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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. 1633

LANXESS 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: A mixture of 5-chloro-2-methyl-4-isothiazolin-3-one (CIT; CAS Reg. No. 26172-55-4) and 2-methyl-4-isothiazolin-3-one (MIT; CAS Reg. No. 2682-20-4) at a ratio of 3 parts to 1 part by weight, optionally stabilized with magnesium or sodium nitrate and optionally further stabilized with 0.15 percent copper(II) nitrate.
Notifier: LANXESS Corporation
Manufacturer/Supplier: LANXESS Corporation
Intended Use: The FCS is intended for use as: (1) an antimicrobial agent in polymer latex solutions used in adhesives complying with 21 CFR 175.105; (2) a preservative in resinous and polymeric coatings for polyolefin films complying with 21 CFR 175.320 and in coatings and/or coating components complying with 21 CFR 175.300; and (3) a biocide in polymer latex emulsions, coating formulations and additives for paper manufacture used for food packaging. Except for use in contact with infant formula and breast milk (see Limitations and Specifications).
Limitations/Specifications: For use at CIT and MIT levels: (1) equivalent to levels specified in 21 CFR 175.105, stabilized with magnesium nitrate, sodium nitrate and up to 0.15 percent copper(II) nitrate as an antimicrobial agent in polymer latex solutions used in adhesives; (2) equivalent to levels specified in 21 CFR 175.300 and 21 CFR 175.320, stabilized with magnesium nitrate, sodium nitrate and up to 0.15 percent copper(II) nitrate as a preservative in resinous and polymeric coatings for polyolefin films and in coatings and/or coating components; (3) equivalent to levels specified in 21 CFR 176.170, stabilized with magnesium nitrate, sodium nitrate and up to 0.15 percent copper(II) nitrate as a biocide in polymer latex emulsions, coating formulations and additives for paper manufacture used for food packaging. The FCS is not for use in contact with infant formula and breast milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Mar 18, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(q)
FDA Decision: Categorical Exclusion Memo

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