EU Regulation 2023/988 or GPSR: New Standards for Product Safety in the EU
General Product Safety Regulation (GPSR) Enters into Force in 2024
As of December 13, 2024, EU Regulation 2023/988, also known as the General Product Safety Regulation (GPSR), will enter into force. This regulation, which replaces the previous Directive 2001/95/EC, aims to update and strengthen the rules on the safety of products placed on the European market, addressing the new challenges arising from digitalization and cross-border trade.
A New Concept of Product Safety
EU Regulation 2023/988 redefines the concept of product safety, placing greater emphasis not only on technical compliance but also on elements such as labeling, instructions for use, warnings, and disposal systems. In particular, the regulation focuses on the protection of vulnerable consumers, such as children and the elderly, and considers the risks related to cybersecurity, especially for connected products (e.g., IoT devices and smart devices).
Products Covered by the Regulation
- Electronics and IT: IT and electronic devices without CE marking.
- Consumer products: Toys, household equipment, and medical devices not covered by specific regulations.
- Imported products: Coming from non-EU countries with risks of non-compliance with European standards.
In general, therefore, all products not subject to the CE marking obligation.
The main changes include:
- Single Point of Contact: Each product must have a clear reference that allows consumers to communicate with the person responsible for safety.
- Compliance independent of the sales channel: Safety standards apply to both online and physical channels, ensuring regulatory consistency.
- Cybersecurity: Connected products must be designed to prevent risks related to cybersecurity and ensure protection from external attacks.
EU Regulation 2023/988: Obligations for Manufacturers, Importers, and Distributors
The regulation applies to various categories of economic operators:
Manufacturers
Must conduct a complete risk assessment, document the results in a technical file, and provide adequate instructions and warnings.
Importers
Are responsible for verifying the conformity of products from non-EU countries, ensuring that they meet safety requirements.
Distributors
Must ensure that products placed on the market comply with regulations and cooperate with competent authorities in the event of reports or recalls.
How to Comply with the GPSR
To comply with EU Regulation 2023/988, companies must:
- Risk assessment: Consider not only classic risks but also those related to cybersecurity and product design.
- Technical documentation: Including user manuals, warnings, instructions, and information related to cybersecurity.
- Cooperation with authorities: Companies must cooperate with authorities in the event of reports or recalls, providing the requested information.
Why Compliance with the GPSR is Crucial
In addition to being a regulatory obligation, the GPSR offers companies the opportunity to improve consumer trust, protect their reputation, and reduce the risk of penalties and recalls. Compliant products not only guarantee safety but can also open up new market opportunities and increase business competitiveness.
For further details on how to comply with EU Regulation 2023/988 and receive specific support, contact us today.
We are ready to guide you step by step to ensure compliance and protect your business from future risks.
