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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. 2231

Nyco

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: Dipentaerythritol, hexaesters with 3,5,5-trimethylhexanoic, decanoic, heptanoic, and octanoic acids (CAS Reg. No. 2640167-40-2).
Notifier: Nyco
Manufacturer/Supplier: Nyco
Intended Use: As a component of lubricants with incidental contact with food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use at a maximum use level of 98 percent by weight of the finished lubricant. The finished lubricant is intended for use on food processing machinery such as oven chains and conveyor belt mechanisms. 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: Aug 19, 2022
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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