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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. 198

Teijin 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: A copolymer of dimethyl terephthalate (CAS Reg. No. 120-61-6), 1,3-dimethyl-5-sulfo-1,3-benzenedicarboxylate, sodium salt (CAS Reg. No. 3965-55-7), and 1,6-hexanediol (CAS Reg. No. 629-11-8).
Notifier: Teijin Ltd.
Manufacturer: Teijin Ltd.
Intended Use: The FCS will be used as a nucleating agent in (a) polyethylene terephthalate (PET) polymers complying with 21 CFR 177.1630 and (b) polyethylene terephthalate (PET) polymers complying with the specifications in 21 CFR 177.1630(f) for which there is an effective food contact notification.
Limitations/Specifications*: 1. The copolymer will be used at levels up to 0.002 percent by weight of the PET polymer in contact with all food types under all conditions of use, including dual-ovenable applications. 2. The finished copolymer contains no more than 3 mole percent of the acid-based monomeric units derived from 1,3-dimethyl-5-sulfo-1,3-benzenedicarboxylate, sodium salt (CAS Reg. No. 3965-55-7)
Effective Date: Mar 13, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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