Dermatox provides the service to perform safety assessments of cosmetic products.

The largest part of the P.I.F. is the safety report (Cosmetic Product Safety Report or CPSR). The CPSR consists of two parts:

Part A: Cosmetic product safety information (data needed for the safety assessment).

Part B: Cosmetic product safety assessment.

NOTE! The safety report must be kept updated. Among the possible reasons for updating the safety report are:

• There is a rising trend of reported undesirable effects (in severity and / or frequency
• The formulation or raw material specifications have been changed
• There is new scientific evidence and toxicological data
• The terms of use have changed

The Commission Guidelines on Annex I to Regulation (EC) No 1223/2009

Important considerations: Safety assessment requires competence and experience of the safety assessor. Annex I is not intended to “teach” these skills. The safety assessment of cosmetics is not a standardized procedure, but performed on a case-by-case basis. “Checklist” approaches and decisions based on hazard alone are considered inappropriate. By utilizing the entire scope of information available, science-based decisions in a weight-of-evidence approach are made.

RISK = HAZARD X EXPOSURE