EUROPEAN UNION submitted a notification to WTO regarding methylisothiazolinone ban as preservatives in leave-on cosmetic products on 4 Jan 2016. A written comitology vote, held by European commission, was open to member states from 11 Mar to 4 Apr. There was unanimous agreement in the support of the ban. The next period is public consultation from 1 Apr to 1 Jul 2016. Then the cosmetics manufactures will have a transition period of six months to place the compliant products to EU market and of nine months to withdraw non-compliant products from the market.
Methylisothiazolinone is proposed to be used as a preservative in cosmetic products. Main uses are leave-on products, namely hand and body lotions and moisturizers (including facial moisturizers), sun tanning lotions and some rinse-off products like shampoos (mostly zinc pyrithione based anti-dandruff shampoos), surfactants and conditioners.
Methylisothiazolinone (MI) was authorized as a preservative in cosmetics products through Annex V, entry 57, of Regulation (EC) No 1223/2009 ("Cosmetics Regulation") at a maximum concentration of 0.01% (100ppm). The Cosmetics Regulation also authorized the mixture of Methylchloroisothiazolinone (MCI) and Methylisothiazolinone (MI) as a preservative in rinse-off cosmetic products at a maximum concentration of 0.0015% (15ppm) in a ratio 3:1 of the two substances (since 16 July 2015).
The first opinion related to MI was adopted by the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) in March 2003. The second opinion on MI was in April 2004. Where it concluded that methylisothiazolinone as a preservative at a maximum concentration of 0.01% (100 ppm) in the finished cosmetic product does not pose a risk to the health of the consumer. With sensitization in young children from moist toilet tissue/hygiene moist tissues (wet wipes) or cosmetics becoming an increasing problem all over the Europe, a third opinion was adopted in Dec 2013. The conclusions include but not limited to:
1) Current clinical data indicate that 100 ppm MI in cosmetic products is not safe for the consumer.
2) For leave-on cosmetic products (including ‘wet wipes’), no safe concentrations of MI for induction of contact allergy or elicitation have been adequately demonstrated.
3) For rinse-off cosmetic products, a concentration of 15 ppm (0.0015%) MI is considered safe for the consumer from the view of induction of contact allergy. However, no information is available on elicitation.
4) Information on the actual concentration of MI present in individual cosmetic products will allow future evaluation of safe concentrations.
5) Labelling is only helpful to a consumer who has a known (established by diagnostic patch test investigations) allergy. It is unknown what proportion of the general population is now sensitized to MI and has not been confirmed as sensitized
6) Consumers cannot find information on the presence of MI in products except in cosmetics and household detergents because, as yet, there is no harmonized classification of MI as a skin sensitizer. The risk for skin sensitisation by MI is at least equivalent to that of other substances which have received a harmonized classification according to the CLP Regulation
The SCCS adopted the fourth opinion in Dec 2015. It was concluded that the information provided does not support the safe use of MI as a preservative in rinse-off cosmetic products up to a concentration limit of 100 ppm from the view of induction of contact allergy. For rinse-off cosmetic products, a concentration of 15 ppm (0.0015%) MI is considered safe for the consumer from the point of view of induction of contact allergy. It was not safe to use MI as a preservative in leave-on hair cosmetic products up to a concentration limit of 100 ppm from the point of view of induction of contact allergy.
The Annex Vof Regulation (EC) No. 1223/2009 of the European Parliament and of the Council on cosmetic productswill be revised as below:
(1) Restricting the use of MI to 15ppm in rinse-off products, with the obligation of a "contains methylisothiazolinone" labelling.
(2) The use of MI as a preservative in hair leave-on cosmetic products is banned.
Note: When a rinse-off product contains the mixture of MCI and MI, Additional MI could not be used in the product.
Requirements in China
According to Hygienic Standard for Cosmetics 2007, the limit level and requirements are same as the original version of (EC) No. 1223/2009. From 1 Dec 2016, Technical Safety Standard for Cosmetics will come into force to replace Hygienic Standard for Cosmetics 2007. The limit level of MI is still 0.01% in cosmetics. The mixture of MCI and MI is only available to rinse-off products with the limit level of 0.0015%in a ratio 3:1 of the two substances. For rinse-off products, the mixture of MCI and MI could not be used with additional MI in cosmetics. The requirements are same as revised (EC) No. 1223/2009 (COMMISSION REGULATION (EU) No 1003/2014 of 18 September 2014).
Related Info in Other Countries
The Korean Ministry of Food and Drug Safety (MFDS) has amended the usage limit of compounds of MCI and MI. The compounds are used as preservative in rinse-off products at maximum level of 0.0015% in a ratio 3:1 of the two substances. In Japan, MI is restricted to a maximum level of 0.01 g/l 00 g(100 ppm) in both wash-off and leave-on cosmetic. MI has been reviewed and approved for use up to 0.0 1% (100 ppm) in both leave-on and rinse-off products by the following nations: the Association of Southeast Asian Nations (Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia,
Myanmar, the Philippines, Singapore, Thailand, Vietnam), Argentina, Australia, Brazil, Canada, Iceland, Israel,Korea, Mexico, Norway, Russia, Switzerland, and Turkey.
References and Source
1. NOTIFICATION about draft commission regulation amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (3 pages + Annex 2 pages, in English)
4. Background-Public consultation on Methylisothiazolinone (MI) in the framework of Regulation (EC) No. 1223/2009 of the European Parliament and of the Council on cosmetic products - rinse-off cosmetic products
6. Rohm & Haas, LLC. 2008. Rohm and Haas Comments on the Scientific Literature Review Methylisothiazolinone, 12 December 2007.