Omnibus Regulation 2019

The Regulation Restricting the Use of Ethoxydiglycol in Cosmetics Has Been Published

The regulation (EU) No 2016/314 has just been published and will enter into force on March 25th, 2016. This new piece of legislation considers the recent toxicological investigations carried out on Ethoxydiglycol and implements use restrictions on this basis. Ethoxydiglycol, also known as DEGEE (CAS 111-90-0), is a cosmetic ingredient widely used as a solvent in many product categories and notably in hair-styling products, face creams and perfumes.

Why is ethoxydiglycol banned ? Ethoxydiglycol is restricted due to its potential risk of causing kidney damage. New regulations limit its use to specific concentrations in various cosmetic products, and ban it entirely in eye and oral products. Additionally, strict purity criteria for ethylene glycol impurity levels have been established.

Mainly due to a risk of kidney damage, the EU Commission and the Member States voted the restrictions that follow:

Product Type Maximum Use Level
Oxidative hair dye products 7 %
Non-oxidative hair dye products 5 %
Rinse-off products other than hair dye products 10 %
Other non-spray cosmetic product 2.6 %
The following spray products: fine fragrances, hair sprays, antiperspirants and deodorants 2.6 %

Furthermore, the use of Ethoxydiglycol in Eye and oral products will get banned. Finally, a strict purity criteria has been established: the level of ethylene glycol impurity in Ethoxydiglycol must be ≤ 0,1 %.

The application of the abovementioned restrictions have been deferred to allow industry to make the necessary adjustments to product formulations. Twelve months have been granted to place on the market compliant products and to withdraw from the market non-compliant products after the entry into force of this Regulation.
In other words, the restrictions on Ethoxydiglycol will be implemented on March 25th, 2017.

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Author

  • Frédéric Lebreux

    Dr. Frédéric Lebreux is Biorius's Chief Executive Officer and has worked in the cosmetic industry for more than 13 years. He is regularly invited as a speaker or Professor to cosmetic events.

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