Compliance Regulations EU: Key Roles of Manufacturers, Distributors & Importers
Compliance
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Founder of Euverify | EU & UKCA Compliance Expert
Ajay is an eCommerce expert with 17+ years of experience as an Amazon, eBay, and Etsy seller and a Shopify specialist. He excels in EU and UK compliance, including GPSR and UKCA, helping businesses expand into European and UK markets. Ajay is the founder of Sweans, a London-based eCommerce agency, and Euverify.com, a SaaS platform streamlining compliance for non-EU sellers.
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Compliance
Compliance regulations EU are critical as global trade expands and regulatory frameworks evolve. Knowing the roles and responsibilities within the supply chain is crucial for accessing markets and adhering to regulatory standards. Businesses must address manufacturers’ responsibility for product safety and meet the specific responsibilities of manufacturers in the EU to remain compliant with the rules. Whether you’re a manufacturer, a white-label brand, an OEM, or a company based outside the EU, adhering to EU selling regulations involves specific obligations. This blog delves into various scenarios, including companies outside the EU, white-labeling, OEM relationships, and fulfillment service providers, under regulations like the General Product Safety Regulation (GPSR), CE marking, and UKCA marking.
Expanded Scenarios and Responsibilities
1. Manufacturer Based Outside the EU
A company based outside the EU (e.g., USA, China) is the physical producer of the product
To sell in the EU, such a company must:
- Appoint an Authorised Representative (AR) in the EU to comply with compliance regulations in EU.
- Ensure compliance with applicable EU directives (e.g., CE marking), which forms a crucial part of manufacturers’ responsibility for product safety.
- Provide technical documentation and issue a Declaration of Conformity (DoC).
Details on Packaging
- Name and address of the manufacturer.
- Name and address of the EU AR.
Example:
A US-based electronics manufacturer selling products in the EU appoints an AR in Ireland to handle labeling and ensure all obligations under EU selling regulations are met.
2. White-Labeling
A company rebrands a product manufactured by another company under their own brand name.
The white-label company legally becomes the manufacturer and assumes full responsibilities of manufacturer in EU.
Responsibilities :
- Ensure compliance with all applicable EU selling regulations.
- Hold technical documentation and issue the DoC under their name, adhering to manufacturers’ responsibility for product safety.
- If the factory’s test reports are used, ensure they apply to the branded product and preferably reissue them in the white-label company’s name.
Details on Packaging:
- White-label company’s name and address as the manufacturer.
- Country of origin (e.g., “Made in China”).
Example
A UK-based skincare brand sourcing products from China ensures compliance with EU selling regulations to meet market standards.
3.OEM (Original Equipment Manufacturer)
An OEM produces products for other companies to sell under their own branding.
The company marketing the product assumes the responsibilities of manufacture in the EU, including ensuring compliance with compliance regulations in the EU.
OEM Responsibilities:
- Provide test reports and technical documentation to their client.
Client (Brand Owner) Responsibilities:
- Ensure compliance and reissue the DoC under their own name.
- Include their own name and address as the manufacturer.
Details on Packaging:
- Client’s name and address (manufacturer)
- Optionally: OEM name in internal documentation (not required on packaging).
Example
An EU-based company selling devices made by an OEM in Taiwan ensures all packaging and documentation meet CE marking standards as per EU selling regulations.
4.Importer
Importers bring products into the EU or UK markets from outside the region.
Responsibilities:
- Verify compliance with applicable standards (CE/UKCA marking), to meet compliance regulations in EU.
- Ensure the technical documentation is accessible.
- Include their name and address on the packaging as the importer.
Details on Packaging:
- Importer’s name and address.
- Manufacturer’s details (optional but recommended).
Example:
A UK importer of toys sourced from China adheres to the Toy Safety Directive and ensures all labeling meets the requirements of EU selling regulations.
5.Distributor
Distributors sell products within the EU/UK that are already compliant
Responsibilities:
- Verify that the product has proper markings (e.g., CE/UKCA).
- Ensure traceability and compliance with GPSR requirements.
Details on Packaging:
None required unless specified by regulation.
Example:
An EU-based distributor selling pre-compliant home appliances must confirm the importer/manufacturer has met all regulatory requirements.
6.Fulfillment Service Providers (FSPs)
FSPs handle storage, packaging, and delivery but may take on compliance responsibilities under GPSR if they market or label products, as required by compliance regulations in the EU.
Responsibilities:
- Ensure compliance for products marketed/packaged under their responsibility.
- Cooperate with authorities during inspections.
Details on Packaging:
None required unless FSP markets/labels products.
Example:
An FSP shipping electronics for an e-commerce retailer must ensure compliance if they package products for sale.
Comparison of Scenarios
Scenario
Manufacturer (Outside EU/UK)
White-Labeling
OEM
Importer
Distributor
Fulfillment Service Providers
Who is Responsible for
Compliance?
Manufacturer (with AR in EU/UK)
Client of the OEM (brand owner)
Importer
Manufacturer/Importer (distributor verifies compliance)
Manufacturer/Importer (FSP if labeling/marketing)
Key Details on Packaging
Name, address, country of origin; AR name and address.
White-label company’s name, address, country of origin.
Brand owner’s name, address, country of origin.
Importer’s name and address; manufacturer’s details optional.
None unless specified.
None unless FSP assumes labeling/marketing roles
Key Takeaways
When it comes to the EU market, any electrical and electronic equipment manufacturer who wants their products placed has several legal obligations. These laws were created with fairness in mind so that all companies could compete against one another without having an unfair advantage because they followed some guidelines better than others.
Compliance Responsibility Shifts:
Depending on the scenario, legal obligations can fall on the manufacturer, importer, white-label company, or FSP, with all roles governed by compliance regulations in EU.
Clear Documentation is Essential:
Ensure all technical documentation and test reports align with the responsible party.
Labeling Requirements Vary:
Accurately list the responsible entity on the packaging to avoid compliance issues.
Conclusion
Understanding your role in the supply chain and its associated responsibilities is essential to ensure regulatory compliance in the EU and UK markets. Whether you are a white-label company, an OEM, or an importer, clear documentation and labeling practices are non-negotiable. Tools like Euverify make managing these complexities simple, ensuring your products are compliant and ready for market entry.
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GPSR
Compliance
Products Before 13/12/24
-
Founder of Euverify | EU & UKCA Compliance Expert
Ajay is an eCommerce expert with 17+ years of experience as an Amazon, eBay, and Etsy seller and a Shopify specialist. He excels in EU and UK compliance, including GPSR and UKCA, helping businesses expand into European and UK markets. Ajay is the founder of Sweans, a London-based eCommerce agency, and Euverify.com, a SaaS platform streamlining compliance for non-EU sellers.
- April 11, 2025Industry InsightsTop Reasons for Consumer Electronics Bans in the EU & UK (And How to Avoid Them)
- April 2, 2025Compliance News & UpdatesHow to Make Your Printful Dropshipping Products GPSR Compliant (and Use Euverify to Stay Ahead)
- April 2, 2025Compliance News & UpdatesHow to Make Your Etsy Listings GPSR Compliant and Add Your EU Economic Operator
- March 10, 2025Compliance News & UpdatesGPSR Compliance: What Happens to Products Manufactured Before 13 December 2024?
Compliance regulations EU are critical as global trade expands and regulatory frameworks evolve. Knowing the roles and responsibilities within the supply chain is crucial for accessing markets and adhering to regulatory standards. Businesses must address manufacturers’ responsibility for product safety and meet the specific responsibilities of manufacturers in the EU to remain compliant with the rules. Whether you’re a manufacturer, a white-label brand, an OEM, or a company based outside the EU, adhering to EU selling regulations involves specific obligations. This blog delves into various scenarios, including companies outside the EU, white-labeling, OEM relationships, and fulfillment service providers, under regulations like the General Product Safety Regulation (GPSR), CE marking, and UKCA marking.
Expanded Scenarios and Responsibilities
Manufacturer Based Outside the EU
A company based outside the EU (e.g., USA, China) is the physical producer of the product
To sell in the EU, such a company must:
- Appoint an Authorised Representative (AR) in the EU to comply with compliance regulations in EU.
- Ensure compliance with applicable EU directives (e.g., CE marking), which forms a crucial part of manufacturers’ responsibility for product safety.
- Provide technical documentation and issue a Declaration of Conformity (DoC).
Details on Packaging
- Name and address of the manufacturer.
- Name and address of the EU AR.
Example:
A US-based electronics manufacturer selling products in the EU appoints an AR in Ireland to handle labeling and ensure all obligations under EU selling regulations are met.
White-Labeling
A company rebrands a product manufactured by another company under their own brand name.
The white-label company legally becomes the manufacturer and assumes full responsibilities of manufacturer in EU.
Responsibilities :
- Ensure compliance with all applicable EU selling regulations.
- Hold technical documentation and issue the DoC under their name, adhering to manufacturers’ responsibility for product safety.
- If the factory’s test reports are used, ensure they apply to the branded product and preferably reissue them in the white-label company’s name.
Details on Packaging:
- White-label company’s name and address as the manufacturer.
- Country of origin (e.g., “Made in China”).
Example
A UK-based skincare brand sourcing products from China ensures compliance with EU selling regulations to meet market standards.
OEM (Original Equipment Manufacturer)
An OEM produces products for other companies to sell under their own branding.
The company marketing the product assumes the responsibilities of manufacture in the EU, including ensuring compliance with compliance regulations in the EU.
OEM Responsibilities:
- Provide test reports and technical documentation to their client.
Client (Brand Owner) Responsibilities:
- Ensure compliance and reissue the DoC under their own name.
- Include their own name and address as the manufacturer.
Details on Packaging:
- Client’s name and address (manufacturer)
- Optionally: OEM name in internal documentation (not required on packaging).
Example
An EU-based company selling devices made by an OEM in Taiwan ensures all packaging and documentation meet CE marking standards as per EU selling regulations.
Importer
Importers bring products into the EU or UK markets from outside the region.
Responsibilities:
- Verify compliance with applicable standards (CE/UKCA marking), to meet compliance regulations in EU.
- Ensure the technical documentation is accessible.
- Include their name and address on the packaging as the importer.
Details on Packaging:
- Importer’s name and address.
- Manufacturer’s details (optional but recommended).
Example:
A UK importer of toys sourced from China adheres to the Toy Safety Directive and ensures all labeling meets the requirements of EU selling regulations.
Distributor
Distributors sell products within the EU/UK that are already compliant
Responsibilities:
- Verify that the product has proper markings (e.g., CE/UKCA).
- Ensure traceability and compliance with GPSR requirements.
Details on Packaging:
None required unless specified by regulation.
Example:
An EU-based distributor selling pre-compliant home appliances must confirm the importer/manufacturer has met all regulatory requirements.
Fulfillment Service Providers (FSPs)
FSPs handle storage, packaging, and delivery but may take on compliance responsibilities under GPSR if they market or label products, as required by compliance regulations in the EU.
Responsibilities:
- Ensure compliance for products marketed/packaged under their responsibility.
- Cooperate with authorities during inspections.
Details on Packaging:
None required unless FSP markets/labels products.
Example:
An FSP shipping electronics for an e-commerce retailer must ensure compliance if they package products for sale.
Comparison of Scenarios
Scenario
Manufacturer (Outside EU/UK)
White-Labeling
OEM
Importer
Distributor
Fulfillment Service Providers
Who is Responsible for
Compliance?
Manufacturer (with AR in EU/UK)
Client of the OEM (brand owner)
Importer
Manufacturer/Importer (distributor verifies compliance)
Manufacturer/Importer (FSP if labeling/marketing)
Key Details on Packaging
Name, address, country of origin; AR name and address.
White-label company’s name, address, country of origin.
Brand owner’s name, address, country of origin.
Importer’s name and address; manufacturer’s details optional.
None unless specified.
None unless FSP assumes labeling/marketing roles
Key Takeaways
When it comes to the EU market, any electrical and electronic equipment manufacturer who wants their products placed has several legal obligations. These laws were created with fairness in mind so that all companies could compete against one another without having an unfair advantage because they followed some guidelines better than others.
Compliance Responsibility Shifts:
Depending on the scenario, legal obligations can fall on the manufacturer, importer, white-label company, or FSP, with all roles governed by compliance regulations in EU.
Clear Documentation is Essential:
Ensure all technical documentation and test reports align with the responsible party.
Labeling Requirements Vary:
Accurately list the responsible entity on the packaging to avoid compliance issues.
Conclusion
Understanding your role in the supply chain and its associated responsibilities is essential to ensure regulatory compliance in the EU and UK markets. Whether you are a white-label company, an OEM, or an importer, clear documentation and labeling practices are non-negotiable. Tools like Euverify make managing these complexities simple, ensuring your products are compliant and ready for market entry.
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