Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2397
EMS-CHEMIE AG
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: | Fatty acids, C18-unsat., dimers, polymers with dodecanedioic acid, isophthalic acid, 4,4-methylenebis[2-methylcyclohexanamine], and terephthalic acid (CAS Reg. No. 2014364-77-1). |
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| Notifier: | EMS-CHEMIE AG |
| Manufacturer/Supplier: | EMS-CHEMIE AG |
| Intended Use: | For use in repeat-use food-contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | For use in contact with all food types under Conditions of Use A through H, as described in Table 1 and Table 2. Adjuvant substances permitted for use in nylon polymers complying with 21 CFR 177.1500 may be used in the subject copolymer, subject to any limitations in the authorizing regulation or notification. 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: | Dec 18, 2024 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment6 (in PDF, 154 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI)7 (in PDF, 216 kB) |
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