JUDGMENT OF THE GENERAL COURT (Second Chamber)
18 October 2023 (*)
(Environment – Genetically modified products – Genetically modified maize containing, consisting of or produced from MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and its subcombinations – Rejection of an application for internal review of an authorisation for placing on the market – Manifest error of assessment – Article 10 of Regulation (EC) No 1367/2006 – Articles 4 to 6 and 16 to 18 of Regulation (EC) No 1829/2003 – Article 5 of Implementing Regulation (EU) No 503/2013)
In Case T‑605/21,
TestBioTech eV, established in Munich (Germany), represented by K. Smith, Barrister,
applicant,
v
European Commission, represented by I. Galindo Martín and F. Castilla Contreras, acting as Agents,
defendant,
THE GENERAL COURT (Second Chamber),
composed of A. Marcoulli, President, V. Tomljenović (Rapporteur) and W. Valasidis, Judges,
Registrar: V. Di Bucci,
having regard to the written part of the procedure,
having regard to the fact that no request for a hearing was submitted by the parties within three weeks after service of notification of the close of the written part of the procedure, and having decided to rule on the action without an oral part of the procedure, pursuant to Article 106(3) of the Rules of Procedure of the General Court,
gives the following
Judgment
1 By its action under Article 263 TFEU, the applicant, TestBioTech eV, seeks annulment of the decision of the European Commission of 8 July 2021 (‘the contested decision’) rejecting the grounds set out in its request for internal review made pursuant to Article 10(1) of Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ 2006 L 264, p. 13), against Commission Implementing Decision (EU) 2021/61 of 22 January 2021 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and genetically modified maize combining two, three or four of the single events MON 87427, MON 87460, MON 89034, MIR162 and NK603, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ 2021 L 26, p. 12) (‘the authorisation decision’).
Background to the dispute
2 On 28 October 2016, Monsanto Europe S.A./N.V., acting on behalf of Monsanto Company, United States (‘Monsanto’), submitted to the competent authority of the Netherlands, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ 2003 L 268, p. 1), an application for the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and genetically modified maize combining two, three or four of the single events MON 87427, MON 87460, MON 89034, MIR162 and NK603 (‘the modified maize’), intended for import, transformation and all uses like any other maize, excluding cultivation, in the European Union.
3 The modified maize is a genetically modified organism within the meaning of Article 2(5) of Regulation No 1829/2003, read in conjunction with Article 2(2) of 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 2001 L 106, p. 1). It is a hybrid product that combines the genetic material of certain parental plants with the following expressed proteins:
– MON 87427 expressing the 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) protein; a plant that expresses the CP4 EPSPS protein has a low affinity for glyphosate, allowing such a plant to continue to grow when treated with glyphosate-based herbicides; plants without the CP4 EPSPS protein (for example, weeds found in agriculture) die when they are exposed to such herbicides;
– MON 87460, which presents resistance to drought and expresses in particular the so-called ‘cold shock protein’ (CspB), which is associated with enhanced abiotic stress tolerance in bacteria;
– MON 89034 expressing insecticidal proteins Cry1A.105 and Cry2Ab2; the proteins known as ‘Cry’ are toxins derived from the bacterium Bacillus thurigiensis, a soil-dwelling bacterium; Cry toxins can be extracted and used as a biological pesticide; those toxins are commonly referred to as ‘Bt toxins’;
– MIR162 expressing the insecticidal proteins Vip3Aa20 and phosphomannose isomerase (PMI); Vip3Aa20 proteins can be used as an insecticide; ‘PMI’ is an enzyme which is used as a selectable marker, that is to say a gene which allows for the identification of cells which have been transformed during the process of genetic engineering based on the expression of that gene; PMI plays a role in the metabolism of mannose, which normally inhibits root growth, respiration and germination;
– NK603 expressing two variants of the CP4 EPSPS protein for tolerance to glyphosate-containing herbicides.
4 Thus, the modified maize combines the herbicide-tolerant traits of MON 87427, the drought-tolerant traits of MON 87460 and the insecticide traits of MON 89034 and MIR162. As it incorporates more than one single transformation event, that is to say more than one genetic modification, the modified maize is a genetically modified plant containing stacked transformation events. The modified maize is therefore a ‘stacked event’ and, in addition, includes 25 possible subcombinations.
5 On 3 July 2019, the Scientific Panel on Genetically Modified Organisms (GMO) of the European Food Safety Authority (EFSA) (‘the GMO Scientific Panel’) issued an opinion on the application for authorisation (‘EFSA’s opinion of 3 July 2019’), the conclusion of which was that – so far as concerns their potential effects on human and animal health and the environment – the modified maize and its subcombinations were as safe as their non-genetically modified comparator and the non-genetically modified varieties tested.
6 On 22 January 2021, as is apparent from Article 2 of the authorisation decision, the Commission authorised, under certain conditions, for the purposes of Article 4(2) and Article 16(2) of Regulation No 1829/2003:
(a) foods and food ingredients containing, consisting of or produced from the modified maize;
(b) feed containing, consisting of or produced from the modified maize;
(c) products containing or consisting of the modified maize for uses other than those provided for in subparagraphs (a) and (b), with the exception of cultivation.
7 By a letter dated 27 August 2018, Monsanto Europe informed the Commission that it had changed its legal form and its company name to Bayer Agriculture BVBA, Belgium. By letter of 28 July 2020, it informed the Commission that, as from 1 August 2020, it would change its legal form and its company name to Bayer Agriculture BV, Belgium. By letter of 28 July 2020, it informed the Commission that, as from 1 August 2020, Monsanto would also change its legal form and its company name to Bayer CropScience LP, United States.
8 On 8 March 2021, the applicant, which is a not-for-profit association seeking to promote research in the field of biotechnology, submitted a request for internal review of the authorisation decision under Article 10(1) of Regulation No 1367/2006 (‘the request for internal review’). The Commission requested EFSA to provide technical assistance, by conducting an in-depth analysis of the scientific aspects of that request.
9 On 3 May 2021, EFSA published a technical report on the detailed scientific grounds provided by the applicant in the request for internal review (‘the technical report’). In that report, entitled ‘Scientific assistance on the internal review under Regulation (EC) No 1367/2006 of the Commission Implementing Decisions on genetically modified soybean MON 87751 x MON 87701 x MON 87708 x MON 89788, maize MON 87427 x MON 87460 x MON 89034 x MIR162 x NK603 and subcombinations and maize MON 87427 x MON 89034 x MIR162 x MON 87411 and subcombinations’, EFSA concluded that that application did not justify reassessing its opinion of 3 July 2019 and its risk management recommendations concerning the modified maize.
10 On 8 July 2021, the Commission replied to the request for internal review by the contested decision. In that decision, to which was attached, as Annex II, the Commission’s detailed assessment of the grounds for review relied on (‘the detailed assessment’), the Commission stated, in essence, that the grounds relied on by the applicant in its request for internal review, including the detailed technical background provided in support thereof, did not justify a re-examination of the conclusions and risk management recommendations of the GMO Scientific Panel on the modified maize.
Forms of order sought
11 The applicant claims that the Court should:
– annul the contested decision;
– order the Commission to pay the costs.
12 The Commission contends that the Court should:
– dismiss the action;
– order the applicant to pay the costs.
Law
13 In support of the present action, the applicant raises a single plea in law. Before providing an answer to that plea, it is necessary to set out certain elements of the relevant legal framework.
Preliminary observations
14 It is apparent from Article 10(1) of Regulation No 1367/2006, in the version in force on the date on which the request for internal review was made, namely 8 March 2021, that any non-governmental organisation which meets the criteria set out in Article 11 of that regulation is entitled to make a request for internal review of administrative acts of individual scope, having legally binding and external effects, and that request must state the grounds for the review.
15 In order to set out the grounds for conducting the review in the manner required, a party requesting the internal review of an administrative act under environmental law is required to put forward the facts or legal arguments of sufficient substance to give rise to substantial or serious doubts as to the assessment made in that act by the EU institution or body (see, to that effect, judgments of 12 September 2019, TestBioTech and Others v Commission, C‑82/17 P, EU:C:2019:719, paragraph 69; of 15 December 2016, TestBioTech and Others v Commission, T‑177/13, not published, EU:T:2016:736, paragraphs 67, 83 and 88; and of 4 April 2019, ClientEarth v Commission, T‑108/17, EU:T:2019:215, paragraph 57).
16 Where the Commission concludes that the evidence adduced by a party requesting an internal review is substantial and liable to raise serious doubts as to the formal or substantive lawfulness of the grant of that authorisation, it is required to examine all relevant information of its own motion (judgments of 15 December 2016, TestBioTech and Others v Commission, T‑177/13, not published, EU:T:2016:736, paragraph 85, and of 4 April 2019, ClientEarth v Commission, T‑108/17, EU:T:2019:215, paragraph 216). At the end of its review, the Commission may withdraw or amend the authorisation decision, thereby granting in whole or in part the request for review, or maintain the authorisation as it was granted, by rejecting the request.
17 If the request for internal review is rejected, as in the present case, the party which made that request may, in accordance with Article 12 of Regulation No 1367/2006, read in conjunction with Article 10 thereof, bring an action – on grounds of lack of competence, infringement of an essential procedural requirement, infringement of the Treaties or of any rule of law relating to their application, or misuse of powers – against the decision rejecting that request as unfounded before the Courts of the European Union in accordance with Article 263 TFEU (judgment of 12 September 2019, TestBioTech and Others v Commission, C‑82/17 P, EU:C:2019:719, paragraph 38).
18 The scope of the judicial review carried out by the Courts of the European Union in their examination of an action for annulment brought pursuant to Article 12 of Regulation No 1367/2006 against a decision of the Commission concerning a request for internal review adopted pursuant to Article 10 of that regulation does not differ from the scope of the judicial review which the General Court carries out on the merits of the grounds of decisions directly challenged on the basis of Article 263(2) and (4) TFEU (see, to that effect, judgment of 15 December 2016, TestBioTech and Others v Commission, T‑177/13, not published, EU:T:2016:736, paragraph 81).
19 In that regard, it must be borne in mind that, where an EU institution is called upon to make complex assessments, it enjoys a wide measure of discretion, the exercise of which is subject to a judicial review restricted to verifying that the measure in question is not vitiated by a manifest error or a misuse of powers and that the competent authority did not clearly exceed the bounds of its discretion (see judgment of 15 December 2016, TestBioTech and Others v Commission, T‑177/13, not published, EU:T:2016:736, paragraph 77 and the case-law cited).
20 In order to establish that an institution committed a manifest error in assessing complex facts such as to justify the annulment of an act, the evidence adduced by the applicant must be sufficient to make the factual assessments used in the act implausible. Subject to that review of plausibility, it is not the Court’s role to substitute its assessment of complex facts for that made by the institution which adopted the decision. Consequently, a plea alleging the existence of a manifest error must be rejected if, despite the evidence adduced by the applicant, the contested assessment may still be accepted as true or valid. That is particularly so where the decision at issue is vitiated by errors which, taken together, are of only minor significance unlikely to have influenced the administration (see judgment of 4 April 2019, ClientEarth v Commission, T‑108/17, EU:T:2019:215, paragraph 246 and the case-law cited).
21 Furthermore, the limits to the review by the Courts of the European Union do not affect their duty to establish whether the evidence relied on is factually accurate, reliable and consistent, whether that evidence contains all the relevant information which must be taken into account in order to assess a complex situation, and whether it is capable of substantiating the conclusions drawn from it (see judgment of 15 December 2016, TestBioTech and Others v Commission, T‑177/13, not published, EU:T:2016:736, paragraph 79 and the case-law cited).
22 Lastly, where the EU institutions have a broad discretion, respect for the rights guaranteed by the EU legal order in administrative procedures is of even more fundamental importance. Those guarantees include, in particular, the duty of the competent institution to examine carefully and impartially all the relevant aspects of the individual case, the right of the person concerned to make his or her views known and also his or her right to have an adequately reasoned decision (see judgment of 15 December 2016, TestBioTech and Others v Commission, T‑177/13, not published, EU:T:2016:736, paragraph 80 and the case-law cited).
The single plea in law
23 In the application, the applicant claims that there are ‘manifest errors of assessment’ stemming from the fact that the authorisation decision had been ‘confirmed’ without ensuring that Monsanto had provided, in the context of the procedure which led to the adoption of the authorisation decision, the appropriate data under Article 5(3)(f), Article 6(3)(a), Article 17(3)(f) and Article 18(3)(a) of Regulation No 1829/2003 and Article 5 of 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 No 1829/2003 and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (OJ 2013 L 157, p. 1). The Commission failed to ensure that EFSA had carried out an adequate risk assessment of the ‘highest possible standard’, focusing in particular on the question whether the stacking of genes presented by the modified maize has potential effects on the gene expression of that modified plant when it is exposed to drought and herbicides, either in isolation or together.
24 Worded in that way, those arguments are ineffective. The question which may arise in the context of an action such as that at issue is not the question whether the Commission was required to ‘ensure’ that the applicant for authorisation or EFSA complied with their obligations deriving from Regulation No 1829/2003 and Implementing Regulation No 503/2013 in the context of the procedure which led to the adoption of the authorisation decision. By contrast, in a case such as that at issue, the question whether and how the Commission responded to the matters raised in the request for internal review is relevant (see paragraph 15 above).
25 In response to a measure of organisation of procedure, the applicant stated that, by its single plea in law, it was in fact alleging infringement of the substantive requirements laid down in Article 4(1)(a) and Article 16(1)(a) of Regulation No 1367/2006 – which form part of all the conditions which an authorisation must satisfy in accordance with Article 4(2), (3) and (5) and Article 16(2), (3) and (5) of Regulation No 1367/2006, and of all the conditions in the light of which the examination enabling the adoption of a decision such as the contested decision must be carried out.
26 An interpretation of the claims raised in the application by reference to the right to an effective remedy, guaranteed by Article 47(1) of the Charter of Fundamental Rights of the European Union, requires that they be regarded as having been put forward in support of a single plea in law alleging infringement of Article 4(1)(a) and Article 16(1)(a) of Regulation No 1367/2006, read in conjunction with Article 5(a) of Implementing Regulation No 503/2013 and with certain provisions contained in Annex II to that regulation, as referred to in the application.
27 In the present case, the requirement in Article 4(1)(a) and Article 16(1)(a) of Regulation No 1367/2006 that food and feed must not have adverse effects on human health, animal health or the environment is the fundamental material assessment criterion on the basis of which an authorisation such as that at issue must be assessed, in accordance with Article 4(2), (3) and (5) and Article 16(2), (3) and (5) of Regulation No 1367/2006; the same is true of a decision based on Article 10(2) of Regulation No 1367/2006, such as the contested decision.
