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

52According to the case-law, in order to be able to pursue effectively the objectives assigned to it by Regulation No1107/2009, and in view of the complex technical assessments which it must carry out, the Commission must be granted a broad discretion (see, to that effect, judgments of 18July 2007, Industrias Químicas del Vallés v Commission, C‑326/05P, EU:C:2007:443, paragraphs74 and 75, and of 6September 2013, Sepro Europe v Commission, T‑483/11, unreported, EU:T:2013:407, paragraph38). That applies, in particular, to the risk management decisions which it has to take pursuant to that regulation.

53The exercise of that power is not, however, exempt from judicial review. In that regard, it is settled case-law that, in the context of that review, the EU Courts must verify compliance with the procedural rules, the substantive accuracy of the facts adopted by the Commission, the absence of a manifest error in the assessment of those facts or the absence of misuse of powers (judgments of 25January 1979, Racke, 98/78, EU:C:1979:14, paragraph5; of 22October 1991, Nölle, C‑16/90, EU:C:1991:402, paragraph12; and of 9September 2008, Bayer CropScience and Others v Commission, T‑75/06, EU:T:2008:317, paragraph83).

54As regards the assessment by the EU Courts of the existence of a manifest error of assessment, it should be made clear that, in order to establish that the Commission committed a manifest error in the assessment of complex facts such as to justify the annulment of the contested measure, the evidence adduced by the applicant must be sufficient to render the assessments of the facts contained in the measure implausible (see, to that effect, judgment of 12December 1996, AIUFFASS and AKT v Commission, T‑380/94, EU:T:1996:195, paragraph59). Subject to that examination of plausibility, it is not for the Court to substitute its assessment of complex facts for that of the author of the act (judgment of 9September 2011, Dow AgroSciences and Others v Commission, T‑475/07, EU:T:2011:445, paragraph152; see also, to that effect, judgment of 15October 2009, Enviro Tech (Europe), C‑425/08, EU:C:2009:635, paragraph47).

55In addition, it should be noted that, in cases where an institution has a wide discretion, the monitoring of compliance with the guarantees conferred by the Union legal order in administrative procedures is of fundamental importance. The Court has had occasion to specify that those guarantees include the obligation of the competent institution to examine, with care and impartiality, all the relevant factors of the case and to give adequate reasons for its decision (judgments of 21November 1991, Technische Universität München, C‑269/90, EU: C:1991:438, paragraph14; of 7May 1992, Pesquerias De Bermeo and Naviera Laida v Commission, C‑258/90 and C‑259/90, EU:C:1992:199, paragraph26; and of 6November 2008, Netherlands v Commission, C‑405/07P, EU:C:2008:613, paragraph56).

56Thus, it has been held that 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 (judgment of 11September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraph172).

(b)The burden of proof

57Article4(1) of Regulation No1107/2009, which sets out the conditions for the approval of active substances, requires that it must be ‘expected’ that plant protection products containing an active substance comply with the conditions set out in paragraphs2 and 3 of that article. The latter paragraphs, in turn, require that such products and their residues comply with the conditions set out thereafter (namely, that they have no harmful effects on human or animal health or unacceptable effects on the environment). In accordance with the principle that it is for the party relying on a legal provision to prove that the conditions for its application are met, it follows from those formulations that it is the applicant who must prove that the conditions for approval are met, in order to obtain approval, and not the Commission which must prove that the conditions for approval are not met in order to be able to refuse it (judgment of 17May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph88).

58The principles set out in paragraph57 above are applicable in the context of the procedure for the renewal of the approval of an active substance.

59It is in the light of those considerations that the pleas in law referred to in paragraph51 above must be examined, beginning with the fifth plea, alleging failure to respect the rights of the defence.

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

60The applicants claim that the Commission violated their rights of the defence on two counts.

61In the first place, they were not given the opportunity to comment on the reduction of the reference value used in the assessment of long-term risk to mammals, which was significantly reduced during the meeting 148 held prior to the adoption of the updated RMS RAR in November 2016.

62In that respect, the applicants state that the reduction of the reference value at issue was not previously discussed. Furthermore, the Commission rejected their proposals, first, to provide new data to address the concerns arising from that reduction of the reference value and, secondly, to reconsider its proposal for the renewal of thiram on the basis of seed treatment only.

63The applicants also draw attention to the fact that, in order to respond to the reduction of the reference value at issue, they informed the Commission and the Member States in 2017 of the existence of higher tier-field studies and provided updates in 2017 and 2018 with available results confirming that the risk would be acceptable. Furthermore, they note that EFSA, in its conclusions, and some Member States considered that the data for birds and mammals could be accepted at Member State level. They also cite a review by the Kingdom of Belgium of the new field study that monitored potential long-term reference values on field mice from thiram-treated maize seed, which reportedly concluded in June 2018 that there were no concerns for long-term effects on small mammals.

64The applicants add that, had the Commission not significantly reduced the initial reference value for mammals proposed by the RMS in October 2016, and had it subsequently accepted the higher tier-field studies submitted in July 2018, the mammalian risk assessment would have been unopposed and the mammal uses would have been considered safe.

65In the second place, the applicants state that they were not given the opportunity to comment on a proposal for a new classification of thiram in the EFSA conclusions.

66The Commission contests the applicants’ arguments.

67It should be noted that respect for the rights of the defence in any procedure initiated against a person and likely to result in an act adversely affecting him or her constitutes a fundamental principle of EU law which must be ensured even in the absence of any rules concerning the procedure. That principle requires that the addressees of decisions which appreciably affect their interests be given the opportunity to make their views known in a meaningful way (see, to that effect, judgment of 15June 2006, Dokter and Others, C‑28/05, EU:C:2006:408, paragraph74 and the case-law cited).

68By contrast, in the case of acts of general application, neither the process of their preparation nor the acts themselves require, under the general principles of EU law, such as the right to be heard, consulted or informed, the participation of those affected. This is not the case if an express provision of the legal framework governing the adoption of that act confers such a procedural right on an affected person (see judgment of 19December 2019, Probelte v Commission, T‑67/18, EU:T:2019:873, paragraph87 and the case-law cited).

69Furthermore, it has been held that measures approving, extending or renewing the approval of active substances adopted on the basis of Regulation No1107/2009 are of general application (see, to that effect, judgment of 27September 2018, Mellifera v Commission, T‑12/17, EU:T:2018:616, paragraph71).

70In the present case, first, the contested implementing regulation concerns the non-renewal of the approval of thiram, prohibiting the use and sale of seeds treated with plant protection products containing thiram, in accordance with Regulation No1107/2009, and, second, that implementing regulation is not addressed to the applicants. Consequently, that implementing regulation must be regarded as an act of general application.

71In that context, the procedural rights enjoyed by the applicants in the context of the procedure for the renewal of the approval of thiram are those explicitly provided for by Regulation No1107/2009 laying down general provisions relating in particular to the procedure for the renewal of the approval of an active substance, and by Implementing Regulation No844/2012 laying down specific provisions relating to the implementation of the procedure for the renewal of the approval of an active substance.

72In particular, as regards the rights of the applicant to be heard during the evaluation of the application for renewal of the approval of an active substance, it follows from Implementing Regulation No844/2012 that the applicant may submit comments, first, on the draft RAR (Article12(3)) and, second, on the Commission’s renewal report (third subparagraph of Article14(1)).

73It follows from Article12(1) and (3) of Implementing Regulation No844/2012 that EFSA is to communicate to the applicant and the other Member States, no later than 30days after receiving it, the draft RAR forwarded to it by the RMS and is to allow for written comments to be submitted for a period of 60days from the date on which the report is made available to the public. In the present case, it is common ground that the applicants were given the opportunity to submit their comments on the draft RAR, in accordance with Article12(3) of that implementing regulation (see paragraph18 above).

74According to the third subparagraph of Article14(1) of Implementing Regulation No844/2012, the applicant is given the opportunity to submit comments on the renewal report within 14days. That opportunity was given to the applicants and they made use of it, as can be seen from paragraph26 above.

75It should also be noted that, by email of 31January 2017, the Commission invited the applicants to submit their comments on the EFSA conclusions, while stating that the relevant regulation did not provide for a formal consultation of the applicants on such conclusions. The applicants submitted their comments on 22February 2017. In addition, a meeting was held in May 2017 between the Commission and the applicants during which the latter were given the opportunity to present their views.

76It should be noted at the outset that, in the contested implementing regulation, the Commission established a high risk for birds and that that risk was fixed on the basis of a reference value which was not modified in relation to that taken into consideration by the RMS. Furthermore, the applicants do not allege a breach of their right to be heard in that respect.

77In the first place, with regard to the applicants’ claim that they were not given the opportunity to express their views on the reduction of the reference value used in the assessment of the long-term risk to mammals during the meeting 148, which was held prior to the adoption of the updated assessment report on the renewal of the RMS in November 2016, the following should be noted.

78First, it is apparent from the January 2017 Thiram Peer Review Report and, more specifically, from the reporting table dated 27June 2016 that, prior to the meeting 148, submissions had been made in relation to the relevant reference value that had been proposed by the applicants and retained by the RMS in the draft RAR. In their submissions, the applicants were given the opportunity, first, to defend the reference value which they had proposed in their application and which had been retained by the RMS in that project and, second, to comment on the 2005 scientific study which would later be used as the basis for setting a lower reference value.

79Next, it is common ground that at the meeting 148, the experts decided to use a reference value of 1.6mg/kg for the long-term risk assessment for mammals and that that reference value was included in the EFSA conclusions.

80Furthermore, as the applicants recalled in their written replies to the Court’s questions, in their observations of 22February 2017 on the EFSA conclusions, they disagreed with the reduction of the reference value in question on the grounds that the reasons underlying that decision were unclear, that the method of dosing did not represent the true exposure paradigms in mammals and that the reference value chosen was scientifically questionable.

81In addition, the applicants reiterated their disagreement in a presentation document submitted to the Commission for the purposes of a meeting held with the latter in May 2017. On that occasion, they explained, inter alia, that the scientific study of 2005 which had served as a basis for setting the contested reference value was too conservative and was not supported by an interpretation based on the probative value of the data.

82Finally, it should be noted that, on 14June 2017, the Commission invited the applicants to submit, within 14days, their observations on its renewal report. On that occasion, it stated that the applicants’ observations would be forwarded to the Standing Committee.

83In response to that invitation, the applicants limited their comments on 26June 2017 to seed treatment. The applicants’ comments took the form of a report drafted by a third party on their behalf in which it was explained that the risk assessment for birds and mammals could be resolved at Member State level when additional data and a revised risk assessment were taken into account. An annex prepared by the applicants accompanied that report. In that annex, the applicants again challenged the 2005 scientific study that had been used as the basis for setting the reference value at 1.6mg/kg.

84Consequently, the applicants were given the opportunity to submit their observations in a meaningful way at each stage of the procedure initiated by their application for renewal, in accordance with Articles12 and 14 of Implementing Regulation No844/2012. The fact that, despite the content of the applicants’ observations, the Commission adopted the contested implementing regulation in which it did not renew the approval of the thiram cannot be interpreted as meaning that the applicants’ right to be heard was infringed.

85The applicants also rely on the evidence they provided to the Commission after the adoption of the EFSA conclusions, which could establish that the long-term risk to mammals should be considered acceptable and that the renewal procedure could thus have led to a different outcome. They state that they informed the Commission and Member States in 2017 of the existence of higher tier-field studies and provided updates in 2017 and 2018 with the available results confirming that the risk to mammals was acceptable. That information was never taken into account by the Commission.

86In that context, in response to the measures of organisation of procedure, the applicants stated, inter alia, that, in December 2017, they had had a meeting with the Commission at which the first results of the recently completed higher tier-field studies had been presented and discussed, and that those results had been sent to the Commission in a fact sheet dated 23January 2018.

87However, on the dates on which the applicants submitted and communicated to the Commission the results of the ‘higher tier-field studies’, namely 7December 2017 and 23January 2018, no opportunity to submit new data, additional evidence or comments was open under Articles12 and 14 of Implementing Regulation No844/2012. Therefore, even if the results of the studies in question had called into question the EFSA conclusions regarding the long-term risk to mammals, which, according to recital8 of the contested implementing regulation, was recognised as high for all the representative uses evaluated and which was one of the reasons for the non-renewal of thiram (see paragraph24 above), it must be noted that, pursuant to Regulation No1107/2009 and that implementing regulation, the Commission was under no obligation to examine them at that stage. Furthermore, in response to a question from the Court, the applicants explained that they were not challenging the legality of the procedure provided for by those measures.

88As regards the applicants’ arguments that the data relating to birds and mammals could be accepted at Member State level and the examination carried out by the Kingdom of Belgium concerning the new field study (see paragraph63 above), those arguments are inoperative in so far as they are formally raised in support of the fifth plea in law, but will be addressed in the context of the examination of the second and third pleas in law, to which they are in fact related (see paragraphs107 to 147 below).

89In the second place, as regards the applicants’ claim that they were not given the opportunity to express their views on the new classification of thiram, it is apparent from the dossier and, more specifically, from the reporting table that, as the Commission stated in essence in the defence, the question of the carcinogenicity of thiram had already been raised by two Member States in May 2016. On that occasion, the applicants had already been led to express their views and challenge the carcinogenicity of thiram and its possible classification.

90It is also apparent from the dossier that, following the Commission’s invitation to the applicants to comment on the EFSA conclusions, the applicants were given the opportunity to challenge EFSA’s proposal to classify thiram as a carcinogen. On that occasion, the applicants explained that that proposal was flawed from both a procedural and a scientific point of view. They further contested that classification proposal in a submission to the Commission for a meeting with the latter in May 2017.

91The applicants had another opportunity to express their views on that subject in their observations on the draft renewal report. The fact that they did not do so cannot be held against the Commission.

92Consequently, the applicants were given the opportunity to make meaningful submissions in the course of the procedure with regard to the proposed classification of thiram which they attribute to EFSA.

93It follows from the considerations set out in paragraphs75 to 92 above that the procedure for the adoption of the contested implementing regulation is not vitiated by any irregularity capable of constituting a breach of the applicants’ right to be heard.

94It follows that the fifth plea in law must be rejected.

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

95The applicants submit that, in so far as they had withdrawn their application for renewal of the approval of thiram for uses of that active substance by foliar spraying, the Commission should not have taken into account the concerns relating solely to foliar uses, which EFSA reported in its conclusions. The Commission has made no distinction between the uses of thiram by foliar spraying and seed treatment uses thereof, despite that withdrawal.

96According to the applicants, it is for the applicant for renewal of the approval of an active substance not only to initiate the renewal procedure but also to determine the scope of the review, in particular as regards representative uses of the active substances concerned. The Commission should have complied with the applicants’ application under Regulation No1107/2009 and Implementing Regulation No844/2012 by strictly respecting the content of the application, from which the use of thiram by foliar spraying had been withdrawn.

97The Commission contests the applicants’ arguments.

98In that regard, firstly, it is important to emphasise that Regulation No1107/2009 does not provide for the situation in which the applicant for renewal of an approval of an active substance withdraws its application for one of the representative uses which it has previously designated. With regard to the document referred to by the applicants in their replies to the Court’s questions, namely the document entitled ‘EFSA, Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances’, it is true that that document explains that, if an applicant wishes at any time to withdraw its application, it must inform the RMS in writing and also notify EFSA and the Commission by email. However, that document concerns the procedure that starts with the submission of an application and ends with the adoption and publication of the EFSA conclusions. Furthermore, it should be noted that the document in question dates from 2019 and is therefore subsequent to the adoption of the contested implementing regulation. In addition, that document does not provide for the case of a partial withdrawal of the renewal application. Finally, that document states that the withdrawal of an application after the adoption of those conclusions has no effect on the result adopted, which will in any event be published in the EFSA Journal.

99Secondly, it should be noted, first, that, in recital12 of the contested implementing regulation, the Commission stated that, on 18May 2018, the applicants had requested the withdrawal of the renewal application for the representative uses concerning application by foliar spraying. Second, in recital13 of the same implementing regulation, the Commission provided for the amendment of Implementing Regulation No540/2011 accordingly.

100Thirdly, it should first be noted that the contested implementing regulation is a general act (see paragraph70 above) which was adopted following a renewal application by the applicants. In that application, the applicants freely defined the scope of the risk assessment process when they included two representative uses.

