(Plant protection products– Active substance thiram– Non-renewal of approval– Regulation No1107/2009 and Implementing Regulation No844/2012

165According to settled case-law, the principle of proportionality, which forms part of the general principles of EU law, requires that acts of the EU institutions should not exceed the limits of what is appropriate and necessary for the achievement of the legitimate objectives pursued by the legislation in question, it being understood that, where there is a choice between several appropriate measures, the least restrictive should be used and that the inconvenience caused must not be disproportionate to the aims pursued (see judgment of 9September 2011, Dow AgroSciences and Others v Commission, T‑475/07, EU:T:2011:445, paragraph279 and the case-law cited).

166It should also be noted that the Commission has a broad discretion for the purposes of adopting risk management measures involving complex policy choices and technical assessments (see paragraphs52 to 56 above). Consequently, only the manifestly inappropriate nature of a measure adopted in that field, in relation to the objective which the Commission intends to pursue, may affect the legality of such a measure (see, to that effect, judgment of 9September 2011, Dow AgroSciences and Others v Commission, T‑475/07, EU:T:2011:445, paragraph280 and the case-law cited).

167In the present case, in the light of the applicants’ arguments, it must be ascertained whether, in order to comply with the principle of proportionality, the Commission was obliged to have recourse to the options arising from Articles6, 21 and 78 of Regulation No1107/2009 which would make it possible to preserve the renewal of the thiram and therefore to choose the less restrictive measure.

168In the first place, as regards Article6 of Regulation No1107/2009, that provision lays down the conditions and restrictions to which the approval of an active substance may be subject. The applicants refer in particular to subparagraphs (f) and (j) of that article.

169In that regard, first, it follows from Article6(f) of that regulation that such approval may be made subject to the ‘submission of further confirmatory information to Member States, the Commission and [EFSA], where new requirements are established during the evaluation process or as a result of new scientific and technical knowledge’. The applicants consider that the reduction of the reference value used in the long-term mammalian risk assessment (see paragraph21 above) should be considered as a new data requirement arising from Commission Regulation (EU) No283/2013 of 1March 2013 setting out the data requirements for active substances, in accordance with Regulation No1107/2009 (OJ2013 L93, p.1).

170In that regard, the Commission stated at the hearing, without being contradicted by the applicants, that the requirement relied on by the latter came into force in 2013, when they submitted the dossier for the renewal of the approval of thiram in November 2014 (see paragraph16 above). Thus, it cannot be considered that such a requirement was established ‘during the evaluation process’.

171Second, with regard to Article6(j) of Regulation No1107/2009, it appears that the approval of an active substance may be made subject to ‘any other particular conditions that result from the evaluation of information made available in the context of [that regulation]’. According to the applicants, that provision could allow the submission of ‘new data providing clarification regarding the birds and mammals risk assessment’, in particular the data provided in the fact sheet dated 23January 2018.

172In that regard, it was found in paragraph137 above that the new data submitted by the applicants to the Commission, including those provided in the fact sheet dated 23January 2018, did not confirm the existence of an acceptable risk to birds and mammals. Furthermore, in paragraph145 above, it was concluded that the applicants had not demonstrated that the risk to birds and mammals was higher when using thiram as a foliar spray than when treating seeds with that substance.

173Consequently, the applicants do not establish that, in so far as the Commission did not make use of the options provided for in Article6(f) and (j) of Regulation No1107/2009, the contested implementing regulation was manifestly inadequate to achieve the objectives of protection of health and the environment pursued by that measure.

174In the second place, as regards Article21 of Regulation No1107/2009, that provision allows the Commission to review the approval of an active substance at any time after its approval, in the light of new scientific and technical knowledge. The applicants are of the opinion that that provision could be applied after the renewal procedure or in parallel with it.

175In that regard, even if the review procedure could be conducted in parallel with the renewal procedure, it is sufficient to note, as the Commission has done, that the applicants asked the Commission to make use of Article21 of Regulation No1107/2009 to allow for the consideration of additional data concerning birds and mammals after the adoption of the EFSA conclusions. In light of the conclusion in paragraph138 above, the applicants do not establish the existence of new data demonstrating an acceptable risk to birds and mammals. Consequently, and for the same reason that it was found, in paragraph173 above, that the contested implementing regulation was not manifestly inappropriate for attaining the objectives of protection of health and the environment pursued by that measure, it must be held that the Commission did not commit an error by failing to avail itself of the possibility provided for in that provision.

