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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. 1820

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: Styrene-isobutylene block copolymer (CAS Reg. No. 9011-12-5).
Notifier: Kaneka North America, LLC
Manufacturer/Supplier: Kaneka North America, LLC
Intended Use: As a component of blended polymers that will be used in the manufacture of single-use food-contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use in food packaging applications in contact with all food types under Conditions of Use A through H and J. 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: Nov 15, 2017
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 536 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

*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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