Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 9
Far Eastern New Century Corporation APG Polytech LLC
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: | Poly(oxy-1,2-ethanediyloxycarbonyl-2,6 -naphthalanedicarbonyl) homopolymer and copolymers with ethylene terephthalate |
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| Notifier: | Shell Chemicals Company |
| Manufacturer/Supplier: | Far Eastern New Century Corporation APG Polytech LLC |
| Intended Use: | As articles and films or components of articles and films in contact with food |
| Limitations/Specifications: | The finished compolymers may contain up to 50 weight percent of the polymer units derived from ethylene terephthalate. The finished homopolymer and copolymer must meet any applicable specifications in 21 CFR 177.1630 appropriate for their intended use. The finished homopolymer is prepared by condensation of dimethyl-2,6-naphthalenedicarboxylate or 2,6-naphthalenedicarboxylic acid with ethylene glycol. The finished copolymers are prepared by the condensation of dimethyl-2,6-naphthalenedicarboxylate or 2,6-naphthalenedicarboxylic acid and dimethyl terephthalate or terephthalic acid with ethylene glycol and are used as components of articles and films in contact with all food types under Conditions of Use A through H as described in Table 2. Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1630 may be used in the subject copolymers subject to any limitations in the authorizing regulation or notification. |
| Effective Date: | Mar 23, 2000 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 3.83 MB) |
| FDA Decision: | Finding of No Significant Impact (FONSI)/EA Supplement |
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