What Is GPSR Compliance and Why US Businesses Can’t Ignore It?

US businesses selling products in the European market face a new regulatory reality that demands immediate attention. The General Product Safety Regulation (EU) 2023/988 (GPSR) has transformed product safety requirements across the EU, creating compliance obligations that directly impact American companies accessing this lucrative market. Whether you sell through Amazon, work with distributors, or ship directly to European consumers, understanding GPSR compliance isn’t optional anymore.

This regulation affects everything from technical documentation to product labelling, and the consequences of non-compliance can shut down your European operations entirely. Many US businesses remain unaware of these requirements or underestimate their complexity, putting their EU market access at serious risk.

What is GPSR and why it affects US businesses

The General Product Safety Regulation (EU) 2023/988 (GPSR) replaced the previous General Product Safety Directive on 13 December 2024, establishing comprehensive safety requirements for products sold in the European Union. This regulation applies to virtually all consumer products, whether new, used, repaired, or reconditioned, that are placed on or made available in the EU market.

Products Covered by GPSR

Physical consumer products
Digital products including software
Items provided free of charge
Products sold through online marketplaces
Products distributed through fulfilment centres
Professional-use items that consumers might reasonably use

Products Exempt from GPSR

Medicinal products
Food and feed
Living plants and animals
Antiques

For US businesses, the GPSR creates mandatory compliance obligations regardless of your business size or sales volume. The regulation’s scope extends beyond traditional retail sales. If your products reach European consumers through online marketplaces like Amazon or eBay, fulfilment centres, or distribution partners, you must comply with GPSR requirements.

US companies cannot ignore this regulation simply because they operate outside the EU. The GPSR applies based on where products are sold, not where companies are located. This means American manufacturers, brands, and retailers selling to European markets must understand and implement these safety requirements to maintain market access.

How GPSR compliance protects your business from costly penalties

Non-compliance with GPSR obligations exposes US businesses to severe financial and operational consequences that can devastate European market operations. EU market surveillance authorities have extensive enforcement powers, including the ability to impose significant fines, order product recalls, and restrict market access entirely.

Enforcement Consequences of Non-Compliance

Consequence Type	Impact	Business Effect
Significant Fines	Financial penalties	Direct revenue loss and compliance costs
Product Recalls	Market retrieval, notifications, communications	High costs, brand damage, consumer trust loss
Market Access Restrictions	Sales suspension, marketplace removal	Loss of major sales channels, distribution partner reluctance
Platform Penalties	Amazon/eBay listing removal	Immediate loss of online sales channels

The regulation works alongside the Market Surveillance Regulation (EU) 2019/1020 (MSR) to create a comprehensive enforcement framework. Authorities can suspend product sales immediately when safety concerns arise, leaving businesses scrambling to address compliance gaps while losing revenue and market position.

Market access restrictions can effectively end your European business operations. Online marketplaces like Amazon and eBay now require GPSR compliance before allowing product listings, meaning non-compliant businesses lose access to major sales channels. Traditional distribution partners also face compliance obligations, making them reluctant to work with non-compliant suppliers.

The regulation’s enforcement extends to online platforms, which must verify compliance and can face their own penalties for hosting non-compliant products. This creates additional pressure on US businesses to demonstrate compliance proactively rather than waiting for enforcement actions.

Meeting GPSR requirements: documentation and responsible persons

GPSR compliance requires US businesses to establish comprehensive documentation systems and appoint specific roles within the EU. The regulation mandates that companies compile technical documentation demonstrating product safety, though this requirement only applies to products first made available on the EU market after 13 December 2024.

Required Technical Documentation Components

Detailed product information and specifications
Comprehensive risk assessments
Safety evaluations and testing results
Evidence of compliance with applicable safety standards
Risk mitigation measures and implementation evidence

This documentation serves as proof that manufacturers have properly assessed product safety and implemented appropriate risk mitigation measures. Companies must make this documentation available to market surveillance authorities upon request.

The most critical requirement for US businesses involves appointing a Responsible Person established within the EU. This appointment is mandatory under the GPSR and creates a formal point of contact between your business and European market surveillance authorities. The Responsible Person must have access to technical documentation and authority to take corrective actions when safety issues arise.

Key Responsible Person Requirements

Must be established within the EU
Requires access to technical documentation
Must have authority to take corrective actions
Serves as point of contact with market surveillance authorities
Can be combined with Authorized Representative role

While appointing an Authorized Representative isn’t mandatory, it often provides the most practical solution for US businesses. When appointed, Authorized Representatives typically also serve as the Responsible Person, streamlining compliance obligations and creating a single point of contact for regulatory matters.

Product labelling and information requirements add another compliance layer. Products must display appropriate safety information, warnings, and contact details in the languages of EU Member States where they’re sold. This information must be easily accessible to consumers and include details about proper product use and safety precautions.

Common GPSR compliance mistakes that put US companies at risk

Many US businesses make critical errors when approaching GPSR compliance, often stemming from misunderstanding the regulation’s scope or underestimating implementation requirements. These mistakes can trigger enforcement actions and disrupt European market operations.

Top 6 GPSR Compliance Mistakes

Inadequate Technical Documentation
- Incomplete safety assessments
- Poorly documented risk evaluation processes
- Basic product specifications instead of comprehensive safety analysis
Improper Responsible Person Selection
- Designating distributors without proper expertise
- Choosing parties without regulatory knowledge
- Failing to ensure authority for corrective actions
Misunderstanding Ongoing Obligations
- Treating compliance as one-time certification
- Failing to maintain continuous monitoring
- Inadequate preparation for regulatory interactions
Language and Labelling Violations
- Relying solely on English documentation
- Missing safety warnings in local languages
- Inaccessible safety information for consumers
Online Sales Channel Oversights
- Assuming different standards for marketplace sales
- Inadequate compliance for direct-to-consumer shipping
- Misunderstanding platform compliance requirements
Reactive Instead of Proactive Approach
- Waiting for enforcement actions
- Insufficient compliance assessment
- Lack of experienced regulatory support

Effective Responsible Persons require regulatory knowledge and responsiveness to handle safety issues, authority communications, and potential recall situations properly.

To avoid these mistakes, US businesses should conduct thorough compliance assessments, invest in proper documentation systems, and work with experienced regulatory professionals who understand both GPSR requirements and practical implementation challenges. Taking a proactive approach to compliance protects market access and prevents costly enforcement actions that can disrupt European business operations.

GPSR compliance represents a fundamental requirement for US businesses accessing European markets, not an optional consideration. The regulation’s comprehensive scope and enforcement mechanisms make compliance necessary for sustainable EU market operations. By understanding these requirements and implementing appropriate compliance systems, American companies can maintain their European market presence while protecting consumers and meeting regulatory obligations. At EARP, we specialise in helping US businesses navigate these complex requirements through comprehensive Authorized Representative and Responsible Person services that ensure ongoing compliance and market access protection.

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