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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. 2020

LANXESS 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: Mixed esters of C5-C12 fatty acids with pentaerythritol, dipentaerythritol, and polypentaerythritol.
Notifier: LANXESS Solutions US Inc.
Manufacturer/Supplier: LANXESS Corporation
Intended Use: As a lubricant with incidental contact with food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For repeat use with 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: Jan 3, 2020
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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