The European Commission has just transmitted to WTO a draft Regulation aimed to amend Annex V to the Cosmetics Regulation 1223/2009 (list of allowed preservatives). On the agenda: the ban of Methylisothiazolinone in leave-in cosmetic products.
Notification date
January 4, 2016
Content
This draft Commission Regulation aims at banning the use of Methylisothiazolinone as a preservative in leave-on cosmetic products.
Text of the draft regulation
Whereas
(1) Methylisothiazolinone is authorized as a preservative in cosmetic products at concentrations 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 (sensitization only) on 12 December 2013.
(3) The SCCS concluded that current clinical data indicate that the concentration of 100 ppm of Methylisothiazolinone in cosmetic products is not safe for the consumer. For leave-on cosmetic products (including ‘wet wipes’), no safe concentrations of Methylisothiazolinone for induction of contact allergy or elicitation have been adequately demonstrated.
(4) In light of the SCCS opinion mentioned above, it is important to address the increased incidence of allergies induced by Methylisothiazolinone and this substance should therefore be banned in leave-on products.
(5) Regulation (EC) No.1223/2009 should therefore be amended accordingly.
(6) The application of the above-mentioned ban should be deferred to allow the industry to make the necessary adjustments to product formulations. In particular, undertakings should be granted six months …
