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
Résumé
The GMO Panel was previously not in the position to complete the food/feed safety assessment ofmaize 5307 due to an inadequate 28-day toxicity study necessary for an appropriate assessment ofeCry3.1Ab protein. Following a mandate from the European Commission, the GMO Panel assessed asupplementary 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 onthe market of the maize 5307 for food and feed uses, import and processing. The supplementary28-day toxicity study did not show adverse effects. Taking into account the previous assessment andthe new information, the GMO Panel concludes that maize 5307, as assessed in the scientific opinionon application EFSA-GMO-DE-2011-95 (EFSA GMO Panel, 2015) and in the supplementary toxicitystudy, is as safe and nutritious as its conventional counterpart in the scope of this application.