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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. 2329

Novvi, LLC

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: Octadecene, reaction products with hexadecene, hydrogenated (CAS Reg. No. 2241366-04-9).
Notifier: Novvi, LLC
Manufacturer/Supplier: Novvi, LLC
Intended Use: For use as a plasticizer in the manufacture of thermoplastic elastomers (TPE) and rubber intended for repeat-use gaskets and O-rings, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use at a maximum use level of 40 weight percent of the TPE or rubber gasket or O-ring for use in contact with all types of food. The finished TPE or rubber will comply with applicable authorizations. 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: Mar 30, 2024
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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