1

By their action under Article 263 TFEU, the applicants, UPL Europe Ltd and Indofil Industries (Netherlands) BV, seek annulment of Commission Implementing Regulation (EU) 2020/2087 of 14 December 2020 concerning the non-renewal of approval of the active substance mancozeb, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ 2020 L 423, p. 50) (‘the contested implementing regulation’).

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51

The applicants claim that the Court should:

52

The Commission contends that the Court should:

95

The applicants submit, in essence, that the implication of the Commission’s decision to continue the procedure for renewal of mancozeb, without making the new RMS’s assessment subject to public consultation and without ensuring that EFSA produced its conclusions on that assessment, is that the contested implementing regulation is based on an incomplete assessment and is, therefore, scientifically unreliable, meaning that the Commission exceeded its regulatory powers as risk manager and usurped EFSA’s mandate as risk assessor.

96

As a preliminary point, it should be noted that Implementing Regulation No 844/2012, which lays down, inter alia, the rules concerning the various stages of the procedure for the renewal of an active substance, including that involving its evaluation by the RMS (see paragraph 59 above), does not contain any provision concerning the conduct of those stages in the event of the appointment of a new RMS during that procedure.

97

Thus, given that Implementing Regulation No 844/2012 is silent as to the conduct of the procedure for the renewal of an active substance in the event of the designation of a new RMS in the course of that procedure, the designation of a new RMS cannot be regarded as requiring the evaluation procedure provided for in Articles 12 and 13 of that implementing regulation to be recommenced.

98

In addition, it is apparent from Articles 11 to 14 of Implementing Regulation No 844/2012 (see paragraph 59 above) that the RMS’s assessment as part of the renewal procedure for a substance is one of the mandatory stages of that procedure. It is compulsory for that assessment to be submitted to EFSA and the applicant and be the subject of public consultation, followed by the adoption of EFSA’s conclusions, unless the Commission decides to inform EFSA that such conclusions are not necessary (see the second subparagraph of Article 13(1) of Implementing Regulation No 844/2012).

99

In the present case, the appointment on 1 February 2020 of the new RMS for the evaluation of mancozeb and its assessment of that substance took place after completion of the process of assessment of mancozeb’s risks by the initial RMS in its draft RAR of September 2017, as updated by the draft RAR of March 2019, and by EFSA in its conclusions of 12 June 2019 (see paragraphs 17, 18 and 20 above). Accordingly, in the present case, the applicants had already had the opportunity to submit comments, on 16 July 2019, thus making use of their rights under Article 12(3) of Implementing Regulation No 844/2012, on the updated draft RAR of March 2019 and EFSA’s conclusions of 12 June 2019 (see paragraphs 10 and 21 above).

100

Nevertheless, the applicants submit, in essence, that if they had had the opportunity to submit their comments on the new RMS’s assessment, namely the updated draft RAR of September 2020, and if the Commission had asked EFSA to update its conclusions of 12 June 2019, the Commission might have submitted a different proposal to the standing committee. In that regard, they observe that in the section of its September 2020 report concerning human health, the new RMS had identified a safe use for single applications of the substance in the area of non-dietary exposure (in other words for operators, workers and persons living nearby). Furthermore, in the residues sections, a safe use was identified in the report, particularly for cereals, grapevines and potatoes.

101

In that regard, it should be borne in mind that it is apparent from the draft RAR of March 2019 that the initial RMS proposed that mancozeb be found not to satisfy the conditions for approval laid down in Article 4 of Regulation No 1107/2009, given that mancozeb was considered to be an endocrine disruptor for humans and that there was a risk resulting from non-dietary exposure, as well as a risk to birds and mammals, non-target arthropods and soil organisms (see paragraph 18 above).

102

Similarly, in its conclusions of 12 June 2019, EFSA expressed certain specific concerns (see paragraph 44 above). In particular, it concluded that mancozeb was classified as a toxic substance for reproduction category 1B and that the new criteria for identifying endocrine disrupting properties were met for humans and most likely for non-target organisms. It also concluded that the non-dietary exposure estimates exceeded the reference values for the representative uses in tomatoes, potatoes, cereals and grapevines. Consequently, in its view, for the representative uses considered, nor could non-dietary exposure to mancozeb be considered negligible in terms of endocrine disrupting properties causing adverse effect in humans (point 3.6.5 of Annex II to Regulation No 1107/2009). EFSA also considered that, in view of the concerns raised, nor could the derogation provided for in Article 4(7) of Regulation No 1107/2009 apply.

103

It is true that, in its updated draft RAR of September 2020, following its own assessment of the mancozeb risks, the new RMS found that, by altering the GAP on cereals and using water-soluble bags, it was possible to identify a use that was safe for human health (that is to say, for operators, workers and persons living nearby) (see paragraph 38 above). The applicants stated, in their replies to the measures of organisation of procedure, that that conclusion related only to non-dietary exposure to mancozeb.

104

However, as the Commission points out, without being challenged on this point by the applicants, the new RMS’s assessment led to the same conclusion as that of the initial RMS in its draft RAR of March 2019, namely that mancozeb did not satisfy the conditions for approval laid down in Article 4 of Regulation No 1107/2009. In its assessment, the new RMS stated, inter alia, that mancozeb was considered to be an endocrine disruptor for humans and non-target organisms and that there was a risk to birds and mammals as well as non-target arthropods (see paragraph 38 above).

105

As noted in paragraph 98 above, in the context of the procedure for the renewal of a substance, it is for the RMS and EFSA to carry out a scientific assessment. In the present case, it is apparent that the new RMS’s conclusions are not substantively different from EFSA’s conclusions as regards two concerns identified, first, that mancozeb was considered an endocrine disruptor for humans and non-target organisms and, second, that there was a risk to birds and mammals as well as non-target arthropods.

106

It follows that those concerns had already been assessed by the initial RMS and EFSA and that the new RMS had adopted the same position in that regard.

107

Furthermore, at the hearing, the Commission argued, without being challenged on the point by the applicants, that each risk identified was sufficient on its own for the non-renewal of mancozeb. It is true that the possibility of concluding that there was a safe use for human health concerning non-dietary exposure to mancozeb, identified by the new RMS in its evaluation (see paragraph 103 above), could mean, as indicated by the applicants during the procedure for the renewal of the substance at issue (see paragraph 39 above), that they could apply for the derogation provided for in Article 4(7) of Regulation No 1107/2009. However, that derogation is not applied at the scientific assessment stage, but at the risk management stage.

108

Moreover, as is apparent from recital 12 of Regulation No 1107/2009, in the procedure for approval of plant protection products at EU level, it is the Commission which assumes the risk management role and takes the final decision concerning an active substance.

109

Thus, in the circumstances described in paragraphs 99 to 108 above, and having regard to the broad discretion conferred on the Commission by Regulation No 1107/2009 to adopt appropriate protection measures at the stage of managing risks identified during the scientific evaluation, the Commission could choose to continue with the procedure for the renewal of mancozeb without submitting the new RMS’s assessment to public consultation and without ensuring that EFSA would produce its conclusions on that assessment.

110

In the light of the foregoing considerations, the applicants’ argument that the Commission exceeded its regulatory powers as risk manager and usurped EFSA’s mandate as risk assessor must be rejected. Nor can their argument concerning the Commission’s usual practice of mandating EFSA to update its conclusions succeed. In the present case, the Commission performed its function as provided for by Regulation No 1107/2009. Moreover, the applicants do not specify how the four examples on which they rely are comparable to the situation in the present case and how they establish that the implication of the Commission’s decision in the present case to continue the procedure is that the contested implementing regulation is based on an incomplete and therefore scientifically unreliable assessment of the risks.

111

In the light of the foregoing, the complaint alleging failure to comply with the renewal procedure as a result of the Commission’s decision to continue the procedure for renewal of mancozeb without submitting the assessment of the new RMS to public consultation and without ensuring that EFSA produces its conclusions on that assessment must be rejected.

112

The applicants state that a public consultation on any updated version of EFSA’s conclusions is required by Article 12(3) of Implementing Regulation No 844/2012.

113

As the Commission correctly states, that provision does not require EFSA’s conclusions or their updated version to be the subject of public consultation, as that kind of consultation is required only for the draft RAR. This complaint must therefore be rejected.

114

The applicants complain that the Commission adopted its renewal report in January 2020 before the new RMS completed its assessment. It is true that, before the completion of that assessment and the expiry of the time limit set by the Commission in that regard, at the beginning of March 2020, in January 2020 the Commission adopted a draft renewal report pursuant to Article 14 of Implementing Regulation No 844/2012. It forwarded that draft to the applicants on 16 January 2020, giving them a time limit in that regard of 31 January 2020, and submitted the draft implementing regulation to the standing committee containing the proposal not to renew mancozeb for inclusion on the agenda of the meeting of 23 and 24 March 2020 (see paragraphs 26, 31 and 32 above).

115

Nevertheless, it is clear from the file that, later in the procedure for the renewal of mancozeb, namely in October 2020, the Commission sent the applicants and the standing committee the updated version of its draft renewal report following the submission by the new RMS of the updated version of the draft RAR of September 2020 (see paragraphs 38 to 42 above).

116

In those circumstances, it cannot be maintained that the Commission adopted its renewal report before the new RMS completed its own risk assessment. Consequently, this complaint must be rejected in so far as it has no factual basis.

117

In conclusion, in the light of the foregoing, the complaint alleging failure to comply with the renewal procedure provided for in Implementing Regulation No 844/2012 must be rejected as unfounded, as must, therefore, the first plea as well.

118

The Court notes that the applicants’ arguments examined in paragraphs 95 to 111 above are essentially the same as those which they put forward in their second plea, alleging infringement of their rights of defence in that they were not given an opportunity to comment on the draft RAR of September 2020, in accordance with Article 12(1) of Implementing Regulation No 844/2012. It should be noted that the applicants do not put forward, in the context of the second plea, any specific evidence as to the aspects on which they wished to express their views in that regard. They again object to how the procedure following the draft RAR of September 2020 was conducted and, more specifically, the complete lack of public consultation about that draft RAR under Article 12 of Regulation No 1107/2009. In the light of the conclusion drawn in paragraph 111 above, the second plea must therefore also be rejected.

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130

The applicants submit that the Commission made manifest errors of assessment in the mancozeb renewal procedure, for three reasons.

131

First of all, they state that, in the contested implementing regulation, the Commission relied on a classification proposal that was based on the properties of the metabolite ETU and not on the properties of the substance itself. The Commission thus incorporated irrelevant factors into its decision-making process relating to mancozeb. In that regard, the applicants submit that it is clear from Article 3(32) of Regulation No 1107/2009 that metabolites are not to be a decisive factor in the renewal procedure for an active substance. The Commission’s approach is also inconsistent with the principle according to which each substance must be assessed separately on the basis of its own intrinsic properties.

132

Next, the applicants criticise the Commission for failing to take account of significant new factors supporting the classification of mancozeb as toxic for reproduction category 2 in the context of the CLH dossier. More specifically, they refer to scientific flaws in the classification of mancozeb as a toxic substance for reproduction category 1B and to the Republic of Malta’s notification of its intention to submit a new classification dossier for that substance to ECHA in March 2020, confirming the category 2 classification of the substance. The applicants also refer to subsequent updates to the ECHA registry of intentions on 4 May and 13 July 2020 They further submit that the Commission ignored the recent studies relied on by them in their comments on EFSA’s conclusions, even though those studies refuted the conclusions of a 1980 study on the basis of which the RAC had proposed that mancozeb should be classified as a toxic substance for reproduction category 1B.

133

Lastly, the RAC opinion proposing that mancozeb should be classified as a toxic substance for reproduction category 1B is not legally binding, as only delegated acts deciding on the procedure for classifying a substance and published in the Official Journal of the European Union are legally binding.

134

The Commission disputes the applicants’ arguments.

135

It is appropriate to begin by examining the complaints alleging, first, that the classification of mancozeb as a toxic substance for reproduction category 1B is not legally binding and, second, that the Commission failed to take account of significant new factors concerning the classification of mancozeb as a toxic substance.

136

As a preliminary point, it should be noted that EFSA’s conclusions, set out in recital 12 of the contested implementing regulation, to the effect that mancozeb had ‘been classified as toxic for reproduction category 1B’ (see paragraph 44 above), was based on the RAC’s opinion (see paragraph 47 above) adopted in November 2018 on the proposal of the initial RMS of August 2017 (see paragraph 45 above), submitted to ECHA pursuant to Regulation No 1272/2008.

137

Regulation No 1272/2008 lays down, inter alia, rules concerning the various stages of the procedure for the harmonisation of the classification and labelling of substances. In accordance with Article 37(4) thereof, where a proposal for classification is submitted to the ECHA, the RAC set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1, corrigendum OJ 2007 L 136, p. 3) is to adopt an opinion on that classification proposal, which opinion ECHA is to forward to the Commission, along with any comments received from the parties concerned. Article 37(5) of that regulation provides that, where the Commission finds that the harmonisation of the classification of the substance concerned is appropriate, it is to submit a draft decision concerning the inclusion of that substance together with the relevant classification elements in the list of harmonised classifications of hazardous substances.

138

As the applicants state, in essence, the RAC’s opinion is merely a recommendation in the context of the harmonised classification and labelling procedure for an active substance, since only delegated acts adopted in the context of the procedure for classifying a substance and published in the Official Journal are legally binding. Moreover, as is also apparent from the information available in the dossier, at the time of adoption of the contested implementing regulation on 14 December 2020, no delegated act on the substance classification procedure had yet been adopted following the RAC’s opinion. It follows that, on that date, mancozeb was formally classified as a toxic substance for reproduction category 2 for developmental toxicity, which the Commission does not dispute.

139

The question thus arises whether EFSA, and then the Commission, could take into consideration the RAC’s opinion on the classification of mancozeb as a toxic substance for reproduction category 1B, given that, formally, at the time of the adoption of EFSA’s conclusions and the contested implementing regulation, that substance was classified as toxic for reproduction category 2 for developmental toxicity.

140

According to the case-law, as is apparent from Article 4(1) and (7) and point 3.6.4 of Annex II to Regulation No 1107/2009, the elements emerging from the harmonised classification and labelling procedure for an active substance, governed by Regulation No 1272/2008, may have a substantive impact on the approval of that substance under Regulation No 1107/2009 (see, to that effect, judgment of 19 December 2019, Probelte v Commission, T‑67/18, EU:T:2019:873, paragraph 91). The question whether an active substance is or should be classified in a particular hazard class may be relevant not only for the purpose of identifying and communicating the hazards of substances, in accordance with Regulation No 1272/2008, but also for the purposes of determining whether or not it meets the approval criteria provided for in Article 4 of Regulation No 1107/2009.

141

However, it is also apparent from the case-law that the procedures laid down in Regulations No 1272/2008 and No 1107/2009 are separate, each of them being organised according to its own rules (see, to that effect, judgment of 19 December 2019, Probelte v Commission, T‑67/18, EU:T:2019:873, paragraph 91). First, in accordance with Regulation No 1272/2008, operators are required to classify and label substances or mixtures in a certain way, and ECHA is the competent authority for classifying or reclassifying substances as hazardous. Second, under Regulation No 1107/2009, active substances are checked for the purpose of approving their placing on the market, and assessing compliance with objective categories or classes of hazard belonging to EFSA.

142

However, the fact that the RAC’s opinion adopted in the context of the harmonised classification and labelling procedure for mancozeb is not legally binding does not diminish the scientific value of that opinion and, therefore, does not prevent it from being taken into consideration for the purposes of the approval of an active substance under Regulation No 1107/2009. In that regard, as the Commission observes, the existence of a formal classification of an active substance is not decisive for the purposes of its approval under Regulation No 1107/2009. Under point 3.6.4 of Annex II to Regulation No 1107/2009, an active substance is to be approved only if it is ‘not’ or ‘not to be’ classified as toxic for reproduction category 1A or 1B in accordance with the provisions of Regulation No 1272/2008.

143

In the light of the foregoing, it must be held that the Commission did not commit a manifest error of assessment when it took into consideration, for the purposes of the procedure for the renewal of mancozeb, the RAC’s opinion on the classification of that substance as toxic for reproduction category 1B, despite the fact that it is not legally binding for the purposes of the procedure for harmonising classification and labelling provided for in Regulation No 1272/2008.

144

By this complaint, the applicants again object to how EFSA and subsequently the Commission took account of the RAC’s opinion. First, they submit that that opinion is based on an old study, the Gallo study dating from 1980, which does not comply with the applicable guidelines, in particular as regards the number of animals, posology and duration of exposure. In calling into question the reliability of that study, they rely on a recent study from 2015 on developmental toxicity. Second, according to the applicants, that RAC opinion does not present the latest scientific advances for the purposes of classifying mancozeb as a toxic substance. In their submission, the Commission should have taken into account the Republic of Malta’s notification concerning its intention to submit a new classification dossier for that substance to ECHA in March 2020, confirming the classification of mancozeb as a toxic substance for reproduction category 2.

145

Article 114(3) TFEU, on which inter alia Regulation No 1107/2009 is based, provides that, in its proposals concerning health, safety, environmental protection and consumer protection which have as their object the establishment and functioning of the internal market, the Commission is to take as a base a high level of protection, taking account in particular of any new development based on scientific facts. Furthermore, it has been held that that protection, in particular of public health and the environment, takes precedence over economic considerations, with the result that it may justify adverse economic consequences, even those which are substantial, for certain traders. It follows from those principles, which constitute the basis of the general protection goal of that regulation, that, unless otherwise specified, the decisions which the Commission is required to take in the context of that regulation must always take account of the latest scientific and technical knowledge (see judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 289 and the case-law cited).

146

More specifically, as regards the procedure for renewing the approval of an active substance, those considerations of principle are expressed, first, in Article 2(2) of Implementing Regulation No 844/2012. As noted in paragraph 58 above, that provision provides that the application for renewal must contain the list of new information that the applicant intends to submit and that is necessary, in accordance with the first subparagraph of Article 15(2) of Regulation No 1107/2009. It follows from that provision that the need for new information is aimed inter alia at meeting data requirements or criteria which did not apply at the time of the last approval of the active substance. Furthermore, it is for applicants to identify that new scientific information.

147

Second, as regards the supplementary dossiers submitted for renewal, recital 8 of Implementing Regulation No 844/2012 indicates that such dossiers should include necessary new data and new risk assessments. In that regard, it is apparent from Article 7 of that implementing regulation, relating to the content of supplementary dossiers, that those dossiers must include data and risk assessments which were not included in the approval dossier or subsequent renewal dossiers and which are necessary to reflect, inter alia, changes in legal requirements which have occurred since the approval or last renewal of the approval of the active substance concerned and changes in scientific and technical knowledge since the approval. It is also for applicants to identify the new information in question.

148

In the present case, the RAC’s opinion was adopted in the context of the procedure for harmonising the classification and labelling of substances in accordance with Regulation No 1272/2008. As is apparent from paragraph 137 above, the RAC carries out its scientific evaluation on any proposal submitted in the context of that procedure.

