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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. 2019

GEA Food Solutions Germany GmbH

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: Platinum 5,10,15,20-tetrakis(pentafluorophenyl)porphyrin (CAS Reg. No. 109781-47-7).
Notifier: GEA Food Solutions Germany GmbH
Manufacturer/Supplier: GEA Food Solutions Germany GmbH
Intended Use: As a component of an oxygen sensor utilized in modified atmosphere food packaging, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The oxygen sensor consists of polystyrene containing the FCS at levels not to exceed 5 weight percent of the sensor, which is applied to the food-contact surface layer of films used in modified atmosphere packaging. The oxygen sensor has a maximum surface area of 1.13 cm2 and thickness of 2.5 μm, and may contact all food types under Conditions of Use E through G, as described in Tables 1 and 2. The FCS is 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: Jan 2, 2020
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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