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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. 1374

Toyobo 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: Phosphonic acid, [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]-,diethyl ester (CAS Reg. No. 976-56-7).
Notifier: Toyobo Co., LTD
Manufacturer/Supplier: Toyobo Co., LTD
Intended Use: The FCS is intended for use as an antioxidant/stabilizer for all polyesters compliant with 21 CFR 177.1630 in contact with all food types, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The finished FCS will be used at levels not to exceed 1100 ppm (0.11 weight-percent) for polyesters, in contact with all food types as listed in Table 1 of 21 CFR 176.170 (c) under the Conditions of Use A through H as described in Table 2 of 21 CFR 176.170 (c). The safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Feb 26, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1.46 MB)
FDA Decision: Finding of No Significant Impact (FONSI)