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), Regulation (EU) 2023/988, replaced the old General Product Safety Directive and has applied since 13 December 2024. It sets stricter requirements for product safety, traceability, technical documentation, distance sales, and market surveillance. Companies that are not prepared risk product recalls, fines, market restrictions, or having their listings removed from platforms such as Amazon, Etsy, or eBay.

This checklist gives you a clear, step-by-step overview of what you should address before placing a new consumer product on the EU market.

1. Confirm the Product Category and Scope

Before anything else, determine whether your product is covered primarily by the GPSR or whether additional EU product legislation applies. Many products are subject to sector-specific requirements in addition to the GPSR. For example, toys, cosmetics, and electrical and electronic products are subject to additional directives or regulations.

Depending on the product, you may also need to consider legislation covering chemicals, radio equipment, electromagnetic compatibility, batteries, machinery, food-contact materials, personal protective equipment, textiles, packaging, WEEE, or other regulated areas.

You should also define the intended user group and reasonably foreseeable users. A product intended for children may require age grading, specific testing, additional warnings, and compliance with toy-safety rules. Products that are not marketed as toys may still require child-related risk assessment where their appearance, function, or foreseeable use makes interaction by children likely.

Packaging, accessories, batteries, components, and accompanying items should also be assessed where they may create safety or regulatory obligations.

2. Carry Out a Risk Assessment

Manufacturers must perform and document an internal risk analysis before placing a product on the EU market. The assessment should identify relevant hazards and evaluate the risks associated with normal use and reasonably foreseeable misuse.

Depending on the product, this may include:

Mechanical and physical hazards
Chemical exposure
Electrical risks
Fire and thermal hazards
Choking, strangulation, suffocation, or ingestion risks
Sharp points, edges, or entrapment hazards
Battery-related hazards
Cybersecurity risks where connectivity may affect product safety
Risks resulting from evolving, learning, or predictive product functions

Where relevant European standards exist, they can provide important evidence of product safety. Harmonised standards may also provide a presumption of conformity where applicable sector-specific EU legislation provides for this.

Your identified hazards, risk ratings, supporting evidence, 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 documentation is mandatory under the GPSR. It must contain sufficient information to identify the product and assess whether it complies with the general safety requirement.

Depending on the product and its risks, the file should typically include:

Product description and identification
Product photos, drawings, and specifications
A bill of materials or relevant material composition information
The documented risk assessment
Test reports and supporting compliance evidence
Supplier declarations and material specifications
User instructions and safety information
Copies of product labels and packaging artwork
Applicable standards and legislation
Where required under applicable sector-specific legislation, an EU Declaration of Conformity

The manufacturer must keep the technical documentation available to market-surveillance authorities for at least 10 years after the product has been placed on the market. The documentation should also be reviewed and updated when changes to the product, materials, suppliers, standards, manufacturing process, intended use, or other relevant factors affect the original safety assessment.

Include Safety Data Sheets (SDS) Where Relevant

Where substances or mixtures are supplied or used in a way that makes an SDS relevant, retain current Safety Data Sheets as supporting evidence.

Examples may include coatings, adhesives, inks, paints, cleaning agents, certain chemicals, textile treatments, and other substances or mixtures used in manufacturing or incorporated into the product.

The term SDS is used under EU chemicals legislation and has replaced the older term MSDS in common regulatory practice. SDS follow the standard 16-section format under REACH.

However, an SDS is not automatically required for every finished consumer product or every component. Whether one must legally be supplied depends on the substance or mixture and the applicable requirements under REACH and CLP.

Where an SDS must be provided under REACH, it must generally be supplied in an official language of the Member State where the substance or mixture is placed on the market, unless that Member State provides otherwise.

4. Identify the EU Responsible Economic Operator

If the manufacturer is established outside the EU, the product may only be placed on the EU market if an economic operator established in the Union is responsible for the functions required under Article 16 of the GPSR.

The responsible economic operator may be:

The EU-based manufacturer
The importer, where the manufacturer is established outside the EU
An EU-established Authorised Representative or Responsible Person where properly appointed
In certain cases, an EU-established fulfilment service provider where no other qualifying economic operator exists

The responsible economic operator must have access to the required technical documentation, cooperate with market-surveillance authorities, and perform the applicable tasks assigned by 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 must appear on the product, its packaging, the parcel, or an accompanying document where permitted by the applicable requirements.

