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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. 2511

Cotek Specialties (Taicang) Co., Ltd.

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: Cotek Specialties (Taicang) Co., Ltd.
Manufacturer/Supplier: Cotek Specialties (Taicang) Co., Ltd.
Intended Use: As an antimicrobial in uncured liquid rubber latex used to manufacture repeat-use rubber gloves, except for use in contact with infant formula and human milk. (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used in contact with all food types. The maximum level of the FCS in latex emulsions is 250 ppm. The FCS is not for use in contact with infant formula and human milk. Such uses were not part of the intended use of the substance in the FCN.
Effective Date: Jun 12, 2026
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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