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CFSAN/Office of Food Additive Safety
June 2, 2004
Date: June 2, 2004
From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)
Subject: FCN No. 423 - Vectra® copolymers as a basic component used in the production of articles (including bottles) intended to contact food
Notifier: Ticona
86 Morris Avenue
Summit, New Jersey
To: Division of Food Contact Notifications (HFS-275)
Attention: Ken McAdams
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG
Attached is the Finding of No Significant Impact (FONSI) for FCN 423. Vectra® copolymers are 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 copolymer units are derived individually from resorcinol and isophthalic acid.
When this notification becomes effective, this FONSI and the notifier's environmental assessment, dated April 9, 2004, may be made available to the public.
Please let us know if there is any change in the identity or use of the food-contact substance.
Annette M. McCarthy, Ph.D.
A food contact notification (FCN No. 423), submitted by Ticona, to provide for the safe use of 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 copolymer units are derived individually from resorcinol and isophthalic acid. The copolymers will be used as a basic polymer in the production of articles (including bottles) intended to contact food
The Environmental Review Group has determined that allowing this notification to become effective will not significantly affect the quality of the human environment and therefore will not require the preparation of an environmental impact statement. This finding is based on information submitted by the notifier in an environmental assessment dated April 9, 2004.
Prepared by____________________________________________ Date: June 2, 2004
Annette McCarthy, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by____________________________________________ Date: June 2, 2004
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
