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:

• Toxicology & Safety Assessment of Cosmetic products
• Preparation of Cosmetic Product Safety Report (CPSR parts A& B)
• Notification of cosmetics in CPNP/ UK SCPN
• Methods to search for alternative ingredients for Cosmetic formulations
• Skin penetration & evaluation of active ingredients
• Formulation of cosmetic recipes including allergen labeling and Nordic Swan labelling
• GMP, Quality management & compliance with stability testing .

Cosmetovigilance

Since the evaluating the final cosmetic products’ safety does not end with CPNP notification, Tox Regulatory Advisor offers a full package of cosmetovigilance to monitor complaints and recommendations for reformulations. We manage the whole process, from undesirable effects notifications and communicating with consumers to causality assessments.