Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2424
Ningbo Tianan Biologic Material 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-hydroxyvaleric acid) (CAS Reg. No. 92267-82-8). |
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| Notifier: | Ningbo Tianan Biologic Material Co., Ltd. |
| Manufacturer/Supplier: | Ningbo Tianan Biologic Material Co., Ltd. |
| Intended Use: | The FCS is intended for use as a base resin in single-use molded articles, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | Food contact articles containing the FCS may contact all types of food 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: | Jun 18, 2025 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 351 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 216 kB) |
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