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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. 2214

DuPont Nutrition & Biosciences ApS

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: Hydrogenated castor oil monoglycerides, acetylated (CAS Reg. No. 736150-63-3). REPLACES FCN 2047
Notifier: DuPont Nutrition & Biosciences ApS
Manufacturer/Supplier: DuPont Nutrition & Biosciences ApS
Intended Use: As a carrier for additives in the manufacture of polypropylene and polyethylene homopolymers and copolymers intended to contact food, including infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use at levels up to 350 parts per million (ppm) in polypropylene and polyethylene homopolymers and copolymers, in contact with all food types under Conditions of Use A through H and J, as described in Table 2. The FCS may be used in films and articles intended to contact infant formula and human milk.
Effective Date: Jun 24, 2022
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 895 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 260 kB)

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