Assessment of genetically modified soybean MON 87705 for renewal authorisation under Regulation (EC) No 1829/2003 (application GMFF‐2023‐21236)

TL;DR

This paper assesses the safety of genetically modified soybean MON 87705 for continued use in food and feed, finding no new risks.

Contribution

The study confirms the original safety conclusions for MON 87705 with new data, supporting its renewal authorization.

Findings

No new hazards were identified in MON 87705 soybean.

Post-market monitoring reports did not reveal modified exposure or uncertainties.

Updated bioinformatics analyses confirmed prior risk assessments.

Abstract

Following the submission of application GMFF‐2023‐21236 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, increased oleic acid genetically modified soybean MON 87705, 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, post‐market 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 87705 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application GMFF‐2023‐21236 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87705.

Full text

SUMMARY

Following the submission of application GMFF‐2023‐21236 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, increased oleic acid genetically modified soybean MON 87705. The scope of the renewal application GMFF‐2023‐21236 is for the renewal of the placing on the market of soybean MON 87705 for food and feed uses, excluding cultivation within the European Union (EU).

In delivering its scientific opinion, the GMO Panel took into account application GMFF‐2023‐21236, 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‐2023‐21236 contained: post‐market environmental monitoring reports, post‐market 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 87705 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application GMFF‐2023‐21236 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87705 (EFSA GMO Panel, 2012, 2013).

INTRODUCTION

1

Background

1.1

On 11 March 2024, the European Food Safety Authority (EFSA) received from the European Commission (EC) application GMFF‐2023‐21236 for the renewal of the authorisation of soybean MON 87705 (Unique Identifier MON‐877Ø5‐6), submitted by Bayer CropScience LP (hereafter referred to as ‘the applicant’) according to Regulation (EC) No 1829/2003.1

Following receipt of application GMFF‐2023‐21236, 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 application 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 11 December 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‐2010‐78 and a request to the GMO Panel from the EC to assess the safety of soybean MON 87705 oil for commercial frying, and the publication of the EFSA scientific opinions (EFSA GMO Panel, 2012, 2013), the placing on the market of soybean MON 87705 for (a) foods and food ingredients containing, consisting of, or produced from this GM soybean, (b) feed containing, consisting of, or produced from this GM soybean, and (c) products containing this GM soybean or consisting of it for any other use than (a) and (b), excluding cultivation in the EU, was authorised by Commission Implementing Decision (EU) 2015/696.4 A copy of these authorisation 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 application GMFF‐2023‐21236. 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 3 months to make their opinion known on application GMFF‐2023‐21236 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 87705 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 87705, 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‐2023‐21236 following the EFSA requirements as detailed in EFSA GMO Panel (2015a) and EFSA (2021).

In accordance with Art. 38 of the Regulation (EC) No 178/20029 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. According to Art. 32c(2) of Regulation (EC) No 178/2002 and to the Decision of EFSA's Executive Director laying down the practical arrangements on pre‐submission phase and public consultations,10 EFSA carried out a public consultation on the non‐confidential version of the dossier from 4 March to 25 March 2025 for which no comments were received.

The GMO Panel based its scientific assessment of soybean MON 87705 on the valid dossier GMFF‐2023‐21236, additional information provided by the applicant during the risk assessment, relevant scientific comments submitted by EU MS and relevant peer‐reviewed scientific publications.

In the frame of the contracts OC/EFSA/MESE/2022/03‐01‐SC17 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, respectively.

Post‐market monitoring and post‐market environmental monitoring reports

11

2.1.1

Post‐market monitoring

Soybean MON 87705 expresses fragments of the endogenous FAD2‐1A and FATB1‐A genes resulting, through RNA interference, in the decreased levels of fatty acid Δ12‐desaturase (FAD2) and palmitoyl acyl carrier protein thioesterase (FATB) enzymes and, in turn, in an increased oleic acid phenotype.

During the pre‐market risk assessment of soybean MON 87705, the compositional analysis in seeds showed an alteration of the fatty acid profile as compared to its conventional counterpart (EFSA GMO Panel, 2012, 2013).

The nutritional assessment in humans was focused on the intended increase of oleic acid (C18:1) and the accompanying decreases of linoleic acid (C18:2) and palmitic acid (C16:0).

At the time of the pre‐market risk assessment, dietary intake estimations were considered to assess the nutritional relevance of the changes, using different assumptions of consumption and replacement scenarios. Based on these assumptions, the GMO Panel concluded that the consumption of soybean MON 87705 does not represent a nutritional concern in humans (EFSA GMO Panel, 2012, 2013).

Notwithstanding the safety of soybean MON 87705, the GMO Panel recommended that the applicant should provide a proposal for a post‐market monitoring (PMM) plan with the aim to confirm the expected consumption and the application of conditions of use in accordance with Regulation (EC) No 1829/2003 (EFSA GMO Panel, 2013).

In accordance with the market authorisation (Commission Implementing Decision (EU) 2015/696 of 24 April 2015; Art. 5 and Annex (g)), the authorisation holder should collect import data into Europe of soybean MON 87705 oil and MON 87705 soybeans for oil extraction for the placing on the market as or in products for food.

Following the identification of imports, available information on consumption should be collected (i.e. quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed). Based on this information, the pre‐market nutritional assessment might need revision, accordingly.

The applicant provided annual PMM reports for soybean MON 87705 oil and soybean for oil extraction for the placing on the market as or in products for food only for the period 2015–2023 in line with EFSA GMO Panel Statement (2013) and Commission Implementing Decision (EU) 2015/696. The outcome of the PMM reports is presented in Section 3.1.

Post‐market environmental monitoring

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 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 87705, was a condition for the authorisation. As no potential adverse environmental effects were identified in the environmental risk assessment of soybean MON 87705 (EFSA GMO Panel, 2012), case‐specific monitoring was not considered necessary by the GMO Panel.

The applicant provided 10 annual PMEM reports covering a reporting period from April 2015 to June 2024. 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 EuropaBio12 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 87705; (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

13

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 publications were identified as relevant for food and feed safety assessment. The relevant publications are listed in Appendix A.

Updated bioinformatics

14

2.1.3

At the time of submission of the renewal dossier, the applicant provided a complete bioinformatics dataset for soybean MON 87705 including an analysis of the insert and flanking sequences, an analysis of the potential similarity to allergens and toxins of the newly expressed protein CP4 EPSPS and of all possible open reading frames (ORFs) within the insert and spanning the junction sites, a bioinformatics analysis to identify potential off‐target genes due to the expression of FAD2‐1A and FATB1‐A dsRNAs (EFSA, 2025), an analysis of possible horizontal gene transfer (EFSA, 2017), and a safety assessment of the newly expressed protein CP4 EPSPS regarding their 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

15

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 87705 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

16

2.1.5

The applicant provided an overall assessment concluding that information provided in the application for renewal of authorisation of soybean MON 87705 for food and feed uses in the EU does not change the outcome of the original risk assessment (EFSA GMO Panel, 2012, 2013).

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

17

2.1.6

The applicant indicated in the dossier that the post‐market environmental 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 87705 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

Post‐market monitoring

As authorisation holder, the applicant collaborated with third parties, such as farmers, crushers and exporters to collect information on the quantities of MON 87705 soybean oil and MON 87705 soybean for oil extraction imported in the EU for the placing on the market as or in products for food. On the basis of this information, the applicant confirmed that no MON 87705 soybean oil or MON 87705 soybean for crushing into oil was exported to the EU for the placing on the market as or in products for food. Therefore, the GMO Panel considers that there is no need to update the pre‐market nutritional assessment.

Post‐market environmental monitoring

The GMO Panel assessed the 10 PMEM reports submitted by the applicant. During the general surveillance activities covering the authorisation period of soybean MON 87705, 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 87705, on the newly expressed protein CP4 EPSPS and FATB1‐A and FAD2‐1A gene segments. The quality of the performed literature searches is acceptable.

The GMO Panel reviewed the publication 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 87705 was identified. (EFSA GMO Panel, 2012, 2013).

Evaluation of the updated bioinformatics analyses

3.3

The updated bioinformatics analysis to assess the potential interruption of soybean endogenous genes confirms previous results indicating that no known endogenous genes were interrupted (EFSA GMO Panel, 2012, 2015b, 2020).

The updated analysis of the amino acid sequence of the newly expressed protein CP4 EPSPS reveal 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 (EFSA GMO Panel, 2012, 2015b, 2020).

According to Regulation (EU) No 503/2013, when silencing approaches by RNAi have been used in GM plant applications, a bioinformatics analysis to identify potential off‐target genes is required. The applicant has performed an updated RNAi off‐target search in the available soybean transcriptome following EFSA's recommendations (EFSA, 2025). This updated bioinformatics analysis confirms previous results (EFSA GMO Panel, 2020) that do not indicate an off‐target effect that would need further assessment.

The updated bioinformatics analyses for possible horizontal gene transfer for event MON 87705 confirm previous conclusions (EFSA GMO Panel, 2012, 2015b, 2020). Given the results of this analysis and that the recombinant DNA in soybean MON 87705 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 87705 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‐2023‐21236 indicating new hazards, relevant changes in exposure or scientific uncertainties that would change previous conclusions on soybean MON 87705.

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

3.6

Post‐market monitoring

The GMO Panel recommends a PMM in food and considers that a PMM for feed is not needed.18 This is in accordance with Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013, and in line with the recommendations described in EFSA GMO Panel scientific opinion (2012), EFSA GMO Panel statement (2013) and Commission Implementing Decision (EU) 2015/696.

Post‐market environmental monitoring

The PMEM plan covers general surveillance of imported GM plant material, including soybean MON 87705. This general surveillance is coordinated by CropLife Europe and implemented by selected operators (federations involved in soybean seeds 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‐2023‐21236, but reminds that the final adoption and implementation of the PMEM plan falls outside the mandate of EFSA.

Labelling

3.7

In accordance with Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003, the applicant proposed in renewal dossier GMFF‐2023‐21236 specific labelling for MON 87705 soybean: ‘genetically modified soybean with increased oleic acid and reduced linoleic acid’. The EFSA GMO Panel considered the labelling as proposed by the applicant, taking into account the altered composition and nutritional values of soybean MON 87705. In the absence of new information provided by the applicant and based on the compositional data of soybean MON 87705 seeds and the derived oil as submitted during the pre‐market risk assessment (EFSA GMO Panel, 2012, 2013), the GMO Panel considers that this proposal is consistent with the compositional data of this soybean.

CONCLUSIONS

4

Under the assumption that the DNA sequence of the event in soybean MON 87705 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‐2023‐21236 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87705 (EFSA GMO Panel, 2012, 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 87705 submitted in accordance with articles 11 and 23 of Regulation (EC) No 1829/2003 by Bayer CropScience LP (GMFF‐2023‐21236).
• The application was made valid on 11 December 2024.
• Additional Information (Clock 1) was requested on 31 January 2025.
• Additional Information (Clock 1) was received on 3 April 2025.
• Additional Information (Clock 2) was requested on 15 May 2025.
• Additional Information (Clock 2) was received on 7 July 2025.
• Additional Information (Clock 3) was requested on 31 July 2025.
• Additional Information (Clock 3) was received on 27 August 2025.

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

REQUESTOR

European Commission (DG SANTE)

QUESTION NUMBER

EFSA‐Q‐2024‐00153

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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_MON87705

Annex B_Labelling proposal_MON87705

Annex C_PMEM plan_MON87705

Annex D_Validation report_MON87705

Annex E_Validated method_MON87705

Annex F_CRM report_MON87705

Annex G_Sampling and DNA extraction_MON87705

Annex H_Member States comments_MON87705