Regulatory Assessment

The General Product Safety Regulation (GPSR) is the new regulation for the safety of consumer products sold in the European Union. One key requirement is the compilation of a technical file.

Content Overview of General Products’ Technical Documentation

For GPSR compliance, manufacturers / importers must prepare technical documentation for products placed on the EU market. The technical documentation should contain sufficient information to declare and determine whether the product is considered "safe" according to the GPSR.

A complete technical file should include:

• Labels and, if applicable, instructions for use
• A general description of the product and its essential characteristics
• An analysis of possible risks users might encounter while using the product and solutions adopted to eliminate or mitigate them, supported by relevant reports
• A list of relevant European standards followed for product manufacturing, if applicable
• Details of testing performed and toxicological assessment, if applicable
  
  

Internal Risk Assessment and Product Aspects to Consider

The technical documentation should be based on an internal risk assessment conducted by the manufacturer. When performing a risk analysis, manufacturers should consider various product aspects, including:

• General characteristics
• Appearance and presentation
• Intended category of consumers (e.g., children, elderly, general public)
• Effects on other products when used together
• Cybersecurity features, if applicable
• Evolving functionalities that may impact safety

The purpose of the technical documentation is to provide evidence that the product is safe and compliant with applicable requirements.

Technical Documentation – Model Template

The European Commission has provided a draft template as guidance for manufacturers compiling GPSR technical documentation. The template includes the following sections:

1. Product Identification
   1. Brand
   2. Name of product
   3. Model type/ batch / serial number or other identification element
   4. Product description
   5. Picture of product
   6. Packaging description
   7. Picture of packaging
      
      
2. Characteristics and Composition of Product
   1. Characteristics
   2. Material
   3. Composition
      
      
3. Risk Analysis and Risk Mitigation Measures
   
   1. Description of potential risks
   2. Measures to address this potential risks
      
      
4. Compliance with applicable European standards
   
   
5. Warnings and instructions for use provided
   
   

Is Lab Testing Required?

The GPSR mandates compliance with applicable European standards. Examples include:

• EN 71 – The EU Toy Safety Directive is a legislative framework established by the European Union (EU) to ensure the safety of toys sold within its member states.
• EN 12520 – This European Standard specifies the minimum requirements for the safety, strength and durability of all types of domestic seating for adults.
• EN 60335 – This European Standard deals with the safety of electrical appliances for household environment and commercial purposes, their rated voltage being not more than 250 V.

If a product falls under such categories, corresponding test reports must be included in the technical documentation, and these reports must be obtained through accredited laboratory testing.

Responsible Person for GPSR Compliance

The designation of a Responsible Person varies by scenario:

• EU-based manufacturers automatically act as the Responsible Person.
• Importers act as the Responsible Person when the manufacturer is based outside the EU.
• If the manufacturer is non-EU and no importer exists (e.g., in online sales), the EU-based fulfillment service provider assumes the role.
• Manufacturers may also appoint an Authorized Representative to act as the Responsible Person.

The Responsible Person must ensure compliance before placing the product on the market, verify the availability of all necessary documents, and maintain updated technical documentation. Their details must be displayed on the product, its packaging, or an accompanying document.

Who Will Review the Documentation?

Technical documentation is not generally submitted for approval but must be made available upon request by national market surveillance authorities in EU member states. These requests may arise due to:

1. Routine import checks
2. Targeted industry audits
3. Consumer complaints or safety concerns

Market surveillance authorities assess the technical documentation to verify compliance with applicable European standards. Additionally, online marketplaces such as Amazon may request these documents, similar to how they require Declarations of Conformity for specific products.

Consequences of Non-Compliance

Failure to provide technical documentation demonstrating product safety may lead to:

• Product recalls
• Market access restrictions
• Fines or other regulatory penalties

The GPSR aims to ensure all products sold in the EU meet safety standards, and technical documentation is a critical component in demonstrating compliance.

References

• EUR-Lex (2024) - Regulation (EU) 2023/988
• European Commission - Obligations for businesses
• Safety Gate - the EU rapid alert system for dangerous non-food products