The General Product Safety Regulation (GPSR) is a European regulation on consumer protection. It replaces Directive 2001/95/EC on general product safety. The regulation is intended to ensure that products placed on the market in the European internal market do not endanger the health and safety of consumers through a high level of consumer protection.[1]
The regulation applies to products placed on the market or made available in the EU. If certain other harmonized legal provisions apply to these products, they are fully or partially exempt from certain obligations, such as the assessment through an internal risk analysis. Some categories of products, like medicinal products, are exempt.
The scope of the regulation includes economic operators such as fulfillment service providers and online marketplace operators.[2]
Economic operators
The GPSR establishes in §3(13) the following roles for economic operators:
To confirm compliance with the general safety requirement under Section 5 of the GPSR ("Economic operators shall place or make available on the market only safe products."), manufacturers are obligated to assess the safety of the product as part of an internal risk analysis. To make this possible, economic operators need internal product safety procedures that enable them to comply with the relevant requirements of this Regulation (that is, to conduct risk management). Various aspects, such as the product's characteristics, composition or packaging, or its interaction with other products, are evaluated. Relevant European standards, for example, may be used for this assessment. The internal risk analysis and the list of any relevant European standards part of the technical documentation for a product. The risk assessment must be documented and made available to market surveillance authorities upon request. Failure to conduct an adequate assessment may result in penalties, recalls, or restrictions on market access.[4]
Labeling Requirements
To improve transparency and consumer safety, GPSR mandates specific labeling requirements.[5] Products must display:
The manufacturer's name, registered trade name, and contact details.
A reference for product traceability, such as a batch or serial number.
Safety warnings in a language easily understood by consumers in the target market.
The regulation also encourages the use of digital labels and QR codes to provide additional compliance documentation and safety instructions.
Online Marketplace Registration
Article 22 of the GPSR introduces new requirements for online marketplaces. Providers of online shops and other digital marketplaces must:
Register with the EU Safety Gate portal.
Designate a single point of contact for EU authorities.
Ensure compliance with product safety reporting obligations.
Marketplaces must also cooperate with regulatory bodies to remove unsafe products swiftly and prevent repeat violations.[6]
Market Surveillance and Penalties
GPSR strengthens enforcement mechanisms across the EU by:[7]
Requiring mandatory incident reporting within two working days for serious product safety risks.
Enhancing coordination between national authorities through the EU Safety Gate.
Harmonizing penalties, including significant fines and product bans for non-compliance.
Distance Sales, Economic Operators, and Authorised Representatives
The GPSR also includes provisions for distance selling that apply to online providers. These providers must register on the Safety Gate portal. Online providers of products covered by the GPSR are also required to fulfill information obligations for consumers. According to Article 19 of the regulation, details about the manufacturer (name or trade name) or the EU-authorized representative of the manufacturer, as well as product identification information (including a product image) and any warnings or safety information about the product, must be provided on the offering website (online interface). Article 22 additionally names specific obligations of providers of online marketplaces that are related to product safety and information.
To enhance accountability, GPSR mandates that non-EU manufacturers appoint an EU-based economic operator to ensure compliance. This can be an EU-based importer, distributor, or an authorized representative.[8]
The EU-based economic operator is responsible for:
Holding and maintaining the product’s technical documentation.
Cooperating with EU market surveillance authorities.
Acting as the official contact point for regulatory compliance inquiries.
If a non-EU manufacturer does not designate an EU-based economic operator, the importer or distributor automatically assumes legal responsibility for product compliance.
Transitional provisions
This regulation applies to all products within its scope that are placed on the market from 13 December 2024. The making available on the market of products covered by Directive 2001/95/EC, which comply with that directive and were placed on the market before 13 December 2024, shall not be impeded by EU member states.
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