New EU Regulation Targets Allergy-causing Substance Methylisothiazolinone in Cosmetic Products
11 August 2017
On 7 July 2017, the Official Journal published Commission Regulation 2017/1224 updating existing limitations on the use of Methylisothiazolinone (MI) concentrations in cosmetic products. Previously, MI which is included in cosmetic products as a preservative to help inhibit the development of micro-organisms, had been authorised up to a 0.01% (100 ppm) concentration, but will, due to the new Regulation, only be permitted at a concentration of up to 0.0015% (15 ppm).
This move is largely in line with recent demands by individual Member States who have argued that a new classification was necessary as a means to address the increasing number of allergenic incidents in the EU.
These demands have been supported by recent studies which have shown that sensitisation, allergic reactions, and cell and nerve damage were increasingly becoming a problem all over Europe. The European Union’s Scientific Committee on Consumer Safety (SCCS) more specifically concluded that the hitherto authorised concentration of 100 ppm of MI in cosmetic products is not safe. For cosmetic products that can be rinsed off, a concentration of 15 ppm is considered to be safe; while a safe concentration of MI for leave-on cosmetic products has not, thus far, been established.
So as to allow the industry to make the necessary adjustments to product formulations, the application of the above-mentioned restriction will be temporarily deferred to allow the industry a “reasonable period of time to make the necessary adjustments to product formulations” and “for the withdrawal of non-compliant products from the market.”
In particular, from 27 January 2018 only cosmetic products which comply with this Regulation shall be placed on the Union market, and from 27 April 2018 only cosmetic products which comply with this Regulation shall be made available on the Union market.
Hong Kong’s cosmetics sellers should also pay attention to footnote 1 of the new Regulation. It is stated in that footnote that “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.”
The maximum concentration in a ready-for-use preparation of the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone is permitted in rinse-off products according to the following: 0.0015% (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one).
Please click on the following to view new Commission Regulation 2017/1224.
Hong Kong’s cosmetics suppliers should also be reminded that Methylisothiazolinone has already been banned in leave-on cosmetic products, pursuant to Commission Regulation 2016/1198, which entered into force on 12 August 2016.
For leave-on cosmetic products (including so-called “wet wipes”, sunscreens, moisturisers, etc.), no safe concentrations of methylisothiazolinone in the field of allergic contact dermatitis have been adequately demonstrated. As a result, this substance has been banned in leave-on products. However, so as to allow the industry to make the necessary adjustments to product formulations, the application of this ban was deferred. In particular, undertakings were granted six months to place compliant products on the market and to withdraw from the market non-compliant products after the entry into force of Commission Regulation 2016/1198.
The Regulation entered into force on the twentieth day following its publication in the Official Journal. Thus, since 12 February 2017, only cosmetic products which comply with Regulation 2016/1198 are allowed on the EU market. Please click on the following to view Commission Regulation 2016/1198.
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