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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. 8

M&G Polymers USA, 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: Ethylene terephthalate-2,6-naphthalate copolymers
Notifier: Shell Chemicals Company
Manufacturer/Supplier: M&G Polymers USA, LLC
Intended Use: As the base sheet or base polymer for manufacturing food contact articles
Limitations/Specifications*: The finished compolymers 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 imethyl-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.
Effective Date: Mar 23, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (1.59 MB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement