WHAT IS THE AIM OF THE REGULATION?
KEY POINTS
The regulation:
- applies to new, used, repaired or reconditioned products:
- available for distribution, consumption or use in the EU (‘placed or made available on the market’), whether for free or against payment, which are not covered by other specific EU product safety legislation,
- subject to existing specific EU safety requirements regarding the risks and aspects that are not already covered therein;
- applies to products offered to consumers in the EU via all sales channels;
- does not apply to the following:
- medicinal products for human or veterinary use,
- food and feed,
- living plants and animals, genetically modified organisms and microorganisms in contained use,
- animal-derived and by-products,
- plant protection products,
- transport equipment operated by a service provider,
- aircraft whose design, production, maintenance and operation pose a low safety risk,
- antiques,
- products clearly marked to be repaired or reconditioned prior to use.
This regulation provides obligations for the relevant economic operators1 and providers of online marketplaces and also clarifies market surveillance rules and the powers of national authorities. It is closely linked to other relevant EU legislation, such as the market surveillance regulation and the Digital Services Act.
This regulation will be implemented by all relevant actors, taking due account of the precautionary principle.
Safety requirements
Economic operators will place or make available on the market only safe products (general safety requirement).
- The safety of products must be assessed, taking into account, in particular, the following criteria:
- the characteristics of the product, such as design, technical features, composition, packaging and instructions;
- the effect on other products;
- the presentation of the product, the labelling, any warnings and safety instructions and information;
- the categories of consumers using the product;
- the appearance of the product, in particular food-imitating or child-appealing aspects;
- the cybersecurity features and any evolving, learning and predictive functionalities of the product.
- This regulation also provides for cases where a product is presumed to be safe. Such cases include products in conformity with relevant European standards referenced in the Official Journal of the European Union.
- Other elements that can be taken into account for assessing the safety of a product are national and international standards, voluntary certification schemes, good-practice codes and reasonable consumer expectations.
Information on unsafe products
- A product deemed dangerous in one EU Member State is presumed to be dangerous in all others.
- When a product is recalled, the information must be available to the public in clear and detailed language, and consumers need to be offered an effective, cost-free and timely remedy.
- Information on dangerous products should, in general, be made available to the public via the Safety Gate portal.
Requirement to have a responsible economic operator in the EU
For each product covered by the regulation, there has to be a responsible economic operator in the EU (an EU manufacturer, importer, authorised representative or a fulfilment service provider) entrusted with tasks relating to the safety of the product.
Main obligations of manufacturers:
- ensure products are safe by design;
- carry out internal risk analyses and draw up relevant technical documentation;
- act immediately and inform consumers and national authorities, through the Safety Business Gateway, if they believe a product on the market is dangerous;
- share information on accidents;
- provide essential product safety and traceability information on products or their packaging;
- provide contact details to receive complaints, investigate them and keep an internal register of complaints received.
Manufacturers may appoint an authorised representative to carry out their obligations.
Main obligations of importers:
- ensure products comply with the regulation’s general safety requirement, refusing to place on the market any they consider do not meet this requirement;
- provide their contact details on the products and check that they are accompanied by clear instructions and safety information;
- take responsibility for the items in their care during transport and storage;
- inform manufacturers and national market surveillance authorities, through the Safety Business Gateway, if they believe a dangerous product is on the market and ensure the public is alerted.
Main obligations of distributors:
- ensure manufacturers and, where applicable, importers comply with the regulation’s requirements, refusing to place on the market any they consider do not meet these requirements;
- inform manufacturers, importers and national surveillance authorities, through the Safety Business Gateway, if they believe a dangerous product is on the market and ensure suitable action is taken.
Economic operators' horizontal obligations:
- establish internal product safety processes to comply with the regulation;
- cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- on request by authorities, provide specific product information (risks, complaints, corrective measures) for 10 years and supply chain traceability information for 6 years;
- inform authorities about accidents caused by a product;
- provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- directly inform all affected consumers about product safety recalls and safety warnings, in the case of product recalls using a mandatory recall notice template;
- offer consumers the choice of at least two of the following remedies when a product is recalled: either repair or replacement of the product or an adequate refund;
- follow specific rules for distance sales by giving details, as part of the pre-contractual product offer, of the manufacturer or their representative, a clear description of the product and any warning or safety information, as in a brick-and-mortar shop.
Specific product safety obligations of providers of online marketplaces
The following product-specific obligations build on the horizontal requirements of the Digital Services Act:
- implement two single points of contact for direct communication on safety issues: one for market surveillance authorities, the other for the public;
- register with the Safety Gate portal;
- have in place internal product safety processes;
- ensure that without the minimum product safety and traceability information, to be provided by the relevant trader, a listing cannot be published (compliance by design obligation);
- check at random whether products offered are safe by using public databases, including the Safety Gate portal;
- react within a short deadline to governmental orders and third-party notices and ensure that listings that were taken down cannot reappear;
- supply appropriate and timely information to consumers when a product is recalled by directly contacting all who bought the item on their site and publishing details on their web page;
- inform, in the event of a recall or an accident, the relevant economic operator and inform and cooperate with market surveillance authorities.
Market surveillance and implementation
- Enforcement of EU product safety rules falls under the competence of national market surveillance authorities.
- Market surveillance under this regulation and Regulation (EU) 2019/1020 (market surveillance regulation) is aligned to the extent possible.
- Authorities, when a dangerous product is identified, can ask a manufacturer for details of other items using the same procedure or components or in the same batch.
- Member States will determine effective, proportionate and dissuasive penalties for infringements of the regulation.
The Consumer Safety Network of national authorities, coordinated by the Commission:
- facilitates the regular exchange of information, expertise, best practices and product safety enforcement;
- organises joint surveillance and testing projects;
- improves EU cooperation on the tracing, withdrawal and recall of dangerous products.
Market surveillance authorities:
- may cooperate with other colleagues and economic operators or consumer organisations to ensure public health and safety where specific product categories are concerned;
- will conduct simultaneous coordinated control actions (‘sweeps’) relating to products to ensure compliance with the regulation.
The Commission:
- develops, modernises and maintains the EU rapid alert system used to exchange information on the national measures taken against dangerous non-food products (Safety Gate);
- maintains a web portal (the Safety Business Gateway) for economic operators and online marketplace sellers to provide market surveillance authorities and the public with information on potentially dangerous products;
- operates the Safety Gate portal, which provides the public with free information on identified risks;
- may cooperate with non-EU countries and international organisations to improve the overall safety of products, including via information exchanges on dangerous products;
- draws up a number of evaluation reports on the regulation’s implementation;
- has the power and obligation to adopt certain implementing and delegated acts.
The regulation amends Regulation (EU) No 1025/2012 (see summary) and Directive (EU) 2020/1828 (see summary) and repeals Directives 87/357/EEC (see summary) and 2001/95/EC (see summary).
FROM WHEN DOES THE REGULATION APPLY?
It applies from 13 December 2024.
BACKGROUND
The regulation repeals the general product safety directive from 2001 and provides a new EU general product safety framework to keep up with the challenges of digitalisation and the increasing amount of goods and products sold online.
KEY TERMS
- Economic operator. Manufacturer, authorised representative, importer, distributor, fulfilment service provider or any person subject to legal obligations on manufacturing or making a product available.
MAIN DOCUMENT
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, pp. 1–51).
RELATED DOCUMENTS
Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on representative actions for the protection of the collective interests of consumers and repealing Directive 2009/22/EC (OJ L 409, 4.12.2020, pp. 1–27).
Successive amendments to Directive (EU) 2020/1828 have been incorporated into the original text. This consolidated version is of documentary value only.
Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, pp. 1–44).
Directive (EU) 2019/770 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the supply of digital content and digital services (OJ L 136, 22.5.2019, pp. 1–27).
Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 2009/22/EC, and repealing Directive 1999/44/EC (OJ L 136, 22.5.2019, pp. 28–50).
Consolidated version of the Treaty on the Functioning of the European Union – Part Three – Union policies and internal actions – Title XV – Consumer protection – Article 169 (ex Article 153 TEC) (OJ C 202, 7.6.2016, p. 124).
Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, pp. 12–33).
See consolidated version.
Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, pp. 64–88)
Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, pp. 4–17).
See consolidated version.
Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of consumers (OJ L 192, 11.7.1987, pp. 49–50).
