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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. 2213

International N&H Denmark 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: Oleic acid, mono ester with oxybis(propanediol) (CAS Reg. No. 49553-76-6). REPLACES FCN 2037
Notifier: DuPont Nutrition & Biosciences ApS
Manufacturer/Supplier: International N&H Denmark ApS
Intended Use: As an antistatic agent 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, 780 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 289 kB)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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