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Document 02023R0988-20260529
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)
Consolidated text: 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)
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)
02023R0988 — EN — 29.05.2026 — 001.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
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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 (OJ L 135 23.5.2023, p. 1) |
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REGULATION (EU) 2024/2748 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 October 2024 |
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8.11.2024 |
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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):
Chapter II does not apply insofar as the risks or categories of risks covered by Union harmonisation legislation are concerned;
Chapter IIa, Chapter III, Section 1, Chapters V and VII and Chapters IX to XI do not apply.
This Regulation does not apply to:
medicinal products for human or veterinary use;
food;
feed;
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;
animal by-products and derived products;
plant protection products;
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;
aircraft referred to in Article 2(3), point (d) of Regulation (EU) 2018/1139;
antiques.
Article 3
Definitions
For the purposes of this Regulation the following definitions apply:
‘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;
‘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;
‘dangerous product’ means any product which is not a ‘safe product’;
‘risk’ means the combination of the probability of an occurrence of a hazard causing harm and the degree of severity of that harm;
‘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;
‘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;
‘placing on the market’ means the first making available of a product on the Union market;
‘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;
‘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;
‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market;
‘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;
‘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;
‘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;
‘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;
‘online interface’ means any software, including a website, part of a website or an application, including mobile applications;
‘distance contract’ means a distance contract as defined in Article 2, point (7), of Directive 2011/83/EU;
‘consumer’ means any natural person who acts for purposes which are outside that person’s trade, business, craft or profession;
‘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;
‘European standard’ means a European standard as defined in Article 2, point (1), point (b) of Regulation (EU) No 1025/2012;
‘international standard’ means an international standard as defined in Article 2, point (1), point (a) of Regulation (EU) No 1025/2012;
‘national standard’ means a national standard as defined in Article 2, point (1), point (d) of Regulation (EU) No 1025/2012;
‘European standardisation organisation’ means a European standardisation organisation as listed in Annex I to Regulation (EU) No 1025/2012;
‘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;
‘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;
‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the consumer;
‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market;
‘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;
‘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;
‘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 );
‘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:
the characteristics of the product, including its design, technical features, composition, packaging, instructions for assembly and, where applicable, for installation, use and maintenance;
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;
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;
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;
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;
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:
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;
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;
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;
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:
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
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:
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;
international standards;
international agreements;
voluntary certification schemes or similar third-party conformity assessment frameworks, in particular those conceived to support Union law;
Commission recommendations or guidelines on product safety assessment;
national standards drawn up in the Member State in which the product is made available;
the state of the art and technology, including the opinion of recognised scientific bodies and expert committees;
product safety codes of good practice in force in the sector concerned;
reasonable consumer expectations concerning safety;
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:
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
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:
take the corrective measures necessary to bring in an effective manner the product into conformity, including a withdrawal or recall, as appropriate;
inform consumers thereof, in accordance with Article 35 or 36, or both; and
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:
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;
where the authorised representative considers or has reason to believe that a product in question is a dangerous product, informing the manufacturer thereof;
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;
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:
inform the manufacturer thereof;
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;
ensure that consumers are immediately informed thereof in accordance with Article 35 or 36, or both; and
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:
immediately inform the manufacturer or the importer, as applicable, thereof;
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
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
A modification of a product, by physical or digital means, shall be deemed to be substantial where it has an impact on the safety of the product and the following criteria are met:
the modification changes the product in a manner which was not foreseen in the initial risk assessment of the product;
the nature of the hazard has changed, a new hazard has been created or the level of risk has increased because of the modification; and
the modifications have not been made by the consumers themselves or on their behalf for their own use.
Article 14
Internal processes for product safety
Economic operators shall ensure that they have internal processes for product safety in place, allowing them to comply with the relevant requirements of this Regulation.
Article 15
Cooperation of economic operators with market surveillance authorities
On request by a market surveillance authority, the economic operator shall provide all necessary information, in particular:
a full description of the risk presented by the product, related complaints and known accidents; and
a description of any corrective measure taken to address the risk.
On request, the economic operators shall also identify and communicate the following relevant traceability information for the product:
any economic operator who has supplied them with the product, or with a part, a component or any software embedded into the product; and
any economic operator to whom they have supplied the product.
Article 16
Responsible person for products placed on the Union market
Without prejudice to any obligations of economic operators under this Regulation, in addition to the tasks referred to in Article 4(3) of Regulation (EU) 2019/1020, and to ensure the safety of the product it is responsible for, where appropriate with regard to the possible risks related to a product, the economic operator referred to in paragraph 1 of this Article shall regularly check:
that the product complies with the technical documentation referred to in Article 9(2) of this Regulation;
that the product complies with the requirements provided for in Article 9(5), (6) and (7) of this Regulation.
The economic operator referred to in paragraph 1 of this Article shall, upon request by the market surveillance authorities, provide documented evidence of the checks performed.
Article 17
Information to economic operators
The Commission shall adopt specific guidelines for economic operators, with particular regard to the needs of those that qualify as SMEs, including micro-enterprises, on how to fulfil the obligations laid down in this Regulation.
Article 18
Specific traceability requirements for certain products, categories or groups of products
The Commission is empowered to adopt delegated acts in accordance with Article 45 to supplement this Regulation by:
determining the products, categories or groups of products or components likely to present a serious risk to the health and safety of consumers as referred to in paragraph 1; the Commission shall state in the delegated acts concerned whether it has used the risk analysis methodology provided for in Commission Implementing Decision (EU) 2019/417 ( 5 ) or, if that methodology is not appropriate for the product concerned, it shall give a detailed description of the methodology used;
specifying the type of data which economic operators are to collect and store by means of the system of traceability referred to in paragraph 2;
specifying the modalities to display and to access data, including placement of a data carrier on the product, its packaging or accompanying documents as referred to in paragraph 2;
specifying the actors that shall have access to the data as referred to in point (b) and to what data they shall have access, including consumers, economic operators, providers of online marketplaces, competent national authorities, the Commission, and public interest organisations, or any organisation acting on their behalf.
When adopting the measures referred to in paragraph 3, the Commission shall take into account:
the cost-effectiveness of the measures, including the impact of the measures on businesses, in particular SMEs;
an adequate timeframe to allow economic operators to prepare for those measures; and
the compatibility and interoperability with other product traceability systems already set up at Union or at international level.
SECTION 2
Article 19
Obligations of economic operators in the case of distance sales
Where economic operators make products available on the market online or through other means of distance sales, the offer of those products shall clearly and visibly indicate at least the following information:
name, registered trade name or registered trade mark of the manufacturer, as well as the postal and electronic address at which they can be contacted;
where the manufacturer is not established in the Union, the name, postal and electronic address of the responsible person within the meaning of Article 16(1) of this Regulation or Article 4(1) of Regulation (EU) 2019/1020;
information allowing the identification of the product, including a picture of it, its type and any other product identifier; and
any warning or safety information to be affixed to the product or to the packaging or included in an accompanying document in accordance with this 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.
Article 20
Obligations of economic operators in the case of accidents related to safety of products
Article 21
Information in electronic format
Without prejudice to Article 9(5), (6) and (7), Article 11(3) and Article 16(3), and the relevant provisions of Union harmonisation legislation, economic operators may additionally make the information referred to in those provisions available in a digital format by means of electronic technical solutions clearly visible on the product or, where that is not possible, on its packaging or in a document accompanying the product. That information shall be 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, including in accessible formats for persons with disabilities.
CHAPTER IV
PROVIDERS OF ONLINE MARKETPLACES
Article 22
Specific obligations of providers of online marketplaces related to product safety
Providers of online marketplaces shall register with the Safety Gate Portal and shall indicate on the Safety Gate Portal the information concerning their single contact point.
Providers of online marketplaces shall take the necessary measures to receive and process orders issued pursuant to this paragraph and they shall act without undue delay, and in any event within two working days from receipt of the order. They shall inform the issuing market surveillance authority of the effect given to the order by electronic means using the contact details of the market surveillance authority published in the Safety Gate Portal.
