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)

In the framework of the activities referred to in Article 30(3), point (b), market surveillance authorities may agree with other relevant authorities or with organisations representing economic operators or consumers to carry out activities aimed at ensuring safety and protection of consumers health with respect to specific categories of products made available on the market, in particular categories of products that are often found to present a serious risk to the health and safety of consumers.

The relevant market surveillance authorities and the parties referred to in paragraph 1 shall ensure that the agreement to carry out such activities does not lead to unfair competition between economic operators and does not affect the objectivity, independence and impartiality of those parties.

The Commission shall organise on a regular basis joint activities of market surveillance authorities whereby the market surveillance authorities conduct inspections regarding products offered online or offline, which those authorities acquired under a cover identity.

A market surveillance authority may use any information obtained as a result of the joint activities carried out as part of any investigation undertaken by it regarding the safety of products.

The market surveillance authority concerned shall make the agreement on joint activities, including the names of the parties involved, available to the public and shall enter that agreement in the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020. The Commission shall make that agreement available on the Safety Gate Portal.

The market surveillance authorities concerned shall conduct simultaneous coordinated control actions (‘sweeps’) of particular products or categories of products with the objective of checking compliance with this Regulation.

Unless otherwise agreed upon by the market surveillance authorities involved, sweeps shall be coordinated by the Commission. The coordinator of the sweep shall, where appropriate, make the aggregated results publicly available.

When conducting sweeps, the market surveillance authorities involved may use the investigation powers set out in Chapter V and any other powers conferred upon them by national law.

Market surveillance authorities may invite Commission officials and other accompanying persons authorised by the Commission to participate in sweeps.

Information available to the authorities of the Member States or to the Commission relating to measures on products presenting risks to the health and safety of consumers shall in general be made available to the public, in accordance with the requirements of transparency and without prejudice to the restrictions required for monitoring and investigation activities. In particular, the public shall have access to information on product identification, the nature of the risk and the measures taken. That information shall also be provided in accessible formats for persons with disabilities.

Member States and the Commission shall take the necessary steps to ensure that their officials and agents are required to protect information obtained for the purposes of this Regulation. That information shall be treated as confidential in accordance with Union and national law.

Protection of professional secrecy shall not prevent the dissemination to the competent authorities of Member States and to the Commission of information relevant for ensuring the effectiveness of market monitoring and surveillance activities. The authorities receiving information covered by professional secrecy shall ensure its protection in accordance with Union and national law.

Member States shall give consumers and other interested parties the opportunity to submit complaints to the competent authorities on product safety, on surveillance and control activities related to specific products as well as on instances where remedies offered to consumers in the case of product recalls are not satisfactory. Such complaints shall be followed up appropriately. The competent authorities shall provide the complainant with appropriate information on the follow-up, in accordance with national law.

For the purpose of Article 9(9), Articles 20 and 22, Article 31(5) and Article 33(1), the Commission shall maintain a Safety Gate Portal, providing the general public with free of charge and open access to selected information notified in accordance with Article 26 (the ‘Safety Gate Portal’).

The Safety Gate Portal shall have an interface which is intuitive for users and the information provided on that portal shall be easily accessible by the public, including by persons with disabilities.

Consumers and other interested parties shall have the possibility to inform the Commission of products that might present a risk to the health and safety of consumers through a separate section of the Safety Gate Portal. The Commission shall give due consideration to the information received and, after verification of its accuracy, where appropriate, forward that information to the relevant Member States without undue delay to ensure that that information is appropriately followed-up. The Commission shall inform consumers and other interested parties of its action.

The Commission shall, by means of an implementing act, adopt the modalities for the sending of information by consumers in accordance with paragraph 3, as well as for the transmission of such information to the national authorities concerned for possible follow up. This implementing act shall be adopted in accordance with the examination procedure referred to in Article 46(3).

By 13 December 2024 the Commission shall develop an interoperable interface that allows providers of online marketplaces to link their interfaces to the Safety Gate Portal.

The Commission shall adopt implementing acts specifying the implementation of the interoperable interface on the Safety Gate Portal in accordance with paragraph 5, in particular concerning the access to the system and its operation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(3).

In the case of a product safety recall, or where certain information has to be brought to the attention of consumers to ensure the safe use of a product (‘safety warning’), economic operators, in accordance with their respective obligations as provided for in Articles 9, 10, 11 and 12, and providers of online marketplaces in accordance with their obligations as provided for in Article 22(12), shall ensure that all affected consumers that can be identified are notified directly and without undue delay. Economic operators and, where applicable, providers of online marketplaces that collect their customers’ personal data shall make use of that information for recalls and safety warnings.

Where economic operators and providers of online marketplaces have in place product registration systems or customer loyalty programs enabling the identification of products bought by consumers for purposes other than contacting their customers with safety information, they shall offer the possibility to their customers to provide separate contact details only for safety-related purposes. The personal data collected for that purpose shall be limited to the necessary minimum and shall only be used to contact consumers in the event of a recall or safety warning.

The Commission may, by means of implementing acts, set out, for specific products or categories of products, requirements to be met by economic operators and providers of online marketplaces to provide the possibility for consumers to register a product they have purchased in order to be notified directly in the case of a product safety recall or safety warning in relation to that product, in accordance with paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(3).

Where not all of the affected consumers can be contacted under paragraph 1, economic operators and providers of online marketplaces, in accordance with their respective responsibilities, shall disseminate a clear and visible recall notice or safety warning through other appropriate channels, ensuring the widest possible reach including, where available, the company’s website, social media channels, newsletters and retail outlets and, as appropriate, announcements in mass media and other communication channels. Information shall be accessible to persons with disabilities.

Where information on a product safety recall is provided to consumers in a written form, in accordance with Article 35(1) and (4), it shall take the form of a 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:

The Commission shall, by means of implementing acts, set out the template for a recall notice, taking into account scientific and market developments. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 46(2). That template shall be made available by the Commission in a format that enables economic operators to easily create a recall notice, including in accessible formats for persons with disabilities.

Without prejudice to Directives (EU) 2019/770 and (EU) 2019/771, in the case of a product safety recall initiated by an economic operator or ordered by a national competent authority, the economic operator responsible for the product safety recall shall offer the consumer an effective, cost-free and timely remedy.

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:

Repair by a consumer shall only be considered an effective remedy where it can be carried out easily and safely by the consumer and where envisaged in the recall notice. In such cases, the economic operator responsible for the product safety recall shall provide consumers with the necessary instructions, free replacement parts or software updates. Repair by a consumer shall not deprive the consumer of the rights provided for in Directives (EU) 2019/770 and (EU) 2019/771.

Disposal of the product by consumers shall only be included in the actions to be taken by consumers under Article 36(2), point (d) where such disposal can be carried out easily and safely by the consumer, and shall not affect the right of the consumer to receive a refund for or replacement of the recalled product under paragraph 1 of this Article.

The remedy shall not entail significant inconvenience for the consumer. The consumer shall not bear the costs of shipping or otherwise returning the product. For products that by their nature are not portable, the economic operator shall arrange for the collection of the product.

National competent authorities and the Commission may promote voluntary memoranda of understanding with economic operators or providers of online marketplaces, as well as with organisations representing consumers or economic operators, aimed at undertaking voluntary commitments to enhance product safety.

Voluntary commitments under such memoranda of understanding shall be without prejudice to the obligations of economic operators and providers of online marketplaces under this Regulation and other relevant Union law.

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:

The Commission may provide third countries or international organisations with selected information from the Safety Gate Rapid Alert System and receive relevant information on the safety of products and on preventive, restrictive and corrective measures taken by those third countries or international organisations. The Commission shall share such information with national authorities, where relevant.

The information exchange referred to in paragraph 2 may take the form of either:

Full participation in the Safety Gate Rapid Alert System may be open to applicant countries and third countries, provided that their legislation is aligned with the relevant Union law and that they participate in the European Standardisation System. Such participation shall entail the same obligations as for Member States according to this Regulation, including notification and follow-up obligations. Full participation in the Safety Gate Rapid Alert System shall be based on agreements between the Union and those countries, according to arrangements defined in those agreements.

Any information exchange under this Article shall, to the extent it involves personal data, be carried out in accordance with Union data protection rules. Personal data shall only be transferred to the extent that such exchange is necessary for the sole purpose of the protection of the health or safety of consumers.

The information exchanged pursuant to this Article shall be used for the sole purpose of the protection of the health or safety of consumers.

The Union shall finance the following activities in relation to the application of this Regulation:

The Union may finance the following activities in relation to the application of this Regulation:

The Union’s financial assistance to the activities under this Regulation shall be implemented in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council ([^E0006]), either directly, or indirectly by delegating budget implementation tasks to the entities listed in Article 62(1), point (c) of that Regulation.

The appropriations allocated to activities referred to in this Regulation shall be determined each year by the European Parliament and the Council within the limits of the financial framework in force.

The appropriations determined by the European Parliament and the Council for the financing of market surveillance activities may also cover expenses pertaining to preparatory, monitoring, control, audit and evaluation activities which are required for the management of the activities pursuant to this Regulation and the achievement of their objectives; in particular, studies, meetings of experts, information and communication actions, including corporate communication of the political priorities of the Union insofar as they are related to the general objectives of market surveillance activities, expenses linked to information technology networks focusing on information processing and exchange, together with all other technical and administrative assistance expenses incurred by the Commission for the management of the activities pursuant to this Regulation.

The Commission shall take appropriate measures to ensure that, when actions financed under this Regulation are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks and, if irregularities are detected, by the recovery of the amounts wrongly paid and, where appropriate, by effective, proportionate and dissuasive administrative and financial penalties.

The Commission or its representatives and the Court of Auditors shall have the power of audit, on the basis of documents and of on-the-spot inspections, over all grant beneficiaries, contractors and subcontractors who have received Union funds under the Single Market Programme and its successor in accordance with the provisions and procedures laid down in Council Regulation (Euratom, EC) No 2185/96 ([^E0007]).

OLAF may carry out investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council ([^E0008]) and Regulation (Euratom, EC) No 2185/96, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant agreement or grant decision or a contract funded under the programme.

Without prejudice to paragraphs 1, 2 and 3, cooperation agreements with third countries and with international organisations, contracts, grant agreements and grant decisions resulting from the implementation of this Regulation shall contain provisions expressly empowering the Commission, the Court of Auditors and OLAF to conduct such audits and investigations, in accordance with their respective competences.

Any decision taken pursuant to this Regulation that imposes restrictions on the placing of or making a product available on the market or requires its withdrawal or its recall shall not affect the assessment of the liability of the party concerned, in the light of the national law applicable in the case in question.

This Regulation shall not affect Council Directive 85/374/EEC ([^E0009]).

Member States shall lay down the rules on penalties applicable to infringements of this Regulation that impose obligations on economic operators and providers of online marketplaces and shall take all measures necessary to ensure that they are implemented in accordance with national law.

The penalties provided for shall be effective, proportionate and dissuasive.

The Member States shall, by 13 December 2024, notify the Commission of those rules and of those measures, where they have not previously been notified, and shall notify it, without delay, of any subsequent amendment affecting them.

The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

The power to adopt delegated acts referred to in Article 18(3) and Article 26(10) shall be conferred on the Commission for an indeterminate period of time from 12 June 2023.

The delegation of power referred to in Article 18(3) and Article 26(10) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

A delegated act adopted pursuant to Article 18(3) or Article 26(10) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

By 13 December 2029 the Commission shall carry out an evaluation of this Regulation. The Commission shall submit to the European Parliament, the Council and to the European Economic and Social Committee a report on the main findings. That report shall assess whether this Regulation, and in particular Articles 18, 22 and 25, achieved the objective of enhancing the protection of consumers against dangerous products while taking into account the challenges posed by new technologies and its impact on businesses and in particular on SMEs.

By 13 December 2029, the Commission shall draw up an evaluation report on the implementation of Article 16. That report shall in particular assess the scope, effects, and costs and benefits of that Article. The report shall be accompanied, where appropriate, by a legislative proposal.

By 13 December 2027 the Commission shall assess the modalities for implementation of the provisions on the removal of illegal content from online marketplaces referred to in Article 22(4), (5) and (6) by means of a Union notification system designed and developed within the Safety Gate Portal. Such assessment shall be accompanied, where appropriate, by a legislative proposal.

By 13 December 2026 the Commission shall publish a report on the functioning of the interconnection between information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 and the Safety Gate Portal referred to in this Regulation, including information on their respective functionalities, further improvements or on the development of a new interface, if appropriate.

By 13 December 2029, the Commission shall draw up an evaluation report on the implementation of Article 44. That report shall in particular assess the effectiveness and deterrent effect of the penalties imposed under that Article. The report shall be accompanied, where appropriate, by a legislative proposal.

On request, Member States shall provide the Commission with information necessary for the evaluation of this Regulation.

The Commission shall publish information on its website on the harmonised standards and European standards drafted in support of Regulation (EU) 2023/988 that have been subject to a decision pursuant to paragraph 1.

The Commission shall inform the European standardisation organisation concerned of any decision adopted pursuant to paragraph 1 and, if necessary, request the revision of the harmonised standards or of the European standards concerned drafted in support of Regulation (EU) 2023/988.’

Directives 87/357/EEC and 2001/95/EC are repealed with effect from 13 December 2024.

References to the repealed directives shall be construed as references to this Regulation and to Regulation (EU) No 1025/2012, and shall be read in accordance with the correlation table in the Annex to this Regulation.