Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1) Directive 2001/95/EC of the European Parliament and of the Council (3) lays down the requirement that consumer products must be safe and that Member States’ market surveillance authorities must take action against dangerous products as well as exchange information to that effect through the Union Rapid Information System (RAPEX).

(2) Directive 2001/95/EC needs to be revised and updated in light of the developments related to new technologies and online selling, to ensure consistency with developments in Union harmonisation legislation and in standardisation legislation, to ensure a better functioning of product safety recalls as well as to ensure a clearer framework for food-imitating products hitherto regulated by Council Directive 87/357/EEC (4). In the interest of clarity, Directives 2001/95/EC and 87/357/EEC should be repealed and replaced by this Regulation.

(3) A regulation is the appropriate legal instrument as it imposes clear and detailed rules which leave no scope for divergent transposition by Member States. The choice of a regulation instead of a directive also allows for better delivery of the objective of ensuring coherence with the market surveillance legislative framework for products falling within the scope of Union harmonisation legislation, where the applicable legal instrument is also a regulation, namely Regulation (EU) 2019/1020 of the European Parliament and of the Council (5). Finally, such a choice will further reduce the regulatory burden through a consistent application of product safety rules across the Union.

(4) The aim of this Regulation is to contribute to the attainment of the objectives referred to in Article 169 of the Treaty on the Functioning of the European Union (TFEU). In particular, it should aim to ensure the health and safety of consumers and the functioning of the internal market as regards products intended for consumers.

(5) This Regulation should aim at protecting consumers and their safety as one of the fundamental principles of the Union legal framework and as enshrined in the Charter of Fundamental Rights of the European Union (the ‘Charter’). Dangerous products can have very negative consequences for consumers and citizens. All consumers, including the most vulnerable, such as children, older persons or persons with disabilities, have the right to safe products. Consumers should have at their disposal sufficient means to enforce that right and Member States should have adequate instruments and measures at their disposal to enforce this Regulation.

(6) Despite the development of sector-specific Union harmonisation legislation that addresses the safety aspects of specific products or categories of products, it is practically impossible to adopt Union law for all consumer products that exist or may be developed. There is therefore a need for a broad-based legislative framework of a horizontal nature to fill gaps and to complement provisions in existing or forthcoming sector-specific Union harmonisation legislation and ensure consumer protection not otherwise ensured by that legislation, in particular with a view to achieving a high level of protection of the health and safety of consumers, as required by Articles 114 and 169 TFEU.

(7) At the same time, in respect of products that are subject to sector-specific Union harmonisation legislation, the scope of the different parts of this Regulation should be clearly set out to avoid overlapping provisions and to ensure a clear legal framework.

(8) Whilst some of the provisions of this Regulation, such as most of the obligations of economic operators, should not apply to products covered by Union harmonisation legislation, certain other provisions of this Regulation are complementary to Union harmonisation legislation and should therefore apply to such products. In particular, the general product safety requirement and related provisions should apply to consumer products covered by Union harmonisation legislation when certain types of risks are not covered by that Union harmonisation legislation. The provisions of this Regulation concerning the obligations of providers of online marketplaces, the obligations of economic operators in the event of accidents, the right to information and to a remedy for consumers as well as the product safety recalls should apply to products covered by Union harmonisation legislation to the extent that there are no specific provisions with the same objective in such Union harmonisation legislation. Likewise, RAPEX is already used for the purposes of Union harmonisation legislation, as referred to in Article 20 of Regulation (EU) 2019/1020: therefore the provisions of this Regulation regulating the Safety Gate and its functioning should apply to products covered by Union harmonisation legislation.

(9) Products which are designed exclusively for professional use, but which have subsequently migrated to the consumer market, should be subject to this Regulation because they could pose risks to the health and safety of consumers when used under reasonably foreseeable conditions.

(10) Medicinal products are subject to a pre-market assessment that includes a specific risk-benefit analysis. Those products should therefore be excluded from the scope of this Regulation.

(11) Union law on food, feed and related areas sets up a specific system ensuring the safety of the products covered by it. Indeed, food and feed products have a specific legal framework established, in particular, by Regulation (EC) No 178/2002 of the European Parliament and of the Council (6). Furthermore, food and feed products are also regulated by Regulation (EU) 2017/625 of the European Parliament and of the Council (7), which ensures a harmonised approach with regard to official controls for verifying compliance with feed and food law, animal health and animal welfare rules. Therefore, food and feed products should be excluded from the scope of this Regulation, with the exception of materials and articles intended to come into contact with food insofar as risks are concerned that are not covered by Regulation (EC) No 1935/2004 of the European Parliament and of the Council (8) or by other food-specific legislation which only covers chemical and biological food-related risks.

(12) Living plants are subject to a specific legal framework, provided for, in particular, by Regulation (EU) 2016/2031 of the European Parliament and of the Council (9) which takes into consideration the specificities of those products to ensure consumer safety.

(13) Animal by-products are materials of animal origin that people do not consume. Those products, such as feed, are subject to a specific legal framework, provided for, in particular, by Regulation (EC) No 1069/2009 of the European Parliament and of the Council (10).

(14) Plant protection products, also referred to as pesticides, are subject to specific provisions for their authorisation at national level, based on Regulation (EC) No 1107/2009 of the European Parliament and of the Council (11), and should therefore also be excluded from the scope of this Regulation.

(15) Aircraft referred to in Article 2(3), point (d) of Regulation (EU) 2018/1139 of the European Parliament and of the Council (12) are subject to the regulatory control of the Member States, in light of their limited risk to civil aviation safety. Those aircraft should therefore be excluded from the scope of this Regulation.

(16) The requirements laid down in this Regulation should apply to second-hand products or products that are repaired, reconditioned or recycled, that re-enter the supply chain in the course of a commercial activity, except for those products for which the consumer cannot reasonably expect that they fulfil state-of-the art safety standards, such as products which are explicitly presented as to be repaired or to be reconditioned, or which are made available on the market as collectible items of historical significance.

(17) Services should not be covered by this Regulation. However, in order to protect the health and safety of consumers, products that are supplied or made available to consumers in the context of the provision of services, including products to which consumers are directly exposed during the provision of a service, should fall within the scope of this Regulation. However, equipment on which consumers ride or travel, where such equipment is directly operated by a service provider within the context of a transport service, should be excluded from the scope of this Regulation since it has to be dealt with in conjunction with the safety of the service provided.

(18) Antiques, such as works of art or collectors’ items are specific categories of products which cannot be expected to meet the safety requirements laid down by this Regulation, and should therefore be excluded from its scope. However, in order to prevent other products from being mistakenly considered as belonging to those categories, it is necessary to take into account that works of art are products created solely for artistic purposes, that collectors’ items are of sufficient rarity and historical or scientific interest to justify their collection and preservation, and that antiques, if they are not already works of art or collectors’ items or both, are of an extraordinary age. When assessing whether a product is an antique, such as a work of art or a collector’s item, Annex IX to Council Directive 2006/112/EC (13) could be taken into account.

(19) The World Health Organisation defines ‘health’ as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.

(20) Distance selling, including online selling, should also fall within the scope of this Regulation. Online selling has grown consistently and steadily, creating new business models, new challenges regarding product safety and new actors in the market, such as providers of online marketplaces.

(21) In the case of a product offered for sale online or through other means of distance sales, the product should be considered to have been made available on the market if the offer for sale is targeted at consumers in the Union. In line with the applicable Union rules on private international law, a case-by-case analysis should be carried out in order to establish whether an offer is targeted at consumers in the Union. An offer for sale should be considered to be targeted at consumers in the Union if the relevant economic operator directs, by any means, its activities to a Member State. For the case-by-case analyses, relevant factors, such as the geographical areas to which dispatch is possible, the languages available, used for the offer or for ordering, means of payment, the use of currency of the Member State or a domain name registered in one of the Member States should be taken into consideration. In the case of online sales, the mere fact that the economic operators’ or the providers of online marketplaces’ interface is accessible in the Member State in which the consumer is established or domiciled is insufficient.

(22) Under the general safety requirement laid down in this Regulation, economic operators should be obliged to place only safe products on the market. Such a high level of safety should be primarily achieved through the design and the features of the product, taking into account the intended and foreseeable use and conditions of use of the product. The remaining risks, if any, should be alleviated by means of certain safeguards, such as warnings and instructions.

