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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. 1113

Nye Lubricants, 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: Sodium nitrite (CAS Reg. No. 7632-00-0).
Notifier: Nye Lubricants, Inc.
Manufacturer: Nye Lubricants, Inc.
Intended Use: As an additive in lubricants with incidental contact with food in compliance with 21 CFR 178.3570.
Limitations/Specifications*: The FCS will be used at a level not to exceed 5 percent by weight in repeated-use lubricants that may have incidental contact with all food types under Conditions of Use A through H and J as described in Table 2.
Effective Date: Nov 8, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo