Cases T‑429/13 and T‑451/13

Bayer CropScience AG and Others

v

European Commission

(Plant protection products — Active substances clothianidin, thiamethoxam and imidacloprid — Review of approval — Article 21 of Regulation (EC) No 1107/2009 — Prohibition of the use and sale of seeds treated with plant protection products containing the active substances in question — Article 49(2) of Regulation No 1107/2009 — Precautionary principle — Proportionality — Right to be heard — Non-contractual liability)

Summary — Judgment of the General Court (First Chamber, Extended Composition), 17 May 2018

Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Adoption of measures restricting the use and sale of products containing a certain active substance — Prohibition by the Commission of the placing on the market of seeds treated with plant protection products containing a certain active substance — Conditions under which applicable

Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Review of the approval of an active substance — Withdrawal or amendment of the approval for failure to satisfy the approval criteria — Infringement of the rights to property and the freedom to conduct a business — None

Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Review of the approval of an active substance — Request for review by a Member State in the light of new scientific and technical knowledge and of monitoring data — Commission’s obligation to take account of monitoring data — Scope

Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Approval of an active substance — Assessment of risks — Criteria — Taking into account of the likelihood of inappropriate use — Imposition of a prohibition on non-professional uses where data show a high rate of non-compliance with instructions for use — Lawfulness

Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Adoption of measures restricting the use and sale of products containing a certain active substance — Prior assessment of the risks for human health and the environment — Application of the precautionary principle — Scope

Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Review of the approval of an active substance — Assessment of risks — Obligation to use only documents available at the time of the request for approval — None — Breach of the principle of legal certainty — None

Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Review of the approval of an active substance — Obligation of consistency between the grounds justifying initiation of the procedure and those underpinning the amendment of the approval — None

Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Review of the approval of an active substance — Request for review by a Member State in the light of new scientific and technical knowledge and of monitoring data — Commission’s discretion as regards the need for a review

Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Review of the approval of an active substance — Request for review by a Member State in the light of new scientific and technical knowledge and of monitoring data — Concept of monitoring data

Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Review of the approval of an active substance — Initiation of the procedure where new studies raise doubts as to whether the approval criteria are satisfied — Lawfulness — Concept of new studies

Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Review of the approval of an active substance — Withdrawal or amendment of the approval for failure to satisfy the approval criteria — Burden of proof on the Commission

Actions for annulment — Admissibility criteria — Natural or legal persons — Action brought by several applicants against the same decision — Capacity to act of one of them — Admissibility of the action as a whole

Actions for annulment — Natural or legal persons — Regulatory acts — Acts not comprising implementing measures and concerning the applicant directly — Concept of implementing measures — Criteria — Commission Regulation requiring Member States that have granted authorisations for plant protection products containing a certain active substance to amend or withdraw them — Act not entailing implementing measures

Actions for annulment — Natural or legal persons — Measures of direct and individual concern to them — Individual concern — Criteria — Commission Regulation requiring Member States that have granted authorisations for plant protection products containing a certain active substance to amend or withdraw them — Action by an undertaking which produces and markets that substance — Admissibility

Actions for annulment — Natural or legal persons — Measures of direct and individual concern to them — Whether directly concerned — Criteria — Commission Regulation requiring Member States that have granted authorisations for plant protection products containing a certain active substance to amend or withdraw them — Action by an undertaking which produces and markets that substance — Admissibility

See the text of the decision. (see paras 57, 59-67)

See the text of the decision. (see paras 69, 70)

See the text of the decision. (see paras 82-87)

See the text of the decision. (see paras 88-91)

See the text of the decision. (see para. 96)

See the text of the decision. (see paras 109, 110, 112, 113, 115-126)

It is evident from the wording and the organisation of the relevant provisions of Regulation No 1107/2009 concerning the placing of plant protection products on the market that the burden of proving that the conditions for approval under Article 4 of that regulation are met lies, in principle, with the notifier, as was expressly provided for in Directive 91/414 concerning the placing of plant protection products on the market. However, in the context of a review taking place before the end of the approval period, it is for the Commission to demonstrate that the conditions of approval are no longer met. It is the party that relies on a legal provision — in this instance, Article 21(3) of Regulation No 1107/2009 — that must prove that the conditions of its application are met. Acceptance that in cases of scientific uncertainty reasonable doubts as to the safety of an active substance approved at EU level are capable of justifying a precautionary measure cannot be treated as equivalent to a reversal of the burden of proof. Nevertheless, the Commission discharges the burden of proof if it establishes that the conclusion, at the time of the initial approval, that the approval criteria provided for in Article 4 of Regulation No 1107/2009 were satisfied is invalidated by subsequent regulatory or technical developments. Thus, the Commission will discharge to the requisite legal standard its burden of proof, in the light of Article 21(3) of Regulation No 1107/2009, if it is able to demonstrate that, in the light of a legislative change involving a strengthening of the conditions of approval, the data generated by studies carried out for the purposes of the initial approval were insufficient to identify all the risks for bees linked to the active substance concerned, as regards, for example, certain routes of exposure. The precautionary principle requires the withdrawal or amendment of an approval of an active substance where new data invalidate the earlier conclusion that that substance satisfies the approval criteria provided for in Article 4 of Regulation No 1107/2009. Against that background, the Commission need do no more than provide, in accordance with the general rules of evidence, solid and convincing evidence which, while not resolving the scientific uncertainty, may reasonably raise doubts as to the fact that the active substance in question satisfies the approval criteria. (see paras 137, 140-142)

If the Commission is to be able to pursue effectively the objectives assigned to it by Regulation No 1107/2009 concerning the placing of plant protection products on the market, account being taken of the complex technical assessments which it must undertake, it must be recognised as enjoying a broad discretion. That applies, in particular, to risk management decisions which it must take pursuant to that regulation. The exercise of that discretion is not, however, excluded from judicial review. In that regard, in the context of such a review the Courts of the European Union must verify whether the relevant procedural rules have been complied with, whether the facts admitted by the Commission have been accurately stated and whether there has been a manifest error of assessment or a misuse of powers. In order to establish that the Commission made a manifest error in assessing complex facts such as to justify the annulment of the contested measure, the evidence adduced by the applicant must be sufficient to make the factual assessments used in that measure implausible. Without prejudice to that examination of plausibility, it is not for the Courts of the European Union to substitute their assessment of complex facts for that of the institution which adopted the measure. Moreover, where an institution has a wide discretion, the review of observance of guarantees conferred by the EU legal order in administrative procedures is of fundamental importance. Those guarantees include, in particular for the competent institution, the obligations to examine carefully and impartially all the relevant elements of the individual case and to give an adequate statement of the reasons for its decision. Thus, a scientific risk assessment carried out as thoroughly as possible on the basis of scientific advice founded on the principles of excellence, transparency and independence is an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures. (see paras 143-147)

In order for the Commission to be able to carry out a review of the approval of an active substance under Article 21(1) of Regulation No 1107/2009 concerning the placing of plant protection products on the market, it is sufficient that there are new studies (that is to say, studies which have not yet been taken into account by the European Food Safety Authority (EFSA) or the Commission in an earlier assessment of the substance concerned) the results of which, as compared with the knowledge available at the time of the earlier assessment, raise concerns as to whether the conditions of approval in Article 4 of Regulation No 1107/2009 are still satisfied, and it is not necessary, at that stage, to verify whether those concerns are well founded, such verification being a matter for the review itself. In order to be able to establish whether the conditions under Article 4 of Regulation No 1107/2009 are no longer satisfied, taking account, in particular, of the objective of protection pursued by that regulation, the Commission must be able to initiate a review even if the degree of doubt raised by the new scientific and technical knowledge is only relatively small. Nonetheless, that does not mean that the Commission is entirely free in making its assessment. The concept of ‘new scientific and technical knowledge’ cannot be understood as only temporal; it also has a qualitative component which applies, moreover, both to the term ‘new’ and to the term ‘scientific’. It follows that the threshold for the application of Article 21(1) of Regulation No 1107/2009 is not reached if the ‘new knowledge’ concerns mere repetition of what was previously known, new suppositions without a well-founded basis, or political considerations detached from science. Ultimately, the ‘new scientific and technical knowledge’ must therefore be genuinely relevant to the assessment as to whether the conditions of approval under Article 4 of Regulation No 1107/2009 are still met. In addition, as regards the definition of the level of previous scientific and technical knowledge, the previous level of knowledge cannot be that which immediately precedes publication of the new knowledge, but rather that which obtained at the time of the previous risk assessment of the substance concerned. First, that previous assessment represents a stable benchmark since it contains a summary of the knowledge available at the time. Second, if the novelty of the knowledge related to the level of knowledge immediately preceding its publication, it would not be possible to take account of the gradual development of scientific and technical knowledge, each stage of which may not necessarily in itself raise concerns, but which, as a whole, may give rise to concern. (see paras 161-164)

‘Monitoring data’ within the meaning of Article 21(4) of Regulation No 1107/2009 concerning the placing of plant protection products on the market are data gathered following the real-life application in the field of plant protection products containing a substance approved pursuant to that regulation. Such data, whether collected in the context of a monitoring programme or otherwise, cannot be treated in the same way as data generated by field studies as regards their ability to be used to support specific findings as to the existence or absence of a cause-and-effect relationship. Field studies are experimental scientific studies, with clear parameters and a control group, whereas monitoring studies are (non-interventional) observational studies, without defined parameters. Consequently, the quality of the data generated by the two types of study differs, particularly as regards their ability to sustain conclusions concerning the relationship of cause and effect of a phenomenon observed, or concerning a lack of causality, in the absence of a phenomenon observed. It follows from this that, while monitoring studies may reveal evidence of the existence of a risk, they cannot, unlike field studies, be used to demonstrate the absence of a risk. (see paras 202, 208, 210, 212)

It is apparent from the first subparagraph of Article 21(1) of Regulation No 1107/2009 concerning the placing of plant protection products on the market that, although the Commission is required to take into account the request of a Member State to review the approval of an active substance, it is free to assess whether such a review must be undertaken, taking into account new scientific knowledge available. That constitutes, moreover, protection for producers of approved active substances against unfounded, or unlawful, requests for review that might be put forward by Member States. As regards the role of monitoring data in the context of the decision to undertake a review, such data are mentioned in the second sentence of that subparagraph solely in order to describe the circumstances in which Member States may request that an approval be reviewed, and not those governing the Commission’s decision to initiate a review procedure. The latter circumstances are determined in the second subparagraph of Article 21(1) of Regulation No 1107/2009, which provides only for new scientific and technical knowledge to be taken into account. (see paras 213, 214)

There is no obligation of consistency or of equivalence between the grounds justifying initiation of the procedure for reviewing the approval of an active substance under Article 21(1) of Regulation No 1107/2009 concerning the placing of plant protection products on the market, on the one hand, and the grounds underpinning an amendment of the approval pursuant to Article 21(3) of that regulation, on the other. The review procedure is required, in accordance with Article 21(1) of Regulation No 1107/2009, to enable the Commission, in the event of new scientific knowledge emerging to suggest that the substance in question might no longer satisfy the approval criteria in Article 4 of that regulation, to verify whether that is indeed the case. Article 21 of Regulation No 1107/2009 does not contain any restriction as to the grounds on which it may be found that the approval criteria are no longer met, and, in particular, it does not indicate that the review should relate only to the ‘new scientific and technical knowledge’ on which the initiation of that review was based. Furthermore, such a restriction would be contrary to the principle of good administration and to the protective purpose of that regulation. (see paras 222-224)

As regards the procedure for reviewing the approval of an active substance under Article 21 of Regulation No 1107/2009 concerning the placing of plant protection products on the market, Article 12(2) of that regulation cannot be interpreted as requiring that the risk assessment of the active substances be carried out using the guidance documents available at the time of the request for approval of the substance in question. In the context of the review procedure, there is no provision for a draft assessment report to be drawn up or, moreover, to be made available to the public. The second subparagraph of Article 12(2), the object of which is, inter alia, to set a time limit for the presentation of the conclusion of the European Food Safety Authority (EFSA), is not therefore applicable to the review, since the starting point for the time limit cannot be determined. By contrast, Article 21(2) of Regulation No 1107/2009 prescribes a different time limit for submission of the results of EFSA’s risk assessment in the context of the review, namely within three months of the date of the request by the Commission. Furthermore, in the light of the protection goals of Regulation No 1107/2009, it would be difficult to accept that the methods for assessing the risks posed by an approved substance must remain fixed as at the date of the request for approval, in the context of a review which may possibly take place more than 10 years after that date. Consequently, Article 12(2) of Regulation No 1107/2009 cannot properly be relied upon in order to challenge the application, in the context of the review of an active substance, of methodologies and criteria that differ from those applied when those substances were approved. Nor, moreover, do notifiers have a general right, arising from the principle of legal certainty, to expect the risk assessment and risk management criteria in respect of an active substance to remain fixed, in the event of a review, as at the date of the request for approval. Article 114(3) TFEU, on which Regulation No 1107/2009 is notably based, provides that, in its proposals concerning, in particular, environmental protection, made on the basis of the approximation of legislation having as its object the establishment and functioning of the internal market, the Commission will take as a base a high level of protection, taking account in particular of any new development based on scientific facts. Furthermore, that protection of the environment takes precedence over economic considerations, with the result that it may justify adverse economic consequences, even those which are substantial, for certain traders. It follows from those principles, which constitute the basis of the general protection goal of Regulation No 1107/2009, that, unless otherwise specified, the decisions which the Commission is required to take in the context of that regulation must always take account of the latest scientific and technical knowledge. (see paras 260, 265-267, 288, 289)

