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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

 
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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.
 
Effective Date:  06/06/2000
 
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.
 
Environmental Impact Decisions:  Environmental Decisions Site
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