101Next, in the present case, the withdrawal of the application for renewal of the approval of thiram for application by foliar spraying took place on 18May 2018, namely, after the completion of the risk assessment process which materialised in the adoption, on 27January 2017, of the EFSA conclusions.

102Furthermore, in its conclusions, EFSA had found several risks associated with the application of thiram by foliar spraying and, in particular, a high acute risk to consumers and users. The high acute risk to consumers and users is not contested by the applicants in the present action.

103Furthermore, the risks identified and linked to the application of thiram by foliar spraying concerned products already on the market. The risks assessed were therefore real risks and not hypothetical risks. The applicants’ argument that, in essence, the Commission should have withdrawn all reference to application by spraying and carried out a new assessment on the basis of seed treatment would have had the effect of delaying the adoption of a position on the renewal of thiram.

104Finally, as is apparent from recital12 of Regulation No1107/2009, the Commission assumes the role of risk management and takes the final decision on an active substance. In the context of that risk management role, the Commission considered in the present case that, despite the arguments put forward by the applicants, the concerns relating to the substance thiram and, in particular, the concerns relating to the application of that substance by foliar spraying could not be dispelled. It is also in the context of that role and in order to draw the consequences, applicable to the whole of the European Union, of its findings, that the Commission provided in Article5 of that contested implementing regulation that ‘any grace period granted by Member States in accordance with Article46 of [that regulation] shall be as short as possible and shall expire by 30April 2019 for plant protection products used for foliar application’.

105Therefore, despite the partial withdrawal of the renewal application by the applicants, the Commission was not required to base the contested implementing regulation solely on grounds relating to the use of thiram as a seed treatment. Nor was the Commission required to carry out, or have carried out, a new risk assessment limited to the use of thiram as a seed treatment.

106The applicants’ argument, based on a procedural irregularity or, more generally, a defect in form, must therefore be rejected. It follows that the first plea in law must be rejected.

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

107The second and third pleas in law must be examined together. Those pleas are closely linked inasmuch as the third plea in law concerns, in essence, the consequences of a manifest error of assessment raised in the context of the second plea in law.

108More specifically, in the context of the second plea in law, the applicants submit that the Commission committed a manifest error of assessment, in so far as the withdrawal of the application for renewal of the approval of the use of thiram as a foliar spray constitutes one of the relevant elements of the case which should have been examined carefully and impartially. They consider that the fact that the Commission assessed uses of thiram both as a foliar spray and as a seed treatment together influenced its conclusion relating to thiram.

109In that regard, the applicants point out, firstly, that, as regards the use of thiram as a seed treatment, the only risk involved is to birds and mammals, so that the high acute risk to consumers, workers and aquatic organisms resulting from their exposure to DMCS should not have been taken into account, in view of the fact that the use of thiram as a foliar spray had been withdrawn from their application for renewal of the approval of thiram.

110Secondly, the applicants consider that the incomplete information on the metabolite M1 which did not allow the establishment of residue definitions for the purposes of risk assessment, to which the Commission refers in the contested implementing regulation, concerned only the foliar spray uses of thiram. In any event, they rely on a genotoxicity dossier according to which that metabolite was not genotoxic. In that respect, they note that the residue definition for that metabolite was not included in the ‘initial dossier’, but that it evolved during the ‘review process’ by including the metabolite in question in that definition. They consider that that evolution cannot be invoked to oppose the renewal of thiram and that they should have been put in a position to submit additional data, in accordance with the Commission’s guidance (SANCO/2010/13170 rev. 14, of 7October 2016). They note that the metabolite in question was not relevant for the seed treatment of maize, which is the only representative use for that treatment.

111Thirdly, the applicants state that the risk to aquatic organisms from exposure to DMCS and the formation of NDMA in drinking water when surface and groundwater containing thiram and its metabolite DMCS are subjected to water treatment processes are also exclusively related to the foliar spray uses of thiram. In that respect, they point out that, for seed treatment uses of thiram, the estimated levels of DMCS and NDMA are below those considered acceptable in the European Union. In relation to the risk to aquatic organisms from exposure to DMCS, they recall that EFSA does not express any concern with regard to maize. Furthermore, they state that that risk is that of a ‘data gap’ and not a ‘critical area of concern’ preventing approval. As for the possible formation of NDMA in drinking water, they state that there is no acceptable limit for NDMA in the European Union’s regulations. In that respect, they invoke the ‘threshold of toxicological concern’ approach, which would mean that the estimated levels of NDMA in drinking water after water treatment processes would be much lower for seed treatment. Furthermore, they challenge the Commission’s application, for the purposes of assessing the tolerable level of NDMA, of the ‘as low as reasonably achievable’ principle, according to which, as the Commission explains, the level of the substance should be as low as reasonably achievable, aiming at zero exposure.

112Fourthly, the applicants are of the opinion that thiram does not give rise to any concerns arising from endocrine disrupting properties.

113In the context of the third plea in law, the applicants consider that the manifest error of assessment committed by the Commission, which was complained of in the context of the second plea in law, led to a breach of Article4(5) of Regulation No1107/2009. According to the applicants, it follows from that provision that it is sufficient to demonstrate one single safe use of an active substance in order to conclude on its approval. The applicants submit that the use of thiram as a seed treatment could be carried out safely, which they have demonstrated.

114In that respect, as regards the risk to birds and mammals, the applicants consider that that is the only risk incurred in the context of the use of thiram as a seed treatment. However, that risk is low and acceptable and therefore does not raise any concern. In that regard, the applicants rely on the general conclusions of the RMS in the RAR, from which it appears that seed treatment with thiram would not give rise to any concern with regard to small mammals such as rodents. Furthermore, that conclusion, which was endorsed by all other Member States during the commenting period, is not mentioned in the EFSA conclusions or in the Commission review report on thiram.

115The applicants point out that EFSA had indeed accepted that the issue of birds and mammals could be assessed at Member State level. In the reply and at the hearing, they pointed out that the Commission had failed to consider and had never explained why the application of risk mitigation measures was unacceptable, in particular with regard to seed treatment of maize. In their view, the risk to birds and mammals could be assessed at Member State level, as that risk would relate to residues and to birds and mammals in specific areas. It would be common practice to delegate those tasks to the Member States for risk mitigation measures in the fields, as there might be differences between Member States depending on priority species, landscape types, etc.

116With regard to the assessment of the risk to mammals in general, the applicants also refer to the RAR, from which it appears that the risk is low. In addition, they point out that the repellent properties of thiram on birds and mammals are demonstrated not only by them in the file which they submitted, but also by bibliographical sources available in Europe, the United States, India and New Zealand, as well as by additional publications taken into consideration by the RMS and listed in the RAR. They added that the results of their own studies on the reduction of residue levels in seeds and seedlings and of higher tier-field studies to assess the effects by simulating realistic use by seed treatment confirm that the risks to birds ingesting thiram-treated seeds are acceptable.

117Furthermore, and in any event, the applicants submit that the issue of seed treatment with regard to birds and mammals, mentioned in the EFSA conclusions, corresponds to a risk which could not be finalised but which should be distinguished from the areas of concern, so that that issue could be addressed and finalised at national level.

118The Commission contests the applicants’ arguments.

119In the first place, it must be examined whether, as the applicants claim, the incomplete information concerning the metabolite M1, the risk to aquatic organisms from exposure to DMCS and the possible formation of NDMA in drinking water is clearly linked exclusively to the foliar uses of thiram as a spray.

120Firstly, as regards the incomplete information concerning the metabolite M1, it is explained in recital8 of the contested implementing regulation that that data gap made it impossible to establish residue definitions for the purposes of the risk assessment, with the result that it was not possible to complete the assessment of the dietary risk to the consumer or to establish maximum residue levels. In that respect, it should be noted, as indicated by the Commission in its reply to the measures of organisation of procedure, that the EFSA conclusions, to which that implementing regulation refers, show that there is a lack of residue data necessary to complete the evaluation of the use of thiram for seed treatment of maize. According to EFSA, since the residue analysis of thiram (specific) on maize was not covered by the available storage stability data on that compound, the available residue trials on maize and the analysis of the presence of thiram (specific) could not be considered as valid and sufficient critical good agricultural practice in the north and south of the European Union. In that respect, EFSA argued that it was compliant residue trials on maize, to determine the presence of thiram (specific), that were required provided that the residue samples were analysed immediately after collection.

121Secondly, as regards the risk to aquatic organisms from exposure to DMCS, it should be noted, as the Commission stated at the hearing, that it appears from the EFSA conclusions that a high risk was mentioned for all relevant uses. Furthermore, as the Commission also indicated at the hearing, it appears from the conclusions that a data gap was also identified regarding the risk to aquatic organisms from exposure to DMCS for all representative uses.

122Thirdly, as regards the possible formation of NDMA in drinking water, it should be noted that, in order to demonstrate that the estimated levels of DMCS and NDMA are lower than those considered acceptable in the European Union for seed treatment and that those levels were calculated exclusively in respect of foliar uses, the applicants rely on a position paper which they submitted to EFSA in July 2016. The applicants submit that that position paper, which was considered by EFSA, concerned only foliar applications and not seed treatment.

123In that respect, it appears from the EFSA conclusions that EFSA did indeed examine that document. However, EFSA noted that the applicant’s conclusion in that document was, in essence, that the formation of NDMA could be expected as a result of water treatment processes. It added that the RMS had not provided a detailed, transparent and independent assessment of that information on NDMA formation. As a result, it identified a data gap for all representative uses assessed, with the result that an issue could not be finalised. As stated by the Commission at the hearing, EFSA therefore considered that the position paper was relevant for all representative uses assessed. Furthermore, it is not clear from that document, annexed by the applicants to their replies to the measures of organisation of procedure, that it would only concern the treatment of drinking water after foliar application. In any event, the applicants have not explained why that document only concerns the treatment of drinking water after foliar application. As regards the document which the applicants annexed to the application and which they describe as an ‘update’ of the position paper of July 2016, it should be noted that it is dated August 2017 and was submitted to the Commission on 29August 2017. However, it should be recalled that, at that date, no opportunity to submit new data, additional elements or comments was available under Articles12 and 14 of Implementing Regulation No844/2012 (see paragraph87 above). In any case, it does not appear from that document that, in the case of seed treatment, the formation of NDMA is excluded when surface water and groundwater containing thiram and its metabolite DMCS are subjected to water treatment processes.

124It follows that, contrary to the applicants’ contention, the concerns and data gaps mentioned in paragraph119 above are clearly not exclusively related to the uses of thiram by foliar spraying.

125In the second place, it must be examined whether, as the applicants claim, in essence, the Commission committed a manifest error of assessment of the facts when, in the contested implementing regulation, it relied, with regard to seed treatment, on the incompleteness of the information available concerning the metabolite M1, on the risk to aquatic organisms arising from exposure to DMCS and on the impossibility of excluding the formation of NDMA in drinking water.

