Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2452
Versalis S.p.A.
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: | Versalis S.p.A. |
| Manufacturer/Supplier: | Versalis S.p.A. |
| 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 25 weight percent polymer units derived from 1-butene and may be used in contact with all food types under Conditions of Use A through H as described in Tables 1 and 2. The density of the FCS will range from 0.895 to 0.904 g/cm3, and the melt flow rate (190°°C) of the FCS will range from 1.0 to 4.0 g/10 minutes. Additives permitted for use in butene polymers complying with 21 CFR 177.1570 and in olefin polymers complying with 21 CFR 177.1520(c), items 3.1 and 3.2 also may be used in the FCS, provided that the limitations and specifications on the use of the additives 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: | Sep 27, 2025 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment |
| FDA Decision: | Finding of No Significant Impact (FONSI) |
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