Toxicological profiles of the ingredients that are part of the product formula are a vital part of the cosmetic product safety report (CPSR) and are used to determine the safety and compliance of the cosmetic products.
“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)