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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 256

EMS Chemie AG/EMS Primid

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: N,N,N',N'-tetrakis(2-hydroxyethyl)hexanediamide (CAS Reg. No. 6334-25-4).
Notifier: EMS Chemie AG/EMS Primid
Manufacturer/Supplier: EMS Chemie AG/EMS Primid
Intended Use: For use as a cross-linking agent for polyester coatings on metal substrates for contact with food.
Limitations/Specifications: The FCS will be used at up to 6 percent by weight of the polyester. The finished coatings are intended for use in contact with all food types under Conditions of Use E through G, as described in 21 CFR 175.300(d), Table 2.
Effective Date: Oct 19, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo