Overview of Regulation (EU) 2023/988 on General Product Safety (GPSR)
Regulation (EU) 2023/988, adopted on 10 May 2023 and in force since December 2024, establishes a comprehensive framework for general product safety within the European Union and the European Economic Area. It replaces Directive 2001/95/EC and Council Directive 87/357/EEC, consolidating and updating consumer product safety rules to address modern challenges, including those posed by evolving technologies and online sales. The regulation aims to ensure a high level of consumer health and safety while maintaining the functioning of the internal market. It applies to all consumer products placed on the market or made available to consumers, with specific exemptions for medicinal products, food and feed, and living plants, which are governed by sector-specific legislation.
The GPSR introduces a horizontal legislative framework that complements existing sector-specific Union harmonisation legislation. It ensures that gaps in product safety are addressed, particularly for risks not covered by specialized regulations. The regulation also clarifies the scope of its application to avoid overlaps with other legal instruments, such as Regulation (EU) 2019/1020 on market surveillance, which governs products subject to harmonisation legislation.
A key innovation of the GPSR is its explicit inclusion of a product’s learning and evolving features, as well as cybersecurity, among the safety characteristics that must be assessed. This expansion reflects the growing integration of artificial intelligence and connected technologies in consumer goods, bringing AI-enabled products under the scope of recall and marketplace duties.
Scope and Applicability of the GPSR
The GPSR applies broadly to consumer products intended for use by individuals, including those that may have migrated from professional to consumer markets. It covers products placed on the market or made available to consumers within the EU, regardless of where they are manufactured or sold. However, certain categories are excluded from its scope: medicinal products, which undergo pre-market risk-benefit assessments; food and feed products, governed by dedicated regulations such as Regulation (EC) No 178/2002 and Regulation (EU) 2017/625; and living plants, regulated under Regulation (EU) 2016/2031. Materials and articles intended to come into contact with food are included only insofar as risks not covered by food-specific legislation, such as Regulation (EC) No 1935/2004, are concerned.
The regulation also addresses the roles of economic operators, including manufacturers, authorised representatives, importers, distributors, and providers of online marketplaces. Non-EU manufacturers must designate an authorised representative within the EU to act as a contact point for market surveillance authorities. Economic operators are obligated to cooperate with authorities to remove unsafe products from the market and prevent repeat violations.
Key Obligations for Economic Operators
Under the GPSR, manufacturers and other economic operators must ensure that products comply with the general safety requirement. This involves conducting an internal risk analysis to identify hazards associated with a product’s design, materials, and intended use. The technical documentation required to demonstrate conformity includes: a general description of the product, its intended function, essential safety characteristics, and user age category; a list of applicable legal requirements and standards; a systematic assessment of foreseeable hazards, including mechanical, chemical, thermal, electrical, hygiene, and radiation risks; and mitigation measures such as design improvements, warnings, and user instructions. Products conforming to harmonised European standards benefit from a presumption of conformity, provided the risks covered by those standards are addressed.
Labeling requirements under Article 9 of the GPSR mandate that products must display a type, batch, or serial number, the manufacturer’s contact details, and instructions or safety information in a language understood by consumers in each Member State. For products where physical labeling is impractical, this information must appear on packaging or in accompanying documentation. Online sellers must also provide clear manufacturer or authorised representative information, product identification, and warnings on their websites. Digital labels, such as QR codes, may complement but not replace physical labeling requirements.
The GPSR introduces obligations for providers of online marketplaces, including registration with the EU Safety Gate portal and the designation of a single point of contact for regulatory authorities. Online marketplaces must cooperate with authorities to remove unsafe products swiftly and ensure compliance with product safety reporting obligations. Failure to adhere to these requirements can result in enforcement actions, including fines and product bans. The regulation also strengthens incident reporting mechanisms, requiring mandatory notifications within two working days for serious product safety risks.
Safety Assessment and Compliance Mechanisms
The GPSR requires manufacturers to maintain technical documentation, often referred to as a technical file or Digital Product Passport (DPP), to demonstrate compliance with safety requirements. This documentation must include a Declaration of Conformity, a general product description, essential safety characteristics, risk assessments, and testing reports where applicable. The technical file serves as evidence that a product meets the general safety requirement and must be made available to national authorities upon request. Economic operators are responsible for holding and maintaining this documentation, with non-EU manufacturers relying on their EU-based authorised representatives to fulfill these obligations.
Market surveillance authorities are empowered to take action against dangerous products through the EU Safety Gate, a rapid information system that facilitates coordination between Member States. The GPSR harmonizes penalties for non-compliance, ensuring that significant fines and product bans are applied consistently across the Union. Liability for product safety primarily rests with the manufacturer, though other economic operators may assume responsibility under specific conditions, such as when a non-EU manufacturer fails to designate an authorised representative. The regulation also clarifies that authorised representatives and importers are not liable for consumer compensation unless they meet the definition of a producer under EU law.
The GPSR’s emphasis on cybersecurity and learning features in consumer products reflects the increasing complexity of modern goods. This includes evaluating potential vulnerabilities in software, data privacy concerns, and the product’s behavior under reasonably foreseeable conditions of use. The regulation ensures that such products are subject to the same recall and marketplace duties as traditional consumer goods, reinforcing the EU’s commitment to a high level of consumer protection in the digital age.
Required actions
- Assess safety of consumer products including their cybersecurity, evolving and learning features and connections with other products - Non-EU manufacturers need an EU responsible person; online marketplaces must cooperate with recalls and take down unsafe listings - Report accidents to authorities through the Safety Business Gateway