Why US Businesses Are Struggling with EU Market Entry (And How to Fix It)

Expanding into European markets represents a massive opportunity for US businesses. The EU single market offers access to over 440 million consumers with significant purchasing power. Yet many American companies find themselves hitting unexpected walls when they try to enter these markets.

The reality is that EU market entry involves complex regulatory requirements that catch many US businesses unprepared. From the General Product Safety Regulation (EU) 2023/988 (GPSR) to CE marking requirements, European regulatory frameworks operate very differently from US standards. Understanding these differences and preparing properly can mean the difference between successful market entry and costly setbacks.

This guide walks you through the most common challenges US businesses face in Europe, the real costs of getting compliance wrong, and provides a practical roadmap for successful EU market access.

Why US companies face unexpected roadblocks in Europe

The biggest shock for most US businesses entering European markets is discovering that EU regulations apply to all products made available on the EU market, whether new, used, repaired, or reconditioned. This includes products sold through online platforms like Amazon or eBay, fulfilled via warehouses, or distributed by EU-based partners.

Many American companies assume their existing US compliance will translate smoothly to European markets. This assumption creates immediate problems. EU regulations like the GPSR require specific documentation, designated responsible persons within the Union, and compliance with European safety standards that often differ significantly from US requirements.

Key Regulatory Differences Between US and EU Markets

Aspect	US Requirements	EU Requirements
Product Coverage	Varies by agency and product type	All consumer products under GPSR
Local Representation	Not typically required	Mandatory Responsible Person in EU
Documentation Language	English	Local language of each member state
Risk Assessment Approach	Evidence-based standards	Precautionary principle applied

The regulatory landscape becomes even more complex when you consider that different product categories face different requirements:

Consumer electronics: EMC and LVD compliance alongside GPSR requirements
Personal protective equipment: Specific PPE directives and standards
Software products: GPSR obligations when supplied to EU consumers
Medical devices: MDR compliance requirements
Toys and children’s products: Additional safety standards and testing

Another common roadblock involves the mandatory appointment of economic operators within the EU. US manufacturers without a European presence must designate a Responsible Person established within the Union. This isn’t optional, and online marketplaces will not allow you to use their platforms without having proper representation in place.

The timing requirements also catch many businesses off guard. The GPSR became fully enforceable on December 13, 2024, but many US companies only discover these requirements when they’re already trying to list products or when European authorities contact them about compliance issues.

The hidden costs of EU compliance mistakes

Getting EU compliance wrong carries consequences that extend far beyond simple fines. The most immediate impact is market access denial. European authorities can prevent your products from entering the market entirely, and online platforms will suspend your listings until compliance issues are resolved.

Financial Impact of Common Compliance Mistakes

Market Access Denial: Complete loss of sales revenue during suspension periods
Product Recalls: Costs 3-5x more when handled reactively vs. proactively
Relabeling and Documentation: €10,000-50,000+ depending on product complexity
Legal and Administrative Fees: €5,000-25,000 for compliance remediation
Inventory Losses: Products stuck in customs or requiring disposal
Opportunity Costs: Delayed market entry allowing competitors to gain advantage

Product recalls represent another significant cost category. When safety issues arise and you don’t have proper EU representation, the recall process becomes exponentially more complex and expensive. Your designated Responsible Person must coordinate with market surveillance authorities, manage consumer notifications, and support recall actions. Without proper preparation, these processes can take months and cost substantially more than planned market entry investments.

Reputational damage in European markets can be particularly severe. EU consumers and business partners place high value on regulatory compliance and product safety. Companies that face public compliance issues often find it difficult to rebuild trust, even after resolving the underlying problems.

The administrative burden of fixing compliance mistakes after market entry is substantial. You might need to relabel products, reprint manuals in multiple EU languages, reorganize your distribution relationships, and rebuild technical documentation to meet European standards. These reactive measures typically cost three to five times more than proactive compliance planning.

Market surveillance authorities across EU member states share information through systems like the Safety Gate Rapid Alert System. A compliance issue in one country can quickly affect your market access across the entire European Union, multiplying the impact of any single mistake.

What successful US-EU market entry actually requires

Successful European market access starts with understanding that EU regulations cover both physical and digital products, including standalone software supplied to consumers. The GPSR applies to products intended for consumers or likely to be used by consumers under reasonably foreseeable conditions, even if not originally intended for them.

