Commission Regulation (EU) 2017/1224Show full title

Commission Regulation (EU) 2017/1224

of 6 July 2017

amending Annex V 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,

Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products(1), and in particular Article 31(1) thereof,

Whereas:

(1) The substance 2-Methyl-2H-isothiazol-3-one, which has been assigned the name Methylisothiazolinone under the International Nomenclature of Cosmetic Ingredients (INCI), CAS number 2682-20-4, is currently authorised as a preservative in rinse-off cosmetic products at a concentration up to 0,01 % weight/weight (100 ppm) through entry 57 of Annex V to Regulation (EC) No 1223/2009.

(2) The Scientific Committee on Consumer Safety (SCCS) adopted an opinion on the safety of Methylisothiazolinone on 15 December 2015(2). The SCCS concluded that for rinse-off cosmetic products, a concentration up to 0,0015 % (15 ppm) Methylisothiazolinone is considered safe for the consumer from the point of view of induction of contact allergy.

(3) In light of that SCCS opinion, it is important to address the increased incidence of allergies induced by Methylisothiazolinone and that substance should therefore be further restricted in rinse-off products.

(4) Regulation (EC) No 1223/2009 should therefore be amended accordingly.

(5) The industry should be allowed a reasonable period of time to make the necessary adjustments to product formulations in view of their placing on the market and for the withdrawal of non-compliant products from the market.

(6) 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 V to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.

Article 2

From 27 January 2018 only cosmetic products which comply with this Regulation shall be placed on the Union market.

From 27 April 2018 only cosmetic products which comply with this Regulation shall be 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, 6 July 2017.

For the Commission

The President

Jean-Claude Juncker

ANNEX

In Annex V to Regulation (EC) No 1223/2009, entry 57 is replaced by the following:

a Methylisothiazolinone is also regulated in entry 39 of Annex V in a mixture with methylchloroisothiazolinone. The two entries are mutually exclusive: the use of the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone is incompatible with the use of Methylisothiazolinone alone in the same product.’
Reference number	Substance Identification				Conditions			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
‘57	2-Methyl-2H-isothiazol-3-one	Methylisothiazolinonea	2682-20-4	220-239-6	Rinse-off products	0,0015 %

(1)

OJ L 342, 22.12.2009, p. 59.

(2)

SCCS/1557/15 (submission III)