Assessment of genetically modified maize MIR162 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-025)

Abstract

Following the submission of application EFSA-GMO-RX-025 under Regulation (EC) No 1829/2003 from Syngenta Crop Protection NV/SA, 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 genetically modified maize MIR162, for food and feed uses, excluding cultivation within the EU. 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. The GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-025 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MIR162.

Full text

SCIENTIFIC OPINION
ADOPTED: 1 September 2022
doi: 10.2903/j.efsa.2022.7562
Assessment of genetically modified maize MIR162
for renewal authorisation under Regulation (EC)
No 1829/2003 (application EFSA-GMO-RX-025)
EFSA Panel on Genetically Modified Organisms (GMO),
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 Nogu
e, Nils Rostoks,
Jose Juan S
anchez Serrano, Giovanni Savoini, Eve Veromann, Fabio Veronesi,
Ana Mart

ın Camargo, Tilemachos Goumperis, Dafni Maria Kagkli, Paolo Lenzi,
Aleksandra Lewandowska, Tommaso Raffaello and Franz Streissl
Abstract
Following the submission of application EFSA-GMO-RX-025 under Regulation (EC) No 1829/2003 from
Syngenta Crop Protection NV/SA, 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 genetically modified maize MIR162,
for food and feed uses, excluding cultivation within the EU. 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. The GMO Panel concludes that
there is no evidence in renewal application EFSA-GMO-RX-025 for new hazards, modified exposure or
scientific uncertainties that would change the conclusions of the original risk assessment on maize
MIR162.
Keywords: maize, MIR162, renewal, Articles 11 and 23, Regulation (EC) No 1829/2003
Requestor: European Commission
Question number: EFSA-Q-2021-00122
Correspondence: nif@efsa.europa.eu
EFSA Journal 2022;20(9):7562www.efsa.europa.eu/efsajournal
© 2022 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of
European Food Safety Authority.

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 Nogu
e, Nils Rostoks, Jose Juan S
anchez Serrano, Giovanni Savoini, Eve Veromann and
Fabio Veronesi.
Declarations of interest: If you wish to access the declaration of interests of any expert
contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu.
Acknowledgements: The Panel wishes to thank the members of its standing Working Groups on
Molecular Characterization, Food/Feed and Environmental Risk Assessment for the preparatory work on
this scientific opinion, and the EFSA staff members Michele Ardizzone, Giuseppe Emanuele Condorelli,
Antonio Fernandez Dumont and Pietro Piffanelli for the support provided to this scientific opinion.
Suggested citation: EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E,
Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ,
Naegeli H, Nogu
e F, Rostoks N, S
anchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Camargo AM,
Goumperis T, Kagkli DM, Lenzi P, Lewandowska A, Raffaello T and Streissl F, 2022. Scientific Opinion on
the assessment of genetically modified maize MIR162 for renewal authorisation under Regulation (EC)
No 1829/2003 (application EFSA-GMO-RX-025). EFSA Journal 2022;20(9):7562, 13 pp. https://doi.org/
10.2903/j.efsa.2022.7562
ISSN: 1831-4732
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, a European agency funded by the European Union.
Assessment of genetically modified oilseed rape GT73 for renewal authorisation
www.efsa.europa.eu/efsajournal 2 EFSA Journal 2022;20(9):7562
© 2022 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of
European Food Safety Authority.

Summary
Following the submission of application EFSA-GMO-RX-025 under Regulation (EC) No 1829/2003
from Syngenta Crop Protection NV/SA, 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 genetically
modified maize MIR162. The scope of the renewal application EFSA-GMO-RX-025 is for the renewal of
the placing on the market of products containing, consisting of, or produced from maize MIR162,
excluding cultivation within the European Union (EU).
In delivering its scientific opinion, the GMO Panel took into account application EFSA-GMO-RX-025,
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-025 contained: post-market environmental monitoring reports, an evaluation of the
literature retrieved by a systematic search, 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.
The GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-025
for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the
original risk assessment on maize MIR162 (EFSA, 2012).
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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.................................................................................................................................................. 9
Abbreviations .............................................................................................................................................. 9
Appendix A –List of relevant publications identified by the applicant through systematic literature searches
(January 2010–February 2022)..................................................................................................................... 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 MIR162 ..................................................... 13
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1. Introduction
1.1. Background
On 26 February 2021, the European Food Safety Authority (EFSA) received from the European
Commission (EC) application EFSA-GMO-RX-025 for the renewal of the authorisation of maize MIR162
(Unique Identifier SYN-IR162-4), submitted by Syngenta Crop Protection NV/SA (hereafter referred to
as ‘the applicant’) according to Regulation (EC) No 1829/2003
1
.
Following receipt of application EFSA-GMO-RX-025, 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 16 July 2021, EFSA declared the application valid and made the valid
application available to the MS and the EC.
Following the submission of application EFSA-GMO-DE-2010-82 and the publication of the EFSA
scientific opinion (EFSA, 2012), the placing on the market of maize MIR162 for products containing,
consisting of, or produced from this GM maize, excluding cultivation in the EU, was authorised by
Commission Implementing Decision 2012/651/EU
4
and Commission Implementing Decision (EU) 2019/
60 amending Decision 2009/866/EC, Decision 2010/419/EU, Implementing Decision 2012/651/EU and
Implementing Decision (EU) 2016/1685
5
. Copies of these authorisations were provided by the
applicant.
6
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-025. 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 EC (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
7
. The MS had 3 months to make their opinion known on application EFSA-GMO-RX-025 as of the
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 MIR162 for the renewal of authorization
for placing on the market of products containing, consisting of, or produced from GM maize MIR162 in
the context of its scope as defined in application EFSA-GMO-RX-025.
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.
8
In addition to the present scientific opinion on maize MIR162, 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.
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, pp. 1–23.
2
Available online: https://open.efsa.europa.eu/questions/EFSA-Q-2021-00122
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, pp. 1–48.
4
Commission Implementing Decision of 18 October 2012 authorising the placing on the market of products containing,
consisting of, or produced from genetically modified maize MIR162 (SYN-IR162-4) pursuant to Regulation (EC) No 1829/2003
of the European Parliament and of the Council. Official Journal of the European Union L 290/14, 20.10.2012.
5
Commission Implementing Decision (EU) 2019/60 of 11 January 2019 amending Decision 2009/866/EC, Decision 2010/419/EU,
Implementing Decision 2012/651/EU and Implementing Decision (EU) 2016/1685 as regards the representative of the
authorisation holder. Official Journal of the European Union L 12/31, 15.1.2019.
6
Dossier: Maize MIR162 –Annex I.
7
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, pp. 1–38.
8
Opinions of the nominated risk assessment bodies of EU Member States can be found at the Open EFSA Portal https://open.
efsa.europa.eu/questions, querying the assigned Question Number.
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The relevant information is made available in the Open EFSA portal,
9
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.
2. Data and methodologies
2.1. Data
The data for application EFSA-GMO-RX-025 submitted according to EFSA requirements (EFSA GMO
Panel, 2015; EFSA, 2019a) and provided by the applicant at the time of submission, or in reply to
requests for additional information, are specified below.
In the frame of the contracts OC/EFSA/GMO/2020/01 and OC/EFSA/GMO/2018/04, contractors
performed preparatory work and delivered reports on the methods applied by the applicant in
performing sequencing and literature search, respectively.
2.1.1. Post-market monitoring reports
10
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 MIR162, was a condition for the authorisation. As no
potential adverse environmental effects were identified in the environmental risk assessment of maize
MIR162 (EFSA, 2012), case-specific monitoring was not considered necessary by the GMO Panel.
The applicant provided nine annual PMEM reports covering a reporting period from October 2012 to
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 managed by EuropaBio
11
for the collection of information recorded by various
operators (federations involved in maize grains import, storage and processing) on any observed
adverse effect(s) on human health and the environment arising from handling of maize possibly
containing maize MIR162; (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
12
In addition to the separate searches provided as part of the annual PMEM reports, the applicant
performed two systematic literature searches covering the period from January 2010 until February
2022, in accordance with the recommendations on literature search outlined in EFSA (2010, 2019b).
Searches in electronic bibliographic databases and in websites of relevant organisations were
performed to identify relevant publications. Altogether 3,411 publications were identified (after removal
of duplicates). After applying the eligibility/inclusion criteria defined a priori by the applicant, 50 peer-
reviewed and non-peer-reviewed publications were identified as relevant for food and feed safety
assessment or molecular characterisation. The relevant publications are listed in Appendix A.
2.1.3. Updated bioinformatic data
13
At the time of submission of the renewal dossier, the applicant provided a complete bioinformatic
data set for maize MIR162 event including an analysis of the insert and flanking sequences, an
analysis of the potential similarity to allergens and toxins of the newly expressed protein 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
proteins VIP3Aa20 and PMI 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
Available online: https://open.efsa.europa.eu/questions/EFSA-Q-2021-00122
10
Dossier: Maize MIR162 –Annex II; additional information: 28/4/2022.
11
The responsibilities of EuropaBio in coordinating activities of technology providers on the post-market environmental
monitoring of GM crops were taken over by CropLife Europe as of 1 January 2021.
12
Dossier: Maize MIR162 –Annex III; additional information: 28/4/2022.
13
Dossier: Maize MIR162 –Annex III; additional information: 11/10/2021, 28/4/2022, 19/7/2022.
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2.1.4. Additional documents or studies provided by the applicant
14
In line with the renewal guidance requirements (EFSA GMO Panel, 2015; EFSA, 2019a), the
applicant provided an overview on the worldwide approvals of maize MIR162 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
15
The applicant provided an overall assessment concluding that information provided in the
application for renewal of authorisation of maize MIR162 for food and feed uses in the EU does not
change the outcome of the original risk assessment (EFSA, 2012).
2.1.6. Monitoring plan and proposal for improving the conditions of the original
authorisation
16
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 MIR162 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 MIR162, 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 MIR162 and the newly
expressed proteins VIP3Aa20 and PMI. 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
MIR162 (EFSA, 2012) 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 have been interrupted by event
MIR162 (EFSA, 2012; EFSA GMO Panel, 2019, 2021).
Analyses of the amino acid sequence of the newly expressed proteins VIP3Aa20 and PMI reveal no
significant similarities to toxins, allergens or immunogenic gluten-related epitopes. The updated
bioinformatic analyses of the newly created ORFs within the insert do not indicate sequence similarities
to toxins or allergens in maize MIR162. In addition, the updated bioinformatic analysis of the newly
created ORFs spanning the junctions with genomic DNA confirms previous results which did not
indicate sequence similarities to toxins or allergens in maize MIR162 (EFSA, 2012; EFSA GMO
Panel, 2019, 2021).
14
Dossier: Maize MIR162 –Annex III; additional information: 11/10/2021, 28/4/2022.
15
Dossier: Maize MIR162 –Annex III.
16
Dossier: Maize MIR162 –Part III –Summary.
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The updated bioinformatic analyses for event MIR162 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, 2012; EFSA GMO Panel, 2019,
2021). Given the results of this analysis and that the recombinant DNA in maize MIR162 does not
confer selective advantages to 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, including a new
sequencing study (Appendix B). The sequencing data are compliant with the requirements laid down in
the EFSA Technical Note on the quality of DNA sequencing for the molecular characterisation of
genetically modified plants (EFSA GMO Panel, 2018). The study reports a nucleotide difference in the
sequence of the event in recent plant material (year of collection 2018), compared to the sequence of
the event in the originally assessed application (EFSA, 2012). The difference is located in a cytosine
homopolymer region in the second of the two ZmUbiInt promoters contained in the MIR162 insert (bp
6,770–6,782). The location of the difference suggests that it is due to the technical difficulties with
sequencing the homopolymer regions. Bioinformatic analyses identified no risks for human and animal
safety related to the nucleotide difference.
Overall, the new additional documents or studies provided by the applicant do not raise any
concern for human and animal health and the environment, which would change the original risk
assessment conclusions on maize MIR162.
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-025 indicating new hazards, relevant changes in
exposure or scientific uncertainties that would change previous conclusions on maize MIR162.
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 MIR162.
This general surveillance is coordinated by CropLife Europe 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-025, 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
The GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-025 for
new hazards, modified exposure or scientific uncertainties that would change the conclusions of the
original risk assessment on maize MIR162 (EFSA, 2012).
5. Documentation as provided to EFSA
1) Letter from the European Commission to EFSA received on 26 February 2021 for the
continued marketing of genetically modified maize MIR162 submitted in accordance with
articles 11 and 23 of Regulation (EC) No 1829/2003 by Syngenta Crop Protection NV/SA
(EFSA-GMO-RX-025).
2) Application EFSA-GMO-RX-025 validated by EFSA, 16 July 2021.
3) Request for supplementary information to the applicant, 11 August 2021.
4) Receipt of supplementary information from the applicant, 10 November 2021.
5) Request for supplementary information to the applicant, 2 February 2022.
6) Receipt of supplementary information from the applicant, 28 April 2022.
7) Request for supplementary information to the applicant, 20 May 2022.
8) Receipt of supplementary information from the applicant, 19 July 2022.
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Opinion on the assessment of genetically modified maize MON 87427 9MON 89034 9MIR162 9MON 87411
and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-
2017-144). EFSA Journal 2019;17(11):5848, 33 pp. https://doi.org/10.2903/j.efsa.2019.5848
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, De Sanctis, G, Devos, Y, Fernandez,
A, Gennaro, A, G
omez Ruiz, J
A, Lanzoni, A, Neri, FM, Papadopoulou, N, Paraskevopoulos, K and Raffaello, T,
2021. Scientific Opinion on the assessment of genetically modified maize 1507 9MIR162 9MON810 9NK603
and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-
2015-127). EFSA Journal 2021;19(1):6348, 40 pp. https://doi.org/10.2903/j.efsa.2021.6348
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
PMI phosphomannose isomerase
VIP3Aa20 vegetative insecticidal protein (vip3Aa variant)
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Appendix A –List of relevant publications identified by the applicant
through systematic literature searches (January 2010–February 2022)
References
Dively GP, Huang F, Oyediran I, Burd T, Morsello S. 2020. Evaluation of gene flow in structured and seed blend
refuge systems of non-Bt and Bt corn. J Pest Sci 93:439–447.
Food Standards Australia New Zealand. 2011a. A1060 GM Corn Line 5,307 AR FINAL.
https://www.foodstandards.gov.au/code/applications/Documents/A1060%20GM%20Corn%20Line%205307%
20AR%20FINAL.pdf
Food Standards Australia New Zealand. 2011b. A1060.
https://www.foodstandards.gov.au/code/applications/Documents/A1060.zip
Food Standards Australia New Zealand. 2012. A1060 GM Corn Line 5,307 AppR FINAL.
https://www.foodstandards.gov.au/code/applications/Documents/A1060%20GM%20Corn%20Line%205307%
20AppR%20FINAL.pdf
Food Standards Australia New Zealand. 2016. A1138 Application_Redacted.
https://www.foodstandards.gov.au/code/applications/Documents/A1138%20Application_Redacted.pdf
Food Standards Australia New Zealand. 2017a. A1138_SD1_at approval.
https://www.foodstandards.gov.au/code/applications/Documents/A1138_SD1_at%20approval.pdf
Food Standards Australia New Zealand. 2017b. A1138 SD1.
https://www.foodstandards.gov.au/code/applications/Documents/A1138%20SD1.pdf
Food Standards Australia New Zealand. 2020a. A1060 GM Corn Line 5,307 AppR SD1 Safety Assess.
https://www.foodstandards.gov.au/code/applications/Documents/A1060%20GM%20Corn%20Line%205307%
20AppR%20SD1%20Safety%20Assess.pdf
Food Standards Australia New Zealand. 2020b. A1060 GM Corn Line 5,307 AR SD1 Safety Assess.
https://www.foodstandards.gov.au/code/applications/Documents/A1060%20GM%20Corn%20Line%205307%
20AR%20SD1%20Safety%20Assess.pdf
Food Standards Australia New Zealand. 2020c. A1202 Executive Summary_Redacted.
https://www.foodstandards.gov.au/code/applications/Documents/A1202%20Executive%20Summary_Redacted.pdf
Food Standards Australia New Zealand. 2020d. A1202 SD1.
https://www.foodstandards.gov.au/code/applications/Documents/A1202%20SD1.pdf
Health Canada. 2010a. Decision Document DD2010-79 Determination of the Safety of Syngenta Seeds Canada
Inc.’s Corn (Zea mays L.) Event MIR162.
https://www.canada.ca/en/news/archive/2010/07/decision-document-dd2010-79-determination-safetysyngenta-
seeds-canada-inc-corn-zea-mays-eventmir162.html
Health Canada. 2010b. DD2010-79: Determination of the Safety of Syngenta Seeds Canada Inc.’s Corn (Zea
mays L.) Event MIR162 - Canadian Food Inspection Agency.
https://www.inspection.gc.ca/plant-health/plants-withnovel-traits/approved-under-review/decisiondocuments/
dd2010-79/eng/1310494079263/1310494159104
Health Canada. 2011. DD2007-68: Determination of the Safety of Syngenta Seeds Inc.’s Corn (Zea mays L.)
Event MIR604 - Canadian Food Inspection Agency.
https://inspection.canada.ca/plant-varieties/plantswith-novel-traits/approved-under-review/decisiondocuments/
dd2007-68/eng/1310746461506/1310746547873
Health Canada. 2013. Decision Document DD 2013–96: Determination of the Safety of Syngenta Canada Inc.’s
Corn (Zea mays L.) Event 5,307 - Canadian Food Inspection Agency.
https://www.inspection.gc.ca/plants/plants-with-noveltraits/approved-under-review/decision-documents/dd-2013-
96/eng/1378914978025/1378915059235
Health Canada. 2015a. Novel Food Information –Insect Resistant Corn 5,307.
https://www.canada.ca/en/health-canada/services/foodnutrition/genetically-modified-foods-other-novelfoods/
approved-products/novel-food-informationinsect-resistant-corn-5307.html
Health Canada. 2015b. Novel Food Information –Insect Resistant Corn Event MIR 162.
https://www.canada.ca/en/health-canada/services/foodnutrition/genetically-modified-foods-other-novelfoods/
approved-products/novel-food-informationinsect-resistant-corn-event-162.html
Health Canada. 2018. Novel Food Information –Provitamin A Biofortified Rice Event GR2E (Golden Rice).
https://www.canada.ca/en/health-canada/services/foodnutrition/genetically-modified-foods-other-novelfoods/
approved-products/novel-food-informationgolden-rice-gr2e.html
Herman, R. A.,Hou, Z.,Mirsky, H.,Nelson, M. E.,Mathesius, C. A.,Roper, J. M. 2021. History of safe exposure and
bioinformatic assessment of phosphomannose-isomerase (PMI) for allergenic risk. Transgenic Res 30:201–206.
Assessment of genetically modified oilseed rape GT73 for renewal authorisation
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References
Liu W, Liu X, Liu C, Zhang Z, Jin W. 2020. Development of a sensitive monoclonal antibody-based sandwich
ELISA to detect Vip3Aa in genetically modified crops. Biotechnol Lett 42:1467–1,478.
Long, N, Bottoms, J, Meghji, M, Hart, H, Que, Q, Pulliam, D. 2012. Corn event MIR162. Syngenta Participations
AG, assignee. U.S. Patent No. 8,232,456. Washington, DC: U.S. Patent Office.
Long, N, Bottoms, J, Meghji, M, Hart, H, Que, Q, Pulliam, D. 2013a. Corn event MIR162. Syngenta Participations
AG, assignee. U.S. Patent No. 8,455,720. Washington, DC: U.S. Patent Office.
Long, N, Bottoms, J, Meghji, M, Hart, H, Que, Q, Pulliam, D. 2013b. Corn event MIR162. Syngenta Participations
AG, assignee. U.S. Patent No. 8,618,272. Washington, DC: U.S. Patent Office.
Long, N, Bottoms, J, Meghji, M, Hart, H, Que, Q, Pulliam, D. 2017. Corn event MIR162. Syngenta Participations
AG, assignee. U.S. Patent No. 9,752,198. Washington, DC: U.S. Patent Office.
Ministry of Agriculture, Forestry and Fisheries. 2010a. Safety confirmation related to “heat-resistant? -amylase-
producing corn 3,272 line”.http://www.maff.go.jp/j/press/syouan/tikusui/pdf/100326_1-01.pdf
Ministry of Agriculture, Forestry and Fisheries. 2010b. Coleoptera pest-resistant corn (ecry3.1Ab, Zea mays subsp ...)
https://www.affrc.maff.go.jp/docs/commitee/diversity/100201/pdf/siryou_2-2.pdf
Ministry of Agriculture, Forestry and Fisheries. 2018. Document 5–2.
https://www.affrc.maff.go.jp/attach/pdf/20190201-13.pdf
Ministry of Agriculture, Forestry and Fisheries. N.d. Document 5–2.
http://www.maff.go.jp/j/council/sizai/siryou/22_21/pdf/data5-2.pdf
Ministry of Agriculture, Forestry and Fisheries. N.d. Document 5–3.
http://www.maff.go.jp/j/council/sizai/siryou/25_24/pdf/data5-3.pdf
Ministry of Agriculture, Forestry and Fisheries. N.d. Document 7.
http://www.maff.go.jp/j/council/sizai/siryou/33/pdf/data7.pdf
Ministry of Agriculture, Forestry and Fisheries. N.d. Safety confirmation for “Lepidoptera pest resistant corn
MIR162 line”.http://www.maff.go.jp/j/press/syouan/tikusui/pdf/100326_1-02.pdf
Ministry of Agriculture, Forestry and Fisheries. N.d. vip3A, pat, mEPSPS, Zea mays subsp. Mays.
http://www.affrc.maff.go.jp/docs/commitee/diversity/091217/pdf/siryou_3-1.pdf
National Technical Commission on Biosafety. 2016. Opinion Views Rapporteur Karen.
http://ctnbio.mctic.gov.br/documents/566529/2076451/Parecer+Vistas+Relator+Karen/403c4035-8db2-4422-
8d61-055e1b44c414
Raybould A, Higgins, LS, Horak, MJ, Layton, RJ, Storer, NP, De La Fuente, J M, Herman, RA. 2012. Assessing the
ecological risks from the persistence and spread of feral populations of insect-resistant transgenic maize.
Transgenic Res, 21:655–664.
Raybould A, Vlachos D. 2011. Non-target organism effects tests on Vip3A and their application to the ecological
risk assessment for cultivation of MIR162 maize. Transgenic Res 20:599–611.
United States Department of Agriculture. 2010. 20,560 Federal Register /Vol. 75, No. 75/Tuesday, April 20, 2010 -
Syngenta Biotechnology, Inc.; Determination of Nonregulated Status for Corn Genetically Engineered for Insect
Resistance.
https://www.aphis.usda.gov/brs/fedregister/BRS_20100420.pdf
United States Department of Agriculture. 2011a. NATIONAL ENVIRONMENTAL POLICY ACT DECISION AND
FINDING OF NO SIGNIFICANT IMPACT: MIR162 Maize SYN-IR162-4.
https://www.aphis.usda.gov/brs/aphisdocs2/07_25301p_com.pdf
United States Department of Agriculture. 2011b. NATIONAL ENVIRONMENTAL POLICY ACT DECISION AND
FINDING OF NO SIGNIFICANT IMPACT: ALPHA-AMYLASE MAIZE EVENT 3272.
https://www.aphis.usda.gov/brs/aphisdocs/05_28001p_fonsi_rtc.pdf
United States Department of Agriculture. 2011c. Event 5,307 USDA Petition –USDA-APHIS.
https://www.aphis.usda.gov/brs/aphisdocs/10_33601p.pdf
United States Department of Agriculture. 2011d. ENVIRONMENTAL REPORT Petition for Determination of
Nonregulated Status of Event 5,307 Corn.
https://www.aphis.usda.gov/brs/aphisdocs/10_33601p_syngenta_er.pdf
United States Department of Agriculture. 2013. Final Environmental Assessment - USDA-APHIS.
https://www.aphis.usda.gov/brs/aphisdocs/10_33601p_fea.pdf
United States Department of Agriculture. 2019. Petition for the Determination of Nonregulated Status of Maize
Event PY203.
https://www.aphis.usda.gov/brs/aphisdocs/19_17601p.pdf
Assessment of genetically modified oilseed rape GT73 for renewal authorisation
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References
United States Department of Agriculture. N.d. I. Summary –USDA-APHIS.
https://www.aphis.usda.gov/brs/aphisdocs/04_36201p_pea.pdf
United States Department of Agriculture. N.d. Plant Pest Risk Assessment for MIR162 Corn - USDA-APHIS.
https://www.aphis.usda.gov/brs/aphisdocs/07_25301_pra.pdf
United States Department of Agriculture. N.d. Plant Pest Risk Assessment for Event 3,272 Corn –USDA.
https://www.aphis.usda.gov/brs/aphisdocs/05_28001p_pra.pdf
United States Department of Agriculture. N.d. Plant Pest Risk Assessment for Event 3,272 Corn.
https://www.aphis.usda.gov/brs/aphisdocs/05_28001p_ppra.pdf
United States Environmental Protection Agency. N.d. Bacillus thuringiensis Cry1Ab Delta-Endotoxin Protein and
the Genetic Material Necessary for Its Production (via Elements of Vector pZO1502) in Event Bt11 Corn (OECD
Unique Identifier: SYN-BTØ11-1)(006444) & Bacillus thuringiensis Vip3Aa20 Insecticidal Protein and the Genetic
Material Necessary for Its Production (via Elements of Vector pNOV1300) in Event.
https://www3.epa.gov/pesticides/chem_search/reg_actions/registration/fs_PC-006444_01-Mar-09.pdf
United States Food and Drug Administration. 2018. Biotechnology Notification File No. 000158 Note to the File.
https://www.fda.gov/media/113374/download
Wang, X, Zhang, S, Hu, D, Zhao, X, Li, Y, Liu, T, Li, Y. 2014. BcPMI2, isolated from nonheading Chinese cabbage
encoding phosphomannose isomerase, improves stress tolerance in transgenic tobacco. Mol Biol Rep 41:2207–
2,216.
Zhang, M, Zhuo, X, Wang, J, Yang, C, Powell, CA, Chen, R. 2015. Phosphomannose isomerase affects the key
enzymes of glycolysis and sucrose metabolism in transgenic sugarcane overexpressing the manA gene. Mol
Breeding 35:100.
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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 MIR162
Study
identification Title
TK0060148 Metabolic Profiling of Sugars and Sugar Phosphates in Grain Derived from MIR162 Maize
JY150240-1 Report of oral acute toxicity study of PMI protein
TK0107154 Characterisation of Vegetative Insecticidal Protein (Vip3Aa20) Test Substance and
Certificate of Analysis
TK0235588 Characterisation of Microbially Produced Test Substance PMI-0114 Containing
Phosphomannose Isomerase (PMI) Protein and Certificate of Analysis
TK0285529 In vitro Digestibility of Phosphomannose Isomerase (PMI) Protein Under Simulated
Mammalian Gastric Conditions for China
TK0329350 Effect of Temperature on the Stability of Phosphomannose Isomerase (PMI) Protein
WIL-639227;
TK0256516
A Single-Dose Oral Gavage Toxicity Study of PMI-0114 in CD-1 Mice with a 14-Day
Recovery Period
TK0428575 Event MIR162: Insert and Flanking Sequence Analysis of Event MIR162 in Material ID
12MG000996
TK0537123 Storage Stability Assessment of Microbially Produced Test Substance VIP3A20–0111
Containing Vip3Aa20 Protein
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