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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. 2162

Kuraray Co., Ltd.
Kuraray America, Inc.
Kuraray Europe GmbH
Kuraray GC Advanced Materials Co., Ltd.

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 block polymer with 1,3-butadiene, hydrogenated (CAS Reg. No. 66070-58-4) as further described in your submission.
Notifier: Kuraray Co., Ltd.
Kuraray America, Inc.
Kuraray Europe GmbH
Kuraray GC Advanced Materials Co., Ltd.
Manufacturer/Supplier: Kuraray Co., Ltd.
Kuraray America, Inc.
Kuraray Europe GmbH
Kuraray GC Advanced Materials Co., Ltd.
Intended Use: For use in blends with other polymers in food-contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS is to be manufactured as specified in the submission. The finished articles may be used in contact with fatty food under Conditions of Use A 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: Dec 11, 2021
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 44 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 129 kB)
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