SAFEGUARDS | Cosmetics, Personal Care & Household NO. 150/16

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The European Commission published Commission Regulation (EU) 2016/1198 on July 22, 2016 amending Annex V of Regulation (EC) No. 1223/2009. Restrictions on the preservative, Methylisothiazolinone (MI), are updated.

The Scientific Committee on Consumer Safety (SCCS) studied the safety of MI in 2013. It concluded that 100 ppm of MI in leave-on cosmetic products (including wet wipes) is not safe for the consumer. Following completion of a public consultation on the use of MI on July 1, 2016, the European Commission is further restricting the use of MI. With immediate effect, it is only allowed at maximum concentration at 0.01% on rinse-off products only, and the use of MI on leave-on products is forbidden.

The regulation enters into force on August 11, 2016. From February 12, 2017 only cosmetic products that comply with this Regulation may be placed and made available on the Union market.

Annex V of Regulation (EC) No. 1223/2009 is amended as follows:

Reference number Substance identification
Chemical name/INN Name of Common Ingredients Glossary CAS number EC number
a b c d e
‘57 2-Methyl-2H-isothiazol-3-one Methylisothiazolinone (1) 2682-20-4 220-239-6


Reference number Conditions Wording of conditions of use and warnings
Product type, body parts Maximum concentration in ready for use preparation Other
a f g h i
‘57 Rinse-off products 0,01 % - -

(1) 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.’

It is crucial that all cosmetic, personal care and household products are 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 recognized 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.

Reference Sources:

[1] Commission Regulation (EU) 2016/1198 on 22 July 2016

For enquiries, please contact:

Queenie Tse
Technical Service Executive, Cosmetics, Personal Care & Household

t: +852 2765 3672

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