The inclusion of the new point 3.8.3 in Annex II to Regulation No 1107/2009 concerning the placing of plant protection products on the market constitutes a change in the requirements for approval of active substances as regards the risk that pesticides pose to bees. In that regard, the regulatory framework has evolved through the adoption of that regulation and associated implementing regulations, which now provide that special attention must be paid to the risks that active substances and notably pesticides pose to bees. That change is supposed to be applied to any risk assessment performed since the entry into force of that regulation, whether it is an initial approval or a review. In those circumstances, it must be concluded that not only does point 3.8.3 of Annex II to Regulation No 1107/2009 not preclude the application, by the European Food Safety Authority (EFSA), of criteria and methodologies differing from those applied when an active substance was initially approved, but, on the contrary, and in accordance with the EU legislature’s intentions, the application of amended criteria was required by Regulation No 1107/2009. It follows from the abovementioned point 3.8.3 that the approval of an active substance is not precluded only if the survival of bee colonies is jeopardised but even where there are unacceptable effects on colony development. In that regard, there is a correlation between the risk to individual bees and the risk to colonies, in the sense that a large number of individual bee losses can transform itself into a risk to the colony concerned. However, there is at this stage scientific uncertainty as to the individual bee mortality rate threshold above which unacceptable acute or chronic effects on colony survival and development are likely to arise. In those circumstances, the Commission is fully entitled to find that, in the light of the hazard quotient values identified in respect of the substances concerned in EFSA’s conclusions, a risk to the colonies cannot be ruled out, and that it is therefore for the Commission, on the basis of the precautionary principle, to adopt protective measures without having to wait for the conditions under which, and the mortality rate threshold above which, the loss of individual bees is likely to endanger colony survival or development to be established. (see paras 273-276, 496, 498-500)

See the text of the decision. (see para. 278)

See the text of the decision. (see paras 285, 286)

The adoption, in the absence of scientific certainty, of preventive measures which, once that certainty has been acquired, might prove to be overly conservative cannot be regarded in itself as a breach of the precautionary principle and is, on the contrary, inherent in that principle. (see para. 324)

See the text of the decision. (see paras 339, 340)

Point 6.3.4 of the Commission Communication on the precautionary principle provides for an examination to be carried out of the benefits and costs of action and lack of action. However, the format and scope of that examination are not specified. In particular, it is not at all apparent that the authority concerned is obliged to initiate a specific assessment procedure culminating, for example, in a formal, written assessment report. In addition, it is apparent from the text that the authority applying the precautionary principle enjoys considerable discretion regarding methods of analysis. Although the communication indicates that the examination should include an economic analysis, the authority concerned must in any event also include non-economic considerations. Furthermore, it is expressly stated that it may be the case that, in certain circumstances, economic considerations must be considered less important than other interests which are given priority; interests such as the environment or health are expressly mentioned by way of example. Moreover, it is not necessary for the economic analysis of the costs and benefits to be made on the basis of a precise calculation of the respective costs of the action proposed or of inaction. Such precise calculations will in most cases be impossible to make, given that, in the context of the application of the precautionary principle, their results depend on different variables which are, by definition, unknown. If all the consequences of inaction and of action were known, it would not be necessary to resort to the precautionary principle; it would be possible to decide on the basis of certainties. In conclusion, the requirements of the Communication on the precautionary principle are satisfied where the authority concerned has in fact acquainted itself with the effects, positive and negative, economic and otherwise, to which the proposed action, as well as the failure to act, may lead, and has taken that into account in its decision. By contrast, it is not necessary for those effects to be estimated precisely, if that is not possible or would require disproportionate effort. In that regard, the impact assessment to be conducted by the Commission can take into account, on the one hand, the fact that it is possible, if necessary, to grant exemptions at national level and, on the other, the fact that, in certain Member States, agriculture has in the past been able to function satisfactorily without recourse to plant protection products containing the substances concerned. The politically sensitive nature of an issue is an aspect which the Commission, as a political body, can and must take into account in determining its priorities and in its decisions. That does not mean, however, that the measure taken is the result of inappropriate political pressure. (see paras 459, 460, 466, 467)

See the text of the decision. (see paras 505, 506)

The responsibility for determining the level of risk deemed unacceptable for society lies with the institutions responsible for the political choice of determining an appropriate level of protection for that society. In that regard, according to the EU legislature’s understanding of risk management, as expressed, for example, in recital 19 of Regulation No 178/2002 laying down the general principles and requirements of food law, the Commission is entitled to take into account matters such as the fact that certain groups of users might be more likely than others not to follow the instructions given on the use of plant protection products, and the impossibility of controlling the way in which they apply those products. Thus, where a survey, conducted throughout all the Member States, reveals that 34% of those surveyed read the instructions on the labels of plant protection products only ‘sometimes’ or ‘never’, and given, in particular, the high degree of toxicity of the substances concerned, the Commission is fully entitled to conclude that non-professional users are likely, more so than professional users, not to comply with the instructions for use. In those circumstances, a prohibition of non-professional uses outdoors of the substances concerned cannot be categorised as ‘manifestly inappropriate for the purpose of achieving the objective pursued’. Similarly, with regard to non-professional uses indoors, misuse, by a failure to comply with the instructions for use, cannot be ruled out, particularly in the case of non-professional users. Consequently, and given the greater certainty in any event in respect of a use that is entirely prohibited than a use in respect of which it is necessary to rely on the conscience of the user, the restriction of those non-professional uses indoors also cannot be categorised as ‘manifestly inappropriate for the purpose of achieving the objective pursued’. (see paras 551, 552, 556-559)

The available monitoring data must be taken into account, in the same way as any other relevant information, in a review of the approval of an active substance on the basis of Article 21 of Regulation No 1107/2009 concerning the placing of plant protection products on the market. As to the precise scope of that obligation, a distinction must be drawn between the risk assessment stage and the risk management stage. In the context of the assessment of risk, given that the lessons to be learned from the monitoring data are incorporated into the conclusions of the European Food Safety Authority (EFSA), the risks which that authority has identified, or those whose non-existence it considered could not be established, are therefore those that subsist or which cannot be ruled out in view, inter alia, of the monitoring data available. In the context of the decision on managing those risks which the Commission is required to take under Article 21(3) of Regulation No 1107/2009, it is not therefore for the Commission to call into question the findings made in EFSA’s conclusions, in the light of data that EFSA has already taken into account. It is, however, required to examine whether, in the light of the monitoring data, the risks which have been found to exist or which cannot be ruled out can be alleviated by the adoption of mitigation measures. (see paras 569, 571)

See the text of the decision. (see paras 585-588)

Assuming that the approval of an active substance under Regulation No 1107/2009 concerning the placing of plant protection products on the market has created new rights with respect to the applicant which are protected by Article 17 of the Charter of Fundamental Rights, that does not mean that Article 21 of that regulation concerning the review of the approval must be interpreted narrowly, since it contains sufficient guarantees for anyone who has had an active substance approved. In particular, withdrawal or amendment of an existing approval presupposes that the Commission has concluded, on the basis of new scientific knowledge, that the approval criteria are no longer satisfied. It cannot, moreover, be claimed that the amendment or withdrawal of the approval following the review infringes upon the very substance of the freedom to conduct a business or of the right to property. Applicants remain free to carry on their business of producing plant protection products. In particular, the substances concerned are still approved for certain uses within the European Union and may also be exported. (see paras 592, 593)

As is apparent from Article 49(2) of Regulation No 1107/2009 concerning the placing of plant protection products on the market, under which the Commission may restrict or prohibit the placing on the market of seeds treated with plant protection products, the application of that provision presupposes that two conditions are satisfied: first, there must be substantial concerns as to the serious risk constituted by the treated seeds, notably to the environment, and, second, it must be the case that that risk cannot be contained satisfactorily by measures taken by the Member States. The requirement that the Commission examine the evidence before taking restrictive or prohibitive measures is only declaratory, since the Commission is in all events bound, if only under the principle of good administration, to examine the available evidence before adopting measures. As regards the first condition, relating to the existence of substantial concerns, it is automatically fulfilled in the case of seeds treated with plant protection products containing active substances the approval of which no longer covers the application concerned and in respect of which any authorisations at national level have been withdrawn, because the Commission concluded that the conditions for approval under Article 4 of Regulation No 1107/2009 were no longer satisfied. In such a situation, the Commission has already established, in the context of the amendment or withdrawal of the approval of the active substance in question, that there are substantial concerns linked to the use of the seeds concerned. (see paras 608, 609)