For the purpose of compliance with the requirements of Article 31(1) and (2) of Regulation (EU) 2022/2065 as regards product safety information, providers of online marketplaces shall design and organise their online interface in a way that enables traders offering the product to provide at least the following information for each product offered and that ensures that the information is displayed or otherwise made easily accessible by consumers on the product listing:
name, registered trade name or registered trade mark of the manufacturer, as well as the postal and electronic address at which the manufacturer can be contacted;
where the manufacturer is not established in the Union, the name, postal and electronic address of the responsible person within the meaning of Article 16(1) of this Regulation or Article 4(1) of Regulation (EU) 2019/1020;
information allowing the identification of the product, including a picture of it, its type and any other product identifier; and
any warning or safety information to be affixed on the product or to accompany it in accordance with this 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.
The internal processes referred to in paragraph 3 shall include mechanisms which enable traders to provide:
information in accordance with paragraph 9 of this Article including information on the manufacturer established in the Union or, where applicable, the responsible person within the meaning of Article 16(1) of this Regulation or Article 4(1) of Regulation (EU) 2019/1020; and
their self-certification committing to offer only products that comply with this Regulation and additional identification information, in accordance with Article 30(1) of Regulation (EU) 2022/2065, where applicable.
In particular, providers of online marketplaces shall:
ensure that they provide appropriate and timely information to consumers including by:
directly notifying all affected consumers who bought through their interfaces the relevant product in the event of a product safety recall of which they have actual knowledge or where certain information has to be brought to the attention of consumers to ensure the safe use of a product (the ‘safety warning’) in accordance with Article 35 or 36, or both;
publishing information on product safety recalls on their online interfaces;
inform the relevant economic operator of the decision to remove or disable access to the content referring to an offer of a dangerous product;
cooperate with market surveillance authorities and with relevant economic operators to ensure effective product recalls, including by abstaining from obstructing product recalls;
immediately inform, through the Safety Business Gateway, the market surveillance authorities of the Member States in which the relevant product has been made available on the market about dangerous products that were offered on their online interfaces, of which they have actual knowledge, by providing the appropriate details available to them of the risk to the health and safety of consumers, of the quantity by Member State of products still circulating on the market, if available, and of any corrective measure that, to their knowledge, has already been taken;
cooperate with regard to accidents notified to them, including by:
informing the relevant traders and economic operators without delay about the information they have received regarding accidents or safety issues, where they have knowledge that the product in question was offered by those traders through their interfaces;
notifying without undue delay through the Safety Business Gateway of any accident, of which they have been informed, resulting in a serious risk or actual damage to the health or safety of a consumer, caused by a product made available on their online marketplace and inform the manufacturer thereof;
cooperate with law enforcement agencies at Union and national level, including the European Anti-Fraud Office (OLAF), through regular and structured exchange of information on offers that have been removed on the basis of this Article by providers of online marketplaces;
allow access to their interfaces for the online tools operated by market surveillance authorities to identify dangerous products;
cooperate in identifying, as far as possible, the supply chain of dangerous products by responding to data requests where the relevant information is not publicly available;
upon a reasoned request of the market surveillance authorities, when providers of online marketplaces or online sellers have put in place technical obstacles to the extraction of data from their online interfaces (data scraping), allow the scraping of such data only for product safety purposes based on the identification parameters provided by the requesting market surveillance authorities.
CHAPTER V
MARKET SURVEILLANCE AND IMPLEMENTATION
Article 23
Market Surveillance
For the purpose of this Regulation, Regulation (EU) 2019/1020 shall apply as follows:
references to ‘Union harmonisation legislation’, ‘applicable Union harmonisation legislation’, ‘this Regulation and for the application of Union harmonisation legislation’, ‘the relevant Union harmonisation legislation’ and ‘Union harmonisation legislation or this Regulation’ in Articles 11, 13, 14, 16, 18 and 23 of that Regulation shall be read as references to ‘this Regulation’;
reference to ‘that legislation and this Regulation’ in Article 11(1), point (b) of that Regulation shall be read as a reference to ‘this Regulation’;
references to ‘Network’ in Articles 11 to 13 and Article 21 of that Regulation shall be read as references to ‘Network and Consumer Safety Network referred to in Article 30 of this Regulation’;
references to ‘non-compliance’, ‘non-compliances’ and ‘non-compliant’ in Article 11, Articles 13 to 16, Articles 22 and 23 of that Regulation shall be read as references to ‘failure to comply with this Regulation’;
the reference to ‘Article 41’ in Article 14(4), point (i) of that Regulation shall be read as a reference to ‘Article 44 of this Regulation’;
the reference to ‘Article 20’ in Article 19(1) of that Regulation shall be read as a reference to ‘Article 26 of this Regulation’.
