2025 GPSR Compliance: How the EU Is Reinventing Product Safety
From 13 December 2024, the General Product Safety Regulation (EU) 2023/988 (“GPSR”) became fully applicable across the European Union. It replaces Directive 2001/95/EC, introducing directly applicable, uniform safety rules for all consumer products not governed by sector-specific legislation. Unlike its predecessor, the GPSR leaves no room for national interpretation, ensuring consistent consumer protection across the EU.
The Regulation extends product-safety obligations to online marketplaces, connected products, and cross-border e-commerce, while harmonising recall procedures and transparency requirements. For an overview, see the European Commission’s article on the new GPSR framework.
Why the change was necessary
The original 2001 directive predates the rise of digital commerce and smart devices. With connected, AI-enabled, and updateable products now ubiquitous, the European Commission recognised the need for a modern legal framework. The GPSR reflects that shift by expanding the concept of “safety” beyond physical hazards to include cybersecurity risks, mental-health impacts, and software modifications.
Key improvements under the new Regulation
- Mandatory safety compliance for all consumer products not covered by other EU laws.
- Explicit obligations for online marketplaces and fulfilment-service providers.
- Enhanced traceability, technical documentation, and labeling requirements.
- Modern recall procedures, including digital consumer notifications.
- Improved cooperation between market-surveillance authorities through the Safety Gate system.
See the official EUR-Lex summary for details on scope and obligations.
What market-surveillance data reveals
The European Commission’s Safety Gate Rapid Alert System (formerly RAPEX) has reported record numbers of unsafe products. In 2024, the system validated 4 137 alerts — nearly double 2022 levels — with cosmetics (36%) leading, followed by toys (15%), electrical products (10%), and motor vehicles (9%). The most common hazards were chemical risks (49%), injuries (14%), and electric shock (7%). These figures, published in the Safety Gate 2024 Report, show more active enforcement and stronger digital surveillance.
Core obligations for businesses in 2025
1. Appoint an EU-based economic operator
Manufacturers outside the EU must designate an Authorised Representative or Responsible Person based within the EU, whose contact details appear on the product or packaging. This requirement ensures an accountable point of contact for authorities and consumers alike.
2. Maintain comprehensive technical documentation
Each product must have a technical file including design details, risk assessments, applied standards, and compliance evidence. This documentation must be updated if software or hardware modifications affect safety. Learn more in our GPSR risk analysis guide.
3. Labeling and traceability
Products must display identifying information such as type, batch, and serial number, plus the manufacturer’s and importer’s names and addresses. Instructions and safety information must appear in the official language(s) of the Member State of sale. See our detailed post on labelling requirements for GPSR compliance.
4. Online-marketplace responsibilities
Marketplaces must verify trader information, provide contact points for national authorities, and remove unsafe product listings upon notice. They are required to register through the Safety Business Gateway, part of the integrated Safety Gate ecosystem.
5. Reporting and recall readiness
Economic operators must promptly report serious incidents, product defects, or recalls using the Safety Business Gateway. Consumer-friendly recall templates, available in all EU languages, ensure effective risk communication. For practical steps, read our guide on handling product recalls under the GPSR.
6. Market-surveillance cooperation
Businesses must respond swiftly to authority requests and provide traceability data on demand. Failure to cooperate can lead to product withdrawals, public notices, and penalties—explained further in our article on non-compliance consequences.
What this means for compliance strategy
For brands, importers, and online sellers entering or operating in the EU, GPSR compliance now requires continuous vigilance. Safety must be embedded from design through post-market monitoring. Digital traceability, multilingual documentation, and active participation in recall processes are no longer optional — they are central to maintaining access to the EU market. See our 2025 EU product launch checklist for step-by-step preparation.
How EaseCert supports compliance
EaseCert | GPSR Compliance assists manufacturers, importers, and retailers in aligning with the new GPSR framework. Our services include preparation of risk assessments and technical files, labeling materials, and EU Responsible Person representation. We also manage Safety Gate reporting, recalls, and corrective actions. Explore our full list of services and pricing options or reach out via the contact page.
Looking ahead: digital enforcement and global alignment
The combination of GPSR and the Safety Gate IT ecosystem marks a decisive shift toward real-time, data-driven enforcement. Market surveillance is becoming continuous, automated, and globally connected. Businesses that integrate compliance-by-design, transparent labeling, and rapid communication channels will be best positioned to thrive under this new framework. Learn more in our overview of GPSR penalties and recall management.
Frequently Asked Questions
What is the General Product Safety Regulation (EU) 2023/988?
The General Product Safety Regulation (GPSR) is the EU’s updated legal framework for all consumer products not covered by specific sector legislation. It became applicable on 13 December 2024 and replaces the former 2001 General Product Safety Directive. You can find the full regulation on the EUR-Lex website.
Who needs to comply with the GPSR?
All businesses placing consumer products on the EU market—manufacturers, importers, distributors, and online sellers—must comply with GPSR. Even companies based outside the EU must appoint an EU Responsible Person to ensure compliance and maintain communication with EU market authorities.
What products fall under the GPSR?
The GPSR covers all non-food consumer products that are not governed by other EU sector-specific rules (for example, toys, electronics, clothing, furniture, and cosmetics). If you sell products through platforms like Amazon or Shopify, review our EU compliance guide for consumer products.
What are the main changes compared to the old Directive?
Key updates include stricter traceability requirements, digital recall obligations, stronger enforcement of labelling rules, and accountability for online marketplaces. The regulation also introduces digital safety concepts—such as risks from connected devices or software updates—that did not exist in the previous directive.
Do I need a risk assessment for every product?
Yes. Every product must undergo a documented risk analysis process identifying possible hazards, risk levels, and mitigation measures. This forms part of your technical file, which must be made available to authorities on request.
What information must appear on the product label?
Labels must include the manufacturer’s name, contact details, product identifier, and safety warnings in the official language(s) of the destination country. See our article on GPSR labelling and warning examples for full details.
What happens if my product is found unsafe?
You must immediately report the issue using the Safety Business Gateway and take corrective measures such as recall or withdrawal. Our guide on handling a product recall explains each step. Non-compliance can result in fines, sales bans, or market removal—learn more in this article.
How can EaseCert help with compliance?
EaseCert provides complete GPSR certification packages including risk assessment, technical documentation, labelling review, and EU Responsible Person services. See our services overview or use the contact form to start your compliance process.
How much does GPSR certification cost?
EaseCert’s pricing is transparent and one-time only (no annual renewals). You can review typical costs and coverage on our dedicated pricing page: GPSR cost and Responsible Person pricing guide.
Where can I learn more?
Visit our full FAQ section or explore the EU selling guide for non-EU manufacturers. For updates on recall trends and product alerts, check the European Commission’s Safety Gate portal.
References
- Regulation (EU) 2023/988 on General Product Safety (EUR-Lex)
- General Product Safety Regulation 2023 – Summary (EUR-Lex)
- EU’s General Product Safety Regulation: A New Era of Consumer Protection (European Commission Trade)
- Safety Gate: EU Rapid Alert System for Dangerous Non-Food Products (European Commission)
- BAuA – National Safety Gate Contact Point (Germany)