Restrictions on the Use of Ethoxydiglycol in Cosmetics
March 2016 - Ethoxydiglycol restrictions
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 product | 7% |
| Non-oxidative hair-dye product | 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.
Modification of Annex V – Allowed preservatives:
| INCI name | CAS number | Future restriction | Current situation |
|---|---|---|---|
| TRICLOCARBAN | 101-20-2 | Max. 0.2% in all cosmetic products with the exception of mouthwash. Purity criteria: 3,3′,4,4′- Tetrachloroazobenzene ≤ 1 ppm 3,3′,4,4′- Tetrachloroazoxybenzene ≤ 1 ppm Not to be used in toothpaste intended for children under 6 years of age. Obligatory labelling for toothpaste containing Triclocarban: ‘Not to be used for children under 6 years of age’. For uses other than preservative, see Annex III/100. | Max. 1.5% in rinse-off products. Purity criteria: 3,3′,4,4′-Tetrachloroazobenzene ≤ 1 ppm 3,3′,4,4′-Tetrachloroazoxybenzene ≤ 1 ppm. For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product. For uses other than preservative, see Annex III/100 (Annex V/23) |
| TRICLOSAN | 3380-34-5 | Max. 0.3% in toothpastes; hand soaps ; body soaps/shower gels; deodorants (non-spray); face powders and blemish concealers; nail product for cleaning the fingernails and toenails before the application of artificial nail systems. Not to be used in toothpaste intended for children under 3 years of age. Obligatory labelling for toothpaste containing Triclosan: ‘Not to be used for children under 3 years of age’. | Max. 0.3% in toothpastes; hand soaps ; body soaps/shower gels; deodorants (non-spray); face powders and blemish concealers; nail product for cleaning the fingernails and toenails before the application of artificial nail systems. Max. 0.2% in Mouthwashes (Annex V/23) |
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