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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. 131

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: Rohm and Haas Company
Manufacturer/Supplier: LANXESS Corporation
Intended Use: 1. As an antimicrobial agent for adhesives and components of adhesives used in accordance with 21 CFR 175.105. 2. as an antimicrobial agent for polymer latex emulsions in paper coatings complying with 21 CFR 176.170(b) at a level not to exceed 250 ppm (based on 2-methyl-4-isothiazolin-3-one), and 3. as an antimicrobial agent for finished paper and paperboard coating formulations complying with 21 CFR 176.170(b) and for additives used in the manufacture of paper and paperboard complying with 21 CFR 176.170 including latex emulsions, fillers, binders, pigment slurries, and sizing solutions at a level not to exceed 150 ppm (based on 2-methyl-4-isothiazolin-3-one) in the individual additives and not to exceed 150 ppm in the finished coating formulation.
Limitations/Specifications: None
Effective Date: Apr 17, 2001
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(q)
FDA Decision: Categorical Exclusion Memo
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