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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. 1617

Klüber Lubrication München SE & Co. KG

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: Reaction product of 4,4-methylenediphenyl diisocyanate (MDI) with octylamine and oleylamine (9-octadecene-1-amine).
Notifier: Klüber Lubrication München SE & Co. KG
Manufacturer/Supplier: Klüber Lubrication München SE & Co. KG
Intended Use: As a thickener for use in lubricants with incidental contact with food, used on food processing machinery consistent with 21 CFR 178.3570, except for use in the processing of infant formula (see Limitations/Specifications).
Limitations/Specifications: For use at a level not to exceed 20 weight percent of the lubricant, at service temperatures up to 160° C, with short term increases of temperature up to 180° C. The FCS is not for use in the processing of infant formula. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Mar 29, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo