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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. 1478

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: As an antioxidant in adhesives and pressure-sensitive adhesives.
Limitations/Specifications: The FCS may be used at levels not to exceed 0.675 percent by weight of adhesives and pressure-sensitive adhesives in accordance with the provisions set out in 21 CFR 175.105 (Adhesives) and 21 CFR 175.125 (Pressure-sensitive adhesives). Permitted uses in contact with infant formula and breast milk: articles containing the FCS may be used in contact with infant formula and breast milk. The FCS may contain not more than 0.75 percent by weight of triisopropanolamine (CAS Reg. No. 122-20-3).
Effective Date: Nov 18, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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