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Responsible Person EU, UK & USA – Full Compliance Guide | Annel Ltd

The Responsible Person: How to Safely Scale Your Brand in the EU, UK & USA

For brands planning to enter the markets of the European Union, the United Kingdom, and the United States, establishing the Responsible Person EU UK USA is crucial. This misunderstanding can lead to blocked sales, penalties, or total product withdrawal.

The Responsible Person is not a passive mailbox but an active compliance guardian and risk manager.

European Union – The Gold Standard of Safety and RP

The EU market operates under Regulation (EC) No 1223/2009, one of the most rigorous frameworks in the world.

  • Product Information File (PIF) Management: The RP must maintain and provide authorities access to the PIF.
  • Cosmetovigilance and Safety Oversight: Managing reporting of Serious Undesirable Effects (SUE) via CPNP.
  • Regulatory Liaison and Market Surveillance: Handling authority enquiries on claims, labelling, and ingredient compliance.

Proactive Compliance Management: The RP monitors EU law to ensure continuous compliance. Ensure full compliance with Regulation 1223/2009 and safe market entry in the EU.

United Kingdom – UK Responsible Person (UKRP) Compliance

Following Brexit, the UK established a separate regulatory regime. Key obligations in the UK:

  • UK Responsible Person (UKRP): Required for all products sold in Great Britain.
  • Notification via SCPN: Products must be notified in the SCPN portal.
  • Documentation: PIF and CPSR obligations remain analogous to the EU.

Proactive Compliance Management: The RP monitors the SCPN system and evolving UK law. Contact us to appoint your UK Responsible Person and avoid penalties.

United States – MoCRA Compliance: The US Agent Role

MoCRA (2022) modernized the US regulatory system.

Key obligations under MoCRA:

  • Responsible Person Accountability: The RP is accountable for product safety.
  • US Agent & Adverse Event Contact: Mandatory communication link with the FDA.
  • Safety Substantiation: Products must have safety evidence.
  • Mandatory FDA Listing & Registration: All facilities and products must be listed.
  • Adverse Event Reporting: Severe events must be reported within 15 days.
  • New Labelling Requirements: Including allergen declarations.

Register with the FDA and appoint your US Agent / Adverse Event Contact.

Why One Partner Across Three Markets Is an Advantage

  • Consistency and Simplification: One partner ensures unified compliance across EU, UK, and USA.
  • Risk Mitigation: Cross-market expertise prevents errors and penalties.
  • Peace of Mind: You focus on growth while compliance stays protected.
Responsible Person Strategy Diagram

Conclusion

The Responsible Person is a compliance guardian and strategic advisor. A professional RP / UKRP / US Agent ensures safety, continuity, and brand protection.

References

  1. Kramarczuk, P., Gałęcki, K. (2023). A comparative analysis of European and British cosmetic products legislation.
  2. SGS USA. Cosmetic Product Safety Report (CPSR).
  3. Office for Product Safety & Standards. Toys (Safety) Regulations 2011.
  4. FDA. Modernisation of Cosmetics Regulation Act (MoCRA).
  5. FDA. Registration & Listing of Cosmetic Product Facilities and Products.
  6. FDA. Adverse Event Reporting for Cosmetics.