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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 fundamental misunderstanding can lead to blocked sales, costly penalties, or even the complete withdrawal of a product. The Responsible Person is not a passive mailbox, but an active risk manager, bearing full legal responsibility for product compliance before regulatory authorities.

European Union – The Gold Standard of Safety and RP

The EU market operates under Regulation (EC) No 1223/2009, one of the most rigorous regulatory frameworks in the world. The guiding principle is prevention: the product must be fully compliant before it reaches the consumer. Failure to comply can result in immediate product recall and severe financial penalties.

  1. 📄 Product Information File (PIF) Management: The RP must maintain and, upon request, provide regulatory authorities with access to the PIF. This file includes the core Cosmetic Product Safety Report (CPSR), which must be signed off by a qualified safety assessor. Authorities can request this file within 72 hours.
  2. 🧴 Cosmetovigilance and Safety Oversight: The RP must manage a cosmetovigilance system, which includes the collection, evaluation, and compulsory reporting of all Serious Undesirable Effects (SUE) through the CPNP (Cosmetic Product Notification Portal).
  3. 🧾 Regulatory Liaison and Market Surveillance: The RP acts as the primary point of contact for all market surveillance authorities, answering queries related to product claims, labelling, and ingredient compliance.

For products such as candles, although not covered by the Cosmetics Regulation, the General Product Safety Directive (GPSD) applies. Manufacturers and importers must ensure technical documentation and compliance with EN standards such as EN 15493 (fire safety) and EN 15494 (safety labelling).

Proactive Compliance Management: The RP monitors the CPNP system and evolving EU cosmetic law, collaborating with the client to implement necessary product and documentation adjustments to ensure continuous market 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 an almost identical but completely separate regulatory regime. Ignoring this separation and the requirement for a UK-based entity constitutes a major compliance risk. An effective Responsible Person EU UK USA strategy requires dedicated UK compliance.

Key obligations in the UK:

  • 🇬🇧 UK Responsible Person (UKRP): Every product placed on the Great Britain market (England, Scotland, and Wales) must appoint a Responsible Person established in the UK.
  • 📋 Notification via SCPN: Products must be notified through the dedicated SCPN portal.
  • 📘 Documentation: Obligations regarding the PIF and CPSR remain legally analogous to those in the EU.

Proactive Compliance Management: The RP proactively monitors the SCPN system and evolving UK cosmetic law, collaborating with the client to implement necessary adjustments to ensure continuous compliance.

Contact us to appoint your UK Responsible Person and avoid penalties.

United States – MoCRA Compliance: The US Agent Role

The Modernisation of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant overhaul of US regulations since 1938. MoCRA transforms the US market from a post-market surveillance system into a preventative, EU-aligned framework, introducing several mandatory compliance requirements for the cosmetics industry.

Key roles and obligations under MoCRA:

  1. ⚖️ Responsible Person (RP) Accountability: Defined as the manufacturer, packager, or distributor whose name appears on the labelling. The RP is ultimately accountable for product safety and compliance.
  2. 📞 US Agent & Adverse Event Contact: The foreign RP must appoint a US Agent to serve as the domestic contact for reporting adverse events and managing communication with the FDA.
  3. 🧪 Safety Substantiation: Each product must be supported by adequate safety substantiation before being placed on the market.
  4. 🗂️ Mandatory FDA Listing and Registration: MoCRA mandates registration of all facilities and listing of each cosmetic product with the FDA.
  5. ⏱️ Adverse Event Reporting: Serious adverse events must be reported to the FDA within 15 business days.
  6. 🏷️ New Labelling Requirements: The RP must ensure compliance with new rules, including allergen declarations and visible US Agent contact details.

If compliance requirements are neglected, the RP risks receiving a Warning Letter from the FDA, which can permanently damage brand reputation and result in a complete distribution ban in the US.

Register with the FDA and appoint your US Agent / Adverse Event Contact to meet MoCRA requirements.

Why One Partner Across Three Markets is a Strategic Advantage

  • 🌍 Consistency and Simplification: One partner means a harmonised PIF strategy and unified process for EU, UK, and FDA submissions.
  • 🛡️ Risk Mitigation: Expert knowledge across markets protects your brand from errors, customs issues, and penalties.
  • 🤝 Peace of Mind: Focus on business growth while specialists ensure full compliance and uninterrupted sales.
Grafika symbolizująca jedną, zintegrowaną strategię Responsible Person EU UK USA

Conclusion

The Responsible Person is not merely an address on a label. They are a compliance guardian, risk manager, and strategic advisor. Investing in a professional RP / UKRP / US Agent means investing in product safety, uninterrupted sales, and international brand protection.

📚 References

  1. 📘 Kramarczuk, P., & Gałęcki, K. (2023). A comparative analysis of European and British cosmetic products legislation. Biotechnology and Food Science, 85(1), 49–54.
  2. 🧾 SGS USA. (2025). Cosmetic Product Safety Report (CPSR).
  3. 📋 Office for Product Safety & Standards. (2021). Toys (Safety) Regulations 2011 – as they apply to Great Britain from 1 January 2021.
  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.
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