The purpose of this paper is to review current approaches to toxicological profile evaluation of cosmetic preparations and substances in Europe. Cosmetic substances as well as final products must be safe for consumers. The law 76/768/EEC with appendices regulates this area in European Community. It is required that cosmetic substances subdue the basic toxicological tests, including acute toxicity, subchronical toxicity, eye and skin irritability, sensibilisation, percutaneous absorption, phototoxicity, photoirritation and mutagenicity. The safety evaluation of a final product depends on its way of use. It is necessary to take in an account quantity and frequency of product use, consumer target group, concentration and toxicological profile of used substances. Nowadays, evaluation of a final products is based on combination of information sources like available databases, information about composition of products, in vitro tests and results of studies on human volunteers. Regarding cosmetic substances it is in particular cases necessary to perform tests in vivo on laboratory animals, because not for all tests required does a validated alternative methods exist.

        Key words: safety evaluation - cosmetics - in vitro - validation - alternative methods