28 The single plea in law concerns three distinct aspects, namely, first, exposure to drought conditions, second, exposure to the application of herbicides and, third, exposure to a combination of drought and herbicide application conditions, which it is appropriate to address as three different parts of that single plea.
The first part, concerning the exposure of that plant to drought conditions
29 The applicant submits, in essence, that the Commission’s answers in the contested decision to the criticisms made in the request for internal review regarding the possibility that drought may have an adverse effect on gene expression of the modified maize are vitiated by five manifest errors of assessment, the existence of which leads to the conclusion that the Commission infringed, in particular, Article 4(1)(a) and Article 16(1)(a) of Regulation No 1367/2006, read in conjunction with Article 5(a) of Implementing Regulation No 503/2013 and with Sections 1.2.2.3 and 1.3.2.1(b) of Part II of Annex II thereto.
30 In the first place, the Commission was wrong to consider that it was unnecessary to request that field trials be conducted under drought conditions for the modified maize, on the basis of the finding in Section 3.4.2.4 of EFSA’s opinion of 3 July 2019, according to which the conditions of cultivation and the meteorological and agronomic conditions under which the modified maize had been tested, as set out in the documentation provided by Monsanto, sufficiently replicated the range of environmental and agronomic conditions under which the modified maize would be grown in practice. Similarly, the Commission was wrong to consider that there was no need to request that field trials be conducted under drought conditions for the modified maize simply because the comparative analysis in water-limited conditions and other stressful conditions of parental plant MON 87460, namely the event conferring enhanced drought tolerance, had been specifically carried out for that event and because there was no indication of an interaction between the events.
31 Accordingly, first, contrary to the requirements set out in Section 1.3.2.1(b) of Part II of Annex II to Implementing Regulation No 503/2013, the range of the sites used for field trials provided by Monsanto in its documentation was insufficiently broad to allow reliable conclusions to be drawn as to how the modified maize will react to the variety of environments in which it will be grown. Moreover, contrary to the requirement set out in Section 1.2.2.3 of Part II of Annex II to Implementing Regulation No 503/2013, the Commission did not sufficiently assess protein expression data obtained from field trials and ‘related to the [relevant] conditions in which the crop is grown’ at issue. Only four samples from five closely located American sites (located in five American States) were used in 2014 to generate the data on gene expression. First of all, there are significant differences in the climatic conditions of the countries which are the main exporters of maize to the European Union (for example, Brazil). Next, not only were the sites chosen to carry out the field trials not representative of the climatic conditions of the main countries exporting maize to the European Union, but they were representative of only a very limited range of climatic and environmental conditions compared with those in major maize-growing regions. Finally, the meteorological data of 2014 referred to in Monsanto’s documentation showed that there was more precipitation than normal at the sites in Illinois (United States), as is apparent, in particular, from the explanations in the technical background annexed to the request for internal review.
32 Second, the Commission was also wrong to endorse the conclusion expressed by EFSA in footnote 14 to Section 3.4.2.4 of its opinion of 3 July 2019, according to which there was no need to request field testing under drought conditions for the modified maize, since the parental plant in question, namely modified maize MON 87460, had already been assessed under ‘water-limited’ conditions and since there was no indication of interaction between the events. Even if it must be accepted that there are data on gene expression, obtained from the parental plant in question grown under drought conditions, the fact remains that those data are in no way conclusive so far as concerns the safety of the modified maize. This is so because the combination of events in a stacked event, as is the case with the modified maize, may have synergistic effects which may not occur when any of the factors are taken in isolation (such as the parental plant).
33 According to the applicant, due to the higher concentration of EPSPS proteins in the modified maize compared to parental plant MON 87460 and the addition of other proteins or Bt toxins, field trials with genetically modified maize MON 87460 were insufficient to determine how the different proteins from the modified maize would respond to drought conditions. The applicant also claims that the Commission should therefore have considered how each of those proteins respond in drought conditions by conducting field trials under drought conditions on the relevant parental plants.
34 In the second place, the Commission’s response regarding the relevance of a study relied on by the applicant in the request for internal review, namely the Trtikova et al. (2015) study (Trtikova, M., Wikmark, O.G., Zemp, N., Widmer, A. and Hilbeck A., ‘Transgene expression and Bt protein content in transgenic Bt maize (MON 810) under optimal and stressful environmental conditions’, PLoS ONE, 10(4): e0123011, 8 April 2015) is also erroneous. More specifically, in Section 1.2.1 of the detailed assessment, the Commission considered, in essence, that the findings reported by Trtikova et al. (2015) had previously been assessed by EFSA, that those findings concerned only genetically modified maize MON 810 and that EFSA’s conclusions on the findings of Trtikova et al. (2015) concerning MON 810 were valid and applicable to the modified maize at issue in the present case. That response is inadequate. The results of Trtikova et al. (2015) cannot be examined solely in the light of the specific event at issue, namely MON 810, or plants expressing the Cry1Ab protein. Instead, the Trtikova et al. (2015) study should have been considered as part of a broad and robust body of research which indicates that gene expression, in particular Bt protein content and Vip3Aa20 content, is influenced by environmental or varietal backgrounds. The applicant submits that, faced with that body of research, which includes eight other studies referred to in paragraph 26 of the reply, the Commission should have undertaken a new review with the help of EFSA to understand the role of environmental and varietal backgrounds in the gene expression of the modified maize.
35 In the third place, the fact that the Commission did not take into account other scientific publications referred to in the request for internal review which referred to unpredictable possible consequences for protein expression levels constitutes a manifest error of assessment. In disregard of the fact that, according to EFSA itself, the publications referred to in the request for internal review made it possible to conclude that the protein expression levels could be influenced by stress conditions, the Commission, in Section 1.2.1 of the detailed assessment, merely concluded that the possible consequences for protein expression levels was unpredictable and could result in either higher or reduced protein expression levels. In light of the precautionary principle, far from allowing the Commission to bring its examination to a close, the finding that the possible consequences of stressful conditions for gene expression were ‘unpredictable’ should have led the Commission to assess with even greater care and meticulosity the gene expression of the modified maize under the appropriate field conditions. It is necessary to examine in particular whether and to what extent the expression of the additional proteins is affected by environmental stress factors such as drought.
36 In the fourth place, according to the applicant, the Commission was wrong not to take account of the findings of a number of specific studies relied on in the request for internal review in order to demonstrate the need to carry out additional field trials on the possible impact of more extreme climate conditions and stress factors such as drought on the modified maize, for the simple reason that the studies cited by the applicant did not concern maize. It submits that the Commission’s approach, which is apparent from Section 1.2.1 of the detailed assessment and which seeks to dismiss the scientific analysis submitted by the applicant in support of the conclusions of the Wang et al. (2014), Yang et al. (2017), Fang et al. (2018), Beres et al. (2018) and Beres (2019) studies, simply because those effects were observed in rice, in Arabidopsis thaliana and Conyza canadensis, but not in maize, is incorrect. Pleiotropic effects have already been demonstrated in species belonging to both groups of flowering plants, namely, monocotyledons, such as rice and maize, and dicotyledons, such as Arabidopsis thaliana. As is apparent from certain studies, the latter is ‘the standard reference plant for all of biology’. The emergence of pleiotropic effects in Arabidopsis thaliana plants, which have been genetically modified with the EPSPS gene, is compelling evidence of the more general fact that genetic modification with the EPSPS gene may lead to a change in the gene expression of plants subject to that genetic modification. The argument that the findings are only relevant for Arabidopsis thaliana is contradicted by the underlying scientific research. For example, the authors of the Beres et al. (2018) and Beres (2019) studies state that these effects are not unlikely to also occur in other plant species. Indeed, the Beres et al (2018) study was initiated on the basis of observations made in over 10 weedy species in relation to which researchers discovered that, under exposure to high amounts of glyphosate, the plants independently acquired glyphosate resistance by overproducing the EPSPS gene, making as many as 100 additional copies of the EPSPS gene in response to high levels of glyphosate. Therefore, the pleiotropic effects found in Arabidopsis thaliana are clearly relevant for all plants in which additional EPSPS genes have been inserted, such as the modified maize, unless the contrary has been demonstrated for that plant. However, the Commission has not submitted any evidence to show that those effects do not exist in maize.
37 In the fifth place, the Commission was not justified in stating, as it did in Section 1.2.1 of the detailed assessment, that it is unfeasible to assess genetic modification events ‘under all possible receiving environments’. According to the applicant, the Commission did not respond to its claim that the diversity of receiving environments must be sufficient to capture the range of meteorological and agronomic conditions to which the crop is likely to be exposed. However, field trials relating to the modified maize carried out in the present case were not performed in accordance with the condition relating to the diversity of receiving environments.
38 The Commission disputes the applicant’s arguments.
39 It should be noted that, by its claims referred to in paragraphs 30 to 37 above, which concern, in essence, the conduct of a whole series of trials on certain plants, the applicant does not provide any evidence that would render implausible the factual assessments made in the contested decision, as regards the possible effects of drought conditions on the gene expression of the modified maize. It follows that the applicant has not demonstrated the existence of manifest errors vitiating the contested decision and, therefore, there is no infringement of Article 4(1)(a) and Article 16(1)(a) of Regulation No 1367/2006, read in conjunction with Article 5(a) of Implementing Regulation No 503/2013 and with Section 1.2.2.3 and Section 1.3.2.1(b) of Part II of Annex II thereto. All those claims must therefore be rejected, albeit for different reasons.
40 In the first place, the applicant’s arguments that, in essence, the Commission was wrong not to ask for field trials to be carried out in order to ascertain the impact of drought on the gene expression of the modified maize (see paragraphs 30 to 32 above) are unfounded.
41 In the third paragraph of Section 3.2 (at page 9) of the technical report, EFSA had set out the standard of scientific evidence on which it intended to base its assessment, which is different from the standard relied on by the applicant. According to EFSA’s assessments, ‘it is not a requirement to conduct field trials under extreme weather conditions’. As is apparent from that section, ‘if the [genetically modified] plants have traits specifically intended to reduce the susceptibility of the plant to a defined abiotic stressor, then substantial field trials would be required as part of a much broader risk assessment’. However, for such trials, it is sufficient that they are carried out on all sites ‘over a natural gradient of the stressor or through local manipulation of the environment’. Moreover, EFSA adds in that report that ‘the lack of reported extreme events does not imply that the plants have not been exposed to abiotic and biotic stressors: these are naturally occurring during cultivation under typical environmental conditions’. The Commission essentially endorsed those assessments in Section 1.2.1 of the detailed assessment.
42 The standard of proof applied by EFSA in the present case allows in particular for abiotic and biotic stressors on a natural gradient to be taken into account, bearing in mind that the lack of reports of extreme events does not mean that the plants have not been exposed to abiotic and biotic stressors. The applicant does not call into question, in a substantiated manner and with supporting evidence, the validity of the standard of the scientific evidence chosen by EFSA as the basis for its assessment. Admittedly, it does refer to the need for the modified maize to actually be exposed to conditions of natural or artificial drought, which amounts to the existence of a different standard of proof, but it does not explain why that standard of proof is better suited than that chosen by EFSA for the purposes of interpreting, in the present case, the expressions ‘growing conditions’, ‘meteorological and agronomic conditions under which the crop is to be grown’ and ‘to be representative of the range of likely receiving environments where the plant is to be grown’ which appear in the first to third subparagraphs of Section 1.3.2.1(b) of Part II of Annex II to Implementing Regulation No 503/2013. So long as the validity of EFSA’s standard of proof has not been called into question as such, the Commission cannot legitimately be criticised for not having requested that the modified maize be exposed to drought conditions in order to ascertain the impact of such conditions on the gene expression of that GMO.
43 Lastly, it must be stated that, at page 21 of the request for internal review, the applicant acknowledged that, in the documentation accompanying its application for authorisation, Monsanto had reported cases of drought, heat, cold, flooding and frost during the field trials. Those elements appear to have been brought to EFSA’s attention in order to take account of the rule set out, in particular, in the third paragraph of Section 3.2 (at page 9) of the technical report, according to which ‘the occurrence of extreme weather conditions should be reported … to relate such events with the data collected from field trials’. The applicant does not explain why the results concerning the drought cases reported by Monsanto to EFSA were not sufficient to meet the standard of scientific evidence on which it relied itself. Nor does it link the drought cases reported by Monsanto to the standard of proof used by EFSA relating to abiotic and biotic stressors on a natural gradient, in order to demonstrate the misapplication of that standard.
44 For those reasons, there can be no finding as to the existence of the first error which the applicant claims the Commission made (see paragraph 30 above). An infringement of the first to third subparagraphs of Section 1.3.2.1(b) of Part II of Annex II to Implementing Regulation No 503/2013 has therefore not been established.
45 Moreover, the other claims put forward to demonstrate the first error which the Commission allegedly made also cannot succeed, namely, first, the argument relating to the allegedly ‘extremely narrow’ nature of the range of receiving environments in which the field trials for gene expression had been conducted (see paragraph 30 above) and, second, the argument based on the inadequacy of the Commission’s answers to the question whether the comparative analysis under water-limited conditions and other stressful conditions for parental plant MON 87460 could suffice (see paragraph 30 above).
46 First, it is apparent from Section 1.2.3 of the detailed assessment which accompanies the contested decision that, since receiving environments are highly diverse and dynamic over time, it had been ‘considered unfeasible, in practice, to assess [genetically modified] events under all possible receiving environments’. The applicant does not provide any evidence to show why that explanation of the Commission is incorrect or how the experimental design and the tested materials used to examine the modified maize were incompatible with the first to third subparagraphs of Section 1.3.2.1(b) of Part II of Annex II to Implementing Regulation No 503/2013.
47 In addition, it must be stated that the criticism that the range of American sites chosen to carry out the field trials was ‘extremely narrow’ has no factual basis. As is apparent from Monsanto’s application for authorisation and from EFSA’s opinion of 3 July 2019, it is common ground that the field trials included several sites in a number of different states of the United States located in the main maize-producing regions of the United States. Furthermore, in Section 3.4.2.4 of its opinion, EFSA concluded, in the context of an overall analysis, that the geographical locations, soil characteristics and meteorological conditions of the sites at issue were typical of receiving environments where the test materials could be grown. The applicant has not adduced any evidence to the contrary.
48 The applicant claims that the testing conditions were not representative of the climatic conditions of the countries which are the main exporters of maize to the European Union and cites the example of Brazil. However, it does not substantiate that argument with any factual evidence, either for Brazil or for other major exporters of maize to the European Union. It is true that, in that context, it states that other producing regions ‘may’ have precipitation rates or average temperatures which are substantially higher or lower. However, it does not establish the rate of precipitation or average temperature which is usual in those countries for the relevant harvest periods in the present case.
49 Lastly, in so far as the applicant submits that the meteorological data existing in 2014 in the United States, as mentioned in Monsanto’s documentation, showed that there had been more precipitation than usual on the sites located in Illinois and in so far as, in support of that argument, it refers to the diagrams and maps of the State of Illinois in Annex A.10 to the application, it must be noted that those diagrams and maps concern the years 2020 and 2021. That evidence is not in any way sufficient to demonstrate the rate of precipitation in Illinois in 2014, which was the year in which the field trials at issue were carried out. Furthermore, in so far as the applicant refers, in that context, to the explanations set out in the technical background annexed to the request for internal review, it must be held that those explanations are also mere unsubstantiated assertions. The four footnotes at page 23 of that technical background contain mere references to certain websites; however, a mere reference to a website is insufficient evidence in the present proceedings. It is not for the Court to carry out searches on websites – which may, moreover, change, or even disappear, at any time – for evidence which could be used in support of the action.
50 Second, it is necessary to reject the applicant’s argument that, in essence, even if there are data on gene expression obtained from parental plant MON 87460 grown in drought conditions, taking those data into account could not have been sufficient, since, in the combination of events, specific to the modified maize at issue, there are ‘synergistic effects’ which are not present in that parental plant (see paragraph 32 above).
51 The applicant does not call into question in a substantiated manner the explanations set out in Section 3.4.1.4 of EFSA’s opinion of 3 July 2019 which referred also and in particular to the issue of the ‘synergistic effects’ potentially present in the modified maize (but lacking in parental plant MON 87460). According to those explanations, in the course of the field trials, the MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 events had been retained in their integrity and, as regards the ‘protein expression analysis’ of genetically modified maize MON 87460, ‘there [was] no indication of an interaction that may affect the integrity of the events or the levels of the newly expressed proteins in the stack’. Those findings allowed EFSA to conclude that no safety concerns arose as regards the stacked event that is the modified maize. In so doing, EFSA in fact extrapolated the results recorded in parental plants MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and MON 87460 to the modified maize, thus giving a negative answer to the question whether the modified maize had ‘adverse effects on human [or] animal health’ within the meaning of Article 4(1)(a) and Article 16(1)(a) of Regulation No 1829/2003. The applicant does not link its argument based on the existence of potential ‘synergistic effects’ affecting the modified maize (but not parental plant MON 87460) to those explanations by EFSA. Not only does it fail to establish any error that might vitiate EFSA’s premiss that none of the parental plants in question (MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 or even MON 87460) had caused a problem in terms of stability of events or even in terms of the level of newly expressed proteins in the stack, but it also does not put forward any evidence which might cast doubt on the validity of EFSA’s extrapolation carried out in order to conclude that the modified maize did not have ‘adverse effects’ within the meaning of Article 4(1)(a) and Article 16(1)(a) of Regulation No 1829/2003.
52 Moreover, the applicant’s argument referred to in paragraph 33 above must be rejected as inadmissible in accordance with Article 84(1) of the Rules of Procedure of the General Court, since, first, it was not put forward either in the request for internal review or in the application, but only at the stage of the reply, and, second, it is not based on matters of law or of fact which came to light in the course of the procedure. In paragraph 2.1.3 of that request for internal review and in paragraphs 68 to 73 of the application, the applicant stated that the modified maize should have been tested under drought conditions, not that each of the parental plants other than MON 87460 should have been tested under such conditions. In any event, that latter argument is also unfounded. The applicant does not put forward any clear scientific working hypothesis to support the conclusion that it was necessary to carry out field trials on the parental plants concerned other than MON 87460.
53 In the second place, the applicant’s complaints concerning the Trtikova et al. (2015) study and the impact of that study on the assessment of the modified maize cannot succeed either.
54 In short, the applicant submits that the Trtikova et al. (2015) study should have been ‘considered as part of a broad and robust body of research which indicates that gene expression in general, as well as Bt and Vip3Aa20 content in particular, are influenced by environmental or varietal backgrounds’ and that the ‘body of research’ in that study should have led to ‘a fresh consideration by EFSA in relation to the specific circumstance of the Modified Maize, in particular given (i) the significantly more complex stacked genes it comprises, and (ii) the agronomic conditions under which the Modified Maize is likely to be cultivated.’
55 However, the applicant’s argument is not convincing. It is apparent from page 2 of the Trtikova et al. (2015) study, in essence, that the objective of that study was ‘to explore the relationship between Bt transgene expression and Bt protein content in two [varieties of modified maize MON 810], and to experimentally test whether abiotic environmental stress conditions influence the relationship between transgene expression and protein content’. By way of conclusion, at page 8 of that study, its authors stated that they had ‘found large variation in the transgene expression [of genetically modified maize MON 810 and plants expressing the Cry1Ab protein] and Bt protein content caused by plant genetic background and environmental conditions’ and that ‘any assessment of transgenic Bt plants [would] be incomplete without measuring transgene expression in conjunction with Bt protein content and efficacy’. The ‘abiotic environmental stress conditions’ to which modified maize MON 810 had been exposed also appear to have included drought cultivation conditions.
56 EFSA and the Commission addressed the Trtikova et al. (2015) study in EFSA’s technical report of 21 October 2015 (Annex B.5 to the defence) and in the detailed assessment, respectively. The terms used by EFSA to express its views on that study were particularly clear. Thus, at pages 3 and 8 of that report, EFSA stated that ‘taken together, the findings reported by the Trtikova et al. (2015) [study presented] no new scientific information that would invalidate the [GMO Scientific Panel’s] previous risk assessment conclusions and recommendations on risk management of maize MON 810 or any other Cry1Ab-expressing Bt maize events for which it has issued a scientific opinion …’. According to EFSA, that was the case, since ‘at present, [it was] not aware of [the existence of] early warning signs indicating increases in tolerance to Cry1Ab-expressing Bt maize in field populations of the [European corn borer or Mediterranean corn borer;] annual assessments of [European corn borer or Mediterranean corn borer] susceptibility to BtCry1Ab protein in the [United States] and [the European Union had] not revealed any significant change in susceptibility or identified populations that survive on Cry1Ab-expressing Bt-maize plants (after more than 10 years’ exposure to the Bt Cry1Ab protein in the [United States])’. In order to substantiate its opinion, which is evidently based on 10 years of growing experience, EFSA referred to the following studies: Farinos et al. (2004, 2011), Stodola et al. (2006), Andreadis et al. (2007), Siegfried et al. (2007), Crespo et al. (2009, 2010), EFSA (2011b, 2012, 2013, 2014, 2015), Siegfried and Hellmich (2012). It was only after an analysis of those factors and studies that EFSA considered that the findings in the Trtikova et al. (2015) study had no impact on the previous conclusions on the risk assessment or on the previous risk management recommendations for maize MON 810 and all other Cry1Ab-expressing Bt-maize events. Equally, it was only after the analysis of those factors and studies that EFSA suggested that the previous conclusions concerning the risk assessment of maize MON 810 remain valid and applicable. The Commission endorsed those EFSA assessments in Section 1.2.1 of the detailed assessment.
57 The applicant does not explain how EFSA’s analysis is unjustified or insufficient. While it states that the findings in the Trtikova et al. (2015) study are relevant more broadly – and not only for maize MON 810 or the variability in the level of Bt and Cry1Ab proteins – it fails to explain the scientific starting point that would allow the extrapolation it suggests. However, such an explanation was necessary since that study is devoted to an assessment of the characteristics of maize MON 810 and not to the assessment of all the parental plants on which the modified maize was based and even less on that plant as such. The applicant also does not address the analysis carried out by EFSA by linking the Trtikova et al. (2015) study to the Farinos et al. (2004, 2011), Stodola et al. (2006), Andreadis et al. (2007), Siegfried et al. (2007), Crespo et al. (2009, 2010), EFSA (2011b, 2012, 2013, 2014, 2015), Siegfried and Hellmich (2012) studies. It has thus failed to adduce evidence from which it may be concluded that the Commission made a manifest error regarding that issue. The applicant’s arguments referred to in paragraph 34 above must therefore be rejected as unfounded.
58 Lastly, in the technical report, EFSA also assessed a series of scientific publications referred to by the applicant in the reply and which appear to constitute the ‘broad and robust body’ of research mentioned by the applicant in its application. EFSA concluded, in particular on the basis of other studies, that the scientific publications referred to by the applicant had no impact on its previous conclusions and recommendations concerning risk, including for the modified maize. According to EFSA, ‘there is [admittedly] evidence in the peer-reviewed scientific literature suggesting that stressful conditions could in some instances be a factor influencing protein expression’, however ‘the possible consequences for protein content are unpredictable and may result in either higher or reduced protein levels’. The applicant does not address that EFSA conclusion in its written pleadings.
59 In the third place, it is impossible to accept the applicant’s argument that, in the light of the precautionary principle, the Commission should have assessed with even greater meticulosity the gene expression of the modified maize, since EPSPS enzymes are present in the modified maize ‘at higher concentrations compared to the [parental] plants’ and that there are scientific publications which indicate an adverse effect on plants that inherit additional EPSPS enzymes in terms of their protein expression levels (see paragraph 35 above).
60 It is true that the precautionary principle, which is a general principle of EU law, as interpreted in the case-law of the Court of Justice, implies that where there is uncertainty as to the existence or extent of risks to human health, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent (judgment of 9 September 2003, Monsanto Agricoltura Italia and Others, C‑236/01, EU:C:2003:431, paragraph 111).
61 Nevertheless, while the precautionary principle applies in situations of scientific uncertainty, the case-law has ruled out a ‘purely hypothetical approach to the risk, founded on mere conjecture which has not been scientifically verified’ (judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 116). Such is the case here. The applicant relies on hypothetical risks as regards the possible impact of the exposure of the modified maize to certain stress conditions. According to the documents before the Court, the twofold finding in the technical report, which is not contested by the parties, that certain stressful conditions could in some instances be a factor influencing protein expression levels in certain plants other than the modified maize, on the one hand, and that the ‘possible consequences for protein content are unpredictable and may result in either higher or reduced protein expression levels’, on the other, cannot be equated with a situation of ‘uncertainty’ as to ‘the existence or extent of risks to human health’ within the meaning of the definition of the precautionary principle referred to in paragraph 60 above. As long as the applicant does not call into question, in a substantiated manner, the finding set out in Section 3.4.1.4 of EFSA’s opinion of 3 July 2019, according to which ‘there [was] no indication of an interaction that may affect the integrity of the events or the levels of the newly expressed proteins in this stack’ in relation to the modified maize, no real uncertainty – within the meaning of the definition of the precautionary principle – can reasonably be inferred in relation to that plant. This also applies, in particular, to the CP4 EPSPS protein, also present in high-level modified maize. The finding concerning the stability of stacked events, which was made by EFSA in Section 3.4.1.4 of EFSA’s opinion of 3 July 2019, clearly also covers the emergence of that protein.
62 It follows that the applicant has not demonstrated any error of law or manifest error of assessment vitiating the contested decision, which is why its arguments referred to in paragraph 35 above must be regarded as unfounded.
63 In the fourth place, this is also true of the applicant’s arguments set out in paragraph 36 above. As a reminder, by its arguments, the applicant submits, in essence, that the Commission was wrong not to request the submission of further field trial data for the modified maize, since effects of the EPSPS protein overexpression under certain stress conditions were observed in rice, Arabidopsis thaliana and Conyza canadensis (according to the Wang et al. (2014), Yang et al. (2017), Fang et al. (2018), Beres et al. (2018) and Beres (2019) studies), but not in maize.
64 Admittedly, in absolute terms, it cannot be ruled out, from a scientific point of view, that results obtained from field trials on plants other than a certain plant under study may, with reasons and evidence brought in support, be extrapolated to that plant under study.
65 However, in the present case, the results of the Wang et al. (2014), Yang et al. (2017), Fang et al. (2018), Beres et al. (2018) and Beres (2019) studies, which set out certain data on the effects of EPSPS protein overexpression on the tolerance traits of rice, Arabidopsis thaliana and Conyza canadensis, were not such as to induce the Commission to request further testing, irrespective of whether those data concerned plants other than the modified maize or even that Arabidopsis thaliana constitutes, as the applicant states, the ‘standard reference plant for all of biology’.
66 The applicant does not dispute the Commission’s argument in the seventh paragraph of Section 1.2.1 (at page 6) of the detailed assessment that the authors of the Vila-Aiub et al. (2019) study had stated, in relation to the studies referred to in paragraph 65 above, that ‘reports on benefits on common breeding parameters from EPSPS overexpression in transgenic events [needed] to be further validated before it [could] be confirmed that [their] remarkable finding [was] solely due to the intended glyphosate resistance’. Moreover, in the same section of the detailed assessment, the Commission essentially stated that the hypothesis regarding possible pleiotropic effects on resistance in the modified maize had not been confirmed by the agronomic and phenotypic data of the comparative analysis. More specifically, according to the Commission, ‘the agronomic and phenotypic characterisation … [had] revealed no biologically relevant differences between the [modified maize] and its conventional counterpart’.
67 As long as that evidence, which concerns the modified maize itself, is not disputed in a substantiated manner, the applicant’s reliance on studies carried out on other plants (whether or not reference plants), such as the Wang et al. (2014), Yang et al. (2017), Fang et al. (2018), Beres et al. (2018) and Beres (2019) studies (see paragraph 36 above), cannot succeed.
68 In the light of the evidence gathered by the Commission as regards the modified maize itself, that institution was entitled not to extrapolate the conclusions relating to dicotyledone Arabidopsis thaliana, set out in those studies, to the modified maize. Reliance on those studies is therefore not capable of demonstrating any error on the part of the Commission in the assessment which was carried out in the present case.
69 In the fifth and final place, there is nothing to suggest that the range of sites chosen for carrying out the field trials was inadequate. Contrary to what the applicant suggests, the documents in the case do not establish that the modified maize field trials, carried out in the present case, were not in line with the condition relating to the diversity of receiving environments, as is apparent from a combined reading of the first and third subparagraphs of Section 1.3.2.1(b) of Part II of Annex II to Implementing Regulation No 503/2013.
70 It follows that the applicant’s argument set out in paragraph 37 above must also be rejected, as must the first part of the single plea in law.
The second part, concerning exposure to the application of herbicides
71 The applicant claims, in essence, that, in Section 1.2.2 of the detailed assessment, the Commission did not duly respond to the criticism set out in the request for internal review that the experimental design for the testing of the modified maize had not at all been adapted to identify possible unintended changes resulting from the given genetic modifications since the modified maize had not been tested under conditions of application of high and repeated doses of glyphosate. In that regard, the contested decision is therefore vitiated by manifest errors of assessment, the existence of which amounts to an infringement of Article 4(1)(a) and Article 16(1)(a) of Regulation No 1367/2006, read in conjunction with Article 5(a) of Implementing Regulation No 503/2013 and with Sections 1.2.2.3 and 1.3.1 and Section 1.3.2.1(b) of Part II of Annex II thereto.
72 First, the dose of herbicide applied in the field trials referred to in the documentation provided by Monsanto in support of its application was not representative of the expected agricultural practices. It is true that, in Section 1.2.2 of the detailed assessment, annexed to the contested decision, the Commission stated that the dose applied in the present case for the intended herbicide was consistent with the manufacturers’ recommendations. However, that response is inadequate.
73 According to the applicant, the dose of herbicide applied in the Monsanto field trials was lower than the dose recommended by the manufacturers. Thus, in the field trials referred to in the annexes to Monsanto’s application for authorisation, glyphosate was sprayed only at an early growth stage and at the comparatively low rate of 0.87 kg a.e./ha (kilograms of acid equivalent per hectare) despite the fact that current industry recommendations suggest dosages of up to approximately 3.5 kg (active substance) of glyphosate per hectare post-emergence and up to 7 kg per season.
74 Moreover, under real agricultural practices, significantly higher rates of the complementary herbicides are sprayed on herbicide-tolerant genetically engineered plants in comparison to the non-genetically engineered plants which are not made tolerant to those herbicides. Exposure of the modified maize to higher doses of glyphosate is equivalent to a stress situation affecting gene expression and plant composition of the modified maize. Those are the conclusions which may be drawn from the Miyazaki et al. (2019) study.
75 Second, in Section 1.2.2 of the detailed assessment, the Commission maintained that, in the context of the field trials, the intended herbicides are to be kept at a similar application rate across sites, to ensure comparability between locations, while the combinations of conventional herbicides applied at the selected sites were to reflect different weed management practices, chosen to maintain the weed pressure under control. That answer is also problematic. If the application of the complementary intended herbicide on the fields of the genetically engineered plants were to be kept at a similar rate as that applied ‘in the fields with non-genetically engineered plants’, it must be found that ‘the conditions under which field testing was conducted in no way represent the agricultural practices’. Under real agricultural practices, significantly higher rates of the ‘complementary’ intended herbicides are sprayed on herbicide-tolerant genetically engineered plants in comparison to those sprayed [on non-genetically engineered plant[s]’.
76 Third, the Commission’s interpretation of Implementing Regulation No 503/2013 would permit field trials of the relevant herbicide at minute levels (for example at 1% of the dosage to be applied in practice), which is however absurd.
77 The Commission disputes the applicant’s arguments.
78 By its arguments, the applicant does not deprive the assessments set out in Section 1.2.2 of the detailed assessment of their plausibility and there can be no finding of infringement of Article 4(1)(a) and Article 16(1)(a) of Regulation No 1367/2006, read in conjunction with Article 5(a) of Implementing Regulation No 503/2013 and with Sections 1.2.2.3 and 1.3.1 and Section 1.3.2.1(b) of Part II of Annex II thereto.
79 As regards the application of glyphosate, the applicant has not put forward any evidence showing clearly what might be the expected conditions under which the modified maize is to be grown (for the purposes of Section 1.2.2.3(e) and Section 1.3.2.1(b) of Part II of Annex II to Implementing Regulation No 503/2013) or the ‘expected agricultural practices’ for the modified maize (within the meaning of Section 1.3.1 of Part II of Annex II to Implementing Regulation No 503/2013). In particular, it has not been demonstrated that there is or will be a practice that will result in the modified maize being exposed to much higher and repeated doses of the intended herbicide, namely glyphosate, than the doses recommended by the manufacturer. Nor has it been demonstrated that such a practice will be necessary for farmers to benefit from the herbicide-resistant properties of the modified maize. Modified maize growers may benefit from the herbicide resistance of the modified maize if they use doses of the intended herbicide falling within the range recommended by the manufacturer. The applicant does not claim that the use of the doses of glyphosate recommended by the manufacturer fall outside good agricultural practices. Nor does it show that growers ‘need’ or will have to spray bigger volumes of the intended herbicide or spray it at increased frequencies. The Miyazaki et al. (2019) study, which is a study carried out by five authors, three of whom were collaborators of the applicant at the time of its publication, is of no assistance in that context, since that study was carried out in connection with genetically modified soybeans and not in connection with the modified maize. That study is also not an item of evidence with probative value as regards the use of glyphosate in general or in relation to the modified maize in particular. The expected growing conditions for the modified maize can therefore not in any way be inferred therefrom.
80 Moreover, it cannot be accepted that the dose applied in the field trials carried out in the present case differed considerably from the recommendations of the agricultural sector and its practices. It is apparent from Monsanto’s Roundup product label, which appears in the Court’s file as Annex B.8 to the defence, that the dose recommended by the cultivation manufacturer for a single application is between 16 and 22 fluid ounces per acre, which is equivalent to a range between 0.6 and 0.83 kg (acid equivalent) per hectare. In the context of the field trials for the modified maize, glyphosate was sprayed at a dose of 0.87 kg (acid equivalent) per hectare, as the applicant itself states in the application. Therefore, the doses of glyphosate used in the present case cannot be considered to not correspond to manufacturers’ recommendations. Moreover, the applicant’s claim that current industry recommendations recommend doses of up to approximately 3.5 kg (active substance) of glyphosate per hectare post-emergence and up to 7 kg per season has not been substantiated. The applicant does not specify from which document or on the basis of which calculations it draws its assertion. Finally, it does not demonstrate that field trials carried out using doses of glyphosate recommended by the manufacturer are not representative for the agronomic conditions in which plants, in general, or the modified maize, in particular, must be grown.
81 Furthermore, the applicant’s argument that, in essence, the Commission was wrong to accept data from field trials for which the doses of glyphosate had been kept ‘at a similar application rate across sites’ (see paragraph 75 above) is not convincing either.
82 By criticising the fact that the dose of intended herbicide applied in the fields of genetically modified plants was maintained at the same level ‘as applied in [non-genetically modified] plant fields’ (see paragraph 75 above), the applicant submits, in essence, that glyphosate was applied both on the modified maize sites and in the fields of non-genetically modified maize. Such an argument has no factual basis. In the present case, glyphosate was not applied to non-genetically modified plants, but only to the modified maize, which is in line with the fourth paragraph of Section 1.3.1 of Part II of Annex II to Implementing Regulation No 503/2013.
83 Moreover, in so far as, by the criticism at issue, the applicant maintains that glyphosate could not be applied in identical or very similar doses on all sites containing the modified maize, that argument must also be rejected. According to the Commission, that practice is likely to allow a reliable comparison of the results. Admittedly, the applicant disputes that premiss of the Commission, however it does not explain in a substantiated manner how that logic is scientifically or legally incorrect.
84 Lastly, as regards the applicant’s argument that the Commission’s interpretation of Implementing Regulation No 503/2013 would allow for field trials of the relevant herbicide at ‘minute’ levels, suffice it to note that the doses of glyphosate applied in the present case were not minute. That argument is therefore based on a purely speculative premiss and must therefore be rejected.
85 In the light of the foregoing, the second part of the single plea must be rejected.
The third part, concerning exposure to a combination of drought and herbicide application conditions
86 The applicant submits, in essence, that, in the contested decision, the Commission failed to take due account of the criticisms made in the request for internal review regarding the fact that the exposure of the modified maize under conditions of both drought and high/repeated herbicide spraying may have combinatorial or synergistic effects on plant composition and on the phenotypic and agronomic characteristics of the modified maize. The Commission therefore infringed Article 4(1)(a) and Article 16(1)(a) of Regulation No 1367/2006, read in conjunction with Article 5(a) of Implementing Regulation No 503/2013 and Section 1.3.2.1(b) of Part II of Annex II thereto.
87 The applicant claims that, in the light of the precautionary principle, changes in the composition and phenotype of the modified maize caused by stacking ought to have been investigated further by the Commission. Such is the case here since the likelihood of interaction between gene constructs and gene expression, plant composition as well as agronomic and phenotypic characteristics is exacerbated in the stacked modified maize compared to the parental plants. Stress responses can lead to unintended changes in plant metabolism inheriting additional EPSPS enzymes. There are strong indications that that enzyme, which confers glyphosate tolerance, also interferes with the auxin metabolism in the plants. Previous research into NK603 – one of the parental plants involved in the creation of the modified maize – indicated that expression of Cry1A.105, Cry2Ab2 and EPSPS proteins in genetically modified maize could induce changes in the overall proteins expressed by maize with impacts on the plant’s natural metabolic pathways (see the Agapito-Tenfen et al. (2013) and Bevenuto et al. (2017) studies), and changes in the genome and transcriptome of the plant (see the Ben Ali et al. (2020) study).
88 The data obtained from the analysis of the composition of the modified maize submitted by Monsanto itself were incomplete. They therefore raised concerns which clearly required further investigation. The field trials were deficient as a reduced watering protocol or high and/or repeated sprays of herbicide were not integrated into their experimental design. In addition, out of a total of 63 points of comparison raised, only the data of a small number of agronomic parameters, that is to say 12 in total, were the subject of a statistical analysis in accordance with EFSA’s guidelines. In any case, the analysis of the composition of the modified maize relating to 63 points of comparison revealed numerous statistically significant differences. Thus, in plants sprayed with the complementary herbicide, 46 points of comparison displayed statistically significant differences. By contrast, in plants not sprayed with glyphosate but which had been sprayed with other conventional herbicides, 47 endpoints were statistically significantly different.
89 The Commission disputes the applicant’s arguments.
90 As a preliminary point, it should be noted that, in the application, the applicant merely repeats the claims made in the request for internal review, without in any way identifying precisely the elements of the contested decision or the detailed assessment which it seeks to criticise in the context of the present part of the plea.
91 First, by the arguments referred to in paragraph 87 above, the applicant does not dispute the numerous considerations set out in Sections 1.2.4 and 1.2.5 of the detailed assessment relating to the concerns set out in the request for internal review, in particular with regard to the impact of the studies relied on by the applicant.
92 Since it has not put forward arguments actually aimed at the contested decision, all the additional explanations put forward by the applicant in the context of the present part of the plea must be regarded as arguments directed solely against the authorisation decision. Consequently, they must be rejected as inadmissible. The arguments and pleas directed against the administrative act in respect of which an internal review was sought are inadmissible, since the applicant is not entitled in his or her own right, under Article 263(2) and (4) TFEU, to challenge an authorisation decision directly before the Courts of the European Union (see, to that effect, judgment of 4 April 2019, ClientEarth v Commission, T‑108/17, EU:T:2019:215, paragraphs 26 to 28), but may formulate its arguments against such a decision only at the stage of the request for internal review.
93 Second, all the applicant’s criticisms referred to in paragraph 88 above are inadmissible. It is clear that those criticisms are directed against the content of Monsanto’s application for authorisation. Arguments concerning possible errors on the part of the applicant for authorisation are inadmissible (see, to that effect, judgments of 6 October 2021, ClientEarth v Commission, C‑458/19 P, EU:C:2021:802, paragraph 49, and of 4 April 2019, ClientEarth v Commission, T‑108/17, EU:T:2019:215, paragraphs 53, 233 and 235).
94 In any event, even if it were to be considered that the complaints made by the applicant in the present part of the plea in fact relate to the contested decision, all those complaints are unfounded since the applicant has not succeeded in demonstrating a manifest error of assessment vitiating the contested decision.
95 First, in the request for internal review, the applicant had stated that there was a likelihood that the interaction existing, inter alia, between gene constructs and gene expression is exacerbated in the stacked modified maize compared to the parental plants. It had also argued that the studies relating to NK603, one of the parental plants involved in the creation of the modified maize, had indicated that the expression of Cry1A.105, Cry2Ab2 and EPSPS proteins in genetically modified maize could induce changes in the overall proteins expressed by maize with impacts on the plant’s natural metabolic pathways and changes in the genome and transcriptome of the plant.
96 As is apparent from Section 1.2.4 of the detailed assessment, the studies concerning modified maize NK603, relied on by the applicant in the request for internal review, in particular the Ben Ali et al. (2020) and Mesnage et al. (2016) studies, did not prove that differences in gene expression were due to that event rather than to disturbance caused by environmental factors. The applicant does not contest that (scientific) conclusion expressed by the Commission in the detailed assessment.
97 Second, as regards the applicant’s complaints referred to in paragraph 88 above, it must be held that, in Section 1.2.5 of the detailed assessment, the Commission gave particularly precise answers. As is apparent from Section 1.2.5 of the detailed assessment, EFSA had considered that the effective number of significant results was much lower than that claimed by the applicant. Indeed, even if changes were observed in the level of 17 amino acids (32% of analytes in grain), those were highly correlated with the change in the level of a single analyte, namely the ‘crude protein in the grain’. Moreover, regarding all of the agronomic and phenotypic characteristics, the Commission noted that the test of equivalence showed that those of the modified maize were within the range of natural variability, with only two exceptions (number of days elapsed until 50% of plants display silking and final stand count of plants). It also noted that EFSA had carried out a more thorough assessment of those characteristics and found no environmental safety concerns. It also recalled that, on the basis of the above, EFSA had concluded that the actual number of significant results per se did not give rise to concerns.
98 The applicant did not attempt to challenge those replies in the application, with the result that the arguments relied on in support of the present part of the single plea cannot succeed.
99 In the light of the foregoing, the third part of the single plea must be rejected, as must that plea in its entirety.
100 In those circumstances, the present action must be dismissed as unfounded.
Costs
101 Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicant has been unsuccessful, it must be ordered to bear its own costs and to pay those incurred by the Commission, in accordance with the form of order sought by the latter.
On those grounds,
THE GENERAL COURT (Second Chamber)
hereby:
1. Dismisses the action;
2. Orders TestBioTech eV to bear its own costs and to pay those incurred by the European Commission.
Marcoulli | Tomljenović | Valasidis |
Delivered in open court in Luxembourg on 18 October 2023.
V. Di Bucci | | M. van der Woude |
Table of contents
Background to the dispute
Forms of order sought
Law
Preliminary observations
The single plea in law
The first part, concerning the exposure of that plant to drought conditions
The second part, concerning exposure to the application of herbicides
The third part, concerning exposure to a combination of drought and herbicide application conditions
Costs