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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. 1360

Daikin America, Inc.

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-Propenoic acid, 2-methyl-, 2-(dimethylamino)ethyl ester, polymer with 1-ethenyl-2-pyrrolidinone and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-propenoate, acetate (CAS Reg. No. 1334473-84-5).
Notifier: Daikin America, Inc.
Manufacturer/Supplier: Daikin America, Inc.
Intended Use: The FCS will be added at the size press or wet end to impart grease and oil resistance to paper and paperboard, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications*: The FCS will be used as an additive in paper and paperboard at levels not exceeding 1 percent of the dry fiber. The FCS is intended for use in paper that contacts all food types under Conditions of Use A through H as described in Tables 1 and 2. The safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Feb 21, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 21 CFR 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo

679661  

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