92003E1244

WRITTEN QUESTION E-1244/03

by Chris Davies (ELDR) to the Commission

(2 April 2003)

Subject: Methyldibromo glutaronitrile

I understand that this preservative, methyldibromo glutaronitrile, used in cosmetics and toiletries, is currently being investigated by the EU Scientific Committee on Cosmetic and Non-Food Products. Its use is said to be associated with a rise in incidences of allergic contact dermatitis.

What investigations into this substance are being carried out by the Scientific Committee, and has it so far reached any conclusions?

In the meantime has the Commission so far expressed any concerns about the use of this substance in cosmetics, toiletries or other products, and if so with what response from industry?

Answer given by Mr Liikanen on behalf of the Commission

(6 May 2003)

Methyldibromo glutaronitrile (1,2-dibromo-2,4-dicyanobutane) is regulated in the Cosmetics Directive(1) Annex VI, part 1, reference 36 and can therefore be used as a preservative up to a maximum concentration of 0,1 % in the finished product. It shall not be used in cosmetic sunscreen products at a concentration exceeding 0,025 %.

The Commission received a letter from the chairman of the European Environmental and Contact Dermatitis Research Group (EECDRG) with data demonstrating the rising incidence of contact allergy to methyldibromo glutaronitrile. These data were given to the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) for their expert review.

In its Opinion on Methyldibromo Glutaronitrile Colipa No P77 SCCNFP/0585/02, final, adopted during the 20th plenary meeting of 4 June 2002 the SCCNFP stated that until appropriate and adequate information is available to suggest a level of the preservative in leave-on products that poses an acceptable risk to the consumer (compared with the risk to the consumer from other preservatives), its use should be restricted to rinse-off products at the current maximum permitted level of 0,1 %.

Based on this scientific opinion and following the Comitology procedure the Commission will submit a proposal to the Standing Committee and will take the necessary measures in order to modify accordingly the Annex VI of the Cosmetics Directive.

(1) Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products OJ L 262, 27.9.1976.