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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 286

Rohm and Haas Company

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.

Food Contact Substance: 2-Methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4).
Notifier: Rohm and Haas Company
Manufacturer: Rohm and Haas Company
Intended Use: As an antimicrobial agent for preservation of latex emulsions destined for use in latex gloves intended to contact all types of food.
Limitations/Specifications*: At a level not to exceed 250 ppm (based on 2-methyl-4-isothiazolin-3-one) in latex emulsion.
Effective Date: Jan 16, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(q)
FDA Decision: Categorical Exclusion Memo