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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. 1216

Chemishe Fabrik Budenheim KG and branches

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(II) hydroxide phosphate (CAS Reg. No. 12158-74-6). REPLACES FCN 926
Notifier: Chemishe Fabrik Budenheim KG and branches
Manufacturer: Chemishe Fabrik Budenheim KG and branches
Intended Use: As an additive in all food-contact polymers that serves: a) as a colorant, b) as a UV-filter to protect contained goods from UV radiation, c) as an IR absorber in order to reduce the necessary energy for molding and forming processes, d) as a laser marking agent in order to improve the quality of laser marking of articles.
Limitations/Specifications*: The FCS may be used at a level not to exceed 2.6 percent by weight of polymer intended for use in contact with all food types under Conditions of Use C through G, as described in Appendix V, Tables 1 and 2.
Effective Date: Nov 20, 2012
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo