Event MIR162 is a genetically modified maize developed via Agrobacterium tumefaciens mediated transformation of maize embryos. MIR162 plants contain the transgenes vip3Aa20, a modified version of the native vip3Aa1 from Bacillus thuringiensis, and the pmi gene from Escherichia coli. Vip3Aa20 encodes the insecticidal Vip3Aa20-protein, conferring MIR162 with resistance to several species of lepidopteran (order of butterflies and moths) insect pests. Pmi encodes the enzyme phosphomannose isomerase (PMI) which catalyses the isomerization of mannose-6-phosphate to fructose-6-phosphate. PMI was used as a selectable marker during development of MIR162. The scientific documentation provided in the renewal application (EFSA-GMO-RX-025) for maize MIR162 is adequate for risk assessment, and in accordance with EFSA guidance on risk assessment of genetically modified plants for use in food or feed. The VKM GMO panel does not consider the introduced modifications in event MIR162 to imply potential specific health or environmental risks in Norway, compared to EU-countries. The EFSA opinion is adequate also for Norwegian considerations. Therefore, a full risk assessment of maize event MIR162 was not performed by the VKM GMO Panel.Assessment of genetically modified maize MIR162 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (renewal application EFSA-GMO-RX-025)publishedVersio

Bodin, Johanna Eva

Duale, Nur

Jevnaker, Anne-Marthe Ganes

Sanden, Monica

Sipinen, Ville Erling

Thorstensen, Tage

English

Brage IMR

   VKM Report 2023:4 Assessment of genetically modified maize MIR162 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (renewal application EFSA-GMO-RX-025) Scientific Opinion of the Panel on genetically modified organisms of the Norwegian Scientific Committee for Food and Environment  VKM Report 2023:4 VKM Report 2023:4  Title: Assessment of genetically modified maize MIR162 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (renewal application EFSA-GMO-RX-025) Scientific Opinion of the Panel on genetically modified organisms of the Norwegian Scientific Committee for Food and Environment 06.01.2023 ISBN: 978-82-8259-412-7 ISSN: 2535-4019 Norwegian Scientific Committee for Food and Environment (VKM)  Postboks 222 Skøyen 0213 Oslo Norway  Phone: +47 21 62 28 00 Email: vkm@vkm.no vkm.no  Cover photo: Colourbox  Suggested citation: VKM, Monica Sanden (Chair), Johanna Bodin, Nur Duale, Anne Marthe Jevnaker, Ville Erling Sipinen and Tage Thorstensen (2023). Assessment of genetically modified maize MIR162 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (renewal application EFSA-GMO-RX-025). Scientific Opinion of the Panel on genetically modified organisms (GMO) of the Norwegian Scientific Committee for Food and Environment. VKM Report 2023:4, ISBN: 978-82-8259-412-7, ISSN: 2535-4019. Norwegian Scientific Committee for Food and Environment (VKM), Oslo, Norway.    VKM Report 2023:4 Assessment of genetically modified maize MIR162 for food and feed uses, import and processing (renewal application EFSA-GMO-RX-025) under regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed Authors of the opinion The authors have contributed to the opinion in a way that fulfils the authorship principles of VKM (VKM, 2019). The principles reflect the collaborative nature of the work, and the authors have contributed as members of the VKM Panel on genetically modified organisms.  Members of the Panel on genetically modified organisms: Monica Sanden (chair), Johanna Bodin, Nur Duale and Tage Thorstensen. VKM staff: Anne Marthe Jevnaker and Ville Erling Sipinen      VKM Report 2023:4 Table of Contents Summary ................................................................................................................ 5 Sammendrag .......................................................................................................... 6 Background as provided by the Norwegian Food Safety Authority and the Norwegian Environment Agency .................................................................... 7 1 Assessment of genetically modified maize MIR162 (renewal application EFSA-GMO-RX-025) ....................................................................................... 8 1.1 Comments during the EFSA scientific consultation-period .......................................... 8 1.2 Considerations after EFSAs publication of their scientific opinion – part 1 .................. 11 1.3 Considerations after EFSAs publication of their scientific opinion – part 2 .................. 12 2 Conclusions .................................................................................................. 13 3 References ................................................................................................... 14   VKM Report 2023:4  5  Summary  Event MIR162 is a genetically modified maize developed via Agrobacterium tumefaciens mediated transformation of maize embryos. MIR162 plants contain the transgenes vip3Aa20, a modified version of the native vip3Aa1 from Bacillus thuringiensis, and the pmi gene from Escherichia coli. Vip3Aa20 encodes the insecticidal Vip3Aa20-protein, conferring MIR162 with resistance to several species of lepidopteran (order of butterflies and moths) insect pests. Pmi encodes the enzyme phosphomannose isomerase (PMI) which catalyses the isomerization of mannose-6-phosphate to fructose-6-phosphate. PMI was used as a selectable marker during development of MIR162. The scientific documentation provided in the renewal application (EFSA-GMO-RX-025) for maize MIR162 is adequate for risk assessment, and in accordance with EFSA guidance on risk assessment of genetically modified plants for use in food or feed. The VKM GMO panel does not consider the introduced modifications in event MIR162 to imply potential specific health or environmental risks in Norway, compared to EU-countries. The EFSA opinion is adequate also for Norwegian considerations. Therefore, a full risk assessment of maize event MIR162 was not performed by the VKM GMO Panel.    VKM Report 2023:4  6 Sammendrag MIR162 er en genmodifisert mais utviklet via Agrobacterium tumefaciens mediert transformasjon av maisembryoer. MIR162-planter inneholder transgenene vip3Aa20, en modifisert versjon av det opprinnelige genet vip3Aa1 fra Bacillus thuringiensis, og et pmi-gen fra Escherichia coli. Vip3Aa20 koder for det insekticide Vip3Aa20-proteinet, som gir plantene resistens mot flere arter av skadegjørere innen ordenen Lepidoptera (sommerfugler og møll). Pmi koder for enzymet fosfomannoseisomerase (PMI), som katalyserer isomerisering av mannose-6-fosfat til fruktose-6-fosfat. PMI ble brukt som transformasjonsmarkør i utviklingen av MIR162. Den vitenskapelige dokumentasjonen i fornyelsessøknaden (EFSA-GMO-RX-025) for MIR162 er dekkende for risikovurdering, og i samsvar med EFSA retningslinjer for risikovurdering av genmodifiserte planter til bruk i mat eller fôr. De genetiske endringene i maisen tilsier ingen økt helse- eller miljørisiko i Norge sammenlignet med EU-land. EFSAs risikovurdering er derfor tilstrekkelig også for norske forhold. Ettersom det ikke har blitt identifisert særnorske forhold vedrørende egenskaper ved mais MIR162, har VKMs GMO panel ikke utført en fullstendig risikovurdering av maisen.      VKM Report 2023:4  7 Background as provided by the Norwegian Food Safety Authority and the Norwegian Environment Agency The Norwegian Food Safety Authority (NFSA) and the Norwegian Environment Agency (NEA) have assigned VKM to perform assessments of genetically modified organisms (GMOs) and derived products thereof, for which there are sought approval of authorisation to the European market under the Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. VKM is requested to perform assessments for all GMO applications made accessible through the EFSA Document Management System (DMS), where the main focus should be on potential health or environmental risks specific to Norway compared to the EU.     VKM Report 2023:4  8 1 Assessment of genetically modified maize MIR162 (renewal application EFSA-GMO-RX-025)  1.1 Comments during the EFSA scientific consultation-period When EFSA submits an application for scientific consultation with a three-month commenting deadline, VKM shall initiate the scientific assessment. From the application is submitted for scientific consultation until EFSA has published its Scientific Opinion (6.5 months + the period when 'the clock stops') VKM should:  • Use this period to assess the scientific quality of the documentation presented in the application. Possible lack of essential information and other relevant scientific literature should be addressed. The application must be in compliance with Regulation (EU) No. 503/2013 and adhere to EFSA guidance (EFSA 2010, 2011) for risk assessment of genetically modified organisms.  • Provide comments to EFSA within the deadline and inform The Norwegian Food Safety Authority (NFSA) and the Norwegian Environment Agency (NEA) no later than two weeks before the deadline. If no comments are provided to EFSA, VKM notifies the NFSA and NEA for the reasons why no comment was submitted. • Assess whether there are considerations specific to Norway that need to be addressed. If such considerations are identified VKM should immediately inform the NFSA and NEA.     VKM Report 2023:4  9 Stage 1   1. Application EFSA-GMO-RX-025 Genetically modified maize MIR162 2. Information related to the genetic modification: Maize MIR162 was developed via Agrobacterium tumefaciens mediated transformation of maize embryos. MIR162 plants contain the transgenes vip3Aa20, a modified version of the native vip3Aa1 from Bacillus thuringiensis, and a pmi-gene from Escherichia coli. Vip3Aa20 encodes the insecticidal Vip3Aa20 protein, conferring resistance to several species of lepidopteran (order of butterflies and moths) insect pests. Pmi encodes the enzyme phosphomannose isomerase (PMI) which catalyses the isomerization of mannose-6-phosphate to fructose-6-phosphate. PMI was used as a selectable marker during development of MIR162. Genes vip3Aa20 pmi Proteins Vip3Aa20, insecticidal protein  PMI, phosphomannose isomerase 3. Previously assessed by VKM                             YES: X         NO:  4. If yes in item 3. – comments from VKM:  Maize MIR162 was assessed by VKM as a single event in the application   EFSA/GMO/DE/2010/82.  And, on several occasions as part of different stacked maize events:  Bt11 x MIR162 x MIR604 x GA21 (EFSA/GMO/DE/2009/66) Bt11 x MIR162 x GA21 (EFSA/GMO/DE/2009/67) Bt11 x MIR162 x 1507 x GA21 (EFSA/GMO/DE/2010/86) Bt11 x MIR162 x MIR604 x 1507 x 5307 x GA21 (EFSA/GMO/DE/2011/103) 1507 x MON 810 x MIR162 x NK603 (EFSA/GMO/NL/2015/127) MON 87427 x MON 89034 x MIR162 x NK603 (EFSA/GMO/NL/2016/131) MON 87427 x MON 87460 x MON 89034 x MIR162 x NK603 (EFSA/GMO/NL/2016/134) MON 87427 × MON 89034 × MIR162 × MON 87411 (EFSA/GMO/NL/2017/144) Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21 (EFSA/GMO/DE/2018/149) MON 89034 x 1507 x MIR162 x NK603 x DAS-40278-9 (EFSA/GMO/NL/2018/151)  5. Date when EFSA declared the application as valid in accordance with Articles 6(1) and 18(1)   16.07.21 6. Deadline of EFSAs commenting period 16.10.21   VKM Report 2023:4  10  7. VKMs assessment of the documentation in the application  Applicants documentation:      Additional literature used by VKM: No   Documentation in compliance with Regulation (EU) No. 503/2013:   Documentation in accordance with EFSA guidance for risk assessment of genetically modified plants (EFSA 2010, 2011):     The scientific documentation provided in the renewal application (EFSA-GMO-RX-025) for maize MIR162 is adequate for risk assessment     YES:  X        NO:     YES:   X       NO:  8. Comments submitted from VKM during EFSAs public consultation  YES:          NO: X 9. Date of submission from VKM  10. Comment(s) to EFSA:                                            11.  If NO in item 8. – comments from VKM:  VKM did not assess the application during the EFSA scientific consultation-period (stage 1) in accordance with the assignment from NFSA and NEA, due to other pressing priorities.  12. Need for national consideration(s)  YES:          NO:         NA: X 13. If YES in item 12. – comments from VKM:   14.  If NO or NA in item 12. – comments from VKM:  VKM did not assess the application during the EFSA scientific consultation-period (stage 1) in accordance with the assignment from NFSA and NEA, due to other pressing priorities.  15. VKMs conclusion regarding the application:     VKM Report 2023:4  11 1.2 Considerations after EFSAs publication of their scientific opinion – part 1 When EFSA publishes their scientific opinion together with the comments from the member states, VKM shall within a month inform the NFSA and EEA on the following:  • Are EFSA’s answer(s) to the Norwegian comments satisfactorily answered, or do VKM still have scientific objections to EFSA’s conclusions   • Do EFSA’s answers to comments from member states indicate need for follow-up by VKM • Considerations specific to Norway      Stage 2 1. Date of publication of EFSA opinion   22.09.22 2. VKMs deadline for informing NFSA and EEA 22.10.22 3. If YES in item 8. (Table 1)–  Answer from EFSA has been considered by VKM as satisfactory (Annex G)   YES:   NO:   NA: X 4. If YES in item 3 – Comments from VKM:   5. If NO or NA in item 3 – Comment(s) and further considerations from VKM:  VKM did not assess the application during Stage 1. due to other pressing priorities.  6. Follow-up item 12 (table 1) – comments from VKM     7. Considerations from VKM regarding comments from EU member states and other countries under Annex G: No member state comments imply the need for follow-up by VKM.   VKM Report 2023:4  12 1.3 Considerations after EFSAs publication of their scientific opinion – part 2 If VKM’s comments regarding health and environmental risk are not considered to be satisfactorily answered by EFSA, VKM shall within three months carry out a risk assessment of these conditions, as well as conditions specific to Norway. VKM shall highlight uncertainty and knowledge gaps. It shall be stated in what area there are knowledge gaps, and whether the uncertainty, quality of the data, and knowledge gaps will affect the conclusion.   Stage 3 1. Need for further assessment(s)    YES:          NO: X 2. If YES in item 1. – Further considerations from VKM:   3. If NO or NA in item 1. – comments from VKM:   The scientific documentation provided in the application is adequate for risk assessment, and in accordance with the EFSA guidance on risk assessment of genetically modified plants for use in food or feed.  No member state comments regarding the application imply the need for follow-up by VKM.  The EFSA opinion is adequate also for Norwegian considerations. 4. Need for national considerations       YES:          NO: X 5. If YES in item 4. – comments from VKM:   6. If NO in item 4. – comments from VKM   The VKM GMO Panel does not consider the introduced modifications in event maize MIR162 to imply potential specific health or environmental risks in Norway, compared to EU-countries.   7. Need for a risk assessment  YES:          NO: X 8. Date of deadline for risk assessment Not applicable 9. Date of publication of assessment 06.01.2023   VKM Report 2023:4  13 2 Conclusions The VKM GMO Panel has performed an assessment of the genetically modified maize MIR162. MIR162 plants contain the transgenes vip3Aa20 and pmi which encode the proteins Vip3Aa20 and phosphomannose isomerase (PMI). Vip3Aa20 confers MIR162-plants with resistance to species of lepidopteran insect pests. PMI is an enzyme used as a selectable marker during the development of maize MIR162. The VKM GMO panel has assessed the documentation in application EFSA-GMO-RX-025. The scientific documentation provided in the application is adequate for risk assessment, and in accordance with the EFSA guidance on risk assessment of genetically modified plants for use in food or feed.   The GMO panel does not consider the introduced modifications in maize MIR162 to imply potential specific health or environmental risks in Norway, compared to EU-countries. The insect resistance of maize MIR162 has no practical uses in Norway. The EFSA opinion is adequate also for Norwegian considerations.       VKM Report 2023:4  14 3 References EFSA (2010) Guidance on the environmental risk assessment of genetically modified plants. Scientific option from the EFSA Panel on Genetically Modified Organisms (GMO). The EFSA Journal 8 (11):1-111 http://www.efsa.europa.eu/en/efsajournal/doc/1879.pdf EFSA (2011) Guidance for risk assessment of food and feed from genetically modified plants. The EFSA Journal 9(5): 2150. http://www.efsa.europa.eu/en/efsajournal/doc/2150.pdf EFSA (2022) 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. DOI: https://doi.org/10.2903/j.efsa.2022.7562       

Assessment of genetically modified maize MIR162 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (renewal application EFSA-GMO-RX-025)

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Assessment of genetically modified maize MIR162 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (renewal application EFSA-GMO-RX-025)

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