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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. 2102

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 an antimicrobial preservative, alone or in combination with other biocides, in aqueous preparation formulation for:
  1. adhesives and polymers that will be used to fabricate layers or adhesives for laminate structures, complying with 21 CFR 177.1390 and 177.1395 or an effective FCN for laminate structures, and
  2. pressure-sensitive adhesives complying with 21 CFR 175.125 or an effective FCN for a pressure sensitive adhesive to be used on labels to be affixed directly to food, except 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 formulations and at levels not to exceed 0.1 mg/in2 in both the finished laminate structure and the finished adhesive. 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, 4.3 MB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 164 kB)

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