LEARNING OUTCOMES
The aim of the course is for students to understand the basic principles of the safety evaluation of cosmetic products, available to consumers. To be able to estimate the potential toxicological risks before the distribution in the market or to assess the risk (irritations, allergies, phototoxicity, etc.) in the distribution, in order to take any corrective action that may be needed, such as withdrawal or recall of finished products, to ensure public health.
The goal of the course is to teach students the basic principles of toxicity testing of raw materials, packaging materials and finished products. To be able to assess the irritability of chemicals on the skin, through irritation and sensitization testing, as well as the calculation of the Margin of Safety (MoS) for each component, as defined by the European Regulation and the National Organization for Medicines for cosmetics (EC 1223/2009).
Learning results :
After the end of the course the students will be able to know:
- The in vitro and in vivo toxicity tests, applied to a raw material (ingredient) in order to assess its potential risk in the final cosmetic formulation.
- The dermatological tests (Patch test, Repeated Patch test) that must be done, regarding the safety of the final cosmetic product in order to characterize a cosmetic as Non-Irritant or Hypoallergenic.
- How to calculate the Margin of Safety (MoS) for each component.
- To be able to assess the potential toxicity or hazard of impurities of raw materials, packaging materials and final formulations.
- To be able to sign as an assessor the cosmetic product safety assessment, in the technical file, which is required to be prepared by the EU and the National Organization for Medicines, before the product is placed on the market.
- To be able to cooperate with the competent authorities, if required, in order to take into account the risk that may exist and the need for corrective action by the person in charge of the product marketing.
SYLLABUS
Lectures
1. Irritation tests (skin, eye irritation).
2. Phototoxicity tests – Photo-allergy
3. Carcinogenicity – Mutation tests.
4. In vitro & in vivo study of the absorption of substances from the skin.
5. Foreign impurities, traces, information on raw materials and packaging materials.
6. Exposure to the cosmetic product. The toxicological effects to be considered are also taken into account in calculating the exposure (e.g. exposure may need to be calculated per unit of skin surface area or body weight).
7. Toxicological profile of substances. All significant toxicological pathways of absorption are examined while systemic effects as well as the margin of safety (MoS) are calculated based on the level of no observed adverse effect level (NOAEL).
8. Evaluation of a cosmetic product in true conditions of use.
9. Adverse and serious adverse events.
10. Cosmeto-vigilance
11. Warnings and instructions for use in labeling.
12. Preparation of the safety report. How to submit.
13. Assessment conclusion. Explanation of the scientific reasoning that led to the assessment conclusion.