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Statement complementing the EFSA Scientific Opinion on application (EFSA-GMO-DE-2011-95) for the placing on the market of genetically modified maize 5307 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Crop Protection AG taking into consideration an additional toxicological study

Metadata

Panel members at the time of adoption

EFSA Panel on Genetically Modified Organisms (GMO), Hanspeter Naegeli, Andrew Nicholas Birch, Josep Casacuberta, Adinda De Schrijver, Mikołaj Antoni Gralak, Philippe Guerche, Huw Jones, Barbara Manachini, Antoine Messean, Elsa Ebbesen Nielsen, Fabien Nogue, Christophe Robaglia, Nils Rostoks, Jeremy Sweet, Christoph Tebbe, Francesco Visioli and Jean-Michel Wal.

Abstract

The GMO Panel was previously not in the position to complete the food/feed safety assessment of maize 5307 due to an inadequate 28-day toxicity study necessary for an appropriate assessment of eCry3.1Ab protein. Following a mandate from the European Commission, the GMO Panel assessed a supplementary 28-day toxicity study in mice on the eCry3.1Ab protein (1,000 mg/kg body weight (bw) per day) to complement its scientific opinion on application EFSA-GMO-DE-2011-95 for the placing on the market of the maize 5307 for food and feed uses, import and processing. The supplementary 28-day toxicity study did not show adverse effects. Taking into account the previous assessment and the new information, the GMO Panel concludes that maize 5307, as assessed in the scientific opinion on application EFSA-GMO-DE-2011-95 (EFSA GMO Panel, 2015) and in the supplementary toxicity study, is as safe and nutritious as its conventional counterpart in the scope of this application.

Related topic(s)

GMO