# 62018TJ0740

JUDGMENT OF THE GENERAL COURT (Seventh Chamber)

9 February 2022 (
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(Plant protection products – Active substance thiram – Non-renewal of approval – Regulation No 1107/2009 and Implementing Regulation No 844/2012 – Rights of the defence – Procedural irregularity – Manifest error of assessment – Competence of EFSA – Proportionality – Precautionary principle – Equal treatment)

In Case T‐740/18,

Taminco BVBA, established in Ghent (Belgium),

Taminco BVBA

Arysta LifeScience Great Britain Ltd, established in Edinburgh (United Kingdom),

Arysta LifeScience Great Britain Ltd

represented by C. Mereu and M. Grunchard, lawyers,

applicants,

v

European Commission, represented by G. Koleva, acting as Agent,

European Commission

defendant,

APPLICATION under Article 263 TFEU for annulment of Commission Implementing Regulation (EU) 2018/1500 of 9 October 2018 concerning the non-renewal of approval of the active substance thiram, and prohibiting the use and sale of seeds treated with plant protection products containing thiram, 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 Commission Implementing Regulation (EU) No 540/2011 (OJ 2018 L 254, p. 1),

THE GENERAL COURT (Seventh Chamber),

composed of R. da Silva Passos, President, V. Valančius and I. Reine (Rapporteur), Judges,

Registrar: P. Cullen, Administrator,

having regard to the written part of the procedure and further to the hearing on 17 September 2020,

gives the following

Judgment

Judgment

I. Legal framework

I.

Legal framework

A. Directive 91/414/EEC

A.

Directive 91/414/EEC

| 1 | Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1) establishes the EU regime for the authorisation of the placing on the market of those products. It contains provisions applicable to plant protection products and the active substances contained in them. |
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1

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1) establishes the EU regime for the authorisation of the placing on the market of those products. It contains provisions applicable to plant protection products and the active substances contained in them.

| 2 | According to Article 4 of Directive 91/414, governing the granting, review and withdrawal of authorisations of plant protection products, a plant protection product must meet certain criteria in order to be approved. In particular, such a product is authorised if its active substances are included in Annex I to that directive and if the conditions set out in that annex are met. Articles 5 and 6 of that directive lay down the details for the inclusion of an active substance in Annex I. |
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2

According to Article 4 of Directive 91/414, governing the granting, review and withdrawal of authorisations of plant protection products, a plant protection product must meet certain criteria in order to be approved. In particular, such a product is authorised if its active substances are included in Annex I to that directive and if the conditions set out in that annex are met. Articles 5 and 6 of that directive lay down the details for the inclusion of an active substance in Annex I.

| 3 | Directive 91/414 was repealed by Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1), with effect from 14 June 2011. |
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3

Directive 91/414 was repealed by Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1), with effect from 14 June 2011.

B. Regulation No 1107/2009

B.

Regulation No 1107/2009

| 4 | Pursuant to Article 1(3), Regulation No 1107/2009 aims to ensure a high level of protection of human and animal health and the environment and to improve the functioning of the internal market by harmonising the rules concerning the placing of plant protection products on the market, while improving agricultural production. |
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4

Pursuant to Article 1(3), Regulation No 1107/2009 aims to ensure a high level of protection of human and animal health and the environment and to improve the functioning of the internal market by harmonising the rules concerning the placing of plant protection products on the market, while improving agricultural production.

| 5 | Article 4 of Regulation No 1107/2009 provides criteria for the approval of active substances of plant protection products. |
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5

Article 4 of Regulation No 1107/2009 provides criteria for the approval of active substances of plant protection products.

| 6 | In accordance with Article 5 of Regulation No 1107/2009, the first approval of an active substance is valid for a period not exceeding 10 years. |
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6

In accordance with Article 5 of Regulation No 1107/2009, the first approval of an active substance is valid for a period not exceeding 10 years.

| 7 | Articles 14 to 20 of Regulation No 1107/2009 deal with the renewal of the approval of active substances. The approval of an active substance is to be renewed upon application by a producer of the active substance to a Member State at the latest three years before the expiry of the approval, if it is established that the approval criteria set out in Article 4 of that regulation are satisfied (Articles 14(1) and 15(1)). When applying for renewal of the approval, the applicant is to specify the new data he or she intends to submit and demonstrate that they are necessary, having regard to data requirements or criteria which did not apply at the time of the last approval of the active substance or because his or her application concerns a modification of the approval (Article 15(2)). The applicant is at the same time to provide a timetable of all new and ongoing studies (Article 15(2)). A regulation, adopted in accordance with the regulatory procedure referred to in Article 79(3) of Regulation No 1107/2009, provides that the approval of an active substance is renewed and, where appropriate, subject to conditions and restrictions, or the approval of an active substance is not renewed (Article 20(1)). |
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7

Articles 14 to 20 of Regulation No 1107/2009 deal with the renewal of the approval of active substances. The approval of an active substance is to be renewed upon application by a producer of the active substance to a Member State at the latest three years before the expiry of the approval, if it is established that the approval criteria set out in Article 4 of that regulation are satisfied (Articles 14(1) and 15(1)). When applying for renewal of the approval, the applicant is to specify the new data he or she intends to submit and demonstrate that they are necessary, having regard to data requirements or criteria which did not apply at the time of the last approval of the active substance or because his or her application concerns a modification of the approval (Article 15(2)). The applicant is at the same time to provide a timetable of all new and ongoing studies (Article 15(2)). A regulation, adopted in accordance with the regulatory procedure referred to in Article 79(3) of Regulation No 1107/2009, provides that the approval of an active substance is renewed and, where appropriate, subject to conditions and restrictions, or the approval of an active substance is not renewed (Article 20(1)).

C. Implementing Regulation No 844/2012

C.

Implementing Regulation No 844/2012

| 8 | Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation No 1107/2009 (OJ 2012 L 252, p. 26) sets out, inter alia, the rules for the various stages of the renewal procedure. |
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8

Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation No 1107/2009 (OJ 2012 L 252, p. 26) sets out, inter alia, the rules for the various stages of the renewal procedure.

| 9 | Articles 1 to 8 of Implementing Regulation No 844/2012 provide for the rules concerning the admissibility of the application submitted by a producer of the active substance to a Member State. In accordance with Article 3 of that implementing regulation, that application is first checked by the rapporteur Member State (‘the RMS’) to ensure that it has been submitted within the time limit provided for in the first subparagraph of Article 1(1) of that implementing regulation and that it contains all the elements provided for in Article 2 of that implementing regulation. In particular, in accordance with Article 2(2) of that implementing regulation, the renewal application 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 (see paragraph 7 above). Then, in accordance with Article 6 of that implementing regulation, after receiving the affirmative answer from the RMS on that verification, the applicant is to submit the supplementary dossiers to the RMS, the co-rapporteur Member State, the European Commission and the European Food Safety Authority (EFSA). Finally, in accordance with Article 8 of the relevant implementing regulation, where the supplementary dossiers have been submitted within the time limit and contain all the elements provided for, the RMS is to inform the applicant, the co-rapporteur Member State, the Commission and EFSA of the date of receipt of the supplementary dossiers and the admissibility of the application. |
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9

Articles 1 to 8 of Implementing Regulation No 844/2012 provide for the rules concerning the admissibility of the application submitted by a producer of the active substance to a Member State. In accordance with Article 3 of that implementing regulation, that application is first checked by the rapporteur Member State (‘the RMS’) to ensure that it has been submitted within the time limit provided for in the first subparagraph of Article 1(1) of that implementing regulation and that it contains all the elements provided for in Article 2 of that implementing regulation. In particular, in accordance with Article 2(2) of that implementing regulation, the renewal application 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 (see paragraph 7 above). Then, in accordance with Article 6 of that implementing regulation, after receiving the affirmative answer from the RMS on that verification, the applicant is to submit the supplementary dossiers to the RMS, the co-rapporteur Member State, the European Commission and the European Food Safety Authority (EFSA). Finally, in accordance with Article 8 of the relevant implementing regulation, where the supplementary dossiers have been submitted within the time limit and contain all the elements provided for, the RMS is to inform the applicant, the co-rapporteur Member State, the Commission and EFSA of the date of receipt of the supplementary dossiers and the admissibility of the application.

| 10 | Articles 11 to 14 of Implementing Regulation No 844/2012 set out the procedure for the evaluation of the application for renewal of the approval of an active substance. Firstly, the RMS, after consulting the co-rapporteur Member State, is to prepare and submit to the Commission, with a copy to EFSA, a report assessing whether the active substance can be expected to meet the criteria for approval in accordance with Article 4 of Regulation No 1107/2009 (Article 11 of that implementing regulation). After receiving the draft assessment report from the RMS, EFSA is to communicate it to the applicant and the other Member States (Article 12 of that implementing regulation). Following the expiry of the period for submission of written comments, EFSA is to adopt, taking into account the state of scientific and technical knowledge and using the guidance documents in force at the date of submission of the supplementary dossiers, conclusions on whether the active substance can be expected to meet the approval criteria set out in Article 4 of that regulation. Where appropriate, EFSA is to organise a consultation of experts, including experts from the RMS and the co-rapporteur Member State. It is to communicate its conclusions to the applicant, the Member States and the Commission and to make them publicly available (Article 13 of that implementing regulation). Finally, following receipt of the EFSA conclusions and taking into account the draft assessment report prepared by the RMS, the comments of the applicant and the other Member States and the conclusions adopted by EFSA, the Commission is to submit a report, referred to as the ‘renewal report’, and a draft regulation to the Standing Committee on the Food Chain and Animal Health (‘the Standing Committee’). The applicant is given the opportunity to comment on the renewal report (Article 14(1) of that implementing regulation). On the basis of the renewal report and taking into account the comments submitted by the applicant, the Commission is to adopt a regulation in accordance with Article 20(1) of Regulation No 1107/2009 (Article 14(2) of the implementing regulation in question). |
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10

Articles 11 to 14 of Implementing Regulation No 844/2012 set out the procedure for the evaluation of the application for renewal of the approval of an active substance. Firstly, the RMS, after consulting the co-rapporteur Member State, is to prepare and submit to the Commission, with a copy to EFSA, a report assessing whether the active substance can be expected to meet the criteria for approval in accordance with Article 4 of Regulation No 1107/2009 (Article 11 of that implementing regulation). After receiving the draft assessment report from the RMS, EFSA is to communicate it to the applicant and the other Member States (Article 12 of that implementing regulation). Following the expiry of the period for submission of written comments, EFSA is to adopt, taking into account the state of scientific and technical knowledge and using the guidance documents in force at the date of submission of the supplementary dossiers, conclusions on whether the active substance can be expected to meet the approval criteria set out in Article 4 of that regulation. Where appropriate, EFSA is to organise a consultation of experts, including experts from the RMS and the co-rapporteur Member State. It is to communicate its conclusions to the applicant, the Member States and the Commission and to make them publicly available (Article 13 of that implementing regulation). Finally, following receipt of the EFSA conclusions and taking into account the draft assessment report prepared by the RMS, the comments of the applicant and the other Member States and the conclusions adopted by EFSA, the Commission is to submit a report, referred to as the ‘renewal report’, and a draft regulation to the Standing Committee on the Food Chain and Animal Health (‘the Standing Committee’). The applicant is given the opportunity to comment on the renewal report (Article 14(1) of that implementing regulation). On the basis of the renewal report and taking into account the comments submitted by the applicant, the Commission is to adopt a regulation in accordance with Article 20(1) of Regulation No 1107/2009 (Article 14(2) of the implementing regulation in question).

II. Background to the dispute

II.

Background to the dispute

| 11 | The applicants, Taminco BVBA and Arysta LifeScience Great Britain Ltd, are companies which market the active substance thiram (‘thiram’) and plant protection products containing thiram for fungicidal purposes throughout the European Union. |
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11

The applicants, Taminco BVBA and Arysta LifeScience Great Britain Ltd, are companies which market the active substance thiram (‘thiram’) and plant protection products containing thiram for fungicidal purposes throughout the European Union.

A. First approval of thiram at EU level

A.

First approval of thiram at EU level

| 12 | Thiram was first approved on 1 August 2004 for a period of 10 years by Commission Directive 2003/81/EC of 5 September 2003 amending Council Directive 91/414/EEC to include molinate, thiram and ziram as active substances (OJ 2003 L 224, p. 29), following its first evaluation at EU level under Directive 91/414. |
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12

Thiram was first approved on 1 August 2004 for a period of 10 years by Commission Directive 2003/81/EC of 5 September 2003 amending Council Directive 91/414/EEC to include molinate, thiram and ziram as active substances (OJ 2003 L 224, p. 29), following its first evaluation at EU level under Directive 91/414.

| 13 | Thiram was first listed in Annex I to Directive 91/414 and was subsequently added to the list of approved active substances set out in the annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ 2011 L 153, p. 1). That implementing regulation has been amended three times to extend the validity of the approval of thiram, first until 30 April 2017, then until 30 April 2018 and finally until 30 April 2019. |
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13

Thiram was first listed in Annex I to Directive 91/414 and was subsequently added to the list of approved active substances set out in the annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ 2011 L 153, p. 1). That implementing regulation has been amended three times to extend the validity of the approval of thiram, first until 30 April 2017, then until 30 April 2018 and finally until 30 April 2019.

B. Renewal of the approval of thiram at EU level

B.

Renewal of the approval of thiram at EU level

| 14 | The approval of thiram was subject to the standard regulatory procedure for renewal of approvals provided for in Article 14 et seq. of Regulation No 1107/2009 (see paragraph 7 above). |
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14

The approval of thiram was subject to the standard regulatory procedure for renewal of approvals provided for in Article 14 et seq. of Regulation No 1107/2009 (see paragraph 7 above).

| 15 | Thiram is part of the third phase of the renewal programme (RIA3) – set out in Commission Implementing Regulation (EC) No 686/2012 of 26 July 2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of active substances whose approval expires on 31 December 2018 at the latest (OJ 2012 L 200, p. 5). In accordance with that implementing regulation, the French Republic was designated as the RMS for the renewal, the co-rapporteur Member State being the Kingdom of Belgium. |
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15

Thiram is part of the third phase of the renewal programme (RIA3) – set out in Commission Implementing Regulation (EC) No 686/2012 of 26 July 2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of active substances whose approval expires on 31 December 2018 at the latest (OJ 2012 L 200, p. 5). In accordance with that implementing regulation, the French Republic was designated as the RMS for the renewal, the co-rapporteur Member State being the Kingdom of Belgium.

| 16 | The time limit for submission of the application for renewal of the approval of thiram was 30 April 2014 and the time limit for submission of the supplementary dossier was 1 November 2014 (see paragraph 9 above). That application was submitted within the time limit set by the ‘Thiram Task Force’ and concerned the use of thiram as a foliar by spraying and its use as a seed treatment. At the hearing, the applicants stated, in essence, that they were the only members of that task force. |
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16

The time limit for submission of the application for renewal of the approval of thiram was 30 April 2014 and the time limit for submission of the supplementary dossier was 1 November 2014 (see paragraph 9 above). That application was submitted within the time limit set by the ‘Thiram Task Force’ and concerned the use of thiram as a foliar by spraying and its use as a seed treatment. At the hearing, the applicants stated, in essence, that they were the only members of that task force.

| 17 | The RMS confirmed the eligibility of the application for renewal of the approval of thiram and provided its draft renewal assessment report (‘the draft RAR’) to EFSA in January 2016. In that draft, the RMS proposed to renew the approval of thiram for seed treatment use only. |
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17

The RMS confirmed the eligibility of the application for renewal of the approval of thiram and provided its draft renewal assessment report (‘the draft RAR’) to EFSA in January 2016. In that draft, the RMS proposed to renew the approval of thiram for seed treatment use only.

| 18 | On 15 March 2016, EFSA circulated the draft RAR to the Member States and the applicants for comments, pursuant to Article 12 of Implementing Regulation No 844/2012. The applicants submitted their comments on 13 May 2016. EFSA forwarded all comments to the Commission on 17 May 2016. |
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18

On 15 March 2016, EFSA circulated the draft RAR to the Member States and the applicants for comments, pursuant to Article 12 of Implementing Regulation No 844/2012. The applicants submitted their comments on 13 May 2016. EFSA forwarded all comments to the Commission on 17 May 2016.

| 19 | In June 2016, the applicants responded to the observations referred to in paragraph 18 above. |
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19

In June 2016, the applicants responded to the observations referred to in paragraph 18 above.

| 20 | From 24 to 26 October 2016, an expert meeting was held at EFSA (‘the meeting 148’), where all the experts agreed that it was appropriate to submit a proposal for the classification of thiram as a category 2 carcinogen H351 due to hepatocellular adenoma and C-cell adenoma, taking into account that the criteria, provided for in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1), recommended that benign tumours should also be taken into account. |
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20

From 24 to 26 October 2016, an expert meeting was held at EFSA (‘the meeting 148’), where all the experts agreed that it was appropriate to submit a proposal for the classification of thiram as a category 2 carcinogen H351 due to hepatocellular adenoma and C-cell adenoma, taking into account that the criteria, provided for in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1), recommended that benign tumours should also be taken into account.

| 21 | At the meeting 148, the reference value for the long-term risk assessment for mammals was reduced from 9 mg/kg body weight per day to 1.6 mg/kg body weight per day. |
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21

At the meeting 148, the reference value for the long-term risk assessment for mammals was reduced from 9 mg/kg body weight per day to 1.6 mg/kg body weight per day.

| 22 | On 23 November 2016, the applicants received from the RMS the updated renewal assessment report (‘the RAR’) as well as the reporting tables, supplemented with information from the peer review on pesticides at the meeting 148. |
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22

On 23 November 2016, the applicants received from the RMS the updated renewal assessment report (‘the RAR’) as well as the reporting tables, supplemented with information from the peer review on pesticides at the meeting 148.

| 23 | On 20 January 2017, EFSA submitted its conclusions on the pesticide risk assessment of thiram, together with the list of reference values (‘the EFSA conclusions’), which, together with the RAR and the peer review report, containing, inter alia, the reporting table and the evaluation table, were received by the applicants on 1 February 2017. |
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23

