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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. 337

General Electric

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: Trilauryl phosphite (CAS Reg. No. 3076-63-9) containing not more than 1 percent by weight triisopropanolamine (CAS Reg. No. 122-20-3).
Notifier: General Electric
Manufacturer: General Electric
Intended Use: As an antioxidant in linear low density polyethylene.
Limitations/Specifications*: For use at levels not to exceed 0.25 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. Linear low density polyethylene articles containing the FCS may be used in contact with food types I, II, IV-B, VI-A, VI-B, VI-C (up to 15 percent alcohol), VII-B, and VIII as described in Table 1, under Conditions of Use B through H as described in Table 2.
Effective Date: Aug 12, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo