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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. 85

M&G Polymers, USA LLC
Eastman Chemical Company
E.I. Du Pont de Nemours & Co.
DuPont Polyester Enterprise and DuPont Teijin Films
Wellman, Inc.
Indorama Ventures USA Inc. and its stewarded affiliates around the world.

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: 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 not more than 10 mole-percent of 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: M&G Polymers, USA LLC
Eastman Chemical Company
E.I. Du Pont de Nemours & Co.
DuPont Polyester Enterprise and DuPont Teijin Films
Wellman, Inc.
Indorama Ventures USA Inc. and its stewarded affiliates around the world.
Manufacturer: M&G Polymers, USA LLC
Eastman Chemical Company
E.I. Du Pont de Nemours & Co.
DuPont Polyester Enterprise and DuPont Teijin Films
Wellman, Inc.
Indorama Ventures USA Inc. and its stewarded affiliates around the world.
Intended Use: For use as films or articles intended for contact with aqueous, acidic, low-alcohol, and fatty foods under Conditions of Use A through H as described in Table 2, and for use in contact with high-alcohol foods under conditions of use E through G as described in Table 2.
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).
Effective Date: Oct 5, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (1.28 MB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement
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