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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. 546

Gruppo Mossi & Ghisolfi 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: 1,3-Benzenedicarboxylic acid, 5-sulfo-, monolithium salt (CAS Reg. No. 46728-75-0).
Notifier: Gruppo Mossi & Ghisolfi M&G Polymers USA LLC
Manufacturer: Gruppo Mossi & Ghisolfi M&G Polymers USA LLC
Intended Use: The FCS is intended for use as a modifier of ethylene phthalate polymers regulated under 21 CFR 177.1630 and ethylene phthalate polymers that are the subject of an effective FCN.
Limitations/Specifications*: At levels not to exceed 0.6 percent by weight of the finished food-contact articles. The modified polymers may be used in the manufacture of bottles under Conditions of Use C through G, as described in Table 2 and in contact with food types I, II, VI-A, VI-B and VI-C (to 15 percent alcohol), as described in Table 1. The finished modified polyester must meet any specifications applicable to the unmodified polyester that are appropriate to its intended use.
Effective Date: Jan 28, 2006
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (433 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement
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