The French Agency for the Safety of Health Products (AFSSAPS) has decided that it will ban the use of 3-Benzylidene-camphor (3-BC) in cosmetics. The decision is concerning the withdrawal and the ban on manufacture, importation, exportation, wholesale distribution, placing on the market for free or not, keeping in view the sale or free distribution and use of cosmetics containing the substance 3-benzylidene camphor (CAS: 15087-24-8) because of it potentially dangerous endocrine disrupting properties.
3-Benzylidene-camphor is used as a UV filter in sunscreens & cosmetic products at concentrations of 2%; it can be absorbed through the skin, and has been detected in human breast milk.
The opinion mentioned is what was observed in rats, first-fetal toxic effects such as a decrease in the number of fetuses per female and delayed ossification, and the effects of maternal toxicity including an enlarged spleen, uterine bleeding, the placental hemorrhage and necrosis in studies of reproductive toxicity, and second, effects on thyroid hormones; Considering further that the opinion is based primarily on two studies of skin absorption conducted in humans, which include methodological bias, in fact, on one hand, a exposure of volunteers limited to 6 hours can be considered as an expected period use and the other, the rate of absorption was calculated from the average of two values from these studies, while choosing the highest value should be taken into account to lead to a risk assessment maximizing exposure.
Considering that many recent studies from the literature referenced in the evaluation report, in vitro and in vivo, suggesting that the substance 3-benzylidene camphor disrupts the endocrine particularly in view of the results positive tests obtained in estrogenic in vitro and in a test in the rat uterotrophic female (increased uterine weight) and changes observed in organs breeding in a study of reproductive toxicity; Whereas the substance 3-Benzylidene camphor is likely to result in endocrine disruption and affect particular on fertility and its
presence in cosmetic products is liable to pose a serious hazard to health human.
The Agence française de sécurité sanitaire des produits de santé (French Agency for the Safety of Health Products), often abbreviated AFSSAPS or AFSSaPS, is a French government institution whose main mission is to assess health risks posed by health products intended for human consumption, particularly pharmaceutical drugs. It is responsible for issuing permits for marketing approval. More recently, it has also become the single authority in the regulation of biomedical research.
Written by : SpecialChem Editorial Team
Based on Information Displayed on www.afssaps.fr