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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. 251

FCS: Mitsubishi Gas Chemical Company, Inc., Tokyo, Japan; Polymers modified with the FCS: 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: Hexanedioic acid, polymer with 1,3-benzenedimethanamine (CAS Reg. No. 25718-70-1), meeting the specifications in 21 CFR 177.1500(b) item 10.2, when tested by the method given in 21 CFR 177.1500(c). The FCS is also known as Nylon MXD-6.
Notifier: Gruppo Mossi & Ghisolfi
Manufacturer: FCS: Mitsubishi Gas Chemical Company, Inc., Tokyo, Japan; Polymers modified with the FCS: Gruppo Mossi & Ghisolfi
Intended Use: a) ethylene phthalate polymers complying with 21 CFR 177.1630(e)(4)(i) and 177.1630(e)(4)(ii), items 2 and 3; b) ethylene phthalate polymers complying with FCN numbers 000004 and 000085; c) ethylene phthalate-naphthalate polymers complying with FCN numbers 000008, 000009, and 000135; d) poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalanedicarbonyl) resins complying with 21 CFR 177.1637 and FCN No. 000009; and e) ethylene phthalate polymers and copolymers modified with pyromellitic dianhydride according to FCN numbers 000010, 000145, 000151, and 000200.
Limitations/Specifications*: The FCS will be used at a level not to exceed 5 weight percent of the finished food-contact article. The modified polymers may be used in the manufacture of containers for single-serve use under Conditions of Use C through G, as described in Table 2, and in contact with food types I, II, VI-A, VI-B, as described in Table 1.
Effective Date: Aug 24, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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