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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. 2244

Palsgaard A/S

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).
Notifier: Palsgaard A/S
Manufacturer/Supplier: Palsgaard A/S
Intended Use: As an antistatic/antifouling 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 100 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: Oct 7, 2022
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 794 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 220 kB)
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