Division 4.3.1 Safety Evaluation of Substances and/or Mixtures

The safety evaluation of substances and/or mixtures consists of three main steps:

1. (1)

   hazard characterisation of substances and mixtures;

2. (2)

   assessment of the local and systemic exposure (considering absorption data);

3. (3)

   risk assessment of systemic effects (calculation of margin of safety) and risk assessment of local effects (such as skin allergy, skin irritation).

For fragrance and flavour compounds, where information on their composition is confidential, a safety assessment may be provided to the responsible person for the finished cosmetic product by the manufacturer of that mixture. Taking into account the concentration in the final cosmetic product and its exposure pattern, the safety assessment of the fragrance and flavour compound should be prepared following the principles described in Annex I to Regulation (EC) No 1223/2009 and these guidelines. An appropriate document demonstrating the safety of the fragrance or flavour compound should be provided by the supplier to the responsible person for the finished cosmetic product.