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

(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.