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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. 44

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: Hexanedioic acid polymer with 1,3-benzenedimethanamine meeting the specifications in 21 CFR 177.1500(b) item 10.2, when tested by the methods given in 21 CFR 177.1500(c) (CAS Reg. No. 25718-70-1).
Notifier: Toyobo Co., Ltd.
Manufacturer: Toyobo Co., Ltd.
Intended Use: As a modifier for polyethylene terephthalate (PET) polymers.
Limitations/Specifications*: (a) At levels not to exceed 30 percent by weight of the modified PET in contact with food types I, II, IVB, VIA, VIB, VIIB and VIII as described in Table 1 of this chapter, and under conditions of use C through G as described in Table 2 of this chapter. Chloroform soluble extractives shall not exceed 0.08 milligrams/centimeter2 (0.5 mg/inch2) of food-contact surface of the modified polyethylene terephthalate article when exposed to water at 95°C (203°F) for 1 hour followed by 49°C (120°F) for 24 hours. (b) At levels not to exceed 10 percent by weight of the modified PET in contact with foods containing greater than 8 percent ethanol, at temperatures not exceeding 71°C (160°F). Chloroform soluble extractives shall not exceed 0.08 milligrams/centimeter2 (0.5 mg/inch2) of food-contact surface of the modified polyethylene terephthalate article when exposed to 50 percent ethanol at 71°C (160°F) for one hour followed by 49°C (120°F) for 24 hours.
Effective Date: Jun 6, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (646 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement
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