Case T-177/13 TestBioTech ev and others v European Commission
Environment – Genetically modified products – Genetically modified soybean MON 87701 × MON 89788 – Request for internal review of the decision on marketing authorisation dismissed as unfounded – Obligation to state reasons – Manifest error of assessment
I Background
On 15 December 2016 the General Court (the Court) handed down its opinion in Case T-177/13 TestBioTech ev and others v European Commission (TestBioTech case). The applicants are non-governmental organisations based in Germany, who had asked the Commission to review its implementing decision which authorises the marketing of genetically modified soybean. The case represents the next episode in two legal wars waged by environmentalists in the EU – for standing to challenge acts of the Union institutions and, of course, for keeping GMOs out of the continent. While the applicants failed to get anywhere close to the annulment they hoped for, they scored an important victory on the issue of standing. They also managed to wrest a few important statements on the powers of the Commission in the process of GMO authorisation and standards of judicial review.
Standing for individuals and organisations to challenge acts of the EU institutions which are not addressed to them is notoriously limited. Article 263 TFEU stipulates that natural or legal persons may institute proceedings against acts which are either addressed to or which are of “direct and individual concern” to them. The EU courts tend to interpret this very narrowly. In one of its earliest cases the Court of Justice (CJEU) stated that “Persons other than those to whom a decision is addressed may only claim to be individually concerned if that decision affects them by reason of certain attributes which are peculiar to them or by reason of circumstances in which they are differentiated from all other persons and by virtue of these factors distinguishes them individually just as in the case of the person addressed.”Footnote
1
Thus far this rule is very judiciously adhered to by the CJEU, presumably because of its concern about a potentially overwhelming caseload.Footnote
2
This stance has met a lot of criticism from various quarters, but creates particular problems when it comes to decisions concerning the environment. Such decisions almost by definition concern a large number of people, and therefore no one can possibly challenge them.Footnote
3
Moreover, the lack of standing places the Union in violation of the UN Convention for Access to Justice in Environmental Matters (the Aarhus Convention). The EU is a party to the Convention, whose Article 9 guarantees to interested parties, environmental organisations explicitly included, “access to a review procedure before a court of law and/or another independent and impartial body established by law, to challenge the substantive and procedural legality of any decision” concerning the environment. The incompatibility of the Plaumann doctrine with the Aarhus Convention – as if it was not so apparent – was declared by the Aarhus Convention Compliance Committee (AAAC).Footnote
4
Despite the pressure from the Committee, thus far the EU satisfies itself with the provision of possibility of “internal review” of acts concerning the environment at the request of the relevant organisations.Footnote
5
Crucially, the regulation allows these organisations to instigate judicial review of the decision on this review. TestBioTech is the first case in which the Court was called to review a Commission’s decision on conclusion of such internal review.
As for the substantive issue, readers of this journal are doubtlessly aware that marketing of any GMO in the EU is subject to authorisation via centralised procedure, allegedly the most stringent in the world.Footnote
6
It makes the safety assessment, conducted by the European Food Safety Authority (EFSA) pivotal for the outcome. While formally factors other than safety are also to be taken into account,Footnote
7
they are never considered seriously, and the Commission has on a number of occasions asserted that it is obliged to follow the opinion of its advisor.Footnote
8
That is why any opponents of the decision are forced to fight proxy wars, and seek to expose any flaws or incompleteness in the opinion of EFSA – something that most civil society organisations are ill-equipped to do.Footnote
9
Thus, GMO authorisation is inevitably a tortuous process, which on its face appears to be “fighting science with science” while the politics remain hidden firmly behind the scene. That is why in the better part of this judgment the Court had to consider a number of claims by the applicants and counterclaims by the Commission of quite technical issues which will not be addressed in this note.
II Judgment
1 Admissibility: bypassing Plaumann, or not?
As mentioned above, the first issue of interest in this case is the admissibility of a particular type of complaint, made by non-governmental organisations against refusals of the Commission to review (and possibly withdraw) its own earlier decisions. This is interesting, as in effect such complaints represent an indirect request for annulment of the original decision and can offer a possible way for applicants to bypass the stringent requirements of Plaumann.
The applicants sought internal review of an implementing decision of the Commission by which it authorised the marketing of GM soybean. As explained above, Regulation 1367/2006 generally allows environmental organisations to request “internal review to the Community institution or body that has adopted an administrative act under environmental law” (Article 10).Footnote
10
What is more interesting is that all applicants for internal review are explicitly allowed to institute proceedings before the Court of Justice (Article 12). The text of Article 12, however, is pretty short, and does not provide any guidance as for the scope or even of the subject of the ensuing proceedings. Prima facie, only the outcome of the internal review – that is any action or inaction taken within these proceedings – can be reviewed by the Court, as the standing to challenge the original decision is governed by Article 263 TFEU and Regulation 1367/2006 cannot possibly change the primary law. Moreover, internal review was introduced as an alternative to judicial review, the availability of which was meant to remain limited. On the other hand, however, any review of the merits of the allegations made by the applicants in the internal review inevitably involves considerations of the validity of the original decision and this is precisely what the applicants were after in this case. The Commission claimed that the plea is only partly admissible. It argued that on review the Court cannot consider the lawfulness of the original decision, but the review “should be limited to the question whether applicant’s request … was dealt with in a comprehensive and appropriate manner” (para 41). It also argued that for the same reason the arguments of the applicants which are aimed at the lawfulness of the original decision should not be considered in the present proceedings.
The Court disagreed. It confirmed that Regulation 1367/2006 does not provide standing for environmental organisations to initiate action for annulment of the original decision, however it also noted that Art 263 does not prejudice the power of the Commission itself to amend or repeal the act whose review is requested.Footnote
11
In the view of the Court it is irrelevant whether the initiative for such withdrawal comes from the Commission itself, or from a third party’s request. Indeed, if the position of the defendant were accepted, any judicial review of the internal review would be rendered perfunctory and redundant in practice. Absent effective judicial review, there will be little to prevent the Commission, or the other Union bodies, to summarily dismiss requests for internal review as a matter of routine.
Still, the position taken is also wrought with difficulties and the Court itself struggled with them in the reminder of the judgment. If the request for internal review is not to become a fast track to annulment action, in contravention of the established standing rules, there should be a fine line drawn to establish some differences between the review of the conclusion of internal review of a certain administrative act and of an annulment action against the same act. Thus, the Court stated that when reviewing internal review, courts should consider only the following allegations: lack of powers, infringement of essential procedural requirements, infringement of the treaties or of any legal rule relating to their application, or misuse of powers (paragraph 56). Yet, the applicant is supposed not to challenge the original decision “directly” as unlawful or unfounded in the proceedings before the court (ibid), although they could have done this during the internal review. One cannot help wondering how a decision which features one of the defects from this list will be characterised if not “unlawful”. It makes a little more sense, from purely legalistic perspective, to bar the complainants from arguing that the original decision is unfounded, as this invites the courts to engage in substantive review, which is something they feel uneasy about anyway. However, this goes against the spirit and even the letter of the Aarhus Convention, which requires that wide access to justice is provided and it is certainly not limited to procedural issues only.Footnote
12
In any event, the Court dismissed the partial inadmissibility claim of the Commission. At no point did it engage in review of the authorisation decision itself, but engaged with each of the arguments complainants made in their original plea instead.Footnote
13
As Anais Berthier from ClientEarth was quick to point out, “this falls short from the requirements of Article 9(3) of the Aarhus Convention which requires that access to justice is provided to members of the public against acts which contravene the law relating to the environment.”Footnote
14
Referring to the draft findings of the ACCC, she insisted that to comply with the Convention, European courts must interpret Regulation 1367/2006 in a way that would allow them to consider the substance of an act subject to an internal review request.Footnote
15
2 Substance: a question of standards?
In their request for internal review the applicants challenged the soundness of the safety assessment conducted by EFSA on which the Commission authorisation decision is based. In particular they claimed that the assessment that the GM soybean was “substantially equivalent” to its conventional counterpart was flawed; also that the synergistic or combinatorial effects of the soybean, e.g. when sprayed with glyphosate – a herbicide whose safety itself recently came into question – were disregarded, and that the post-authorisation monitoring of the health effects was not adequate. In its own review, the Court, barring itself from reviewing the latter decision, reviewed one by one each of these arguments and the response the Commission gave in the review. One can consider this as an exercise of rigorous review of the Commission’s duty to give reasons (see paragraph 80 in that sense).
The Court started by pointing out that when the Union institutions must make a complex judgment, their discretion is wide, while judicial review is limited to verifying that the measure is not vitiated by manifest error, misuse of power or that the bounds of discretion are clearly exceeded. Thus far, this triad is very well established in its case law, most notably in Pfizer.Footnote
16
However, the Court went on to add that this does not prevent the courts from verifying whether the evidence relied on is factually accurate, reliable and consistent, and whether that evidence contains all the information that must be taken into account to assess a complex situation and whether it can substantiate the conclusions drawn from it (paragraph 79).
The Commission’s claim that it is for the applicant to prove that the act under review violates the relevant legislation was also dismissed; the Court asserted that in light of the requirement for a high level of health protection (Article 168 TFEU and elsewhere), it is sufficient if serious doubts as to the lawfulness of the authorisation decision are raised (paragraph 88). Next the Court engaged in a fairly extensive reconstruction of the current rules for GMO authorisation, and analysis of the role of safety assessment conducted by EFSA. Importantly, it explicitly stated that the Commission is not bound to follow the opinion of its advisor (paragraph 103). To the reader this may appear as a matter of course, but may represent a small revolution, as the Commission time and again has asserted that it is bound to authorise GMOs whenever they are assessed as ‘safe’. This must change now.
The other interesting pronouncement the Court made in passing was about the need for the institutions to comply with their own guidance. EFSA had issued three such guidance documents and the applicants alleged that the safety assessment did not meet the conditions set there. The Court stated that these documents are not intended to confer rights to third parties and in any event EFSA’s guidance cannot possibly bind the Commission and its decision (paragraph 115). While this is legally sound, it is unfortunate that the Court considered the legal value from a rights perspective only. If guidance documents are aimed to ascertain the soundness of the scientific assessment, then certainly it would make a huge difference for the reliability of this assessment if they are not complied with. In this case the Court considered whether doubts were raised as to the scientific underpinning of the authorisation decision, so it is striking that the Court failed to appreciate the importance of guidance from such perspective.
In the remainder of the judgment, the Court engaged in a seemingly meticulous review of each plea of the applicants and the adequacy of Commission’s response. Perhaps it meant to set an example of a review of the soundness of the grounds of the original decision, without engaging in review of the soundness of the decision itself. If this appears as scholastic distinction, so it is, but this seems to be the only conceivable way to square the circle of satisfying both the Aarhus Convention and the Plaumann doctrine. The more sensible approach, of course, is for the latter to be abandoned, but this is a matter for the CJEU. Thus, after nearly 200 paragraphs (paragraphs 123–294) the Court dismissed each of the pleas of the applicants as unfounded (with a few inadmissible) and ordered them to pay the costs. This last pronouncement was preceded by a brief acknowledgement that the Aarhus Convention stipulates that judicial review should not be prohibitively expensive and that Court’s own rules enable it to order that each party bears their own costs. However, a general reference to this stipulation does not suffice, and in its view the applicants in this case failed to demonstrate how the costs incurred by the Commission would be too burdensome for them.
III Concluding comment
While the applicants had many reasons to dislike the decision – not least the order to pay the Commission’s costs – there are at least three reasons for them, and everyone interested in broadening access to justice, to cheer. The first is the breakthrough on admissibility: while the route to Luxemburg has been persistently closed for most non-governmental organisations, now any environmental organisation can request internal review, and then they are entitled to institute proceedings in court. Even though the courts will be at pains not to allow direct challenges of the original act, this is certainly an opportunity for indirect challenges. Moreover, the Court engaged in what appeared to be quite rigorous review of the scientific arguments on both sides. The author knows these arguments only from the reconstruction by the court itself and is not in position to opine if the Court was fair or deferential to the Commission (whose wide discretion was explicitly recognised), but one can easily imagine that in the near future some applicants in such cases will have arguments that cannot be easily dismissed. In any event, such exemplary engagement with the scientific arguments that were made by the environmentalists is the second good news. The bad news here is that the Court is still not prepared to judge the arguments of the defendant institutions against their own guidance. The third good news is, of course, that the Commission is not bound to authorise GMOs that are “cleared” by EFSA. Regardless of where one stands in the pro- or anti-GMO debate, there should be little doubt that the decision properly belongs to the EU institutions responsible for determining the appropriate level of protection for society (paragraph 105), which in this case falls on the Commission. With the Court finally setting the competences in the process right, the Commission will finally have to take seriously the host of other considerations which the law requires it to take.Footnote
17
Case T-177/13 TestBioTech ev and others v European Commission
Environment – Genetically modified products – Genetically modified soybean MON 87701 × MON 89788 – Request for internal review of the decision on marketing authorisation dismissed as unfounded – Obligation to state reasons – Manifest error of assessment
I Background
On 15 December 2016 the General Court (the Court) handed down its opinion in Case T-177/13 TestBioTech ev and others v European Commission (TestBioTech case). The applicants are non-governmental organisations based in Germany, who had asked the Commission to review its implementing decision which authorises the marketing of genetically modified soybean. The case represents the next episode in two legal wars waged by environmentalists in the EU – for standing to challenge acts of the Union institutions and, of course, for keeping GMOs out of the continent. While the applicants failed to get anywhere close to the annulment they hoped for, they scored an important victory on the issue of standing. They also managed to wrest a few important statements on the powers of the Commission in the process of GMO authorisation and standards of judicial review.
Standing for individuals and organisations to challenge acts of the EU institutions which are not addressed to them is notoriously limited. Article 263 TFEU stipulates that natural or legal persons may institute proceedings against acts which are either addressed to or which are of “direct and individual concern” to them. The EU courts tend to interpret this very narrowly. In one of its earliest cases the Court of Justice (CJEU) stated that “Persons other than those to whom a decision is addressed may only claim to be individually concerned if that decision affects them by reason of certain attributes which are peculiar to them or by reason of circumstances in which they are differentiated from all other persons and by virtue of these factors distinguishes them individually just as in the case of the person addressed.”Footnote 1 Thus far this rule is very judiciously adhered to by the CJEU, presumably because of its concern about a potentially overwhelming caseload.Footnote 2
This stance has met a lot of criticism from various quarters, but creates particular problems when it comes to decisions concerning the environment. Such decisions almost by definition concern a large number of people, and therefore no one can possibly challenge them.Footnote 3 Moreover, the lack of standing places the Union in violation of the UN Convention for Access to Justice in Environmental Matters (the Aarhus Convention). The EU is a party to the Convention, whose Article 9 guarantees to interested parties, environmental organisations explicitly included, “access to a review procedure before a court of law and/or another independent and impartial body established by law, to challenge the substantive and procedural legality of any decision” concerning the environment. The incompatibility of the Plaumann doctrine with the Aarhus Convention – as if it was not so apparent – was declared by the Aarhus Convention Compliance Committee (AAAC).Footnote 4 Despite the pressure from the Committee, thus far the EU satisfies itself with the provision of possibility of “internal review” of acts concerning the environment at the request of the relevant organisations.Footnote 5 Crucially, the regulation allows these organisations to instigate judicial review of the decision on this review. TestBioTech is the first case in which the Court was called to review a Commission’s decision on conclusion of such internal review.
As for the substantive issue, readers of this journal are doubtlessly aware that marketing of any GMO in the EU is subject to authorisation via centralised procedure, allegedly the most stringent in the world.Footnote 6 It makes the safety assessment, conducted by the European Food Safety Authority (EFSA) pivotal for the outcome. While formally factors other than safety are also to be taken into account,Footnote 7 they are never considered seriously, and the Commission has on a number of occasions asserted that it is obliged to follow the opinion of its advisor.Footnote 8 That is why any opponents of the decision are forced to fight proxy wars, and seek to expose any flaws or incompleteness in the opinion of EFSA – something that most civil society organisations are ill-equipped to do.Footnote 9 Thus, GMO authorisation is inevitably a tortuous process, which on its face appears to be “fighting science with science” while the politics remain hidden firmly behind the scene. That is why in the better part of this judgment the Court had to consider a number of claims by the applicants and counterclaims by the Commission of quite technical issues which will not be addressed in this note.
II Judgment
1 Admissibility: bypassing Plaumann, or not?
As mentioned above, the first issue of interest in this case is the admissibility of a particular type of complaint, made by non-governmental organisations against refusals of the Commission to review (and possibly withdraw) its own earlier decisions. This is interesting, as in effect such complaints represent an indirect request for annulment of the original decision and can offer a possible way for applicants to bypass the stringent requirements of Plaumann.
