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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. 547

 
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Food Contact Substance:  Polyethylene terephthalate copolyesters (diethylene glycol-isophthalate modified) prepared by the condensation of dimethyl terephthalate or terephthalic acid and ethylene glycol with one or more of the following: dimethyl isophthalate, isophthalic acid, and diethylene glycol. The finished polymer shall contain a total of up to 16 mole-percent of total diethylene glycol and isophthalate units, with the diethylene glycol content expressed as a mole-percent of the total glycol units and the isophthalate content expressed as a mole-percent of the total isophthalate/terephthalate units.
 
Notifier:  Futura Polymers A division of Futura Polyesters Limited
 
Manufacturer:  Futura Polymers A division of Futura Polyesters Limited
 
Intended Use:  For finished polymers containing up to 12 mole-percent of total diethylene glycol and isophthalate units, for use as films or articles intended for contact with aqueous, acidic, low-alcohol (up to 50 percent alcohol by volume), dry and fatty foods under Conditions of Use A through H as described in Table 2, and for use in contact with high-alcohol foods (greater than 50 percent alcohol by volume) under Conditions of Use E through G as described in Table 2. For finished polymers containing between 12 and 16 mole-percent total diethylene glycol and isophthalate units, for use as films or articles intended for contact with aqueous, acidic, low-alcohol (up to 50 percent alcohol by volume), dry, and fatty foods under Conditions of Use B through H as described in Table 2.
 
Effective Date:  01/26/2006
 
Limitations/Specifications:  The finished food-contact film or article must meet any applicable specifications, and is subject to all applicable Conditions of Use cited in Title 21 CFR 177.1630(f), (g), and/or (j). Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1630 may be used in the copolyesters that are the subject of this notification, subject to any limitations in the authorizing regulation.
 
Environmental Impact Decisions:  Environmental Decisions Site
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