title: Opinion of the Scientific Committee on Consumer safety (SCCS) - Opinion on the safety of the use of Methylisothiazolinone (MI) (P94), in cosmetic products (sensitisation only).
abstract: 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. 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. 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.
authors.affiliation: SCCS Secretariat at the European Commission, Directorate General for Health and Food Safety, 11, rue E. Ruppert, L-2920 Luxembourg, Luxembourg. Electronic address: SANTE-C2-SCCS@ec.europa.eu.
authors.affiliation: Department of Dermatology, Hospital del Mar. Parc de Salut Mar. Universitat Autònoma, Barcelona, Spain.
authors.forename: A M
authors.initials: AM
authors.lastname: Giménez-Arnau
mesh_terms: D000818:Animals; D003257:Consumer Product Safety; D003358:Cosmetics / Q000009:adverse effects* / Q000032:analysis; D017449:Dermatitis, Allergic Contact / Q000209:etiology*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects* / Q000032:analysis; D018570:Risk Assessment; D012307:Risk Factors; D013844:Thiazoles / Q000009:adverse effects* / Q000032:analysis; D018675:Toxicity Tests
chemical_list: D003358:Cosmetics; D011310:Preservatives, Pharmaceutical; D013844:Thiazoles; C011506:2-methyl-4-isothiazolin-3-one
keywords: CAS 2682-20-4; EC 220-239-6; Methylisothiazolinone (MI) (P94); Regulation 1223/2009; SCCS; Scientific opinion; Sensitisation