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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. 1544

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) REPLACES FCN 1422, FCN 1466, FCN 1251 and FCN 1183
Notifier: Addivant
Manufacturer/Supplier: Addivant
Intended Use: As an antioxidant in linear low-density polyethylene (LLDPE), high-density polyethylene (HDPE), adhesives, and pressure-sensitive adhesives, except for use in contact with infant formula and breast milk (see Limitations/Specifications)
Limitations/Specifications: The FCS may be used at levels up to 0.2 percent by weight in LLDPE or HDPE in contact with all food types under Conditions of Use A through H, as described in Table 2. The FCS may be used at levels up to 1 percent by weight in adhesives authorized under 21 CFR 175.105 (Adhesives) and 21 CFR 175.125 (Pressure-sensitive adhesives) in accordance with the provisions set forth therein. 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. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jul 1, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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