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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. 2101

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: 1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5).
Notifier: LANXESS Corporation
Manufacturer/Supplier: LANXESS Corporation
Intended Use: As a preservative in aqueous additive formulations such as latex emulsions, fillers, binders, mineral (pigment) slurries, and sizing solutions that comply with 21 CFR 176.170, 176.180 or an effective FCN for use in food-contact paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use at a level not to exceed 300 ppm (0.03 weight-percent) in the aqueous formulation and at levels not to exceed 0.003 mg/in2 in the finished paper and paperboard. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Mar 10, 2021
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 594 kB)
FDA Decision: Finding of No Significant Impact (FONSI) and EA Revision Sheet (in PDF, 172 kB)

*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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