Assessment of genetically modified maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2017‐139)
2021; Wiley; Volume: 19; Issue: 1 Linguagem: Inglês
10.2903/j.efsa.2021.6351
ISSN1831-4732
AutoresHanspeter Naegeli, Jean‐Louis Bresson, Tamás Dalmay, Ian Crawford Dewhurst, M. Epstein, Leslie George Firbank, Philippe Guerche, Jan Hejátko, F. Javier Moreno, Ewen Mullins, Fabien Nogué, Nils Rostoks, Jose Juan Sánchez Serrano, G. Savoini, Eve Veromann, Fabio Veronesi, Fernando Álvarez, Michele Ardizzone, Giacomo De Sanctis, Antonio Fernandez, Andrea Gennaro, José Ángel Gómez Ruiz, Dafni Maria Kagkli, Anna Lanzoni, Franco Maria Neri, Nikoletta Papadopoulou, Konstantinos Paraskevopoulos, Tommaso Raffaello,
Tópico(s)CRISPR and Genetic Engineering
ResumoEFSA JournalVolume 19, Issue 1 e06351 Scientific Opinion Open Access Assessment of genetically modified maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2017-139) EFSA Panel on Genetically Modified Organisms (GMO), Corresponding Author GMO_Secretariat_Applications@efsa.europa.eu Correspondence:GMO_Secretariat_Applications@efsa.europa.euSearch for more papers by this authorHanspeter Naegeli, Search for more papers by this authorJean–Louis Bresson, Search for more papers by this authorTamas Dalmay, Search for more papers by this authorIan Crawford Dewhurst, Search for more papers by this authorMichelle M Epstein, Search for more papers by this authorLeslie George Firbank, Search for more papers by this authorPhilippe Guerche, Search for more papers by this authorJan Hejatko, Search for more papers by this authorFrancisco Javier Moreno, Search for more papers by this authorEwen Mullins, Search for more papers by this authorFabien Nogué, Search for more papers by this authorNils Rostoks, Search for more papers by this authorJose Juan Sánchez Serrano, Search for more papers by this authorGiovanni Savoini, Search for more papers by this authorEve Veromann, Search for more papers by this authorFabio Veronesi, Search for more papers by this authorFernando Álvarez, Search for more papers by this authorMichele Ardizzone, Search for more papers by this authorGiacomo De Sanctis, Search for more papers by this authorAntonio Fernandez, Search for more papers by this authorAndrea Gennaro, Search for more papers by this authorJose Ángel Gómez Ruiz, Search for more papers by this authorDafni Maria Kagkli, Search for more papers by this authorAnna Lanzoni, Search for more papers by this authorFranco Maria Neri, Search for more papers by this authorNikoletta Papadopoulou, Search for more papers by this authorKonstantinos Paraskevopoulos, Search for more papers by this authorTommaso Raffaello, Search for more papers by this author EFSA Panel on Genetically Modified Organisms (GMO), Corresponding Author GMO_Secretariat_Applications@efsa.europa.eu Correspondence:GMO_Secretariat_Applications@efsa.europa.euSearch for more papers by this authorHanspeter Naegeli, Search for more papers by this authorJean–Louis Bresson, Search for more papers by this authorTamas Dalmay, Search for more papers by this authorIan Crawford Dewhurst, Search for more papers by this authorMichelle M Epstein, Search for more papers by this authorLeslie George Firbank, Search for more papers by this authorPhilippe Guerche, Search for more papers by this authorJan Hejatko, Search for more papers by this authorFrancisco Javier Moreno, Search for more papers by this authorEwen Mullins, Search for more papers by this authorFabien Nogué, Search for more papers by this authorNils Rostoks, Search for more papers by this authorJose Juan Sánchez Serrano, Search for more papers by this authorGiovanni Savoini, Search for more papers by this authorEve Veromann, Search for more papers by this authorFabio Veronesi, Search for more papers by this authorFernando Álvarez, Search for more papers by this authorMichele Ardizzone, Search for more papers by this authorGiacomo De Sanctis, Search for more papers by this authorAntonio Fernandez, Search for more papers by this