Assessment of genetically modified maize Bt11 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-016)

SCIENTIFIC OPINION ADOPTED: 25 November 2020 doi: 10.2903/j.efsa.2021.6347 Assessment of genetically modified maize Bt11 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-016) EFSA Panel on Genetically Modified Organisms (GMO), 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 Nogu e, Nils Rostoks, Jose Juan S anchez Serrano, Giovanni Savoini, Eve Veromann, Fabio Veronesi, Fernando  Alvarez, Michele Ardizzone and Tommaso Raffaello Abstract Following the submission of application EFSA-GMO-RX-016 under Regulation (EC) No 1829/2003 from Syngenta the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant and herbicide-tolerant genetically modified maize Bt11, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the event in maize Bt11 considered for renewal is identical to the sequence of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-016 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize Bt11. ©2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. Keywords: Maize, Bt11, renewal, Articles 11 and 23, Regulation (EC) No 1829/2003 Requestor: European Commission (DG SANTE) Question number: EFSA-Q-2018-00799 Correspondence: GMO_secretariat_appl[email protected] EFSA Journal 2021;19(1):6347www.efsa.europa.eu/efsajournal 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 Nogu e, Nils Rostoks, Jose Juan S anchez Serrano, Giovanni Savoini, Eve Veromann and Fabio Veronesi. Acknowledgments: The Panel wishes to thank the members of its standing Working Groups on Molecular Characterisation, Food/Feed and Environmental Risk Assessment for the preparatory work on this scientific opinion, and the EFSA staff members Antonio Fernandez Dumont, Andrea Gennaro, Irene Mu~ noz-Guajardo, Konstantinos Paraskevopoulos and Irina Vlas for the support provided to this scientific opinion. Suggested citation: EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Naegeli H, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Mullins E, Nogu e F, Rostoks N, S anchez Serrano JJ, Savoini G, Veromann E, Veronesi F,  Alvarez F, Ardizzone M and Raffaello T, 2021. Scientific Opinion on the assessment of genetically modified maize Bt11 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-016). EFSA Journal 2021;19(1):6347, 15 pp. https://doi.org/10.2903/j.efsa.2021.6347 ISSN: 1831-4732 ©2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. Assessment of genetically modified maize Bt11 for renewal authorisation www.efsa.europa.eu/efsajournal 2 EFSA Journal 2021;19(1):6347 Summary Following the submission of application EFSA-GMO-RX-016 under Regulation (EC) No 1829/2003 from Syngenta, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant and herbicide-tolerant genetically modified maize Bt11. The scope of application EFSA-GMO-RX-016 is for the renewal of the placing on the market of products containing, consisting of, or produced from maize Bt11, excluding cultivation within the European Union (EU). In delivering its scientific opinion, the GMO Panel took into account application EFSA-GMO-RX-016, additional information provided by the applicant, scientific comments submitted by the EU Member States and relevant scientific publications. The data received in the context of the renewal application EFSA-GMO-RX-016 contained: post-market environmental monitoring reports, an evaluation of the literature retrieved by a systematic search, updated bioinformatics analyses and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in maize Bt11 considered for renewal is identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-016 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize Bt11 (EFSA, 2009). Assessment of genetically modified maize Bt11 for renewal authorisation www.efsa.europa.eu/efsajournal 3 EFSA Journal 2021;19(1):6347 Table of contents Abstract................................................................................................................................................... 1 Summary................................................................................................................................................. 3 1. Introduction................................................................................................................................... 5 1.1. Background ................................................................................................................................... 5 1.2. Terms of Reference as provided by the requestor ............................................................................. 5 2. Data and methodologies ................................................................................................................. 6 2.1. Data.............................................................................................................................................. 6 2.1.1. Post-market monitoring reports ....................................................................................................... 6 2.1.2. Systematic search and evaluation of literature .................................................................................. 6 2.1.3. Updated bioinformatic data ............................................................................................................. 6 2.1.4. Additional documents or studies provided by the applicant ................................................................ 7 2.1.5. Overall assessment as provided by the applicant .............................................................................. 7 2.1.6. Monitoring plan and proposal for improving the conditions of the original authorisation....................... 7 2.2. Methodologies................................................................................................................................7 3. Assessment.................................................................................................................................... 7 3.1. Evaluation of the post-market monitoring reports ............................................................................. 7 3.2. Evaluation of the systematic search and evaluation of literature......................................................... 7 3.3. Evaluation of the updated bioinformatic data.................................................................................... 7 3.4. Evaluation of the additional documents or studies provided by the applicant....................................... 8 3.5. Evaluation of the overall assessment as provided by the applicant ..................................................... 8 3.6. Evaluation of the monitoring plan and proposal for improving the conditions of the original authorisation.................................................................................................................................. 8 4. Conclusions.................................................................................................................................... 8 5. Documentation as provided to EFSA ................................................................................................ 8 References............................................................................................................................................... 8 Abbreviations ........................................................................................................................................... 9 Appendix A –List of relevant publications identified by the applicant through systematic literature searches (1 January 2008–1 July 2020) ................................................................................................................... 10 Appendix B –List of additional studies performed by or on behalf of the applicant over the course of the authorisation period and not previously submitted to the EU with regard to the evaluation of the safety of the food and feed for humans, animal or the environment from maize Bt11 ................................................. 13 Appendix C –Outcome of the assessment of a 90-day oral repeated dose toxicity study in rat with maize Bt11 (study number 502983) 17 .................................................................................................................. 14 Assessment of genetically modified maize Bt11 for renewal authorisation www.efsa.europa.eu/efsajournal 4 EFSA Journal 2021;19(1):6347 1. Introduction 1.1. Background On 11 October 2018, the European Food Safety Authority (EFSA) received from the European Commission (EC) application EFSA-GMO-RX-016 for the renewal of the authorisation of maize Bt11 (Unique Identifier SYN-BTØ11-1), submitted by Syngenta (hereafter referred to as ‘the applicant’) according to Regulation (EC) No 1829/2003. 1 Following receipt of application EFSA-GMO-RX-016 EFSA informed the Member States (MS) and made the summary of the application available to the public on the EFSA website. 2 EFSA checked the application for compliance with the relevant requirements of Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013 3 and, when needed, asked the applicant to supplement the initial application. On 26 November 2018, EFSA declared the application valid and made the valid application available to the MS and the European Commission. Following the submission of application EFSA-GMO-RX-Bt11 and the publication of the EFSA scientific opinion (EFSA, 2009), the placing on the market of maize Bt11 for products containing, consisting of, or produced from this GM maize, excluding cultivation in the EU, was authorised by Commission Decision 2010/419/EU 4 . A copy of this authorisation was provided by the applicant. 5 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-RX-016. 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 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 the MS, including national Competent Authorities within the meaning of Directive 2001/18/EC 6 . The MS had 3 months to make their opinion known on application EFSA-GMO-RX-016 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 Bt11 for the renewal of authorisation for placing on the market of products containing, consisting of, or produced from GM maize Bt11 in the context of its scope as defined in application EFSA-GMO-RX-016. 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 the MS. 7 In addition to the present scientific opinion on maize Bt11, 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, 8 including the information required under Annex II to the Cartagena Protocol, a labelling proposal, a post-market environmental 1 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. 2 Available online: http://registerofquestions.efsa.europa.eu/roqFrontend/questionDocumentsLoader?question=EFSA-Q-2018-00799 3 Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation 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 L 157, 8.6.2013, p. 1–48. 4 Commission Decision of 28 July 2010 renewing the authorisation for continued marketing of products containing, consisting of, or produced from genetically modified maize Bt11 (SYN-BTØ11-1), authorising foods and food ingredients containing or consisting of field maize Bt11 (SYN-BTØ11-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council and repealing Decision 2004/657/EC. Official Journal of the European Union L 197/11, 29.7.2010. 5 Dossier: Maize Bt11 –Appendix 2.1-1. 6 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. 7 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. 8 http://registerofquestions.efsa.europa.eu/roqFrontend/questionDocumentsLoader?question=EFSA-Q-2019-00524 Assessment of genetically modified maize Bt11 for renewal authorisation www.efsa.europa.eu/efsajournal 5 EFSA Journal 2021;19(1):6347 monitoring (PMEM) plan as provided by the applicant; the method(s), validated by the Community reference laboratory, for detection, including sampling, identification of the transformation event in the food-feed and/or foods-feeds produced from it and the appropriate reference materials. 2. Data and methodologies 2.1. Data The data for application EFSA-GMO-RX-016 provided by the applicant at the time of submission, or in reply to requests for additional information, are specified below. In the context of this renewal application, a new sequencing study was submitted among the additional documents or studies performed by or on behalf of the applicant (Appendix B). In accordance with the GMO Panel guidelines for renewal of applications of GM food and feed authorised under Regulation (EC) No 1829/2003 (EFSA GMO Panel, 2015), the GMO Panel evaluated the data provided in the context of this maize Bt11 renewal application under the assumption that Bt11 event sequences is identical to the sequences of the originally assessed event (EFSA, 2009). 2.1.1. Post-market monitoring reports 9 Based on the outcome of the initial food and feed risk assessment, a post-market monitoring plan for monitoring of GM food and feed was not required by the authorisation decision. The implementation of a PMEM plan, consisting of a general surveillance plan to check for any adverse effects on the environment arising from maize Bt11, was a condition for the authorisation. As no potential adverse environmental effects were identified in the environmental risk assessment of maize Bt11 (EFSA, 2009), case-specific monitoring was not considered necessary by the GMO Panel. The applicant provided nine annual PMEM reports covering a reporting period from July 2010 till June 2018. The annual PMEM plans submitted by the applicant included (1) commodity crop (GM and non GM) imports into the EU by country of origin and destination; (2) the description of a centralised system established by EuropaBio for the collection of information recorded by various operators (federations involved in maize grains import and processing) on any observed adverse effect(s) on human health and the environment arising from handling of maize possibly containing maize Bt11; (3) the reports of the surveillance activities conducted by such operators; and (4) the review of relevant scientific peer-reviewed studies retrieved from literature searches. 2.1.2. Systematic search and evaluation of literature 10 In addition to the separate searches provided as part of the annual PMEM reports, the applicant performed three systematic literature searches covering the period from January 2008 till July 2020, in accordance with the recommendations on literature search outlined in EFSA (2010, 2017a). Searches in electronic bibliographic databases and in websites of relevant organisations were performed to identify relevant publications. Altogether, 6,059 publications were identified (after removal of duplicates). After applying the eligibility/inclusion criteria defined a priori by the applicant, 61 publications were identified as relevant for food and feed safety assessment or molecular characterisation. The list of relevant publications is provided in Appendix A. 2.1.3. Updated bioinformatic data 11 At the time of submission of the renewal dossier, the applicant provided a complete bioinformatic dataset for maize Bt11 event including an analysis of the insert and flanking sequences, an analysis of the potential similarity to allergens and toxins of the newly expressed proteins and of all possible open reading frames (ORFs) within the insert and spanning the junction sites, an analysis of possible horizontal gene transfer (EFSA, 2017b), and a safety assessment of the newly expressed proteins Cry1Ab and PAT regarding their capacity to trigger celiac disease (EFSA GMO Panel, 2017). The outcome of the updated bioinformatic analyses is presented in Section 3.3. 9 Dossier: Maize Bt11 –Appendices 2.2-01 to 2.2-08b. 10 Dossier: Maize Bt11 –Folder 2.3.1-01; additional information: 20/6/2019, 28/10/2019; spontaneous information 7/9/2020. 11 Dossier: Maize Bt11 Part II –Section 2.3.2; spontaneous information 16/4/2020. Assessment of genetically modified maize Bt11 for renewal authorisation www.efsa.europa.eu/efsajournal 6 EFSA Journal 2021;19(1):6347 2.1.4. Additional documents or studies provided by the applicant 12 In line with the renewal guidance requirements (EFSA GMO Panel, 2015), the applicant provided an overview on the worldwide approvals of maize Bt11 and searched for any available full reports of studies performed by or on behalf of the applicant over the course of the authorisation period and not previously submitted to the EU (Appendix B). The relevance of the listed studies for molecular characterisation, human and animal safety and the environment was assessed by the applicant. 2.1.5. Overall assessment as provided by the applicant 13 The applicant provided an overall assessment concluding that information provided in the application for renewal of authorisation of maize Bt11 for food and feed uses in the EU does not change the outcome of the original risk assessment (EFSA, 2009). 2.1.6. Monitoring plan and proposal for improving the conditions of the original authorisation 14 The applicant indicated in the dossier that the environmental post-market monitoring plan is appropriate and does not need any changes. 2.2. Methodologies The GMO Panel assessed the application for renewal of the authorisation of maize Bt11 for food and feed uses in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003. The GMO Panel took into account the requirements described in its guideline for the risk assessment of renewal applications of GM food and feed authorised under Regulation (EC) No 1829/2003 (EFSA GMO Panel, 2015). The comments raised by the nominated risk assessment bodies of EU Member States were taken into consideration during the scientific risk assessment. 3. Assessment 3.1. Evaluation of the post-market monitoring reports During the general surveillance activities covering the authorisation period of maize Bt11, no adverse effects were reported by the applicant. 3.2. Evaluation of the systematic search and evaluation of literature The GMO Panel assessed the applicant’s literature searches on maize Bt11 and the newly expressed proteins Cry1Ab and PAT. The overall quality of the performed literature searches is acceptable. The GMO Panel acknowledges that no publications raising a safety concern for human and animal health and the environment which would change the original risk assessment conclusions on maize Bt11 (EFSA, 2009) have been identified by the applicant. 3.3. Evaluation of the updated bioinformatic data The results of the updated bioinformatic analyses to assess the interruption of maize endogenous genes confirm previous results indicating that no endogenous genes were interrupted (EFSA, 2009). Analyses of the amino acid sequence of the newly expressed Cry1Ab and PAT proteins reveal no significant similarities to toxins, allergens or immunogenic gluten-related epitopes. In addition, bioinformatic analyses of the newly created ORFs within the insert or spanning the junctions with genomic DNA confirm the previous conclusions indicating that the expression of ORFs showing significant similarities to toxins or allergens in maize Bt11 is highly unlikely (EFSA, 2009). The updated bioinformatic analysis for event Bt11 did not reveal any DNA sequence that could provide sufficient length and identity which could facilitate horizontal gene transfer (HGT) by double homologous recombination, confirming previous conclusions (EFSA, 2009). Given the results of this analysis and that the recombinant DNA in maize Bt11 does not confer selective advantages to 12 Dossier: Maize Bt11 Part II –Section 2.3.3. 13 Dossier: Maize Bt11 Part II –Section 3. 14 Dossier: Maize Bt11 Part II –Section 4. Assessment of genetically modified maize Bt11 for renewal authorisation www.efsa.europa.eu/efsajournal 7 EFSA Journal 2021;19(1):6347 microorganisms, the GMO Panel identified no safety concern linked to an unlikely but theoretically possible HGT. 3.4. Evaluation of the additional documents or studies provided by the applicant The GMO Panel evaluated the full study reports of the additional studies provided (Appendix B,C 15 ). This new information does not raise any concern for human and animal health and the environment, which would change the original risk assessment conclusions on maize Bt11 (EFSA, 2009). 3.5. Evaluation of the overall assessment as provided by the applicant The GMO Panel evaluated the overall assessment provided by the applicant and confirms that there is no evidence in renewal application EFSA-GMO-RX-016 –indicating new hazards, relevant changes in exposure or scientific uncertainties that would change previous conclusions on maize Bt11. 3.6. Evaluation of the monitoring plan and proposal for improving the conditions of the original authorisation The PMEM plan covers general surveillance of imported GM plant material, including maize Bt11. This general surveillance is coordinated by EuropaBio and implemented by selected operators (federations involved in maize grains import and processing). In addition, the applicant reviews relevant scientific publications retrieved from literature searches on an annual basis. The GMO Panel is of the opinion that the scope of the plan provided by the applicant is consistent with the scope of application EFSA-GMO-RX-016, but reminds that monitoring is related to risk management, and thus the final adoption and implementation of the PMEM plan falls outside the mandate of EFSA. 4. Conclusions Under the assumption that the DNA sequence of the event in maize Bt11 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-016 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize Bt11 (EFSA, 2009). 5. Documentation as provided to EFSA 1) Letter from the European Commission to EFSA received on 11 October 2018 concerning a request for the continued marketing of food and feed containing, consisting of or produced from genetically modified maize Bt11 and products other than food and feed containing or consisting of it with the exception of cultivation, authorised under Regulation 1829/2003 (commission Decision 2010/419/EU) by Syngenta Crop Protection NV/SA. 2) Application EFSA-GMO-RX-016 validated by EFSA, 26 November 2018. 3) Request for supplementary information to the applicant, 19 December 2019. 4) Receipt of supplementary information from the applicant, 20 June 2019. 5) Request for supplementary information to the applicant, 25 July 2019. 6) Request for supplementary information to the applicant, 06 August 2019. 7) Receipt of supplementary information from the applicant, 28 October 2019. 8) Receipt of supplementary information from the applicant, 03 April 2020. 9) Receipt of spontaneous information from the applicant, 16 April 2020. 10) Receipt of spontaneous information from the applicant, 07 September 2020. References EFSA (European Food Safety Authority), 2009. Scientific Opinion on application reference EFSA-GMO-RX-Bt11 for renewal of the authorisation of existing products produced from insect-resistant genetically modified maize Bt11, under Regulation (EC) No 1829/2003 from Syngenta. EFSA Journal 2009;7(2):977, 13 pp. https://doi. org/10.2903/j.efsa.2009.977 15 Appendix Ccontains the GMO Panel assessment of a 90-day study on Bt11 maize provided by the applicant in the context of this application. Assessment of genetically modified maize Bt11 for renewal authorisation www.efsa.europa.eu/efsajournal 8 EFSA Journal 2021;19(1):6347 EFSA (European Food Safety Authority), 2010. Application of systematic review methodology to food and feed safety assessments to support decision making. EFSA Journal 2010;8(6):1637, 90 pp. https://doi.org/10.2903/ j.efsa.2010.1637 EFSA (European Food Safety Authority), 2014. Explanatory statement for the applicability of the Guidance of the EFSA Scientific Committee on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/ feed for GMO risk assessment. EFSA Journal 2014;12(10):3871, 25 pp. https://doi.org/10.2903/j.efsa.2014. 3871 EFSA (European Food Safety Authority), Devos Y, Guajardo IM, Glanville J and Waigmann E, 2017a. Explanatory note on literature searching conducted in the context of GMO applications for (renewed) market authorization and annual post-market environmental monitoring reports on GMOs authorised in the EU market. EFSA supporting publications 2017;EN-1207, 48 pp. https://doi.org/10.2903/sp.efsa.2017.en-1207 EFSA (European Food Safety Authority), Gennaro A, Gomes A, Herman L, Nogue F, Papadopoulou N and Tebbe C, 2017b. Technical report on the explanatory note on DNA sequence similarity searches in the context of the assessment of horizontal gene transfer from plants to microorganisms. EFSA supporting publication 2017;EN1273, 11 pp. https://doi.org/10.2903/sp.efsa.2017.en-1273 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2015. Guidance for renewal applications of genetically modified food and feed authorised under Regulation (EC) No 1829/2003. EFSA Journal 2015;13 (6):4129, 8 pp. https://doi.org/10.2903/j.efsa.2015.4129 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Naegeli H, Birch AN, Casacuberta J, De Schrijver A, Gralak MA, Guerche P, Jones H, Manachini B, Messean A, Nielsen EE, Nogue F, Robaglia C, Rostoks N, Sweet J, Tebbe C, Visioli F, Wal J-M, Eigenmann P, Epstein M, Hoffmann-Sommergruber K, Koning F, Lovik M, Mills C, Moreno FJ, van Loveren H, Selb R and Fernandez Dumont A, 2017. Guidance on allergenicity assessment of genetically modified plants. EFSA Journal 2017;15(5):4862, 49 pp. https://doi.org/10.2903/ j.efsa.2017.4862 EFSA Scientific Committee, 2011. EFSA guidance on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed. EFSA Journal 2011;9(12):2438, 21 pp. https://doi.org/10.2903/j.efsa.2011.2438 Steinberg P, van der Voet H, Goedhart PW, Kleter G, Kok EJ, Pla M, Nadal A, Zeljenkov aD,Al  a cov a R, Babincov aJ, Rollerov a E, Jad’ud’ov a S, Kebis A, Szabova E, Tulinsk aJ,L  ı  skov aA,Tak  acsov a M, Lehotsk a Miku sov aM, Krivo s ıkov aZ,Sp € ok A, Racovita M, de Vriend H, Alison R, Alison C, Baumg€ artner W, Becker K, Lempp C, Schmicke M, Schrenk D, P€ oting A, Schiemann J and Wilhelm R, 2019. Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats. Archives of Toxicology, 93, 1095. https://doi.org/10.1007/s00204-019-02400-1 Abbreviations ALT alanine aminotransferase APTT activated partial thromboplastin time ANOVA analysis of variance BUN blood urea nitrogen ELISA Enzyme-linked immunosorbent assay GLP good laboratory practice GM genetically modified GMO genetically modified organism GMO Panel EFSA Panel on Genetically Modified Organisms HGT horizontal gene transfer OECD Organisation for Economic Co-operation and Development ORFs open reading frames PCR polymerase chain reaction PMEM post-market environmental monitoring PT partial thromboplastin time Assessment of genetically modified maize Bt11 for renewal authorisation www.efsa.europa.eu/efsajournal 9 EFSA Journal 2021;19(1):6347