European Cosmetics Regulations

The European Union (EU) Cosmetics Directive defines cosmetics as “any substance or mixture intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition”. Lists of prohibited and restricted ingredients are provided in the Directive in Annex II and III respectively. Cosmetic products (or constituent ingredients) which have been tested on animals are prohibited in the EU. Effective 11 July 2013, the Cosmetics Directive will be replaced by the Cosmetic Products Regulation (EU Regulation 1223/2009), which harmonizes and simplifies the cosmetics regulations across the EU member states. Manufacturers must submit a product notification to the competent authority, and must also prepare a Product Information File. An understanding of requirements and expectations and a pro-active approach is warranted to document safety, manufacturing information, and appropriate label information.

Intertek Cantox can assist with the following:

• Safety Assessments
  • Cosmetics Ingredient Profiles
  • Product Information Files (PIFs)
    • Part A Cosmetics Product Safety Information
    • Part B Cosmetic Product Safety Assessments
• Regulatory Compliance Support
  • Regulatory advice
  • Product notifications
  • PIF assembly
• Clinical Studies for Claim Substantiation
  • Design, placement, and monitoring
• Product Labelling Review and Support