Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2368
Beijing PhaBuilder Biotechnology 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: | Butanoic acid, 3-hydroxy-, (3R)-, polymer with 4-hydroxybutanoic acid (CAS Reg. No. 125495-90-1) and butanoic acid, 3- hydroxy-, (3R)-, homopolymer (CAS Reg. No. 29435-48-1). |
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| Notifier: | Beijing PhaBuilder Biotechnology Co., Ltd. |
| Manufacturer/Supplier: | Beijing PhaBuilder Biotechnology Co., Ltd. |
| Intended Use: | As a polymer or a component of polymers used in articles that may contact food, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS may contain up to 16 weight percent units derived from 4-hydroxybutanoic acid (4HB). The FCS will 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: | Jul 30, 2024 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 1.1 MB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 182 kB) |
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