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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. 1854

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: Polyurethane resin produced by reacting a mixture of 2,4-toluene diisocyanate (CAS Reg. No. 584-84-9) and 2,6-toluene diisocyanate (CAS Reg. No. 91-08-7) with polyoxyethylene-polyoxypropylene glyceryl ether (CAS Reg. No. 9082-00-2) and 1,4-butanediol (CAS Reg. No. 110-63-4).
Notifier: Amorim & Irmãos, S.A.
Manufacturer/Supplier: Amorim & Irmãos, S.A.
Intended Use: As a binder or adhesive in the manufacture of agglomerated cork stoppers that contact wine, sparkling wine, and microbrew beer under Conditions of Use E through G, as described in Table 2.
Limitations/Specifications: For use at levels not to exceed 18% by weight of finished agglomerated stoppers.
Effective Date: May 8, 2018
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 71 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 103 kB)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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