Effective 11 July 2013, the European Union (EU) Cosmetics Directive 76/768/EEC will be replaced by the Cosmetic Products Regulation 1223/2009, which harmonizes and simplifies the cosmetics regulations across the EU member states. The goal is a higher level of consumer protection from hazardous substances and the lists of prohibited and restricted ingredients are provided in Annex II and III respectively.
Manufacturers must submit a product notification to the designated competent authority and prepare a product safety assessment and Product Information File (PIF). An understanding of the regulatory requirements is needed to successfully document safety, manufacturing information, and appropriate label information.

We provide cosmetics companies with complete scientific and regulatory support for compliance with Regulation (EC) No 1223/2009.
Our services include:

  • Preparation of a product safety assessment and Product Information File
  • Determination of the normal and reasonably foreseeable use of the product
  • Preparation of Cosmetics Ingredient Profiles
  • Preparation of Part A Cosmetics Product Safety Information
  • Preparation of Part B Cosmetic Product Safety Assessments
  • Regulatory Compliance Support and Product notifications
  • Preparation of Product Labelling Review and Support

For further information, please contact us at +4526 70 96 48 and send questions to info@slet-dette.toxregulatoryaffairs.com