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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. 200

Nippon Shokubai Co. Ltd. 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/Supplier: Nippon Shokubai Co. Ltd. Gruppo Mossi & Ghisolfi
Intended Use: As a modifier for ethylene phthalate polymers identified in 21 CFR 177.1630(e)(4)(i) 21 CFR 177.1630(e)(4)(ii), items 2 and 3; poly(ethylene terephthalate-2,6-naphthalate) polymers identified in FCN numbers 8 and 9; poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalanedicarbonyl) polymers identified in 21 CFR 177.1637 and FCN 9, and polyethylene terephthalate-isophthalate-2,6-naphthalate) polymers identified in FCN 135.
Limitations/Specifications: The level of pyromellitic dianhydride in finished articles and films shall not exceed 0.05 percent by weight of the finished polymer. The modified polymers arer intended for use in the manufacture of containers for single serve or repeated use at temperatures up to and including Conditions of Use A through H as described in Table 2. Such articles and films may be used in contact with aqueous, acidic and low-alcohol food types I, II, IV-B, VI-A, VI-B, VII-B and VIII. The finished pyromellitic dianhydride-modified polyesters must meet any specifications applicable to the unmodified polyester that are appropriate to their intended use. Adjuvant substances permitted for use in ethylene phthalate polymers complying with 21 CFR 177.1630, or ethylene naphthalate polymers complying with 21 CFR 177.1637 may be used in the pyromellitic dianhydride-modified copolymers.
Effective Date: Mar 20, 2002
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)