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Triggering of EU Law Imminent to Further Restrict Allergy-causing Substance “MI” in Cosmetic Products

As from 27 April 2018, only cosmetic products which comply with a particular Regulation dating from 2017 may be made available by sellers on the European Union market. The law concerned is Regulation 2017/1224 updating existing limitations on the use of methylisothiazolinone (MI) concentrations in cosmetic products. MI has been used in cosmetic products as a preservative to help inhibit the development of micro-organisms.

Hong Kong’s cosmetics sellers may recall that Regulation 2017/1224 was published on 7 July 2017 in the EU’s Official Journal. Previously, MI had been authorised up to a 0.01% (100 ppm) concentration, but, due to Regulation 2017/1224, is only permitted at a concentration of up to 0.0015% (15 ppm).

This move is largely in keeping with demands that had been made by individual Member States, who had in effect argued that a new restriction was necessary as a means to address the increasing number of allergenic incidents in the EU. These demands were supported by 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 previously authorised concentration of 100 ppm of MI in cosmetic products was not safe. For cosmetic products that can be rinsed off, a concentration of 15 ppm is considered to be safe. However, a safe concentration of MI for leave-on cosmetic products has not, thus far, been established.

Thus, pursuant to Regulation 2017/1224, as from 27 January this year only cosmetic products which comply with that Regulation have been allowed to be placed on the EU market. Market players related to the industry (manufacturers, sellers) were, nonetheless, given a further three-month grace period, until 27 April 2018. As from this latter-mentioned date, they have to withdraw any non-compliant products from the EU market.

Hong Kong’s cosmetics sellers should also pay attention to footnote 1 of Regulation 2017/1224. It is stated in that footnote that “Methylisothiazolinone is also regulated in entry 39 of Annex V [of Regulation 1223/2009 on the safety of cosmetic products] 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 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: since 12 February 2017, only cosmetic products which are in compliance with Regulation 2016/1198 are allowed on the EU market. Please click on the following to view Commission Regulation 2016/1198.

Content provided by Picture: HKTDC Research
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