It has been ensured by laws and regulations (Cosmetic Regulations Article 12) that the cosmetic products that we frequently use at every moment of our lives, regardless of age limit, are reliable products so that they do not cause irreparable results and do not cause long-term negative effects, and that they do not contain components harmful to human health. According to the scope of the determined law, the safety assessment of a cosmetic product should include its chemical structure, the toxicological profile of the substances it contains, the level of exposure to the product, its physical properties and the information about the cosmetic product. Responsible persons who will make safety assessments should also have the competencies to perform the assessment and the documents required by law, and have a diploma in pharmacy, medicine, dentistry, biology, chemistry, biochemistry, microbiology.
Product Safety Information and Evaluation Report The safety margin (MoS) of the product components should be calculated in the Product Safety Evaluation Report. The highest application amount (NOAEL) of the substance for which no undesirable effect is observed is used in MoS calculations. In addition, the expected amount of the component to pass into the bloodstream, ie the systemic exposure dose (SED), will also be required in order to be able to evaluate for all toxicological routes of absorption and systemic effects. The safety assessment consists of two parts, the part containing the product safety information and the reporting part
The first section contains the following information;
- Quantitative and qualitative composition of the cosmetic product
- Physical/chemical characteristics and stability of the cosmetic product
- Microbiological quality
- Impurities, traces, information about the packaging material
- Normal and reasonably foreseeable use
- Exposure to the cosmetic product
- Exposure to substances
- Toxicological profile of substances
- Undesirable effects and serious undesirable effects
- Information on the cosmetic product
The second part contains the following information;
- Assessment conclusion
- Labelled warnings and useions of use
- Reasoning
- Assessor’s credentials and approval of part B
