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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. 1066

Milligan Bio-Tech 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: Rapeseed oil, methyl ester (CAS Reg. No. 73891-99-3).
Notifier: Milligan Bio-Tech Inc.
Manufacturer: Milligan Bio-Tech Inc.
Intended Use: As a lubricant with incidental food contact consistent with 21 CFR 178.3570 (Lubricants with incidental food contact).
Limitations/Specifications*: This product should not be used in temperatures above 90oC to reduce oxidation and prevent thermal degradation of product.
Effective Date: May 4, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo
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