An Update on Methylisothiazolinone (MI)

Dr Chris Flower

For some years now, MI has been the most controversial preservative on our cosmetic shelves, with increasing reports of severe allergic reactions to it. Contrary to a report on Global Cosmetics News in June, it has not been banned in leave-on products, as many believe it to be. Dr Chris Flower, Director-General of CTPA (the UK cosmetic trade association) tells Skins Matter about the actual current state of play.

In the EU, ingredients whose primary function is to preserve products must be listed on Annex V to the Cosmetics Regulation. 

There are two entries on this list which incorporate methylisothiazolinone (MI). The first entry is a blend of methylchloroisothiazolinone and methylisothiazolinone (MCI/MI) in a ratio of 3:1. The second entry is MI on its own.  

There is a set process for changing cosmetics laws via the European Commission (EC):

1. If the safety of a cosmetic ingredient is questioned, the EC requests the Scientific Committee on Consumer Safety (SCCS) to review data on the ingredient and form an opinion. 
2. Once the SCCS issues an opinion, it is reviewed by the EC and all European Member States ahead of any legislative action.
3. The EC may then use the resulting opinion to amend the Cosmetics Regulation.

The two entries MCI/MI and MI are regulated separately.

Following a review of the MCI/MI blend, the SCCS stated that the blend should only be allowed to be used in rinse-off cosmetic products. The EC published an amendment to the Cosmetics Regulation on 26 September 2014 to change the use of the blend of MCI/MI from any product type to rinse-off products only.

Amendments to the Cosmetics Regulation usually have transition periods. For the blend of MCI/MI the transition periods for the amendment of the product type to rinse-off products are:

* Only products which comply shall be placed on the market from 16 July 2015.
* Only products which comply shall be supplied to the final consumer from 16 April 2016.

This means that from 16 April 2016 there should be no leave-on products on the shelf which contain the blend of MCI/MI.

If MCI/MI is used, the names methylisothiazolinone and methylchloroisothiazolinone will both be present in the ingredients list.

The use of MI on its own is also undergoing a review by the SCCS but it is at an earlier stage in the process. The SCCS has recommended that MI be removed from leave-on cosmetic products. It has also recommended that the amount of MI used in rinse-off products be reduced. However, the amount suggested by the SCCS is at a level where the efficacy of MI as a preservative could be lost. Industry has provided the SCCS with more information about the use of MI in rinse-off products at a safe and effective level. This is still under review by the SCCS.

At present, the Annex entry permits the use of MI on its own in all product types, i.e. it can be used in both rinse-off and leave-on products.

However, following discussions with dermatologists, who have reported an increase in cases of allergy to MI in their clinics, the European cosmetics industry has assessed the available information regarding the risk of allergic reactions to MI, and agreed that this ingredient should no longer be used in leave-on skin care cosmetic products.

As a result, Cosmetics Europe issued a recommendation in December 2013 asking all cosmetics companies to remove MI from leave-on products as soon as possible.

Formulations will take some time to change and people who know they are allergic to MI should avoid any cosmetic containing this ingredient, whether leave-on or rinse-off. The name will always be listed as methylisothiazolinone.

The European Commission has started the process to amend the Annex entry to rinse-off products only, but we do not know when this will be finalised.

Further information on MCI/MI and MI can be found on the CTPA’s consumer website and on the Methylisothiazolinone Free website.

Skins Matter’s previous articles on MI can be found here and here. Our blog on the subject, with hundreds of comments from those with MI allergy, which includes product recommendations, can be found here.


August 2015

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