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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. 411

Colors and Effects USA LLC

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: Copper, (1,3,8,16,24-hexabromo-2,4,9,10,11,15,17,22,23,25-decachloro-29H,31H-phthalocyanato(2-)-N29,N30,N31,N32)-, (SP-4-2)- (CAS Reg. No. 14302-13-7).
Notifier: BASF Corporation
Manufacturer/Supplier: Colors and Effects USA LLC
Intended Use: As a colorant in all types of food-contact polymers.
Limitations/Specifications: The FCS is to be used at levels not to exceed 1% by weight as a colorant in all types of food-contact polymers. The finished polymers are intended to contact all types of food under Conditions of Use C-G, as described in Table 2, and not to exceed temperatures of 70°C. Use of the colorant is subject to the provisions and definitions set forth in 21 CFR 178.3297.
Effective Date: Oct 2, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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