Scientific Opinion on an application by Dow AgroSciences LLC (EFSA-GMO-NL-2011-91) for the placing on the market of genetically modified herbicide-tolerant soybean DAS-68416-4 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

被引:5
作者
Naegeli, Hanspeter
Birch, Andrew Nicholas
Casacuberta, Josep
De Schrijver, Adinda
Gralak, Mikofaj Antoni
Jones, Huw
Manachini, Barbara
Messean, Antoine
Nielsen, Elsa Ebbesen
Nogue, Fabien
Robaglia, Christophe
Rostoks, Nils
Sweet, Jeremy
Tebbe, Christoph
Visioli, Francesco
Wal, Jean-Michel
Ardizzone, Michele
Devos, Yann
Gomes, Ana
Liu, Yi
Neri, Franco Maria
Olaru, Irina
机构
基金
英国生物技术与生命科学研究理事会;
关键词
GMO; soybean (Glycine max); DAS-68416-4; herbicide tolerance; AAD-12; PAT; Regulation (EC) No 1829/2003; ENVIRONMENTAL MONITORING PMEM; NATURAL CROSS-POLLINATION; GENERAL SURVEILLANCE; GLYCINE-MAX; LECTINS; SEEDS; RAW; CULTIVARS; GUIDANCE; REGION;
D O I
10.2903/j.efsa.2017.4719
中图分类号
TS2 [食品工业];
学科分类号
0832 ;
摘要
Soybean DAS-68416-4 was developed by Agrobacterium tumefaciens-mediated transformation to express the aryloxyalkanoate dioxygenase-12 (AAD-12) protein, conferring tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and other related phenoxy herbicides, and the phosphinothricin acetyltransferase (PAT) protein, conferring tolerance to glufosinate ammonium-based herbicides. The molecular characterisation data and bioinformatics analyses did not identify issues requiring further assessment for food/feed safety. The agronomic and phenotypic characteristics tested revealed no relevant differences between soybean DAS-68416-4 and its conventional counterpart, except for 'days to 50% flowering'. The compositional analysis identified no differences requiring further assessment, except for an increase (up to 36%) in lectin activity in soybean DAS-68416-4. Such increase is unlikely to raise additional concerns for food/feed safety and nutrition for soybean DAS-68416-4 as compared to its conventional counterpart and the non-GM reference varieties. There were no concerns regarding the potential toxicity and allergenicity of the two newly expressed proteins, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean DAS-68416-4. Soybean DAS-68416-4 is as nutritious as its conventional counterpart and the non-GM reference varieties. There are no indications of an increased likelihood of establishment and spread of occasional feral soybean DAS-68416-4 plants, unless these are exposed to the intended herbicides. The likelihood of environmental effects resulting from the accidental release of viable seeds from soybean DAS-68416-4 into the environment is therefore very low. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS-68416-4. The GMO Panel concludes that the information available addresses the scientific comments of the Member States and that soybean DAS-68416-4, as described in this application, is as safe as its conventional counterpart and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
引用
收藏
页数:31
相关论文
共 50 条
[41]   Scientific Opinion on application (EFSA-GMO-UK-2007-49) for the placing on the market of the insect resistant and herbicide tolerant genetically modified maize Bt11xGA21 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Seeds [J].
Andersson, Hans Christer ;
Arpaia, Salvatore ;
Bartsch, Detlef ;
Casacuberta, Josep ;
Davies, Howard ;
du Jardin, Patrick ;
Flachowsky, Gerhard ;
Herman, Lieve ;
Jones, Huw ;
Karenlampi, Sirpa ;
Kiss, Jozsef ;
Kleter, Gijs ;
Kuiper, Harry ;
Messean, Antoine ;
Nielsen, Kaare Magne ;
Perry, Joe ;
Poeting, Annette ;
Sweet, Jeremy ;
Tebbe, Christoph ;
von Wright, Atte Johannes ;
Wal, Jean-Michel .
EFSA JOURNAL, 2009, 7 (09)
[42]   Application (Reference EFSA-GMO-NL-2005-15) for the placing on the market of the insect-resistant and herbicide-tolerant genetically modified maize 1507 x 59122, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Mycogen Seeds, c/o Dow AgroSciences LLC and Pioneer Hi-Bred International, Inc. as represented by Pioneer Overseas Corporation [J].
Andersson, Hans Christer ;
Arpaia, Salvatore ;
Bartsch, Detlef ;
Casacuberta, Josep ;
Davies, Howard ;
Herman, Lieve ;
Du Jardin, Patrick ;
Hendriksen, Niels ;
Kaerenlampi, Sirpa ;
Kiss, Jozsef ;
Kleter, Gijs ;
Kryspin-Sorensen, Ilona ;
Kuiper, Harry ;
Nes, Ingolf ;
Panopoulos, Nickolas ;
Perry, Joe ;
Poeting, Annette ;
Schiemann, Joachim ;
Seinen, Willem ;
Sweet, Jeremy ;
Wal, Jean-Michel .
EFSA JOURNAL, 2009, 7 (05)
[43]   Scientific Opinion on application (EFSA-GMO-NL-2007-38) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MON89034 x NK603 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto1 EFSA Panel on Genetically Modified Organisms (GMO)(2,3) [J].
Andersson, Hans Christer ;
Arpaia, Salvatore ;
Bartsch, Detlef ;
Casacuberta, Josep ;
Davies, Howard ;
du Jardin, Patrick ;
Flachowsky, Gerhard ;
Herman, Lieve ;
Jones, Huw ;
Karenlampi, Sirpa ;
Kiss, Jozsef ;
Kleter, Gijs ;
Kuiper, Harry ;
Messean, Antoine ;
Nielsen, Kaare Magne ;
Perry, Joe ;
Poeting, Annette ;
Sweet, Jeremy ;
Tebbe, Christoph ;
von Wright, Atte Johannes ;
Wal, Jean-Michel .
EFSA JOURNAL, 2009, 7 (09)
[44]   Assessment of genetically modified maize MON 87403 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA-GMO-BE-2015-125) [J].
Naegeli, Hanspeter ;
Birch, Andrew Nicholas ;
Casacuberta, Josep ;
De Schrijver, Adinda ;
Gralak, Mikolaj Antoni ;
Guerche, Philippe ;
Jones, Huw ;
Manachini, Barbara ;
Messean, Antoine ;
Nielsen, Elsa Ebbesen ;
Nogue, Fabien ;
Robaglia, Christophe ;
Rostoks, Nils ;
Sweet, Jeremy ;
Tebbe, Christoph ;
Visioli, Francesco ;
Wal, Jean-Michel ;
Devos, Yann ;
Broll, Hermann ;
Ramon, Matthew .
EFSA JOURNAL, 2018, 16 (03)
[45]   Statement complementing the EFSA Scientific Opinion on the assessment of genetically modified oilseed rape MS11 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA-GMO-BE-2016-138) [J].
Mullins, Ewen ;
Bresson, Jean-Louis ;
Dalmay, Tamas ;
Dewhurst, Ian Crawford ;
Epstein, Michelle M. ;
Firbank, Leslie George ;
Guerche, Philippe ;
Hejatko, Jan ;
Naegeli, Hanspeter ;
Moreno, Francisco Javier ;
Nogue, Fabien ;
Rostoks, Nils ;
Serrano, Jose Juan Sanchez ;
Savoini, Giovanni ;
Veromann, Eve ;
Veronesi, Fabio ;
Gennaro, Andrea ;
Neri, Franco Maria .
EFSA JOURNAL, 2022, 20 (03)
[46]   Opinion of the Scientific Panel on Genetically Modified Organisms on an application (Reference EFSA-GMO-NL-2005-12) for the placing on the market of insect-resistant genetically modified maize 59122, for food and feed uses, import and processing under Regulation (EC) No 1829/2003, from Pioneer Hi -Bred International, Inc. and Mycogen Seeds, c/o Dow Agrosciences LLC. [J].
Andersson, Hans Christer ;
Arpaia, Salvatore ;
Bartsch, Detlef ;
Casacuberta, Josep ;
Davies, Howard ;
Herman, Lieve ;
De Loose, Marc ;
Hendriksen, Niels ;
Karenlampi, Sirpa ;
Kiss, Jozsef ;
Kryspin-Sorensen, Ilona ;
Kuiper, Harry ;
Nes, Ingolf ;
Panopoulos, Nickolas ;
Perry, Joe ;
Poting, Annette ;
Schiemann, Joachim ;
Seinen, Willem ;
Sweet, Jeremy ;
Wal, Jean-Michel .
EFSA JOURNAL, 2007, 5 (04)
[47]   Scientific Opinion on application (EFSA-GMO-DE-2010-82) for the placing on the market of insect-resistant genetically modified maize MIR162 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta EFSA Panel on Genetically Modified Organisms (GMO) [J].
Andersson, Hans Christer ;
Arpaia, Salvatore ;
Bartsch, Detlef ;
Casacuberta, Josep ;
Davies, Howard ;
du Jardin, Patrick ;
Flachowsky, Gerhard ;
Herman, Lieve ;
Jones, Huw ;
Karenlampi, Sirpa ;
Kiss, Jozsef ;
Kleter, Gijs ;
Kuiper, Harry ;
Messean, Antoine ;
Nielsen, Kaare Magne ;
Perry, Joe ;
Poting, Annette ;
Sweet, Jeremy ;
Tebbe, Christoph ;
von Wright, Atte Johannes ;
Wal, Jean-Michel .
EFSA JOURNAL, 2012, 10 (06)
[48]   Scientific Opinion on application (EFSA-GMO-UK-2007-48) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MIR604 x GA21 for food and feed uses, import and processing under Regulation (EC) No 1829/ 2003 from Syngenta Seeds [J].
Andersson, Hans Christer ;
Arpaia, Salvatore ;
Bartsch, Detlef ;
Casacuberta, Josep ;
Davies, Howard ;
du Jardin, Patrick ;
Flachowsky, Gerhard ;
Herman, Lieve ;
Jones, Huw ;
Karenlampi, Sirpa ;
Kiss, Jozsef ;
Kleter, Gijs ;
Kuiper, Harry ;
Messean, Antoine ;
Nielsen, Kaare Magne ;
Perry, Joe ;
Poeting, Annette ;
Sweet, Jeremy ;
Tebbe, Christoph ;
von Wright, Atte Johannes ;
Wal, Jean-Michel .
EFSA JOURNAL, 2010, 8 (05)
[49]   Scientific Opinion on application (EFSA-GMO-NL-2005-16) for the placing on the market of insect resistant genetically modified cotton (Gossypium hirsutum L.) 281-24-236 x 3006-210-23 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Dow AgroSciences [J].
Andersson, Hans Christer ;
Arpaia, Salvatore ;
Bartsch, Detlef ;
Casacuberta, Josep ;
Davies, Howard ;
du Jardin, Patrick ;
Flachowsky, Gerhard ;
Herman, Lieve ;
Jones, Huw ;
Karenlampi, Sirpa ;
Kiss, Jozsef ;
Kleter, Gijs ;
Kuiper, Harry ;
Messean, Antoine ;
Nielsen, Kaare Magne ;
Perry, Joe ;
Poeting, Annette ;
Sweet, Jeremy ;
Tebbe, Christoph ;
von Wright, Atte Johannes ;
Wal, Jean-Michel .
EFSA JOURNAL, 2010, 8 (06)
[50]   Assessment of genetically modified soybean MON 87708 x MON 89788 x A5547-127, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2016-135) [J].
Naegeli, Hanspeter ;
Bresson, Jean-Louis ;
Dalmay, Tamas ;
Dewhurst, Ian Crawford ;
Epstein, Michele ;
Firbank, Leslie George ;
Guerche, Philippe ;
Hejatko, Jan ;
Moreno, Francisco Javier ;
Mullins, Ewen ;
Nogue, Fabien ;
Rostoks, Nils ;
Serrano, Jose Juan Sanchez ;
Savoini, Giovanni ;
Veromann, Eve ;
Veronesi, Fabio ;
Alvarez, Fernando ;
Dumont, Antonio Fernandez ;
Papadopoulou, Nikoletta ;
Ardizzone, Michele ;
Devos, Yann ;
Gennaro, Andrea ;
Gomez, Jose Angel Ruiz ;
Lanzoni, Anna ;
Neri, Franco Maria ;
Paraskevopoulos, Konstantinos ;
Raffaello, Tommaso ;
De Sanctis, Giacomo .
EFSA JOURNAL, 2019, 17 (07)