The Cosmetic Product Safety Report is an important element of the PIF (Product Information File). It is made up of two parts: the first (safety information) contains all data necessary for assessing risks and the second (safety assessment) must be lead by an expert toxicologist who must judge, on the basis of current knowledge, that the product is safe for human health.
Part I: Information on the safety of the cosmetic product
- Qualitative and quantitative composition of the cosmetic product
- Stability of the cosmetic product and its physical and chemical characteristics
- Microbiological quality
- Impurities, traces and packaging material information
- Normal and reasonably foreseeable use
- Exposure to the cosmetic product
- Exposure to its substances
- Toxicological profile of substances
- Undesirable effects and serious undesirable effects
- Information on the cosmetic product
Part II: Safety assessment of the cosmetic product
- Conclusion of the safety assessment
- Instructions and warnings appearing on the product labeling
- Reasoning
- Assessor’s references and approval of part II
This second part, conducted by an assessor, consists of:
- An analysis of the toxicological data relating to the product’s different ingredients,
- An assessment of the individual’s risk of exposure based on where the product will be applied,
- An assessment of the risks of the substances and the packaging interacting,
- Impacts of stability on the safety of the cosmetic product