Case T‑584/13

BASF Agro BV and Others

v

European Commission

(Plant protection products — Active substance fipronil — 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 substance in question — Article 49(2) of Regulation No 1107/2009 — Precautionary principle — Impact assessment)

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 — Prior assessment of the risks for human health and the environment — Commission’s obligation to carry out an impact assessment — Failure to fulfil obligations — Breach of the precautionary principle

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 — 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 — 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 33, 35-42)

See the text of the decision. (see paras 44, 45)

See the text of the decision. (see para. 49)

See the text of the decision. (see paras 58, 59, 61, 62, 64-75)

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 86, 89-91)

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 92-96)

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 of approval 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 110-112, 114)

‘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 128, 132, 134, 136)

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 137, 138)

The application of the precautionary principle is not limited to cases in which it is uncertain that there is a risk; the principle may also be applied where a risk has been proved to exist and where the Commission must assess whether that risk is acceptable or not, or assess how it should be dealt with in a risk management context. As regards the application of that principle in the context of Regulation No 1107/2009 concerning the placing of plant protection products on the market, as is apparent from recital 8 and Article 1(4) of that regulation, all the provisions of that regulation are underpinned by the precautionary principle with a view to ensuring that active substances or plant protection products do not adversely affect, inter alia, the environment. It follows from this that any act adopted on the basis of the regulation is ipso jure founded on the precautionary principle. That basis is not limited to Articles 69 and 70 of Regulation No 1107/2009, relating to emergency procedures. The precautionary principle must be applied for the assessment of the approval criteria provided for in Article 4 of that regulation, to which Article 21(3) thereof refers. (see paras 153, 154, 156)

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. (see paras 162, 163)