Article 24
Reporting
Following the communication from the Member States, the Commission shall draw up annually a summary report and make it available to the public.
CHAPTER VI
SAFETY GATE RAPID ALERT SYSTEM AND SAFETY BUSINESS GATEWAY
Article 25
Safety Gate Rapid Alert System
The Commission shall adopt an implementing act specifying the roles and tasks of single national contact points. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 46(3).
Article 26
Notification of dangerous products through the Safety Gate Rapid Alert System
Member States shall notify through the Safety Gate Rapid Alert System corrective measures taken by their authorities or by economic operators on the basis of:
provisions of this Regulation, in relation to dangerous products presenting a serious risk to the health and safety of consumers; and
Article 20 of Regulation (EU) 2019/1020.
The Commission shall adopt delegated acts in accordance with Article 45 to supplement this Regulation by specifying, in particular:
the access to the Safety Gate Rapid Alert System;
the operation of the Safety Gate Rapid Alert System;
the information to be entered in the Safety Gate Rapid Alert System;
the requirements notifications must meet; and
the criteria for assessment of the level of risk.
Article 27
Safety Business Gateway
CHAPTER VII
COMMISSION’S ROLE AND ENFORCEMENT COORDINATION
Article 28
Union action against products presenting a serious risk
If the Commission becomes aware of a product, or a specific category or group of products, presenting a serious risk to the health and safety of consumers, it may take any appropriate measures, either on its own initiative or upon request of Member States, by means of implementing acts, adapted to the gravity and urgency of the situation if:
the risk cannot be dealt with, in view of the nature of the safety issue posed by the product, category or group of products, in a manner compatible with the degree of gravity or urgency of the case, under other procedures laid down by the specific Union law applicable to the products concerned; and
the risk can be eliminated in an effective manner only by adopting appropriate measures applicable at Union level, in order to ensure a consistent and high level of protection of the health and safety of consumers and the proper functioning of the internal market.
Those measures may include measures prohibiting, suspending or restricting the placing or making available on the market of such products or laying down special conditions for their conformity assessment with regard to the safety requirement, as applicable, or for their marketing, such as representative sample testing of those products, in order to ensure a high level of consumer safety protection.
Member States shall, within their jurisdiction, take all appropriate enforcement measures necessary to ensure the effective implementation of those implementing acts. The competent authorities of the Member States concerned shall inform the Commission of the enforcement measures taken.
The Commission shall regularly evaluate the efficiency of the enforcement measures taken by Member States and inform the Consumer Safety Network of the outcome of that evaluation.
Article 29
Request for an opinion from the Commission on divergences in risk assessment
Article 30
Consumer Safety Network
The purpose of the Consumer Safety Network shall be 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.
The tasks of the Consumer Safety Network shall be, in particular, to:
facilitate the regular exchange of information on risk assessments, dangerous products, test methods and results, standards, methodologies for the collection of data, interoperability of information and communication systems, recent scientific developments and the use of new technologies as well as other aspects relevant for control activities;
organise the establishment and execution of joint surveillance and testing projects, including in the context of e-commerce;
promote the exchange of expertise and best practices and cooperation in training activities;
improve cooperation at Union level with regard to the tracing, withdrawal and recall of dangerous products;
facilitate enhanced and structured cooperation on product safety enforcement between Member States, in particular to facilitate the activities referred to in Article 32; and
facilitate the implementation of this Regulation.
