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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. 1588

Chemische Fabrik Budenheim KG

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: Diphosphoric acid, copper (2+) salt, hydrate (1:2:x) (CAS Reg. No. 16570-28-8) (Note: where x is unspecified, therefore this submission can cover both the anhydrous and hydrated versions of copper pyrophosphate.)
Notifier: Chemische Fabrik Budenheim KG
Manufacturer/Supplier: Chemische Fabrik Budenheim KG
Intended Use: As a colorant and UV/IR absorber (specifically for laser marking on the non-food contact surface of polymers, fingerprinting/identity preservation, and/ or heat accelerating for molding and forming polymers) for all food-contact polymers, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at a level not to exceed 1.1 percent copper by polymer weight intended to be used in single- or repeat-use food contact articles. The finished food contact articles will contact all food types under Conditions of Use E through G, as described in Table 1. The finished food contact articles will not be used in contact with infant formula or breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Nov 19, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo

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