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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. 14

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 poly(oxy-1,2-ethanediyloxy carbonyl-2,6-naphthalenediyl carbonyl) homopolymer and copolymers with ethylene terephthalate
Limitations/Specifications: The finished copolymers may contain up to 50 weight percent of the polymer units derived from ethylene terephthalate. The finished homopolymer and copolymers must meet any applicable specifications in 21 CFR 177.1630 appropriate to 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. The finished homopolymer and copolymers are used as components of the base sheet or base polymer for manufacturing 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 polymers subject to any limitations in the authorizing regulation or notification. Manufacturers of the polymers may market the finished polymers 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, 3.83 MB)
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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