authorAndrea Gennaro, Search for more papers by this authorJose Ángel Gómez Ruiz, Search for more papers by this authorDafni Maria Kagkli, Search for more papers by this authorAnna Lanzoni, Search for more papers by this authorFranco Maria Neri, Search for more papers by this authorNikoletta Papadopoulou, Search for more papers by this authorKonstantinos Paraskevopoulos, Search for more papers by this authorTommaso Raffaello, Search for more papers by this author First published: 19 January 2021 https://doi.org/10.2903/j.efsa.2021.6351 Requestor: European Commission Question number: EFSA-Q-2017-00115 Panel members: Hanspeter Naegeli, Jean-Louis Bresson, Tamas Dalmay, Ian Crawford Dewhurst, Michelle M Epstein, Leslie George Firbank, Philippe Guerche, Jan Hejatko, Francisco Javier Moreno, Ewen Mullins, Fabien Nogué, Nils Rostoks, Jose Juan Sánchez Serrano, Giovanni Savoini, Eve Veromann and Fabio Veronesi. Acknowledgements: The Panel wishes to thank the members of the Working Groups on Molecular Characterisation, Food and Feed Safety Assessment and Working Group on Comparative Analysis and Environmental Risk Assessment for the preparatory work on this scientific output and EFSA staff members Sonia Hernández Valero, Sylvie Mestdagh, Irene Muñoz-Guajardo and Lorenz Oberkofler for the support provided to this scientific output. Adopted: 25 November 2020 AboutSectionsPDF 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 onEmailFacebookTwitterLinked InRedditWechat Abstract Maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 (six-event stack maize) was produced by conventional crossing to combine six single events: MON 87427, MON 87460, MON 89034, 1507, MON 87411 and 59122. The GMO Panel previously assessed the six single maize events and 17 of the subcombinations and did not identify safety concerns. No new data on the single maize events or the 17 subcombinations were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins and dsRNA in the six-event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the six-event stack maize, as described in this application, is as safe as its non-GM comparator and the selected non-GM reference varieties. In the case of accidental release of viable grains of the six-event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the 39 maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the six–event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of the six-event stack maize. Post-market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the six-event stack maize and its subcombinations are as safe as the non-GM comparator and the selected non-GM reference varieties with respect to potential effects on human and animal health and the environment. Summary Following the submission of application EFSA-GMO-NL-2017-139 under Regulation (EC) No 1829/2003 from Monsanto Company (referred to hereafter as 'the applicant'), the Panel on Genetically Modified Organisms of the European Food Safety Authority (referred to hereafter as 'GMO Panel') was asked to deliver a Scientific Opinion on the safety of genetically modified (GM) glufosinate and glyphosate tolerant, insect resistant and drought tolerant maize (Zea mays L.) MON 87427 × MON 87460 ×MON 89034 × 1507 × MON 87411 × 59122 (referred to hereafter as 'six-event stack maize') and its subcombinations independently of their origin, according to Regulation (EU) No 503/2013 (referred to hereafter as 'subcombinations'). The scope of application EFSA-GMO-NL-2017-139 is for import, processing, and food and feed uses within the European Union (EU) of maize MON 87427 ×MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 and all its subcombinations independently of their origin, and does not include cultivation in the EU. The term 'subcombination' refers to any combination of up to five of the events present in the six-event stack maize. The safety of subcombinations occurring as segregating progeny in the harvested grains of maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 is evaluated in the context of the assessment of the six-event stack maize. The safety of subcombinations that have either been or could be produced by conventional crossing through targeted breeding approaches, and which can be bred, produced and marketed independently of the six-event stack, are risk assessed separately in the present scientific opinion. The six-event stack maize was produced by conventional crossing to combine six single maize events: MON 87427 expressing the 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) protein to confer tolerance to glyphosate-containing herbicides; MON 87460 expressing the cold shock protein B (CspB) (to confer drought tolerance) and the neomycin phosphotransferase II protein (NPTII) (used as a selectable marker); MON 89034 expressing the Cry1A.105 and Cry2Ab2 proteins (for protection against certain lepidopteran pests); 1507 expressing the Cry1F protein (for protection against certain lepidopteran pests) and the PAT protein (for tolerance to glufosinate-ammonium-containing herbicides); MON 87411 expressing the Cry3Bb1 protein and the DvSnf7 dsRNA (for protection against certain coleopteran pests) and the CP4 EPSPS protein (for tolerance to glyphosate-containing herbicides); and 59122 expressing the Cry34Ab1 and Cry35Ab1 proteins (for protection against certain coleopteran pests) and the PAT protein. The GMO Panel evaluated the six-event stack maize and its subcombinations with reference to the scope and appropriate principles described in its applicable guidelines for the risk assessment of GM plants and the post-market environmental monitoring. The GMO Panel considered the information submitted in application EFSA-GMO-NL-2017-139, additional information provided by the applicant during the risk assessment, the scientific comments submitted by the Member States and the relevant scientific literature. For application EFSA-GMO-NL-2017-139, previous assessments of the six single events (MON 87427, MON 87460, MON 89034, 1507, MON 87411 and 59122), and 17 of the subcombinations provided a basis for the assessment of the six-event stack maize and all its subcombinations. No safety concerns were identified by the GMO Panel in the previous assessments. No safety issue concerning the six single maize events was identified by the updated bioinformatic analyses, nor reported by the applicant since the publication of the previous GMO Panel scientific opinions. Therefore, the GMO Panel considers that its previous conclusions on the safety of the single maize events remain valid. For the six-event stack maize, the risk assessment included the molecular characterisation of the inserted DNA and analysis of protein expression. An evaluation of the comparative analysis of agronomic, phenotypic and compositional characteristics was carried out, and the safety of the newly expressed proteins, of the dsRNAs and the whole food and feed were evaluated with respect to potential toxicity, allergenicity and nutritional characteristics. Environmental impacts and post-market environmental monitoring (PMEM) plan were also evaluated. The molecular characterisation data establish that the events stacked in maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 have retained their integrity. Protein expression analysis showed that the levels of the newly expressed proteins are similar in the six-event stack maize and in the single events, except for CP4 EPSPS and PAT protein levels that are expected to be different because of the combination of events MON 87427 and MON 87411 (both producing CP4 EPSPS) and events 1507 and 59122 (both producing PAT) in the in the six-event stack maize. In addition, the provided data indicate that there is no impact of the dsRNAs on the expression levels of the newly expressed proteins. No indications were identified of interactions that may affect the integrity of the events and the levels of the newly expressed proteins in this six–event stack maize. The comparative analysis of agronomic and