Scientific Opinion on applications (EFSA‐GMO‐RX‐40‐3‐2[8‐1a/20‐1a], EFSA‐GMO‐RX‐40‐3‐2) for renewal of authorisation for the continued marketing of (1) food containing, consisting of, or produced from genetically modified soybean 40‐3‐2; (2) feed containing, consisting of, or produced from soybean 40‐3‐2; (3) other products containing or consisting of soybean 40‐3‐2 with the exception of cultivation, all under Regulation (EC) No 1829/2003 from Monsanto
2010; Wiley; Volume: 8; Issue: 12 Linguagem: Inglês
10.2903/j.efsa.2010.1908
ISSN1831-4732
Tópico(s)Insect Resistance and Genetics
ResumoEFSA JournalVolume 8, Issue 12 1908 OpinionOpen Access Scientific Opinion on applications (EFSA-GMO-RX-40-3-2[8-1a/20-1a], EFSA-GMO-RX-40-3-2) for renewal of authorisation for the continued marketing of (1) food containing, consisting of, or produced from genetically modified soybean 40-3-2; (2) feed containing, consisting of, or produced from soybean 40-3-2; (3) other products containing or consisting of soybean 40-3-2 with the exception of cultivation, all under Regulation (EC) No 1829/2003 from Monsanto EFSA Panel on Genetically Modified Organisms (GMO), EFSA Panel on Genetically Modified Organisms (GMO)Search for more papers by this author EFSA Panel on Genetically Modified Organisms (GMO), EFSA Panel on Genetically Modified Organisms (GMO)Search for more papers by this author First published: 01 December 2010 https://doi.org/10.2903/j.efsa.2010.1908Citations: 4 Panel members: Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel Wal Correspondence: gmo@efsa.europa.eu Acknowledgement: The Panel wishes to thank the members of the Working Group on Molecular Characterisation, Food and Feed and Environment for the preparatory work on this scientific opinion, Boet Glandorf, Niels Hendriksen as external experts and EFSA's staff members Zoltán Divéki (MC), Karine Lheureux (ENV) and Claudia Paoletti (FF) for the support provided to this EFSA scientific opinion. Adoption date: 10 November 2010 Published date: 1 December 2010 Question number: EFSA-Q-2007-141, EFSA-Q-2007-142 On request from: European Commission AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract This scientific opinion is an evaluation of a risk assessment for the renewal of authorisations for continued marketing of the genetically modified herbicide tolerant soybean 40-3-2 (Unique Identifier MON-Ø4Ø32-6) for (1) food containing, consisting of, or produced from genetically modified (GM) soybean 40-3-2; (2) feed containing, consisting of, or produced from soybean 40-3-2; and (3) of other products containing or consisting of soybean 40-3-2 with the exception of cultivation. Soybean 40-3-2 has been developed for tolerance to glyphosate herbicides by the introduction, via particle gun acceleration technology, of a gene coding for 5-enolpyruvylshikimate-3-phosphate synthase from Agrobacterium sp. strain CP4 (CP4 EPSPS). Molecular analyses indicated that soybean 40-3-2 contains one functional insert expressing CP4 EPSPS and a non-functional insert consisting of a fragment of the CP4 EPSPS coding sequence. Updated bioinformatic analyses of the flanking sequences and the open reading frames spanning the insert-plant DNA junctions and the levels of the newly expressed protein in soybean 40-3-2 did not raise any safety concern. The stability of the inserted DNA was confirmed over several generations. Available compositional and agronomic data show that soybean 40-3-2 is compositionally and agronomically equivalent to its conventional counterpart and to other commercial soybean varieties, except for expressing the CP4 EPSPS protein. It is estimated that the European consumers have been exposed to soybean 40-3-2 mainly via soybean oil Processed meal of soybean 40-3-2 has been given to farm animals in the EU at an estimated maximum dietary inclusion levels around 21% for broiler chickens, 18% for pigs, and 12% for dairy cattle. No adverse effects have been linked to these exposures. The safety assessment of the CP4 EPSPS protein expressed in soybean 40-3-2 and the whole soybean plant identified no concerns regarding potential toxicity and allergenicity of soybean 40-3-2. Considering the intended uses of soybean 40-3-2, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of GM soybean 40-3-2 was required. In case of accidental release of viable grains produced by soybean 40-3-2 into the environment during transportation and processing, there are no indications of an increased likelihood of establishment and spread of feral soybean plants, except in the presence of the glyphosate herbicides. The EFSA GMO Panel considers unlikely that the recombinant DNA in soybean 40-3-2 transfers to bacteria and other micro-organisms and that the risk caused by a rare but theoretically possible transfer of the recombinant epsps gene from soybean 40-3-2 to environmental microorganisms is regarded to be negligible due to the lack of a selective advantage in the context of its intended use that would be conferred. Taking into account the scope of the application, the rare occurrence of feral soybean plants and the low levels of exposure through other routes, indicate that the risk to non-target organisms is extremely low. 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