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Understanding Responsible Persons in EU, UK, Canada & US Agents for Cosmetics
Regulatory Compliance for Cosmetics: EU, UK, US (MOCRA), and Canada
When marketing cosmetics internationally, compliance with local regulations is crucial. The EU, UK, US, and Canada each require a designated Responsible Person (RP) or US Agent to ensure compliance with cosmetic laws. Below, we outline the key differences between these roles and their responsibilities.
🇪🇺 European Union (EU) Responsible Person
Legal Basis: EU Regulation (EC) No. 1223/2009
Who Needs an EU RP?
Any cosmetic product sold in the EU must have a Responsible Person (RP) established within the European Union. This is required whether the brand is based in the EU or is an international company exporting to the EU.
Role of an EU RP:
- Ensures cosmetic products comply with EU safety regulations.
- Reviews Product Information File (PIF) and Safety Assessment Report.
- Registers products on the Cosmetic Products Notification Portal (CPNP).
- Acts as the point of contact with EU regulatory authorities and in case of adverse effects or recalls.
- Maintains compliance documentation for at least 10 years.
Who Can Be an EU RP?
- The manufacturer, if based in the EU.
- An authorized third party (such as Cosmereg) acting as the RP on behalf of a non-EU company.
🇬🇧 United Kingdom (UK) Responsible Person
Legal Basis: UK Cosmetic Regulation (Post-Brexit)
Who Needs a UK RP?
If you market cosmetics in Great Britain (England, Scotland, Wales), a UK Responsible Person is required.
Role of a UK RP:
- Ensures compliance with UK Cosmetic Product Safety Regulations.
- Registers products with the UK Submit Cosmetic Product Notification (SCPN) portal.
- Maintains the PIF and ensures that cosmetic claims meet UK advertising laws.
- Serves as the point of contact for the UK regulatory authorities (OPSS).
Who Can Be a UK RP?
- The manufacturer (if based in the UK).
- A distributor or importer.
- A third-party service like Cosmereg acting as the UK RP for non-UK brands.
🇺🇸 United States: US Agent under MOCRA
Legal Basis: Modernization of Cosmetics Regulation Act (MOCRA) 2022
Who Needs a US Agent?
Under MOCRA, any foreign cosmetic company selling in the US must appoint a US Agent.
Role of a US Agent:
- Acts as the official FDA contact for foreign cosmetic companies.
- Handles Facility Registration & Product Listing in the FDA database.
- Assists in responding to FDA inspections and inquiries.
- Facilitates adverse event reporting if necessary.
Who Can Be a US Agent?
- A US-based entity or individual.
- A regulatory consultant (like Cosmereg) acting on behalf of a foreign company.
💡 Unlike the EU and UK RP, the US Agent under MOCRA does not take legal responsibility for compliance but serves as a communication link with the FDA.
🇨🇦 Canada: Responsible Person for Cosmetics
Legal Basis: Food and Drugs Act (Cosmetic Regulations)
Who Needs a Canadian RP?
All cosmetic products imported into Canada must have a Responsible Person (RP), who submits a Cosmetic Notification Form (CNF) to Health Canada.
Role of a Canada RP:
- Ensures product compliance with Health Canada regulations.
- Submits and maintains the Cosmetic Notification Form (CNF).
- Acts as the contact point for Health Canada inspections.
- Ensures product labeling complies with bilingual (English & French) requirements.
Who Can Be a Canada RP?
- A manufacturer or importer based in Canada.
- A third-party consultant like Cosmereg, serving as the Responsible Person for non-Canadian brands.
How to Appoint a Responsible Person or US Agent?
At Cosmereg, we provide Responsible Person (RP) services for the EU, UK, and Canada, as well as US Agent services under MOCRA.
🔹 Steps to Appoint an RP/US Agent with Cosmereg:
✅ Contact us for a compliance assessment.
✅ We review your product portfolio and regulatory needs.
✅ We sign an agreement to act as your RP or US Agent.
✅ We handle product registration, safety compliance, and regulatory support.
💡 Need a Responsible Person or US Agent?
Do you want to know more about MoCRA, EU, UK, or Canada RP?
US Agent and Responsbile Person Roles
EU, UK Responsible Person for Cosmetics
Canadian Base Responsible Person
FAQ
If you sell cosmetics in the EU, UK, or Canada, you are required to have an RP based in that region to ensure compliance with local regulations. In the US, you need a US Agent under MOCRA if you are a foreign manufacturer.
- The EU RP is legally responsible for product compliance, safety, and regulatory documentation.
- The US Agent under MOCRA does not assume legal responsibility but serves as an FDA contact for foreign companies.
Yes, but this may not be ideal since distributors often lack regulatory expertise and may not be willing to take legal responsibility for compliance. Using a third-party RP like Cosmereg ensures independent compliance and regulatory expertise.
- EU/UK: Registration is almost instant once the Product Information File (PIF) is complete and uploaded to the CPNP/SCPN portal.
- US (MOCRA): Facility Registration & Product Listing with the FDA must be completed before December 2023 for existing brands and before selling in the US for new brands.
- Canada: The Cosmetic Notification Form (CNF) must be submitted to Health Canada within 10 days of selling in Canada.
Without an RP or US Agent:
- Your cosmetics cannot be legally sold in those markets.
- You risk fines, recalls, and regulatory actions.
- You may face border rejections and customs delays.
No, each region requires a separate RP or US Agent:
- EU RP (for the European market).
- UK RP (for Great Britain post-Brexit).
- US Agent (for FDA compliance under MOCRA).
- Canada RP (for Health Canada regulations).
Yes! Cosmereg provides full RP and US Agent services, including:
✅ EU Responsible Person
✅ UK Responsible Person
✅ US Agent (MOCRA compliance)
✅ Canada Responsible Person
Getting started is simple:
- Contact us for a compliance assessment.
- Submit your product details (ingredients, labeling, PIF, etc.).
- We take care of the rest—from registration to ongoing compliance!
