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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. 1933

Performance Fluids, Ltd.

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: Isononanoic acid esters with dipentaerythritol
Notifier: Performance Fluids, Ltd.
Manufacturer/Supplier: Performance Fluids, Ltd.
Intended Use: As a component of lubricants with incidental food contact, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS is for use at a level not to exceed 50 percent by weight of the finished lubricant. Finished lubricants containing the FCS are limited to repeat use on food processing machinery such as oven-chain and conveyor belt mechanisms only. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Dec 21, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo