The General Product Safety Regulation (GPSR) represents the most significant overhaul of EU product safety legislation in decades. Coming into full effect on December 13, 2024, this regulation replaces the General Product Safety Directive (GPSD) and introduces sweeping changes that affect manufacturers, importers, distributors, and online marketplaces. This article examines the key changes and what they mean for your business.
From Directive to Regulation: Why It Matters
The shift from a directive to a regulation is more than a technical change. Unlike directives, which require implementation into national law by each EU member state (often with variations), regulations apply directly and uniformly across all member states. This means:
- Consistent requirements across all EU markets
- No delays or discrepancies in national implementation
- Greater legal certainty for businesses operating across multiple EU countries
For manufacturers, this translates to simplified compliance processes and reduced costs associated with navigating different national interpretations of product safety requirements.
Expanded Scope and Product Coverage
The GPSR significantly expands its scope compared to the previous directive. Key expansions include:
Digital Products and Connected Devices
The definition of "product" now explicitly includes software and connected devices, whether the connectivity is embedded or not. This means manufacturers of IoT devices, smart appliances, and standalone software must now ensure their products meet GPSR requirements.
Second-hand Products
Previously excluded, second-hand products that have been substantially modified now fall under the GPSR's scope. Refurbishers and resellers need to be aware of their new obligations.
Products Provided as Part of a Service
The GPSR clarifies that products provided to consumers as part of a service (e.g., rental equipment) are subject to the same safety requirements as products sold directly.
Case Example: Smart Home Devices
A manufacturer of smart thermostats previously focused primarily on hardware safety. Under GPSR, they must now also ensure that the software controlling the device is safe, that cybersecurity risks are addressed, and that the device remains safe throughout its lifecycle, including after software updates.
Enhanced Obligations for Economic Operators
The GPSR introduces more stringent and detailed obligations for all economic operators in the supply chain:
For Manufacturers
- Risk Assessment: Formal risk assessments must be conducted and documented before placing products on the market
- Technical Documentation: More comprehensive technical files must be maintained, including risk assessments and test reports
- Post-Market Surveillance: Enhanced requirements for monitoring product safety after market placement
- Incident Reporting: Serious incidents must be reported through the Safety Business Gateway within two working days
A compliance team reviewing technical documentation requirements under the new GPSR framework
For Importers and Distributors
Importers and distributors face expanded due diligence requirements:
- Verification that manufacturers have conducted appropriate conformity assessments
- Ensuring products bear required markings and are accompanied by necessary documentation
- Sample testing of products when appropriate based on risks
- Maintaining a register of complaints and product recalls
New Obligations for Online Marketplaces
Perhaps the most significant expansion of scope is the inclusion of online marketplaces as economic operators with specific obligations:
- Establishing a single point of contact for market surveillance authorities
- Verifying that product listings contain required information
- Responding to notices about illegal product listings within two working days
- Regularly checking for product recalls and dangerous products
- Informing consumers about recalled or dangerous products purchased through their platform
This represents a fundamental shift in responsibility for online platforms, which previously had limited liability for third-party products sold through their services.
"The inclusion of online marketplaces as economic operators with specific obligations is one of the most significant changes in the GPSR. It acknowledges the reality of modern commerce and closes a major gap in consumer protection."
Enhanced Traceability Requirements
Traceability has been significantly strengthened under the GPSR:
Digital Product Passport
While not fully implemented yet, the GPSR lays groundwork for digital product passports that will contain key information about a product's origin, composition, repair and dismantling possibilities, and end-of-life handling.
Information Requirements
Products must be accompanied by more detailed information, including:
- The manufacturer's name, registered trade name or trademark, and contact details
- The importer's information (if applicable)
- Product identification information
- Safety warnings and instructions in the language of each member state where the product is made available
Product Recalls and Market Surveillance
The GPSR strengthens the recall framework and market surveillance mechanisms:
Enhanced Recall Requirements
When a product recall is necessary, manufacturers must now:
- Offer consumers a choice between repair, replacement, or refund (at least equal to the product's purchase value)
- Ensure recall notices are effective in reaching affected consumers
- Maintain high visibility of recall information on websites for at least 12 months
Strengthened Market Surveillance
The regulation enhances coordination between national market surveillance authorities and provides them with additional powers to:
- Conduct mystery shopping to identify non-compliant products
- Order the removal of product listings from online interfaces
- Impose more significant penalties for non-compliance
Penalties for Non-Compliance
The GPSR introduces a harmonized approach to penalties, with maximum fines of:
- €10,000,000 or 6% of annual turnover (whichever is higher) for serious infringements
- €2,000,000 or 4% of annual turnover for less severe infringements
These penalties represent a significant increase compared to the previous regime and underscore the EU's commitment to product safety.
Practical Steps for Manufacturers
To ensure compliance with the GPSR, manufacturers should take the following steps:
- Review product portfolio: Assess which products fall under the expanded scope of the GPSR
- Update risk assessment procedures: Ensure they meet the enhanced requirements
- Revise technical documentation: Update to include all newly required information
- Enhance traceability systems: Prepare for more stringent traceability requirements
- Review recall procedures: Update to comply with new requirements
- Train staff: Ensure all relevant personnel understand the new obligations
- Audit supply chain partners: Verify that importers and distributors understand their obligations
Conclusion
The GPSR represents a significant evolution in EU product safety legislation, reflecting changes in technology, business models, and consumer expectations. While compliance will require investment and adaptation, the regulation ultimately creates a more level playing field and enhances consumer protection across the EU market.
Manufacturers who proactively address these changes will not only ensure compliance but may gain competitive advantages through enhanced consumer trust and streamlined operations across the EU single market.
For personalized guidance on GPSR compliance, contact our expert team at GPSR Compliance Gate.