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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. 2372

Bluepha 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: Poly((R)-3-hydroxybutyric acid-co-(R)-3-hydroxyhexanoic acid) (CAS Reg. No. 198007-37-3).
Notifier: Bluepha Co., Ltd.
Manufacturer/Supplier: Bluepha Co., Ltd.
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 all food types, except those containing more than 15% alcohol, 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: Nov 19, 2024
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
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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