phenotypic characteristics and grain and forage composition identified no differences between maize MON 87427 × MON 87460 ×MON 89034 × 1507 × MON 87411 × 59122 and the non-GM comparator that required further assessment except for the changes in root lodged plants, in levels of acid detergent fibre (ADF) in forage and in levels of protein, arginine, glycine, leucine, lysine and manganese in grain. These changes were further assessed for food/feed safety and environmental impact and raised no concern. The molecular characterisation, the comparative analysis and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins and dsRNA in the six-event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122, as described in this application, is as safe as the non-GM comparator and the selected commercial non-GM maize reference varieties (referred to hereafter as non-GM reference varieties). Considering the combined events and their potential interactions, the outcome of the comparative analysis, and the routes and levels of exposure, the GMO Panel concludes that maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 would not raise safety concerns in the case of accidental release of viable GM maize grains into the environment. Since no new safety concerns were identified for the 17 previously assessed subcombinations, and no new data leading to the modification of the original conclusions on safety were identified, the GMO Panel considers that its previous conclusions on these maize subcombinations remain valid. For the remaining 39 subcombinations included in the scope of application EFSA-GMO-NL-2017-139, no experimental data were provided. The GMO Panel assessed the possibility of interactions between the events in the 39 subcombinations and concludes that these subcombinations would not raise safety concerns. These subcombinations are therefore expected to be as safe as the single events, the previously assessed subcombinations and the six-event stack maize. Given the absence of safety concerns for foods and feeds from maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 and its subcombinations, the GMO Panel considers that post–market monitoring of these products is not necessary. The PMEM plan and reporting intervals are in line with the intended uses of the six-event stack maize and its subcombinations. The literature searches did not identify any relevant publications on maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122. In the context of annual PMEM reports, the applicant could further fine tune future literature searches according to the GMO Panel recommendations provided in this scientific opinion. The GMO Panel concludes that maize MON 87427 × MON 87460 × MON 89034 × 1507 ×MON 87411 × 59122 and its subcombinations, as described in this application, are as safe as the non-GM comparator and the selected non-GM reference varieties with respect to potential effects on human and animal health and the environment. 1 Introduction The scope of application EFSA-GMO-NL-2017-139 is for food and feed uses, import and processing within the European Union (EU) of the genetically modified (GM) herbicide-tolerant, insect-resistant and drought-tolerant maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 ×59122 and all its subcombinations independently of their origin and does not include cultivation in EU. 1.1 Background On 21 February 2017, the European Food Safety Authority (EFSA) received from the Competent Authority of The Netherlands application EFSA-GMO-NL-2017-139 for authorisation of maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 (hereafter referred to as 'the six-event stack maize') (Unique Identifier MON-87427-7 × MON-8746Ø-4 × MON-89Ø34-3 ×DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7), submitted by Monsanto Europe S.A. (hereafter referred to as 'the applicant') according to Regulation (EC) No 1829/200311 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. OJ L 268, 18.10.2003, p. 1–23. . Following receipt of application EFSA-GMO-NL-2017-139, EFSA informed the Member States (MS) and the European Commission and made the summary of the application available to the public on the EFSA website.22 Available online at the EFSA Register of Questions: http://registerofquestions.efsa.europa.eu/roqFrontend/questionDocumentsLoader?question=EFSA-Q-2017-00115 EFSA checked the application for compliance with the relevant requirements of Regulation (EC) No 1829/2003 and Regulation (EU) No 503/201333 Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorization of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006. OJ L157, 8.6.2013, p. 1–48. and, when needed, asked the applicant to supplement the initial application. On 31 May 2017, EFSA declared the application valid and made the application available to MS and the EC. From the validity date, EFSA and its scientific Panel on Genetically Modified Organisms (hereafter referred to as 'the GMO Panel') endeavoured to respect a time limit of 6 months to issue a scientific opinion on application EFSA-GMO-NL-2017-139. Such time limit was extended whenever EFSA and/or its GMO Panel requested supplementary information to the applicant. According to Regulation (EC) No 1829/2003, any supplementary information provided by the applicant during the risk assessment was made available to the EU MS and European Commission (for further details, see the section 'Documentation', below). In accordance with Regulation (EC) No 1829/2003, EFSA consulted the nominated risk assessment bodies of EU Member States, including national Competent Authorities within the meaning of Directive 2001/18/EC44 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. OJ L 106, 12.3.2001, p. 1–38. . The EU Member States had three months to make their opinion known on application EFSA-GMO-NL-2017-139 as of date of validity. 1.2 Terms of Reference as provided by the requestor According to Articles 6 and 18 of Regulation (EC) No 1829/2003, EFSA and its GMO Panel were requested to carry out a scientific risk assessment of maize MON 87427 × MON 87460 ×MON 89034 × 1507 × MON 87411 × 59122 and all its subcombinations independently of their origin according to the of application EFSA-GMO-NL-2017-139. According to Regulation (EC) No 1829/2003, this scientific opinion is to be seen as the report requested under Articles 6(6) and 18(6) of that Regulation including the opinions of the nominated risk assessment bodies of EU Member States.55 Opinions of the nominated risk assessment bodies of EU Member States can be found at the EFSA Register of Questions (http://registerofquestions.efsa.europa.eu/roqFrontend/login), querying the assigned Question Number. In addition to the present scientific opinion, EFSA and its GMO Panel were also asked to report on the particulars listed under Articles 6(5) and 18(5) of Regulation (EC) No 1829/2003. The relevant information is made available in the EFSA Register of Questions,2 including the information required under Annex II to the Cartagena Protocol, a labelling proposal, a post-market environmental monitoring (PMEM) plan as provided by the applicant; the methods, validated by the Community reference laboratory, for detection, including sampling, identification of the transformation events in the food-feed and/or foods-feeds produced from it and the appropriate reference materials. 2 Data and methodologies 2.1 Data The GMO Panel based its scientific assessment of maize MON 87427 × MON 87460 ×MON 89034 × 1507 × MON 87411 × 59122 on the valid application EFSA-GMO-NL-2017-139, additional information provided by the applicant during the risk assessment, relevant scientific comments submitted by EU MS and relevant peer-reviewed scientific publications. As part of this comprehensive information package, the GMO Panel received additional unpublished studies submitted by the applicant in order to comply with the specific provisions of Regulation (EU) No 503/2013. A list of these additional unpublished studies is provided in Appendix A. 2.2 Methodologies