The Consumer Safety Network shall meet at regular intervals and, where necessary, at the duly justified request of the Commission or a Member State.
The Consumer Safety Network may invite experts and other third parties, including consumer organisations, to attend its meetings.
Article 31
Joint activities on product safety
Article 32
Simultaneous coordinated control actions of market surveillance authorities (‘Sweeps’)
CHAPTER VIII
RIGHT TO INFORMATION AND TO A REMEDY
Article 33
Information between authorities and general public
Article 34
Safety Gate Portal
Article 35
Information from economic operators and providers of online marketplaces to consumers on product safety
Article 36
Recall notice
A recall notice which can be easily understood by consumers shall be available in the language(s) of the Member State(s) where the product has been made available on the market and include the following elements:
a headline consisting of the words ‘Product safety recall’;
a clear description of the recalled product, including:
picture, name and brand of the product;
product identification numbers, such as batch or serial number, and, if applicable, graphical indication of where to find them on the product; and
information on when, where and by whom the product was sold, if available;
a clear description of the hazard associated with the recalled product, avoiding any elements that may decrease consumers’ perception of risk, such as by using terms and expressions such as ‘voluntary’, ‘precautionary’, ‘discretionary’, ‘in rare situations’ or ‘in specific situations’ or by indicating that there have been no reported accidents;
a clear description of the action consumers should take, including an instruction to immediately stop using the recalled product;
a clear description of the remedies available to consumers in accordance with Article 37;
a free phone number or interactive online service, where consumers can get more information in relevant official language(s) of the Union; and
encouragement to share the information about the recall with other persons, if appropriate.
Article 37
Remedies in the event of a product safety recall
Without prejudice to any other remedies that the economic operator responsible for the recall may offer the consumer, the economic operator shall offer the consumer the choice between at least two of the following remedies:
the repair of the recalled product;
a replacement of the recalled product with a safe one of the same type and at least the same value and quality; or
an adequate refund of the value of the recalled product, provided that the amount of the refund shall be at least equal to the price paid by the consumer.
By way of exception to the first subparagraph, the economic operator may offer the consumer only one remedy where other remedies would be impossible or, compared to the proposed remedy, would impose costs on the economic operator responsible for the product safety recall that would be disproportionate, taking into account all circumstances, including whether the alternative remedy could be provided without significant inconvenience to the consumer.
The consumer shall always be entitled to a refund of the product when the economic operator responsible for the product safety recall has not completed the repair or replacement within a reasonable time and without significant inconvenience to the consumer.
Article 38
Memoranda of understanding
Article 39
Representative actions
Directive (EU) 2020/1828 shall apply to the representative actions brought against infringements by economic operators and providers of online marketplaces of provisions of this Regulation that harm, or may harm, the collective interests of consumers.
CHAPTER IX
INTERNATIONAL COOPERATION
Article 40
International cooperation
In order to improve the overall level of safety of products made available on the market and to ensure a level playing field at international level, the Commission may cooperate, including through the exchange of information, with authorities of third countries or international organisations in the field of application of this Regulation. Any such cooperation shall be based on reciprocity, shall include provisions on confidentiality corresponding to those applicable in the Union and shall ensure that any exchange of information take place in accordance with applicable Union law. The cooperation or exchange of information may relate, inter alia, to the following:
enforcement activities and measures related to safety, also with a view to preventing the circulation of dangerous products, including market surveillance;
risk assessment methods and product testing;
coordinated product recalls and other similar actions;
scientific, technical and regulatory matters, aiming to improve product safety and to develop common priorities and approaches at international level;
emerging issues of significant health and safety relevance;
use of new technologies to improve product safety and increase traceability in the supply chain;
standardisation-related activities;
exchange of officials and training programmes.
The information exchange referred to in paragraph 2 may take the form of either:
a non-systematic exchange, in duly justified and specific cases; or
a systematic exchange, based on an administrative arrangement specifying the type of information to be exchanged and the modalities for the exchange.
CHAPTER X
FINANCIAL PROVISIONS
Article 41
Financing activities
The Union shall finance the following activities in relation to the application of this Regulation:
performance of the tasks of the Consumer Safety Network;
the development and operation of the Safety Gate Rapid Alert System, including the development of electronic interoperability solutions for the exchange of data:
between the Safety Gate Rapid Alert System and the national market surveillance systems;
between the Safety Gate Rapid Alert System and customs systems;
with other relevant restricted systems used by market surveillance authorities for their enforcement purposes;
the development and maintenance of the Safety Gate Portal and the Safety Business Gateway, including a public non-restricted software interface for data exchange with platforms and third parties.
The Union may finance the following activities in relation to the application of this Regulation:
the development of instruments of international cooperation referred to in Article 40;
the drawing up and updating of contributions to guidelines on market surveillance and product safety;
the making available to the Commission of technical or scientific expertise for the purpose of assisting the Commission in its implementation of market surveillance administrative cooperation;
the performance of preliminary or ancillary work in connection with the implementation of market surveillance activities linked to the application of this Regulation such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits and visit programmes, exchange of personnel, research work, the development and maintenance of databases, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work;
Union market surveillance campaigns and associated activities, including resources and equipment, IT tools and training;
activities carried out under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of Union market surveillance policies and systems among interested parties at Union and international levels, including activities carried out by consumer organisations for the enhancement of consumer information.
Article 42
Protection of the Union’s financial interests
CHAPTER XI
FINAL PROVISIONS
Article 43
Liability
Article 44
Penalties
Article 45
Exercise of the delegation
Article 46
Committee procedure
Article 47
Evaluation and review
Article 48
Amendments to Regulation (EU) No 1025/2012
Regulation (EU) No 1025/2012 is amended as follows:
in Article 10, the following paragraph is added:
in Article 11, paragraphs 1, 2 and 3 are replaced by the following:
When a Member State or the European Parliament considers that a harmonised standard or European standard drafted in support of Regulation (EU) 2023/988 does not entirely satisfy the requirements which it aims to cover and which are set out in the relevant Union harmonisation legislation or in that Regulation, it shall inform the Commission thereof with a detailed explanation. The Commission shall, after consulting the committee set up by the corresponding Union harmonisation legislation, if it exists, or the committee set up by that Regulation, or after other forms of consultation of sectoral experts, decide:
to publish, not to publish or to publish with restriction the references to the harmonised standard or European standard concerned drafted in support of that Regulation in the Official Journal of the European Union; and
to maintain, to maintain with restriction or to withdraw the references to the harmonised standard or European standard concerned drafted in support of that Regulation in or from the Official Journal of the European Union.
.
Article 49
Amendment to Directive (EU) 2020/1828
In Annex I to Directive (EU) 2020/1828, point (8) is replaced by the following:
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 (OJ L 135, 23.5.2023, p. 1).’.
Article 50
Repeal
Article 51
Transitional provision
Member States shall not impede the making available on the market of products covered by Directive 2001/95/EC which are in conformity with that Directive and which were placed on the market before 13 December 2024.
