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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. 78

Lubrizol Corporation

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: Sebacic acid (1,8-octanedicarboxylic acid, as a component of lubricants that otherwise comply with 21 CFR 178.3570 (CAS Reg. No. 111-20-6).
Notifier: Lubrizol Corporation
Manufacturer/Supplier: Lubrizol Corporation
Intended Use: Incidental food-contact lubricants made with sebacic acid (added as a corrosion inhibitor).
Limitations/Specifications*: Maximum use level of 0.5 percent of sebacic acid by weight in the lubricant. The FCS shall contain no less than 85 percent sebacic acid and no less than 95 percent total sebacic, un- and dodecanedioic acids.
Effective Date: Aug 31, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (116 kB)
FDA Decision: Finding of No Significant Impact (FONSI)