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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. 2047

DuPont Nutrition & Biosciences ApS and DuPont de Nemours, 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: Hydrogenated castor oil monoglycerides, acetylated (CAS Reg. No. 736150-63-3).
Notifier: DuPont Nutrition & Biosciences ApS and DuPont de Nemours, Inc.
Manufacturer/Supplier: DuPont Nutrition & Biosciences ApS and DuPont de Nemours, Inc.
Intended Use: As a carrier for additives in 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 50 parts per million (ppm) in polypropylene homopolymers and copolymers, and at levels up to 350 ppm in 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 articles intended to contact infant formula and human milk.
Effective Date: Jun 4, 2020
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 570 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 103 kB)

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