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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. 966

Toyo Ink Manufacturing Company, Ltd

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: Phthalimidomethyl copper phthalocyanine (CAS Reg. No. 68411-06-3).
Notifier: Toyo Ink Manufacturing Company, Ltd
Manufacturer/Supplier: Toyo Ink Manufacturing Company, Ltd
Intended Use: The FCS will be used as a heat-resistant pigment in the coloration of plastic used in films and molded articles such as food containers.
Limitations/Specifications: The FCS is intended for use as a colorant in food contact polymers at levels not to exceed 0.006 weight percent. The FCS is mixed with copper phthalocyanine, complying with 21 CFR 178.3297 ("Colorants for polymers"), at a level of 1-5 weight percent before use. The food contact articles manufactured with polymers containing the FCS will be used in contact with aqueous, acidic, low-alcohol, and high-alcohol foods under FDA's Conditions of Use E through F, as described in Tables 1 and 2. The FCS, used as a colorant, will be subject to the provisions set forth in 21 CFR 178.3297.
Effective Date: Jun 1, 2010
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo