Differences Between EU, UK, and US Agent

In the cross-border e-commerce industry, when your products set sail for massive markets like the EU, UK, and US, have you ever felt stressed by complex compliance requirements? Even if your product quality is excellent, it may face obstacles during customs clearance, rejection on platforms, or even penalties if a compliant authorized representative is missing. EU, UK, and US authorized representatives play a crucial role in this process.

Definitions and Responsibilities of EU, UK, and US Authorized Representatives

eu authorized representative (EU AR)

Definition:

A natural or legal person registeRED within the EU, authorized in writing by a non-EU manufacturer, representing the manufacturer to fULfill obligations under EU regulations.

Core Responsibilities:

- Receive compliance inquiries and product recall notices from EU market surveillance authorities and promptly forward them to the manufacturer.

- Maintain product technical documentation for regulatory inspection.

- Mark the EU AR’s name and contact information on product labels, packaging, and instructions.

- Assist in investigations and corrective actions related to product safety incidents.

UK Authorized Representative (UK AR)

Definition:

A compliance role established in the UK after Brexit, designated by non-UK manufacturers to fulfill obligations under ukca certification.

Core Responsibilities:

- Replace the EU AR in handling regulatory communication with UK market authorities (MHRA).

- Maintain technical documentation required for ukca certification for at least 10 years.

- Ensure product labels comply with UK regulations, including the UK AR’s name, address, and unique product identifier.

- Assist with product complaints and safety incidents within the UK.

US Authorized Representative (US AR)

Definition:

A US-based agent designated by non-US manufacturers, primarily serving products regulated by the FDA (Food and Drug Administration), CPSC (Consumer Product Safety Commission), and other regulatory bodies.

Core Responsibilities:

- Serve as a communication bridge between FDA/CPSC and the manufacturer, receiving inspection notices and warning letters.

- Assist with product registration and submission of conformity declarations.

- Support customs inspections and provide necessary compliance documents at product entry.

- Monitor product safety feedback in the US market to assist with recalls or corrective actions.

Importance of EU, UK, and US Authorized Representatives

- Mandatory compliance for market access:EU gpsr, UKCA, and US FDA rules require non-local manufacturers to appoint an authorized representative; otherwise, products may be considered non-compliant, facing detention, delisting, or fines.

- Risk mitigation and liability transfer:Authorized representatives can respond promptly to regulatory investigations, buying companies time to manage issues.

- Boost consumer trust:Displaying proper EU/UK/US AR information enhances consumer confidence in product compliance.

Differences Between EU, UK, and US Authorized Representatives

1. Applicable Market

- EU AR: 27 EU countries + Northern Ireland

- UK AR: UK (England, Scotland, etc.)

- US AR: Entire US

2. Core Regulations

- EU AR: GPSR, CE certification

- UK AR: UKCA certification, UK product safety laws

- US AR: FDA, CPSC, fcc certification, etc.

3. Language Requirement

- EU AR: Official language of the country (e.g., German, French)

- UK AR: English

- US AR: English

4. Registration Requirement

- EU AR: No official registration, written authorization required

- UK AR: No official registration, UKCA-related declaration required

- US AR: Some categories require regulatory filing (e.g., FDA)

5. Label Information

- EU AR: Name, address, email

- UK AR: Name, address

- US AR: Name, address (some categories)

6. Liability Duration

- EU AR: At least 10 years after product withdrawal

- UK AR: At least 10 years after product withdrawal

- US AR: Varies by category, usually during product lifecycle

Registration Process for EU, UK, and US Authorized Representatives

Choosing a qualified agent can streamline the registration process and reduce direct interaction with regulatory authorities.

EU / UK Registration:

- Manufacturer signs a written authorization agreement with the agent, specifying roles and responsibilities.

- Agent provides qualification documents (e.g., business license, proof of address).

- Manufacturer updates the agent information on product labels, packaging, and technical files.

US Registration (FDA-regulated categories as example):

- Agent completes and submits FDA Form 2579 (Letter of Authorization).

- Complete product registration/listing with the FDA.

- Include US AR information on product labels and import documents.