the Regulation are recommended to review whether their operations comply with the Regulation.
Satoshi Minami
Vilá Abogados
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