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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. 772

Alcan Packaging, Alcoa, Inc., Amgraph Packaging, Inc., Ashland Specialty Chemical Company, Bayer Polymers LLC, Bostik-Findley, Bryce Corporation, Coating and Adhesives Corporation, Crown Cork & Seal, Cytec Industries, Dart Container, Dixie Packaging, Ener

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: A mixture of one or more of tripropylene glycol diacrylate (CAS Reg. No. 42978-66-5), trimethylolpropane triacrylate (CAS Reg. No. 15625-89-5), trimethylolpropane ethoxylate triacrylate (CAS Reg. No. 28961-43-5), and bisphenol A diglycidyl ether diacrylate (CAS Reg. No. 4687-94-9, 53814-24-7, 55127-80-5, 55818-57-0 or 37625-93-7), and optionally the difunctional α-hydroxy ketone described in the notification as a photoinitiator. The mixture will be cured by either ultraviolet (UV) or electron beam (EB) irradiation.
Notifier: Alcan Packaging, Alcoa, Inc., Amgraph Packaging, Inc., Ashland Specialty Chemical Company, Bayer Polymers LLC, Bostik-Findley, Bryce Corporation, Coating and Adhesives Corporation, Crown Cork & Seal, Cytec Industries, Dart Container, Dixie Packaging, Ener
Manufacturer: Alcan Packaging, Alcoa, Inc., Amgraph Packaging, Inc., Ashland Specialty Chemical Company, Bayer Polymers LLC, Bostik-Findley, Bryce Corporation, Coating and Adhesives Corporation, Crown Cork & Seal, Cytec Industries, Dart Container, Dixie Packaging, Ener
Intended Use: To be used as coatings (including inks) or components of coatings (including inks) on polymeric substrates, paper and paperboard, metal substrates, or as a component in adhesives.
Limitations/Specifications*: The cured resins may include other substances permitted for the intended use by regulation under 21 CFR. The finished coating, when tested according to the compliance test protocol set forth in the FCN, shall yield a migration level for each monomer and photoinitiator used that is the subject of this FCN that does not exceed 10 micrograms per square inch (ug/in2) and the total level of nonvolatile extractables derived from the finished coating will not exceed 10 ug/in2, after correction for the migration levels for each monomer and photoinitiator used. For use in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2. The food contact articles containing the coatings will meet all applicable regulations under 21 CFR.
Effective Date: Mar 8, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i), (j), and Environmental Assessment (393 kB)
FDA Decision: Categorical Exclusion Memo/Finding of No Significant Impact (FONSI)
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