The qualitative and quantitative composition of the cosmetic product, including chemical identity of the substances (incl. chemical name, INCI, CAS, EINECS/ELINCS, where possible) and their intended function. In the case of perfume and aromatic compositions, description of the name and code number of the composition and the identity of the supplier.
The physical and chemical characteristics of the substances or mixtures, as well as the cosmetic product.
The stability of the cosmetics product under reasonably foreseeable storage conditions.
The microbiological specifications of the substance or mixture and the cosmetic product. Particular attention shall be paid to cosmetics used around the eyes, on mucous membranes in general, on damaged skin, on children under three years of age, on elderly people and persons showing compromised immune responses.
Results of preservation challenge test.
The purity of the substances and mixtures.
In the case of traces of prohibited substances, evidence for their technical unavoidability.
The relevant characteristics of packaging material, in particular purity and stability.
The normal and reasonably foreseeable use of the product. The reasoning shall be justified in particular in the light of warnings and other explanations in the product labelling.
Data on the exposure to cosmetic product taking into consideration the findings under Section 5 in relation to
The site(s) of application;
The surface area(s) of application;
The amount of product applied;
The duration and frequency of use;
The normal and reasonably foreseeable exposure route(s);
The targeted (or exposed) population(s). Potential exposure of a specific population shall also be taken into account.
The calculation of the exposure shall also take into consideration the toxicological effects to be considered (e.g. exposure might need to be calculated per unit area of skin or per unit of body weight). The possibility of secondary exposure by routes other than those resulting from direct application should also be considered (e.g. non-intended inhalation of sprays, non-intended ingestion of lip products, etc.).
Particular consideration shall be given to any possible impacts on exposure due to particle sizes.
Data on the exposure to the substances contained in the cosmetic product for the relevant toxicological endpoints taking into account the information under Section 6.
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.
All available data on the undesirable effects and serious undesirable effects to the cosmetic product or, where relevant, other cosmetic products. This includes statistical data.
Other relevant information, e.g. existing studies from human volunteers or the duly confirmed and substantiated findings of risk assessments carried out in other relevant areas.