On 20 January 2017, EFSA submitted its conclusions on the pesticide risk assessment of thiram, together with the list of reference values (‘the EFSA conclusions’), which, together with the RAR and the peer review report, containing, inter alia, the reporting table and the evaluation table, were received by the applicants on 1 February 2017.

| 24 | In its conclusions, EFSA raised several concerns, including a critical concern related to the identification of a high dietary risk to birds and mammals. |
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24

In its conclusions, EFSA raised several concerns, including a critical concern related to the identification of a high dietary risk to birds and mammals.

| 25 | On 27 January 2017, EFSA communicated its findings to the Commission. On 31 January 2017, the Commission invited the applicants to submit their comments on those findings, which the applicants did on 22 February 2017. |
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25

On 27 January 2017, EFSA communicated its findings to the Commission. On 31 January 2017, the Commission invited the applicants to submit their comments on those findings, which the applicants did on 22 February 2017.

| 26 | On 14 June 2017, the Commission sent the applicants its draft renewal report in which it proposed not to renew the approval of thiram for seed treatment and foliar spray use. Furthermore, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation No 844/2012, the Commission invited the applicants to submit their comments on the draft report, which they did on 26 June 2017. |
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26

On 14 June 2017, the Commission sent the applicants its draft renewal report in which it proposed not to renew the approval of thiram for seed treatment and foliar spray use. Furthermore, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation No 844/2012, the Commission invited the applicants to submit their comments on the draft report, which they did on 26 June 2017.

| 27 | On 20 July 2017, the Commission sent its draft renewal report and draft implementing regulation to the Standing Committee. |
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27

On 20 July 2017, the Commission sent its draft renewal report and draft implementing regulation to the Standing Committee.

| 28 | The proposal not to renew thiram was discussed at several meetings of the Standing Committee in 2017 and 2018, namely: on 22 and 23 March, 17 and 18 May, 19 and 20 July, 5 and 6 October and 12 and 13 December 2017, as well as on 25 and 26 January, 21 and 22 March and 24 and 25 May 2018. On 22 and 23 March and 24 and 25 May 2018, a proposal to vote was made but the vote was not held. |
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28

The proposal not to renew thiram was discussed at several meetings of the Standing Committee in 2017 and 2018, namely: on 22 and 23 March, 17 and 18 May, 19 and 20 July, 5 and 6 October and 12 and 13 December 2017, as well as on 25 and 26 January, 21 and 22 March and 24 and 25 May 2018. On 22 and 23 March and 24 and 25 May 2018, a proposal to vote was made but the vote was not held.

| 29 | During the Standing Committee meeting of 13 and 14 June 2018, a vote was held on the proposal for non-renewal of thiram. The vote resulted in a ‘no opinion’. |
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29

During the Standing Committee meeting of 13 and 14 June 2018, a vote was held on the proposal for non-renewal of thiram. The vote resulted in a ‘no opinion’.

| 30 | On 12 July 2018, the Appeal Committee voted on the proposed non-renewal of the approval of thiram. The vote again resulted in a ‘no opinion’. |
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30

On 12 July 2018, the Appeal Committee voted on the proposed non-renewal of the approval of thiram. The vote again resulted in a ‘no opinion’.

| 31 | It appears from the minutes of the meetings of the two committees referred to in paragraphs 29 and 30 above that the reasons for a ‘no opinion’ in the case of thiram were, inter alia, the existence of new data on the acceptable risk to birds and mammals from the use of thiram by seed treatment, the possibility of dealing with that risk at national level and the view that the renewal could be limited to the use of thiram by seed treatment. |
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31

It appears from the minutes of the meetings of the two committees referred to in paragraphs 29 and 30 above that the reasons for a ‘no opinion’ in the case of thiram were, inter alia, the existence of new data on the acceptable risk to birds and mammals from the use of thiram by seed treatment, the possibility of dealing with that risk at national level and the view that the renewal could be limited to the use of thiram by seed treatment.

| 32 | In the meantime, on 7 December 2017, at the initiative of the applicants, a meeting took place between the applicants and the Commission, during which the applicants presented the first results of the higher tier-field studies concerning the risk assessment for birds and mammals, which they had initiated in March and April 2017 (‘the higher tier-field studies’). The applicants provided the Commission with information on those studies and their results in a fact sheet dated 23 January 2018. |
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32

In the meantime, on 7 December 2017, at the initiative of the applicants, a meeting took place between the applicants and the Commission, during which the applicants presented the first results of the higher tier-field studies concerning the risk assessment for birds and mammals, which they had initiated in March and April 2017 (‘the higher tier-field studies’). The applicants provided the Commission with information on those studies and their results in a fact sheet dated 23 January 2018.

| 33 | By letter of 19 March 2018, the applicants proposed, inter alia, that the Commission provide new data to address the concerns arising from the change in the long-term mammalian reference value at the meeting 148. In response, by letter of 5 June 2018, the Commission rejected the applicants’ proposal. |
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33

By letter of 19 March 2018, the applicants proposed, inter alia, that the Commission provide new data to address the concerns arising from the change in the long-term mammalian reference value at the meeting 148. In response, by letter of 5 June 2018, the Commission rejected the applicants’ proposal.

| 34 | On 18 May 2018, the applicants withdrew their application for the renewal of the approval of thiram for foliar application. On 6 June 2018, the Commission indicated that it had taken note of that withdrawal and amended the draft implementing regulation and the draft renewal report accordingly to take account of that withdrawal. |
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34

On 18 May 2018, the applicants withdrew their application for the renewal of the approval of thiram for foliar application. On 6 June 2018, the Commission indicated that it had taken note of that withdrawal and amended the draft implementing regulation and the draft renewal report accordingly to take account of that withdrawal.

| 35 | By letter of 2 July 2018, the applicants asked the Commission to reconsider, on the basis of scientific evidence alone, its proposal for the renewal of thiram solely on the basis of seed treatment. That request was rejected by the Commission in its letter of 17 July 2018. |
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35

By letter of 2 July 2018, the applicants asked the Commission to reconsider, on the basis of scientific evidence alone, its proposal for the renewal of thiram solely on the basis of seed treatment. That request was rejected by the Commission in its letter of 17 July 2018.

| 36 | On 9 October 2018, the Commission adopted Implementing Regulation (EU) 2018/1500 concerning the non-renewal of the approval of the active substance thiram, and prohibiting the use and sale of seeds treated with plant protection products containing thiram, in accordance with Regulation No 1107/2009, and amending Commission Implementing Regulation No 540/2011 (OJ 2018, L 254, p. 1) (‘the contested implementing regulation’). |
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36

On 9 October 2018, the Commission adopted Implementing Regulation (EU) 2018/1500 concerning the non-renewal of the approval of the active substance thiram, and prohibiting the use and sale of seeds treated with plant protection products containing thiram, in accordance with Regulation No 1107/2009, and amending Commission Implementing Regulation No 540/2011 (OJ 2018, L 254, p. 1) (‘the contested implementing regulation’).

| 37 | Recitals 8 to 11 of the contested implementing regulation set out the reasons for the non-renewal as follows:





  ‘(8) | On 27 January 2017, [EFSA] communicated to the Commission its conclusion on whether thiram can be expected to meet the approval criteria provided for in Article 4 of [Regulation No 1107/2009]. [EFSA] identified a high acute risk to consumers and to workers from application of thiram by foliar spraying. Furthermore, it identified a high risk to birds and mammals from all representative uses assessed, including as a seed treatment, even taking into account the application of higher tier refinements in the risk assessment. Residue definitions for risk assessment purposes could not be derived from the incomplete information available on metabolite M1, consequently the assessment of consumer risk through dietary intake could not be completed and maximum residue levels could not be established. Furthermore, the formation of N,N-dimethylnitrous amide (NDMA), a substance of concern given its intrinsic hazard, in drinking water when surface water and groundwater containing thiram and its metabolite DMCS is subject to water treatment processes could not be excluded by [EFSA] based on the available information and in addition a high risk to aquatic organisms from exposure to DMCS was concluded by [EFSA] based on the limited information available. Also, based on the information available, [EFSA] could not conclude on the endocrine disrupting potential of thiram. |
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37

Recitals 8 to 11 of the contested implementing regulation set out the reasons for the non-renewal as follows:

‘(8)

On 27 January 2017, [EFSA] communicated to the Commission its conclusion on whether thiram can be expected to meet the approval criteria provided for in Article 4 of [Regulation No 1107/2009]. [EFSA] identified a high acute risk to consumers and to workers from application of thiram by foliar spraying. Furthermore, it identified a high risk to birds and mammals from all representative uses assessed, including as a seed treatment, even taking into account the application of higher tier refinements in the risk assessment. Residue definitions for risk assessment purposes could not be derived from the incomplete information available on metabolite M1, consequently the assessment of consumer risk through dietary intake could not be completed and maximum residue levels could not be established. Furthermore, the formation of N,N-dimethylnitrous amide (NDMA), a substance of concern given its intrinsic hazard, in drinking water when surface water and groundwater containing thiram and its metabolite DMCS is subject to water treatment processes could not be excluded by [EFSA] based on the available information and in addition a high risk to aquatic organisms from exposure to DMCS was concluded by [EFSA] based on the limited information available. Also, based on the information available, [EFSA] could not conclude on the endocrine disrupting potential of thiram.

| (9) | The Commission invited the applicant to submit its comments on the conclusion of EFSA. Furthermore, in accordance with the third subparagraph of Article 14(1) of Implementing [Regulation No 844/2012], the Commission invited the applicant to submit comments on the draft renewal report. The applicant submitted its comments, which have been carefully examined. |
| --- | --- |

(9)

The Commission invited the applicant to submit its comments on the conclusion of EFSA. Furthermore, in accordance with the third subparagraph of Article 14(1) of Implementing [Regulation No 844/2012], the Commission invited the applicant to submit comments on the draft renewal report. The applicant submitted its comments, which have been carefully examined.

| (10) | However, despite the arguments put forward by the applicant, the concerns related to the substance could not be eliminated. |
| --- | --- |

(10)

However, despite the arguments put forward by the applicant, the concerns related to the substance could not be eliminated.

| (11) | Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of [Regulation No 1107/2009] are satisfied. It is therefore appropriate not to renew the approval of the active substance thiram in accordance with Article 20(1)(b) of that Regulation.’ |
| --- | --- |

(11)

Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of [Regulation No 1107/2009] are satisfied. It is therefore appropriate not to renew the approval of the active substance thiram in accordance with Article 20(1)(b) of that Regulation.’

