Cosmetic Regulations in the European Union: What You Need to Know

1. Governing Body & Legislation:

• European Medicines Agency (EMA):
  • EMA oversees the regulation of cosmetic products within the EU.
• Regulation (EC) No 1223/2009:
  • This is the main regulatory document for cosmetic products in the EU, aimed at ensuring product safety for human health when used under normal conditions.
  • It applies to all member states of the EU and the European Economic Area (EEA).

2. Definition of Cosmetics:

• Cosmetics are defined as any substance or mixture intended to be placed in contact with the external parts of the human body or with the teeth and mucous membranes of the oral cavity to clean, perfume, change appearance, protect, keep in good condition, or correct body odors.

3. Responsible Person & Product Information File (PIF):

• A designated "Responsible Person" must ensure compliance with regulations.
• A Product Information File (PIF) must be created for each cosmetic product, containing details on product formulation, safety assessment, method of manufacturing, and proof of claims, among other data.

4. Cosmetic Product Notification Portal (CPNP):

• Before placing a cosmetic product on the EU market, the Responsible Person must submit a product notification via the CPNP.
• The CPNP is accessible to competent authorities, poison centers, and the EMA for market surveillance, non-compliance reporting, and medical treatment.

5. Labeling and Claims:

• Labels must include information such as the name and address of the Responsible Person, country of origin, contents by weight or volume, expiration date, precautions, batch number, and function of the product.
• Product claims must be substantiated and compliant with the "Common Criteria for Cosmetic Claims" to avoid misleading consumers.

6. Ingredient Restrictions & Prohibitions:

• The regulation lists substances that are prohibited in cosmetic products, as well as those subject to restrictions regarding concentration and application.
• The use of colorants, preservatives, and UV filters is specifically regulated.

7. Safety Assessment & Good Manufacturing Practices (GMP):

• A safety assessment must be conducted, and a safety report must be included in the PIF.
• Cosmetics must be produced according to Good Manufacturing Practices to ensure product quality and safety.

8. Animal Testing & Nanomaterials:

• The sale and marketing of cosmetic products and ingredients tested on animals are prohibited in the EU.
• If a product contains nanomaterials, they must be explicitly mentioned in the ingredient list, and additional safety assessments may be required.

9. Recall, Withdrawal & Reporting:

• In case of non-compliance or safety issues, there are provisions for recall or withdrawal of products.
• Any serious undesirable effects must be reported to the competent national authority.

10. Organic and Natural Cosmetics:

• There is no legal definition for "organic" or "natural" in cosmetic regulations, but such claims must be truthful, not misleading, and substantiated.
• Various private certification bodies provide standards for organic and natural cosmetics.

Additional Resources:

• European Commission - Cosmetics Regulation - Official page for EU cosmetics legislation, guidance documents, and related resources.
• CosIng Database - The EU’s database for information on cosmetic substances and ingredients.