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)

CHAPTER I

GENERAL PROVISIONS

Article 1

Objective and subject matter

Article 2

Scope

Where products are subject to specific safety requirements imposed by Union law, this Regulation applies only to those aspects and risks or categories of risks which are not covered by those requirements.

With regard to products subject to specific requirements imposed by Union harmonisation legislation as defined in Article 3, point (27):

(a) Chapter II does not apply insofar as the risks or categories of risks covered by Union harmonisation legislation are concerned;

(b) Chapter IIa, Chapter III, Section 1, Chapters V and VII and Chapters IX to XI do not apply.

This Regulation does not apply to:

(a) medicinal products for human or veterinary use;

(b) food;

(c) feed;

(d) living plants and animals, genetically modified organisms and genetically modified microorganisms in contained use, as well as products of plants and animals relating directly to their future reproduction;

(e) animal by-products and derived products;

(f) plant protection products;

(g) equipment on which consumers ride or travel where that equipment is directly operated by a service provider within the context of a transport service provided to consumers and is not operated by the consumers themselves;

(h) aircraft referred to in Article 2(3), point (d) of Regulation (EU) 2018/1139;

(i) antiques.

Article 3

Definitions

For the purposes of this Regulation the following definitions apply:

(1) ‘product’ means 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;

(2) ‘safe product’ means 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;

(3) ‘dangerous product’ means any product which is not a ‘safe product’;

(4) ‘risk’ means the combination of the probability of an occurrence of a hazard causing harm and the degree of severity of that harm;

(5) ‘serious risk’ means a risk which, based on a risk assessment and taking into account the normal and foreseeable use of the product, is considered to require rapid intervention by the market surveillance authorities, including cases where the effects of the risk are not immediate;

(6) ‘making available on the market’ means any 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;

(7) ‘placing on the market’ means the first making available of a product on the Union market;

(8) ‘manufacturer’ means 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;

(9) ‘authorised representative’ means 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;

(10) ‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market;

(11) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

(12) ‘fulfilment service provider’ means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services as defined in Article 2, point (1) of Directive 97/67/EC of the European Parliament and of the Council (¹), parcel delivery services as defined in Article 2, point (2) of Regulation (EU) 2018/644 of the European Parliament and of the Council (²), and any other postal services or freight transport services;

(13) ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products or making them available on the market in accordance with this Regulation;

(14) ‘provider of an online marketplace’ means a provider of an intermediary service using an online interface which allows consumers to conclude distance contracts with traders for the sale of products;

(15) ‘online interface’ means any software, including a website, part of a website or an application, including mobile applications;

(16) ‘distance contract’ means a distance contract as defined in Article 2, point (7), of Directive 2011/83/EU;

(17) ‘consumer’ means any natural person who acts for purposes which are outside that person’s trade, business, craft or profession;

(18) ‘trader’ means any natural person or any legal person irrespective of whether privately or publicly owned, who is acting, including through any person acting in that natural or legal person’s name or on that natural or legal person’s behalf, for purposes relating to the natural or legal person’s trade, business, craft or profession;

(19) ‘European standard’ means a European standard as defined in Article 2, point (1), point (b) of Regulation (EU) No 1025/2012;

(20) ‘international standard’ means an international standard as defined in Article 2, point (1), point (a) of Regulation (EU) No 1025/2012;

(21) ‘national standard’ means a national standard as defined in Article 2, point (1), point (d) of Regulation (EU) No 1025/2012;

(22) ‘European standardisation organisation’ means a European standardisation organisation as listed in Annex I to Regulation (EU) No 1025/2012;

(23) ‘market surveillance’ means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements set out in this Regulation;

(24) ‘market surveillance authority’ means an authority designated by a Member State under Article 10 of Regulation (EU) 2019/1020 as responsible for organising and carrying out market surveillance in the territory of that Member State;

(25) ‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the consumer;

(26) ‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market;

(27) ‘Union harmonisation legislation’ means Union legislation listed in Annex I to Regulation (EU) 2019/1020 and any other Union legislation harmonising the conditions for the marketing of products to which that Regulation applies;

(28) ‘antiques’ means products, such as collectors’ items or works of art, in relation to which consumers cannot reasonably expect that they fulfil state-of-the-art safety standards;

(29) ‘crisis-relevant goods’ means crisis-relevant goods as defined in Article 3, point (6), of Regulation (EU) 2024/2747 of the European Parliament and of the Council (³);

(30) ‘internal market emergency mode’ means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.

Article 4

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.

CHAPTER II

SAFETY REQUIREMENTS

Article 5

General safety requirement

Economic operators shall place or make available on the market only safe products.

Article 6

Aspects for assessing the safety of products

When assessing whether a product is a safe product, the following aspects in particular shall be taken into account:

(a) the characteristics of the product, including its design, technical features, composition, packaging, instructions for assembly and, where applicable, for installation, use and maintenance;

(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;

(d) the presentation of the product, the labelling, including the labelling regarding age suitability for children, any warnings and instructions for its safe use and disposal, and any other indication or information regarding the product;

(e) the categories of consumers using the product, in particular by assessing the risk for vulnerable consumers such as children, older people and persons with disabilities, as well as the impact of gender differences on health and safety;

(f) the appearance of the product where it is likely to lead consumers to use the product in a way different to what it was designed for, and in particular: (i) where a product, although not foodstuff, resembles foodstuff and is likely to be confused with foodstuff due to its form, odour, colour, appearance, packaging, labelling, volume, size or other characteristics and might therefore be placed in the mouth, sucked or ingested by consumers, especially by children; (ii) where a product, although neither designed nor intended for use by children, is likely to be used by children or resembles an object commonly recognised as appealing to or intended for use by children because of its design, packaging or characteristics;

(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.

Article 7

Presumption of conformity with the general safety requirement

For the purpose of this Regulation, a product shall be presumed to be in conformity with the general safety requirement laid down in Article 5 of this Regulation in the following cases:

(a) it conforms to relevant European standards or parts thereof as far as the risks and risk categories covered by those standards are concerned, the references of which have been published in the Official Journal of the European Union in accordance with Article 10(7) of Regulation (EU) No 1025/2012; or

(b) in the absence of any relevant European standards as referred to in point (a) of this paragraph, the product conforms to national requirements, as regards the risks and risk categories covered by health and safety requirements laid down in the national law of the Member State in which it is made available on the market, provided that such law is in compliance with Union law.

Article 8

Additional elements to be taken into account for assessing the safety of products

For the purpose of Article 6 and where the presumption of safety under Article 7 does not apply, when assessing whether a product is safe, the following elements in particular shall be taken into account, when available:

(a) European standards other than those the references of which have been published in the Official Journal of the European Union in accordance with Article 10(7) of Regulation (EU) No 1025/2012;

(b) international standards;

(c) international agreements;

(d) voluntary certification schemes or similar third-party conformity assessment frameworks, in particular those conceived to support Union law;

(e) Commission recommendations or guidelines on product safety assessment;

(f) national standards drawn up in the Member State in which the product is made available;

(g) the state of the art and technology, including the opinion of recognised scientific bodies and expert committees;

(h) product safety codes of good practice in force in the sector concerned;

(i) reasonable consumer expectations concerning safety;

(j) safety requirements adopted in accordance with Article 7(2).

