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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. 1649

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: 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4).
Notifier: LANXESS Corporation
Manufacturer/Supplier: LANXESS Corporation
Intended Use: As a preservative in: (1) coatings that comply with 21 CFR 175.300 (Resinous and polymeric coatings) and 175.320 (Resinous and polymeric coatings for polyolefin films) and (2) can-end and side-seam cements that comply with 21 CFR 175.300. The FCS is not 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 under Conditions of Use A through H as described in Table 1. The maximum level of the FCS in aqueous emulsions for can coatings or polymeric coatings on polyolefin film is 100 ppm. The maximum level of the FCS in aqueous emulsions of can-end or side-seam cement is 150 ppm. The FCS is not for use in contact with infant formula and human milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Aug 27, 2016
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 660 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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