“Toxicological profile of the substances

Without prejudice to Article 18, the toxicological profile of substance contained in the cosmetic product for all relevant toxicological endpoints. A particular focus on local toxicity evaluation (skin and eye irritation), skin sensitisation, and in the case of UV absorption photo-induced toxicity shall be made.

All significant toxicological routes of absorption shall be considered as well as the systemic effects and margin of safety (MoS) based on a no observed adverse effects level (NOAEL) shall be calculated. The absence of these considerations shall be duly justified.

Particular consideration shall be given to any possible impacts on the toxicological profile due to:

• particle sizes, including nanomaterials,

• impurities of the substances and raw material used, and

• interaction of substances.

Any read-across shall be duly substantiated and justified.
The source of information shall be clearly identified.”

(Annex I, 8, Regulation 1223/2009)