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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. 1839

Oerlikon Balzers Coating AG
Oerlikon Surface Solutions AG

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: Chromium (III) oxide (CAS Reg. No.1308-38-9).
Notifier: Oerlikon Balzers Coating AG
Manufacturer/Supplier: Oerlikon Balzers Coating AG
Oerlikon Surface Solutions AG
Intended Use: As a surface coating on repeat-use food processing and food packaging equipment to prevent abrasive wear to the components of the equipment, except for use in contact with infant formula and human milk. (see Limitations/Specifications).
Limitations/Specifications: For use at a thickness not to exceed 200 nanometers. The coating may contact all food types under Conditions of Use A through H, as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and human milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Jan 4, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

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