Essential EU Compliance Requirements

Economic Operator Appointment
- Responsible Person (mandatory for GPSR compliance)
- Authorized Representative (recommended for comprehensive coverage)
- Must be established within the EU
Technical Documentation
- Risk assessments covering all foreseeable use scenarios
- Product safety evaluations
- Compliance evidence and test reports
- Available in local languages
Product Information and Labeling
- Safety warnings and instructions
- Traceability information
- Contact details for EU representatives
- CE marking where applicable
Market Surveillance Cooperation
- Rapid response procedures
- Documentation access protocols
- Recall coordination capabilities

The foundation of EU compliance involves appointing proper economic operators within the Union. A Responsible Person is mandatory for all products covered by the GPSR when you don’t have a place of business in the EU. An Authorized Representative, while not mandatory, often serves as the most practical solution for handling multiple compliance requirements across different regulatory frameworks.

Technical documentation requirements form another critical component. You must compile documentation demonstrating product safety, conduct risk assessments considering potential hazards and foreseeable misuse, and ensure all information is available in the languages of EU member states where products will be sold.

Product labelling and information obligations require careful attention to European standards. This includes providing detailed safety information, warnings, and product details in appropriate languages. The Market Surveillance Regulation (EU) 2019/1020 (MSR) establishes specific requirements for traceability and information that economic operators must verify.

Your compliance approach must also account for the precautionary principle, which requires businesses to consider potential risks even when scientific evidence is insufficient or uncertain. This principle influences risk assessments, safety measures, and documentation requirements across EU regulatory frameworks.

For products falling under multiple regulatory frameworks, you need comprehensive coverage. CE marking requirements might apply alongside GPSR obligations. Products with electronic components could need EMC and LVD compliance. Each framework has specific requirements, but coordinated compliance planning can address multiple obligations efficiently.

Your step-by-step roadmap to EU market success

Start your EU market entry planning at least six months before your intended launch date. This timeline allows proper documentation preparation, regulatory review, and partner selection without rushing critical compliance steps.

Phase 1: Assessment and Planning (Months 1-2)

Conduct comprehensive product assessment
- Identify applicable EU regulations (GPSR, CE marking, product-specific directives)
- Review existing documentation and identify gaps
- Assess target markets and language requirements
Develop compliance strategy
- Define regulatory pathway for each product category
- Establish budget and timeline for compliance activities
- Identify required testing and certification

Phase 2: Partner Selection and Documentation (Months 2-4)

Appoint EU economic operators
- Select Responsible Person with proven regulatory expertise
- Consider Authorized Representative for comprehensive coverage
- Prioritize regulatory expertise and independence over cost
Develop technical documentation
- Conduct risk assessments addressing precautionary principle
- Compile safety evaluations and compliance evidence
- Prepare documentation in required languages

Phase 3: Market Preparation (Months 4-6)

Prepare market surveillance procedures
- Establish communication protocols with EU representatives
- Develop rapid response procedures for authority requests
- Create recall coordination procedures
Finalize market entry requirements
- Update product labeling and packaging
- Prepare online marketplace listings
- Establish distribution relationships

Phase 4: Launch and Monitoring (Ongoing)

Execute market entry
- Launch products through chosen channels
- Monitor compliance performance
- Address any initial market feedback
Maintain ongoing compliance
- Regular compliance reviews and updates
- Monitor regulatory changes and guidance
- Update documentation as needed

Begin with a comprehensive product assessment to determine which EU regulations apply to your specific products. The GPSR covers most consumer products, but you might also need to address product-specific directives, CE marking requirements, or other regulatory frameworks depending on your product categories.

Identify and appoint your EU economic operators early in the process. Your Responsible Person must be established within the Union and capable of handling market surveillance cooperation, risk notifications, and recall support. When selecting partners, prioritize regulatory expertise and independence over cost considerations. Importers and distributors focused on sales might not provide the regulatory objectivity you need for long-term compliance success.

Develop your technical documentation systematically. This includes risk assessments, safety evaluations, product specifications, and compliance evidence. Ensure documentation addresses the precautionary principle and covers all reasonably foreseeable use scenarios, including potential misuse.

Prepare your market surveillance cooperation procedures. Your designated representatives must be able to respond quickly to authority requests, provide documentation access, and coordinate any necessary safety actions. Establish clear communication protocols and ensure your EU partners understand their obligations under both the GPSR and MSR.

Plan your labelling and information requirements for each target market. This includes translating safety information, updating product packaging, and ensuring online marketplace listings meet EU information obligations. Consider how these requirements might affect your distribution relationships and inventory management.

Finally, establish ongoing compliance monitoring procedures. EU regulations evolve, and market surveillance authorities regularly update guidance and enforcement priorities. Your compliance approach should include regular reviews and updates to maintain market access over time.

Successful EU market entry requires thorough preparation and expert guidance, but the European market opportunity makes this investment worthwhile. By understanding the regulatory landscape, preparing comprehensive compliance strategies, and working with experienced EU partners, US businesses can access European markets successfully while avoiding costly compliance mistakes. At EARP, we specialize in providing the Authorized Representative and Responsible Person services that make European market access straightforward for US companies, allowing you to focus on growing your business while we handle the regulatory complexities.

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