Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2406
Chitec Technology Co., Ltd.
Double Bond Chemical Ind. Co., Ltd.
FDC, Lees 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-tert-butyl-2-(5-tert-butyl-2-oxo-3H-benzofuran-3-yl)phenyl] 3,5-ditertbutyl-4-hydroxy-benzoate (CAS Reg. No. 1261240-30-5). REPLACES FCNs 1254 and 1433 |
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| Notifier: | Chitec Technology Co., Ltd. |
| Manufacturer/Supplier: |
Chitec Technology Co., Ltd. Double Bond Chemical Ind. Co., Ltd. FDC, Lees Co., Ltd. |
| Intended Use: | The FCS will be blended with hindered phenolic and phosphite-based antioxidants to provide a synergistic effect. The FCS will be used in polyolefin articles, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS may be used at a level up to 1) 500 ppm in polyolefin articles in contact with aqueous and acidic foods under Conditions of Use (COU) A through H; and 2) 100 ppm in polypropylene articles (thickness shall not exceed 10 mil) in contact with dry, alcoholic and fatty foods under COU 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: | Apr 8, 2025 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 209 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 161 kB) |
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