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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. 1753

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, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters (CAS Reg. No. 939402-02-5).
Notifier: Addivant
Manufacturer/Supplier: Addivant
Intended Use: As an antioxidant in all polymers, except low density polyethylene (LDPE), that are used to form repeat use articles in contact with infant formula and human milk, as well as in polymers used as packaging for powdered infant formula.
Limitations/Specifications: The FCS may be used at levels up to 2000 parts per million (ppm) in (1) all polymers, except LDPE, in repeat use articles intended for the feeding of infant formula and human milk; and (2) all polymers intended for use as packaging for powdered infant formula. The FCS may be used in conjunction with triisopropanolamine (CAS Reg. No. 122-20-3) at a maximum use level of 0.75 percent by weight of the FCS.
Effective Date: Apr 21, 2017
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo

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