Skip to Menu Skip to Search Contact Us Global Websites & Languages Skip to Content

Europe announces public consultation on the inclusion of methylchloroisothiazolinone (MCIT) and methylisothiazolinone (MIT) in cosmetic products.

Acting on advice from the EU’s Scientific Committee on Consumer Safety (SCCS), delivered in 2009 (SCCS/1238/09), the European Commission has launched a public consultation regarding their proposal to further limit the approved use of MCIT and MIT, two common preservatives, in cosmetic products.

EXISTING RESTRICTIONS

Presently, Cosmetics Regulation (EC) No 1223/2009 authorises the use of MCIT and MIT as preservatives in all cosmetic formulations, as mentioned in Annex V (List of Preservatives Allowed in Cosmetic Products) entry 39, with the maximum authorised concentration of 0.0015% (15 ppm) of a mixture in the ratio 3:1 of 5-chloro-2-methyl-2H-isothiazol-3-one and 2-methyl-2Hisothiazol-3-one. Methylisothiazolinone is also allowed on its own in entry 57.  However, the new advice states that the mixture of these two preservatives may have a ‘sensitising’ effect on skin.  As a result, further restrictions are being considered. Proposed changes to Annex V of the Cosmetics Regulation “would restrict the use of the MCIT and MIT mixture to rinse-off products only” as suggested by the SCCS. Hence, it would not be authorised to use this mixture for any leave-on products.  The Commission proposes that entries 39 and 57 of Annex V to Regulation (EC) No 1223/2009 on cosmetic products are amended as shown in Table 1 below.

TIME TO REPLY

Launched in May 2013 interested parties had until October 8, 2013 to submit their comments on the considered measure and on its possible economic impact to the public consultation.

NEXT STEPS

After the public consultation the European Commission will decide whether to adopt the recommendations in full, or part, and to incorporate it into European legislation, or to leave the legislation unaltered. To enact the change to Annex V a regulation will be required.

A number of recommendations made by the SCCS have yet to be put out to public consultation (including recommendations on propylparaben and butylparaben, among others). The responsible person and manufacturers should keep up-to-date with SCCS in order to be aware of upcoming changes that may affect their products.

Table 1. Amendments to entries 39 and 57 of Annex V to Regulation (EC) No 1223/2009

substance identificationCONDITIONS
Reference
number
Chemical name
/ INN
Name of
common
ingredients
glossary
CAS
number
EC
number

Product
Type
Body
parts

Maximum
concentration no.
in ready for use
preparation
Other Wording of
conditions
of use and
warnings
a b c d e f g h i
39

Mixture of
5-chloro-2-methyl-
isothiazol-
3(2H)-one and
2-methylisothiazol-
3(2H)-one

Methylchloroiso
thiazolinone and
Methylisothiazol
inone1
26172-
55-4,
2682-20-
4, 55965-
84-9
247-500-
7, 220-
239-6
Rinse-off
products
0,0015% (of a
mixture in the ratio
3;1 of 5-chloro-2-methylisothiazol-
3(2H)-one
57 2-Methyl-2Hisothiazol-
3-one
Methylisothia
zolinone2
2682-20-4 220-
239-6
0,01%

1 Methylisothiazolinone is also regulated in entry 57. The two entries are mutually exculsive.
2 Methylisothiazolinone is also regulated in entry 39 in a mixture with methylchloroisothiazolinone. The two entries are mutually exclusive.

For information and advice on the cosmetic regulation please contact your local SGS representative or our global team:

Hubert Brundu
Global Technical Manager – Cosmetics, Personal Care and Household
SGS France
t: +33 4 42 61 64 91