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Expert opinion

Revision of the opinion on Methylisothiazolinone (P94) Submission II (Sensitisation only)

Final Opinion

Details

Publication date
27 March 2014
Author
Scientific Committee on Consumer Safety (SCCS)

Description

WG on Cosmetic Ingredients
SCCS members: U. Bernauer, P.J. Coenraads, G. Degen, M. Dusinska, D. Gawkrodger, W. Lilienblum, A. Luch, E. Nielsen, T. Platzek, S.C. Rastogi (chairman), Ch. Rousselle, J. van Benthem
External experts: V. Rogiers, T. Sanner, I.R. White (rapporteur)
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1521/14
Doi: 10.2772/7297
Adopted on: 27 March 2014

Conclusion of the opinion:

1. On the basis of the new evidence in relation to sensitising potential, does the SCCS consider Methylisothiazolinone (MI) still safe for consumers, when used as a preservative in cosmetic products up to concentration limit of 100 ppm? If no, it is asked for the SCCS to revise this concentration limit on the basis of information provided.

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 (0.0015%) MI is considered safe for the consumer from the view of induction of contact allergy. However, no information is available on elicitation.

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

MI should not be used as an addition to a cosmetic product already containing MCI/MI. More frequent review of data (than suggested in SCCS/1482/12) to monitor sensitisation frequencies of MI and related isothiazolinone preservatives is recommended. This permits trends in consumers’ sensitisation to be observed and timely intervention to be taken. Information on the actual concentration of MI present in individual cosmetic products will allow future evaluation of safe concentrations. Labelling is only helpful to a consumer who has a known (established by diagnostic patch test investigations) allergy. It is unknown what proportion of the general population is now sensitized to MI and has not been confirmed as sensitized. Since MI is widely used in other consumer products (eg. detergents, paints), exposures from such sources should also be assessed. Consumers cannot find information on the presence of MI in products except in cosmetics and household detergents because, as yet, there is no harmonised classification of MI as a skin sensitizer. The risk for skin sensitisation by MI is at least equivalent to that of other substances which have received a harmonised classification according to the CLP Regulation.

Keywords:

SCCS, scientific opinion, cosmetic ingredients, methylisothiazolinone, MI, Regulation 1223/2009, contact allergy, epidemic, CAS no. 2682-20-4, EC 220-239-6

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on Methylisothiazolinone (P94) – Submission II, 12 December 2013, SCCS/1521/13, revision of 27 March 2014.

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