Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2369
GCH Technology 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: | 4-Cyclohexene-1,2-dicarboxylic acid, calcium salt (1:1) (CAS Reg. No. 57545-78-5) |
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| Notifier: | GCH Technology Co., Ltd. |
| Manufacturer/Supplier: | GCH Technology Co., Ltd. |
| Intended Use: | As a nucleating agent in polypropylene homopolymers and copolymers, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS may be used at levels not to exceed 0.2 weight percent in polypropylene homopolymers and copolymers that may contact all food types under Conditions of Use A 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: | Sep 25, 2024 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 170 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 228 kB) |
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