III. Procedure and forms of order sought

III.

Procedure and forms of order sought

| 38 | By application filed on 18 December 2018, the applicants brought the present action. |
| --- | --- |

38

By application filed on 18 December 2018, the applicants brought the present action.

| 39 | By separate document filed on 19 December 2018, one of the applicants, Taminco BVBA, brought an application for interim measures seeking a stay of execution of the contested implementing regulation. |
| --- | --- |

39

By separate document filed on 19 December 2018, one of the applicants, Taminco BVBA, brought an application for interim measures seeking a stay of execution of the contested implementing regulation.

| 40 | By order of 26 September 2019, Taminco v Commission (T‐740/18 R, not published, EU:T:2019:717), the President of the General Court dismissed the application for a stay of execution of the contested implementing regulation and reserved the costs. |
| --- | --- |

40

By order of 26 September 2019, Taminco v Commission (T‐740/18 R, not published, EU:T:2019:717), the President of the General Court dismissed the application for a stay of execution of the contested implementing regulation and reserved the costs.

| 41 | Since the composition of the Chambers of the Court has been changed, pursuant to Article 27(5) of the Rules of Procedure of the Court, the Judge-Rapporteur has been assigned to the Seventh Chamber, to which the present case has consequently been assigned. |
| --- | --- |

41

Since the composition of the Chambers of the Court has been changed, pursuant to Article 27(5) of the Rules of Procedure of the Court, the Judge-Rapporteur has been assigned to the Seventh Chamber, to which the present case has consequently been assigned.

| 42 | On 28 April 2020, the Chamber decided to open the oral phase of the proceedings and to invite the parties, as part of the measures of organisation of procedure provided for in Article 89 of the Rules of Procedure, to reply to certain questions for written answer before the hearing. The parties replied within the time limit set. |
| --- | --- |

42

On 28 April 2020, the Chamber decided to open the oral phase of the proceedings and to invite the parties, as part of the measures of organisation of procedure provided for in Article 89 of the Rules of Procedure, to reply to certain questions for written answer before the hearing. The parties replied within the time limit set.

| 43 | On 12 August 2020, as part of the measures of organisation of procedure provided for in Article 89 of the Rules of Procedure, the Court invited the parties to reply to certain questions for oral answer at the hearing. |
| --- | --- |

43

On 12 August 2020, as part of the measures of organisation of procedure provided for in Article 89 of the Rules of Procedure, the Court invited the parties to reply to certain questions for oral answer at the hearing.

| 44 | The parties were heard in their pleadings and in their replies to oral questions put by the Court at the hearing on 17 September 2020. |
| --- | --- |

44

The parties were heard in their pleadings and in their replies to oral questions put by the Court at the hearing on 17 September 2020.

| 45 | The applicants claim that the Court should:





  – | annul the contested implementing regulation in its entirety and refer the evaluation of thiram back to EFSA and to the Commission as appropriate; |
| --- | --- | --- |

45

The applicants claim that the Court should:

–

annul the contested implementing regulation in its entirety and refer the evaluation of thiram back to EFSA and to the Commission as appropriate;

| – | order the extension of the expiry date of the thiram approval to allow for its reassessment; |
| --- | --- |

–

order the extension of the expiry date of the thiram approval to allow for its reassessment;

| – | in the alternative, annul in part that implementing regulation in so far as it prohibits the renewal of the thiram as a seed treatment; |
| --- | --- |

–

in the alternative, annul in part that implementing regulation in so far as it prohibits the renewal of the thiram as a seed treatment;

| – | order the Commission to pay the costs. |
| --- | --- |

–

order the Commission to pay the costs.

| 46 | The Commission contends that the Court should:





  – | dismiss the action; |
| --- | --- | --- |

46

The Commission contends that the Court should:

–

dismiss the action;

| – | order the applicants to pay the costs. |
| --- | --- |

–

order the applicants to pay the costs.

IV. Law

IV.

Law

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

A.

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

| 47 | In their first head of claim, the applicants ask the Court, inter alia, to refer the evaluation of thiram to EFSA and to the Commission, as necessary. In addition, by their second head of claim, they ask the Court to order the extension of the expiry date of the approval of thiram, in order to allow its evaluation. |
| --- | --- |

47

In their first head of claim, the applicants ask the Court, inter alia, to refer the evaluation of thiram to EFSA and to the Commission, as necessary. In addition, by their second head of claim, they ask the Court to order the extension of the expiry date of the approval of thiram, in order to allow its evaluation.

| 48 | In that regard, it is sufficient to recall that, in the context of the review of legality based on Article 263 TFEU, the Court does not have jurisdiction to issue injunctions against the institutions, bodies, offices and agencies of the Union (see order of 26 October 1995, Pevasa and Inpesca v Commission, C‐199/94 P and C‐200/94 P, EU:C:1995:360, paragraph 24 and case-law cited; see also, to that effect, judgment of 25 September 2018, Sweden v Commission, T‐260/16, EU:T:2018:597, paragraph 104 and case-law cited). |
| --- | --- |

48

In that regard, it is sufficient to recall that, in the context of the review of legality based on Article 263 TFEU, the Court does not have jurisdiction to issue injunctions against the institutions, bodies, offices and agencies of the Union (see order of 26 October 1995, Pevasa and Inpesca v Commission, C‐199/94 P and C‐200/94 P, EU:C:1995:360, paragraph 24 and case-law cited; see also, to that effect, judgment of 25 September 2018, Sweden v Commission, T‐260/16, EU:T:2018:597, paragraph 104 and case-law cited).

| 49 | In accordance with Article 264 TFEU, the Court may only annul the contested act, in whole or in part, or dismiss the action. It is then for the institution concerned, pursuant to Article 266 TFEU, to take the measures necessary to comply with the judgment of the Court (see judgment of 9 April 2019, Sopra Steria Group v Parliament, T‐182/15, EU:T:2019:228, paragraph 52 and the case-law cited). |
| --- | --- |

49

In accordance with Article 264 TFEU, the Court may only annul the contested act, in whole or in part, or dismiss the action. It is then for the institution concerned, pursuant to Article 266 TFEU, to take the measures necessary to comply with the judgment of the Court (see judgment of 9 April 2019, Sopra Steria Group v Parliament, T‐182/15, EU:T:2019:228, paragraph 52 and the case-law cited).

| 50 | It follows that the request contained in the first part of the applicants’ application that the Court refer the assessment of thiram to EFSA and to the Commission, first, and the second part of the applicants’ application, second, must be rejected on the ground of lack of jurisdiction. |
| --- | --- |

50

It follows that the request contained in the first part of the applicants’ application that the Court refer the assessment of thiram to EFSA and to the Commission, first, and the second part of the applicants’ application, second, must be rejected on the ground of lack of jurisdiction.

B. The application for annulment

B.

The application for annulment

| 51 | In support of the action, the applicants put forward, in essence, six pleas in law. In the context of the first three pleas in law, they allege that the contested implementing regulation is vitiated by a formal defect and manifest errors of assessment resulting in a breach of Article 4(5) of Regulation No 1107/2009, in that the Commission failed to take into account the fact that the applicants had withdrawn their application for renewal of the approval of the use of thiram by foliar spraying and maintained their application only for seed treatment use. The fourth plea in law alleges misuse of powers in that EFSA classified thiram as a carcinogen. The fifth plea in law alleges breach of the rights of the defence. The sixth plea in law alleges infringement of the precautionary principle, the principle of proportionality and the principle of equal treatment. |
| --- | --- |

51

In support of the action, the applicants put forward, in essence, six pleas in law. In the context of the first three pleas in law, they allege that the contested implementing regulation is vitiated by a formal defect and manifest errors of assessment resulting in a breach of Article 4(5) of Regulation No 1107/2009, in that the Commission failed to take into account the fact that the applicants had withdrawn their application for renewal of the approval of the use of thiram by foliar spraying and maintained their application only for seed treatment use. The fourth plea in law alleges misuse of powers in that EFSA classified thiram as a carcinogen. The fifth plea in law alleges breach of the rights of the defence. The sixth plea in law alleges infringement of the precautionary principle, the principle of proportionality and the principle of equal treatment.