176In the third place, as regards Article78 of Regulation No1107/2009, the applicants allege that it may be relied on to trigger the application of Article6(f) or (j) of that regulation. In view of the conclusion reached in paragraph173 above concerning the application of those provisions, the argument based on recourse to Article78 of that regulation must be rejected as inoperative.

177In the light of the foregoing, the applicants do not establish that the adoption of the contested implementing regulation was manifestly inadequate to attain the objectives of protection of health and the environment pursued by that measure.

(b)The alleged breach of the precautionary principle

(1)Preliminary remarks on the precautionary principle

178It should be noted, first of all, that, while Article191(2) TFEU provides that environmental policy is to be based, inter alia, on the precautionary principle, that principle is also intended to apply in the context of other EU policies, in particular the policy of protection of public health and when the EU institutions adopt, under the common agricultural policy or the policy of the internal market, measures for the protection of human health (see judgment of 1October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph41 and the case-law cited).

179It is therefore incumbent on the EU legislature, when adopting rules governing the placing of plant protection products on the market, such as those set out in Regulation No1107/2009, to comply with the precautionary principle, with a view, in particular, to ensuring, in accordance with Article35 of the Charter of Fundamental Rights of the European Union and Article9 and Article168(1) TFEU, a high level of protection of human health (see judgment of 1October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph42 and the case-law cited).

180The precautionary principle means 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 for the reality and seriousness of those risks to be fully demonstrated (see judgment of 1October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph43 and the case-law cited).

181According to settled case-law, the EU institutions enjoy, in implementing the measures to be taken for the protection of human health, a wide discretion as regards the definition of the objectives pursued and the choice of appropriate means of action (see judgment of 11February 2015, Spain v Commission, T‑204/11, EU:T:2015:91, paragraph30 and the case-law cited).

182The considerations set out in paragraphs178 to 181 above are applicable, by analogy, in relation to the other interests protected by Article4 of Regulation No1107/2009, namely, inter alia, animal health and the environment (see, to that effect, judgment of 17May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph130).

183Within the process leading to the adoption by an institution of appropriate measures to prevent certain potential risks to public health, safety and the environment by reason of the precautionary principle, three successive stages can be identified: first, identification of the potentially adverse effects arising from a phenomenon; second, assessment of the risks to public health, safety and the environment which are related to that phenomenon; and, third, when the potential risks identified exceed the threshold of what is acceptable for society, risk management by the adoption of appropriate protective measures (judgment of 17May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph60).

184With regard to the third stage concerning risk management, it should be noted that point6.3.4 of the Communication on the precautionary principle, entitled ‘Examination of the benefits and costs of action and lack of action’ (‘the examination of the benefits and costs’) to which the applicants refer, is worded as follows:

‘A comparison must be made between the most likely positive or negative consequences of the envisaged action and those of inaction in terms of the overall cost to the [European Union], both in the long and short term. The measures envisaged must produce an overall advantage as regards reducing risks to an acceptable level.

Examination of the pros and cons cannot be reduced to an economic cost‑benefit analysis. It is wider in scope and includes non-economic considerations.

However, examination of the pros and cons should include an economic cost‑benefit analysis where this is appropriate and possible.

Besides, other analysis methods, such as those concerning the efficacy of possible options and their acceptability to the public may also have to be taken into account. A society may be willing to pay a higher cost to protect an interest, such as the environment or health, to which it attaches priority.

The Commission affirms, in accordance with the case-law of the Court that requirements linked to the protection of public health should undoubtedly be given greater weight [than] economic considerations.

The measures adopted presuppose examination of the benefits and costs of action and lack of action. This examination should include an economic cost/benefit analysis when this is appropriate and feasible. However, other analysis methods, such as those concerning efficacy and the socio-economic impact of the various options, may also be relevant. Besides the decision-maker may, in certain circumstances, [be] guided by non-economic considerations such as the protection of health.’

185It is in the light of the foregoing legal framework and case-law that it is necessary to examine whether, in applying the precautionary principle, the Commission was required in the present case to carry out an examination of the benefits and costs within the meaning of point6.3.4 of the Communication on the precautionary principle and, if so, whether it did so in the present case.

(2)The Commission’s obligation to examine the benefits and costs

186In the first place, it must be ascertained whether, as the Commission maintains, it is not obliged to carry out an examination of the benefits and costs, within the meaning of point6.3.4 of the Communication on the precautionary principle, in a procedure for the renewal of the approval of an active substance, provided for in Regulation No1107/2009 and in the context of which it is incumbent on the applicant to demonstrate the efficacy and safety of the active substance in question.

187It follows from recital8 and Article1(4) of Regulation No1107/2009 that the provisions of that regulation are based on the precautionary principle in order to prevent active substances or products placed on the market from harming human and animal health or the environment.

188As recalled in point184 above, point6.3.4 of the Communication on the precautionary principle requires the consideration of benefits and costs. It should be noted that that point is included under the heading ‘The general principles of application’. Thus, such an examination is considered to be one of the general principles applicable to the use of the precautionary principle. In that respect, the first paragraph of point6.3 of that communication specifies that those general principles apply to ‘all risk management measures’.

189In those circumstances, contrary to what the Commission maintains, it cannot be considered that the examination of the benefits and costs in the context of the application of the precautionary principle applies solely to the procedures for reviewing the approval of an active substance under Article21 of Regulation No1107/2009.

190That conclusion cannot be called into question by the Commission’s arguments.

191Firstly, the Commission relies on the judgment of 17May 2018, BASF Agro and Others v Commission (T‑584/13, EU:T:2018:279), in which the Court held that the Commission was obliged to carry out an examination of the benefits and costs in the context of a review of the approval of an active substance under Article21 of Regulation No1107/2009. However, that judgment cannot be interpreted a contrario as meaning that the Commission is not obliged to carry out an examination of the benefits and costs in the context of a renewal procedure.

192Secondly, the Commission states that the renewal procedure is different from the review procedure under Article21 of Regulation No1107/2009 as regards the burden of proof to demonstrate the efficacy and safety of the active substance concerned. In that respect, it is sufficient to recall, as noted in paragraph184 above, that the consideration of benefits and costs is part of the management of the identified risks. By contrast, the burden of demonstrating the efficacy and safety of the active substance concerned, which falls on the applicant in a renewal procedure, is relevant only in the context of the first two stages referred to in paragraph183 above, namely the identification of potentially adverse effects arising from a phenomenon and the assessment of the risks to public health, safety and the environment associated with that phenomenon.

193Thirdly, the Commission alleges that it has no choice or discretion in the case of an application for renewal, in that it is obliged to act to renew the approval, not to renew it or to renew it subject to certain conditions and restrictions. However, it is precisely the three options indicated that give the Commission a margin of discretion to choose the most appropriate option for an active substance to be renewed, with a view to preventing certain potential risks to public health, safety and the environment under the precautionary principle. Even if the risk assessment identifies animal and human health concerns and if there are various data gaps, the Commission retains two options: either not to renew the active substance in question or to renew it subject to certain conditions and restrictions.

194In the light of the foregoing, it must be concluded that the Commission was required to carry out an examination of the benefits and costs within the meaning of point6.3.4 of the Communication on the precautionary principle. It is still necessary to examine whether the Commission carried out such an examination in the present case.

(3)The conduct by the Commission of the review of benefits and costs

195It should be noted that point6.3.4 of the Communication on the precautionary principle does not specify the format and scope of the examination of benefits and costs. In particular, it does not follow from the provisions of that point that the authority concerned is obliged to initiate a specific assessment procedure, leading for example to a formal written assessment report. Furthermore, it follows from that text that the authority applying the precautionary principle has a considerable margin of appreciation as to the methods of analysis. While that communication states that the examination ‘should’ include an economic analysis, the authority concerned must in any case also integrate non-economic considerations. Moreover, it is expressly pointed out that in certain circumstances economic considerations may have to be regarded as less important than other interests recognised as important; expressly mentioned by way of example are interests such as the environment or health (judgment of 17May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph162).

196Furthermore, the requirements of the Communication on the precautionary principle are satisfied where the authority concerned, in this case the Commission, 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 (judgment of 17May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph163).

197In the present case, it should be noted that, in order to demonstrate that it has met its obligation to carry out a review of the benefits and costs, the Commission relies on the information provided to the Standing Committee at the meeting of 24 and 25May 2018. In that respect, the Commission quotes point B.11 of the summary of that meeting, which states that it considered that ‘the risks and issues identified overrule[d] the impact of possible loss of the substance for resistance management and also any economic impact, also taking into account the alternatives still available’.

198In those circumstances, it can be considered that the Commission did in fact take cognisance of the effects, positive and negative, economic and otherwise, likely to be induced by the non-renewal of the approval of thiram and that it took them into account in adopting the contested implementing regulation.

199That conclusion cannot be called into question by the applicants’ argument that the examination of the benefits and costs, within the meaning of point6.3.4 of the Communication on the precautionary principle, should include a thorough assessment of the most likely positive or negative consequences of the proposed non-renewal.

