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2023/05/23
   Final act published in Official Journal
Details

PURPOSE: to make products safer for consumers.

LEGISLATIVE ACT: Regulation (EU) 2023/988 of the European Parliament and of the Council 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.

CONTENT: the increasing number of goods and products sold online required an update to keep the rules fit for current digital and technological developments. The General Product Safety Regulation transforms the general product safety directive into a regulation. It modernises the rules applicable to all economic operators, online businesses and online marketplaces.

The regulation lays down the essential rules on the safety of consumer products placed or made available on the market. It strengthens the safety rules applicable to products sold both offline and online. The regulation will strengthen market surveillance for dangerous products and consumer rights for anyone who has been sold a dangerous product. A single market surveillance regime will apply to all products.

The main elements of the regulation are as follows:

Better assessment of the safety of products

Economic operators should place or make available on the market only safe products. When assessing whether a product is a safe product, the following aspects in particular should be taken into account: (i) the characteristics of the product, including its design, technical features, composition, packaging, instructions for assembly and, where applicable, for installation, use and maintenance; (ii) 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 .

Obligations of economic operators

The new regulation strengthens the obligations of economic operators (manufacturers, importers and distributors).

Before placing their products on the market, manufacturers will carry out an internal risk analysis and draw up technical documentation containing at least a general description of the product and its essential characteristics relevant for assessing its safety.

Economic operators should have a person responsible for products sold online and offline (independently of the product’s origin), who will ensure the availability of technical documentation, instructions, and safety information.

Where an economic operator has reason to believe that a product which it has placed on the market is a dangerous product, it will immediately: (i) take the necessary corrective action to bring the product into effective compliance, including withdrawal or recall , as appropriate; (ii) inform consumers; and (iii) inform the market surveillance authorities of the Member States in which the product was made available on the market.

The manufacturer will ensure that an accident caused by a product placed on the market is notified, via the Safety Business Gateway and without undue delay from the moment it becomes aware of the accident, to the competent authorities of the Member State where the accident occurred.

Providers of online marketplaces

The new regulation introduces clear obligations for online marketplace providers.

Online marketplaces will have to co-operate with market surveillance authorities if they detect a dangerous product on their platform and must establish a single point of contact in charge of product safety.

Member States will confer on their market surveillance authorities the necessary power, as regards specific content referring to an offer of a dangerous product, to issue an order requiring the providers of online marketplaces to remove such content from their online interface, to disable access to it or to display an explicit warning. Providers of online marketplaces will take the necessary measures to receive and process orders issued and they will act without undue delay, and in any event within two working days from receipt of the order.

Providers of online marketplaces will 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.

Remedies in the event of a product safety recall

The revised legislation improves the product recall procedure. In the event of a product recall for safety reasons initiated by an economic operator or ordered by a competent national authority, the economic operator responsible for the product recall for safety reasons will have to offer the consumer effective, free and rapid redress .

If a product has to be recalled, consumers will be entitled to repair, replacement or reimbursement (and will be able to choose between at least two of these options).

Safety Gate rapid alert system

The Commission will develop, modernise and manage the rapid alert system for exchanging information on corrective measures concerning dangerous products (Safety Gate rapid alert system), and increase its effectiveness.

Representative actions

Consumers will also have the right to bring representative actions for infringements by economic operators and providers of online marketplaces of provisions of this Regulation that harm, or may harm, the collective interests of consumers.

ENTRY INTO FORCE: 12.6.2023.

APPLICATION: from 13.12.2024.

2023/05/12
   EC - Commission response to text adopted in plenary
Documents
2023/05/10
   CSL - Draft final act
Documents
2023/05/10
   CSL - Final act signed
2023/04/25
   EP/CSL - Act adopted by Council after Parliament's 1st reading
2023/03/30
   EP - Results of vote in Parliament
2023/03/30
   EP - Decision by Parliament, 1st reading
Details

The European Parliament adopted by 569 votes to 13, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council, and repealing Council Directive 87/357/EEC and Directive 2001/95/EC of the European Parliament and of the Council.

The revised regulation aims to improve the functioning of the internal market, while ensuring a high level of consumer protection. It lays down essential rules on the safety of consumer products placed or made available on the market.

The European Parliament's position adopted at first reading under the ordinary legislative procedure amends the Commission's proposal as follows:

Better assessment of the safety of products

Economic operators should place or make available on the market only safe products. When assessing whether a product is a safe product, the following aspects in particular should 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 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:

- 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;

Obligations of economic operators

The new regulation strengthens the obligations of economic operators (manufacturers, importers and distributors).

Before placing their products on the market, manufacturers should carry out an internal risk analysis and draw up technical documentation containing at least a general description of the product and its essential characteristics relevant for assessing its safety.

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 should immediately inform consumers thereof 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.

Manufacturers should make publicly available communication channels such as a telephone number, electronic address or dedicated section of their website, taking into account accessibility needs for persons with disabilities , enabling consumers to submit complaints and to inform manufacturers of any accident or safety issue they have experienced with a product.

Providers of online marketplaces

The new regulation introduces clear obligations for online marketplace providers.

Providers of online marketplaces should:

- designate a single contact point for direct electronic communication with Member States' market surveillance authorities on product safety issues;

- register on the Safety Gate portal and provide information about their single point of contact;

- designate a single contact point to enable consumers to communicate directly and quickly with them on product safety issues.

Market surveillance authorities should have the power, in relation to specific content referring to an unsafe product offering, to issue an injunction requiring online marketplace providers to remove such content from their online interface, to disable access to it or to display an explicit warning. Providers of online marketplaces should act without undue delay, and in any event within two working days of receiving the order.

In particular, providers of online marketplaces should:

- directly notify 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;

- publish 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.

Safety gate portal

The Commission will operate a Safety Gate portal that will provide the general public with free and open access to certain notified information. The Safety Gate Portal should 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.

Remedies in the event of a product safety recall

The revised legislation improves the product safety recall. 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 should offer the consumer an effective, cost-free and timely remedy .

The economic operator should offer the consumer the choice between at least two of the following remedies :

(a) the repair of the recalled product;

(b) a replacement of the recalled product with a safe one of the same type and at least the same value and quality; or

(c) 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.

The consumer should 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.

Consumers will also have the right to bring representative actions for infringements by economic operators and providers of online marketplaces of provisions of this Regulation that harm, or may harm, the collective interests of consumers.

Documents
2023/03/29
   EP - Debate in Parliament
2023/01/23
   EP - Approval in committee of the text agreed at 1st reading interinstitutional negotiations
Documents
2022/12/21
   CSL - Coreper letter confirming interinstitutional agreement
2022/12/21
   EP - Text agreed during interinstitutional negotiations
Documents
2022/07/06
   EP - Committee decision to enter into interinstitutional negotiations confirmed by plenary (Rule 71)
2022/07/04
   EP - Committee decision to enter into interinstitutional negotiations announced in plenary (Rule 71)
2022/06/30
   EP - Amendments tabled in committee
Documents
2022/06/24
   EP - Committee report tabled for plenary, 1st reading
Details

The Committee on the Internal Market and Consumer Protection adopted the report by Dita CHARANZOVÁ (Renew Europe, CZ) on the proposal for a regulation of the European Parliament and of the Council on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council, and repealing Council Directive 87/357/EEC and Directive 2001/95/EC of the European Parliament and of the Council.

As a reminder, the proposed Regulation aims to revise Directive 2001/95/EC on general product safety to ensure that only safe products are placed on the internal market and to guarantee a high level of safety and consumer protection.

The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows:

Subject matter

Members stipulated that the objective of this Regulation is to improve the functioning of the internal market and maintain a high level of health, safety and consumer protection by laying down essential rules to ensure the safety of consumer products made available on the Union market.

Clarification of definitions

The report clarifies key definitions such as those on ‘product’, ‘safe product’, ‘distance contract’ and ‘antiques’, to give greater certainty to authorities and economic operators.

Obligations of manufacturers

Members proposed to delete certain obligations for manufacturers such as on the previsions for manufacturers on technical documentation as well as the obligation to investigate complaints received concerning products they made available on the market. Members suggested that manufacturers should ensure that the technical documentation is up to date. They should keep it for a period of ten years after the product has been placed on the market at the disposal of the market surveillance authorities, upon request.

Information to economic operators

The amended text proposed that the Commission should adopt specific guidelines for economic operators, particularly those that qualify as SMEs, including micro-enterprises, on how to fulfil the obligations laid down in this Regulation. In particular they should aim to simplify and limit the administrative burden for smaller businesses while ensuring the effective and consistent application in accordance with the general objective of ensuring product safety and consumer protection.

Obligations of economic operators in case of accidents related to safety of products

Manufacturers should ensure that, through the Safety Business Gateway, an accident directly caused by a product made available on the market is notified immediately after it knows about the accident or about the results of the investigation, to the competent authorities of the Member State where the accident has occurred.

Information requirements in electronic format

Economic operators should additionally make information available in a digital format by means of electronic solutions, such as a non-removable QR or matrix code.

Specific obligations of online marketplaces related to product safety

The amended text proposed an updated and targeted set of rules for online marketplaces to increase safety, better protect consumers and help in reaching a level playing field between the online and offline sectors while preserving the competitiveness of our economic operators, especially the smaller ones.

In particular, Members suggested that online marketplaces should easily register with the Safety Gate portal and indicate on the portal the information concerning their single contact point. They should make use of the single point of contact to enable consumers to communicate directly and swiftly with them. They should inform economic operators about the information communicated by consumers on accidents or safety issues with regard to the product offered for sale online by those economic operators through their services.

Online marketplaces should inform, where possible, the relevant economic operator of the decision to remove or disable access to the illegal content.

Customers information should be strengthened especially on actions taken with regard of dangerous products and on possible remedies. In addition, the exchange of information between platforms, traders and market surveillance authorities has been strengthened.

The report also encouraged additional and voluntary commitments to be taken by online marketplaces in the form of ‘ memoranda of understanding ’ to setting up further concrete actions to strengthen the safety of products. These will include measures preventing the reappearance of dangerous products online, exploiting the potential use of new technologies for an improved market surveillance, and investment in training for online traders.

Market surveillance

According to Members, market surveillance authorities should, on a regular basis, conduct inspections on samples of products , categories or groups of products acquired under a cover identity. Where market surveillance authorities in other Member States reach a different conclusion in terms of identification or level of the risk on the basis of their own investigation and risk assessment, the Commission should start an arbitration process.

Consumer safety network and international cooperation

Members consider it crucial to strengthen the existing cooperation between national authorities and the Commission; this is why the proposed article on ‘Consumer Safety Network’ has been further developed to add new areas of cooperation and to clarify the objectives.

Similarly, the article on international cooperation with third countries’ regulatory authorities has been further specified, focusing in particular on preventing the circulation of dangerous products, on the use of new technologies and the exchange on regulatory matters to guarantee a level playing field.

Entry into force

The report suggested that the new Regulation should enter into force as soon as possible in order to increase the overall safety in the European Union. However, the required time foreseen for the application of new provisions is too short in light of the significant changes foreseen by the proposal. Therefore, it is proposed to extend the date of application of the Regulation from 6 to 12 months after its entry into force.

Documents
2022/06/16
   EP - Vote in committee, 1st reading
2022/06/16
   EP - Committee decision to open interinstitutional negotiations with report adopted in committee
2022/03/18
   EP - Committee opinion
Documents
2022/02/02
   EP - REPASI René (S&D) appointed as rapporteur in JURI
2022/01/19
   EP - Amendments tabled in committee
Documents
2022/01/19
   EP - Amendments tabled in committee
Documents
2021/12/10
   EP - Committee draft report
Documents
2021/11/21
   ES_PARLIAMENT - Contribution
Documents
2021/11/21
   ES_PARLIAMENT - Contribution
Documents
2021/10/20
   ESC - Economic and Social Committee: opinion, report
Documents
2021/09/13
   EP - Committee referral announced in Parliament, 1st reading
2021/07/15
   EP - CHARANZOVÁ Dita (Renew) appointed as rapporteur in IMCO
2021/07/01
   EC - Document attached to the procedure
Documents
2021/07/01
   EC - Document attached to the procedure
2021/07/01
   EC - Document attached to the procedure
2021/06/30
   EC - Legislative proposal published
Details

PURPOSE: to revise existing legislation on general product safety (GPSD) to ensure that EU consumers are protected from dangerous products.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

BACKGROUND: Directive 2001/95/EC on general product safety, in force since 2001, ensures that only safe products are sold on the EU single market. However, too many unsafe products still circulate on the EU market, creating an uneven playing field for businesses and an important cost for society and consumers.

The rules need to be updated to:

- ensure the EU legal framework provides for general safety rules for all consumer products and safety risks, including those linked to new technologies;

- address product safety challenges in the online sales channels;

- make product recalls more effective and efficient to keep unsafe products away from consumers;

- enhance market surveillance and ensure better alignment of rules for harmonised and non-harmonised consumer products and;

- address safety issues related to food imitating products.

IMPACT ASSESSMENT: the preferred option should: (i) decrease the estimated consumer detriment by approximately EUR 1 billion in the first year of implementation of the preferred option and by approximately EUR 5.5 billion over the next decade; (ii) reduce consumer detriment related to ineffective recalls by more than EUR 400 million per year.

CONTENT: the proposed Regulation aims to revise Directive 2001/95/EC on general product safety to ensure that only safe products are placed on the internal market and to guarantee a high level of safety and consumer protection in a world reshaped by digitalisation and the COVID-19 pandemic.

More specifically, it:

- provides a ‘safety net’ for all products falling under its scope of application establishing requirements to ensure the safety of consumer products and therefore the safety of consumers;

- provides rules on the application of this Regulation to the non-harmonised legislation;

- introduces the general safety requirement , confirms the importance of standards published in the EU Official Journal as providing presumption of safety and updates aspects for assessing the safety of products to take into consideration food-imitating products in the risk evaluation. New aspects for assessing product safety also include the possible risks related to products based on new technologies;

- introduces the general safety requirement and updates the aspects of product safety assessment to take into account food-imitating products in the risk assessment, as well as products based on new technologies;

- defines the obligations of economic operators to ensure product safety and extends the concept of the person responsible for market surveillance and product compliance to non-harmonised products. This is a necessary condition for making products available on the market in order to tackle the issues of direct imports from third countries;

- examines the role played by online marketplaces and provides clarification on how the legislation would apply to the risks posed by new technologies and online sales;

- adapts the provisions on market surveillance with a view to creating, as far as possible, a single regime for harmonised and non-harmonised products;

- contains the basic provisions on traceability and the possibility, in the case of products susceptible to pose a serious risk to people’s health and safety, to adopt a more stringent system of traceability, to be adopted by a delegated act;

- lays down the principle for exchanging information in the case of a dangerous product and changes the name of the RAPEX system to Safety Gate , while maintaining the same characteristics of the system. The proposal adds more specific deadlines;

- provides the possibility for the Commission to adopt measures, through implementing acts, in case of a serious risk which cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned or by any other procedure under EU legislation. This possibility already exists in the GPSD: the proposed regulation makes its scope of application more precise;

- introduces a voluntary arbitration mechanism where Member States can submit to the Commission questions concerning the identification or the level of a risk linked to a product in case of diverging risk assessments. This will make it possible to take more uniform action at EU level against dangerous products;

- confirms the obligation for the Commission and Member States to make available to consumers information relating to risks to health and safety posed by products;

- sets the obligation for Member States to give consumers the opportunity to submit complaints to the competent national authorities;

- provides the legal basis for the Commission to establish forms of cooperation to improve product safety. These include common enforcement actions, technical support, exchange of officials, and the exchange of information on dangerous products and in particular information contained in the Safety Gate;

- provides in particular for a system of penalties : while recognising that establishing penalties is a national competence, it sets out guiding principle for penalties, in particular criteria for setting penalties, the types of infringements to be penalised, criteria on maximum ceilings, as well as the possibility to impose periodic penalty payments.

Budgetary implications

The proposed regulation requires the Commission to support and facilitate the cooperation of market surveillance enforcement authorities, including coordinated market surveillance activities, the new arbitration mechanism and peer reviews. It also provides for the adoption of implementing acts and delegated acts (related to traceability and recalls) and possible higher standardisation activity through a simplified standardisation procedure. This will trigger additional workload for the Commission, estimated at four extra full-time officials (three administrators and one assistant). These resources will be obtained through the redistribution and refocusing of the existing personnel’s tasks.

The Commission will also finance electronic interfaces, namely the Safety Gate webpage, the Safety Gate portal (which provides notifications of dangerous products) and the Safety Business Gateway collecting notifications from economic operators to market surveillance authorities.

Additional costs for these coordination activities and electronic interfaces can be covered by the single market programme under the current multiannual financial framework 2021-2027.

Documents

  • Final act published in Official Journal: Regulation 2023/988
  • Final act published in Official Journal: OJ L 135 23.05.2023, p. 0001
  • Commission response to text adopted in plenary: SP(2023)227
  • Draft final act: 00079/2022/LEX
  • Results of vote in Parliament: Results of vote in Parliament
  • Decision by Parliament, 1st reading: T9-0090/2023
  • Debate in Parliament: Debate in Parliament
  • Approval in committee of the text agreed at 1st reading interinstitutional negotiations: PE740.576
  • Coreper letter confirming interinstitutional agreement: GEDA/A/(2023)000062
  • Text agreed during interinstitutional negotiations: PE740.576
  • Amendments tabled in committee: PE719.841
  • Committee report tabled for plenary, 1st reading: A9-0191/2022
  • Committee opinion: PE699.339
  • Amendments tabled in committee: PE703.262
  • Amendments tabled in committee: PE704.597
  • Committee draft report: PE702.956
  • Contribution: COM(2021)0346
  • Contribution: SWD(2021)0169
  • Economic and Social Committee: opinion, report: CES3583/2021
  • Document attached to the procedure: SEC(2021)0280
  • Document attached to the procedure: EUR-Lex
  • Document attached to the procedure: SWD(2021)0168
  • Document attached to the procedure: EUR-Lex
  • Document attached to the procedure: SWD(2021)0169
  • Legislative proposal published: COM(2021)0346
  • Legislative proposal published: EUR-Lex
  • Document attached to the procedure: SEC(2021)0280
  • Document attached to the procedure: EUR-Lex SWD(2021)0168
  • Document attached to the procedure: EUR-Lex SWD(2021)0169
  • Economic and Social Committee: opinion, report: CES3583/2021
  • Committee draft report: PE702.956
  • Amendments tabled in committee: PE703.262
  • Amendments tabled in committee: PE704.597
  • Committee opinion: PE699.339
  • Amendments tabled in committee: PE719.841
  • Coreper letter confirming interinstitutional agreement: GEDA/A/(2023)000062
  • Text agreed during interinstitutional negotiations: PE740.576
  • Draft final act: 00079/2022/LEX
  • Commission response to text adopted in plenary: SP(2023)227
  • Contribution: COM(2021)0346
  • Contribution: SWD(2021)0169

Activities

Votes

Règlement sur la sécurité générale des produits - General Product Safety Regulation - Verordnung über die allgemeine Produktsicherheit - A9-0191/2022 - Dita Charanzová - Accord provisoire - Am 237 #

2023/03/30 Outcome: +: 569, -: 13
DE IT FR PL ES RO NL SE PT BE HU DK IE HR SK CZ EL FI AT LT LV SI BG CY LU EE MT
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80
64
64
48
47
26
25
19
19
17
17
13
13
11
13
17
13
9
17
9
7
7
6
5
5
7
4
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1

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3

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Portugal Verts/ALE

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AmendmentsDossier
1235 2021/0170(COD)
2021/12/14 JURI 377 amendments...
source: 703.003
2022/01/19 IMCO 619 amendments...