The aim of tolerance evaluation is to ensure that cosmetic products are safe for consumer use. By subjecting these products to rigorous testing protocols, tolerance evaluations strive to confirm the absence of irritation, photo irritation, sensitization, or other undesired reactions, under the specific conditions intended for use. Through meticulous examination and analysis, these evaluations provide invaluable insights into the product’s compatibility with various skin types and ensure that it meets the highest standards of safety and performance expected by consumers.

The “Guidelines for the Safety Assessment of a Cosmetic Product” article published by Cosmetics Europe in 2004 provides comprehensive directives for evaluating the safety of cosmetic products before their launch onto the market. These guidelines address specific responsibilities that manufacturers bear in ensuring the safety of their products.

The local tolerance of a cosmetic product largely depends on the complete formulation. When comprehensive toxicological data analysis isn’t sufficient to definitively establish the local tolerance of the finished product, in-vitro and in-vivo evaluations on human volunteers have to be conducted. These studies do not consist of only ingredient testing but also the evaluation of the compatibility of the finished product with human skin.

Human clinical trials must adhere to the ethical principles of Good Clinical Practice (GCP). They may include single or repeated open or closed epicutaneous applications, or even home (safety) in-use tests, and are conducted under the supervision of qualified personnel and dermatologists. Therefore, the safety assessment of any cosmetic product is closely related to its mode of use (frequency, duration, exposure, etc.).

Based on compelling evidence, in addition to tolerance and skin compatibility evaluation, some of these tests also allow to also obtain safety claims such as “dermatologically tested” or “hypoallergenic”, although the latter also depends on the ingredients contained in the tested product.

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