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

EFSA JOURNAL(2018)

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Abstract
The GMO Panelwas 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 Panelassessed a supplementary 28-day toxicity study in mice on the eCry3.1Ab protein (1,000mg/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 Panelconcludes that maize 5307, as assessed in the scientific opinion on application EFSA-GMO-DE-2011-95 (EFSA GMO Panel, ) and in the supplementary toxicity study, is as safe and nutritious as its conventional counterpart in the scope of this application. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
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Key words
GMO,maize 5307,food and feed safety,import and processing,eCry3.1Ab,28-day study
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