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Laws and regulations

France bans 3-benzylidene-camphor in cosmetics

The French Agency for the Safety of Health Products (AFSSAPS) has decided to ban an ultraviolet filter that is suspected to behave as an endocrine disruptor.

The 3-benzylidene-camphor (CAS: 15087-24-8), which has been banned in France, is a substance that, in practice, is scarcely used by cosmetics makers. However, it can be found in some products, in particular in sun protection creams. Indeed, the European regulation has bee allowing its use so far, in particular as a UV filter at a maximum concentration of 2 %.

Endocrine disruptor

In a decision dated August 24, 2011, the French Agency for Safety of Health Products (AFSSAPS) says that this substance is likely to cause endocrine disruption and particularly to affect fertility.

According the AFSSAPS, many recent studies, conducted both in vitro and in vivo demonstrate these effects, "especially given the positive results achieved during in vitro estrogenic tests and an uterotrophic assay in female rats (increased weight of the uterus) as well as changes observed in reproductive organs in a reproductive toxicity study.

In addition, the Agency points out two skin absorption studies that were part of the file upon which this substance was authorized as a UV filter. According to the authority responsible for ensuring the safety of cosmetic products sold in France, these studies were affected by methodological flaws: “on the one hand, an exposure of volunteer limited to six hours can not be considered as a foreseeable duration of use and, on the other hand, the dermal absorption rate was calculated from the average of the two rates obtained from these studies, while it the highest value that must be considered in order to assess the risk on the base of maximum exposure.

European decision required

Considering that 3-Benzylidene-camphor can present “a serious danger to human health”, Afssaps has decided to prohibit its use in cosmetic products manufactured, imported or distributed in France.

Concerned manufacturers and importers are asked to take, without delay, all necessary measures in order to stop the distribution of products that contain this substance. This measure, said the agency, was adopted pending a decision of the European Commission. Should the Commission consider that the decision of French authorities is scientifically substantiated, the ban would be extended in Europe.

The endocrine disruptors issue is highly sensitive in France where a majority of MPs voted on the 3rd of May to ban them from consumer products.

For additional information, read the AFSSAP’s decision here below or on the Agency’s website (in French):

AFSSAPS - decision of August 24, 2011

AFSSAPS - decision of August 24, 2011

Or the text as it was published on September 17, 2011 in the Official Journal (Update September 19, 2011):

Official Journal - September 17, 2011

Official Journal - September 17, 2011

Vincent Gallon

© 2011 - Premium Beauty News -
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