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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. 1463

Everspring Chemical Co., 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).
Notifier: Everspring Chemical Co., Ltd.
Manufacturer/Supplier: Everspring Chemical Co., 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 for use in contact with food, except for infant formula and breast milk (see Limitations/Specifications).
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 types under Conditions of Use A through H as described in Tables 1 and 2, subject to limitations of the base polymer. The FCS is not for use in contact with infant formula and breast milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Oct 21, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo