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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. 423

Ticona

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 produced by the polymerization of 6-hydroxy-2-naphthoic acid with one or more of the following monomers: 4-hydroxybenzoic acid; 4,4'-biphenol; N-(4-hydroxyphenyl)acetamide; terephthalic acid; resorcinol; and isophthalic acid such that a minimum of 55 percent of the polymer units are derived from 6-hydroxy-2-naphthoic acid alone or in combination with 4-hydroxybenzoic acid, not more than 25 percent of the polymer units are derived individually from 4,4'-biphenol, N-(4-hydroxyphenyl)acetamide and terephthalic acid, and not more than 15 percent of the polymer units are derived individually from resorcinol and isophthalic acid. The copolymers should be manufactured and characterized as described in the notification.
Notifier: Ticona
Manufacturer: Ticona
Intended Use: As a basic polymer used in the production of articles (including bottles) intended to contact food.
Limitations/Specifications*: The finished copolymers are intended to contact all food types under Conditions of Use A through H, as described in Table 2.
Effective Date: Aug 11, 2004
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (312 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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