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Expert opinion

Revision of the opinion on Dichloromethane - Submission IV

Final Opinion

Details

Publication date
28 October 2015
Author
Scientific Committee on Consumer Safety (SCCS)

Description

WG on Cosmetic ingredients
SCCS members:U. Bernauer, P.J. Coenraads, G. Degen, M. Dusinska, W. Lilienblum, E. Nielsen, T. Platzek, S. C. Rastogi, Ch. Rousselle, Ja. van Benthem
External experts: A. Bernard, A.M. Giménez-Arnau, T. Vanhaecke
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1547/15
Adopted on: 25 March 2015

1. In light of the new data provided, does the SCCS consider Dichloromethane (CAS No 75-09-2) safe when used in cosmetic products under the current use conditions up to maximum of 35%?

No new data on the neurobehavioural effects and the exposure-related observations in humans of dichloromethane have been provided in Submission IV.

The conclusion remains therefore as in the previous Opinion 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.”

2. Can the SCCS assess whether the restriction on purity present in column (h) is related to purity criteria for the dichloromethane itself or is related to its presence as an impurity in cosmetic products that should be restricted to 0.2%?

Not applicable.

3. Does the SCCS have any further scientific concern regard the use of Dichloromethane in cosmetic products?

No information concerning other uses in cosmetic products is available to the SCCS.

Keywords:

SCCS, scientific opinion, dichloromethane, Regulation 1223/2009, CAS No 75- 09-2, EC 200-838-9

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on Dichloromethane, SCCS/1547/15, 25 March 2015.

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