The GMO Panel conducted its assessment in line with the principles described in Regulation (EU) No 503/2013, its applicable guidelines (EFSA GMO Panel, 2010a, 2011a,b, 2015a), explanatory notes and statements (EFSA GMO Panel, 2010b; EFSA, 2014, 2017a,b, 2019) for the risk assessment of GM plants. During its risk assessment the GMO Panel considered all additional unpublished studies as listed in Appendix A for potential effects on human and animal health and the environment. For the assessment of 90-day animal feeding studies, the GMO Panel took into account the criteria included in the EFSA guidance (EFSA Scientific Committee, 2011) and the explanatory statement for its applicability (EFSA, 2014). The GMO Panel also assessed the applicant's literature searches, which include a scoping review, in accordance with the recommendations on literature searching outlined in EFSA (2010, 2017a). In the frame of the contracts OC/EFSA/GMO/2014/01 and OC/EFSA/GMO/2018/02 contractors performed preparatory work and delivered report on the methods applied by the applicant in performing statistical and toxicological analyses, respectively. 3 Assessment 3.1 Introduction Application EFSA-GMO-NL-2017-139 covers the six-event stack maize MON 87427 × MON 87460 ×MON 89034 × 1507 × MON 87411 × 59122 and all its 56 subcombinations independently of their origin (Table 1). Table 1. Stacked maize events covered by the scope of application EFSA-GMO-NL-2017-139 Degree of stacking Event Unique identifiers Six-event stack MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 MON-87427-7 × MON-8746Ø-4 × MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7 Five-event stack 59122 × MON 89034 × MON 87460 × MON 87427 × MON 87411 DAS-59122-7 × MON-89Ø34-3 × MON-8746Ø-4 × MON-87427-7 × MON-87411-9 1507 × MON 89034 × MON 87460 × MON 87427 × MON 87411 DAS-Ø15Ø7-1 × MON-89Ø34-3 × MON-8746Ø-4 × MON-87427-7 × MON-87411-9 1507 × 59122 × MON 87460 × MON 87427 × MON 87411 DAS-Ø15Ø7-1 × DAS-59122-7 × MON-8746Ø-4 × MON-87427-7 × MON-87411-9 1507 × 59122 × MON 89034 × MON 87427 × MON 87411 DAS-Ø15Ø7-1 × DAS-59122-7 × MON-89Ø34-3 × MON-87427-7 × MON-87411-9 1507 × 59122 × MON 89034 × MON 87460 × MON 87411 DAS-Ø15Ø7-1 × DAS-59122-7 × MON-89Ø34-3 × MON-8746Ø-4 × MON-87411-9 1507 × 59122 × MON 89034 × MON 87460 × MON 87427 DAS-Ø15Ø7-1 × DAS-59122-7 × MON-89Ø34-3 × MON-8746Ø-4 × MON-87427-7 Four-event stack MON 89034 × MON 87460 × MON 87427 × MON 87411 MON-89Ø34-3 × MON-8746Ø-4 × MON-87427-7 × MON-87411-9 59122 × MON 87460 × MON 87427 × MON 87411 DAS-59122-7 × MON-8746Ø-4 × MON-87427-7 × MON-87411-9 59122 × MON 89034 × MON 87427 × MON 87411 DAS-59122-7 × MON-89Ø34-3 × MON-87427-7 × MON-87411-9 59122 × MON 89034 × MON 87460 × MON 87411 DAS-59122-7 × MON-89Ø34-3 × MON-8746Ø-4 × MON-87411-9 59122 × MON 89034 × MON 87460 × MON 87427 DAS-59122-7 × MON-89Ø34-3 × MON-8746Ø-4 × MON-87427-7 1507 × MON 87460 × MON 87427 × MON 87411 DAS-Ø15Ø7-1 × MON-8746Ø-4 × MON-87427-7 × MON-87411-9 1507 × MON 89034 × MON 87427 × MON 87411 DAS-Ø15Ø7-1 × MON-89Ø34-3 × MON-87427-7 × MON-87411-9 1507 × MON 89034 × MON 87460 × MON 87411 DAS-Ø15Ø7-1 × MON-89Ø34-3 × MON-8746Ø-4 × MON-87411-9 1507 × MON 89034 × MON 87460 × MON 87427 DAS-Ø15Ø7-1 × MON-89Ø34-3 × MON-8746Ø-4 × MON-87427-7 1507 × 59122 × MON 87427 × MON 87411 DAS-Ø15Ø7-1 × DAS-59122-7 × MON-87427-7 × MON-87411-9 1507 × 59122 × MON 87460 × MON 87411 DAS-Ø15Ø7-1 × DAS-59122-7 × MON-8746Ø-4 × MON-87411-9 1507 × 59122 × MON 87460 × MON 87427 DAS-Ø15Ø7-1 × DAS-59122-7 × MON-8746Ø-4 × MON-87427-7 1507 × 59122 × MON 89034 × MON 87411 DAS-Ø15Ø7-1 × DAS-59122-7 × MON-89Ø34-3 × MON-87411-9 1507 × 59122 × MON 89034 × MON 87427 DAS-Ø15Ø7-1 × DAS-59122-7 × MON-89Ø34-3 × MON-87427-7 1507 × 59122 × MON 89034 × MON 87460 DAS-Ø15Ø7-1 × DAS-59122-7 × MON-89Ø34-3 × MON-8746Ø-4 Three-event stack MON 87460 × MON 87427 × MON 87411 MON-8746Ø-4 × MON-87427-7 × MON-87411-9 MON 89034 × MON 87427 × MON 87411 MON-89Ø34-3 × MON-87427-7 × MON-87411-9 MON 89034 × MON 87460 × MON 87411 MON-89Ø34-3 × MON-8746Ø-4 × MON-87411-9 MON 89034 × MON 87460 × MON 87427 MON-89Ø34-3 × MON-8746Ø-4 × MON-87427-7 59122 × MON 87427 × MON 87411 DAS-59122-7 × MON-87427-7 × MON-87411-9 59122 × MON 87460 × MON 87411 DAS-59122-7 × MON-8746Ø-4 × MON-87411-9 59122 × MON 87460 × MON 87427 DAS-59122-7 × MON-8746Ø-4 × MON-87427-7 59122 × MON 89034 × MON 87411 DAS-59122-7 × MON-89Ø34-3 × MON-87411-9 59122 × MON 89034 × MON 87427 DAS-59122-7 × MON-89Ø34-3 × MON-87427-7 59122 × MON 89034 × MON 87460 DAS-59122-7 × MON-89Ø34-3 × MON-8746Ø-4 1507 × MON 87427 × MON 87411 DAS-Ø15Ø7-1 × MON-87427-7 × MON-87411-9 1507 × MON 87460 × MON 87411 DAS-Ø15Ø7-1 × MON-8746Ø-4 × MON-87411-9 1507 × MON 87460 × MON 87427 DAS-Ø15Ø7-1 × MON-8746Ø-4 × MON-87427-7 1507 × MON 89034 × MON 87411 DAS-Ø15Ø7-1 × MON-89Ø34-3 × MON-87411-9 1507 × MON 89034 × MON 87427 DAS-Ø15Ø7-1 × MON-89Ø34-3 × MON-87427-7 1507 × MON 89034 × MON 87460 DAS-Ø15Ø7-1 × MON-89Ø34-3 × MON-8746Ø-4 1507 × 59122 × MON 87411 DAS-Ø15Ø7-1 × DAS-59122-7 × MON-87411-9 1507 × 59122 × MON 87427 DAS-Ø15Ø7-1 × DAS-59122-7 × MON-87427-7 1507 × 59122 × MON 87460 DAS-Ø15Ø7-1 × DAS-59122-7 × MON-8746Ø-4 1507 × 59122 × MON 89034 DAS-Ø15Ø7-1 × DAS-59122-7 × MON-89Ø34-3 Two-event stack MON 87427 × MON 87411 MON-87427-7 × MON-87411-9 MON 87460 × MON 87411 MON-8746Ø-4 × MON-87411-9 MON 87460 × MON 87427 MON-8746Ø-4 × MON-87427-7 MON 89034 × MON 87411 MON-89Ø34-3 × MON-87411-9 MON 89034 × MON 87427 MON-89Ø34-3 × MON-87427-7 MON 89034 × MON 87460 MON-89Ø34-3 × MON-8746Ø-4 59122 × MON 87411 DAS-59122-7 × MON-87411-9 59122 × MON 87427 DAS-59122-7 × MON-87427-7 59122 × MON 87460 DAS-59122-7 × MON-8746Ø-4 59122 × MON 89034 DAS-59122-7 × MON-89Ø34-3 1507 × MON 87411 DAS-Ø15Ø7-1 × MON-87411-9 1507 × MON 87427 DAS-Ø15Ø7-1 × MON-87427-7 1507 × MON 87460 DAS-Ø15Ø7-1 × MON-8746Ø-4 1507 × MON 89034 DAS-Ø15Ø7-1 × MON-89Ø34-3 1507 × 59122 DAS-Ø15Ø7-1 × DAS-59122-7 The term 'subcombination' refers to any combination of up to five of the maize events MON 87427, MON 87460, MON 89034, 1507, MON 87411 and 59122. The safety of subcombinations occurring as segregating progeny in harvested grains of maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 is evaluated in the context of the assessment of the six-event stack maize in Section 3.5 of the present scientific opinion. 'Subcombination' also covers combinations that have either been or could be produced by conventional crossing through targeted breeding approaches (EFSA GMO Panel, 2011a). These are maize stacks that can be bred, produced and marketed independently of the six-event stack maize. These subcombinations are assessed in Section 3.5 of this scientific opinion. The six-event stack maize was produced by conventional crossing to combine six single maize events: MON 87427 expressing the 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) protein to confer tolerance to glyphosate-containing herbicides; MON 87460 expressing the cold shock protein B (CspB) to confer drought tolerance and expressing the neomycin phosphotransferase II protein (NPTII) used as selectable marker to facilitate the selection process of transformed plant cells; MON 89034 expressing the Cry1A.105 and Cry2Ab2 proteins to confer protection against certain lepidopteran pests; 1507 expressing the Cry1F protein to confer protection against certain lepidopteran pests and the PAT protein to confer tolerance to glufosinate-ammonium-containing herbicides; MON 87411 expressing the Cry3Bb1 protein and the DvSnf7 dsRNA to confer protection against certain coleopteran pests and the CP4 EPSPS protein for tolerance to glyphosate-containing herbicides; and 59122 expressing the Cry34Ab1 and Cry35Ab1 protein to confer protection against certain coleopteran pests and the PAT protein. It should be noted that the assessment of herbicide residues in maize herbicide-tolerant crops relevant for this application has been investigated by the EFSA Pesticides Unit (EFSA, 2018). All 6 single maize e
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