149

Thus, it was under Regulation No 1272/2008, and not under Regulation No 1107/2009, that the RAC adopted its opinion on the classification of mancozeb as a toxic substance for reproduction category 1B, a classification which was adopted by EFSA and subsequently by the Commission in the context of the procedure for the renewal of that substance under Regulation No 1107/2009. It follows that any complaint alleging that that classification by the RAC is not well founded must be examined solely in the light of the rules laid down in Regulation No 1272/2008, with the result that the applicants may not rely on an alleged material infringement occurring in that procedure in order to call into question the lawfulness of the contested implementing regulation. Accordingly, the complaint alleging that the RAC’s opinion is based on an old study must be rejected.

150

As to whether the Commission could consider the RAC’s opinion to be the latest scientific development for the purposes of classifying mancozeb as a toxic substance, it should be noted that that opinion was adopted on a proposal from the initial RMS and before EFSA’s conclusions were adopted in the procedure for the renewal of that substance (see paragraphs 45 to 47 above), namely when the scientific assessment of mancozeb was under way in that procedure. It follows that the RAC’s opinion could be regarded as a document showing the most recent scientific knowledge concerning the classification of mancozeb as a toxic substance, especially since, during the procedure for the renewal of that substance, the applicants provided the data requested by EFSA after the expiry of the time limit for their communication.

151

Furthermore, as regards the Republic of Malta’s notification concerning its intention to submit a new classification dossier for mancozeb to ECHA in March 2020, it should be noted, as the Commission did, that the submission of a dossier by a competent authority of a Member State is only the first stage of the procedure for the harmonisation of the classification and labelling of substances in accordance with Regulation No 1272/2008, without prejudice to the final outcome. According to the information available in the dossier, on the date of adoption of the contested implementing regulation, that proposal had not yet been assessed from a scientific point of view in the context of that procedure.

152

Accordingly, it must be held that the Commission did not make a manifest error of assessment when it relied on the RAC’s opinion, and not on the notification from the Republic of Malta in question, to propose the classification of mancozeb as a toxic substance.

153

The applicants claim that the Commission adopted a proposal for classification of mancozeb as a toxic substance for reproduction category 1B on the basis of the properties of the metabolite ETU and not on the properties of the substance itself. In so doing, the applicants confirm that that proposal is apparent from the RAC’s opinion.

154

As held in paragraph 149 above, the applicants may not rely on an alleged material infringement occurring in the context of the procedure for the harmonisation of the classification and labelling of substances in accordance with Regulation No 1272/2008 in order to call into question the lawfulness of the contested implementing regulation.

155

Moreover, although the applicants state that it follows from Article 3(32) of Regulation No 1107/2009 that metabolites are not a determining factor in the procedure for the renewal of an active substance, it is nevertheless apparent from that article that, in certain cases, metabolites may be so.

156

In that regard, Article 3(32) of Regulation No 1107/2009 provides as follows:

‘…

A metabolite is deemed relevant if there is a reason to assume that it has intrinsic properties comparable to the parent substance in terms of its biological target activity, or that it poses a higher or comparable risk to organisms than the parent substance or that it has certain toxicological properties that are considered unacceptable. Such a metabolite is relevant for the overall approval decision or for the definition of risk mitigation measures[.]’

157

Second, as regards the applicants’ argument that each substance must be assessed separately on the basis of its intrinsic properties, it is common ground that mancozeb is a metabolised substance. In that regard, the applicants do not dispute the Commission’s contention that, if a substance is metabolised and the resulting metabolites produce critical effects, that is relevant for the classification of an active substance, since it is exposure to the substance that leads to the critical toxic effect (directly or through metabolic activity in humans).

158

Accordingly, the applicants’ arguments in support of the present complaint do not demonstrate that the RAC’s opinion accorded undue influence to the metabolite ETU rather than to the substance itself. The present complaint must therefore also be rejected as unfounded.

159

In the light of the foregoing, the Commission did not commit a manifest error of assessment and, consequently, the fourth plea must be rejected.

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On those grounds,

THE GENERAL COURT (Seventh Chamber)

hereby: