9 February 2009

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Europe updates its regulations for cosmetic ingredients

A new directive updating the rules governing cosmetic ingredients with regard to the progress of science was recently adopted by the European Union. Two substances have been prohibited in cosmetics, while the use of three other ingredients has been restricted.

The directive 2009/06/EC of 4 February 2009 [1] prohibits the use of phytonadione and of diethylene glycol (DEG) in all cosmetic products put on the market of the European Union.

The prohibition of phytonadione (a man-made form of vitamin K) in cosmetic products is due to the fact that this substance may cause cutaneous allergy and individuals so affected may be denied an important therapeutic agent.

Concerning diethylene glycol (DEG), scientific experts of the European Union consider that it should not be used as an ingredient in cosmetic products, but that a maximum concentration of up to 0,1 % of DEG from impurities in the finished cosmetic products can be considered to be safe. This is the reason why, in spite of this substance being banned for use in cosmetic products, presence of residual traces are admitted up to 0,1 %.

Furthermore, the directive has restricted the use of toluene, a substance classified as a CMR substance of category 3, of diethylene glycol monobutyl ether (DEGBE) and of ethylene glycol monobutyl ether (EGBE).

Toluene is subsequently limited to 25 % in nail products and its inhalation by children should be avoided. The use of DEGBE as a solvent in hair dye products is limited to a concentration up to 9,0 %. The use of EGBE as a solvent is limited to a maximum concentration of 4,0 % in oxidative hair dye products and 2,0 % in non-oxidative hair dye products.

Member States shall apply those provisions from 5 November 2009. However, they shall apply the provisions concerning the substance toluene from 5 February 2010.

Click here below to retrieve the English version of directive 2009/06/EC:

PDF - 42.3 kb
directive 2009/06/EC of 4 February 2009
Vincent Gallon

Footnotes

[1] Published in the Official Journal of the European Union, 5 February 2009 (L 36/15)


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