6533b829fe1ef96bd1289a66

RESEARCH PRODUCT

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

Josep M. CasacubertaBarbara ManachiniBarbara ManachiniChristophe RobagliaAdinda De SchrijverAdinda De SchrijverAndrew Nicholas BirchAndrew Nicholas BirchJean-michel WalFrancesco VisioliFrancesco VisioliHanspeter NaegeliHanspeter NaegeliAntoine MesséanElsa Ebbesen NielsenElsa Ebbesen NielsenAnna LanzoniAnna LanzoniKonstantinos ParaskevopoulosKonstantinos ParaskevopoulosChristoph TebbeChristoph TebbeFabien NoguéNils RostoksNils RostoksHuw JonesHuw JonesPhilippe GuercheJeremy SweetJeremy SweetMikołaj Antoni GralakMikołaj Antoni Gralak

subject

040301 veterinary sciencesVeterinary (miscellaneous)[SDV]Life Sciences [q-bio]2405 Parasitology28‐day studyPlant ScienceTP1-1185010501 environmental sciencesBody weight01 natural sciencesMicrobiology0403 veterinary scienceimport and processing1110 Plant ScienceEuropean commissionTX341-6411106 Food Science0105 earth and related environmental sciences2. Zero hungerGenetically modified maizebusiness.industryNutrition. Foods and food supplyGMOChemical technology2404 Microbiologyfungi10079 Institute of Veterinary Pharmacology and Toxicology04 agricultural and veterinary sciencesfood and feed safetyeCry3.1AbBiotechnologyCrop protection3401 Veterinary (miscellaneous)Scientific OpinionSettore AGR/11 - Entomologia Generale E Applicata570 Life sciences; biologyAnimal Science and ZoologyParasitologymaize 53071103 Animal Science and Zoologybusiness28-day studyFood Science

description

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.

https://hal.archives-ouvertes.fr/hal-02187475