The GPSR Technical File & EU Product Compliance
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Since December 2024, the General Product Safety Regulation (EU) 2023/988 replaced the old directive and raised the bar on safety evidence. Whether you sell via Amazon, Etsy, or distributors, this 2025 checklist from GPSR Solutions shows what should be ready before any shipment to the EU. Companies that are not prepared risk delays, withdrawals, or removal of listings.
1. Confirm Your Product Category
Check if your product is only under GPSR or also under sector rules such as toys, cosmetics, electrical goods, PPE, or machinery. A toy, for example, must meet both GPSR and the Toy Safety Directive 2009/48/EC. Define the intended user group. Products marketed for children face tighter thresholds and stricter warnings. Accessories and packaging can fall under GPSR if they create risks for consumers.
2. Carry Out a Risk Assessment
Document hazards that are reasonably foreseeable: choking, sharp edges, chemical exposure, flammability, electric shock, magnet ingestion, strangulation, and misuse. Where available, apply harmonised EN standards to show how risks are controlled. Your findings and mitigations are a central part of the technical documentation. See the step-by-step overview of the GPSR risk analysis process.
3. Prepare the Technical File
GPSR requires technical documentation (often called a “digital product passport”) to be available for 10 years after the product was last placed on the market. The file should be indexed, versioned, and easy to supply on request. Typical contents include:
- Bill of Materials and supplier references with change history
- Accredited test reports with methods, limits, and results (ISO/IEC 17025)
- Safety Data Sheets (SDS) for relevant substances or mixtures used in coatings, inks, adhesives, cleaning agents, batteries, or textile treatments
- Risk assessment with applied standards and mitigations
- Design drawings, specifications, photos, and variant coverage
- User manuals, multilingual warnings, and label artwork
- Signed EU Declaration of Conformity, where applicable
Other useful documents: supplier declarations and material specifications that reference exact grades, Certificates of Analysis for critical inputs, control plans and inspection records, and REACH Article 33 SVHC communications with any SCIP notifications where required.
For a concise overview of required elements, see GPSR requirements.
4. Appoint an EU Responsible Person
Non-EU businesses must appoint an EU Responsible Person (RP). The RP holds the technical file, cooperates with market surveillance, and must be named on packaging or documentation. Without an RP, goods cannot legally be sold in the EU.
5. Draft and Sign the Declaration of Conformity
The EU Declaration of Conformity (DoC) states that the product complies with GPSR and any other applicable EU laws. It identifies the product, the manufacturer, the RP if relevant, the applied standards, and the signatory. Authorities and marketplaces frequently request the DoC during checks.
6. Label Correctly
Labels should include:
- Product identification, such as model, batch, or serial number
- Manufacturer name and address or EU RP details
- Age restrictions where relevant (for example, “Keep away from children under 3 years old”)
- Safety warnings and user information in the official languages of the EU countries of sale
Use the reference template in labelling requirements.
7. Secure Testing and Verification
Choose the right scope and variants: map essential requirements to standards or methods and cover worst-case materials, sizes, and constructions so a single report set can justify coverage of all variants.
Use competent labs and complete reports: request ISO/IEC 17025 reports that include report IDs, sample descriptions, methods, limits, results with units, dates, authorisation, and where relevant measurement uncertainty and decision rules for pass or fail. Keep amendments traceable.
Tie reports to product identity: include photos, label checks, and user instruction verification. Model numbers and SKUs should match the DoC and the technical file index.
Keep a clean chain of custody: record sample source, sampling plan, conditioning, and any deviations. If the lab selects samples, retain the plan with dates in the file.
8. Meet Marketplace Requirements
Platforms such as Amazon, Etsy, eBay, Temu, or TikTok Shop may request documentation before or after listing approval. Typical requests include EU Responsible Person details, a valid DoC where applicable, representative test reports, and safety warnings on the product detail page. Listings without adequate documentation risk removal.
9. Maintain Ongoing Compliance
Compliance continues after launch. Update the technical file when materials, suppliers, or designs change, track REACH restrictions and new standards, and monitor incident reports. Where risks are identified, products may need to be notified or withdrawn via the EU Safety Gate.
Frequently Asked Questions
Is a technical file required for every product?
Yes. Keep it ready to provide to authorities and maintain it for up to 10 years after the product was last placed on the market.
Do non-EU brands need an EU Responsible Person?
Yes. An EU-based contact must be listed on packaging or documentation. The RP maintains the file and communicates with authorities.
Are SDS still needed if the product is an article?
Often yes. Chemicals used in coatings, inks, adhesives, batteries, or finishes should be supported with current SDS in the language of sale.
What should a test report include?
Clear identification of the sample, methods and limits, dated results with units, authorisation, and where relevant measurement uncertainty and decision rules. Photos and label checks help link results to the marketed product.
What happens if documentation is incomplete?
Authorities can block goods, request withdrawals, or impose corrective actions. Response windows are short, so the file should be ready.
Where can support be requested?
Contact GPSR Solutions for assistance with documentation, EU representation, and practical file setup: contact page.