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Wednesday, January 7, 2015SCCS

SCCS: 3 requests for Opinion

© CosmeticOBS-L'Observatoire des Cosmétiques

Methylisothiazolinone (following a submission by Cosmetics Europe for rinse-off products and leave-on hair products), Dichloromethane, and sunscreen Methylene bis-benzotriazolyl tetramethylbutylphenol (following a submission by BASF for the use of nano forms): the safety of these three cosmetic ingredients will be re-evaluated by the SCCS.

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Methylisothiazolinone

Background

The Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) adopted two opinions on "Methylisothiazolinone" respectively in March 2003 (SCCNFP/0625/02) and in April 2004 (SCCNFP/0805/04).
On the basis of those opinions Methylisothiazolinone (MI) was listed in Annex V/57 of Regulation (EC) No 1223/2009 to be used as preservative at maximum concentration of 0.01% (100 ppm) in cosmetics products.

According to several Member States and some literature, the sensitization to MI is becoming an increasing problem all over Europe, particularly with sensitization in young children from moist toilet paper/hygiene moist tissues or cosmetics and, in light of this information, the Commission requested to the Scientific Committee (SCCS) a reassessment of the safety of the MI when it is used as preservative in cosmetics products at maximum concentration of 100 ppm.

The scientific opinion (SCCS/1521/13) on Methylisothiazolinone (P94) Submission II (Sensitization only) was delivered in March 2014 with the following conclusion:
Current clinical data indicate that 100 ppm MI in cosmetic products is not safe for the consumer.
For leave-on cosmetic products (including 'wet wipes'), no safe concentrations of MI for induction of contact allergy or elicitation have been adequately demonstrated.
For rinse-off cosmetic products, a concentration of 15 ppm …

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