For online and other distance sales, the relevant manufacturer and Responsible Person information must also be displayed in the product offer.

5. Determine Whether an EU Declaration of Conformity Is Required

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

An EU DoC is mandatory where the product is subject to EU harmonisation legislation that specifically requires one. Examples may include legislation covering toys, electrical equipment, electromagnetic compatibility, radio equipment, machinery, personal protective equipment, and certain other regulated 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 GPSR technical documentation and internal risk analysis.

Where a DoC is required, it normally includes:

The manufacturer’s name and address
Product identification
A statement that the declaration is issued under the manufacturer’s sole responsibility
References to applicable EU legislation
Applicable harmonised standards or technical specifications
Notified body details where relevant
Name and signature of the authorised signatory
Place and date of issue

EaseCert can prepare draft Declarations of Conformity where a DoC is appropriate for the applicable product and legislation.

6. Apply Correct Labelling and Warnings

Product labeling must reflect the applicable GPSR requirements as well as any sector-specific legislation.

Depending on the product, this typically includes:

The manufacturer’s name, registered trade name or trademark, postal address, and electronic address
For non-EU manufacturers, the required EU Responsible Person or responsible economic operator information
A product identifier such as type, batch, serial number, model number, or another element enabling product identification
Relevant safety warnings
Instructions and safety information necessary for safe use
Age restrictions where justified by the product’s intended use, risk assessment, or applicable product legislation
Other markings required by applicable legislation, such as CE marking, WEEE symbols, battery markings, textile information, recycling information, or other sector-specific identifiers

Warnings and safety information must be provided in a language that can be easily understood by consumers, as determined by the Member State where the product is made available.

This does not necessarily mean that every product must carry every official EU language. Language coverage should match the actual markets in which the product is sold.

See our guide on labelling requirements for GPSR compliance and download the free product label template.

7. Be Prepared for Market Surveillance

EU market-surveillance authorities may request technical documentation and other compliance evidence when checking a product.

Economic operators must cooperate with authorities and provide the information and documentation necessary to demonstrate compliance. Requests should be answered without undue delay and within any deadline set by the competent authority.

The GPSR does not establish a universal rule that all technical documentation requests must always be answered within exactly 10 days. The applicable deadline depends on the legal request and instructions from the authority.

Businesses should also maintain procedures for:

Handling safety complaints
Recording incidents and accidents
Investigating potentially dangerous products
Implementing corrective actions
Withdrawing or recalling products where necessary
Notifying authorities through the Safety Business Gateway where required

Providers of online marketplaces have separate registration obligations under the GPSR and must register through the relevant Safety Gate Online Marketplace framework.

Ordinary manufacturers, importers, distributors, or businesses operating their own online shop do not need to register as an online marketplace merely because they sell products online.

8. Secure Appropriate Testing and Verification

Testing provides important evidence that identified risks have been adequately controlled. The type and extent of testing depends on the product, its hazards, applicable legislation, relevant standards, and the manufacturer’s risk assessment.

This may include chemical safety testing, mechanical testing, flammability testing, electrical safety testing, EMC testing, radio testing, battery testing, migration testing, food-contact testing, or other product-specific assessments.

Examples include REACH substance restrictions and EN 71-3 testing where relevant to the product category and applicable legal framework.

Always request full test reports where possible and avoid relying solely on generic certificates, summary pages, supplier statements, or reports that cannot be clearly linked to the exact product being placed on the EU market.

Choose the right scope and variants

Map each applicable requirement and identified risk to an appropriate standard, test method, assessment, or other form of evidence. Where several variants exist, determine whether representative or worst-case testing can reasonably cover them.

The justification should consider differences in materials, construction, components, size, electrical ratings, suppliers, manufacturing locations, intended use, and risk profile.

Use competent labs and complete reports

Where laboratory testing is used, select a laboratory with suitable technical competence. ISO/IEC 17025 accreditation is an important indicator of laboratory competence and may be required or expected under certain conformity-assessment procedures, contractual requirements, standards, or regulatory contexts.

Reports should ideally include:

A unique report number
Clear sample and model identification
Photographs of tested samples
Applicable standards or test methods
Test limits and acceptance criteria
Results with appropriate units
Test dates
Laboratory authorisation
Measurement uncertainty and decision rules where relevant
Traceable amendments or revisions

Tie reports to product identity

Test reports should clearly identify the product they cover. Product photos, model numbers, SKUs, rating plates, labels, packaging, and user instructions should be consistent with the technical file and any applicable Declaration of Conformity.

Keep a clean chain of custody

Where relevant, record the source of test samples, sampling date, sampling method, sample conditioning, laboratory receipt, deviations, and other information necessary to demonstrate that the tested sample is representative of the marketed product.

9. Meet Distance-Selling and Marketplace Requirements

The GPSR introduced specific information requirements for products offered through distance sales, including websites, online marketplaces, and other digital sales channels.

Before the consumer completes the purchase, the online product offer must clearly display the applicable information, including:

Manufacturer name and contact information
Where the manufacturer is outside the EU, the EU Responsible Person or responsible economic operator information
Information enabling identification of the product, including an image where appropriate
Applicable warnings and safety information

Online platforms such as Amazon, Etsy, eBay, Temu, or TikTok Shop may also impose their own compliance-document requirements. Depending on the product, they may request:

Responsible Person information
Technical documentation
Test reports
Product and packaging labels
Warnings and instructions
An EU Declaration of Conformity where legally required
CE marking or other regulatory evidence where applicable

Marketplace requirements may go beyond the minimum documents expressly required by the GPSR. Products with incomplete or inconsistent compliance information may be restricted or removed from sale.

10. Check Packaging, EPR, WEEE, Batteries, and PPWR Requirements

Product-safety compliance is only one part of placing a product on the EU market. Depending on the product and countries of sale, additional environmental and producer-responsibility obligations may apply.

These may include:

Packaging EPR registration
Packaging reporting and recycling-system participation
WEEE registration for electrical and electronic equipment
Battery producer-registration obligations
National authorised representative requirements for EPR schemes
Packaging labeling and recycling information

The Packaging and Packaging Waste Regulation (EU) 2025/40 (PPWR) applies from 12 August 2026. It introduces and strengthens requirements relating to packaging design, minimisation, recyclability, substances, labeling, recycled content, reuse, and producer responsibility.

These obligations are separate from the GPSR technical file but should form part of the wider EU market-access review before launch.

11. Check Whether Digital Product Passport Requirements Apply

The Digital Product Passport (DPP) is becoming an important part of the EU product-compliance framework, but it should not be confused with the GPSR technical file.

The main DPP framework is established under Regulation (EU) 2024/1781, the Ecodesign for Sustainable Products Regulation (ESPR). DPP obligations will apply progressively to product categories through product-specific rules.

A DPP may eventually contain information such as:

Product identification
Manufacturer information
Material composition
Sustainability information
Recycled content
Repairability and durability information
Compliance information
End-of-life and recycling instructions

Not every GPSR product currently requires a DPP. Businesses should determine whether their specific product category is subject to a product-specific DPP obligation and monitor upcoming delegated acts and sector legislation.

Certain batteries are among the first major categories for which an EU battery passport becomes mandatory from 18 February 2027.

12. Monitor Ongoing Compliance

Compliance does not end when a product is launched. Manufacturers, importers, and other economic operators should continuously monitor whether the product remains compliant throughout its lifecycle.

This includes:

Monitoring changes to EU legislation and relevant standards
Reviewing supplier and material changes
Updating risk assessments when products change
Updating technical documentation
Monitoring consumer complaints and safety incidents
Keeping batch and distribution traceability records
Maintaining corrective-action and recall procedures
Reviewing marketplace and labeling requirements

The revised EU Product Liability Directive (EU) 2024/2853 also modernises the EU product-liability framework, including rules relevant to software, digital products, product modifications, and access to evidence.

Strong technical documentation, traceability, supplier control, and post-market monitoring are therefore increasingly important both for regulatory compliance and liability risk management.

Frequently Asked Questions

What is the General Product Safety Regulation (GPSR)?

The GPSR (Regulation (EU) 2023/988) is the EU regulation governing the safety of consumer products. It replaced the General Product Safety Directive and has applied since 13 December 2024. It strengthens requirements relating to risk assessment, technical documentation, traceability, labeling, distance sales, recalls, market surveillance, and online marketplaces.

Does GPSR apply to my products?

The GPSR applies broadly to consumer products made available on the EU market. Where a product is subject to specific EU product-safety legislation, the GPSR generally applies to aspects, risks, and requirements that are not already covered by equivalent sector-specific rules.

Common product categories include toys, personal care products, electronics, household goods, clothing, sports products, accessories, furniture, and many other consumer products. However, the exact legal framework must be assessed product by product.

What documents are required for GPSR compliance?

At a minimum, manufacturers need documented technical information sufficient to identify the product, an internal risk assessment, and supporting evidence demonstrating product safety.

The technical file may also include test reports, material specifications, supplier declarations, labels, user instructions, warnings, photographs, and other supporting documents.

An EU Declaration of Conformity is required only where applicable EU harmonisation legislation specifically requires one. It is not a universal standalone GPSR requirement.

EaseCert provides resources including a free risk analysis template and label template.

Do I need SDS or MSDS for my product?

Safety Data Sheets may be relevant where substances or mixtures are supplied or used in the product or manufacturing process. SDS are governed primarily by REACH and follow the standard 16-section format.

An SDS is not automatically required for every finished consumer product. Whether one must be provided depends on the chemical product and applicable REACH and CLP requirements.

Where available, SDS can support the technical file and risk assessment for coatings, inks, adhesives, paints, cleaning agents, textile treatments, and similar chemical inputs.

Do I always need laboratory testing?

No. The GPSR does not require the same laboratory testing for every product. The appropriate evidence depends on the product’s hazards, applicable legislation, relevant standards, materials, intended users, and conclusions of the risk assessment.

For many products, laboratory testing is an important or necessary part of the evidence. In other cases, specifications, supplier documentation, engineering assessment, standards, existing reports, or other evidence may also contribute to demonstrating safety.

What should a test report include?

A strong laboratory report should clearly identify the tested sample and normally include the applicable test method, acceptance limits, results, units, test dates, photographs, model information, laboratory authorisation, and any relevant uncertainties or decision rules.

The report should clearly correspond to the product, models, materials, and variants covered by the technical documentation.

Do I need an EU Responsible Person?

If the manufacturer is established outside the EU, the product must have an economic operator established in the EU performing the functions required under Article 16 of the GPSR.

Depending on the supply chain, this may be the importer, an appointed EU Authorised Representative or Responsible Person, or in certain circumstances an EU fulfilment service provider.

Do I need a Declaration of Conformity for GPSR?

Not necessarily. A formal EU Declaration of Conformity is required where applicable EU harmonisation legislation specifically requires one. GPSR-only products do not automatically require an EU DoC.

They do, however, require appropriate technical documentation and a documented internal risk analysis.

Do I need Safety Gate registration?

Ordinary manufacturers, importers, distributors, and online retailers do not generally need to register in the Safety Gate Online Marketplace Registration system merely because they sell online.

The registration obligation applies specifically to providers of online marketplaces under Article 22 of the GPSR. Other economic operators may still need to use the Safety Business Gateway when reporting dangerous products, accidents, or other matters where notification is legally required.

Does my product need a Digital Product Passport?

Not necessarily. A GPSR technical file is not the same as a Digital Product Passport. DPP requirements arise under the Ecodesign for Sustainable Products Regulation and other product-specific legislation.

Whether a DPP is mandatory depends on the product category and the applicable implementation timetable.

What happens if I don’t comply with GPSR?

Non-compliance can result in requests for corrective action, additional testing, product withdrawal, recalls, Safety Gate notifications, fines, sales restrictions, customs intervention, or removal of online listings.

Market-surveillance authorities may also prohibit a product from being made available on the EU market where it presents a risk or does not meet applicable legal requirements.

Final Thoughts

The EU offers one of the largest consumer markets in the world, but the regulatory framework is extensive. The GPSR has strengthened requirements for safety assessment, documentation, traceability, online sales, and post-market responsibilities.

A proper EU product-launch review should therefore go beyond a single checklist item. It should cover the product’s legal classification, risk assessment, technical documentation, applicable testing, Responsible Person or importer structure, labeling, distance-selling information, environmental obligations, market-surveillance readiness, and ongoing compliance.

Businesses should also consider related requirements such as packaging EPR, PPWR, WEEE, batteries, REACH, CE-marking legislation, and future Digital Product Passport requirements where applicable.

If any step is unclear, working with a compliance specialist can help identify the correct regulatory route before the product is placed on the EU market.

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