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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. 1224

ColorMatrix Group

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: Sodium borohydride (CAS Reg. No. 16940-66-2) used in conjunction with palladium acetate (CAS Reg. No. 3375-31-3) REPLACES FCN 1114 and FCN 1160
Notifier: ColorMatrix Group
Manufacturer/Supplier: ColorMatrix Group
Intended Use: The FCS will be used as an oxygen scavenging system in beverage containers as described in the Limitations/Specifications.
Limitations/Specifications: Sodium borohydride may be used in the non-food contact layer of a multi-layered inner liner for beverage bottle closures at a level not to exceed 12 percent by weight (as sodium borohydride) of the non-food contact layer and 64 mg per square inch of the liner's food-contact surface area. The liner's food-contact surface area may not exceed 1.84 square inches. The non-food contact layer containing sodium borohydride must be separated from food by a food-contact barrier layer. Both the non-food contact layer containing sodium borohydride and the food-contact barrier layer may consist of any polymer regulated for use in contact with the food types and Conditions of Use listed below for the finished food contact article. The food-contact barrier layer must have a minimum thickness of no less than 15 mil with the following exceptions: 1) If the barrier layer is styrene-ethylene-butadiene-styrene, the minimum thickness of the barrier may be 14 mil; or 2) If the barrier layer is poly(styrene-ethylene-ethylene/propylene-styrene), the minimum thickness of the barrier may be 10 mil. Sodium borohydride is used in conjunction with palladium acetate, which is present in the finished article as palladium metal (Pd(0)). Palladium acetate may be used in a) beverage bottle walls consisting of ethylene phthalate/naphthalate polymers and copolymers at a level not to exceed 5 parts per million (ppm) by weight (as palladium) or b) in the facing layer of a closure liner at a level not to exceed 50 ppm by weight (as palladium). The palladium acetate in the facing layer will be processed at a minimum temperature of 220°C in a polymer as described in the notification (October 11, 2012 submission). The finished food contact article may be used in contact with food under Conditions of Use C through G, as described in Table 2.
Effective Date: Dec 13, 2012
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1.3 MB)
FDA Decision: Finding of No Significant Impact (FONSI)