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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. 2157

OLEON NV

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: Decanedioic acid, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, isooctadecanoate (CAS Reg. No. 2294927-19-6).
Notifier: OLEON NV
Manufacturer/Supplier: OLEON NV
Intended Use: As a lubricant with incidental food contact applied to machinery used in the processing of canned food and polyethylene terephthalate (PET)-bottled food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: 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: Sep 10, 2021
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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