EU Consumer Goods General Product Safety Regulation (GPSR)
General Product Safety Regulation establishes more vital EU safety rules for placing consumer products on the EU market. The European Union (EU) recently introduced the General Product Safety Regulation (GPSR), which was adopted in May 2023, replacing the General Product Safety Directive (GPSD) of 2001. The regulation will apply as of December 13, 2024. This regulation introduces new safety requirements for consumer products sold within the EU, both directly to consumers and B2B, making it essential for U.S. exporters to adapt to new compliance requirements to gain or maintain market access. The new rules seek to address significant societal changes that have affected consumer product safety, such as increasing digitalization, new technological developments, and globalized supply chains.
Expanded Scope and Responsibilities for U.S. Exporters
The GPSR addresses the gaps in the current framework, focusing on e-commerce, online marketplaces, artificial intelligence, connected devices and product recalls to ensure the safety of consumer products sold in the EU. These requirements apply to all manufacturers who place products on the EU market, regardless of the place of establishment of the manufacturer. In other words, EU and U.S. manufacturers must comply with the new regulation when placing products on the EU market. The regulation is complementary to the sector-specific legislation. This means that if a product is not covered by a more specific regulation, the GPSR applies. However, if a sector-specific regulation exists, the GPSR will apply to the risks and safety aspects not regulated by those sector-specific rules.
Enhanced Product Safety Requirements
The GPSR expands on the basic safety requirements laid out in the previous directive. U.S. companies exporting to the EU must take a proactive approach in identifying risks associated with their products. The regulation mandates that products undergo a risk assessment considering foreseeable use, misuse, and potential hazards. Manufacturers must draw up technical documentation containing all the necessary information to prove the products are safe. Exporters must also ensure that safety information and warnings are clear and provided in the languages of the EU Member States where the products will be sold.
Introduction of the EU Responsible Person Requirement
A significant change introduced by the GPSR is the requirement for a “responsible person” within the EU who will act as the point of contact for product compliance and safety issues. U.S. exporters must designate a responsible person within the EU, who will be accountable for ensuring that products sold in the market meet all applicable safety standards. Responsible persons can be the manufacturer, the authorized representative, the importer, the distributor, the fulfillment service provider, or any other natural or legal person established in the EU.
This responsible person must have access to the technical documentation and, in some cases, will need to collaborate with local authorities in case of product recalls or safety concerns.
Digital and Online Marketplace Compliance
In light of increasing e-commerce activity, the GPSR addresses safety risks posed by products sold online. U.S. exporters distributing goods through online platforms should be aware that these platforms are subject to the same safety regulations as brick-and-mortar retailers. The regulation introduces specific measures to hold online marketplaces accountable for ensuring that products available on their platforms meet EU safety standards. For U.S. companies using e-commerce to reach EU consumers, it is essential to implement robust safety and tracking systems to comply with the new requirements. This includes providing accessible and transparent safety information for digital transactions.
The GPSR enhances the traceability of consumer products, requiring U.S. exporters to implement stronger tracking mechanisms to monitor product movements within the EU market. In the event of a product recall, exporters must act swiftly to remove unsafe goods from the market, inform consumers, and notify EU authorities. Traceability is a key focus. The regulation requires that products include batch numbers, manufacturer details, and other identifying information to ensure quick identification and removal in case of a safety issue. Non-compliance with recall protocols may result in penalties and a loss of market access.
Penalties for Non-Compliance
Non-compliance with the GPSR can lead to consequences for U.S. exporters, including fines, product bans, and reputational damage. U.S. companies should conduct thorough due diligence to avoid breaching EU safety laws.
Market Surveillance and Data Sharing
The GPSR strengthens market surveillance mechanisms across the EU. Member States must now actively monitor and enforce compliance with product safety laws. For U.S. exporters, this means increased scrutiny, with local authorities empowered to perform random checks and impose sanctions on non-compliant products. The regulation also enhances data sharing between Member States and EU agencies, creating a more efficient and coordinated response to unsafe products. U.S. exporters should maintain thorough records and technical documentation on their products to ensure smooth cooperation with EU authorities if requested.
Formal EU Guidance
The European Commission has not yet released the official detailed guidance for the General Product Safety Regulation (GPSR). However, companies can expect further communications and clarifications from the Commission to be published by the regulation’s entry into application at the latest.
For now, if companies have questions about their obligations, they may reach out to national regulatory authorities or consider working with legal experts specializing in EU regulatory compliance until the Commission’s official guidance is published. You can also watch updates through industry portals or directly from the European Commission as more information becomes available.
While we cannot offer legal advice, feel free to contact our Commercial Service team at the U.S. Mission to the EU in Brussels to discuss this further. Contact information is at the bottom of this report.
Recommendations for U.S. Exporters:
U.S. companies exporting to the EU should:
1. Enhance Risk Assessment Procedures: Conduct a thorough risk analysis of all consumer products and document compliance with the GPSR safety requirements.
2. Strengthen Supply Chain Traceability: Implement systems for tracking products from production to distribution, ensuring all identifying information is accurate and accessible for recalls.
3. Collaborate with Online Marketplaces: Ensure that goods sold through e-commerce platforms meet the same safety standards as those sold through traditional retail channels.
4. Prepare for Increased Surveillance: Be prepared for increased market surveillance activities, including random product checks and regulatory investigations.
5. Ensure there is an EU-based Responsible Person if the product only falls under the scope of the GPSR: Ensure an authorized representative is established within the EU to manage compliance and serve as the point of contact with local authorities.
Helpful Links:
1. European Commission website:
The official European Commission page on the General Product Safety Regulation provides comprehensive information about the regulation, its objectives, timeline, and latest updates.
2. Official Journal of the European Union:
The full text of Regulation (EU) 2023/988 on general product safety was published in the Official Journal of the EU on May 23, 2023.
For more information, please contact:
Jim Curtis – Commercial Officer and Standards Attaché – jim.curtis@trade.gov
Eva D’Agostino – Commercial Specialist – Eva.D’Agostino@trade.gov
Kiliane Huyghebaert – Commercial Specialist – Kiliane.huyghebaert@trade.gov