200First, it is clear from the case-law cited in paragraph181 above that the EU institutions enjoy, in implementing the measures to be taken for the protection of human health, a wide discretion as regards the definition of the objectives pursued and the choice of appropriate policy instruments. It should, moreover, be made clear that, because of the need to balance several objectives and principles, as well as the complexity of the implementation of the relevant criteria, judicial review must necessarily be limited to the question whether the EU institutions have committed a manifest error of assessment (see, to that effect, judgment of 21December 2016, Associazione Italia Nostra Onlus, C‑444/15, EU:C:2016:978, paragraph46). Nevertheless, in the present case, the applicants do not put forward any specific argument as to a possible error on the part of the Commission with regard to the examination of the benefits and costs, within the meaning of point6.3.4 of the Communication on the precautionary principle.

201Second, as noted in paragraph196 above, it is not necessary that the effects, positive and negative, economic and otherwise, to which the proposed action, as well as the failure to act, may lead, be precisely estimated, if that is not possible or would require disproportionate effort.

202Consequently, the applicants have no basis for claiming that the Commission misapplied the precautionary principle.

(c)The alleged breach of the principle of equal treatment

203It should be noted that the principle of equal treatment precludes comparable situations from being treated differently and different situations from being treated identically, unless such treatment is objectively justified (judgments of 25October 2005, Groupe Danone v Commission, T‑38/02, EU:T:2005:367, paragraph453, and of 12April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph310).

204In the present case, by arguing that the Commission infringed the principle of equal treatment, the applicants rely on the assessment of the fungicidal compounds copper and methoxyfenozide, as well as on some of their possible similarities with thiram (see paragraph163 above). However, it is incumbent on the applicants to specify and demonstrate which situation is comparable to another situation which has been treated differently.

205By merely identifying common areas of concern with thiram and the lack of specific guidance for assessing naturally occurring metals such as copper, the applicants do not provide any demonstration to that effect. They do not provide any evidence that the analysis of the fungicidal compounds of copper and methoxyfenozide, their individual merits and the scientific background against which those substances were assessed are comparable in all those respects concerning thiram.

206Therefore, the sixth plea in law must be rejected.

207In view of all the above, the action must be dismissed in its entirety.

V.Costs

208Under Article134(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.

209Since the applicants have been unsuccessful, they must be ordered to bear their own costs and to pay those incurred by the Commission in the present action, in accordance with the form of order sought by the Commission.

210Since Taminco was unsuccessful in the proceedings for interim measures and the costs were reserved (see paragraph40 above), it must be ordered to bear its own costs and to pay those incurred by the Commission in that procedure, in accordance with the form of order sought by the Commission.

On those grounds,

THE GENERAL COURT (Seventh Chamber)

hereby:

1.Dismisses the action;

2.Orders Taminco BVBA and Arysta LifeScience Great Britain Ltd to bear their own costs and those incurred by the European Commission in the context of the present action;

3.Orders Taminco to bear its own costs and those incurred by the Commission in the context of the proceedings for interim measures.

Delivered in open court in Luxembourg on 9 February 2022.

Table of contents

I. Legal framework

A. Directive 91/414/EEC

B. Regulation No1107/2009

C. Implementing Regulation No844/2012

II. Background to the dispute

A. First approval of thiram at EU level

B. Renewal of the approval of thiram at EU level

III. Procedure and forms of order sought

IV. Law

A. The jurisdiction of the Court to deal with certain claims made in the application

B. The application for annulment

1. Preliminary remarks

(a) The scope of the Court’s review

(b) The burden of proof

2. The fifth plea in law, alleging failure to respect the rights of the defence

3. The first plea in law, alleging a formal defect in that the Commission failed to take account of the withdrawal of the application for renewal of the approval of the use of thiram by foliar spraying

4. The second and third pleas in law, alleging, respectively, a manifest error of assessment and infringement of Article4(5) of Regulation No1107/2009

5. The fourth plea in law, alleging a proposed classification of thiram ultra vires

6. The sixth plea in law, alleging breach of the precautionary principle, the principle of proportionality and the principle of equal treatment

(a) The alleged violation of the principle of proportionality

(b) The alleged breach of the precautionary principle

(1) Preliminary remarks on the precautionary principle

(2) The Commission’s obligation to examine the benefits and costs

(3) The conduct by the Commission of the review of benefits and costs

(c) The alleged breach of the principle of equal treatment

V. Costs

*Language of the case: English.