Assessment of genetically modified soybean MON 87708 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21237)

TL;DR

This paper assesses the safety of genetically modified soybean MON 87708 for food and feed use, finding no new risks since its original approval.

Contribution

The study confirms the safety of MON 87708 based on new data, supporting its continued authorization.

Findings

No new hazards were identified in the renewal dossier for MON 87708.

Exposure and scientific uncertainties remain unchanged from the original assessment.

The DNA sequence of MON 87708 is identical to the originally assessed event.

Abstract

Following the submission of dossier GMFF‐2023‐21237 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, 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 herbicide tolerant genetically modified soybean MON 87708, 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, an evaluation of the literature retrieved by a scoping review, a search for 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 soybean MON 87708 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‐2023‐21237 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87708.

Full text

SUMMARY

Following the submission of dossier GMFF‐2023‐21237 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, 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 herbicide tolerant genetically modified soybean MON 87708. The scope of the renewal dossier GMFF‐2023‐21237 is for the renewal of the placing on the market of soybean MON 87708 for food and feed uses, excluding cultivation within the European Union (EU).

In delivering its scientific opinion, the GMO Panel took into account dossier GMFF‐2023‐21237, 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 dossier GMFF‐2023‐21237 contained: post‐market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for 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 soybean MON 87708 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‐2023‐21237 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87708 (EFSA GMO Panel, 2013).

INTRODUCTION

1

Background

1.1

On 11 March 2024, the European Food Safety Authority (EFSA) received from the European Commission (EC) dossier GMFF‐2023‐21237 for the renewal of the authorisation of soybean MON 87708 (Unique Identifier MON‐877Ø8‐9), submitted by Bayer CropScience LP (hereafter referred to as ‘the applicant’) according to Regulation (EC) No 1829/2003.1

Following receipt of dossier GMFF‐2023‐21237, 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 supplement the initial application. On 28 June 2024, EFSA declared the application valid and made the valid application available to the MS and the European Commission (EC).

Following the submission of application EFSA‐GMO‐NL‐2011‐93 and the publication of the EFSA scientific opinion (EFSA GMO Panel, 2013), the placing on the market of soybean MON 87708 was authorised by Commission Implementing Decision (EU) 2015/700 for (a) foods and food ingredients containing, consisting of, or produced from soybean MON‐877Ø8‐9, (b) feed containing, consisting of, or produced from soybean MON‐877Ø8‐9, and (c) soybean MON‐877Ø8‐9 in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.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 dossier GMFF‐2023‐21237. 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‐2023‐21237 as of date of validity.

Terms of Reference as provided by the requestor

1.2

EFSA and its GMO Panel were requested to carry out a scientific risk assessment of soybean MON 87708 for the renewal of authorisation, 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 soybean MON 87708, 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

2

Data

2.1

The applicant has submitted a confidential and a non‐confidential version of the dossier GMFF‐2023‐21237 following the EFSA requirements as detailed in EFSA GMO Panel (2015a) 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 10 January to 31 January 2025 for which no comments were received.

The GMO Panel based its scientific assessment of soybean MON 87708 on the valid dossier GMFF‐2023‐21237, additional information provided by the applicant during the risk assessment, relevant scientific comments submitted by EU MS and peer‐reviewed scientific publications.

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

Post‐market monitoring and post‐market environmental monitoring reports

12

2.1.1

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 soybean MON 87708, was a condition for the authorisation. As no potential adverse environmental effects were identified in the environmental risk assessment of soybean MON 87708 (EFSA GMO Panel, 2013), case‐specific monitoring was not considered necessary by the GMO Panel.

The applicant provided nine annual PMEM reports covering a reporting period from April 2015 to June 2023. 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 soybean import and processing) on any observed adverse effect(s) on human health and the environment arising from handling of soybean possibly containing soybean MON 87708; (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 literature

14

2.1.2

In addition to the separate searches provided as part of the annual PMEM reports, the applicant performed scoping reviews covering the period from January 2014 to February 2025, 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. After applying the eligibility/inclusion criteria defined a priori by the applicant, five peer‐reviewed and three non peer‐reviewed publications were identified as relevant for food and feed safety assessment. The relevant publications are listed in Appendix A.

Updated bioinformatics analyses

15

2.1.3

At the time of submission of the renewal dossier, the applicant provided a complete bioinformatics dataset for soybean MON 87708 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 DMO regarding their potential capacity to trigger celiac disease symptoms (EFSA GMO Panel, 2017) The outcome of the updated bioinformatics analyses is presented in Section 3.3.

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

16

2.1.4

In line with the renewal guidance requirements (EFSA, 2021; EFSA GMO Panel, 2015a), the applicant provided an overview on the worldwide approvals of soybean MON 87708 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 assessment

17

2.1.5

The applicant provided an overall assessment concluding that information provided in the application for renewal of authorisation of soybean MON 87708 for food and feed uses in the EU does not change the outcome of the original risk assessment (EFSA GMO Panel, 2013).

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

18

2.1.6

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

Methodologies

2.2

The GMO Panel assessed the application for renewal of the authorisation of soybean MON 87708 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, 2015a). The opinions raised by the nominated risk assessment bodies of EU Member States were taken into consideration during the scientific risk assessment.

ASSESSMENT

3

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

3.1

The GMO Panel assessed the nine PMEM reports submitted by the applicant. During the general surveillance activities covering the authorisation period of soybean MON 87708, no adverse effects were reported by the applicant. This was confirmed by the evaluation of the results of the annual literature searches and the annual communications by the operators collating reports of adverse effects from their member organisations and companies. No safety concerns were identified by the GMO Panel.

Evaluation of the systematic search and evaluation of literature

3.2

The GMO Panel assessed the applicant's literature searches on soybean MON 87708 and the newly expressed protein DMO. The overall quality of the performed literature searches is acceptable.

The GMO Panel reviewed the publications identified as relevant by the applicant. No new information raising safety concerns for human and animal health and the environment which would change the original risk assessment conclusions on soybean MON 87708 was identified (EFSA GMO Panel, 2013).

Evaluation of the updated bioinformatics analyses

3.3

Updated bioinformatics analyses to assess the potential interruption of soybean endogenous genes confirm previous results indicating that no endogenous genes were interrupted (EFSA GMO Panel, 2013, 2015b, 2019).

The updated analyses of the amino acid sequence of the newly expressed DMO protein confirm no significant similarities to toxins, allergens or immunogenic gluten‐related epitopes. Moreover, the updated bioinformatics analyses of the newly created ORFs within the insert and spanning the junctions between the insert and genomic DNA confirm previous results which did not indicate sequence similarities to toxins or allergens in soybean MON 87708 (EFSA GMO Panel, 2013, 2015b, 2019).

The updated bioinformatics analyses for event MON 87708 reveal 2 elements of bacterial origin with sufficient length and sequence identity to facilitate homologous recombination with native bacterial genes. However, no pairs of sequences which would facilitate transfer of inserts by double homologous recombination were identified. These results confirm previous conclusions that there is no indication for facilitated double homologous recombination from MON 87708 (EFSA GMO Panel, 2015b, 2019). Given the results of this analysis and that the recombinant DNA in maize MON 87708 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

3.4

Taking into account (i) the relevance for molecular characterisation, human and animal safety and the environment; and (ii) the scope of this renewal application, the applicant declared that there were no unpublished studies produced, controlled or sponsored by the applicant or provided to the applicant by a third party and not previously submitted to the EU since soybean MON 87708 was authorised.

Evaluation of the overall assessment

3.5

The GMO Panel evaluated the overall assessment provided by the applicant and confirms that there is no evidence in renewal dossier GMFF‐2023‐21237 indicating new hazards, relevant changes in exposure or scientific uncertainties that would change previous conclusions on soybean MON 87708.

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

3.6

The PMEM plan covers general surveillance of imported GM plant material, including soybean MON 87708. This general surveillance is coordinated by CropLife Europe and implemented by selected operators (federations involved in soybean 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‐2023‐21237, but reminds that the final adoption and implementation of the PMEM plan falls outside the mandate of EFSA.

CONCLUSIONS

4

Under the assumption that the DNA sequence of the event in soybean MON 87708 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‐2023‐21237 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87708 (EFSA GMO Panel, 2013).

DOCUMENTATION AS PROVIDED TO EFSA

5

• Letter from the European Commission to EFSA received on 11 March 2024 for the continued marketing of genetically modified soybean MON 87708 submitted in accordance with articles 11 and 23 of Regulation (EC) No 1829/2003 by Bayer CropScience LP (GMFF‐2023‐21237).
• The application was made valid on 28 June 2024.
• Additional Information (Clock 1) was requested on 4 October 2024.
• Additional Information (Clock 1) was received on 2 December 2024.
• Additional Information (Clock 2) was requested on 31 January 2025.
• Additional Information (Clock 2) was received on 25 March 2025.

ABBREVIATIONSGMgenetically modifiedGMOgenetically modified organismGMO PanelEFSA Panel on Genetically Modified OrganismsHGThorizontal gene transferORFsopen reading framesPMEMpost‐market environmental monitoring

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2024‐00154

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 copyright holder and users should seek permission to reproduce the content from the original source.

PANEL MEMBERS

Josep Casacuberta, Francisco Barro, Albert Braeuning, Ruud de Maagd, Michelle M. Epstein, Thomas Frenzel, Jean‐Luc Gallois, Frits Koning, Antoine Messéan, F. Javier Moreno, Fabien Nogué, Giovanni Savoini, Alan H. Schulman, Christoph Tebbe, and Eve Veromann.

Supporting information

Annex A_Cartagena protocol_soybean MON87708

Annex B_Labelling_soybean MON87708

Annex C_PMEM plan_soybean MON87708

Annex D_Validation report_soybean MON87708

Annex E_Validated method_soybean MON87708

Annex F_CRM_report_soybean MON87708

Annex G_DNA extraction_soybean MON87708

Annex H_MS comments_soybean MON 87708_nCI