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U.S. Department of Health and Human Services

Inventory of Environmental Impact Decisions for Food Contact Substance Notifications

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FCN No. 103

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.
Environmental Assessment NEPA Submission: Environmental Assessment (in PDF, 472 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
FCN Premarket Authorization Issued: FCN description
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