1.
   
  Preliminary remarks

1.

Preliminary remarks

(a)
   
  The scope of the Court’s review

(a)

The scope of the Court’s review

| 52 | According to the case-law, in order to be able to pursue effectively the objectives assigned to it by Regulation No 1107/2009, 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 18 July 2007, Industrias Químicas del Vallés v Commission, C‐326/05 P, EU:C:2007:443, paragraphs 74 and 75, and of 6 September 2013, Sepro Europe v Commission, T‐483/11, unreported, EU:T:2013:407, paragraph 38). That applies, in particular, to the risk management decisions which it has to take pursuant to that regulation. |
| --- | --- |

52

According to the case-law, in order to be able to pursue effectively the objectives assigned to it by Regulation No 1107/2009, 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 18 July 2007, Industrias Químicas del Vallés v Commission, C‐326/05 P, EU:C:2007:443, paragraphs 74 and 75, and of 6 September 2013, Sepro Europe v Commission, T‐483/11, unreported, EU:T:2013:407, paragraph 38). That applies, in particular, to the risk management decisions which it has to take pursuant to that regulation.

| 53 | The 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 25 January 1979, Racke, 98/78, EU:C:1979:14, paragraph 5; of 22 October 1991, Nölle, C‐16/90, EU:C:1991:402, paragraph 12; and of 9 September 2008, Bayer CropScience and Others v Commission, T‐75/06, EU:T:2008:317, paragraph 83). |
| --- | --- |

53

The 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 25 January 1979, Racke, 98/78, EU:C:1979:14, paragraph 5; of 22 October 1991, Nölle, C‐16/90, EU:C:1991:402, paragraph 12; and of 9 September 2008, Bayer CropScience and Others v Commission, T‐75/06, EU:T:2008:317, paragraph 83).

| 54 | As 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 12 December 1996, AIUFFASS and AKT v Commission, T‐380/94, EU:T:1996:195, paragraph 59). 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 9 September 2011, Dow AgroSciences and Others v Commission, T‐475/07, EU:T:2011:445, paragraph 152; see also, to that effect, judgment of 15 October 2009, Enviro Tech (Europe), C‐425/08, EU:C:2009:635, paragraph 47). |
| --- | --- |

54

As 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 12 December 1996, AIUFFASS and AKT v Commission, T‐380/94, EU:T:1996:195, paragraph 59). 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 9 September 2011, Dow AgroSciences and Others v Commission, T‐475/07, EU:T:2011:445, paragraph 152; see also, to that effect, judgment of 15 October 2009, Enviro Tech (Europe), C‐425/08, EU:C:2009:635, paragraph 47).

| 55 | In 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 21 November 1991, Technische Universität München, C‐269/90, EU: C:1991:438, paragraph 14; of 7 May 1992, Pesquerias De Bermeo and Naviera Laida v Commission, C‐258/90 and C‐259/90, EU:C:1992:199, paragraph 26; and of 6 November 2008, Netherlands v Commission, C‐405/07 P, EU:C:2008:613, paragraph 56). |
| --- | --- |

55

In 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 21 November 1991, Technische Universität München, C‐269/90, EU: C:1991:438, paragraph 14; of 7 May 1992, Pesquerias De Bermeo and Naviera Laida v Commission, C‐258/90 and C‐259/90, EU:C:1992:199, paragraph 26; and of 6 November 2008, Netherlands v Commission, C‐405/07 P, EU:C:2008:613, paragraph 56).

Technische Universität München

| 56 | Thus, 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 11 September 2002, Pfizer Animal Health v Council, T‐13/99, EU:T:2002:209, paragraph 172). |
| --- | --- |

56

Thus, 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 11 September 2002, Pfizer Animal Health v Council, T‐13/99, EU:T:2002:209, paragraph 172).

(b)
   
  The burden of proof

(b)

The burden of proof

| 57 | Article 4(1) of Regulation No 1107/2009, 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 paragraphs 2 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 17 May 2018, BASF Agro and Others v Commission, T‐584/13, EU:T:2018:279, paragraph 88). |
| --- | --- |

57

Article 4(1) of Regulation No 1107/2009, 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 paragraphs 2 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 17 May 2018, BASF Agro and Others v Commission, T‐584/13, EU:T:2018:279, paragraph 88).

| 58 | The principles set out in paragraph 57 above are applicable in the context of the procedure for the renewal of the approval of an active substance. |
| --- | --- |

58

The principles set out in paragraph 57 above are applicable in the context of the procedure for the renewal of the approval of an active substance.

| 59 | It is in the light of those considerations that the pleas in law referred to in paragraph 51 above must be examined, beginning with the fifth plea, alleging failure to respect the rights of the defence. |
| --- | --- |

59

It is in the light of those considerations that the pleas in law referred to in paragraph 51 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

2.

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

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

60

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

| 61 | In 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. |
| --- | --- |

61

In 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.

| 62 | In 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. |
| --- | --- |

62

In 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.

| 63 | The 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. |
| --- | --- |

63

The 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.

| 64 | The 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. |
| --- | --- |

64

The 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.

| 65 | In 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. |
| --- | --- |

65

In 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.

| 66 | The Commission contests the applicants’ arguments. |
| --- | --- |

66

The Commission contests the applicants’ arguments.

| 67 | It 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 15 June 2006, Dokter and Others, C‐28/05, EU:C:2006:408, paragraph 74 and the case-law cited). |
| --- | --- |

67

It 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 15 June 2006, Dokter and Others, C‐28/05, EU:C:2006:408, paragraph 74 and the case-law cited).

| 68 | By 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 19 December 2019, Probelte v Commission, T‐67/18, EU:T:2019:873, paragraph 87 and the case-law cited). |
| --- | --- |

68

By 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 19 December 2019, Probelte v Commission, T‐67/18, EU:T:2019:873, paragraph 87 and the case-law cited).

| 69 | Furthermore, it has been held that measures approving, extending or renewing the approval of active substances adopted on the basis of Regulation No 1107/2009 are of general application (see, to that effect, judgment of 27 September 2018, Mellifera v Commission, T‐12/17, EU:T:2018:616, paragraph 71). |
| --- | --- |

69

Furthermore, it has been held that measures approving, extending or renewing the approval of active substances adopted on the basis of Regulation No 1107/2009 are of general application (see, to that effect, judgment of 27 September 2018, Mellifera v Commission, T‐12/17, EU:T:2018:616, paragraph 71).

| 70 | In 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 No 1107/2009, and, second, that implementing regulation is not addressed to the applicants. Consequently, that implementing regulation must be regarded as an act of general application. |
| --- | --- |

70

In 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 No 1107/2009, and, second, that implementing regulation is not addressed to the applicants. Consequently, that implementing regulation must be regarded as an act of general application.

| 71 | In 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 No 1107/2009 laying down general provisions relating in particular to the procedure for the renewal of the approval of an active substance, and by Implementing Regulation No 844/2012 laying down specific provisions relating to the implementation of the procedure for the renewal of the approval of an active substance. |
| --- | --- |

71

In 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 No 1107/2009 laying down general provisions relating in particular to the procedure for the renewal of the approval of an active substance, and by Implementing Regulation No 844/2012 laying down specific provisions relating to the implementation of the procedure for the renewal of the approval of an active substance.

| 72 | In 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 No 844/2012 that the applicant may submit comments, first, on the draft RAR (Article 12(3)) and, second, on the Commission’s renewal report (third subparagraph of Article 14(1)). |
| --- | --- |

72

In 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 No 844/2012 that the applicant may submit comments, first, on the draft RAR (Article 12(3)) and, second, on the Commission’s renewal report (third subparagraph of Article 14(1)).

| 73 | It follows from Article 12(1) and (3) of Implementing Regulation No 844/2012 that EFSA is to communicate to the applicant and the other Member States, no later than 30 days 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 60 days 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 Article 12(3) of that implementing regulation (see paragraph 18 above). |
| --- | --- |

73

It follows from Article 12(1) and (3) of Implementing Regulation No 844/2012 that EFSA is to communicate to the applicant and the other Member States, no later than 30 days 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 60 days 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 Article 12(3) of that implementing regulation (see paragraph 18 above).

| 74 | According to the third subparagraph of Article 14(1) of Implementing Regulation No 844/2012, the applicant is given the opportunity to submit comments on the renewal report within 14 days. That opportunity was given to the applicants and they made use of it, as can be seen from paragraph 26 above. |
| --- | --- |

74

According to the third subparagraph of Article 14(1) of Implementing Regulation No 844/2012, the applicant is given the opportunity to submit comments on the renewal report within 14 days. That opportunity was given to the applicants and they made use of it, as can be seen from paragraph 26 above.

| 75 | It should also be noted that, by email of 31 January 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 22 February 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. |
| --- | --- |

75

It should also be noted that, by email of 31 January 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 22 February 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.

| 76 | It 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. |
| --- | --- |

76

It 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.

| 77 | In 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. |
| --- | --- |

77

In 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.

| 78 | First, it is apparent from the January 2017 Thiram Peer Review Report and, more specifically, from the reporting table dated 27 June 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. |
| --- | --- |

78

First, it is apparent from the January 2017 Thiram Peer Review Report and, more specifically, from the reporting table dated 27 June 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.

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

79

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

| 80 | Furthermore, as the applicants recalled in their written replies to the Court’s questions, in their observations of 22 February 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. |
| --- | --- |

80

Furthermore, as the applicants recalled in their written replies to the Court’s questions, in their observations of 22 February 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.

| 81 | In 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. |
| --- | --- |

81

In 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.

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

82

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

| 83 | In response to that invitation, the applicants limited their comments on 26 June 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 1.6 mg/kg. |
| --- | --- |

83

In response to that invitation, the applicants limited their comments on 26 June 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 1.6 mg/kg.

| 84 | Consequently, 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 Articles 12 and 14 of Implementing Regulation No 844/2012. 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. |
| --- | --- |

84

Consequently, 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 Articles 12 and 14 of Implementing Regulation No 844/2012. 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.

| 85 | The 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. |
| --- | --- |

85

The 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.

| 86 | In 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 23 January 2018. |
| --- | --- |

86

In 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 23 January 2018.

| 87 | However, on the dates on which the applicants submitted and communicated to the Commission the results of the ‘higher tier-field studies’, namely 7 December 2017 and 23 January 2018, no opportunity to submit new data, additional evidence or comments was open under Articles 12 and 14 of Implementing Regulation No 844/2012. 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 recital 8 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 paragraph 24 above), it must be noted that, pursuant to Regulation No 1107/2009 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. |
| --- | --- |

87

However, on the dates on which the applicants submitted and communicated to the Commission the results of the ‘higher tier-field studies’, namely 7 December 2017 and 23 January 2018, no opportunity to submit new data, additional evidence or comments was open under Articles 12 and 14 of Implementing Regulation No 844/2012. 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 recital 8 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 paragraph 24 above), it must be noted that, pursuant to Regulation No 1107/2009 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.

| 88 | As 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 paragraph 63 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 paragraphs 107 to 147 below). |
| --- | --- |

88

As 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 paragraph 63 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 paragraphs 107 to 147 below).

| 89 | In 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. |
| --- | --- |

89

In 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.

| 90 | It 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. |
| --- | --- |

90

It 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.

| 91 | The 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. |
| --- | --- |

91

The 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.

| 92 | Consequently, 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. |
| --- | --- |

92

Consequently, 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.

| 93 | It follows from the considerations set out in paragraphs 75 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. |
| --- | --- |

93

It follows from the considerations set out in paragraphs 75 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.

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

94

It 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

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

| 95 | The 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. |
| --- | --- |

95

The 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.

| 96 | According 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 No 1107/2009 and Implementing Regulation No 844/2012 by strictly respecting the content of the application, from which the use of thiram by foliar spraying had been withdrawn. |
| --- | --- |

96

According 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 No 1107/2009 and Implementing Regulation No 844/2012 by strictly respecting the content of the application, from which the use of thiram by foliar spraying had been withdrawn.

| 97 | The Commission contests the applicants’ arguments. |
| --- | --- |

97

The Commission contests the applicants’ arguments.

| 98 | In that regard, firstly, it is important to emphasise that Regulation No 1107/2009 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. |
| --- | --- |

98

In that regard, firstly, it is important to emphasise that Regulation No 1107/2009 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.

| 99 | Secondly, it should be noted, first, that, in recital 12 of the contested implementing regulation, the Commission stated that, on 18 May 2018, the applicants had requested the withdrawal of the renewal application for the representative uses concerning application by foliar spraying. Second, in recital 13 of the same implementing regulation, the Commission provided for the amendment of Implementing Regulation No 540/2011 accordingly. |
| --- | --- |

99

Secondly, it should be noted, first, that, in recital 12 of the contested implementing regulation, the Commission stated that, on 18 May 2018, the applicants had requested the withdrawal of the renewal application for the representative uses concerning application by foliar spraying. Second, in recital 13 of the same implementing regulation, the Commission provided for the amendment of Implementing Regulation No 540/2011 accordingly.

| 100 | Thirdly, it should first be noted that the contested implementing regulation is a general act (see paragraph 70 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. |
| --- | --- |

100

Thirdly, it should first be noted that the contested implementing regulation is a general act (see paragraph 70 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.

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

101

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

| 102 | Furthermore, 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. |
| --- | --- |

102

Furthermore, 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.

| 103 | Furthermore, 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. |
| --- | --- |

103

Furthermore, 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.

| 104 | Finally, as is apparent from recital 12 of Regulation No 1107/2009, 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 Article 5 of that contested implementing regulation that ‘any grace period granted by Member States in accordance with Article 46 of [that regulation] shall be as short as possible and shall expire by 30 April 2019 for plant protection products used for foliar application’. |
| --- | --- |

104

Finally, as is apparent from recital 12 of Regulation No 1107/2009, 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 Article 5 of that contested implementing regulation that ‘any grace period granted by Member States in accordance with Article 46 of [that regulation] shall be as short as possible and shall expire by 30 April 2019 for plant protection products used for foliar application’.

| 105 | Therefore, 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. |
| --- | --- |

105

Therefore, 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.

| 106 | The 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. |
| --- | --- |

106

The 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 Article 4(5) of Regulation No 1107/2009

4.

The second and third pleas in law, alleging, respectively, a manifest error of assessment and infringement of Article 4(5) of Regulation No 1107/2009

| 107 | The 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. |
| --- | --- |

107

The 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.

| 108 | More 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. |
| --- | --- |

108

More 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.

| 109 | In 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. |
| --- | --- |

109

In 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.

| 110 | Secondly, 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 7 October 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. |
| --- | --- |

110

Secondly, 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 7 October 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.

| 111 | Thirdly, 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. |
| --- | --- |

111

Thirdly, 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.

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

112

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

| 113 | In 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 Article 4(5) of Regulation No 1107/2009. 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. |
| --- | --- |

113

In 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 Article 4(5) of Regulation No 1107/2009. 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.

| 114 | In 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. |
| --- | --- |

114

In 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.

| 115 | The 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. |
| --- | --- |

115

The 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.

| 116 | With 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. |
| --- | --- |

116

With 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.

| 117 | Furthermore, 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. |
| --- | --- |

117

Furthermore, 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.

| 118 | The Commission contests the applicants’ arguments. |
| --- | --- |

118

The Commission contests the applicants’ arguments.

| 119 | In 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. |
| --- | --- |

119

In 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.

| 120 | Firstly, as regards the incomplete information concerning the metabolite M1, it is explained in recital 8 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. |
| --- | --- |

120

Firstly, as regards the incomplete information concerning the metabolite M1, it is explained in recital 8 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.

| 121 | Secondly, 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. |
| --- | --- |

121

Secondly, 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.

| 122 | Thirdly, 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. |
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122

Thirdly, 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.

| 123 | In 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 29 August 2017. However, it should be recalled that, at that date, no opportunity to submit new data, additional elements or comments was available under Articles 12 and 14 of Implementing Regulation No 844/2012 (see paragraph 87 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. |
| --- | --- |

123

In 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 29 August 2017. However, it should be recalled that, at that date, no opportunity to submit new data, additional elements or comments was available under Articles 12 and 14 of Implementing Regulation No 844/2012 (see paragraph 87 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.

| 124 | It follows that, contrary to the applicants’ contention, the concerns and data gaps mentioned in paragraph 119 above are clearly not exclusively related to the uses of thiram by foliar spraying. |
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124

It follows that, contrary to the applicants’ contention, the concerns and data gaps mentioned in paragraph 119 above are clearly not exclusively related to the uses of thiram by foliar spraying.

| 125 | In 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. |
| --- | --- |

125

In 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.

| 126 | Firstly, 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. |
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126

Firstly, 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.

| 127 | In 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’. |
| --- | --- |

127

In 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’.

| 128 | In 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. |
| --- | --- |

128

In 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.

| 129 | Secondly, as to the existence of a high risk to aquatic organisms resulting from their exposure to DMCS, the applicants first observe that, according to Table 5 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. |
| --- | --- |

129

Secondly, as to the existence of a high risk to aquatic organisms resulting from their exposure to DMCS, the applicants first observe that, according to Table 5 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.

| 130 | Next, 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. |
| --- | --- |

130

Next, 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.

| 131 | Finally, 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 paragraph 57 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. |
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131

Finally, 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 paragraph 57 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.

| 132 | Thirdly, 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 paragraph 111 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 1 March 2016, concerning the identification of substances from the carcinogenicity database that are of particular concern even when ingested at doses below 0.0025 μg/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. |
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132

Thirdly, 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 paragraph 111 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 1 March 2016, concerning the identification of substances from the carcinogenicity database that are of particular concern even when ingested at doses below 0.0025 μg/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.

| 133 | In 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. |
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133

In 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.

| 134 | It 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. |
| --- | --- |

134

It 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.

| 135 | In 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. |
| --- | --- |

135

In 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.

| 136 | It 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. |
| --- | --- |

136

It 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.

| 137 | Furthermore, 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. |
| --- | --- |

137

Furthermore, 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.

| 138 | In 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 7 December 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 7 December 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. |
| --- | --- |

138

In 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 7 December 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 7 December 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.

| 139 | That 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. |
| --- | --- |

139

That 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.

| 140 | With 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. |
| --- | --- |

140

With 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.

| 141 | However, it follows from the second subparagraph of Article 14(1) of Implementing Regulation No 844/2012 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. |
| --- | --- |

141

However, it follows from the second subparagraph of Article 14(1) of Implementing Regulation No 844/2012 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.

| 142 | In any event, as the Commission rightly submits, neither of the two measures proposed by the RMS, referred to in paragraph 140 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 9 June 2017 and 1 September 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’. |
| --- | --- |

142

In any event, as the Commission rightly submits, neither of the two measures proposed by the RMS, referred to in paragraph 140 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 9 June 2017 and 1 September 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’.

| 143 | Furthermore, 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 paragraph 31 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. |
| --- | --- |

143

Furthermore, 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 paragraph 31 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.

| 144 | As 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. |
| --- | --- |

144

As 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.

| 145 | The 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. |
| --- | --- |

145

The 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.

| 146 | Finally, 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 paragraphs 124, 134 and 145 above. |
| --- | --- |

146

Finally, 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 paragraphs 124, 134 and 145 above.

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

147

In 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

5.

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

| 148 | The 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 No 1272/2008. |
| --- | --- |

148

The 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 No 1272/2008.

| 149 | The 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 Table 5 and pages 9 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. |
| --- | --- |

149

The 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 Table 5 and pages 9 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.

| 150 | The Commission contests the applicants’ arguments. |
| --- | --- |

150

The Commission contests the applicants’ arguments.

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

151

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

| 152 | Firstly, 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 No 1272/2008. 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 (recital 10), with a view to facilitating trade both in the internal market and worldwide (recitals 4 and 5). |
| --- | --- |

152

Firstly, 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 No 1272/2008. 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 (recital 10), with a view to facilitating trade both in the internal market and worldwide (recitals 4 and 5).

| 153 | However, 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 paragraph 20 above). |
| --- | --- |

153

However, 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 paragraph 20 above).

| 154 | Secondly, 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 No 1272/2008, but also for the purposes of determining whether or not it fulfils the approval criteria laid down in Article 4 of Regulation No 1107/2009. The procedures provided for in Regulation No 1272/2008 and Regulation No 1107/2009 are distinct. First, under Regulation No 1272/2008, 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 No 1107/2009, 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. |
| --- | --- |

154

Secondly, 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 No 1272/2008, but also for the purposes of determining whether or not it fulfils the approval criteria laid down in Article 4 of Regulation No 1107/2009. The procedures provided for in Regulation No 1272/2008 and Regulation No 1107/2009 are distinct. First, under Regulation No 1272/2008, 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 No 1107/2009, 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.

| 155 | Thirdly, 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. |
| --- | --- |

155

Thirdly, 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.

| 156 | Consequently, 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 No 1272/2008 must be regarded as inoperative. |
| --- | --- |

156

Consequently, 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 No 1272/2008 must be regarded as inoperative.

| 157 | In 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 No 1272/2008. |
| --- | --- |

157

In 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 No 1272/2008.

| 158 | In 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. |
| --- | --- |

158

In 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.

| 159 | In 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 paragraph 21 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. |
| --- | --- |

159

In 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 paragraph 21 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.

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

160

Consequently, 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

6.

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

| 161 | The 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 Articles 6, 21 and 78 of Regulation No 1107/2009, which could alleviate the concerns regarding the risk assessment for birds and mammals. The Commission rejected all those options without any legally valid reason. |
| --- | --- |

161

The 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 Articles 6, 21 and 78 of Regulation No 1107/2009, which could alleviate the concerns regarding the risk assessment for birds and mammals. The Commission rejected all those options without any legally valid reason.

| 162 | Next, 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. |
| --- | --- |

162

Next, 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.

| 163 | Finally, 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. |
| --- | --- |

163

Finally, 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.

| 164 | The Commission contests the applicants’ arguments. |
| --- | --- |

164

The Commission contests the applicants’ arguments.

(a)
   
  The alleged violation of the principle of proportionality

(a)

The alleged violation of the principle of proportionality

| 165 | According 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 9 September 2011, Dow AgroSciences and Others v Commission, T‐475/07, EU:T:2011:445, paragraph 279 and the case-law cited). |
| --- | --- |

165

According 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 9 September 2011, Dow AgroSciences and Others v Commission, T‐475/07, EU:T:2011:445, paragraph 279 and the case-law cited).

| 166 | It 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 paragraphs 52 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 9 September 2011, Dow AgroSciences and Others v Commission, T‐475/07, EU:T:2011:445, paragraph 280 and the case-law cited). |
| --- | --- |

166

It 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 paragraphs 52 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 9 September 2011, Dow AgroSciences and Others v Commission, T‐475/07, EU:T:2011:445, paragraph 280 and the case-law cited).

| 167 | In 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 Articles 6, 21 and 78 of Regulation No 1107/2009 which would make it possible to preserve the renewal of the thiram and therefore to choose the less restrictive measure. |
| --- | --- |

167

In 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 Articles 6, 21 and 78 of Regulation No 1107/2009 which would make it possible to preserve the renewal of the thiram and therefore to choose the less restrictive measure.

| 168 | In the first place, as regards Article 6 of Regulation No 1107/2009, 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. |
| --- | --- |

168

In the first place, as regards Article 6 of Regulation No 1107/2009, 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.

| 169 | In that regard, first, it follows from Article 6(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 paragraph 21 above) should be considered as a new data requirement arising from Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation No 1107/2009 (OJ 2013 L 93, p. 1). |
| --- | --- |

169

In that regard, first, it follows from Article 6(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 paragraph 21 above) should be considered as a new data requirement arising from Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation No 1107/2009 (OJ 2013 L 93, p. 1).

| 170 | In 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 paragraph 16 above). Thus, it cannot be considered that such a requirement was established ‘during the evaluation process’. |
| --- | --- |

170

In 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 paragraph 16 above). Thus, it cannot be considered that such a requirement was established ‘during the evaluation process’.

| 171 | Second, with regard to Article 6(j) of Regulation No 1107/2009, 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 23 January 2018. |
| --- | --- |

171

Second, with regard to Article 6(j) of Regulation No 1107/2009, 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 23 January 2018.

| 172 | In that regard, it was found in paragraph 137 above that the new data submitted by the applicants to the Commission, including those provided in the fact sheet dated 23 January 2018, did not confirm the existence of an acceptable risk to birds and mammals. Furthermore, in paragraph 145 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. |
| --- | --- |

172

In that regard, it was found in paragraph 137 above that the new data submitted by the applicants to the Commission, including those provided in the fact sheet dated 23 January 2018, did not confirm the existence of an acceptable risk to birds and mammals. Furthermore, in paragraph 145 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.

| 173 | Consequently, the applicants do not establish that, in so far as the Commission did not make use of the options provided for in Article 6(f) and (j) of Regulation No 1107/2009, the contested implementing regulation was manifestly inadequate to achieve the objectives of protection of health and the environment pursued by that measure. |
| --- | --- |

173

Consequently, the applicants do not establish that, in so far as the Commission did not make use of the options provided for in Article 6(f) and (j) of Regulation No 1107/2009, the contested implementing regulation was manifestly inadequate to achieve the objectives of protection of health and the environment pursued by that measure.

| 174 | In the second place, as regards Article 21 of Regulation No 1107/2009, 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. |
| --- | --- |

174

In the second place, as regards Article 21 of Regulation No 1107/2009, 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.

| 175 | In 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 Article 21 of Regulation No 1107/2009 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 paragraph 138 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 paragraph 173 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. |
| --- | --- |

175

In 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 Article 21 of Regulation No 1107/2009 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 paragraph 138 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 paragraph 173 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.

| 176 | In the third place, as regards Article 78 of Regulation No 1107/2009, the applicants allege that it may be relied on to trigger the application of Article 6(f) or (j) of that regulation. In view of the conclusion reached in paragraph 173 above concerning the application of those provisions, the argument based on recourse to Article 78 of that regulation must be rejected as inoperative. |
| --- | --- |

176

In the third place, as regards Article 78 of Regulation No 1107/2009, the applicants allege that it may be relied on to trigger the application of Article 6(f) or (j) of that regulation. In view of the conclusion reached in paragraph 173 above concerning the application of those provisions, the argument based on recourse to Article 78 of that regulation must be rejected as inoperative.

| 177 | In 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. |
| --- | --- |

177

In 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

(b)

The alleged breach of the precautionary principle

(1) Preliminary remarks on the precautionary principle

(1)

Preliminary remarks on the precautionary principle

| 178 | It should be noted, first of all, that, while Article 191(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 1 October 2019, Blaise and Others, C‐616/17, EU:C:2019:800, paragraph 41 and the case-law cited). |
| --- | --- |

178

It should be noted, first of all, that, while Article 191(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 1 October 2019, Blaise and Others, C‐616/17, EU:C:2019:800, paragraph 41 and the case-law cited).

