Warning: Methylisothiazolinone Use Has Limits

January 20, 2016 | Contact Author | By: Nicole Urbanowicz
Close
Fill out my online form.
  • Article
  • Keywords/Abstract

Keywords: cosmetics regulation | methylisothiazolinone | SCCS Opinion | sensitization | contact allergy

Abstract: Data shows methylisothiazolinone used as a preservative in rinse-off cosmetic products is unsafe at 100 ppm when considering contact allergy concerns.

The Scientific Committee on Consumer Safety (SCCS) has issued a Final Opinion saying its safety concerns remain with certain levels and usages of methylisothiazolinone (MI), sensitization only, in cosmetic products. 

As a follow up to earlier concerns raised in SCCS Opinion SCCS/1521/13 (12 December 2013 with revision 27 March 2014), the SCCS noted recently provided data "does not support the safe use of MI as a preservative in rinse-off cosmetic products up to a concentration limit of 100 ppm from the view of induction of contact allergy."

Watch Your Levels 

  • For rinse-off cosmetic products, a concentration of 15 ppm (0.0015%) MI is considered safe for the consumer from the point of view of induction of contact allergy, based on a recent study.
  • However, the results of the study do not support safety of MI in rinse-off products at either 100 ppm or at 50 ppm for elicitation or induction.

Previously, 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. However, in a SCCS Opinion on MI from March 2014 (SCCS/1521/13), it was concluded that 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, the SCCS Opinion noted.