126Firstly, with regard to the incompleteness of the information available concerning the metabolite M1, the applicants state that, during the evaluation process, it was proposed to amend the residue definition by including that metabolite, which was not included in the ‘original dossier’. In their view, such a change in the residue definition could not prevent the renewal of thiram for seed treatment, since that metabolite could not be relevant for that use.

127In that context, although the metabolite M1 is not relevant for the specific representative use on maize, as the Commission also admits, the latter notes that no consumer risk assessment of maize could be carried out on the basis of the available information and that no maximum residue limit (MRL) could be set for the use on maize by means of a seed treatment. In support of that claim, the Commission cites the EFSA conclusions that ‘considering the outstanding data to finalise the overall consumer exposure assessment, an MRL for thiram (specific) on maize cannot be proposed’.

128In that regard, it must be noted that, in challenging the contention at issue, the applicants rely on the residue information in maize, which was allegedly submitted and evaluated against the residue definition in force at the time of that submission, and not against the definition used by EFSA in the renewal evaluation of thiram. Although the applicants expected that the residue definition would remain the same throughout the evaluation of thiram in the context of its renewal, they did not put forward any reason to support such an expectation.

129Secondly, as to the existence of a high risk to aquatic organisms resulting from their exposure to DMCS, the applicants first observe that, according to Table5 of the EFSA conclusions, no concern regarding the risk to aquatic organisms was found for maize. In that regard, at the hearing, the Commission explained, without being challenged by the applicants, the reason why the risk to aquatic organisms had not been mentioned in relation to maize. It follows from those explanations that where a high risk is identified at the time of the initial review and where a metabolite is considered to be 10 times more toxic than the parent substance, EFSA, in practice, does not add it to its table of concerns. In that case, the assessment is based on the worst-case scenario and the identified risk can be addressed if toxicity data had been submitted, which the applicants did not do.

130Next, the applicants allege that the assessment was initially carried out on the rates of application related to foliar uses. They state that, with regard to the expected environmental concentrations in surface water, those rates are much higher after foliar use than those following seed treatment. In that respect, it should be noted that the fact that those concentrations are lower for a seed treatment use of thiram does not call into question the data gap found by EFSA with regard to the existence of a high risk to aquatic organisms resulting from their exposure to DMCS.

131Finally, as regards the applicants’ argument that that risk is that of a ‘data gap’ and not a ‘critical area of concern’ opposing approval, it should be noted, as the Commission argues in essence that a data gap or the situation where a risk cannot be finalised does not mean that a risk is not identified, but may simply indicate that, in addition to the identified risk, the applicant has not provided sufficient data to confirm safety. As noted in paragraph57 above, it is the applicant who has to prove that the conditions for approval are met in order to obtain approval, not the Commission who has to prove that the conditions for approval are not met in order to refuse approval.

132Thirdly, as regards the possible formation of NDMA in drinking water and, more particularly, the applicants’ arguments concerning the absence of an EU-wide acceptable limit for assessing the tolerable level of NDMA and the Commission’s application of the ‘as low as reasonably achievable’ principle in that regard (see paragraph111 above), the following should be noted. In response to the measures of organisation of procedure, the Commission contested the application of the reference value used by the applicants to demonstrate the acceptable level of NDMA in drinking water. First, it stated that the applicants’ ‘threshold of toxicological concern’ approach should not be used for highly active carcinogens such as N-nitroso compounds, which include NDMA. In that respect, it referred to the opinion of the EFSA Scientific Committee on the thresholds of toxicological concern of 2012. Second, it contested the reference value proposed by the applicant in the application, which was based on the opinion of the EFSA Panel on Food Contact Materials, Enzymes and Processing Aids, annexed to the application and published on 1March 2016, concerning the identification of substances from the carcinogenicity database that are of particular concern even when ingested at doses below 0.0025µg/kg body weight per day. In that regard, it argued that that document confirmed that the ‘threshold of toxicological concern’ approach was not applicable as NDMA was flagged as a substance of particular concern even if ingested at or below the threshold of toxicological concern.

133In the light of those observations made by the Commission, which have not been called into question by the applicants, and without it being necessary to rule on the application of the ‘as low as reasonably achievable’ principle, invoked by the Commission in its defence, the approach chosen by the applicants to assess the acceptable level of NDMA in drinking water does not demonstrate that the estimated levels of NDMA in drinking water after water treatment processes would be significantly lower for seed treatment, so that, as alleged by the applicants, the only concern would be for foliar uses of thiram.

134It follows that the applicants have not shown that the Commission committed a manifest error of assessment of the facts when, in the contested implementing regulation, it relied, with regard to seed treatment, on the incompleteness of the information available concerning the metabolite M1, on the risk to aquatic organisms arising from exposure to DMCS and on the impossibility of excluding the formation of NDMA in drinking water.

135In the third place, it must be examined whether, as the applicants maintain, the Commission committed a manifest error of assessment when it refused to recognise that there was an acceptable risk to birds and mammals and that that risk could, in any event, be the subject of risk mitigation measures, in particular at the level of the Member States.

136It appears from the EFSA conclusions that, in particular for the seed treatment use on maize, an estimate of the critical forage area was made, but even taking that information into account in conjunction with the available quantitative risk assessment, the experts agreed that it was not possible to conclude that there was a low risk for the representative uses. Therefore, the experts identified a data gap for the purposes of a further examination of the risk to birds and mammals.

137Furthermore, it should be noted, as the Commission recalls, that with regard to the long-term risk to birds and mammals, that risk is considered acceptable if the value of the toxicity/exposure ratio is greater than 5. However, it appears from the dossier that the values retained by EFSA for birds and mammals were significantly lower than that value. In response to the measures of organisation of procedure, the Commission specified that those values were as follows: 0.47 for wood pigeon, 2.77 for small granivorous birds and 0.06 or 0.012, as corrected by the Commission in the context of the measures of organisation of procedure, for the wood mouse.

138In that context, it should be added, as the Commission states in its response to the measures of organisation of procedure, that the new data presented by the applicants to the Commission in a submission dated 7December 2017 and in a fact sheet of January 2018 did not confirm the existence of an acceptable risk for mammals either. According to the submission of 7December 2017, the new toxicity/exposure ratio calculated by the applicants for that risk was equal to 0.39, which, as the Commission rightly points out, was still well below the acceptable value of 5.

139That finding cannot be called into question by the applicants’ argument that the co-rapporteur Member State, the Kingdom of Belgium, considered that the data relating to birds and mammals were sufficient to prove the existence of an acceptable risk. In that regard, the applicants referred to the comments of that Member State of June 2018 on the possible impact of new studies submitted by the applicants on the outcome of the risk assessment for birds and mammals for the proposed use as seed treatment for maize. However, in those comments, that Member State noted that no detailed assessment of the experimental design of those studies had been carried out, and that it was therefore not possible to comment on the acceptability of the respective studies for use in a risk assessment. Furthermore, as stated by the Commission in response to the questions posed in the context of the measures of organisation of procedure, it appears from those observations that the Member State in question expressed doubts as to the sufficiency of the field study on mammals to establish the existence of an acceptable long-term risk for the latter.

140With regard to the applicants’ argument concerning the application of risk mitigation measures, it is true, as they indicate, that, in its conclusions, EFSA noted, specifically for the use of thiram as a seed treatment for maize, that the RMS had proposed some risk mitigation measures which could be considered at Member State level. As indicated by the applicants, it appears from the updated RAR of November 2016 that the RMS proposed the following risk mitigation measures to protect wild birds and mammals: first, the product should be fully incorporated into the soil, ensuring that the product is also incorporated at the end of rows, and second, any spillage should be removed.

141However, it follows from the second subparagraph of Article14(1) of Implementing Regulation No844/2012 that the Commission is not bound by the conclusions of the RMS, even though it must ‘take [them] into account’ in the preparation of the renewal report which serves as the basis for the contested implementing regulation, just as, moreover, it must take into account the EFSA conclusions. However, such taking into account cannot be interpreted as an obligation on the part of the Commission to follow the conclusions of the RMS in all respects, even if those conclusions are the starting point of the assessment and therefore have a significant weight in that assessment.

142In any event, as the Commission rightly submits, neither of the two measures proposed by the RMS, referred to in paragraph140 above, could mitigate the risks which had been identified for birds in relation to germinating seedlings. Furthermore, it appears from the file that two Member States, namely the Kingdom of Sweden and the Kingdom of Denmark, considered, in their emails of 9June 2017 and 1September 2017 respectively sent to the Commission, that some of the measures proposed by the RMS were not ‘realistic’ and that ‘no safe use ha[d] been demonstrated for birds and mammals’.

143Furthermore, the emails in question also confirm that the issue of risk mitigation measures for birds and mammals was indeed discussed in the Standing Committee. Moreover, the existence of such a debate is also evidenced by the fact that the possibility of using risk mitigation measures was one of the reasons for the absence of an opinion in both the Standing Committee and the Appeal Committee (see paragraph31 above). In those circumstances, it cannot be considered, as the applicants allege, that the Commission failed to consider the application of risk mitigation measures in relation to the treatment of maize seeds.

144As to the applicants’ argument that the Commission never explained why the application of risk mitigation measures was unacceptable in relation to the treatment of maize seeds, it should be emphasised that the Commission, as the competent risk management authority, could validly exclude that question in the contested implementing regulation on the grounds that no evidence had been provided to demonstrate that such measures would reduce the risks to birds and mammals to an acceptable level.

145The applicants have therefore not shown that the Commission committed a manifest error of assessment when, in the contested implementing regulation, it relied on the EFSA conclusion that there was a high risk to birds and mammals from the seed treatment by means of thiram. Nor have they shown that the Commission committed a manifest error of assessment when it refused to recognise that there was an acceptable risk to those birds and mammals.

146Finally, in the fourth place, with respect to the applicants’ argument that thiram does not raise concerns arising from endocrine disrupting properties, the Commission indicated at the hearing, without being challenged on that point by the applicants, that the issue of endocrine disruptors was not decisive or critical for the decision on the renewal of thiram. In those circumstances, even if, as the applicants contend, thiram did not give rise to any concerns originating from endocrine disrupting properties, the renewal procedure for thiram could not have led to a different result, in view of the conclusions reached in paragraphs124, 134 and 145 above.

147In view of the foregoing, the second and third pleas in law must be rejected.

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

148The applicants claim that, in their conclusions, EFSA acted ultra vires in that it proposed the classification of thiram as a category 2 carcinogen. They state that the mandate given by the Commission to EFSA to carry out its review does not allow EFSA to make proposals for that classification. The applicants note that it is the European Chemicals Agency (ECHA) which is the competent authority for the classification or reclassification of substances, according to Regulation No1272/2008.

149The applicants consider that the classification proposal made by EFSA had a negative impact on the assessment carried out by the Commission, in particular with regard to the issue of drinking water and mammalian toxicity. In that respect, they refer to Table5 and pages9 and 10 of the EFSA conclusions which, according to them, clearly refer to the classification of thiram as a category 2 carcinogen. In their view, if that classification had not been taken into account, EFSA would not have classified four of the eight exposures as unacceptable.

150The Commission contests the applicants’ arguments.

151It is necessary to examine whether, as the applicants maintain, EFSA acted ultra vires in proposing the classification of thiram as a category 2 carcinogen.

152Firstly, it is true that EFSA is not competent to propose or decide on the classification of the hazards associated with substances incorporated in plant protection products under Regulation No1272/2008. Under the provisions of that regulation, EFSA has no role to play either in the context of self-classification, which is reserved to any manufacturer, importer and downstream user of the substance concerned, or in the context of harmonised classification, which can be proposed by the abovementioned subjects or by the competent authority of a Member State and is subject to an opinion of ECHA, in order to correctly identify and communicate the hazards of substances (recital10), with a view to facilitating trade both in the internal market and worldwide (recitals4 and 5).

153However, it does not appear from the EFSA conclusions that EFSA has made a proposal for the classification of thiram as a category 2 carcinogen. In its conclusions, EFSA merely stated that, with regard to the mammalian toxicity of thiram, ‘all the experts agreed that a proposal should be presented for classification as category 2 carcinogen H351 on the basis of hepatocellular adenoma and C-cell adenoma, considering that the criteria also recommend taking into account benign tumours’ (see paragraph20 above).

154Secondly, it should be noted that the question of whether an active substance is or should be classified in a particular hazard class may be relevant not only for the purposes of identifying and communicating the hazards of substances in accordance with Regulation No1272/2008, but also for the purposes of determining whether or not it fulfils the approval criteria laid down in Article4 of Regulation No1107/2009. The procedures provided for in Regulation No1272/2008 and Regulation No1107/2009 are distinct. First, under Regulation No1272/2008, operators are obliged to classify and label substances or mixtures in a certain way, and it is ECHA that is a competent authority to classify or reclassify substances as dangerous. Second, under Regulation No1107/2009, active substances are controlled for the purpose of approval for placing on the market, including assessment of compliance with objective hazard categories or classes, which is the responsibility of EFSA.

155Thirdly, in so far as the submission of a classification proposal agreed upon by the experts concerned a classification of thiram as a category 2 carcinogen, such an opinion was not, in itself, an obstacle to the approval of the renewal of thiram.

156Consequently, although EFSA did not formulate a proposal for the classification of thiram as a category 2 carcinogen, it is not precluded from referring in its conclusions to the unanimous opinion of the experts on the submission of a proposal for the classification of thiram as a category 2 carcinogen. Therefore, the applicants’ arguments that the mandate given by the Commission to EFSA to carry out its review does not authorise EFSA to make proposals for that classification and that it is ECHA which is the competent authority to classify or reclassify substances under Regulation No1272/2008 must be regarded as inoperative.

157In the light of the foregoing, EFSA cannot therefore be criticised for having acted ultra vires, that is to say, contrary to the provisions of Regulation No1272/2008.

158In those circumstances, and given that, by their fourth plea in law, the applicants limit themselves to challenging the competence of EFSA to propose the classification of thiram as a category 2 carcinogen, it is not necessary to rule on the applicants’ arguments concerning the negative impact of EFSA’s proposal for classification on the assessment carried out by the Commission, in particular with regard to the question of drinking water and toxicity to mammals.

159In any event, while the reference to the experts’ opinion on the classification of thiram as a category 2 carcinogen appears in the part of the EFSA conclusions dealing with mammalian toxicity, it is not clear from those conclusions or from the entire dossier submitted to the Court that the presentation of the classification proposal referred to by the experts influenced EFSA’s assessment of the risk to mammals and, in particular, the setting of the reference value referred to in paragraph21 above. Nor is it clear from the dossier that the concerns for drinking water were decisively influenced by the expert opinion on the submission of a classification proposal for thiram.

160Consequently, the fourth plea in law must be rejected.

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

161The applicants first claim that the contested implementing regulation is disproportionate in that it causes excessive inconvenience in relation to the aims pursued, whereas the Commission could have opted for other possible measures which could have permitted the grant of the renewal of thiram on the basis of an adequate risk assessment. They invoke the legal options based on Articles6, 21 and 78 of Regulation No1107/2009, which could alleviate the concerns regarding the risk assessment for birds and mammals. The Commission rejected all those options without any legally valid reason.

162Next, as regards the complaint alleging infringement of the precautionary principle, the applicants claim that, with regard to the risk to the consumer from food ingestion, the Commission implicitly refers, in its assessment, to that principle. They criticise the Commission for failing to carry out, in accordance with the Commission Communication on the precautionary principle (COM(2000) 1 final) (‘the Communication on the precautionary principle’), an impact assessment comparing the most likely positive or negative consequences of the proposed action with those of inaction in terms of the overall cost to the European Union, in both the short and long term. They also note that the obligation to carry out an impact assessment is a general principle applicable whenever the Commission invokes that principle.

163Finally, as regards the complaint alleging breach of the principle of equal treatment, the applicants state that, in evaluating the copper fungicide compounds, for which three critical areas of concern were identified, the Commission approved their renewal, whereas, in the present case, for thiram, only one critical area of concern was identified. In the reply, they also invoke methoxyfenozide, which was renewed with a restricted use in greenhouses for vegetables or fruit due to concerns about, inter alia, metabolism, endocrine disrupting effects and the impact on water treatment.

164The Commission contests the applicants’ arguments.

(a)The alleged violation of the principle of proportionality

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.