Product Safety
Product Safety
To assure the safety of a raw material used for cosmetic applications, a series of toxicological tests are required. They form the basis for a safety evaluation. These tests can either be carried out on animals (in vivo) or on isolated cells (in vitro = alternative method). Regarding this, the EU has published “Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation”.
In the case of cosmetics, it is particularly important to obtain information concerning a possible sensitizing or irritating effect of a substance. Absorbing substances must be tested for phototoxic effects upon exposure to sunlight. In addition, it has to be known e.g. whether a raw material is suspected of causing cancer (carcinogenic=C), causing genetic mutations (mutagenic=M) or damaging reproduction (reprotoxic=R). Such substances are classified as CMR substances and are banned from use in cosmetic products.
Merck selects which tests are to be carried out on a raw material depending on the application. The safety of the raw material is proven by toxicological studies and literature data. A human patch test is performed to obtain final information on the tolerability of the substance.
The cosmetic manufacturer must be able to refer to the safety of the raw materials in order to prove the safety of cosmetic products. Merck provides this information in short summary as part of the Cosmetic Ingredient Dossier.
