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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. 1975

Amorim & Irmãos, S.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: Oxirane, 2-methyl-, polymer with oxirane, ether with 1,2,3-propanetriol (3:1), polymer with 1,3-diisocyanato-2-methylbenzene and 2,4-diisocyanato-1-methylbenzene (CAS Reg. No. 68227-13-4).
Notifier: Amorim & Irmãos, S.A.
Manufacturer/Supplier: Amorim & Irmãos, S.A.
Intended Use: The FCS will be used as a binder or adhesive in the manufacture of agglomerated cork stoppers.
Limitations/Specifications: The FCS shall be used at levels not to exceed 18% by weight of finished agglomerated stoppers. The finished stoppers are for use in contact with wine, sparkling wine, and beer under Conditions of Use E through G, as described in Table 2.
Effective Date: May 31, 2019
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 656 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 120 kB)