Safety evaluation of cosmetics in the EUReality and challenges for the toxicologist

‘Read this and be safe!’ Comparison of regulatory processes for communicating risks of personal care products to European and South African consumers

“…When these ingredients, however, are used in cosmetic products, they are regulated under the Cosmetics Regulation which does not require risk assessments but a 'safety evaluation' by a competent safety assessor [1]. This evaluation mainly considers irritation and contact allergy, while other possible effects on human health or the environment need not be assessed [54][55][56]. Considering the required administration of vast amounts of data for all chemicals, better coordination of these regulations would go a long way to promote effective PCP risk management [57].…”

“…Step one requires that the issue is well understood by Member States Competent Authorities based on the scientific data in relation to PCP ingredients, although the data availability is not as straightforward as for other chemicals [54,57]. In steps two to four, there is a big discrepancy between the recommendations by ECHA and the actual situations in the EU and SA, illustrating that PCPs RC is not in line with ECHA recommendations.…”

A Reassessment of the in vitro total protein content determination (TPC) with SIRC and 3T3 cells for the evaluation of the ocular irritation potential of shampoos: comparison with the in vivo Draize rabbit test

“…In this context, the chemical industry or even government regulatory and quality control agencies are under ever-growing pressure to replace the animal testing by the methods that do not use animals in the toxicological evaluation of health products (Eun and Suh, 2000;Pauwels and Rogiers, 2004). The evaluation of eye and skin irritation potential is essential to ensure the safety of individuals that are in contact with a wide variety of substances designed for the industrial, pharmaceutical or cosmetic use (Vinardell and Mitjans, 2008).…”

Estudo da aplicabilidade do ensaio de citotoxicidade por quantificação de proteínas totais na avaliação do potencial irritante ocular de tensoativos.

“…No caso da avaliação da toxicidade ocular induzida por produtos, sabese que um único método alternativo dificilmente será capaz de substituir o uso de animais (PAUWELS; ROGIERS, 2004;PRESGRAVE;. Assim, os principais centros internacionais de estudos e validação de métodos alternativos ao uso de animais recomendam que a comunidade científica continue pesquisando novas metodologias e aprofunde seus conhecimentos a respeito das metodologias pré-existentes, procurando conhecer as particularidades desses métodos e avaliando um maior número de substâncias e produtos acabados.…”