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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. 1189

TOTAL Lubrifiants

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: Calcium borate (CAS Reg. No. 12040-58-3).
Notifier: TOTAL Lubrifiants
Manufacturer: TOTAL Lubrifiants
Intended Use: For use as an additive in lubricants with incidental food contact.
Limitations/Specifications*: The FCS may be used at a level not to exceed 7 weight percent of the final lubricant. The final lubricant may be used in contact with all food types.
Effective Date: Oct 27, 2012
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo
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