Methylisothiazolinone (MIT) has been a commonly used preservative which was previously allowable under Annex V of the EU Cosmetics Regulation in both leave-on and rinse-off products. Over recent years studies have shown it to have high sensitisation potential which has resulted in unfavourable opinions from the SCCS and regulatory changes to restrict or prohibit its use. We provided an initial update on MIT restrictions in October 2016 (read here). Given the restrictions coming into force from January to April 2018 it was thought a good time to recap on all of these and the current state of MIT acceptance.
MIT is banned in all Leave-on cosmetic products.
The Commission Regulation (EU) 2016/1198 amending Annex V to Regulation (EC) No 1223/2009 and banning the use of MIT in leave-on products was adopted on 22 July 2016. It has been published in the Official Journal L198 on 23 July 2016, p. 10. The Regulation will enter into force 20 days after publication in the Official Journal.
From 12 February 2017, only cosmetic products which comply with this Regulation could be placed and made available on the Union market.
If you have not already reformulated MIT out of your leave-on products it is of paramount importance that you do this immediately. There has been a rapid increase in the number of leave-on products containing MIT being RAPEX’d (withdrawn from market) over the last few months and this is set to continue. Leave-on products containing MIT are not in compliance with the Cosmetic Regulation 1223/2009 and should not be for sale.
The use of MIT is being heavily restricted, reducing the allowable limit from 0.01% (100pm) to 0.0015% (15ppm).
Regulation 2017/1224 reducing the maximum permitted concentration for use in rinse-off products was published in the Official Journal to the European Union on 6 July 2017.
From 27 January 2018 only cosmetic products which comply with this Regulation shall be placed on the Union market. (‘Placing on the market’ means the first making available of a cosmetic product on the Community market – see below for further definition.)
From 27 April 2018 only cosmetic products which comply with this Regulation shall be made available on the Union market. (‘Making available on the market’ means any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge.)
MCIT / MIT clarification for rinse-off products: Where MCIT/MIT is used in a mixture this must be used in the specified 3:1 ratio as noted in EC 1223/2009 Annex V entry 39. The concentration of this entire mixture cannot exceed the 15ppm limit (i.e both the MIT and MCIT are included in the calculation). The MCIT/MIT mixture cannot be used with any other MIT in the formulation, including if there is MIT present in another raw ingredient – see mutually exclusive footnote on Annex V Entry 57.
Many products fall clearly into the category of rinse-off or leave-on products. Some products such as masks and conditioners blur the boundary between these categories. MSL consider these instances on a case-by-case basis but may view products which remain in contact with the user for less than 20 minutes as rinse-off and longer than this as leave-on.
The date for changes to rinse-off products has now arrived. If you have not already reformulated to reduce the level of MIT to the acceptable limit (15ppm) then this must be done immediately. A change in preservative system is very significant and new challenge (PET) and stability testing must be carried out. This reformulation & new testing must be reflected in an updated CSPR and PIF before the product can be sold on the European Market.