Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 179
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: | Copolymers and polymers made from the reaction of dimethyl terephthalate or terephthalic acid with a mixture containing 99 to 0 mole percent of ethylene glycol and 1 to 100 mole percent of 1,4-cyclohexanedimethanol (70 percent trans isomer, 30 percent cis isomer). The FCS is further identified as follows: Ethylene-1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25640-14-6), manufactured from dimethylterephthalate (DMT), ethylene glycol (EG), and 1,4-cyclohexanedimethanol (CHDM). Ethylene-1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25038-91-9), manufactured from terephthalic acid (TPA), EG, and CHDM. 1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25135-20-0), manufactured with DMT and CHDM. 1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25037-99-4), manufactured with TPA and CHDM. |
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| Notifier: | Eastman Chemical Company |
| Manufacturer/Supplier: | Eastman Chemical Company |
| Intended Use: | The FCS will be used as films or articles or components of films or articles, in either a non-oriented or oriented finished form, intended for contact with aqueous, acidic, low-alcohol (up to 13 percent by volume), and fatty foods under Conditions of Use C through G as described in Table 2, and for use in foods containing up to 25 percent, by volume, alcohol under conditions of use E through G as described in Table 2. |
| Limitations/Specifications: | The finished polymer shall meet the inherent viscosity specification in 21 CFR 177.1315(b)(1) and shall meet the following extractives specifications, based on the intended use, using the analytical method specified in 21 CFR 177.1315(c): (1) for use in contact with aqueous, acidic, and low alcohol (up to 13 percent by volume) foods under Conditions of Use C through G, the finished article shall meet the maximum extractable fractions as specified in 21 CFR 177.1315(b)(1) when tested with water and 3 percent acetic acid; (2) for use in contact with fatty foods under Conditions of Use C through G, the finished article shall meet the maximum extractable fractions as specified in 21 CFR 177.1315(b)(1) when tested with n-heptane. Dimethyl terephthalate may be used as an alternative reference standard; and (3) for use in contact with alcoholic foods containing more than 13 percent but not more than 25 percent by volume alcohol under Conditions of Use E through G, the maximum extractable fraction shall not exceed 2 micrograms per square inch when tested using 25 percent ethanol as described in 21 CFR 177.1315(b)(1). The above description does not affect the authorization of those compositions and uses currently permitted in 21 CFR 177.1315. |
| Effective Date: | Jan 3, 2002 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 4.23 MB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) |
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