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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. 301

Balzers Aktiengesellschaft

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: BALINIT DLC, BALINIT TRITON, chemically identified as diamond-like carbon.
Notifier: Balzers Aktiengesellschaft
Manufacturer: Balzers Aktiengesellschaft
Intended Use: The FCS will be used as components of repeat-use food processing and food packaging equipment as a double layered ceramic coating consisting of a functional diamond-like carbon layer and an interface chromium layer.
Limitations/Specifications*: The FCS will be used in contact with all food types under Conditions of Use A through H, as described in Table 2. The maximum thickness of the functional diamond-like layer shall not exceed 2 micrometers and the maximum thickness of the chromium interface layer shall not exceed 1 micrometer.
Effective Date: Dec 25, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo