How to Enter the EU Market: 7 Essential GPSR Requirements for US Companies

Expanding your business into the European Union market offers tremendous growth opportunities, but navigating GPSR requirements can feel overwhelming for US companies. The General Product Safety Regulation (EU) 2023/988 (GPSR) fundamentally changed how non-EU manufacturers must approach product safety compliance when selling to European consumers.

This guide breaks down the seven most important GPSR requirements that US companies must understand before entering the EU market. You will learn exactly what documentation you need, how to set up proper representation, and the specific steps to maintain ongoing compliance while scaling your European operations.

Understanding GPSR: what US companies need to know

The General Product Safety Regulation (EU) 2023/988 (GPSR) replaced the previous General Product Safety Directive on December 13, 2024. This regulation applies to virtually all consumer products sold in the EU, whether they are new, used, repaired, or reconditioned.

The GPSR covers all types of products including:

Physical consumer items
Digital products and software
Products sold through online platforms (Amazon, eBay)
Items fulfilled through warehouses
Goods distributed by EU-based partners
Products given away free of charge

US companies need to understand that the GPSR works alongside existing EU harmonised legislation. For products already covered by specific safety requirements like toys or electrical equipment, the GPSR applies only to safety aspects not covered by those existing rules. However, certain GPSR chapters apply to all products regardless of other applicable legislation.

The regulation focuses on health and safety risks for consumers, including both physical and mental health concerns. Environmental risks are also covered when they impact consumer health. This broad scope means most US manufacturers selling consumer products in Europe will need to comply with GPSR requirements.

Appointing an EU authorised representative

While an authorised representative is not mandatory under the GPSR, appointing one provides significant advantages for US companies. When you designate an authorised representative, they typically also serve as your responsible person, creating a streamlined compliance structure.

An authorised representative acts as your formal liaison between your US company and EU market surveillance authorities. They must be established within the European Union and have access to your technical documentation. This arrangement allows you to maintain a single point of contact for all regulatory matters.

Key Benefits of Working with an Independent Authorised Representative

Benefit	Description
Regulatory Objectivity	No commercial conflicts of interest in compliance decisions
Proven Expertise	Established knowledge of EU compliance requirements
Business Flexibility	Switch distributors without disrupting compliance or requiring relabelling

Your authorised representative handles critical responsibilities including holding technical documentation, cooperating with market surveillance authorities during inspections, and supporting any recall actions you might need to initiate. They must be experienced and responsive because delays in addressing safety issues can put your entire EU market access at risk.

Product safety documentation requirements

The GPSR requires specific documentation to be available for products first made available on the EU market after December 13, 2024. Your documentation package must include technical files that demonstrate product safety and compliance with applicable requirements.

Technical documentation must contain comprehensive product information including:

Detailed product descriptions
Risk assessments
Test reports
Manufacturing specifications
Internal risk assessment records
Hazard identification and mitigation steps

You need to maintain records of your internal risk assessments, showing how you identified potential hazards and the steps taken to mitigate them. The GPSR requires businesses to consider the precautionary principle when conducting these assessments, meaning you must address potential risks even when scientific evidence is incomplete.

Your authorised representative or responsible person must hold this documentation and make it available to market surveillance authorities upon request. The documentation must be kept current and updated whenever you make changes to your products or manufacturing processes that could affect safety.

Market surveillance cooperation obligations

Market surveillance cooperation forms a critical part of GPSR compliance under the MSR. US companies must be prepared to work closely with EU authorities during inspections, investigations, and safety evaluations.

When market surveillance authorities contact your authorised representative, you must provide prompt cooperation and access to required documentation, including:

Technical files and test reports
Safety assessment procedures explanations
Current product information
Documentation of any known safety concerns

Your authorised representative handles the direct communication with authorities, but you must ensure they have current information about your products and any safety concerns. The responsible person must notify you immediately when they become aware of any safety issues, and you must take appropriate corrective action.

If authorities identify safety concerns with your products, you may need to implement corrective measures such as consumer warnings, product modifications, or recall actions. Your authorised representative supports these activities by coordinating with authorities and helping communicate requirements back to your US operations.

Product labelling and information requirements

GPSR labelling requirements ensure consumers receive important safety information and enable product traceability. Your products must display specific information that helps consumers use them safely and allows authorities to track products when necessary.

Required Product Label Information

Information Type	Requirements
Company Details	Your company name and contact details
Representative Info	Authorised representative information (when applicable)
Safety Information	Clear safety warnings and usage instructions
Traceability Data	Product identification, batch numbers, manufacturing information

Product labels must include your company name and contact details, along with your authorised representative’s information when applicable. You need to provide clear safety warnings and usage instructions that help consumers avoid reasonably foreseeable risks during normal use.

Traceability information helps authorities track products through the supply chain when safety issues arise. This includes product identification details, batch numbers where relevant, and manufacturing information that enables quick identification of affected products.

For products sold online, you must ensure that safety information and labelling requirements are clearly displayed on product listings. Online marketplaces have specific obligations to verify that required information is available to consumers before purchase.

Monitoring and accident reporting procedures

Ongoing product safety monitoring helps you identify potential issues before they become serious problems. The GPSR requires systems for tracking product performance and responding quickly to safety concerns that emerge after products reach the market.

You must establish procedures for collecting and evaluating safety information from various sources:

Consumer complaints and feedback
Distributor reports and observations
Market surveillance authority reports
Industry safety alerts and recalls
Internal quality control findings

When your responsible person becomes aware of serious product risks, they must notify you immediately so you can take appropriate action. Your authorised representative handles communication with authorities about serious risks that require official notification.

Accident reporting procedures ensure that safety incidents are properly documented and investigated. You need systems for collecting accident information, determining whether your products contributed to safety issues, and implementing corrective measures when necessary.

Implementation timeline and compliance strategy

Achieving GPSR compliance requires a structured approach that addresses all requirements systematically. Start by conducting a comprehensive review of your current products and identifying which ones fall under GPSR scope.

GPSR Compliance Implementation Steps

Product Scope Review – Identify which products fall under GPSR requirements
Appoint Representatives – Select and establish relationships with authorised representative and responsible person
Documentation Development – Gather existing safety information and conduct additional risk assessments
System Implementation – Set up monitoring and reporting procedures
Ongoing Maintenance – Establish regular review cycles for continuous compliance

Begin with appointing your authorised representative and responsible person, as this relationship forms the foundation for all other compliance activities. Your representative needs time to understand your products and establish proper documentation systems before you can fully enter the EU market.

Develop your technical documentation package by gathering existing safety information and conducting additional risk assessments where needed. This process often takes several weeks, especially for companies with multiple product lines or complex manufacturing processes.

Implement monitoring and reporting procedures that integrate with your existing quality management systems. These procedures should capture safety information from all sources and provide clear escalation paths when issues arise.

Plan for ongoing compliance maintenance by establishing regular review cycles for your documentation, monitoring procedures, and authorised representative relationship. GPSR compliance is not a one-time activity but requires continuous attention as your products and EU operations evolve.

Successfully navigating GPSR requirements opens significant opportunities for US companies in the European market. The regulation’s focus on consumer safety creates a framework that protects both consumers and responsible manufacturers who invest in proper compliance systems. At EARP, we are dedicated to helping US companies achieve and maintain GPSR compliance while building sustainable EU market operations that support long-term business growth.

If you are looking for support or to learn more, contact our team of experts today