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Cosmetic Days - Sun protection
Monday, July 10, 2017Regulation

MI: no more than 0.0015% in rinse-off products early 2018

© CosmeticOBS-L'Observatoire des Cosmétiques

Regulation 2017/1224 of 6 July 2017, published in Official Journal of the European Union on 7 July, amends Annex V (preservatives) of Cosmetics Regulation 1223/2009, to reduce the maximum authorized concentration of Methylisothiazolinone in rinse-off cosmetic products from 0.1% 0.0015%. This provision is fully implemented from 27 April 2018.

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The whereas of regulation 2017/1224

(1) The substance 2-Methyl-2H-isothiazol-3-one, which has been assigned the name Methylisothiazolinone under the International Nomenclature of Cosmetic Ingredients (INCI), CAS number 2682-20-4, is currently authorised as a preservative in rinse-off cosmetic products at a concentration up to 0.01% weight/weight (100 ppm) through entry 57 of Annex V to Regulation (EC) No 1223/2009.

(2) The Scientific Committee on Consumer Safety (SCCS) adopted an opinion on the safety of Methylisothiazolinone on 15 December 2015. The SCCS concluded that for rinse-off cosmetic products, a concentration up to 0.0015% (15 ppm) Methylisothiazolinone is considered safe for the consumer from the point of view of induction of contact allergy.

(3) In light of that SCCS opinion, it is important to address the increased incidence of allergies induced by Methylisothiazolinone and that substance should therefore be further restricted in rinse-off products.

(4) Regulation (EC) No 1223/2009 should therefore be amended accordingly.

(5) The industry should be allowed a reasonable period of time to make the necessary adjustments to product formulations in view of their placing on the market and for the withdrawal of non-compliant products from the market.

(6) The measures provided for in this Regulation are in accordance with the …

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