On the 25th of March 2015 at its 9th plenary meeting the SCCS adopted an opinion on dichloromethane due to recent concerns on its safety.
What is Dichloromethane and what is its regulatory status in Europe?
Dichloromethane (methylene chloride) is an organic compound widely used as a solvent or in cosmetic products, where the concentration limit is 35% (Annex III listed the ingredients that may used under specific restrictions of the Cosmetics Regulation (EC) 1223/2009).
Due to its high volatility, it is an acute inhalation hazard. It can also be absorbed through the skin. As dichloromethane has been linked to cancer of the liver, lungs and pancreas in laboratory animals, it has been classified by the CLP Regulation (EC) 1272/2008 as CMR 2 substance.
Article 15.1 of the Cosmetic Regulation states that: “The use in cosmetic products of substances classified as CMR substances, of category 2, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited. However, a substance classified in category 2 may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products.
Why are there new safety concerns?
In August 2014 EFfCI2 (The European Federation for Cosmetic Ingredients) provided new data on dichloromethane concerning the neurobehavioural effects and the exposure-related observations in humans. However, the SCCS, after taking into consideration original study reports as well as publicly available data and risk assessments performed by other bodies, concluded that the two documents provided by ECSA (European Chlorinated Solvent Association) did not bring any new information on dichloromethane’s neurobehavioural effects or the exposure-related observations in humans.
As no new data have been provided, the conclusion remains the same as in the previous verdict on dichloromethane (SCCS/1408/11):
The evidence does not suggest that dichloromethane shows cardiotoxicity or reproductive toxicity in man except at high levels. Although it is carcinogenic by inhalation in the mouse, factors have been identified which explain the higher susceptibility of mice compared to humans. Quantification of the risk to humans by modelling and comparison of the toxicokinetics indicates that the cancer risk that dichloromethane may pose would be negligible. Due to the inadequate data on exposure by hair spraying and limited data on neurobehavioral and neurodevelopmental effects of dichloromethane after short-term exposure, dichloromethane in a concentration of up to 35% in hair sprays is not considered safe for the consumer.
The verdict on dichloromethane stays open for comments from the industry until the 22nd of May 2015.
What should manufacturers do?
Make sure that the cosmetic product consists of only safe compounds, every cosmetics manufacturer should consult with the Responsible Person on the ingredients used in the formulations in terms of their safety and possible restrictions introduced by the European law.
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