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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. 1790

Chemische Fabrik Budenheim KG, Germany
Budenheim Ibérica S.L.U., Spain
Budenheim USA Inc.

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: Phosphoric acid, iron (2+) salt, (2:3:x) (CAS Reg. No. 14940-41-1 (anhydrous); (CAS Reg. No. 10028-23-6) (octahydrate).
Notifier: Chemische Fabrik Budenheim KG, Germany
Budenheim Ibérica S.L.U., Spain
Budenheim USA Inc.
Manufacturer/Supplier: Chemische Fabrik Budenheim KG, Germany
Budenheim Ibérica S.L.U., Spain
Budenheim USA Inc.
Intended Use: As an IR absorber used for laser marking on the non-food contact surface of all food contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at a level not to exceed 3 percent by weight of polymers 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 Tables 1 and 2. The finished food contact articles containing the FCS are 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: Aug 3, 2017
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo

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