Abstract
Following the submission of dossier GMFF‐2025‐33580 under Regulation (EC) No 1829/2003 from Syngenta Crop Protection AG, the Panel on Genetically Modified Organisms of the EFSA 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 FG72, 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, 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. Assuming that the DNA sequence of the event in soybean FG72 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‐2025‐33580 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean FG72.
Keywords: Articles 11 and 23, FG72, Regulation (EC) No 1829/2003, renewal, soybean
SUMMARY
Following the submission of dossier GMFF‐2025‐33580 under Regulation (EC) No 1829/2003 from Syngenta Crop Protection AG, 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 genetically modified soybean FG72. The scope of the renewal dossier GMFF‐2025‐33580 is for the renewal of the placing on the market of soybean FG72 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‐2025‐33580, 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‐2025‐33580 contained: post‐market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application.
Assuming that the DNA sequence of the event in soybean FG72 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‐2025‐33580 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean FG72 (EFSA GMO Panel, 2015a).
1. INTRODUCTION
1.1. Background
On 01 April 2025, the European Food Safety Authority (EFSA) received from the European Commission dossier GMFF‐2025‐33580 for the renewal of the authorisation of soybean FG72 (Unique Identifier MST‐FGØ72‐2), submitted by Syngenta Crop Protection AG (hereafter referred to as ‘the applicant’) according to Regulation (EC) No 1829/2003. 1
Following receipt of dossier GMFF‐2025‐33580, 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 503/2013 3 and, when needed, asked the applicant to supplement the initial application. On 24 June 2025, EFSA declared the application valid and made the valid application available to the MS and the European Commission.
Following the submission of application EFSA‐GMO‐BE‐2011‐98 and the publication of the EFSA scientific opinion (EFSA GMO Panel, 2015a), the placing on the market of soybean FG72 for products containing, consisting of, or produced from this GM soybean, excluding cultivation in the EU, was authorised by Commission Implementing Decision 2016/1215 of 22 July 2016. 4 A copy of these authorisations 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‐2025‐33580. 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 European Commission (for further details, see 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 dossier GMFF‐2025‐33580 as of date of validity.
1.2. Terms of Reference as provided by the requestor
EFSA and its GMO Panel were requested to carry out a scientific risk assessment of soybean FG72 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 FG72, 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.
2. DATA AND METHODOLOGIES
2.1. Data
The applicant has submitted a confidential and a non‐confidential version of the dossier GMFF‐2025‐33580 following the data requirement as detailed in EFSA GMO Panel (EFSA GMO Panel, 2015b) and EFSA (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 178/2002 10 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 23 October to 13 November 2025 for which no comments were received.
The GMO Panel based its scientific assessment of soybean FG72 on the valid dossier GMFF‐2025‐33580, 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/MESE/2022/03‐01‐SC17, OC/EFSA/GMO/2021/06 and EOI/EFSA/2022/01 – CT 31 NIF, the contractors performed preparatory work and delivered reports on the methods applied by the applicant in performing literature search, updated bioinformatics analyses and statistical analysis and study design of the 90‐day oral repeated dose toxicity study included in this opinion.
2.1.1. Post‐market monitoring and post‐market environmental monitoring reports 12
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 FG72, was a condition for the authorisation. As no potential adverse environmental effects were identified in the environmental risk assessment of soybean FG72 (EFSA GMO Panel, 2015a), case‐specific monitoring was not considered necessary by the GMO Panel.
The applicant provided nine annual PMEM reports covering a reporting period from July 2015 to June 2024. The annual PMEM plans submitted by the applicant included (1) commodity soybean (GM and non GM) imports into the EU by country of origin and destination; (2) the description of a centralised system established by EuropaBio 13 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 FG72; (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 14
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 2026, in accordance with the recommendations on literature search outlined in (EFSA, 2010, 2019).
Searches in electronic bibliographic databases and in websites of relevant organisations were performed to identify relevant publications. Altogether 1950 publications (including the updated search) were identified (after removal of duplicates). After applying the eligibility/inclusion criteria defined a priori by the applicant, 22 (6 peer‐reviewed and 16 non‐peer reviewed) publications were identified as relevant for food and feed safety assessment. The relevant publications are listed in Appendix A.
2.1.3. Updated bioinformatics analyses 15
At the time of submission of the renewal dossier, the applicant provided a complete bioinformatics data set for soybean FG72 including an analysis to identify potential interrupted genes at the insertion site, 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 (HGT) (EFSA, 2017) and a safety assessment of the newly expressed proteins 2mEPSPS and HPPD W336 regarding their capacity to trigger coeliac disease symptoms (EFSA GMO Panel, 2017a). The outcome of the updated bioinformatics analyses is presented in Section 3.3.
2.1.4. Additional documents or studies performed by or on behalf of the applicant 16
In line with the renewal guidance requirements (EFSA, 2021; EFSA GMO Panel, 2015b), the applicant provided an overview on the worldwide approvals of soybean FG72 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 17
The applicant provided an overall assessment concluding that information provided in the application for renewal of authorisation of soybean FG72 for food and feed uses in the EU does not change the outcome of the original risk assessment (EFSA GMO Panel, 2015a).
2.1.6. Monitoring plan and proposal for improving the conditions of the original authorisation 18
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 soybean FG72 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, 2015b). The opinions 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 and post‐market environmental monitoring reports
The GMO Panel assessed the nine PMEM reports submitted by the applicant. During the general surveillance activities covering the authorisation period of soybean FG72, 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.
3.2. Evaluation of the systematic search and evaluation of literature
The GMO Panel assessed the applicant's literature searches on soybean FG72 and the newly expressed proteins 2mEPSPS and HPPD W336. 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 FG72 was identified (EFSA GMO Panel, 2015a).
3.3. Evaluation of the updated bioinformatics analyses
The results of the updated bioinformatics analysis to assess the interruption of soybean endogenous genes confirm previous results indicating that no endogenous genes were interrupted (EFSA GMO Panel, 2015a, 2017b).
The updated analyses of the amino acid sequence of the newly expressed proteins 2mEPSPS and HPPD W336 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 known toxins or allergens (EFSA GMO Panel, 2015a, 2017b).
The updated bioinformatics analyses for event FG72 reveal two 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 (EFSA GMO Panel, 2015a, 2017b). Given the results of this analysis and that the recombinant DNA in soybean FG72 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 performed by or on behalf of the applicant
The GMO Panel evaluated the reports of the additional studies provided (Appendix B) and the 90‐day oral repeated dose toxicity study in rat with soybean FG72 (Appendix C). 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 soybean FG72.
3.5. Evaluation of the overall assessment
The GMO Panel evaluated the overall assessment provided by the applicant and confirms that there is no evidence in renewal dossier GMFF‐2025‐33580 indicating new hazards, relevant changes in exposure or scientific uncertainties that would change previous conclusions on soybean FG72.
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 soybean FG72. 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‐2025‐33580, but reminds that the final adoption and implementation of the PMEM plan fall outside the mandate of EFSA.
4. CONCLUSIONS
Assuming that the DNA sequence of the event in soybean FG72 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‐2025‐33580 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean FG72 (EFSA GMO Panel, 2015a).
5. DOCUMENTATION AS PROVIDED TO EFSA
Letter from the European Commission to EFSA received on 1 April 2025 for the continued marketing of genetically modified soybean FG72 submitted in accordance with articles 11 and 23 of Regulation (EC) No 1829/2003 by Syngenta Crop Protection AG (GMFF‐2025‐33580)
The application was made valid on 24 June 2025
Additional Information (Clock 1) was requested on 25 August 2025
Additional Information (Clock 1) was received on 19 September 2025
Additional Information (Clock 2) was requested on 12 November 2025
Additional Information (Clock 2) was received on 22 December 2025
Additional Information (Clock 3) was requested on 20 January 2026
Additional Information (Clock 3) was received on 5 March 2026
Additional Information (Clock 4) was requested on 30 March 2026
Additional Information (Clock 4) was received on 3 June 2026 and 10 June 2026.
ABBREVIATIONS
- GM
genetically modified
- GMO
genetically modified organism
- GMO Panel
EFSA Panel on Genetically Modified Organisms
- HGT
horizontal gene transfer
- ORFs
open reading frames
- PCR
polymerase chain reaction
- PMEM
post‐market environmental monitoring
REQUESTOR
European Commission
QUESTION NUMBER
EFSA‐Q‐2025‐00233
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.
LEGAL NOTICE
The published scientific output implements EFSA's decision on the confidentiality requests submitted on specific information items. Information items awarded confidential status by EFSA and included in the relevant scientific output have been withheld from public disclosure by redaction.
Supporting information
Annex A.
Annex B.
Annex C.
Annex D.
Annex E.
Annex F.
Annex G.
Annex H.
ACKNOWLEDGEMENTS
The Panel wishes to thank the members of the Working Groups on Molecular Characterisation, Food and Feed Safety Assessment and Comparative Analysis and Environmental Risk Assessment and the EFSA Staff Michele Ardizzone, Arianna Ferrari and Tilemachos Goumperis for the preparatory work on this scientific output.
APPENDIX A. List of relevant publications identified by the applicant through literature searches (January 2014 to February 2026)
| References |
| Dreesen, R., Capt, A., Oberdoerfer, R., Coats, I., Pallett, K. E. (2018a). Characterization and safety evaluation of HPPD W336, a modified 4‐hydroxyphenylpyruvate dioxygenase protein, and the impact of its expression on plant metabolism in herbicide‐tolerant MST‐FGØ72‐2 soybean. Regulatory Toxicology and Pharmacology, 97, 170–185. |
| Dreesen, R., Capt, A., Oberdoerfer, R., Coats, I., Pallett, K. E. (2018b) Supplementary data on the characterization and safety evaluation of HPPD W336, a modified 4‐hydroxyphenylpyruvate dioxygenase protein, which confers herbicide tolerance, and on the compositional assessment of field grown MST‐FGO72‐2 soybean expressing HPPD W336. Data in Brief, 21, 111–121. |
| Matthews, B. A., Launis, K. L., Bauman, P. A., Juba, N. C. (2017). Double‐Mutated 5‐Enol Pyruvylshikimate‐3‐phosphate Synthase Protein Expressed in MZHG0JG Corn (Zea mays L.) Has No Impact on Toxicological Safety and Nutritional Composition. Journal of Agricultural & Food Chemistry, 65(38), 8459–8465. |
| Schafer, B. W., Embrey, S. K., Herman, R. A. (2016). Rapid simulated gastric fluid digestion of in‐seed/grain proteins expressed in genetically engineered crops. Regulatory Toxicology & Pharmacology, 81, 106–112. |
| Xie Z, Zou S, Xu W, Liu X, Huang K, He X, 2018. No subchronic toxicity of multiple herbicide‐resistant soybean FG72 in Sprague–Dawley rats by 90‐days feeding study. Regulatory Toxicology & Pharmacology, 94, 299–305. |
| Wang, F., Lu, S., Xu, W., & Yang, L. (2025). Deciphering the complex molecular architecture of the genetically modified soybean FG72 through paired‐end whole genome sequencing. Food Chemistry: Molecular Sciences, 10, 100238. |
| CFIA. (2014). DD2014‐105 Event HCEM48. Decision document DD2014‐105: Determination of the safety of Stine Seed Farm, Inc. (Incorporated)'s corn (Zea mays L. (Linnaeaus)) event HCEM485. https://inspection.canada.ca/en/plant‐varieties/plants‐novel‐traits/approved‐under‐review/decision‐documents/dd2014‐105 |
| CFIA. (2016). DD2016‐116 Event MZHG0JG. Decision document DD2016‐116: Determination of the safety of Syngenta Canada Inc.'s corn (Zea mays L.) event MZHG0JG. https://inspection.canada.ca/en/plant‐varieties/plants‐novel‐traits/approved‐under‐review/decision‐documents/dd2016‐116 |
| CFIA. (2018). DD2018‐123 Event GHB811. Decision document 2018–123: Determination of the safety of BASF Canada Inc. (Gossypium hirsutum) event GHB811. https://inspection.canada.ca/en/plant‐varieties/plants‐novel‐traits/approved‐under‐review/decision‐documents/dd2018‐123 |
| CTNBio. (2015). Technical Opinion No. 4750–2015. |
| CTNBio. (2015). Technical Opinion No. 4866–2015. |
| FSANZ. (2016). A1112 Safety assessment. |
| FSANZ. (2018). A1147 Safety assessment. |
| HC. (2014). Glyphosate‐tolerant Corn – HCEM485. |
| HC. (2016). Herbicide Tolerant MZHG0JG Corn. |
| HC. (2018). Herbicide Tolerant Cotton Event GHB811. |
| MAFF. (2016). FG72. |
| MAFF. (2020). GHB811. |
| USDA. (2015). Syngenta Request (15‐124‐01p) for Extension of Determination of Non‐regulated Status for Herbicide‐Tolerant MZHG0JG Corn. |
| USDA. (2018). 17‐138‐01p – Final Environmental Assessment. |
| USDA. (2018). 17‐138‐01p – Final Plant Pest Risk Assessment. |
| USFDA. (2018). GHB811 – Human and Animal Food Uses. |
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 soybean FG72
| Study identification | Title |
|---|---|
| RIR‐0007449, 2025 | A 90‐Day Study of FG72 Soybean by Oral Dietary Administration in CD® (Sprague Dawley) IGS Rats |
| RIR‐0010799, 2023 | Grain Production of Event FG72 Soybean and the Corresponding Non‐transgenic Near‐Isogenic Soybean in Chile in 2022/2023 Growing Season |
APPENDIX C. Outcome of the assessment of a 90‐day oral repeated dose toxicity study in rat with soybean F72 (study number RIR‐0007449)
In this study, pair‐housed Crl:CD(SD) (Sprague Dawley) rats (16 per sex per group; 2 rats per cage) were allocated to two groups using a randomised complete block design with 16 replications per sex.
Groups were fed diets containing 30% of incorporation rate of meal either from soybean FG72 treated with the intended herbicides (test material) or from the non‐GM comparator (control material).
The study was adapted from OECD test guideline 408 (OECD 2018), aligned with EFSA Scientific Committee guidance (EFSA Scientific Committee, 2011) and EFSA Explanatory statement (EFSA, 2014) and complied with the principles of good laboratory practice (GLP) with some minor deviations described in the study report, not impacting the study results and interpretation.
The stability of the test and control materials was not verified; however, in accordance with product expiration declared by the diet manufacturer, the constituents of the diets are considered stable for the duration of the treatment. The GMO Panel considered this justification acceptable. Diet preparation procedures and regular evaluations of the mixing methods guaranteed the homogeneity and the proper concentration of the test or control items in them.
Event‐specific polymerase chain reaction (PCR) analysis confirmed the presence of the FG72 in both the GM meals and diets and excluded the presence of the event in the respective controls. Both the GM and control meals and diets were analysed for nutrients, antinutrients and potential contaminants. Balanced diets were formulated based on the specifications for LabDiet® Certified Rodent Diet 5002. Feed and water were provided ad libitum. In‐life procedures and observations and terminal procedures were conducted in accordance with OECD TG 408 (2018).
An appropriate range of statistical tests were performed on the results of the study. Detailed description of the methodology and of statistically significant findings identified in rats given diets containing meals derived from soybean FG72 is reported below (Section C.1 and Table C.1).
There were no test diet‐related incidents of mortality or clinical signs. No test diet‐related adverse findings were identified in any of the investigated parameters. A small number of statistically significant findings were noted, but these were not considered adverse effects of treatment for one or more of the following reasons:
-
‐
were within the normal variation 19 for the parameter in rats of this age;
-
‐
were of small magnitude;
-
‐
were identified at only a small number of time intervals with no impact on the overall value;
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‐
exhibited no consistent pattern with related parameters or endpoints;
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‐
exhibited no consistency with increasing incorporation levels.
No gross pathology findings related to the administration of the test diet were observed at necropsy, and the microscopic examinations of a wide range of organs and tissues did not identify relevant differences in the incidence or severity of the histopathological findings related to the administration of the test diet compared to the control group.
The GMO Panel concludes that this study is in line with the requirements of Regulation (EU) No 503/2013 and that no treatment‐related adverse effects were observed in rats after feeding on diets containing soybean FG72 meals at 30% for 90 days.
C.1. Statistical analysis of the 90‐day toxicity study on soybean FG72 in rats
The objective of this study was to evaluate the potential toxicity of FG72 soybean by administering a diet containing 30% FG72 soybean meal to rats for at least 90 consecutive days, compared to a non‐transgenic control. Individual body weights at randomisation were within ±20% of the mean for each sex. Crl:CD1(ICR) mice (16 per sex per group) were assigned to either the control diet or the FG72 test diet using a randomised complete block design. Animals were housed in same‐sex pairs, and technicians were blinded to treatment. A broad range of endpoints, including clinical, behavioural and pathological measures, were assessed. Statistical analyses used two‐sided pairwise comparisons at a 5% significance level, with models incorporating treatment, sex, block effects and sex‐by‐treatment interactions, and terminal body weight as a covariate for organ weights. Homogeneity of variance was assessed using Levene's test, outliers were evaluated graphically and analyses were conducted with and without them. Results included estimated means, confidence intervals, p‐values and standardised effect sizes, with no data transformations applied.
TABLE C.1.
Statistically significant findings in the 90‐day toxicity study on soybean FG72 in rats.
| Statistically significant parameter/endpoint | Finding (vs. control) | GMO panel interpretation |
|---|---|---|
| Body weight gain and food utilisation (days 50–57) | Increased (100%; 130%) in females and both sexes combined | Transient finding. No impact on terminal body weights (within 5%). Not an adverse effect of treatment. |
| Body weight gain and food utilisation (days 78–85) | Increased (100%; 120%) in males. | Transient finding. No impact on terminal body weights (within 5%). Not an adverse effect of treatment. |
| Food consumption (days 15–29) | Increased (5%) in females. | Transient finding. Small magnitude. No impact on terminal body weights (within 5%). Not an adverse effect of treatment. |
| Food consumption (days 78–85) | Decreased (11%) in both sexes combined | Transient finding. Small magnitude. No impact on terminal body weights (within 5%). Not an adverse effect of treatment. |
| Food utilisation (days 57–64) | Decreased (10%) in males | Transient finding. Small magnitude. No impact on terminal body weights (within 5%). Not an adverse effect of treatment. |
| % Neutrophils | Increased (22%) in females | Within normal variation. Absolute neutrophil count was not significantly different. No other significant changes in WBC values; mean male % neutrophil value was within 2% of control. Not an adverse effect of treatment. |
| Prothrombin time | Increased (3%) in males | Small magnitude. Within normal variation, all test values are within the control range. Not an adverse effect of treatment. |
| Creatine kinase activity | Reduced (27%) in females | Within normal variation. No associated histopathology findings. Not an adverse effect of treatment. |
| Urinary glucose corrected for creatinine | Increased (39%) in males. | Secondary to a lower level of creatinine that is within normal variation. Absolute value for urinary glucose was increased only 3% (not statistically significant). Not an adverse effect of treatment. |
| Urinary protein | Decreased (39%) in females | Within normal variation, all test group values are within the control range. Not adverse in isolation. No associated pathology findings. Not an adverse effect of treatment. |
| Uterus/cervix weight relative to brain weight | Increased (20%) | Within normal variation, only one value (1.10) was outside the control range (0.48–1.09). No associated histopathology findings. Not an adverse effect of treatment. |
Note: where changes are given as percentages (e.g. reduced (30%)), this indicates the magnitude of the change relative to the control value (e.g. 30% decrease in mean body weights means a value of 70 g in test group animals vs. 100 g in controls).
EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms) , Casacuberta, J. , Barro, F. , Braeuning, A. , de Maagd, R. , Epstein, M. M. , Frenzel, T. , Gallois, J.‐L. , Koning, F. , Messéan, A. , Moreno, F. J. , Nogué, F. , Savoini, G. , Schulman, A. H. , Tebbe, C. , Veromann, E. , Lenzi, P. , Camargo, A. M. , Piffanelli, P. , & Raffaelo, T. (2026). Assessment of genetically modified soybean FG72 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2025‐33580). EFSA Journal, 24(7), e10179. 10.2903/j.efsa.2026.10179
Adopted: 17 June 2026
Correspondence: Ask a Question
The declarations of interest of all scientific experts active in EFSA's work are available at https://open.efsa.europa.eu/experts.
Annexes A‐H are available under the Supporting Information section .
Notes
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, p. 1–23.
Available online: https://open.efsa.europa.eu/questions/EFSA‐Q‐2025‐00233.
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 L157, 8.6.2013, p. 1–48.
Commission Implementing Decision (EU) 2016/1215 of 22 July 2016 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 (MST‐FGØ72‐2) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council; Commission Implementing Decision (EU) 2019/1195 of 10 July 2019 amending Decisions 2008/730/EC, 2008/837/EC, 2009/184/EC, 2011/354/EU, Implementing Decisions 2012/81/EU, 2013/327/EU, (EU) 2015/690, (EU) 2015/697, (EU) 2015/699, (EU) 2016/1215, (EU) 2017/1208 and (EU) 2017/2451 as regards the authorisation holder and the representative for the placing on the market of genetically modified soybean, cotton, oilseed rape and maize.
Dossier number: GMFF‐2025‐33580. Technical dossier – Information to support the risk assessment: the authorisation for the placing of the GM food and/or feed onto the market in EU.
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, p. 1–38.
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.
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L 31, 1.2.2002, p. 1–48.
Decision available at: https://www.efsa.europa.eu/sites/default/files/corporate_publications/files/210111‐PAs‐pre‐submission‐phase‐and‐public‐consultations.pdf.
Dossier number: GMFF‐2025‐33580. Technical dossier – Information to support the risk assessment – Post‐market monitoring and post‐market environmental monitoring reports; additional information: 19/09/2025.
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.
Dossier number: GMFF‐2025‐33580. Technical dossier – Information to support the risk assessment – New information‐Systematic search and evaluation of the literature; additional information: 19/09/2025, 05/03/2026.
Dossier number: GMFF‐2025‐33580. Technical dossier – Information to support the risk assessment – New information‐ Updated bioinformatics; additional information: 05/03/2026; 03/06/2026 and 10/06/2026.
Dossier number: GMFF‐2025‐33580. Technical dossier – Information to support the risk assessment – New information: Additional documents or studies performed by or on behalf of the applicant; additional information: 22/12/2025.
Dossier number: GMFF‐2025‐33580. Technical dossier – Information to support the risk assessment – New information – Overall assessment.
Dossier number: GMFF‐2025‐33580. Technical dossier – Information to support the risk assessment – Post‐market environmental monitoring plan; additional information: 22/12/2025; 03/06/2026 and 10/06/2026.
Although animals used in a toxicology study are of the same strain, from the same supplier and are closely matched for age and body weight at the start of the study, they exhibit a degree of variability in the parameters investigated during the study. This variability is evident even within control groups. To help reach a conclusion on whether a statistically significant finding in a test group is treatment‐related, account is taken of whether the result in the test group is outside the normal range for untreated animals of the same strain and age. To do this, a number of sources of information are considered, including the standardised effect size, the standard deviations and range of values within test and control groups in the study and, if applicable, data from other studies performed in the same test facility within a small timeframe and under almost identical conditions (Historic Control Data).
REFERENCES
- EFSA (European Food Safety Authority) . (2010). Application of systematic review methodology to food and feed safety assessments to support decision making. EFSA Journal, 8(6), 1637. 10.2903/j.efsa.2010.1637 [DOI] [PMC free article] [PubMed] [Google Scholar]
- EFSA (European Food Safety Authority) , Gennaro, A. , Gomes, A. , Herman, L. , Nogué, F. , Papadopoulou, N. , & Tebbe, C. (2017). Technical report on the explanatory note on DNA sequence similarity searches in the context of the assessment of horizontal gene transfer from plants to microorganisms. EFSA Supporting Publications, 14, EN‐1273. 10.2903/sp.efsa.2017.EN-1273 [DOI] [Google Scholar]
- EFSA (European Food Safety Authority) , Devos, Y. , Guajardo, I. M. , Álvarez, F. , & Glanville, J. (2019). Explanatory note on literature searching conducted in the context of GMO applications for (renewed) market authorisation and annual post‐market environmental monitoring reports on GMOs authorised in the EU market—Note on literature searching to GMO risk assessment guidance. EFSA Journal, 16, EN‐1614. 10.2903/sp.efsa.2019.EN-1614 [DOI] [Google Scholar]
- EFSA (European Food Safety Authority) . (2021). Administrative guidance for the preparation of renewal applications on genetically modified food and feed. EFSA Supporting Publications, 18, EN‐6474. 10.2903/sp.efsa.2021.EN-6474 [DOI] [Google Scholar]
- EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms) , Arpaia, S. , Birch, A. N. E. , Chesson, A. , du Jardin, P. , Gathmann, A. , Gropp, J. , Herman, L. , Hoen‐Sorteberg, H.‐G. , Jones, H. , Kiss, J. , Kleter, G. , Løvik, M. , Messéan, A. , Naegeli, H. , Nielsen, K. M. , Ovesná, J. , Perry, J. , Rostoks, N. , & Tebbe, C. (2015). Scientific Opinion on an application (EFSA‐GMO‐BE‐2011‐98) for the placing on the market of herbicide‐tolerant genetically modified soybean FG72 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience. EFSA Journal, 16(7), 4167. 10.2903/j.efsa.2015.4167 [DOI] [PMC free article] [PubMed] [Google Scholar]
- EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms) . (2015). Guidance for renewal applications of genetically modified food and feed authorised under Regulation (EC) No 1829/2003. EFSA Journal, 13(6), 4129. 10.2903/j.efsa.2015.4129 [DOI] [Google Scholar]
- EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms) , Naegeli, H. , Birch, A. N. , Casacuberta, J. , De Schrijver, A. , Gralak, M. A. , Guerche, P. , Jones, H. , Manachini, B. , Messean, A. , Nielsen, E. E. , Nogué, F. , Robaglia, C. , Rostoks, N. , Sweet, J. , Tebbe, C. , Visioli, F. , Wal, J.‐M. , Eigenmann, P. , … Fernandez Dumont, A. (2017a). Guidance on allergenicity assessment of genetically modified plants. EFSA Journal, 15(5), 4862. 10.2903/j.efsa.2017.4862 [DOI] [PMC free article] [PubMed] [Google Scholar]
- EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms) , Naegeli, H. , Birch, A. N. , Casacuberta, J. , De Schrijver, A. , Gralak, M. A. , Guerche, P. , Jones, H. , Manachini, B. , Messéan, A. , Nielsen, E. E. , Nogué, F. , Robaglia, C. , Rostoks, N. , Sweet, J. , Tebbe, C. , Visioli, F. , Wal, J. M. , Gennaro, A. , … Olaru, I. (2017b). Scientific Opinion on application EFSA‐GMO‐NL‐2013‐120 for authorisation of genetically modified soybean FG72 × A5547‐127 for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Bayer CropScience LP and M.S. Technologies LLC. EFSA Journal, 15(4), 4744. 10.2903/j.efsa.2017.4744 [DOI] [PMC free article] [PubMed] [Google Scholar]
Associated Data
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Supplementary Materials
Annex A.
Annex B.
Annex C.
Annex D.
Annex E.
Annex F.
Annex G.
Annex H.