4 Nov 2014
Regulation 1003/2014/EU: EU Restricts the Use of Chloromethylisothiazolinone & Methylisothiazolinone in Cosmetic Products
In order to ensure the safety of cosmetic products for human health, the European Commission has adopted REGULATION (EU) No 1003/2014 that restricts the use of Chloromethylisothiazolinone (CMIT) & Methylisothiazolinone (MIT) in cosmetic products. This was published in the Official Journal on 18 September 2014 and amends Annexes V of existing Regulation (EC) No 1223/2009.
The Scientific Committee on Consumer Safety (SCCS) adopted an opinion on the safety of the mixture of Methylchloroisothiazolinone and Methylisothiazolinone on 8 December 2009 (SCCS/1238/09).
The SCCS concluded that the mixture of Methylchloroisothiazolinone and Methylisothiazolinone in a ratio of 3:1 does not pose a risk to the health of the consumer when used as a preservative up to a maximum authorised concentration of 0,0015 % in rinse-off cosmetic products, however, at the same level of use in leave-on product, a risk of skin sensitizing effect cannot be neglected.
The European Commission has taken and adopted the opinions from SCCS, and now it is incorporated into the EU Cosmetic Regulation EC 1223/2009 as an amendment, as follows:
Entries 39 & 57 of Annex V to Regulation (EC) N° 1223/2009 on cosmetic products are replaced by the following
Name of Common Ingredients Glossary
CAS NO.EC NO.
Product type, Body parts
Maximum concentration in ready for use preparation
Wording of conditions of use and warnings
Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one
Methylchloroisothiazolinone (and) Methylisothiazolinone(1)
26172-55-4, 2682-20-4, 55965-84-9
0,0015 % (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one)’
(1) Methylisothiazolinone is also regulated in entry 57. 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.
(2) Methylisothiazolinone is also regulated in entry 39 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.
This regulation entered into force in all Member States on 16 October 2014.
From 16 July 2015 only cosmetic products which comply with Regulation (EC) No 1223/2009 as amended by this Regulation shall be placed on the Union market.
From 16 April 2016 only cosmetic products which comply with Regulation (EC) No 1223/2009 as amended by this Regulation shall be made available on the Union market.
It is crucial for all cosmetic, personal care and household products to be safe, effective and stable. SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. Our state of the art laboratories offer custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. We also have extensive capabilities in performance testing, claim support studies and consumer panels. Our testing is conducted according to customer specific or recognised standard methods, some of which were developed by SGS. Our cosmetic safety assessors and other technical experts can support customers by making sure new products comply with regulatory requirements. Please do not hesitate to contact us for further information or visit our website.