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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. 1808

Nouryon Functional Chemicals, LLC
Nouryon Chemicals NV/SA

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: 1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9-tris(Et and Pr) derivs. (CAS Reg. No. 1613243-54-1)
Notifier: Akzo Nobel Functional Chemicals, LLC
Manufacturer/Supplier: Nouryon Functional Chemicals, LLC
Nouryon Chemicals NV/SA
Intended Use: As a rheology modifier in the production of polypropylene polymers complying with 21 CFR 177.1520 for repeat-use applications only, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used at a level not to exceed 0.15% by weight of the polypropylene polymer. Repeat-use food contact articles manufactured with polypropylene polymers modified with the food contact substance may be used in contact with all Food Types under all use conditions unless restricted by applicable regulations for the polypropylene polymer. The finished polypropylene polymer must comply with the specifications and use limitations in 21 CFR 177.1520(c). The finished product is not for use in contact with infant formula and human milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Dec 8, 2017
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo