GPSR Technical File

The General Product Safety Regulation (GPSR), Regulation (EU) 2023/988, is a central framework for consumer product safety in the European Union. It requires manufacturers of products within its scope to prepare and maintain comprehensive technical documentation demonstrating that the product complies with the general safety requirement.

This technical documentation is commonly referred to as the technical file. It should not be confused with the Digital Product Passport (DPP). The DPP is a separate EU framework introduced primarily through the Ecodesign for Sustainable Products Regulation (EU) 2024/1781 and other product-specific legislation. DPP requirements apply progressively to product groups where specific EU rules require them.

Content Overview of General Products’ Technical Documentation

For GPSR compliance, manufacturers must prepare technical documentation before placing products on the EU market. Importers must verify that the manufacturer has prepared the required documentation before they place the product on the market.

The technical documentation must contain sufficient information to identify the product and assess whether it complies with the general safety requirement. The level of detail should be proportionate to the complexity of the product and the risks associated with it.

A complete technical file should typically include:

• Labels, packaging artwork, and, where applicable, instructions for use.
• A general description of the product and its essential characteristics relevant to safety.
• An analysis of possible risks associated with normal use and reasonably foreseeable misuse, together with measures adopted to eliminate or mitigate those risks.
• A list of relevant European standards or other technical specifications applied, where appropriate.
• Details of testing performed, test reports, toxicological assessments, chemical evidence, or other supporting documentation where relevant.
• Material specifications, supplier declarations, Safety Data Sheets, Bills of Materials, or other evidence where relevant to the risk assessment.
• Product identification and traceability information, including type, batch, serial number, model number, or another identifier.
  
  

Key Components of the Technical File

1. Product Identification and Description

• Detailed information about the product, including its design, function, construction, and intended use.
• Information on reasonably foreseeable misuse where relevant.
• Clear identification through model, type, batch, serial number, SKU, or another traceability element.
• Product photographs, diagrams, technical specifications, and packaging information.

2. Risk Assessment and Mitigation

• A documented analysis of potential risks associated with the product.
• Identification of hazards, affected users, potential injuries, and foreseeable conditions of use.
• Documentation of measures implemented to eliminate or mitigate identified risks.
• Supporting evidence such as test reports, standards, technical specifications, warnings, or instructions.

3. Compliance Evidence

• A list of relevant European standards or other safety criteria applied during the product’s design and manufacture.
• Test reports, toxicological assessments, chemical compliance evidence, supplier declarations, or other supporting documents where relevant.
• Evidence relating to sector-specific EU legislation where applicable, such as REACH, RoHS, toy safety, radio equipment, electrical safety, batteries, or other product-specific requirements.

4. User Information

• Labels and, where applicable, Instructions for Use (IFUs) providing clear guidance on safe operation, installation, maintenance, storage, charging, cleaning, or disposal.
• Safety warnings and precautions based on the actual product risk assessment.
• Information in languages that can be easily understood by consumers in the Member States where the product is made available.
  
  

Obligations for Manufacturers

• Documentation Maintenance: Manufacturers must keep the technical documentation at the disposal of market surveillance authorities for 10 years after the product has been placed on the market.
• Accessibility: The technical file must be made available to market surveillance authorities upon request, enabling authorities to assess whether the product complies with applicable safety requirements.
• Continuous Compliance: For products produced in series, manufacturers must establish appropriate procedures to ensure continued conformity with the general safety requirement.
• Updates: The technical documentation should be reviewed when changes to the product, materials, components, supplier, design, software, manufacturing process, intended use, or applicable standards may affect product safety.
  
  

Role of the Responsible Person

Under Article 16 of the GPSR, a product covered by the Regulation may only be placed on the EU market if there is an economic operator established within the Union responsible for the relevant compliance functions.

The Responsible Person or responsible economic operator may be:

• The manufacturer, where the manufacturer is established in the EU.
• The importer, where the manufacturer is established outside the EU and the product is imported into the Union.
• An Authorised Representative established in the EU and appointed through a written mandate.
• In certain circumstances, an EU-established fulfilment service provider where no other qualifying economic operator exists.

The responsible economic operator must have access to the documentation necessary to perform its legal duties, cooperate with market surveillance authorities, and carry out the applicable checks and actions required under EU law.

For products manufactured outside the EU, the responsible economic operator’s name, postal address, and electronic address must be provided in accordance with the GPSR. The information may appear on the product, packaging, parcel, or accompanying document as permitted by the applicable requirements.

What About the Declaration of Conformity?

The EU Declaration of Conformity (DoC) is an important compliance document, but it is not a general standalone requirement for every product covered by the GPSR.

A formal EU Declaration of Conformity is required where applicable EU harmonisation legislation specifically requires one. Examples include legislation covering toys, radio equipment, electrical equipment, electromagnetic compatibility, machinery, personal protective equipment, and other CE-marked product categories.

For products covered only by the GPSR and not by sector-specific legislation requiring an EU DoC, the core legal requirement is the manufacturer’s internal risk analysis and technical documentation.

Where an EU Declaration of Conformity is required, the exact contents depend on the applicable legislation, but it normally includes:

• The manufacturer’s name and address.
• Clear identification and description of the product.
• A statement that the declaration is issued under the sole responsibility of the manufacturer.
• References to the applicable EU harmonisation legislation.
• References to applicable harmonised standards or technical specifications.
• Notified body details where relevant.
• The name, position, and signature of the authorised signatory.
• The place and date of issue.

Where required, the Declaration of Conformity should be maintained together with the relevant technical documentation and made available to competent authorities in accordance with the applicable legislation.

A GPSR Responsible Person or authorised representative must have access to the documentation necessary to perform the tasks assigned under the applicable legal framework, but the exact scope depends on the economic operator’s legal role and mandate.

Technical File vs. Digital Product Passport

The GPSR technical file and the Digital Product Passport are separate compliance concepts.

• GPSR Technical Documentation: Focuses primarily on product safety, risk assessment, testing, traceability, and evidence demonstrating compliance with the general safety requirement.
• Digital Product Passport: A structured digital record introduced primarily under the Ecodesign for Sustainable Products Regulation (EU) 2024/1781 and other sector-specific EU legislation.

The Digital Product Passport may contain information relating to materials, sustainability, recycled content, environmental performance, durability, repairability, supply-chain traceability, compliance, and end-of-life treatment.

A DPP is not currently required for every GPSR product. Requirements apply progressively to specific product categories through delegated acts and sector-specific legislation.

Certain batteries are among the first major product categories subject to a mandatory electronic passport, with the relevant battery passport requirements applying from 18 February 2027 for specified battery categories.

Packaging, EPR and Other Compliance Records

GPSR technical documentation forms only one part of the wider EU product-compliance framework. Depending on the product and country of sale, businesses may also need to consider:

• Packaging EPR registration and reporting.
• The Packaging and Packaging Waste Regulation (EU) 2025/40 (PPWR).
• WEEE registration for electrical and electronic equipment.
• Battery producer-registration requirements.
• REACH chemical restrictions and SVHC communication obligations.
• SCIP notifications where applicable.
• RoHS compliance for electrical and electronic equipment.
• CE marking and sector-specific conformity assessment where applicable.

These obligations are separate from the GPSR technical file but should be addressed as part of the overall EU market-access assessment.

Who Will Review the Documentation?

Technical documentation is not generally submitted to an authority for pre-approval under the GPSR. Instead, it must be maintained by the manufacturer and made available upon request to national market surveillance authorities in EU Member States.

Requests may arise as a result of:

1. Routine customs or market surveillance checks.
2. Targeted product-sector enforcement campaigns.
3. Consumer complaints or safety concerns.
4. Safety incidents or accident reports.
5. Safety Gate investigations.
6. Testing or inspections performed by authorities.

Market surveillance authorities may review the technical documentation, risk assessment, product labels, test reports, traceability information, online product listings, and other supporting evidence to determine whether the product complies with applicable EU requirements.

Online marketplaces such as Amazon may also request technical documentation, test reports, product labels, Responsible Person information, warnings, or Declarations of Conformity where legally required. Marketplace documentation requirements may go beyond the minimum documents expressly required by the GPSR.

Conclusion

Comprehensive technical documentation is a central part of demonstrating compliance with the GPSR. Manufacturers should maintain a structured file that identifies the product, documents its safety assessment, records applicable risk controls, and contains appropriate supporting evidence.

The exact contents of the file depend on the product and its risks. Simple consumer goods may require relatively limited documentation, while electrical, electronic, connected, chemical, children’s, or otherwise regulated products may require extensive testing and documentation under several pieces of EU legislation.

Businesses should also distinguish the GPSR technical file from newer compliance frameworks such as the Digital Product Passport, PPWR, EPR, WEEE, and battery requirements. These obligations may overlap operationally, but they arise under different legal frameworks.

References

• Regulation (EU) 2023/988 – General Product Safety Regulation
• European Commission – Obligations for Businesses
• Safety Gate – EU Rapid Alert System for Dangerous Non-Food Products
• Regulation (EU) 2024/1781 – Ecodesign for Sustainable Products Regulation (ESPR)
• European Commission – Technical Documentation and EU Declaration of Conformity