CHAPTERIIa

EMERGENCY PROCEDURES

Article 8a

Application of emergency procedures

Article 8b

Presumption of conformity with the general safety requirement in the context of an internal market emergency

Article 8c

Prioritisation of market surveillance activities and mutual assistance among authorities

CHAPTER III

OBLIGATIONS OF ECONOMIC OPERATORS

SECTION 1

Article 9

Obligations of manufacturers

Where appropriate with regard to possible risks related to the product, the technical documentation referred to in the first subparagraph shall also contain, as applicable:

(a) an analysis of the possible risks related to the product and the solutions adopted to eliminate or mitigate such risks, including the outcome of any reports related to tests conducted by the manufacturer or by another party on their behalf; and

(b) the list of any relevant European standards as referred to in Article 7(1), point (a), or the other elements referred to in Article 7(1), point (b) or Article 8, applied to meet the general safety requirement laid down in Article 5.

Where any of the European standards, health and safety requirements or elements as referred to in Article 7(1) or Article 8 have been only partly applied, the manufacturers shall identify the parts which have been applied.

Where a manufacturer considers or has reason to believe, on the basis of the information in that manufacturer’s possession, that a product which it has placed on the market is a dangerous product, the manufacturer shall immediately:

(a) take the corrective measures necessary to bring in an effective manner the product into conformity, including a withdrawal or recall, as appropriate;

(b) inform consumers thereof, in accordance with Article 35 or 36, or both; and

(c) inform, through the Safety Business Gateway, the market surveillance authorities of the Member States in which the product has been made available on the market thereof.

For the purposes of points (b) and (c) of the first subparagraph, the manufacturer shall give details, in particular, of the risk to the health and safety of consumers and of any corrective measure already taken, and, if available, of the quantity, by Member State, of products still circulating on the market.

Article 10

Obligations of authorised representatives

An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The authorised representative shall provide the market surveillance authorities with a copy of that mandate upon request. The mandate shall allow the authorised representative to perform at least the following tasks:

(a) providing a market surveillance authority, upon that authority’s reasoned request, with all information and documentation necessary to demonstrate the safety of the product in an official language which can be understood by that authority;

(b) where the authorised representative considers or has reason to believe that a product in question is a dangerous product, informing the manufacturer thereof;

(c) informing the competent national authorities about any action taken to eliminate the risks posed by products covered by their mandate through a notification in the Safety Business Gateway, where the information has not been already provided by the manufacturer or upon instruction of the manufacturer;

(d) cooperating with the competent national authorities, at their request, on any action taken to eliminate in an effective manner the risks posed by products covered by their mandate.

Article 11

Obligations of importers

Where an importer considers or has reason to believe, on the basis of the information in that importer’s possession, that a product which it has placed on the market is a dangerous product, the importer shall immediately:

(a) inform the manufacturer thereof;

(b) ensure that the corrective measures necessary to bring in an effective manner the product into conformity are taken including withdrawal or recall, as appropriate; where such measures have not been taken, the importer shall immediately take them;

(c) ensure that consumers are immediately informed thereof in accordance with Article 35 or 36, or both; and

(d) inform the market surveillance authorities of the Member States in which the product has been made available on the market thereof, through the Safety Business Gateway.

For the purposes of points (c) and (d) of the first subparagraph the importer shall give details, in particular, of the risk to health and safety of consumers and of any corrective measure already taken, and, if available, of the quantity, by Member State, of products still circulating on the market.

Article 12

Obligations of distributors

Where a distributor considers or has reason to believe, on the basis of the information in that distributor’s possession, that a product which it has made available on the market is a dangerous product or is not in conformity with Article 9(5), (6) and (7) and Article 11(3) and (4), as applicable, the distributor shall:

(a) immediately inform the manufacturer or the importer, as applicable, thereof;

(b) ensure that the corrective measures necessary to bring in an effective manner the product into conformity are taken, including withdrawal or recall, as appropriate; and

(c) ensure that the market surveillance authorities of the Member States in which the product has been made available on the market are immediately informed thereof through the Safety Business Gateway.

For the purposes of points (b) and (c) of the first subparagraph the distributor shall give appropriate details available to it of the risk to health and safety of consumers, of the number of products involved and of any corrective measure already taken.

Article 13

Cases in which obligations of manufacturers apply to other persons