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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. 211

Eastman Chemical Company

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: Isophthalic acid (CAS Reg. No. 121-91-5).
Notifier: Eastman Chemical Company
Manufacturer/Supplier: Eastman Chemical Company
Intended Use: As a monomer in the manufacture of ethylene terephthalate-isophthalate copolymers.
Limitations/Specifications: The finished copolymers must contain from 3 to 17 weight percent ethylene isophthalate units. The finished copolymers must also meet specifications as described in 21 CFR 177.1630(f)-(j) appropriate to their intended use. Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1630 may be used in the finished copolymers subject to any limitations in the authorizing regulation.
Effective Date: May 25, 2002
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 2.22 MB)
FDA Decision: Finding of No Significant Impact (FONSI)