It is apparently the first such rejection since the new FCN program was instituted in January 2000. FDA has yet to set clear requirements for testing packaging intended to hold food for irradiation. Winning FDAs commitment to an acceptable approach to testing packages for food to be irradiated has been difficult, according to the law firm of Keller & Heckman, which represents several packaging manufacturers. In the case of EVOH, there was a dispute between the agency and FCN submitters over whether polymers should be tested with or without additives and what would be a worst case scenario in the testing process. Reviewers decided that samples of polymer with and without additives should have been tested.
EVOH rejected to hold food for irradiation
The Food and Drug Administration formally rejected a food contact notification (FCN) to market EVOH polymers for packaging materials used to hold food for irradiation.
Mar 31st, 2002