Article 52
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 13 December 2024.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
CORRELATION TABLE
|
Directive 87/357/EEC |
Directive 2001/95/EC |
Regulation (EU) No 1025/2012 |
This Regulation |
|
|
Article 1(2) |
|
Article 2(1) and (2) |
|
|
Article 2 except point (a), 2nd subparagraph and point (b), 2nd subparagraph |
Article 3 |
|
|
|
Article 2, point (a), 2nd subparagraph |
Article 2(2), point (i) and Article 2(3) |
|
|
|
Article 2, point (b), 2nd subparagraph |
Article 6(2) |
|
|
|
Article 3(1) |
Article 5 |
|
|
|
Article 3(2) |
Article 7(1) |
|
|
|
Article 3(3) |
Article 8 |
|
|
|
Article 3(4) |
Article 7(3) |
|
|
|
Article 4(1), points (a) and (b) |
Article 10(1) |
Article 7(2) |
|
|
Article 4(1), point (c) |
- |
- |
|
|
Article 4(1), point (d) |
- |
- |
|
|
Article 4(2), first subparagraph |
Article 10(7) |
Article 48(1), point (a) |
|
|
Article 4(2), second subparagraph |
- |
- |
|
|
Article 4(2), third and fourth subparagraphs |
Article 11(1), point (b) |
Article 48(1), point (b) |
|
|
Article 5(1), first subparagraph |
Article 9(7) |
|
|
|
Article 5(1), second subparagraph |
- |
|
|
|
Article 5(1), third subparagraph, point (a) |
Article 9(10), (12) and (13) and Article 11(9) and (10) |
|
|
|
Article 5(1), third subparagraph, point (b) |
Article 9(8) and Article 11(8) |
|
|
|
Article 5(1), fourth subparagraph, point (a) |
Article 9(5) and (6) and Article 11(3) |
|
|
|
Article 5(1), fourth subparagraph, point (b), first sentence |
Article 9(2) and (3) |
|
|
|
Article 5(1), fourth subparagraph, point (b), second sentence |
Article 9(11), (12) and (13) and Article 11(9), (10) and (11) |
|
|
|
Article 5(1), fifth subparagraph |
Article 9(8), point (a) |
|
|
|
Article 5(2) |
Article 12(1) and (3) |
|
|
|
Article 5(3), first subparagraph |
Article 9(8), Article 11(8) and Article 12(4) |
|
|
|
Article 5(3), second subparagraph |
- |
|
|
|
Article 5(4) |
Article 15 |
|
|
|
Articles 6 to 9 |
Article 2(2), Articles 23 and 44 |
|
|
|
Article 10(1) |
Article 30 |
|
|
|
Article 10(2) |
Articles 31 and 32 |
|
|
|
Article 11(1), first subparagraph |
Article 26(3) |
|
|
|
Article 11(1), second subparagraph |
- |
|
|
|
Article 11(1), third subparagraph |
Article 26(10) |
|
|
|
Article 11(2) |
Article 26(5) |
|
|
|
Article 12(1), first and fourth subparagraph |
Article 26(1) and (2) |
|
|
|
Article 12(1), second subparagraph |
- |
|
|
|
Article 12(1), third subparagraph |
- |
|
|
|
Article 12(2) |
Article 26(5) and (7) |
|
|
|
Article 12(3) |
Article 26(10) |
|
|
|
Article 12(4) |
Article 40(2) to (6) |
|
|
|
Article 13 |
Article 28 |
|
|
|
Articles 14 and 15 |
Article 46 |
|
|
|
Article 16(1), first subparagraph |
Article 33(1) |
|
|
|
Article 16(1), second subparagraph |
Article 33(2) |
|
|
|
Article 16(2) |
Article 33(3) |
|
|
|
Article 17 |
Article 43(2) |
|
|
|
Article 18(1) and (2) |
Article 23 |
|
|
|
Article 18(3) |
Article 43(1) |
|
|
|
Article 19(1) |
- |
|
|
|
Article 19(2) |
Article 47 |
|
|
|
Article 20 |
- |
|
|
|
Article 21 |
Article 52 |
|
|
|
Annex I, (1) |
Article 9(8), Article 10(2), point (c), Article 11(8) and Article 12(4) |
|
|
|
Annex I, (2) and (3) |
Article 26 |
|
|
|
Annex III |
- |
|
|
|
Annex IV |
Annex |
|
|
Articles 1 and 2 |
|
Article 6(1), first subparagraph and Article 6(1)(f), point (i) |
|
|
Articles 3 to 7 |
|
- |
( 1 ) Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the internal market of Community postal services and the improvement of quality of service (OJ L 15, 21.1.1998, p. 14).
( 2 ) Regulation (EU) 2018/644 of the European Parliament and of the Council of 18 April 2018 on cross-border parcel delivery services (OJ L 112, 2.5.2018, p. 19).
( 3 ) Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) (OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj).
( 4 ) Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 (OJ L 91, 29.3.2019, p. 1).
( 5 ) Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system (OJ L 73, 15.3.2019, p. 121).
( 6 ) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
( 7 ) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2).
( 8 ) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1).
( 9 ) Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p. 29).
( *1 ) 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 (OJ L 135, 23.5.2023, p. 1).’;