Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2221
Kuraray GC Advanced Materials Co., Ltd.
Kuraray Co., Ltd.
Kuraray America, Inc.
Kuraray Europe GmbH
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. |
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| Notifier: |
Kuraray GC Advanced Materials Co., Ltd. Kuraray Co., Ltd. Kuraray America, Inc. Kuraray Europe GmbH |
| Manufacturer/Supplier: |
Kuraray GC Advanced Materials Co., Ltd. Kuraray Co., Ltd. Kuraray America, Inc. Kuraray Europe GmbH |
| Intended Use: | For use in blends with other polymers in articles that may contact infant formula and human milk. |
| Limitations/Specifications: | The FCS is to be manufactured as specified in the submission. The FCS will be used at levels not to exceed 80% of the blend in repeat-use articles intended for feeding infants, including baby bottle nipples, at a maximum temperature of approximately 60°C. The FCS may not be used in packaging infant formula or human milk and may not be used in manufacture of infant feeding bottles. Such uses were not included as part of the intended uses of the substance in the FCN. |
| Effective Date: | Jun 8, 2022 |
| National Environmental Policy Act (NEPA)** Submission: | Categorical Exclusion 25.32(j) |
| FDA Decision: | Categorical Exclusion Memo |
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