Assessment of genetically modified maize MON 810 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2022‐9450)

Abstract

Following the submission of dossier GMFF‐2022‐9450 under Regulation (EC) No 1829/2003 from Bayer Agriculture BV, 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 protected genetically modified maize MON 810, for food and feed uses (including pollen), excluding cultivation within the European Union. The data received in the context of this renewal application contained post‐market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. 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 sequence of the event in maize MON 810 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in dossier GMFF‐2022‐9450 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 810.

SUMMARY

Following the submission of dossier GMFF-2022-9450 under Regulation (EC) No 1829/2003 from Bayer Agriculture BV, 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 protected genetically modified maize MON 810. The scope of the renewal dossier GMFF-2022-9450 is for the renewal of the placing on the market of maize MON 810 for food and feed uses (including pollen), excluding cultivation, within the European Union (EU).

In delivering its scientific opinion, the GMO Panel took into account dossier GMFF-2022-9450, 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 GMFF-2022-9450 contained: post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. 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 sequence of the event in maize MON 810 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in dossier GMFF-2022-9450 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 810 (EFSA GMO Panel, 2009, 2012).

INTRODUCTION

Background

On 14 December 2022, the European Food Safety Authority (EFSA) received from the European Commission (EC) dossier GMFF-2022-9450 for the renewal of the authorisation of maize MON 810 (Unique Identifier MON-ØØ81Ø-6), submitted by Bayer Agriculture BV (hereafter referred to as ‘the applicant’) according to Regulation (EC) No 1829/2003.¹

Following receipt of dossier GMFF-2022-9450, EFSA informed the Member States (MS) and made the summary of the application available to the public on the Open EFSA portal.²

EFSA checked the dossier for compliance with the relevant requirements of Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013³ and, when needed, asked the applicant to complete the initial renewal dossier. On 10 March 2023, EFSA declared the application valid and made the valid application available to the MS and the European Commission (EC).

Following the submission of applications EFSA-GMO-RX-MON810 and EFSA-GMO-NL-2012-107, and the publication of the EFSA scientific opinions (EFSA GMO Panel, 2009, 2012), the placing on the market in EU of maize MON 810 was authorised by Commission Implementing Decision 2017/1207/EU for (i) foods and food ingredients produced from MON 810 maize, with the exception of pollen, (ii) feed containing, consisting of or produced from MON 810, and (iii) MON 810 maize in products containing it or consisting of it for any other use than food or feed, with the exception of cultivation, and by Commission Implementing Decision 2013/649/EU for pollen produced from MON 810 maize, as or in foods and food ingredients.⁴ A copy of these authorisations were 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 dossier GMFF-2022-9450. This 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 EC (for further details, see the Section 5).

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 three months to make their opinion known on dossier GMFF-2022-9450 as of date of validity.

Terms of Reference as provided by the requestor

EFSA and its GMO Panel were requested to carry out a scientific risk assessment of maize MON 810 for the renewal of authorization, according to Articles 11 and 23 of Regulation (EC) No 1829/2003.

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 MON 810, 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 OpenEFSA portal,⁸ 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 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.

DATA AND METHODOLOGIES

Data

The applicant has submitted a confidential and a non-confidential version of the dossier GMFF-2022-9450 following the EFSA requirements as detailed in EFSA GMO Panel (2015) and EFSA, (2021).

In accordance with Art. 38 of the Regulation (EC) No 178/2002 and taking into account the protection of confidential information and of personal data in accordance with Articles 39 to 39e of the same Regulation, the non-confidential version of the dossier has been published on OpenEFSA.⁹ According to Art. 32c (2) of Regulation (EC) No 178/2002¹⁰ and to the Decision of EFSA's Executive Director laying down the practical arrangements on pre-submission phase and public consultations,¹¹ EFSA carried out a public consultation on the non-confidential version of the dossier from 19 July to 9 August 2023 for which no comments were received.

The GMO Panel based its scientific assessment of maize MON 810 on the valid dossier GMFF-2022-9450, additional information provided by the applicant during the risk assessment, scientific comments submitted by EU MS and peer-reviewed scientific publications.

In the frame of the contracts OC/EFSA/GMO/2021/06 and OC/EFSA/GMO/2018/04, the contractor performed preparatory work and delivered reports on the methods applied by the applicant in performing updated bioinformatic analyses and literature search, respectively.

Post-market monitoring and post-market environmental monitoring reports¹²

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 MON 810, was a condition for the authorisation. As no potential adverse environmental effects were identified in the environmental risk assessment of maize MON 810 (EFSA GMO Panel, 2009, 2012), case-specific monitoring was not considered necessary by the GMO Panel.

The applicant provided five annual PMEM reports covering a reporting period from July 2016 until June 2021. 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 EuropaBio¹³ for the collection of information recorded by various operators (federations involved in maize import and processing) on any observed adverse effect(s) on human health and the environment arising from handling of maize possibly containing maize MON 810; (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.

Systematic search and evaluation of literature¹⁴

In addition to the separate searches provided as part of the annual PMEM reports, the applicant performed scoping reviews covering the period from January 2012 until July 2022, in accordance with the recommendations on literature search outlined in EFSA (2010, 2019).

Searches in electronic bibliographic databases and in websites of relevant organisations were performed to identify relevant publications. Altogether 1784 publications (including the updated search) were identified (after removal of duplicates). After applying the eligibility/inclusion criteria defined a priori by the applicant, 80 publications were identified as relevant for food and feed safety assessment. The relevant publications are listed in Appendix A.

Updated bioinformatic¹⁵

At the time of submission of the renewal dossier, the applicant provided a complete bioinformatic dataset for maize MON 810 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, 2017) and a safety assessment of the newly expressed protein Cry1Ab regarding their capacity to trigger celiac disease (EFSA GMO Panel, 2017). The outcome of the updated bioinformatic analyses is presented in Section 3.3.

Additional documents or studies performed by or on behalf of the applicant¹⁶

In line with the renewal guidance requirements (EFSA, 2021; EFSA GMO Panel, 2015), the applicant provided an overview on the worldwide approvals of maize MON 810 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.

The relevance of the listed studies for molecular characterisation, human and animal safety and the environment was assessed by the applicant.

Overall assessment¹⁷

The applicant provided an overall assessment concluding that information provided in the application for renewal of authorisation of maize MON 810 for food and feed uses in the EU does not change the outcome of the original risk assessment (EFSA GMO Panel, 2009, 2012).

Monitoring plan and proposal for improving the conditions of the original authorisation¹⁸

The applicant indicated in the dossier that the post-market environmental monitoring plan is appropriate and does not need any changes.

Methodologies

The GMO Panel assessed the application for renewal of the authorisation of maize MON 810 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 opinions raised by the nominated risk assessment bodies of EU Member States were taken into consideration during the scientific risk assessment.

ASSESSMENT

Evaluation of the post-market monitoring and post-market environmental monitoring reports

During the general surveillance activities covering the authorisation period of maize MON 810, no adverse effects were reported by the applicant. Therefore, no further evaluation is needed by the GMO Panel.

Evaluation of the systematic search and evaluation of literature

The GMO Panel assessed the applicant's literature searches on maize MON 810 and the newly expressed protein Cry1Ab. 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 Cry1Ab proteins (EFSA GMO Panel, 2009, 2012) have been identified by the applicant.

Evaluation of the updated bioinformatic analyses

The results of the updated bioinformatic analyses to assess the interruption of maize endogenous genes confirmed previous results indicating that a possible genomic deletion or rearrangement happened at the insertion site, and a predicted maize E3 ubiquitin ligase gene was interrupted by event MON 810 (EFSA GMO Panel, 2009, 2012, 2021a, 2021b, 2022).

The analyses of the amino acid sequence of the newly expressed Cry1Ab protein reveal no significant similarities to toxins, allergens or immunogenic gluten-related epitopes. Moreover, the updated bioinformatic analyses of the newly created ORFs within the insert and spanning the junctions between the insert and the flanking regions confirmed previous results indicating that the expression of any ORF showing significant similarities to toxins or allergens in maize MON 810 is unlikely (EFSA GMO Panel, 2009, 2012, 2021a, 2021b, 2022).

The updated bioinformatic analysis for event MON 810 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 GMO Panel, 2021a, 2021b, 2022). Given the results of this analysis and that the recombinant DNA in maize MON 810 does not confer selective advantages to microorganisms, the GMO Panel identified no safety concern linked to an unlikely but theoretically possible HGT.

Evaluation of the additional documents or studies performed by or on behalf of the applicant

Taking into account (i) the relevance for molecular characterisation, human and animal safety and the environment; and (ii) the scope of this renewal application, there are no unpublished studies available performed by the applicant and not previously submitted to the EU since maize MON 810 was authorised.

Evaluation of the overall assessment

The GMO Panel evaluated the overall assessment provided by the applicant and confirms that there is no evidence in renewal dossier GMFF-2022-9450 indicating new hazards, relevant changes in exposure or scientific uncertainties that would change previous conclusions on maize MON 810.

Evaluation of the monitoring plan and proposal for improving the conditions of the original authorisation

The PMEM plan¹⁹ covers general surveillance of imported GM plant material, including maize MON 810. This general surveillance is coordinated by 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 dossier GMFF-2022-9450, 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.

CONCLUSIONS

Under the assumption that the DNA sequence of the event in maize MON 810 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2022-9450 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 810 (EFSA GMO Panel, 2009, 2012).

DOCUMENTATION AS PROVIDED TO EFSA

• Letter from the European Commission to EFSA received on 14 December 2022 for the continued marketing of genetically modified maize MON 810 submitted in accordance with articles 11 and 23 of Regulation (EC) No 1829/2003 by Bayer Agriculture BV (GMFF-2022-9450).
• The application was made valid on 10 March 2023.
• Additional Information (Clock 1) was requested on 4 May 2023.
• Additional Information (Clock 1) was received on 26 July 2023.
• Additional Information (Clock 2) was requested on 11 September 2023.
• Additional Information (Clock 2) was received on 20 September 2023.
• Spontaneous information was received on 16 November 2023.

ABBREVIATIONS

• GM
• genetically modified
• GMO
• genetically modified organism
• GMO Panel
• EFSA Panel on Genetically Modified Organisms
• HGT
• horizontal gene transfer
• ORFs
• open reading frames
• PMEM
• post-market environmental monitoring

ACKNOWLEDGEMENTS

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 Michele Ardizzone, Antonio Fernandez and Aleksandra Lewandowska for the support provided to this scientific opinion.

CONFLICT OF INTEREST

If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact [email protected].

REQUESTOR

European Commission (DG SANTE)

QUESTION NUMBER

EFSA-Q-2022-00867

COPYRIGHT FOR NON-EFSA CONTENT

EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyrightholder and users should seek permission to reproduce the content from the original source.

PANEL MEMBERS

Ewen Mullins, Jean-Louis Bresson, Tamas Dalmay, Ian Crawford Dewhurst, Michelle M Epstein, Leslie George Firbank, Philippe Guerche, Jan Hejatko, Francisco Javier Moreno, Hanspeter Naegeli, Fabien Nogué, Nils Rostoks, Jose Juan Sánchez Serrano, Giovanni Savoini, Eve Veromann, Fabio Veronesi

Appendix

APPENDIX A - List of relevant publications identified by the applicant through literature searches (January 2012–July 2022)

Abdo, E. M., Barbary, O. M., & Shaltout, O. E.-S. (2014). Feeding study with Bt corn (MON810: Ajeeb YG) on rats: Biochemical analysis and liver histopathology. Food and Nutrition Sciences, 2014.

Agapito-Tenfen, S. Z., Guerra, M. P., Wikmark, O.-G., & Nodari, R. O. (2013). Comparative proteomic analysis of genetically modified maize grown under different agroecosystems conditions in Brazil. Proteome Science, 11, 1–15.

Al-Harbi, A., Lary, S., Edwards, M. G., Qusti, S., Cockburn, A., Poulsen, M., & Gatehouse, A. M. (2019). A proteomic-based approach to study underlying molecular responses of the small intestine of Wistar rats to genetically modified corn (MON810). Transgenic Research, 28, 479–498.

Al-Hmoud, N., Al-Husseini, N., Ibrahim-Alobaide, M. A., Kübler, E., Farfoura, M., Alobydi, H., & Al-Rousan, H. (2014). Unconventional P-35S sequence identified in genetically modified maize. GM Crops & Food, 5, 58–64.

Andreassen, M., Bøhn, T., Wikmark, O.-G., Bodin, J., Traavik, T., Løvik, M., & Nygaard, U. C. (2016). Investigations of immunogenic, allergenic and adjuvant properties of Cry1Ab protein after intragastric exposure in a food allergy model in mice. BMC Immunology, 17, 1–12.

Andreassen, M., Bøhn, T., Wikmark, O.-G., Van den Berg, J., Løvik, M., Traavik, T., & Nygaard, U. C. (2014a). Cry1Ab protein from MON810 transgenic maize and Bacillus thuringiensis has no clear adjuvanticity after intranasal exposure. Toxicology Letters, S207.

Andreassen, M., Bohn, T., Wikmark, O. G., Van den Berg, J., Lovik, M., Traavik, T., & Nygaard, U. C. (2015a). Cry1Ab protein from Bacillus thuringiensis and MON810 cry1Ab-transgenic maize exerts no adjuvant effect after airway exposure. Scandian Journal of Immunology, 81, 192–200.

Andreassen, M., Rocca, E., Bøhn, T., Wikmark, O.-G., Van den Berg, J., Lovik, M., Traavik, T., & Nygaard, U. C. (2014b). Pollen from genetically modified Bt maize does not promote allergic responses in mice. Journal of Allergy and Clinical Immunology, 133, AB89.

Andreassen, M., Rocca, E., Bøhn, T., Wikmark, O.-G., van den Berg, J., Løvik, M., Traavik, T., & Nygaard, U. C. (2015b). Humoral and cellular immune responses in mice after airway administration of Bacillus thuringiensis Cry1Ab and MON810 cry1Ab-transgenic maize. Food and Agricultural Immunology, 26, 521–537.

Arias-Martín, M., Haidukowski, M., Farinós, G. P., & Patiño, B. (2021). Role of Sesamia nonagrioides and Ostrinia nubilalis as vectors of Fusarium spp. and contribution of corn borer-resistant Bt maize to mycotoxin reduction. Toxins, 13, 780.

Balieiro, N., Cividanes, T. S., Branco, R., Felix, M., Rei, F.d.C., & Nogueira, J. (2013). Cry1Ab protein quantification in leaves, stems and grains, and effectiveness to control Spodoptera frugiperda and Helicoverpa zea on two hybrids of genetically modified corn. Boletim de Indústria Animal, 70, 59–66.

Barroso, V. M., Rocha, L. O., Reis, T. A., Reis, G. M., Duarte, A. P., Michelotto, M. D., & Correa, B. (2017). Fusarium verticillioides and fumonisin contamination in Bt and non-Bt maize cultivated in Brazil. Mycotoxin Research, 33, 121–127. Literature search – MON 810 maize Bayer CropScience LP 53.

Bednarek, D., Dudek, K., Kwiatek, K., Świątkiewicz, M., Świątkiewicz, S., & Strzetelski, J. (2013). Effect of a diet composed of genetically modified feed components on the selected immune parameters in pigs, cattle, and poultry. Bull Vet Inst Pulawy, 57, 209–2017.

Ben Ali, S.-E., Schamann, A., Dobrovolny, S., Indra, A., Agapito-Tenfen, S. Z., Hochegger, R., Haslberger, A. G., & Brandes, C. (2018). Genetic and epigenetic characterization of the cry1Ab coding region and its 3′ flanking genomic region in MON810 maize using next-generation sequencing. European Food Research and Technology, 244, 1473–1485.

Bonea, D., & Dunareanu, I. C. (2021). Behavior of some GM and conventional maize hybrids under drought and heat conditions. Scientific Papers: Management, Economic Engineering in Agriculture & Rural Development, 21.

Bowen, K., Flanders, K., Hagan, A., & Ortiz, B. (2014). Insect damage, aflatoxin content, and yield of Bt corn in Alabama. Journal of Economic Entomology, 107, 1818–1827.

Bowers, E., Hellmich, R., & Munkvold, G. (2013). Vip3Aa and Cry1Ab proteins in maize reduce Fusarium ear rot and fumonisins by deterring kernel injury from multiple Lepidopteran pests. World Mycotoxin Journal, 6, 127–135.

Bowers, E., Hellmich, R., & Munkvold, G. (2014). Comparison of fumonisin contamination using HPLC and ELISA methods in Bt and near-isogenic maize hybrids infested with European corn borer or western bean cutworm. Journal of Agricultural and Food Chemistry, 62, 6463–6472.

Buzoianu, S., Walsh, M., Rea, M., Cassidy, J., Ross, R., Gardiner, G., & Lawlor, P. (2012a). Effect of feeding genetically modified Bt MON810 maize to ~40-day-old pigs for 110 days on growth and health indicators. Animal, 6, 1609–1619.

Buzoianu, S. G., Walsh, M. C., Rea, M. C., O'Donovan, O., Gelencser, E., Ujhelyi, G., Szabo, E., Nagy, A., Ross, R. P., & Gardiner, G. E. (2012b). Effects of feeding Bt maize to sows during gestation and lactation on maternal and offspring immunity and fate of transgenic material.

Buzoianu, S. G., Walsh, M. C., Rea, M. C., O'Sullivan, O., Cotter, P. D., Ross, R. P., Gardiner, G. E., Lawlor, P. G. (2012c). High-throughput sequence-based analysis of the intestinal microbiota of weanling pigs fed genetically modified MON810 maize expressing Bacillus thuringiensis Cry1Ab (Bt maize) for 31 days. Applied and Environmental Microbiology, 78, 4217–4224.

Buzoianu, S. G., Walsh, M. C., Rea, M. C., O'Sullivan, O., Crispie, F., Cotter, P. D., Ross, R. P., Gardiner, G. E., & Lawlor, P. G. (2012d). The effect of feeding Bt MON810 maize to pigs for 110 days on intestinal microbiota. PLoS One, 7, e33668.

Buzoianu, S. G., Walsh, M. C., Rea, M. C., Cassidy, J. P., Ryan, T. P., Ross, R. P., Gardiner, G. E., & Lawlor, P. G. (2013a). Transgenerational effects of feeding genetically modified maize to nulliparous sows and offspring on offspring growth and health. Journal of Animal Sciences, 91, 318–330.

Buzoianu, S. G., Walsh, M. C., Rea, M. C., Quigley, L., O'Sullivan, O., Cotter, P. D., Ross, R. P., Gardiner, G. E., & Lawlor, P. G. (2013b). Sequence-based analysis of the intestinal microbiota of sows and their offspring fed genetically modified maize expressing a truncated form of Bacillus thuringiensis Cry1Ab protein (Bt maize). Applied and Environmental Microbiology, 79, 7735–7744.

Chéreau, S., Rogowsky, P., Laporte, B., Coumoul, X., Moing, A., Priymenko, N., Steinberg, P., Wilhelm, R., Schiemann, J., & Salles, B. (2018). Rat feeding trials: A comprehensive assessment of contaminants in both genetically modified maize and resulting pellets. Food and Chemical Toxicology, 121, 573–582. Literature search – MON 810 maize Bayer CropScience LP 54.

Chrenková, M., Pomikalová, S., Chrastinová, L., Polačiková, M., Formelová, Z., Rajský, M., & Mlyneková, Z. (2016). Effect of crimped maize grain ensiled with high moisture grains of transgenic Bt maize in fattening bulls [Conference poster]. National Agricultural and Food Centre (NPPC), 159–162.

Corujo, M., Pla, M., van Dijk, J., Voorhuijzen, M., Staats, M., Slot, M., Lommen, A., Barros, E., Nadal, A., & Puigdomènech, P. (2019). Use of omics analytical methods in the study of genetically modified maize varieties tested in 90 days feeding trials. Food Chemistry, 292, 359–371.

Coumoul, X., Servien, R., Juricek, L., Kaddouch-Amar, Y., Lippi, Y., Berthelot, L., Naylies, C., Morvan, M.-L., Antignac, J.-P., & Desdoits-Lethimonier, C. (2019). The GMO90+ project: Absence of evidence for biologically meaningful effects of genetically modified maize-based diets on Wistar rats after 6-months feeding comparative trial. Toxicological Sciences, 168, 315–338.

Czerwinski, J., Bogacki, M., Jalali, B. M., & Konieczka, P. S. (2015a). The use of genetically modified Roundup Ready soyabean meal and genetically modified MON 810 maize in broiler chicken diets. Part 1. Effects on performance and blood lymphocyte subpopulations. Journal of Animal and Feed Sciences, 25, 134–143.

Czerwinski, J., Słupecka-Ziemilska, M., Wolinski, J., Barszcz, M., Konieczka, P., & Smulikowska, S. (2015b). The use of genetically modified Roundup Ready soyabean meal and genetically modified MON 810 maize in broiler chicken diets. Part 2. Functional status of the small intestine. Journal of Animal Feed Science, 24, 144–152.

Czerwiński, J., Śliżewska, K., Korwin-Kossakowska, A., Bachanek, I., & Smulikowska, S. (2017). Effects of genetically modified maize and soybean meal on the diversity and activity of gut microbiota in broiler chicken. Animal Science Papers and Reports, 35, 279–299.

El-Shamei, Z. S., Gab-Alla, A. A., Shatta, A., Moussa, E., & Rayan, A. M. (2012). Histopathological changes in some organs of male rats fed on genetically modified corn (Ajeeb YG). Journal of Animal Science, 8, 684–696.

Fonseca, C., Planchon, S., Renaut, J., Oliveira, M. M., & Batista, R. (2012). Characterization of maize allergens - MON810 vs. its non-transgenic counterpart. Journal of Proteomics, 75, 2027–2037.

Frank, T., Röhlig, R. M., Davies, H. V., Barros, E., & Engel, K.-H. (2012). Metabolite profiling of maize kernels - genetic modification versus environmental influence. Journal of Agricultural and Food Chemistry, 60, 3005–3012.

Furgał-Dierżuk, I., Strzetelski, J., Kwiatek, K., Twardowska, M., Mazur, M., Sieradzki, Z., Kozaczyński, W., Bednarek, D., & Reichert, M. (2013). Genetically modified maize MON 810 and Roundup Ready soybean meal in cattle feeding. Wiadomości Zootechniczne, 51, 3–30.

Furgał-Dierżuk, I., Strzetelski, J., Kwiatek, K., Twardowska, M., Mazur, M., Sieradzki, Z., Kozaczyński, W., & Reichert, M. (2014). The effect of genetically modified maize (MON 810) and soyabean meal (Roundup Ready) on rearing performance and transfer of transgenic DNA to calf tissues. Journal of Animal and Feed Sciences, 23, 13–22.

Furgał-Dierżuk, I., Strzetelski, J., Twardowska, M., Kwiatek, K., & Mazur, M. (2015). The effect of genetically modified feeds on productivity, milk composition, serum metabolite profiles and transfer of tDNA into milk of cows. Journal of Animal and Feed Sciences, 24, 19–30.

Gu, J., Krogdahl, Å., Sissener, N. H., Kortner, T. M., Gelencser, E., Hemre, G.-I., & Bakke, A. M. (2013). Effects of oral Bt-maize (MON810) exposure on growth and health parameters in normal and sensitised Atlantic salmon, Salmo salar L. British Journal of Nutrition, 109, 1408–1423.

Gu, J., Bakke, A. M., Valen, E. C., Lein, I., & Krogdahl, Å. (2014). Bt-maize (MON810) and non-GM soybean meal in diets for Atlantic salmon (Salmo salar L.) juveniles–impact on survival, growth performance, development, digestive function, and transcriptional expression of intestinal immune and stress responses. PLoS One, 9, e99932.

Guertler, P., Brandl, C., Meyer, H. H., & Tichopad, A. (2012). Feeding genetically modified maize (MON810) to dairy cows: Comparison of gene expression pattern of markers for apoptosis, inflammation and cell cycle. Journal für Verbraucherschutz und Lebensmittelsicherheit, 7, 195–202.

Gulli, M., Salvatori, E., Fusaro, L., Pellacani, C., Manes, F., & Marmiroli, N. (2015). Comparison of drought stress response and gene expression between a GM maize variety and a near-isogenic non-GM variety. PLoS One, 10, e0117073.

Gyurcsó, G., Darvas, B., Baska, F., Simon, L., Takács, E., Klátyik, S., & Székács, A. (2022). Herbivorous juvenile grass carp (Ctenopharyngodon idella) fed with genetically modified MON 810 and DAS-59122 maize varieties containing Cry toxins: intestinal histological, developmental, and immunological investigations. Toxins, 14, 153.

Holderbaum, D. F., Traavik, T. I., Nodari, R. O., & Guerra, M. P. (2019). Comparison of in vitro callus-cultures from transgenic maize AG-5011YG (MON810) and conventional near-isogenic maize AG-5011. Crop Breeding and Applied Biotechnology, 19, 169–175.

Korwin-Kossakowska, A., Sartowska, K., Linkiewicz, A., Tomczyk, G., Prusak, B., & Sender, G. (2013). Evaluation of the effect of genetically modified Roundup Ready soya bean and MON 810 maize in the diet of Japanese quail on chosen aspects of their productivity and retention of transgenic DNA in tissues. Archives Animal Breeding, 56, 597–606.

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