Assessment of the safety for human health
Before being launched on the European Union market, each cosmetic product must prove to be safe for human health. To that end, the company or person placing a cosmetic product on the market is responsible for performing an assessment of the safety for human health of the finished product, which must be included in the product information file.
“[…] The manufacturer shall take into consideration the general toxicological profile of the ingredients, their chemical structure and their level of exposure. It shall take particular account of the specific exposure characteristics of the areas on which the product will be applied or of the population for which it is intended.
There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene.” (Article 7a (1) (d) of the EU Cosmetics Directive)
The safety assessment must be carried out by a scientist qualified in a relevant discipline with a diploma1in the field of pharmacy, toxicology, dermatology, medicine or a similar discipline; and in accordance with the principle of good laboratory practice2(Article 7a (1) (e) and 7a (2) of the EU Cosmetics Directive)
BIORIUS works with safety assessors of cosmetics in the EU who are qualified to assess the safety of cosmetic products for human health.
For incomplete toxicological profiles of the ingredients, BIORIUS also performs specific relevant tests in collaboration with partner labs.
1defined under Article 1 of Directive 89/48/EEC on the recognition of higher education diplomas.
2laid down in Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances.