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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. 1044

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: Introduction into interstate commerce and delivery for introduction into interstate commerce voluntarily ceased by the manufacturer
2-propenoic acid, 2-methyl-, 2-hydroxyethyl ester polymer with 1-ethyenyl-2-pyrrolidinone, 2-propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-propenoate sodium salt (CAS Reg. No. 1206450-10-3).
Notifier: Daikin America, Inc.
Manufacturer/Supplier: Daikin America, Inc.
Intended Use: The FCS will be added at the size press or prior to sheet formation to impart grease and oil resistance to paper and paperboard.
Limitations/Specifications: Introduction into interstate commerce and delivery for introduction into interstate commerce will be voluntarily ceased by the manufacturer
The FCS will be used as a polymer 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-H and J (including microwave susceptor applications) as described in Table 2.
Effective Date: Feb 16, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 23.32(i)
Environmental Assessment
(in PDF, 1.7 MB)
FDA Decision: Categorical Exclusion Memo/Finding of No Significant Impact (FONSI)
Additional Information: Company commitment letter, FDA acknowledgement, and annual update letter
  • Daikin America, Inc Commitment Letter Regarding FCN Nos. 820, 827, 888, 933, 1044, 1360, and 1451 (July 2020)
  • Acknowledgement Receipt to Daikin America, Inc Commitment Letter Regarding FCN Nos. 820, 827, 888, 933, 1044, 1360, and 1451 (July 2020)
  • Daikin America, Inc First Annual Update Letter Regarding FCN Nos. 820, 827, 888, 933, 1044, 1360, and 1451 (January 2022)
  • Daikin America, Inc Second Annual Update Letter Regarding FCN Nos. 820, 827, 888, 933, 1044, 1360, and 1451 (January 2023)
  • Daikin America, Inc Mid Year Annual Update Letter Regarding FCN Nos. 820, 827, 888, 933, 1044, 1360, and 1451 (July 2023)
  • Daikin America, Inc Final Year Update Letter Regarding FCN Nos. 820, 827, 888, 933, 1044, 1360, and 1451 (January 2024)
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