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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. 2434

Henkel Corporation

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: Henkel Corporation
Manufacturer/Supplier: Henkel Corporation
Intended Use: For use as a preservative in can end cements used in packaging for powdered or liquid infant formula (See Limitations/Specifications).
Limitations/Specifications: The FCS may be used in contact with powdered and liquid infant formula under Conditions of Use A through H. The FCS shall contain no more than 3.0 percent (by weight) impurities. The maximum level of the FCS in the finished cement on a dry solids basis is 300 ppm. No other uses in contact with infant formula and human milk were included as part of the intended use of the substance in the FCN.
Effective Date: Jun 25, 2025
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

*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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