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). |
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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) |
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