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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. 1941

SIR Industriale 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: N,N,N',N'-tetrakis(2-hydroxyethyl)hexanediamide (CAS Reg. No. 6334-25-4).
Notifier: SIR Industriale S.p.A.
Manufacturer/Supplier: SIR Industriale S.p.A.
Intended Use: For use as a cross-linking agent for polyester coatings on metal substrates for food contact, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: The FCS is used at a level not to exceed 6% by weight of the polyester. The finished coatings are intended for repeat uses in contact with all food types at room temperature and below. 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: Jan 9, 2019
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

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