Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety replaces Directive 2001/95/EC and aims to ensure the health and safety of consumers and the functioning of the internal market. The EU’s non-food product safety framework chiefly comprises two sets of legislative instruments. Firstly, there is its “harmonised legislation”, including Regulation (EU) 2019/1020 on market surveillance and compliance of products and product-specific safety legislation, such as the Machinery Directive (2006/42/EC) and the PPE Regulation (2016/425/EU). Secondly, there is this General Product Safety Directive, which applies to all non-food products not subject to specific harmonised legal provisions. It also partially applies to said harmonised products with regard to any aspects not covered by the aforementioned specific harmonised legislation. As such, it provides a “safety net”, ensuring that EU consumers are protected against any product safety risks.
Regulation 2023/988/EU replaces the General Product Safety Directive of 2001. The 2001 Directive needed to be updated to address the product safety challenges of emerging technologies, including the use of artificial intelligence (AI) and connected devices, and to set clear obligations for online marketplaces, which are being increasingly used by EU consumers.
Since these general product safety rules are laid down in the form of a Regulation, they are directly applicable in Member States as, unlike those of a Directive, there is no need for them to be transposed into national legislation.
The Regulation also modernises RAPEX, the rapid alert system for dangerous products, which is now renamed “Safety Gate” and focuses on a better exchange of information on measures taken against non-food dangerous products.
The objective of the General Product Safety Regulation is to ensure that EU consumers are protected against dangerous products and to guarantee the proper functioning of its single market.
The Regulation defines terms such as "product", "safe product", "dangerous product", "risk", "serious risk", "placing on the market", "manufacturer", "economic operator", "consumer", etc.
A "safe product" means any product which, under normal or reasonably foreseeable conditions of use, including the actual duration of use, does not present any risk or only the minimum risks compatible with the product’s use, considered acceptable and consistent with a high level of protection of the health and safety of consumers.
It is the responsibility of economic operators to place only safe products on the market. Manufacturers have the obligation to carry out a risk analysis and to draw up technical documentation before placing their products on the market. To ensure the traceability of a product through the supply chain, each product should carry information that allows identification of the product itself as well as the manufacturer or other relevant economic operators. If economic operators become aware that a product is dangerous, they must take corrective measures and inform, through the Safety Business Gateway (part of Safety Gate), market surveillance authorities and cooperate with them.
Providers of online marketplaces have the obligation to register on Safety Gate and identify a single contact point. Providers of online marketplaces must ensure that they have internal processes for product safety in place in order to comply with the requirements of the Regulation.
The Regulation also establishes Safety Gate, which comprises three elements: first, a rapid alert system on dangerous non-food products through which national authorities and the Commission can exchange information on such products (Safety Gate Rapid Alert System); second, a web portal to inform the public and enable them to submit complaints (Safety Gate Portal); and, third, a web portal to enable businesses to comply with their obligation to inform authorities and consumers of dangerous products and accidents (Safety Business Gateway).
The Regulation applies from 13 December 2024. Member States may not impede the making available on the market of products covered by Directive 2001/95/EC which are in conformity with that Directive and which are or were placed on the market before 13 December 2024.
Correlation table Directive 2001/95/EC - Regulation 2023/988/EU
- Safety Gate: the EU rapid alert system for dangerous non-food products
- EU Commission Consumer product safety
- Commission Staff Working Document – Impact assessment accompanying the document 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