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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. 1849

Heubach Colour Pvt 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: Heubach Colour Pvt Ltd.
Manufacturer/Supplier: Heubach Colour Pvt Ltd.
Intended Use: As a colorant in polymeric food packaging, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS is intended for use at levels not to exceed 0.45 percent by weight in single-use polymeric food packaging. Packaging containing the FCS may contact food types I, II, IVB, VIA, VIB, VIC, VIIB and VIII under Conditions of Use E through G as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Mar 30, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo