Introduction
The General Product Safety Regulation (EU) 2023/988 (GPSR) is one of the most important product safety reforms introduced by the European Union in recent years. Since 13 December 2024, the regulation has replaced the former General Product Safety Directive and now applies to almost all consumer products sold in the EU.
This regulation affects manufacturers, importers, distributors, and online sellers worldwide, including those selling through marketplaces like Amazon, Shopify, and Etsy.
If your business sells products to EU consumers, understanding GPSR compliance is essential to avoid penalties, product recalls, or marketplace bans.
What is the EU General Product Safety Regulation (GPSR) ?
The General Product Safety Regulation (GPSR) establishes updated rules to ensure that all consumer products placed on the EU market are safe for use.
The regulation strengthens:
- Product safety requirements
- Supply chain accountability
- Market surveillance enforcement
- Online marketplace obligations
- Consumer protection mechanisms
The goal is to create a uniform safety framework across the European Union, ensuring that both offline and online products meet strict safety standards.
Who Must Comply with GPSR ?
GPSR applies to a wide range of businesses involved in selling products in the EU.
Companies affected include:
- EU manufacturers
- Non-EU manufacturers exporting to Europe
- Importers placing products on the EU market
- Brand owners selling under private labels
- Distributors and fulfilment providers
- Online sellers and marketplace merchants
Even companies located outside Europe must comply if they sell directly to EU consumers through e-commerce platforms.
Key GPSR Compliance Requirements
1. Clear Supply Chain Responsibility
GPSR defines roles for economic operators involved in product distribution:
Manufacturer
- Produces the product or markets it under their brand name
- Responsible for product safety and documentation
Importer
- EU-based company importing products from outside the EU
- Ensures the product complies with EU safety requirements
Distributor or Fulfilment Provider
- Responsible for verifying product compliance before selling
Every party in the supply chain now shares responsibility for ensuring product safety.
2. Mandatory Risk Assessment and Technical File
One of the core requirements under GPSR is the creation of a Technical Documentation File.
Each product must have a documented risk assessment and supporting compliance records stored for 10 years.
The technical file typically includes:
- Product description and specifications
- Risk assessment and mitigation measures
- Testing reports and certifications
- Declaration of Conformity
- Labels and user manuals
- Safety instructions
- Traceability documentation
Authorities can request these documents at any time.
3. EU Responsible Person Requirement
Companies based outside the EU must appoint an EU Responsible Person (EU REP).
The EU Responsible Person acts as a regulatory contact point for authorities.
Responsibilities include:
- Storing product compliance documentation
- Communicating with EU market surveillance authorities
- Coordinating recalls or corrective actions
The EU Responsible Person details must appear on:
- Product
- Packaging
- Accompanying documentation
Without an EU Responsible Person, products cannot legally be sold in the EU market.
4. Stronger Product Labelling Rules
Incorrect or incomplete product labeling is one of the most common reasons for enforcement actions.
Products must include:
- Product identifier (model or serial number)
- Manufacturer contact information
- Importer contact details
- EU Responsible Person details
- Safety warnings and instructions
- Language translations for each EU sales country
GPSR also requires durable physical labels, meaning QR codes alone are not sufficient.
5. Product Risk Analysis
Each product must undergo a structured safety evaluation.
Common risk categories include:
- Mechanical hazards
- Electrical risks
- Fire or thermal hazards
- Chemical exposure risks
- Hygiene hazards
- Radiation risks
Companies must identify risks, evaluate their severity, and implement mitigation measures.
6. EU Safety Gate Registration
Businesses selling products online must register through the **EU Safety Gate platform.
Registration typically requires:
- Company identification details
- EU Responsible Person information
- Confirmation of GPSR compliance
Failure to register can lead to:
- Marketplace listing removal
- Account suspension
- Product bans across EU platforms
GPSR Compliance Checklist
Before selling products in the EU, businesses should ensure they have completed the following:
✔ Appoint an EU Responsible Person
✔ Conduct a documented risk assessment
✔ Prepare a technical compliance file
✔ Implement compliant product labeling
✔ Register with the EU Safety Gate system
✔ Update product listings with compliance details
✔ Maintain documentation for at least 10 years
✔ Monitor regulatory updates
Penalties for GPSR Non-Compliance
EU authorities now have stronger enforcement powers.
Possible penalties include:
- Product recalls
- Market bans
- Regulatory fines
- Safety Gate public alerts
- Marketplace delisting
- Loss of EU market access
These measures make GPSR compliance essential for companies selling into the European market.
How Complico Consulting Can Help
At Complico Consulting GmbH, we help brands, manufacturers, and online sellers navigate complex EU compliance requirements.
Our services include:
- EU Responsible Person representation
- GPSR risk assessments
- Technical documentation preparation
- Label compliance verification
- EU Safety Gate registration
- Marketplace compliance support (Amazon, Shopify, Etsy)
We provide fixed-fee compliance solutions to help businesses enter and operate in the EU market with confidence.
Final Thoughts
The General Product Safety Regulation (GPSR) represents the biggest reform of EU consumer product safety laws in decades.
Companies that prepare early can secure uninterrupted access to the 450-million-consumer European market.
Those that ignore compliance risk product bans, legal penalties, and sudden removal from online marketplaces.
Ensuring GPSR compliance today will protect your business tomorrow.
FAQs
1. What is the EU General Product Safety Regulation (GPSR) ?
The General Product Safety Regulation (EU) 2023/988 is a European regulation that ensures consumer products sold in the European Union meet strict safety standards. It replaced the General Product Safety Directive and became fully applicable on 13 December 2024.
2. Who must comply with the GPSR regulation ?
GPSR applies to all economic operators involved in selling consumer products in the EU, including:
- Manufacturers
- Importers
- Distributors
- Brand owners
- Online sellers
- Fulfilment service providers
Even non-EU companies must comply if they sell products to EU consumers through online platforms.
3. Do non-EU companies need an EU Responsible Person under GPSR ?
Yes. Non-EU manufacturers must appoint an EU Responsible Person (EU REP) to sell products legally in the EU market. The Responsible Person stores compliance documentation and communicates with EU authorities regarding product safety.
4. What documents are required for GPSR compliance ?
Businesses must maintain a technical documentation file that typically includes:
- Product description and specifications
- Risk assessment and safety analysis
- Test reports and certifications
- Declaration of Conformity
- Product labels and safety instructions
- Traceability documentation
These documents must be stored for at least 10 years.
5. What is the EU Safety Gate system ?
The EU Safety Gate is the official EU platform used by authorities to report dangerous consumer products and monitor product safety across the market. Online sellers may need to register and ensure compliance with product safety requirements.
6. What happens if a company does not comply with GPSR ?
Failure to comply with GPSR can result in serious penalties, including:
- Product recalls
- Marketplace delisting
- Fines and legal penalties
- Safety Gate alerts
- Import bans within the EU
7. Does GPSR apply to online marketplaces like Amazon or Shopify ?
Yes. The GPSR regulation applies to products sold online through platforms such as Amazon, Shopify, and Etsy. Online sellers must ensure that their products meet EU safety requirements before listing them.
8. How can businesses ensure GPSR compliance ?
Companies can ensure compliance by:
- Conducting product risk assessments
- Preparing a technical documentation file
- Appointing an EU Responsible Person
- Ensuring proper product labeling
- Registering with the EU Safety Gate system
Working with compliance experts such as Complico Consulting GmbH can simplify the process and reduce regulatory risks.
Europe Official Sources
- European Commission – General Product Safety Regulation
- EU Safety Gate – Product Safety Alert System
- Official EUR – Lex Regulation Text
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