NEWS ALERT
RadTech Food Contact Notification Alliance Achieves Broad Clearance For UV/EB Curing Formulations
Just Announced: Learn about the new FDA FCN for UV/EB direct food contact, Monday May 5, 1:45 to 4:30--Free for RadTech 2008 Technical Conference and End User registrants.
RadTech UV/EB Technology Expo & Conference 2008
May 4-7, 2008, McCormick Place - Chicago
Hotel and discounted registration deadlines are fast approaching
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The RadTech Food Contact Notification Alliance is pleased to announce that Food Contact Notification (FCN) 772 received FDA 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 bisphenol A diglycidyl ether 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.
FOOD PACKAGING ALLIANCE
Past postings
UPDATE
The RadTech FCN Alliance has completed development of the acrylate toxicity profile and found no adverse indications that would contraindicate safe use in food packaging. Extraction studies completed under FDA required protocols confirm that both UV and EB curing formulations can be designed, applied and cured under conditions which assure that extractable monomer, oligomer and photoinitiator levels will be at or below concentrations that can be considered safe for use in food packaging.
Initial feedback from FDA suggests that preliminary data submitted by the Alliance on acrylate monomer toxicity already may be sufficient to support food packaging safety claims for at least two of the monomers submitted for clearance under the FCN. The Alliance plans to conduct two additional toxicity tests to complete clearances for the remaining monomers under consideration.
The FCN is being drafted by Keller and Heckman to allow use of the cleared components in packaging for all food types, under all conditions of use, and to allow maximum flexibility for immediate use in commercial formulations. The Alliance FCN will include a range of permissible monomer, oligomer and photoinitiator use levels in combination with other cleared materials. In plain terms, a formulator may combine the Alliance FCN materials with already FDA sanctioned components to offer inks, coatings and adhesives suitable for food packaging, in many cases without having to obtain additional clearances.
Current plans are to submit the FCN to FDA in the second quarter of 2007. The FCN clearances will be immediately available to Alliance members and their customers, who can reference the Alliance FCN in their own FCN filings, thereby limiting the level of additional effort to the demonstrate the safety of an uncleared component in their proprietary new /formulations/. Alliance members also will have broad options to use the eventual FCN approval and the FCN Master File data to support development and FDA clearances for their own proprietary UV and EB curing /monomers, oligomers and photoinitiators/. Based on the positive findings from our toxicity reviews and migration studies, we anticipate that this groundbreaking FCN will promote a rapid expansion of the range of UV/EB curing materials cleared for use in food packaging applications.
I’ve just received the W. Palm Beach minutes from Donna Bultler. Those should be issued later this week and will be exclusively available only to Alliance members.
The tox committee has just decided on the test protocols and estimated costs for the next round of testing. I’ll be using those costs to develop new assessments for this round of testing and will have those for Jim Kerich shortly.
Both Gidue and Pliant have agreed to continue their participation in the Alliance. Federico D'Annunzio has advised that Gidue would “like to take active part to testing, and give our contribution to make print trials on our demo presses”.
Thus far over 30 companies have signed-up to join the UV and EB Food Pack Alliance. . For information about joining the Alliance please contact Gary Cohen at gary@radtech.org.
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