| 179 | It 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 No 1107/2009, to comply with the precautionary principle, with a view, in particular, to ensuring, in accordance with Article 35 of the Charter of Fundamental Rights of the European Union and Article 9 and Article 168(1) TFEU, a high level of protection of human health (see judgment of 1 October 2019, Blaise and Others, C‐616/17, EU:C:2019:800, paragraph 42 and the case-law cited). |
| --- | --- |

179

It 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 No 1107/2009, to comply with the precautionary principle, with a view, in particular, to ensuring, in accordance with Article 35 of the Charter of Fundamental Rights of the European Union and Article 9 and Article 168(1) TFEU, a high level of protection of human health (see judgment of 1 October 2019, Blaise and Others, C‐616/17, EU:C:2019:800, paragraph 42 and the case-law cited).

| 180 | The 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 1 October 2019, Blaise and Others, C‐616/17, EU:C:2019:800, paragraph 43 and the case-law cited). |
| --- | --- |

180

The 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 1 October 2019, Blaise and Others, C‐616/17, EU:C:2019:800, paragraph 43 and the case-law cited).

| 181 | According 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 11 February 2015, Spain v Commission, T‐204/11, EU:T:2015:91, paragraph 30 and the case-law cited). |
| --- | --- |

181

According 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 11 February 2015, Spain v Commission, T‐204/11, EU:T:2015:91, paragraph 30 and the case-law cited).

| 182 | The considerations set out in paragraphs 178 to 181 above are applicable, by analogy, in relation to the other interests protected by Article 4 of Regulation No 1107/2009, namely, inter alia, animal health and the environment (see, to that effect, judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‐429/13 and T‐451/13, EU:T:2018:280, paragraph 130). |
| --- | --- |

182

The considerations set out in paragraphs 178 to 181 above are applicable, by analogy, in relation to the other interests protected by Article 4 of Regulation No 1107/2009, namely, inter alia, animal health and the environment (see, to that effect, judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‐429/13 and T‐451/13, EU:T:2018:280, paragraph 130).

| 183 | Within 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 17 May 2018, BASF Agro and Others v Commission, T‐584/13, EU:T:2018:279, paragraph 60). |
| --- | --- |

183

Within 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 17 May 2018, BASF Agro and Others v Commission, T‐584/13, EU:T:2018:279, paragraph 60).

| 184 | With regard to the third stage concerning risk management, it should be noted that point 6.3.4 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.’ |
| --- | --- |

184

With regard to the third stage concerning risk management, it should be noted that point 6.3.4 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.’

| 185 | It 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 point 6.3.4 of the Communication on the precautionary principle and, if so, whether it did so in the present case. |
| --- | --- |

185

It 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 point 6.3.4 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

(2)

The Commission’s obligation to examine the benefits and costs

| 186 | In 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 point 6.3.4 of the Communication on the precautionary principle, in a procedure for the renewal of the approval of an active substance, provided for in Regulation No 1107/2009 and in the context of which it is incumbent on the applicant to demonstrate the efficacy and safety of the active substance in question. |
| --- | --- |

186

In 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 point 6.3.4 of the Communication on the precautionary principle, in a procedure for the renewal of the approval of an active substance, provided for in Regulation No 1107/2009 and in the context of which it is incumbent on the applicant to demonstrate the efficacy and safety of the active substance in question.

| 187 | It follows from recital 8 and Article 1(4) of Regulation No 1107/2009 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. |
| --- | --- |

187

It follows from recital 8 and Article 1(4) of Regulation No 1107/2009 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.

| 188 | As recalled in point 184 above, point 6.3.4 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 point 6.3 of that communication specifies that those general principles apply to ‘all risk management measures’. |
| --- | --- |

188

As recalled in point 184 above, point 6.3.4 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 point 6.3 of that communication specifies that those general principles apply to ‘all risk management measures’.

| 189 | In 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 Article 21 of Regulation No 1107/2009. |
| --- | --- |

189

In 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 Article 21 of Regulation No 1107/2009.

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

190

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

| 191 | Firstly, the Commission relies on the judgment of 17 May 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 Article 21 of Regulation No 1107/2009. 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. |
| --- | --- |

191

Firstly, the Commission relies on the judgment of 17 May 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 Article 21 of Regulation No 1107/2009. 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.

a contrario

| 192 | Secondly, the Commission states that the renewal procedure is different from the review procedure under Article 21 of Regulation No 1107/2009 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 paragraph 184 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 paragraph 183 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. |
| --- | --- |

192

Secondly, the Commission states that the renewal procedure is different from the review procedure under Article 21 of Regulation No 1107/2009 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 paragraph 184 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 paragraph 183 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.

| 193 | Thirdly, 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. |
| --- | --- |

193

Thirdly, 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.

| 194 | In 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 point 6.3.4 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. |
| --- | --- |

194

In 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 point 6.3.4 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

(3)

The conduct by the Commission of the review of benefits and costs

| 195 | It should be noted that point 6.3.4 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 17 May 2018, BASF Agro and Others v Commission, T‐584/13, EU:T:2018:279, paragraph 162). |
| --- | --- |

195

It should be noted that point 6.3.4 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 17 May 2018, BASF Agro and Others v Commission, T‐584/13, EU:T:2018:279, paragraph 162).

| 196 | Furthermore, 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 17 May 2018, BASF Agro and Others v Commission, T‐584/13, EU:T:2018:279, paragraph 163). |
| --- | --- |

196

Furthermore, 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 17 May 2018, BASF Agro and Others v Commission, T‐584/13, EU:T:2018:279, paragraph 163).

| 197 | In 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 25 May 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’. |
| --- | --- |

197

In 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 25 May 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’.

| 198 | In 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. |
| --- | --- |

198

In 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.

| 199 | That conclusion cannot be called into question by the applicants’ argument that the examination of the benefits and costs, within the meaning of point 6.3.4 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. |
| --- | --- |

199

That conclusion cannot be called into question by the applicants’ argument that the examination of the benefits and costs, within the meaning of point 6.3.4 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.

| 200 | First, it is clear from the case-law cited in paragraph 181 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 21 December 2016, Associazione Italia Nostra Onlus, C‐444/15, EU:C:2016:978, paragraph 46). 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 point 6.3.4 of the Communication on the precautionary principle. |
| --- | --- |

200

First, it is clear from the case-law cited in paragraph 181 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 21 December 2016, Associazione Italia Nostra Onlus, C‐444/15, EU:C:2016:978, paragraph 46). 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 point 6.3.4 of the Communication on the precautionary principle.

| 201 | Second, as noted in paragraph 196 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. |
| --- | --- |

201

Second, as noted in paragraph 196 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.

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

202

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

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

(c)

The alleged breach of the principle of equal treatment

| 203 | It 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 25 October 2005, Groupe Danone v Commission, T‐38/02, EU:T:2005:367, paragraph 453, and of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‐31/07, not published, EU:T:2013:167, paragraph 310). |
| --- | --- |

203

It 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 25 October 2005, Groupe Danone v Commission, T‐38/02, EU:T:2005:367, paragraph 453, and of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‐31/07, not published, EU:T:2013:167, paragraph 310).

| 204 | In 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 paragraph 163 above). However, it is incumbent on the applicants to specify and demonstrate which situation is comparable to another situation which has been treated differently. |
| --- | --- |

204

In 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 paragraph 163 above). However, it is incumbent on the applicants to specify and demonstrate which situation is comparable to another situation which has been treated differently.

| 205 | By 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. |
| --- | --- |

205

By 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.

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

206

Therefore, the sixth plea in law must be rejected.

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

207

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

V. Costs

V.

Costs

| 208 | Under Article 134(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. |
| --- | --- |

208

Under Article 134(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.

| 209 | Since 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. |
| --- | --- |

209

Since 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.

| 210 | Since Taminco was unsuccessful in the proceedings for interim measures and the costs were reserved (see paragraph 40 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. |
| --- | --- |

210

Since Taminco was unsuccessful in the proceedings for interim measures and the costs were reserved (see paragraph 40 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: |
| --- | --- |

On those grounds,

THE GENERAL COURT (Seventh Chamber)

hereby:

| | 1. | Dismisses the action; |
| --- | --- | --- |

1.

1.

Dismisses the action;

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; |
| --- | --- | --- |

2.

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;

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. |
| --- | --- | --- |

3.

3.

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

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

| | da Silva Passos


  Valančius


  Reine


  Delivered in open court in Luxembourg on 9 February 2022.


  E. Coulon
  Registrar


  M. van der Woude
  President |
| --- | --- |

da Silva Passos

Valančius

Reine

Delivered in open court in Luxembourg on 9 February 2022.

E. Coulon

Registrar

M. van der Woude

President

Table of contents

| | I. Legal framework |
| --- | --- |
| | A. Directive 91/414/EEC |
| | B. Regulation No 1107/2009 |
| | C. Implementing Regulation No 844/2012 |
| | 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 Article 4(5) of Regulation No 1107/2009 |
| | 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 |

I. Legal framework

A. Directive 91/414/EEC

B. Regulation No 1107/2009

C. Implementing Regulation No 844/2012

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 Article 4(5) of Regulation No 1107/2009

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

---

(
  *1
  )	Language of the case: English.

*1