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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. 2378

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: Lauric acid, monoester with oxybis(propanediol) (CAS Reg. No. 96499-68-2)
Notifier: Palsgaard A/S
Manufacturer/Supplier: Palsgaard A/S
Intended Use: As an antistatic/antifouling agent used in the manufacture of polypropylene and polyethylene homopolymers and copolymers for use in contact with food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use at levels not to exceed 80 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 is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Sep 25, 2024
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

*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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