The FDA ruling said that UV or EB cured formulations may be used as coatings (including inks) or as components of coatings (including inks) on polymeric substrates, paper and paperboard, metal substrates, or as a component in adhesives. The finished coating, ink or adhesive is permitted a migration level for each of the cleared monomers and for the photoinitiator up to 1 ppm. The total level of nonvolatile extractables derived from the finished coating may not exceed 1 ppm, after correction for the migration levels for each monomer and photoinitiator used.
The RadTech Food Contact Notification Alliance called the ruling “a breakthrough food contact approval for radiation curable formulations, because it is the first FDA clearance of a range of UV/EB curing materials in any combination for direct food contact; formulations that combine the FCN materials with already FDA sanctioned components may be commercialized for food packaging without having to obtain additional FDA clearance; and the FCN is expected to open new applications for UV and EB curing that previously might have been limited by lack of explicit food contact clearance.”
According to RadTech, FDA regulations permit only Alliance members and their customers to claim clearance for materials and formulations selected from FCN 772. It is expected that the range of cleared acrylates will be expanded because Alliance members are permitted to incorporate the Alliance FCN master files by reference in new FCN filings, thereby limiting the level of additional information, time and cost required to clear their own proprietary UV/EB curing materials and formulations.
Alliance members are: Alcan Packaging, Alcoa, Amgraph Packaging, Ashland Specialty Chemical Company, Bayer Polymers, Bostik-Findley, Bryce Corporation, Coating and Adhesives Corporation, Cognis Corporation, Crown Cork & Seal, Cytec Industries, Dart Container, Dixie Packaging, Energy Sciences, Fujifilm Hunt Chemicals, Fusion UV Systems, Gidue; Graphic Packaging, H.B. Fuller, INX International Ink, Lamberti, Liofol, MeadWestvaco, Nordson, Petroferm, Pliant Corp, PPG Industries, Printpack, Rahn USA, Rock-Tenn, Rohm and Haas, Sartomer, Sealed Air, Siegwerk Group, and Valspar.