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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. 2349

Rianlon Corporation

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: Rianlon Corporation
Manufacturer/Supplier: Rianlon Corporation
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 for use in contact with food, except for use in contact with infant formula and human 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 human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jun 5, 2024
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 205 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 202 kB)
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