The cosmetic product safety report shall, as a minimum, contain the following:
PART A – Cosmetic product safety information
1. Quantitative and qualitative composition of the cosmetic product
2. Physical/chemical characteristics and stability of the cosmetic product
3. Microbiological quality
4. Impurities, traces, information about the packaging material
5. Normal and reasonably foreseeable use
6. Exposure to the cosmetic product
7. Exposure to the substances
8. Toxicological profile of the substances
9. Undesirable effects and serious undesirable effects
PART B – Cosmetic product safety assessment
1. Assessment conclusion
Statement on the safety of the cosmetic product in relation to Article 3.
2. Labelled warnings and instructions of use
Statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1)(d).
3. Reasoning
Explanation of the scientific reasoning leading to the assessment conclusion set out under Section 1 and the statement set out under Section 2. This explanation shall be based on the descriptions set out under Part A. Where relevant, margins of safety shall be assessed and discussed. There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene. Possible interactions of the substances contained in the cosmetic product shall be assessed. The consideration and non-consideration of the different toxicological profiles shall be duly justified. Impacts of the stability on the safety of the cosmetic product shall be duly considered.
4. Assessor’s credentials and approval of part B
Name and address of the safety assessor.
Proof of qualification of safety assessor.
Date and signature of safety assessor.
