RadTech Food Contact Notification Alliance Achieves Broad Clearance For UV/EB Curing Formulations

The 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 UV and EB cured coatings, inks and adhesives may be used in direct contact with all Food Types under Conditions of Use A through H, as described in 21 CFR.

This is 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.

Members of the RadTech FCN Alliance are Alcan Packaging; Alcoa, Inc.; Amgraph Packaging, Inc.; Ashland Specialty Chemical Company; Bayer Polymers LLC; Bostik-Findley; Bryce Corporation; Coating and Adhesives Corporation; Cognis Corporation; Crown Cork & Seal; Cytec Industries; Dart Container; Dixie Packaging; Energy Sciences Inc.; Fujifilm Hunt Chemicals; Fusion UV Systems, Inc.; Gidue SpA; Graphic Packaging Inc.; H.B. Fuller Company; INX International Ink Co.; Lamberti, s.p.a.; Liofol; MeadWestvaco; Nordson Corporation; Petroferm Inc.; Pliant Corp.; PPG Industries, Inc.; Printpack Inc.; Rahn USA Corporation; Rock-Tenn Company; Rohm and Haas Company; Sartomer Company; Sealed Air; Siegwerk Group and Valspar Corporation.