Table of Contents
Understanding the Transition from GPSD to GPSR
In the ever-evolving landscape of product safety, the shift from the General Product Safety Directive (GPSD) to the General Product Safety Regulation (GPSR) marks a significant change. As of December 13, 2024, the GPSR will replace the GPSD, introducing new general product safety regulations. This article delves into the differences between the GPSR Regulation vs. GPSD, examining the implications for industries, the scope of products affected, and the practical aspects of compliance.
Scope and Exclusions: GPSD vs. GPSR
One of the primary questions surrounding these regulations is the scope of products they cover. The GPSD and its successor, the GPSR, provide a safety net for products not covered by specific sectoral directives. This includes items that do not fall under the Machinery Directive or Low Voltage Directive, among others. However, products already governed by detailed sectoral regulations or those not intended for consumer use are excluded from the GPSR’s scope.
Products Excluded from GPSD and GPSR
The GPSD and GPSR exclude:
- Products covered by EU sectoral regulations with specific safety and compliance requirements, such as machinery, low-voltage electrical equipment, and ATEX-regulated devices.
- Products intended solely for professional use, not accessible to consumers.
- Specific categories regulated by other EU legislation, like food, medicinal products, and plant protection products.
- Items with a specific character not intended for functional use, such as antiques and collectibles.
GPSR Regulation vs. GPSD: Changes in Compliance and Documentation
The introduction of the GPSR brings substantial changes to compliance and documentation requirements for manufacturers, importers, and distributors. Unlike the GPSD, the GPSR mandates detailed technical documentation, including risk analysis, technical standards applied, and details of construction and materials. This documentation must be proportionate to the product’s risk and complexity.
Key Compliance Changes Under GPSR
- Mandatory creation of comprehensive technical documentation.
- Obligation to monitor products on the market, including maintaining records of complaints and corrective actions.
- Requirement to store supply chain information for six years to facilitate rapid identification of safety issues.
- Increased responsibility for importers and distributors to ensure product safety and compliance.
RAPEX vs. Safety Gate: Evolving Product Safety Alerts
The transition from the RAPEX system to the Safety Gate under the GPSR represents a modernization of the EU’s rapid alert system for dangerous non-food products. Safety Gate enhances the scope and functionality of RAPEX, incorporating new technologies and expanding its reach to include products with digital features.
Safety Gate: Enhancements Over RAPEX
- Expanded coverage to include products with digital functionalities.
- Integration of automated reporting and data analysis processes.
- Improved user accessibility for consumers and manufacturers.
- Faster information exchange to reduce response times to safety threats.
New Considerations: Cybersecurity and Mental Health
The GPSR introduces new considerations for product safety, focusing on cybersecurity, mental health impacts, and software updates. Manufacturers must now evaluate these factors to ensure comprehensive product safety.
- Cybersecurity measures to protect against digital threats.
- Assessment of mental health impacts, such as addiction risks.
- Evaluation of software updates for safety implications.
If a product isn’t covered by any other sectoral directive, it generally falls under the GPSR, necessitating safety assurance and appropriate documentation.
Safety Gate is the updated version of RAPEX, facilitating rapid information exchange about dangerous products between EU countries and market surveillance authorities.
Manufacturers must store technical documentation for 10 years and supply chain information for 6 years to enable quick problem identification.
Industrial products intended solely for professional use typically do not fall under GPSR, unless they are available to consumers. Sectoral regulations, like the Machinery Directive, are key for such products.
GPSR introduces new requirements, such as detailed risk analysis, technical documentation, and product monitoring, including complaint and corrective action logging.