The applicants sought internal review of an implementing decision of the Commission by which it authorised the marketing of GM soybean. As explained above, Regulation 1367/2006 generally allows environmental organisations to request “internal review to the Community institution or body that has adopted an administrative act under environmental law” (Article 10).Footnote 10 What is more interesting is that all applicants for internal review are explicitly allowed to institute proceedings before the Court of Justice (Article 12). The text of Article 12, however, is pretty short, and does not provide any guidance as for the scope or even of the subject of the ensuing proceedings. Prima facie, only the outcome of the internal review – that is any action or inaction taken within these proceedings – can be reviewed by the Court, as the standing to challenge the original decision is governed by Article 263 TFEU and Regulation 1367/2006 cannot possibly change the primary law. Moreover, internal review was introduced as an alternative to judicial review, the availability of which was meant to remain limited. On the other hand, however, any review of the merits of the allegations made by the applicants in the internal review inevitably involves considerations of the validity of the original decision and this is precisely what the applicants were after in this case. The Commission claimed that the plea is only partly admissible. It argued that on review the Court cannot consider the lawfulness of the original decision, but the review “should be limited to the question whether applicant’s request … was dealt with in a comprehensive and appropriate manner” (para 41). It also argued that for the same reason the arguments of the applicants which are aimed at the lawfulness of the original decision should not be considered in the present proceedings.
The Court disagreed. It confirmed that Regulation 1367/2006 does not provide standing for environmental organisations to initiate action for annulment of the original decision, however it also noted that Art 263 does not prejudice the power of the Commission itself to amend or repeal the act whose review is requested.Footnote 11 In the view of the Court it is irrelevant whether the initiative for such withdrawal comes from the Commission itself, or from a third party’s request. Indeed, if the position of the defendant were accepted, any judicial review of the internal review would be rendered perfunctory and redundant in practice. Absent effective judicial review, there will be little to prevent the Commission, or the other Union bodies, to summarily dismiss requests for internal review as a matter of routine.
Still, the position taken is also wrought with difficulties and the Court itself struggled with them in the reminder of the judgment. If the request for internal review is not to become a fast track to annulment action, in contravention of the established standing rules, there should be a fine line drawn to establish some differences between the review of the conclusion of internal review of a certain administrative act and of an annulment action against the same act. Thus, the Court stated that when reviewing internal review, courts should consider only the following allegations: lack of powers, infringement of essential procedural requirements, infringement of the treaties or of any legal rule relating to their application, or misuse of powers (paragraph 56). Yet, the applicant is supposed not to challenge the original decision “directly” as unlawful or unfounded in the proceedings before the court (ibid), although they could have done this during the internal review. One cannot help wondering how a decision which features one of the defects from this list will be characterised if not “unlawful”. It makes a little more sense, from purely legalistic perspective, to bar the complainants from arguing that the original decision is unfounded, as this invites the courts to engage in substantive review, which is something they feel uneasy about anyway. However, this goes against the spirit and even the letter of the Aarhus Convention, which requires that wide access to justice is provided and it is certainly not limited to procedural issues only.Footnote 12 In any event, the Court dismissed the partial inadmissibility claim of the Commission. At no point did it engage in review of the authorisation decision itself, but engaged with each of the arguments complainants made in their original plea instead.Footnote 13 As Anais Berthier from ClientEarth was quick to point out, “this falls short from the requirements of Article 9(3) of the Aarhus Convention which requires that access to justice is provided to members of the public against acts which contravene the law relating to the environment.”Footnote 14 Referring to the draft findings of the ACCC, she insisted that to comply with the Convention, European courts must interpret Regulation 1367/2006 in a way that would allow them to consider the substance of an act subject to an internal review request.Footnote 15
2 Substance: a question of standards?
In their request for internal review the applicants challenged the soundness of the safety assessment conducted by EFSA on which the Commission authorisation decision is based. In particular they claimed that the assessment that the GM soybean was “substantially equivalent” to its conventional counterpart was flawed; also that the synergistic or combinatorial effects of the soybean, e.g. when sprayed with glyphosate – a herbicide whose safety itself recently came into question – were disregarded, and that the post-authorisation monitoring of the health effects was not adequate. In its own review, the Court, barring itself from reviewing the latter decision, reviewed one by one each of these arguments and the response the Commission gave in the review. One can consider this as an exercise of rigorous review of the Commission’s duty to give reasons (see paragraph 80 in that sense).
The Court started by pointing out that when the Union institutions must make a complex judgment, their discretion is wide, while judicial review is limited to verifying that the measure is not vitiated by manifest error, misuse of power or that the bounds of discretion are clearly exceeded. Thus far, this triad is very well established in its case law, most notably in Pfizer.Footnote 16 However, the Court went on to add that this does not prevent the courts from verifying whether the evidence relied on is factually accurate, reliable and consistent, and whether that evidence contains all the information that must be taken into account to assess a complex situation and whether it can substantiate the conclusions drawn from it (paragraph 79).
The Commission’s claim that it is for the applicant to prove that the act under review violates the relevant legislation was also dismissed; the Court asserted that in light of the requirement for a high level of health protection (Article 168 TFEU and elsewhere), it is sufficient if serious doubts as to the lawfulness of the authorisation decision are raised (paragraph 88). Next the Court engaged in a fairly extensive reconstruction of the current rules for GMO authorisation, and analysis of the role of safety assessment conducted by EFSA. Importantly, it explicitly stated that the Commission is not bound to follow the opinion of its advisor (paragraph 103). To the reader this may appear as a matter of course, but may represent a small revolution, as the Commission time and again has asserted that it is bound to authorise GMOs whenever they are assessed as ‘safe’. This must change now.
The other interesting pronouncement the Court made in passing was about the need for the institutions to comply with their own guidance. EFSA had issued three such guidance documents and the applicants alleged that the safety assessment did not meet the conditions set there. The Court stated that these documents are not intended to confer rights to third parties and in any event EFSA’s guidance cannot possibly bind the Commission and its decision (paragraph 115). While this is legally sound, it is unfortunate that the Court considered the legal value from a rights perspective only. If guidance documents are aimed to ascertain the soundness of the scientific assessment, then certainly it would make a huge difference for the reliability of this assessment if they are not complied with. In this case the Court considered whether doubts were raised as to the scientific underpinning of the authorisation decision, so it is striking that the Court failed to appreciate the importance of guidance from such perspective.
In the remainder of the judgment, the Court engaged in a seemingly meticulous review of each plea of the applicants and the adequacy of Commission’s response. Perhaps it meant to set an example of a review of the soundness of the grounds of the original decision, without engaging in review of the soundness of the decision itself. If this appears as scholastic distinction, so it is, but this seems to be the only conceivable way to square the circle of satisfying both the Aarhus Convention and the Plaumann doctrine. The more sensible approach, of course, is for the latter to be abandoned, but this is a matter for the CJEU. Thus, after nearly 200 paragraphs (paragraphs 123–294) the Court dismissed each of the pleas of the applicants as unfounded (with a few inadmissible) and ordered them to pay the costs. This last pronouncement was preceded by a brief acknowledgement that the Aarhus Convention stipulates that judicial review should not be prohibitively expensive and that Court’s own rules enable it to order that each party bears their own costs. However, a general reference to this stipulation does not suffice, and in its view the applicants in this case failed to demonstrate how the costs incurred by the Commission would be too burdensome for them.
III Concluding comment
While the applicants had many reasons to dislike the decision – not least the order to pay the Commission’s costs – there are at least three reasons for them, and everyone interested in broadening access to justice, to cheer. The first is the breakthrough on admissibility: while the route to Luxemburg has been persistently closed for most non-governmental organisations, now any environmental organisation can request internal review, and then they are entitled to institute proceedings in court. Even though the courts will be at pains not to allow direct challenges of the original act, this is certainly an opportunity for indirect challenges. Moreover, the Court engaged in what appeared to be quite rigorous review of the scientific arguments on both sides. The author knows these arguments only from the reconstruction by the court itself and is not in position to opine if the Court was fair or deferential to the Commission (whose wide discretion was explicitly recognised), but one can easily imagine that in the near future some applicants in such cases will have arguments that cannot be easily dismissed. In any event, such exemplary engagement with the scientific arguments that were made by the environmentalists is the second good news. The bad news here is that the Court is still not prepared to judge the arguments of the defendant institutions against their own guidance. The third good news is, of course, that the Commission is not bound to authorise GMOs that are “cleared” by EFSA. Regardless of where one stands in the pro- or anti-GMO debate, there should be little doubt that the decision properly belongs to the EU institutions responsible for determining the appropriate level of protection for society (paragraph 105), which in this case falls on the Commission. With the Court finally setting the competences in the process right, the Commission will finally have to take seriously the host of other considerations which the law requires it to take.Footnote 17