Documents Needed for the Registration of a Cosmetic in Europe and Great Britain

Documents Needed for the Registration of a Cosmetic in Europe and Great Britain

Overview

In this guide, we will explain the documentation needed, for the registration of a cosmetic, in Europe (EU) and Great Britain (GB). 

Raw Materials

Documents to be provided by raw material suppliers:

  1. Safety Data Sheet (SDS/MSDS): Mandatory for hazardous materials, in compliance with regulation 878/2020.
  2. Certificate of Analysis (COA)/Technical Data Sheet (TDS): Includes physicochemical and microbiological properties, impurities, and batch details.
  3. Regulatory Data Sheet (RDS): Must include:
    • Declarations on CMR substances, BSE, GMOs, impurities, heavy metals, nanomaterials, and SVHC substances.
    • INCI composition, origin, animal testing compliance, and allergen presence.
  4. Non-Animal Testing Statement (NAT): Verifies adherence to cruelty-free practices.
  5. IFRA Certificate and Allergen Reports: Required for fragrances and essential oils.

Finished Products

Documents required from various entities:

  1. From Brand Owners:
    • Labels for all product sizes in English.
  2. From Laboratories:
    • Tests: Stability, compatibility, preservative efficacy (PET), microbiological properties.
    • SPF Testing: UVB (ISO 24444:2019) and UVA (ISO 24443:2012).
  3. From Packaging Manufacturers:
    • Information on container composition, size, technical details, and migration test results.
  4. From Finished Product Manufacturers:
    • Complete composition and supplier details.
    • Statements on animal testing compliance, undesirable effects, and manufacturing method.
    • Certificates: GMP (ISO 22716), SDS, COA/TDS.

Required Tests and Certifications

  1. Stability and Compatibility Tests: Accelerated and real-time testing under specific conditions.
  2. Claims Substantiation: Supporting evidence for product claims (e.g., efficacy tests, clinical studies, or scientific data).
  3. Symbol Certifications: Proof for claims like recycling, cruelty-free, or organic/natural products.

Additional Documentation

  1. Specifications: Microbiological and physicochemical properties.
  2. CMR, SVHC, GMO, and Nano-Free Statement: Prepared by the manufacturer or validated through testing.
  3. Packaging and Food Contact Statements: Details on material composition and compliance.
  4. General Information: Product name, identification code, and notification number.

Glossary of Key Terms

  • MSDS/SDS: A 16-section document for hazardous materials.
  • COA/TDS: Certificate detailing batch-specific properties and compliance.
  • RDS: Regulatory data ensuring compliance with multiple safety and legal standards.
  • NAT: Declaration of non-animal testing practices.
  • IFRA Certificate: Specifies safe allergen levels in fragrances and essential oils.

Symbols & Logos

  1. Recycling: Green Dot, Triman (mandatory in France).
  2. Cruelty-Free: PETA, Leaping Bunny.
  3. Organic/Natural: USDA Organic, Cosmos logos.
  4. FSC Certification: For environmentally responsible packaging.

Need more help? 

If you need more help, no problem. Contact Us, and we'll be happy to help. 

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