FDA to EU & UK Cosmetic Compliance | Responsible Person, CPSR & PIF | Annel Ltd

🇺🇸 FDA-Compliant to 🇪🇺 EU / 🇬🇧 UK-Compliant

Helping US Manufacturers & Brand Owners Enter the EU and UK Cosmetic Markets

Expanding your cosmetic or personal care brand into the European Union (EU) or United Kingdom (UK) is an exciting opportunity — but being FDA-compliant is not the same as being EU- or UK-compliant.

At Annel, we help US manufacturers and brand owners meet all European and UK cosmetic regulatory requirements, using existing documentation where possible to save time and cost — without unnecessary retesting or duplication.


Get EU/UK Compliance Support

Understanding FDA vs EU/UK Compliance

FDA compliance focuses primarily on product safety and labeling under the Federal Food, Drug, and Cosmetic Act (FD&C Act). In contrast, the EU and UK cosmetic frameworks are stricter and require detailed technical documentation, ingredient compliance checks, and official market registration.

Every cosmetic product placed on the market must have:

FDA to EU/UK Cosmetic Compliance – How Annel Helps You Transition

  1. Ingredient Review: Checking all ingredients against Annex II (banned) and Annex III (restricted) lists.
  2. Concentration Check: Verifying formulation concentrations within legal limits.
  3. Testing & Data Verification: Reviewing and validating existing test reports; aligning with EU/UK standards or coordinating necessary tests.
  4. Raw Material & Packaging Documentation: Reviewing manufacturing and packaging data in line with GMP (ISO 22716).
  5. CPSR Preparation & Approval: Compiled and signed by certified EU/UK Safety Assessors.
  6. Label Review & INCI Conversion: Converting to European INCI format and verifying compliance.
  7. Label Translation: Providing accurate translations for EU markets.
  8. Product Registration: Registering on CPNP (EU) or SCPN (UK) portals.
  9. Responsible Person (RP/UKRP) Certification: Issuing certificates confirming compliance.

Test Verification and Cost Efficiency

We verify, interpret, and approve your existing test results wherever possible to ensure they align with EU and UK requirements, minimizing duplication and cost.

  • Review and validate existing test reports from non-EU/UK labs
  • Confirm equivalence of test methods with EU/UK-recognised standards
  • Identify only essential supplementary tests
  • Provide guidance for your lab or coordinate testing with EU partners

Compliance Timeline

  • Ingredient and documentation review: 1–2 weeks
  • Testing and CPSR preparation: 3–5 weeks
  • Label and registration: 1–2 weeks

Average total: 6–8 weeks from start to full EU/UK compliance

Why Choose Annel

  • Based in both the EU and UK for complete coverage
  • Specialists in US-to-EU/UK cosmetic compliance
  • Transparent pricing with multi-SKU discounts
  • Dedicated account management for every client

At Annel, we simplify complex regulations — helping US brands enter Europe and the UK confidently, safely, and legally.

Ready to Enter the EU & UK Cosmetic Markets?

Whether you produce skincare, haircare, or personal care products, Annel ensures your cosmetics meet every EU and UK requirement — from ingredient verification to registration and certification.

Contact Annel for a Free Compliance Review

💬 Frequently Asked Questions

Is my USP <51> test accepted in Europe or the UK?
Not directly. The EU and UK may require different test methodologies. However, Annel can review and, in many cases, accept or align your existing data with European standards to avoid duplication.

How long does it take to achieve EU/UK cosmetic compliance?
On average, 6–8 weeks, depending on product category and available documentation. The process can be shorter if most data is already prepared.

What documents do you need to start the process?
We’ll ask for your ingredient list, formulation details, test reports, label, and packaging information. From there, we handle the rest — including CPSR, INCI conversion, translations, and registration.

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