The French National Agency for the Safety of Medicines and Health products (ANSM) has announced it has banned the production, import and export of cosmetics containing chloroacetamide.
According to the Agency; the preservative has been found to have harmful effects on human fertility and is urging manufacturers, importers, stockholders or those responsible for marketing and distribution of these cosmetics to take necessary steps to stop the distribution and make a withdrawal without delay.
The ANSM has based its decision on an opinion by the Scientific Committee on Security consumers (CSSC) concluding that because of the safety margin being too low, the substance cannot be considered safe for health as part of its implementation in cosmetics.
This prohibition, which is applicable in France, meanwhile a similar decision be taken at the European level, should not have heavy consequence for cosmetics manufacturers as chloroacetamide is no longer used in formulas.
The European legislation still permits using chloroacetamid as a preservative at a concentration of 0.3 per cent, providing products are labeled ‘contains Chloroacetamide.’
Chloroacetamide is a chlorinated aliphatic amide used as a preservative in cosmetic formulations, it is also prohibited in cosmetics and personal care products in Canada.
EC consults cosmetic ingredients
In 2010, The European Commission announced it was looking into cosmetic ingredients chloroacetamide and dichloromethane in an effort to gather comments regarding their potentially hazardous classifications.
Then the Cosmetics Directive classified dichloromethane as a category 3 carcinogen and chloroacetamide as a category 3 mutagenic or reproductive toxin.
Then the objective was to gather comments from interested parties and consult its Scientific Committee on Consumer Safety (SCCS) to see if the classifications for the ingredients should be reconsidered.
The gray area in Category 3 substances
According to the Directive, a substance with a category 3 evaluation – whether it is deemed to be a potential toxin or carcinogen - may be used in cosmetics if it has been evaluated by the SCCNFP and found acceptable for formulation.
The European Commission last consulted with the SCCNFP about category 3 substances back in 2004 and it returned its opinion on 25 May of that year that under Annex 1 of the Directive all substances listed as CM3 at that time would be prohibited.