EFSA Journal. 2024;22:e9061.    | 1 of 9
https://doi.org/10.2903/j.efsa.2024.9061
efsa.onlinelibrary.wiley.com/journal/1831-4732
S T A T E M E N T
Statement complementing the EFSA Scientific Opinion on 
application (EFSA- GMO- NL- 2015- 126) for authorisation of 
food and feed containing, consisting of and produced from 
genetically modified soybean MON 87705 × MON 87708 × MON 
89788
SEFSA Panel on Genetically Modified Organisms (GMO) |  Josep Casacuberta |  
Francisco Barro |  Albert Braeuning |  Pilar Cubas |  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 |  Eve Veromann | 
Michele Ardizzone |  Antonio Fernandez Dumont |  Arianna Ferrari |  Aina Belen Gil Gonzalez | 
José Ángel Gómez Ruiz |  Tilemachos Goumperis
Adopted: 3 October 2024
DOI: 10.2903/j.efsa.2024.9061  
This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the 
original work is properly cited and no modifications or adaptations are made.
© 2024 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.
Correspondence: nif@efsa.europa.eu    
Abstract
Following a request from the European Commission, the GMO Panel assessed 
additional information related to the application for authorisation of food and 
feed containing, consisting of and produced from genetically modified soybean 
MON × MON 87708 × MON 89788 (EFSA- GMO- NL- 2015- 126). The applicant con-
ducted a 90- day feeding study on GM soybean MON 87705 and provided a pro-
posal for post- market monitoring considering the altered fatty acid profile of GM 
soybean MON 87705 × MON 87708 × MON 89788, to fulfil the deficiencies identi-
fied by EFSA GMO Panel, addressing elements that remained inconclusive from a 
previous EFSA scientific opinion issued in 2020. The GMO Panel concludes that the 
90- day feeding study on GM soybean MON 87705 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 diets containing soybean MON 87705 meals at 30% 
or 15% for 90 days. The GMO Panel reiterates the recommendation for a PMM for 
food in accordance with Regulation (EC) No 1829/2003 and Regulation (EU) No 
503/2013 and concludes that the proposal provided by the applicant is in line with 
the recommendations described for the PMM plan of soybean MON 87705 × MON 
87708 × MON 89788 in the adopted scientific opinion. Taking into account the pre-
vious assessment and the new information, the GMO Panel concludes that soy-
bean MON 87705 × MON 87708 × MON 89788, as assessed in the scientific opinion 
on application EFSA- GMO- NL- 2015- 126 and in the supplementary toxicity study, is 
as safe as its non- GM comparator and the non- GM reference varieties tested and 
does not represent a nutritional concern in humans and animals, within the scope 
of this application.
K E Y W O R D S
90- day feeding study, GMO, MON 87705, MON 87705 × MON 87708 × MON 89788, post- market 
monitoring (PMM), soybean (Glycine max)
The declarations of interest of all scientific 
experts active in EFSA’s work are available 
at https://ess.efsa.europa.eu/doi/doiweb/
doisearch
2 of 9 |   ASSESSMENT OF SOYBEAN MON 87705 × MON 87708 × MON 89788
CO NTE NTS
Abstract................................................................................................................................................................................................................................1
Summary .............................................................................................................................................................................................................................3
1. Introduction ..............................................................................................................................................................................................................4
1.1. Background and Terms of Reference as provided by the requestor .........................................................................................4
2. Data and Methodologies ......................................................................................................................................................................................4
2.1. Data ...................................................................................................................................................................................................................4
2.2. Methodologies..............................................................................................................................................................................................4
3. Assessment ................................................................................................................................................................................................................4
3.1. 90- day feeding study .................................................................................................................................................................................4
3.2. Post- market monitoring on the genetically modified food or feed ..........................................................................................5
4. Conclusions ................................................................................................................................................................................................................6
5. Documentation as provided to EFSA ...............................................................................................................................................................6
Abbreviations ....................................................................................................................................................................................................................6
Acknowledgements ........................................................................................................................................................................................................7
Requestor ............................................................................................................................................................................................................................7
Question number .............................................................................................................................................................................................................7
Copyright for non- EFSA content.................................................................................................................................................................................7
Panel members .................................................................................................................................................................................................................7
References...........................................................................................................................................................................................................................7
Appendix A .........................................................................................................................................................................................................................8
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   | 3 of 9ASSESSMENT OF SOYBEAN MON 87705 × MON 87708 × MON 89788
SUM MARY
On 2 April 2020, the GMO Panel adopted a scientific opinion on application EFSA- GMO- NL- 2015- 126 for the placing on the 
market of soybean MON 87705 × MON 87708 × MON 89788 for food and feed uses, import and processing under Regulation 
(EC) No 1829/2003.1 In the context of this application, the applicant did not provide a 90- day feeding study on soybean 
MON 87705 in line with the applicable legal requirements (i.e. no treatment with the intended herbicide was applied to 
MON 87705 soybean used to produce the test material). Furthermore, considering the altered fatty acid profile of soybean 
MON 87705 × MON 87708 × MON 89788, the applicant did not provide a proposal for a post- market monitoring (PMM) in 
accordance with Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013.2 Therefore, the GMO Panel was not in the 
position to finalise the risk assessment of soybean MON 87705 × MON 87708 × MON 89788 under the current regulatory 
frame.
On 10 April 2024, the European Commission requested the GMO Panel to complement its original scientific opinion on 
application EFSA- GMO- NL- 2015- 126 for placing on the market soybean MON 87705 × MON 87708 × MON 89788 for food 
and feed uses, import and processing under Regulation (EC) No 1829/20031, taking into consideration new additional 
information provided by the applicant. This new information consisted of a 90- day feeding study on soybean MON 87705 
and a proposal for a post- market monitoring (PMM).
The GMO Panel assessed the supplementary 90- day feeding study in rats on soybean MON 87705. The study was con-
ducted in accordance with OECD TG 407 and with the principles of Good Laboratory Practice. No adverse effects were 
observed in this study. Taking into account the previous assessment and the new information, the GMO Panel concludes 
that soybean MON 87705 × MON 87708 × MON 89788, as assessed in the scientific opinion on application EFSA- GMO- NL- 
2015- 126 (EFSA GMO Panel, 2020) and in the supplementary toxicity study, is as safe as its non- GM comparator and the 
non- GM reference varieties tested and does not represent a nutritional concern in humans and animals, within the scope 
of the application.
The GMO Panel reiterates the recommendation for a PMM for food in accordance with Regulation (EC) No 1829/2003 
and Regulation (EU) No 503/2013 and concludes that the proposal provided by the applicant is in line with the recommen-
dations described for the PMM plan of soybean MON 87705 × MON 87708 × MON 89788 in the adopted scientific opinion.
 1Regulation (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.
 2Commission 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.
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4 of 9 |   ASSESSMENT OF SOYBEAN MON 87705 × MON 87708 × MON 89788
1 | INTRO DUC TIO N
1.1 | Background and Terms of Reference as provided by the requestor
On 2 April 2020, the GMO Panel adopted a scientific opinion on application EFSA- GMO- NL- 2015- 126 for the placing on the 
market of soybean MON 87705 × MON 87708 × MON 89788 for food and feed uses, import and processing under Regulation 
(EC) No 1829/2003. In the context of this application, the applicant did not provide a 90- day feeding study on soybean MON 
87705 in line with the applicable legal requirements (i.e. no treatment with the intended herbicide was applied to MON 
87705 soybean used to produce the test material). Furthermore, considering the altered fatty acid profile of soybean MON 
87705 × MON 87708 × MON 89788, the applicant did not provide a proposal for a post- market monitoring (PMM) in accord-
ance with Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013. Therefore, the GMO Panel was not in the posi-
tion to finalise the risk assessment soybean MON 87705 × MON 87708 × MON 89788 under the current regulatory frame.
On 10 April 2024, the European Commission asked EFSA to complement the inconclusive scientific opinion (EFSA GMO 
Panel, 2020) on application EFSA- GMO- NL- 2015- 126 for placing on the market soybean MON 87705 × MON 87708 × MON 89788 
for food and feed uses, import and processing under Regulation (EC) No 1829/20031, taking into consideration new additional 
information provided by the applicant, consisting of a 90- day feeding study in rodents with whole GM food and feed from GM 
soybean MON 87705, and a proposal for a post- market monitoring (PMM), provided by the applicant to EC on 20 March 2024.
On 31 May 2024, EFSA asked the applicant clarifications on the confidentiality requests and to provide additional data 
on the 90- day feeding study. The applicant delivered to EFSA the requested Additional Information on 12 July 2024.
In the frame of contract EOI/EFSA/2022/01 - CT NIF 2023 02, the contractor performed preparatory work and delivered a 
report on the statistical analysis of the 90- day feeding study in rodents on soybean MON 87705.
This statement reports the GMO Panel assessment of the 90- day feeding study in rodents with whole GM food and feed 
from GM soybean MON 87705 and a proposal for a post- market monitoring (PMM).
2 | DATA AN D M ETH O DO LOG IES
2.1 | Data
In delivering this statement, the GMO Panel took into account the supplementary 90- day feeding study in rodents on 
soybean MON 87705 provided by the applicant in the context of this mandate, the proposal for a post- market monitoring 
(PMM) plan and the EFSA scientific opinion on application EFSA- GMO- NL- 2015- 126 (EFSA GMO Panel, 2020).
2.2 | Methodologies
The GMO Panel carried out a scientific risk assessment of this supplementary toxicity study taking into account the princi-
ples described in Regulation (EU) No 503/2013 and its guideline for the risk assessment of genetically modified (GM) plants 
and derived food and feed (EFSA GMO Panel, 2011).
3 | ASSESSM E NT
3.1 | 90- day feeding study
In this study, provided in the context of the current mandate, pair- housed Sprague Dawley Crl:CD(SD) rats (16 per sex per group; 
2 rats per cage) were allocated to three groups using a randomised complete block design with 8 replications per sex.
Groups were fed diets containing soybean MON 87705 meal from plants treated with the intended herbicide (glypho-
sate) at 30% and 15% of inclusion level (the latter supplemented with 15% of the non- GM comparator) and the non- GM 
comparator (inclusion level 30%).
The study was adapted from OECD test guideline 408  (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 to 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 substances in them.
Event- specific PCR analysis confirmed the presence of the MON 87705 in both the GM grains 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, an-
tinutrients 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 to OECD test guideline 408 (2018).
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   | 5 of 9ASSESSMENT OF SOYBEAN MON 87705 × MON 87708 × MON 89788
An appropriate range of statistical tests were performed on the results of the study. Detailed description of the meth-
odology and of statistically significant findings identified in rats given diets containing meals derived from soybean MON 
87705 is reported in Appendix A.
There were no test diet- related incidents of mortality or clinical signs. No test diet- related adverse findings were iden-
tified 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 variation3 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;
– exhibited no consistent pattern with related parameters or endpoints.
– 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 micro-
scopic 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 diets containing soybean MON 87705 meals at 30% 
or 15% for 90 days.
3.2 | Post- market monitoring on the genetically modified food or feed
The three- event stack soybean MON 87705 × MON 87708 × MON 89788 was produced by conventional crossing to combine 
three single soybean events: MON 87705 (producing dsRNAs downregulating endogenous FAD2 and FATB enzymes, and 
expressing the CP4 EPSPS protein), MON 87708 (expressing the DMO protein) and MON 89788 (expressing the CP4 EPSPS 
protein). This combination is intended to confer an altered fatty acid profile (increased oleic acid content), and tolerance to 
dicamba and to glyphosate containing herbicides. During the pre- market risk assessment of soybean MON 87705 × MON 
87708 × MON 89788, the compositional analysis in seeds showed that palmitic acid (C16:0), stearic acid (C18:0), oleic acid 
(C18:1), linoleic acid (C18:2), arachidic acid (C20:0), eicosenoic acid (C20:1), behenic acid (C22:0) and total fat were signifi-
cantly different as compared to the non- GM comparator, and showed a lack of equivalence with the set of non- GM refer-
ence varieties (EFSA GMO Panel, 2020).
Post- market monitoring for food 
The nutritional assessment in humans was focused on the refined bleached deodorised oil (RBD oil) as this is the main fat- 
containing processed product from soybean for human consumption, and also the most relevant considering the outcome 
of the compositional analysis. As previously identified during the nutritional assessment of the corresponding single event 
MON 87705 and the two- event stack MON 87705 × MON 89788, the main nutritionally aspect linked to the consumption 
of the RBD oil produced from soybean MON 87705 × MON 87708 × MON 89788 (GM oil) refers to its linoleic acid content. 
The concentration of linoleic acid is more than three- fold lower in the three- event stack soybean seeds as compared to 
the non- GM comparator (EFSA GMO Panel, 2020). At the time of the pre- market risk assessment, dietary intake estimations 
were considered to assess the nutritional relevance of the low levels of linoleic acid in the GM oil. In the absence of real 
consumption data on the GM oil, different assumptions of consumption were made as part of replacement scenarios 
of conventional foods. Based on these assumptions, the GMO Panel concluded that the consumption of soybean MON 
87705 × MON 87708 × MON 89788 does not represent a nutritional concern in humans (EFSA GMO Panel, 2020).
Notwithstanding the safety of the three- event stack soybean, the GMO Panel also recommended that the applicant 
should provide a proposal for post- market monitoring (PMM) with the aim to confirm the expected consumption, the 
application of conditions of use or identified effects, in accordance with Regulation (EC) No 1829/2003 and Regulation (EU) 
No 503/2013 (EFSA GMO Panel, 2020). This post- market monitoring should be initially focused on the collection of import 
data to Europe of the three- event stack soybean and/or its products, in particular RBD oil. Following the identification of 
imports, an updated nutritional assessment should be conducted in the case the available information on consumption 
(e.g. new dietary surveys, data from FAOSTAT database on amounts and type of vegetable oils consumed) differs from that 
used during the risk assessment of the EFSA GMO Panel in 2020. Likewise, the applicant should collect and provide any 
scientific information that might change the conclusions of the pre- market nutritional assessment (EFSA GMO Panel, 2020).
 3Although 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).
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6 of 9 |   ASSESSMENT OF SOYBEAN MON 87705 × MON 87708 × MON 89788
In the additional information provided, the applicant communicated that as authorisation holder they will collaborate 
with third parties, such as farmers, crushers and all exporters involved in the production and trade of GM soybean prod-
ucts for crushing into oil, to collect information on the quantities of soybean oil and soybean for oil extraction from these 
GM soybean products, imported in the EU for the placing on the market as or in products for food. The applicant also 
mentioned that they will monitor significant changes in EU imports of relevant oils considered during the assessment, and 
based on the information collected and reported, review the nutritional assessment conducted as part of the pre- market 
risk assessment. The applicant provided information to further confirm the conclusions reported at the time of the adop-
tion that soybean MON 87705 × MON 87708 × MON 89788 does not represent a nutritional concern in humans.
The GMO Panel reiterates the recommendation for a PMM in food in accordance with Regulation (EC) No 1829/2003 
and Regulation (EU) No 503/2013 and concludes that the proposal provided by the applicant is in line with the recommen-
dations described for the PMM plan of soybean MON 87705 × MON 87708 × MON 89788 in the adopted scientific opinion 
(EFSA GMO Panel, 2020).
Post- market monitoring for feed 
The nutritional assessment in animals considered both the primary soybean products entering the feed supply chain, such 
as meal and oil, as well as other soybean products that might be included in animal diets, such as soybean forage, hulls and 
protein concentrates.
In the absence of compositional differences between the three- event stack soybean and its non- GM comparator and 
the non- GM reference varieties tested, other than those regarding fatty acids levels in seeds as reported in the EFSA GMO 
Panel opinion (2020), the GMO Panel considered that the consumption of defatted soybean products from this soybean 
MON 87705 × MON 87708 × MON 89788 does not represent a nutritional concern for animals.
For full- fat soybean and oil of the three- event stack soybean, a nutritional assessment was conducted considering the 
altered fatty acid profile. The GMO Panel concluded that consumption of the three- event stack soybean products does not 
represent a nutritional concern for animals, in the context of the scope of the application (EFSA GMO Panel, 2020).
The GMO Panel notes that fatty acid composition is properly balanced in rations to satisfy nutrient requirements of 
animals (EFSA GMO Panel, 2020).
In conclusion, the GMO Panel reiterates that, based on the information considered in its safety assessment, a post- mar-
ket monitoring plan for feed is not necessary.
4 | CO NCLUSIO NS
The 90- day feeding study in rodents on soybean MON 87705 provided by the applicant in the context of this mandate was 
assessed by the GMO Panel and did not show adverse effects.
Taking into account the previous assessment and the new information, the GMO Panel concludes that soybean MON 
87705 × MON 87708 × MON 89788, as assessed in the scientific opinion on application EFSA- GMO- NL- 2015- 126 (EFSA GMO 
Panel, 2020) and in the supplementary toxicity study, is as safe as its non- GM comparator and the non- GM reference variet-
ies tested and does not represent a nutritional concern in humans and animals, within the scope of this application.
The GMO Panel reiterates the recommendation for a PMM for food in accordance with Regulation (EC) No 1829/2003 
and Regulation (EU) No 503/2013 and concludes that the proposal provided by the applicant is in line with the recommen-
dations described for the PMM plan of soybean MON 87705 × MON 87708 × MON 89788 in the adopted scientific opinion.
5 | DOCUM E NTATIO N AS PROVIDE D TO E FSA
• Mandate from the European Commission (EC) received on 10 April 2024 requesting EFSA to assess the additional in-
formation related to the application for authorisation of food and feed containing, consisting of and produced from 
GM soybean MON 87705 × MON 87708 × MON89877 (EFSA- GMO- NL- 2015- 126) submitted under Regulation (EC) NO 
1829/2003 by Bayer Agriculture BV.
• The mandate was accepted on 30 April 20204.
• Additional information (Clock 1) was requested on 31 May 2024.
• Additional information (Clock 1) was received on 12 July 2024.
A B B R E V I AT I O N S
ALP alkaline phosphatase
ALT alanine transaminase
BUN blood urea nitrogen
bw body weight
CI confidence interval
DMO dicamba mono- oxygenase
EPSPS 5- enolpyruvulshikimate- 3- phosphate synthase
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   | 7 of 9ASSESSMENT OF SOYBEAN MON 87705 × MON 87708 × MON 89788
FAOSTAT Food and Agriculture Organization Corporate Statistical Database
GLP good laboratory practice
GM genetically modified
GMO Genetically Modified Organism
GMO Panel EFSA Panel on Genetically Modified Organisms
HDL high- density lipoproteins
LDL low- density lipoproteins
LMMs linear mixed models
LS least- square
OECD Organisation for Economic Co- operation and Development
PCR polymerase chain reaction
PMM post- market monitoring
RBD refined bleached deodorised
SD Sprague Dawley
SE standard error
SES standardised effect sizes
TSH thyroid stimulating hormone
AC K N O W L E D G E M E N T S
The GMO Panel of EFSA wishes to thank the following for the support provided to this scientific output: Andrea Gennaro 
and Franco Maria Neri.
R E Q U E S T O R
European Commission
Q U E S T I O N  N U M B E R
EFSA- Q- 2024- 00277
C O P Y R I G H T  F O R  N O N -  E F S A  C O N T E N T
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.
PA N E L  M E M B E R S
Josep Casacuberta, Francisco Barro, Albert Braeuning, Pilar Cubas, 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.
R E F E R E N C E S
EFSA (European Food Safety Authority). (2014). Explanatory statement for the applicability of the guidance of the EFSA scientific committee on con-
ducting repeated- dose 90- day oral toxicity study in rodents on whole food/feed for GMO risk assessment. EFSA Journal, 12(10), 3871. https:// doi. 
org/ 10. 2903/j. efsa. 2014. 3871
EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms). (2011). Scientific Opinion on guidance for risk assessment of food and feed from 
genetically modified plants. EFSA Journal, 9(5), 2150. https://doi.org/10.2903/j.efsa.2011.2150
EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms). (2020). Scientific opinion on the assessment of genetically modified soybean MON 
87705 9 MON 87708 9 MON 89788, for food and feed uses, under regulation (EC) No 1829/2003 (application EFSA- GMO- NL- 2015- 126). EFSA Journal, 
18(5), 6111. https:// doi. org/ 10. 2903/j. efsa. 2020. 6111
EFSA Scientific Committee. (2011). EFSA guidance on conducting repeated- dose 90- day oral toxicity study in rodents on whole food/feed. EFSA Journal, 
9(12), 2438. https:// doi. org/ 10. 2903/j. efsa. 2011. 2438
OECD (Organisation for Economic Cooperation and Development). (2018). OECD guideline for the testing of chemicals - test No. 408: Repeated Dose 
90- Day Oral Toxicity Study in Rodents. OECD Publishing, Paris.
How to cite this article: EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Casacuberta, J., Barro, F., 
Braeuning, A., Cubas, P., 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., Ardizzone, M., Dumont, A. F., Ferrari, A., … 
Goumperis, T. (2024). Statement complementing the EFSA Scientific Opinion on application (EFSA- GMO- NL- 
2015- 126) for authorisation of food and feed containing, consisting of and produced from genetically modified 
soybean MON 87705 × MON 87708 × MON 89788. EFSA Journal, 22(10), e9061. https://doi.org/10.2903/j.efsa.2024.9061
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8 of 9 |   ASSESSMENT OF SOYBEAN MON 87705 × MON 87708 × MON 89788
APPE N D IX A
Statistical analysis and statistically significant findings in the 90- day feeding study on soybean MON 87705 in 
rats
The following endpoints were statistically analysed: food consumption, body weights, cumulative body weight changes, 
clinical pathology values (haematology, coagulation, clinical chemistry and urinalysis), absolute and relative organ weights, 
functional observational battery, locomotor activity and histopathological data. Summary statistics, including sample 
mean, standard deviation, median, minimum and maximum, difference, standardised difference, 95% confidence intervals 
(CI) and standardised 95% CI were provided for each dose group, sex, variable and period. Data were also presented in 
terms of the standardised effect sizes (SES). The main statistical analysis compared rats across the experimental groups, 
distinguishing between those on the test diets (low and high test substance MON 87705, respectively) and those on the 
control diet. Linear mixed models (LMMs) were employed to analyse continuous data for each variable and period, fol-
lowed by pairwise comparisons between each test and control diet group (separately for each sex and period, if necessary) 
using a t- test (at the 5% level of significance). Note that only when the interaction of the ‘dose group per sex’ (F- test) was 
significant (at the 5% level of significance), the comparison of the treated (low and high diets) versus the control group was 
conducted separately for the two sexes. For those where no significant interaction existed, pairwise comparisons between 
each test and control dose groups across sexes were tested using t- tests. For each LMM, the full output, including the visual 
examination of residual plots and histograms, the estimated means and standard errors for each fixed effect (i.e. Least- 
squares (LS) means and standard errors (SE) and degrees of freedom of each fixed effect), and the variance components for 
the random terms in each mixed model is provided. Concerning missing data, a summary was provided for each endpoint 
and no systematic trends were observed that might bias the results (Table A.1).
T A B L E  A .1  Statistically significant findings in the 90- day toxicity study on soybean MON 87705 in rats.
Statistically significant 
parameter/endpoint Finding (versus control) GMO panel interpretation
Food consumption (week 6–7) Increased (25%) in low dose animals 
(sexes combined)
Transient with no impact on overall body weight. Not seen at the 
high dose. Not an adverse effect of treatment
Basophil count Reduced (20%) in low dose animals 
(sexes combined)
Not seen at the high dose. All values within control range. Not an 
adverse effect of treatment
Eosinophil count Reduced (25%) in low and high dose 
animals (sexes combined)
No dose response. All high dose values within control range. Not 
an adverse effect of treatment
Neutrophil count Reduced (15%) in high dose animals 
(sexes combined)
Low magnitude. All values within control range. Not an adverse 
effect of treatment
Erythrocyte count, haematocrit 
and haemoglobin
Increased 2%–5% in low dose animals 
(sexes combined)
Low magnitude. Not seen at the high dose. Not an adverse effect 
of treatment
Potassium Reduced (5%) in high dose animals 
(sexes combined). Increased (4%) in 
low dose females
Low magnitude, no pattern across dose groups. Within normal 
variation. Not an adverse effect of treatment
Calcium Reduced (4%) in low dose females Low magnitude. Not seen at the high dose. Not an adverse effect 
of treatment
ALT Reduced (50%) in females of both dose 
groups
No dose response. Control values showed a high level of 
variability. No associated liver pathology findings. Not an 
adverse effect of treatment
HDL Reduced (25%) in low dose females Not seen at the high dose. Within normal variation. Not an 
adverse effect of treatment
ALP Reduced (15%) in high dose animals 
(sexes combined)
Low magnitude. All values within control range. Not an adverse 
effect of treatment
Cholesterol and LDL Reduced (18%) in low dose animals 
(sexes combined)
Low magnitude. Not seen at the high dose. Not an adverse effect 
of treatment
Chloride Increased (1%) in low dose animals (sexes 
combined)
Low magnitude. Not seen at the high dose. Not an adverse effect 
of treatment
Creatinine Increased (8%) in high dose animals 
(sexes combined)
Low magnitude. Only 3/32 animals outside control range 
(p822/828). No associated kidney pathology. Not an adverse 
effect of treatment
Glucose Reduced (5%) in low dose animals (sexes 
combined)
Low magnitude. Not seen at the high dose. Not an adverse effect 
of treatment
BUN Increased (12%) in low and high dose 
animals (sexes combined)
Low magnitude. No clear dose response. Within normal variation. 
No associated kidney pathology. Not an adverse effect of 
treatment
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   | 9 of 9ASSESSMENT OF SOYBEAN MON 87705 × MON 87708 × MON 89788
The EFSA Journal is a publication of the European Food Safety  
Authority, a European agency funded by the European Union
Statistically significant 
parameter/endpoint Finding (versus control) GMO panel interpretation
Urinary specific gravity Increased (1%) in low dose males Low magnitude. Not seen at the high dose. Not an adverse effect 
of treatment
Urinary creatinine Increased (50%) in low and high dose 
animals (sexes combined)
No clear dose response. Within normal variation. No associated 
kidney pathology. Not an adverse effect of treatment
T4 Increased (20%) in high dose males and 
(35%) in low and high dose females
Within normal variation. No changes in T3. No associated 
Pathology changes
TSH Reduced (40%) in low dose males Not seen at high dose. All values are within control range. No 
impact on T4/T3 Not an adverse effect of treatment
Adrenal weights (relative to 
bw)
Increased (10%) in low dose animals 
(sexes combined)
Low magnitude. No dose response. Within normal variation. No 
associated pathology. Not an adverse effect of treatment
Notes: 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 grams in test group animals vs. 100 grams in controls).
T A B L A .1  (Continued)
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iley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License