EU GPSR Technical File and Product Compliance Guide
Launching a product in the European Union can be highly rewarding, but it also comes with strict compliance obligations. The General Product Safety Regulation (GPSR), which replaced the old General Product Safety Directive, now sets a much higher bar for businesses selling in the EU. Companies that are not prepared risk product recalls, fines, or having their listings removed from platforms like Amazon, Etsy, or eBay.
This 2025 checklist gives you a clear, step-by-step overview of what you need to do before placing a new product on the EU market.
1. Confirm the Product Category and Scope
Before anything else, determine whether your product is covered only by the GPSR or if additional EU legislation applies. For example, toys, cosmetics, or electrical products all have specific directives or regulations in addition to GPSR.
You should also define the intended user group. A product marketed for children requires age grading and often stricter testing. Even accessories and packaging can fall under GPSR if they pose risks to consumers.
2. Carry Out a Risk Assessment
Every product must undergo a documented risk analysis. This should cover hazards such as mechanical, chemical, electrical, fire, or choking risks. Where harmonised EU standards exist, use them as proof of compliance. Your findings and mitigation measures form a central part of the product’s technical documentation.
You can start with this free risk analysis template.
3. Prepare the Technical File
The technical file is mandatory. It must contain a bill of materials, test reports, declarations of conformity, a written risk assessment, user instructions and warnings, and copies of labels and packaging. Keep it for at least 10 years after the product was last placed on the market and update it whenever the product design changes.
Include Safety Data Sheets (SDS)
Where substances or mixtures are used in your product or process, include current Safety Data Sheets. SDS replace the older term MSDS in the EU and follow a 16-section format. Use SDS to evidence control of hazards in coatings, adhesives, inks, cleaning agents, batteries, and textile finishes. Keep the SDS in the official language of the Member State where the product is marketed.
Other useful documents
- Supplier declarations and material specifications that reference exact grades
- Certificates of Analysis for critical inputs
- Drawings, schematics, control plans, inspection records
- SVHC communications under REACH Article 33 and, if applicable, SCIP notifications
4. Appoint an EU Responsible Person
If you are based outside the EU, you cannot sell without appointing an EU Responsible Person. The RP’s name and contact details must appear on the product or its packaging, and the RP is legally responsible for holding your technical documentation and responding to market surveillance authorities.
5. Draft a Declaration of Conformity (DoC)
The Declaration of Conformity is the legal statement that your product complies with GPSR and any other relevant EU legislation. EaseCert prepares draft DoCs for each certified product type as part of its service. It must include the manufacturer’s details, the RP’s details if applicable, product identifiers, applied regulations and standards, and a signature.
6. Apply Correct Labelling and Warnings
Every product sold in the EU must carry:
- The manufacturer or EU RP’s name and address
- A product identifier such as SKU, batch, or serial number
- Safety warnings in all official languages of the countries where the product is sold
- Age restrictions if applicable (for example, “Keep away from children under 3 years old”)
See our guide on labelling requirements for GPSR compliance and download the free product label template.
7. Be Prepared for Market Surveillance
EU authorities can request your documentation at any time. You must provide it within 10 days. Sellers on online marketplaces may also be required to register with the EU Safety Gate Online Marketplace Module. Having a recall plan in place is part of compliance.
8. Secure Testing and Verification
Independent lab testing provides essential evidence of compliance. This includes chemical safety testing such as REACH and EN 71-3 where applicable, flammability tests, and mechanical safety checks. Always request full test reports from suppliers and avoid relying solely on generic certificates.
Choose the right scope and variants
Map each essential requirement to a standard or method. Test worst-case materials, sizes, and constructions so a single report set covers all variants by justification.
Use competent labs and complete reports
Ask for ISO/IEC 17025 reports that include unique 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
Ensure photos, rating plates, labels, and user instruction checks are included or referenced. Model numbers and SKUs must 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 your file.
9. Meet Marketplace Requirements
Online platforms such as Amazon, Etsy, eBay, Temu, or TikTok Shop often request compliance documents before approving listings. Typically, they will require Responsible Person details, a valid Declaration of Conformity, and safety warnings on the product detail page. Products without this documentation risk being removed from sale.
10. Monitor Ongoing Compliance
Compliance does not end at launch. Regulations evolve, and the new EU Product Liability Directive has tightened rules for 2025. Keep communication open with suppliers, update your technical file when changes occur, and monitor customer feedback or incident reports. This is the only way to stay compliant over time.
Frequently Asked Questions
What is the General Product Safety Regulation (GPSR)?
The GPSR (Regulation (EU) 2023/988) is the European safety law that replaces the old General Product Safety Directive. It sets stricter rules for risk assessments, technical documentation, labeling, and online marketplace compliance. It applies to all consumer products that are not fully covered by a specific sector regulation.
Does GPSR apply to my products?
Yes, if your products are sold to consumers in the EU and are not already fully regulated by another framework. Common examples include toys, personal care and beauty items, electronics, household goods, and others.
What documents are required for GPSR compliance?
At a minimum, you need a documented risk assessment, a technical file, a Declaration of Conformity, and proper labeling. EaseCert provides ready-to-use resources like a free risk analysis template and label template.
Do I need SDS or MSDS for my product?
Use Safety Data Sheets when substances or mixtures are part of your product or process. SDS replaced MSDS in the EU and must follow the 16-section format. They support your risk assessment and show supply-chain control for coatings, inks, adhesives, batteries, and textile finishes.
What should a test report include?
Ask labs for ISO/IEC 17025 reports that show methods, limits, results with units, measurement uncertainty if relevant, decision rules for pass or fail, photos, and clear model identification. The report should tie directly to your DoC and technical file.
What happens if I don’t comply with GPSR?
Non-compliance can result in product recalls, fines, or having your listings removed from platforms such as Amazon, Etsy, eBay, Temu, and TikTok Shop. Authorities may also ban your products from the EU market.
Final Thoughts
The EU offers one of the largest and most attractive consumer markets in the world, but it is also heavily regulated. The GPSR makes compliance more transparent, traceable, and enforceable. By following this checklist, covering risk assessments, technical files, EU Responsible Person appointment, labeling, market surveillance readiness, and solid testing, you can place your product on the EU market with confidence.
If any step feels unclear, working with a compliance specialist can keep your launch on track and your products on the market without interruption.