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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. 829

SI Group, Inc.

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).
Notifier: SI Group, Inc.
Manufacturer: SI Group, Inc.
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 limitations of the base polymer.
Effective Date: Oct 8, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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