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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. 1835

Kaneka North America 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: Poly((R)-3-hydroxybutyric acid-co-(R)-3-hydroxyhexanoic acid) (CAS Reg. No. 198007-37-3).
Notifier: Kaneka North America LLC
Manufacturer/Supplier: Kaneka North America LLC
Intended Use: For use in the manufacture of food contact materials, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: Articles composed of the FCS may be used in contact with food types I-V, VIA, VIB, and VII-IX under Conditions of Use B through H as described in Tables 1 and 2. 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 5, 2018
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 106 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 109 kB)