Clinical trials of cosmetic products

Clinical trials of cosmetic products

Poster

Tiyana Apostolov1, Emil Hristov1, Kalina Andreevska1, Iva Parvova2, Tsvetomir Deliyski1
1Faculty of Chemistry and Pharmacy, SU "St. Kliment Ohridski", Bulgaria
2Department of Rheumatology, Medical University Sofia, Bulgaria

It is essential that cosmetic products are safe for human health when used under normal and reasonably foreseeable conditions of use. Aim: To study the requirements for conducting clinical trials of cosmetic products in order to ensure their safety. Methods: A documentary method was used. Results: Cosmetic products placed on the market are safe for human health when the requirements of Regulation (EC) No. 1223/2009 of the European Parliament and of the Council are met. For this purpose, responsible persons and safety assessors are appointed to ensure the fulfillment of the various requirements according to the regulatory documents. Only validated methods without the use of animals can be used to assess the safety of individual ingredients of cosmetic products. The most modern validated methods are 3Rs - Refinement, Reduction and Replacement. The main alternative methods that do not use animals and are relevant to cosmetic risk assessment include in vitro, in chemico and in silico methods and read-across, as well as combinations thereof. For cosmetic product ingredients of known human health concern, the safety assessment is carried out by the Scientific Committee on Consumer Safety (SCCS). Conclusion: The basic and minimum specifications for any cosmetic ingredient to be evaluated are: Chemical identity; Physical form; Molecular mass; Characterization and purity of the chemical, including isomeric composition; Characterization of impurities or co-pollutants; Solubility; Distribution coefficient; Money pressure; Homogeneity and stability; Additional physical and chemical properties.
Keywords: cosmetic products, ingredients, safety