General Product Safety Regulation (GPSR) Checklist

The European Union’s General Product Safety Regulation (Regulation (EU) 2023/988, or GPSR) fully replaced the General Product Safety Directive (GPSD) on December 13, 2024. It applies to all consumer products placed on the EU market, whether sold in physical retail or via digital platforms.

This regulation applies not only to EU-based companies but also to non-EU manufacturers, brand owners, and importers, including those based in the United States, Canada, UK, Switzerland, and Australia, if they sell directly to EU consumers or through marketplaces.

Key Changes Introduced Under the GPSR

1. Expanded Scope and Definitions

The GPSR introduces clarified definitions and expands legal obligations:

Manufacturer: A company that produces a product or has one produced and markets it under its name or trademark.
Importer: An EU-based business that places a product from a third country onto the EU market.
Distributor and Fulfilment Service Provider: These parties now carry responsibility depending on how products move through the supply chain.
A product is only “safe” if it poses no risk under normal or foreseeable conditions, taking into account:
- Misuse scenarios
- Digital components and updates
- Vulnerable user groups (e.g., children, elderly)

2. Risk Assessment and Technical Documentation

All manufacturers must perform a GPSR-compliant risk assessment and compile supporting documentation in a Technical File, which must be retained for 10 years. As outlined in EaseCert’s Technical Documentation Guide, this file must include:

Product details, specifications, and descriptions
Risk analysis and mitigation measures
Conformity declarations and testing reports
Labeling proofs, manuals, and safety instructions
Traceability data and surveillance processes
Contact details for the manufacturer, importer, and EU Responsible Person

This documentation must be provided to EU authorities on request, without delay.

3. Mandatory EU-Based Responsible Person

Non-EU manufacturers must appoint a Responsible Person (RP) within the EU.

As explained in EaseCert’s RP Guide:

The RP is legally responsible for storing compliance documentation, communicating with EU regulators, and coordinating any required corrective action.
Acceptable roles include:
- Authorised Representative
- Importer
- Fulfilment Service Provider
- Distributor (if formally designated)
The RP’s full name, postal address, and email must be printed on the product, its packaging, or the enclosed documentation.
An anonymous or non-EU RP is not permitted.
This is a non-negotiable requirement for listing products on EU marketplaces or placing goods in the EU market.

4. Stronger Traceability and Labelling Requirements

Labeling now falls under stricter rules. According to EaseCert’s Labelling Guide, the following must be included:

Product identifier (type, model, serial/batch number)
Name and contact information of the manufacturer or importer
Responsible Person’s name and address
Required warning messages and safety instructions
Translations for each language where the product is sold
Durable, physical labels (QR codes alone are not accepted)

Missing or incorrect labels are among the top causes of enforcement action under GPSR.

For reference, download our EaseCert Product Label Template.

5. GPSR Risk Analysis Process

Following EaseCert’s Risk Assessment Framework, each product must undergo a structured review for:

Physical and Mechanical Hazards
Flammability / Thermal Hazards
Chemical Hazards
Electrical Hazards
Hygiene Hazards
Radiation Hazards

All risks must be rated (Critical, Major, Minor) and documented in the technical file, along with preventive design measures and warnings.

Download our GPSR Risk Analysis Template for a structured approach to evaluating product safety risks.

6. EU Safety Gate Registration Requirements

Under GPSR Article 25, online marketplace operators and sellers must register via the EU Safety Gate – Online Marketplace Module. This ensures streamlined communication between sellers and EU authorities for incident tracking, enforcement, and recall coordination.

According to EaseCert’s EU Safety Gate Registration Guide:

Registration is mandatory for sellers offering products via their own online stores (e.g., Shopify)
The portal requires:
- Business identification
- Responsible Person details (if applicable)
- Declaration that products comply with GPSR requirements
Once registered, sellers must respond promptly to requests from market surveillance authorities

Failure to register may result in deactivation of listings, product bans, or marketplace restrictions.

7. Compliance Checklist for Importers and Manufacturers

To comply with GPSR, businesses must:

Appoint an EU-Based Responsible Person
Perform and Document a Risk Assessment
Compile a Complete Technical File
Ensure Proper and Multilingual Labelling
Register with the EU Safety Gate (Online Sellers)
Update Online Listings to Include RP Details
Maintain Records for at Least 10 Years
Stay Current with EU Regulatory Guidance

8. Penalties for Non-Compliance

GPSR enforcement includes:

Product bans or market recalls, fines and legal sanctions
Delisting from e-commerce platforms
Public safety alerts (via RAPEX/Safety Gate)
Reputational harm and blocked market access

EU authorities are now equipped for faster enforcement, including digital inspection and monitoring of online stores.

9. Final Thoughts

The GPSR is a sweeping regulatory shift. It places new burdens, but also clearer rules, on how companies can legally place products in the EU market. Non-EU businesses must now plan for:

Documentation
Risk transparency
Accountability via a named Responsible Person
Registration with digital safety platforms like the EU Safety Gate

EaseCert offers tailored, fixed-fee GPSR compliance services (EU Responsible Person representation, risk assessments, technical file documentation, labeling review, and Safety Gate support), ideal for importers, brands, and SMEs selling to the EU.

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