Inventory of Effective Food Contact Substance (FCS) Notifications
-
FCN No. 13
Indorama Ventures
Xylenes & PTA 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: | Dimethyl 2,6-naphthalenedicarboxylate or 2,6-naphthalenedicarboxylic acid |
|---|---|
| Notifier: | BP Amoco Chemicals |
| Manufacturer/Supplier: |
Indorama Ventures Xylenes & PTA LLC |
| Intended Use: | As a chemically-bound component of ethylene terephthalate-2,6-naphthalate compolymers |
| Limitations/Specifications: | The finished copolymers may contain from 0 to 50 weight percent of the polymer units derived from ethylene 2,6-naphthalate. The finished copolymers must meet any applicable specifications in 21 CFR 177.1630 appropriate to their intended use. The finished copolymers are prepared by the condensation of dimethyl terephthalate or terephthalic acid and dimethyl-2,6-naphthalenedicarboxylate or 2,6-naphthalenedicarboxylic acid with ethylene glycol and are used as the base sheet or base polymer for manufacturing articles and films intended to contact 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. Manufacturers of the copolymers may market the finished copolymers in accord with section 409(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act, provided the intended use is in conformity with this notification. |
| Effective Date: | Mar 23, 2000 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 1.53 MB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) |
-
