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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. 1507

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).
Notifier: Kuraray Co., Ltd.
Kuraray America, Inc.
Kuraray Europe GmbH
Manufacturer/Supplier: 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 breast milk.
Limitations/Specifications: 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 breast 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: Feb 18, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

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