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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. 1237

Songwon Industrial Company, Ltd.

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: Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. No. 31570-04-4). REPLACES FCN 767
Notifier: Songwon International- Americas, Inc.
Manufacturer: Songwon Industrial Company, Ltd.
Intended Use: As an antioxidant/stabilizer in olefin copolymers complying with 21 CFR 177.1520(c), items 3.2c, 3.4, or 3.6, or in styrene block copolymers complying with 21 CFR 177.1810.
Limitations/Specifications*: At levels not to exceed 0.2 weight-percent of the finished articles when used in olefin copolymers and at levels not to exceed 0.4 weight-percent of the finished articles when used in styrene block copolymers. The finished articles containing the FCS may be used in contact with all food under Conditions of Use A through H as described in Table 2, subject to the limitations of the base polymer.
Effective Date: Feb 19, 2013
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo