Methylisothiazolinone (MI) (P94) - Submission III (Sensitisation only)

SCCS members: U. Bernauer, Q. Chaudhry, P. Coenraads, G. Degen, M. Dusinska, W. Lilienblum, E. Nielsen, T. Platzek, S. C. Rastogi, Ch. Rousselle, Ja. van Benthem
External experts: A. Bernard, J. Duus-Johansen, J. Ezendam, A. Giménez-Arnau, E. Mirkova,E. Panteri, T. Vanhaecke
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1557/15
Adopted on: 25 June 2015 - finalisation 15 December 2015

Conclusion of the opinion:

1. On the basis of the data provided, does the SCCS consider Methylisothiazolinone (MI) to be safe for consumers, when used as a preservative in rinse-off products up to concentration limit of 100 ppm from the view of induction of contact allergy?

The information provided 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.

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.

2. On the basis of the data provided, does the SCCS consider Methylisothiazolinone (MI) to be safe for consumers, when used as a preservative in leave-on hair products up to concentration limit of 100 ppm from the view of induction of contact allergy?

The information provided does not support the safe use of MI as a preservative in leave-on hair cosmetic products up to a concentration limit of 100 ppm from the point of view of induction of contact allergy.

3. Does the SCCS have any further scientific concerns with regard to the use of Methylisothiazolinone (MI) in cosmetic product

The concerns and opinions raised in SCCS Opinion SCCS/1521/13 (12 December 2013 with revision 27 March 2014) remain. The results of the recent Scandinavian study do not support safety of MI in rinse-off products at either 100 ppm or at 50 ppm for elicitation or induction.

Keywords:

SCCS, scientific opinion, Methylisothiazolinone (MI) (P94), sensitisation, Regulation 1223/2009, CAS 2682-20-4, EC 220-239-6

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on Methylisothiazolinone (MI) (P94) sensitisation only, 25 June 2015, SCCS/1557/15.