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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. 151

Gruppo Mossi & Ghisolfi

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: Pyromellitic dianhydride (CAS Reg. No. 89-32-7).
Notifier: Gruppo Mossi & Ghisolfi
Manufacturer: Gruppo Mossi & Ghisolfi
Intended Use: The FCS will be used as a modifier for polyethylene phthalate polymers prepared by the condensation of dimethyl terephthalate or terephthalic acid and dimethyl isophthalate or isophthalic acid with ethylene glycol.
Limitations/Specifications*: The finished copolymers will contain no more than 5 weight percent of polymer units derived from ethylene isophthalate and the level of pyromellitic dianhydride shall not exceed 0.5 percent by weight of the finished polymer. The finished copolymers shall comply with 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, dimethyl isophthalate or isophthalic acid with ethylene glycol. The copolymers are to be used as the base sheet or base polymer for manufacturing articles and films intended to contact all food types. Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1630 may be used in the subject polymers subject to any limitations in the authorizing regulation.
Effective Date: Aug 29, 2001
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)
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