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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. 1615


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: Hexanoic acid, 3,5,5-trimethyl-, 1,1-[oxybis[2,2-bis[[(3,5,5-trimethyl-1-oxohexyl)oxy]methyl]-3,1-propanediyl]] ester (CAS Reg. No. 65870-97-5).
Notifier: NYCO
Manufacturer/Supplier: NYCO
Intended Use: As a lubricant with incidental food contact as in the context of 21 CFR 178.3570, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The maximum use level in the finished lubricant is 100%, at a maximum temperature of 250°C. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Feb 3, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo