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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. 1251

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 1183.
Notifier: Addivant
Manufacturer: Addivant
Intended Use: As an antioxidant in linear low-density polyethylene (LLDPE) and high-density polyethylene (HDPE).
Limitations/Specifications*: The FCS may be used at levels not to exceed 1500 ppm in LLDPE and 1500 ppm in HDPE in contact with all food types except for those containing greater than 15 percent alcohol under Conditions of Use B through H, as described in Tables 1 and 2. The FCS will 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: Jun 12, 2013
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 23.32(i)
FDA Decision: Categorical Exclusion Memo
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