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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. 403

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: 2-[2,4-bis(1,1-dimethylethyl)phenoxy]5-butyl-5-ethyl-1,3,2-dioxaphosphorinane,(CAS Reg. No. 180071-71-0), which may contain not more than 1 percent by weight triisopropanolamine (CAS Reg. No. 122-20-3).
Notifier: Addivant
Manufacturer: Addivant
Intended Use: 1) As an antioxidant at levels not to exceed 0.16 percent by weight in linear low density polyethylene complying with 21 CFR 177.1520(c), items 3.1 and 3.2, where the density of the polymer is not greater than 0.94 gram per cubic centimeter. 2) As an antioxidant at levels not to exceed 0.16 percent by weight in repeated use food-contact articles.
Limitations/Specifications*: Linear low density polyethylene articles containing the food contact substance, intended for single-use applications, may be used in contact with food types I, II, IV-B, VI-A(up to 15 percent alcohol), VI-B, VII-B, and VIII as described in Table 1, under Conditions of Use B through H as described in Table 2 .
Effective Date: Apr 29, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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