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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. 1988

Addivant

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: Phosphorous acid, cyclic neopentanetetrayl bis(2,4-di-tert-butylphenyl) ester (CAS Reg. No. 26741-53-7).
Notifier: Addivant
Manufacturer/Supplier: Addivant
Intended Use: For use as an antioxidant in polypropylene homopolymers and copolymers that contact food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: For use at levels of up to 0.075 percent by weight of polypropylene homopolymers and copolymers that contacts food under Condition of Use A. The FCS may be used in conjunction with triisopropanolamine (CAS Reg. No. 122-20-3) at a maximum use level of 1 percent by weight of the FCS. 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: Jun 25, 2019
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF)
FDA Decision: Finding of No Significant Impact (FONSI)

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