Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2315
Formosa Plastics Corporation, USA
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: | Ethylene/1-butene copolymer (CAS Reg. No. 25087-34-7). |
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| Notifier: | Formosa Plastics Corporation, USA |
| Manufacturer/Supplier: | Formosa Plastics Corporation, USA |
| Intended Use: | As a component of food contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS may contain up to 10 percent polymer units derived from 1-butene and may be used in contact with all foods types under Conditions of Use A through H, as described in Tables 1 and 2. The density of the FCS will range from 0.85 to 1.00 gm/cm3, and the melt flow index (190°C/2.16 kg) of the FCS will be ≤24 g/10 minutes. Adjuvant substances permitted for use in olefin copolymers complying with 21 CFR 177.1520(c), item 3.1 may be used in the FCS, provided that the limitations on the use of the adjuvant substances are met. 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 18, 2023 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 130 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 149 kB) |
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