(23) The safety of a product should be assessed taking into account all relevant aspects of the product, in particular its characteristics, such as the physical, mechanical and chemical characteristics, and its presentation, as well as the specific needs and risks which the product represents for certain categories of consumers who are likely to use the products, in particular children, older persons and persons with disabilities. Those risks can also include environmental risk insofar as it poses a risk to the health and safety of consumers. That assessment should take into account the health risk posed by digitally connected products, including the risk to mental health, especially of vulnerable consumers, in particular children. Therefore, when assessing the safety of digitally connected products likely to have an impact on children, manufacturers should ensure that the products they make available on the market meet the highest standards of safety, security and privacy by design, in the best interests of children. Furthermore, if specific information is necessary to make products safe for a certain category of persons, the assessment of the safety of the products should take into consideration also the presence of that information and its accessibility. The safety of all products should be assessed taking into consideration the need for the product to be safe over its entire lifespan.

(24) Items which connect to other items or non-embedded items which influence the way another item works can present a risk for the safety of the product. That aspect should be given due consideration as a potential risk. The connections and interrelation that an item might have with external items should not jeopardise its safety.

(25) New technologies might pose new risks to consumers’ health and safety or change the way the existing risks could materialise, such as an external intervention hacking the product or changing its characteristics. New technologies might substantially modify the original product, for instance through software updates, which should then be subject to a new risk assessment if that substantial modification were to have an impact on the safety of the product.

(26) Specific cybersecurity risks affecting the safety of consumers, as well as protocols and certifications, can be dealt with by sectoral legislation. However, it should be ensured that, in cases where such sectoral legislation does not apply, the relevant economic operators and national authorities take into consideration risks linked to new technologies, when designing the products and assessing them respectively, in order to ensure that changes introduced in the product do not jeopardise its safety.

(27) In order to facilitate the effective and consistent application of the general safety requirement laid down in this Regulation, it is important to make use of European standards covering certain products and risks. European standards, the references of which have been published in accordance with Directive 2001/95/EC, should continue providing a presumption of conformity with the general safety requirement laid down in this Regulation. Standardisation requests issued by the Commission in accordance with Directive 2001/95/EC should be deemed to be standardisation requests issued in accordance with this Regulation. In the event that different risks or risk categories are covered by the same standard, the conformity of a product with the part of the standard covering the relevant risk or risk category would also give to the product itself a presumption of safety as far as the relevant risk or risk category is concerned.

(28) Where the Commission identifies a need for a European standard ensuring compliance of certain products with the general safety requirement laid down in this Regulation, it should apply the relevant provisions of Regulation (EU) No 1025/2012 of the European Parliament and of the Council (14) to request one or more European standardisation organisations to either draft or identify a standard which is suitable to ensure that products which conform to it are presumed to be safe.

(29) Products could present different risks for different genders and standardisation activities should take that into account to avoid discrepancies in terms of safety and therefore a gender safety gap. The Declaration on Gender Responsive Standards of the United Nations Economic Commission for Europe outlines several actions that national standards bodies and standards developing organisations should include in their gender action plan for gender responsive standards and standards development, in order to achieve gender-balanced, representative and inclusive standards.

(30) Together with the adaptation of Regulation (EU) No 1025/2012, a specific procedure for the adoption of the specific safety requirements with the assistance of the specialised Committee provided for by this Regulation should be introduced.

(31) In the absence of European standards, the national law of the Member State where the product is made available on the market laying down health and safety requirements should comply with Union law, in particular Articles 34 and 36 TFEU.

(32) Economic operators should have proportionate obligations concerning the safety of products, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of the health and safety of consumers, while also ensuring the efficient functioning of the internal market. All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they only make available on the market products which are safe and in conformity with this Regulation. It is necessary to provide for a clear and proportionate distribution of obligations corresponding to the role of each operator in the supply and distribution process. For example, as regards the verification of whether the manufacturer and, where relevant, the importer have complied with their obligations, the distributor should only be required to perform factual verifications and not an assessment of the information provided by them. The information about the identification of the product and of the economic operators, as well as instructions and safety information, could in addition be provided by the economic operators in a digital form by means of electronic solutions, such as a QR or data matrix code.