Commission Regulation (EU) 2016/314
of 4 March 2016
amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
The substance Diethylene Glycol Monoethyl Ether (DEGEE) with the INCI name Ethoxydiglycol which is used in cosmetic products is not yet regulated under Regulation (EC) No 1223/2009.
The SCCS concluded that the use of DEGEE in oxidative hair dye formulations at a maximum concentration of 7 % w/w, in non-oxidative hair dye formulations at a maximum concentration of 5 % w/w and in other rinse-off products at a maximum concentration of 10 % w/w does not pose a risk to the health of consumers. The SCCS also concluded that the use of DEGEE does not pose a risk to the health of consumers at a maximum concentration of 2,6 % w/w in other non-spray cosmetic products and in the following spray products: fine fragrances, hair sprays, antiperspirants and deodorants. However, the use of DEGEE in oral hygiene products and eye products has not been assessed by the SCCS and thus cannot be considered safe for consumers.
In light of those SCCS opinions, the Commission considers that the non-regulation of DEGEE raises a potential risk to human health.
Regulation (EC) No 1223/2009 should therefore be amended accordingly.
The application of the abovementioned restrictions should be deferred to allow industry to make the necessary adjustments to product formulations. In particular, undertakings should be granted 12 months to place on the market compliant products and to withdraw from the market non-compliant products after the entry into force of this Regulation.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,
HAS ADOPTED THIS REGULATION:
Article 1
Annex III to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.
Article 2
From 25 March 2017 only cosmetic products which comply with this Regulation shall be placed and made available on the Union market.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 March 2016.
For the Commission
The President
Jean-Claude Juncker
ANNEX
In Annex III to Regulation (EC) No 1223/2009, the following entry is added:
Ref. No
Substance identification
Restrictions
Wording of conditions of use and warnings
Chemical name/INN
Name of Common Ingredients Glossary
CAS number
EC number
Product type, body parts
Maximum concentration in ready for use preparation
Other
a
b
c
d
e
f
g
h
i
‘x
2-(2-ethoxyethoxy)ethanol
Diethylene Glycol Monoethyl Ether (DEGEE)
Ethoxydiglycol
111-90-0
203-919-7
(a)
Oxidative hair dye products
(a)
7 %
(a) to (e):
The level of ethylene glycol impurity in Ethoxydiglycol must be ≤ 0,1 %.
Not to be used in eye products and oral products.’
(b)
Non-oxidative hair dye products
(b)
5 %
(c)
Rinse-off products other than hair dye products
(c)
10 %
(d)
Other non-spray cosmetic products
(d)
2,6 %
(e)
The following spray products: fine fragrances, hair sprays, antiperspirants and deodorants
(e)
2,6 %