RadTech Food Contact Alliance: Food Contact Notification 772
FCN 772: Legal & Regulatory Aspects
The RadTech Food Contact Notification Alliance is pleased to announce that Food Contact Notification (FCN) 772 received FDA (click here to go to the FDA website) clearance on March 8, 2008, covering a range of workhorse acrylates and an optional photoinitiator. Specifically, FCN 772 clears for direct food contact any mixture of one or more of tripropylene glycol diacrylate (TPGDA), trimethylolpropane triacrylate (TMPTA), trimethylolpropane ethoxylate triacrylate (TMPEOTA), and epoxy diacrylate and optionally, Esacure One photoinitiator, cured by either ultraviolet (UV) or electron beam (EB) irradiation. Moreover, the applied formulations may include any combination with other reactants, polymers, additives, pigments, etc., already permitted for the intended use under 21 CFR.
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.
Under FDA regulations, only Alliance members and their customers may 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.
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.