Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2430
Freudenberg Sealing Technologies GmbH
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: | Polyurethane resin formulated from bitolylene diisocyanate (CAS Reg. No. 91-97-4); 1,4-butanediol (CAS Reg. No. 110-63-4); poly(carbonic acid-co-hexamethylene glycol) (CAS Reg. No. 25037-68-7); and trimethylolpropane (CAS Reg. No. 77-99-6). |
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| Notifier: | Freudenberg Sealing Technologies GmbH |
| Manufacturer/Supplier: | Freudenberg Sealing Technologies GmbH |
| Intended Use: | For use in the manufacture of molded parts, such as o-rings, gaskets, and seals for food processing equipment, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS may be used in repeat use articles used in food processing equipment intended to contact all food types as described in Table 1, at a maximum temperature of 100°C. 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 5, 2025 |
| National Environmental Policy Act (NEPA)** Submission: | Categorical Exclusion 25.32(j) |
| FDA Decision: | Categorical Exclusion Memo |
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