# C_2020129EN.01000401.xml

| 20.4.2020 | EN | Official Journal of the European Union | C 129/4 |
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20.4.2020

EN

Official Journal of the European Union

C 129/4

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Action brought on 10 February 2020 — Ascenza Agro and Afrasa v Commission

(Case T-77/20)

(2020/C 129/05)

Language of the case: English

Parties

Applicants: Ascenza Agro, SA (Setúbal, Portugal) and Afrasa, SA (Paterna-Valencia, Spain) (represented by: K. Van Maldegem and P. Sellar, lawyers and V. McElwee, Solicitor)

Defendant: European Commission

Form of order sought

The applicants claim that the Court should:

| — | declare the application admissible and well-founded; |
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declare the application admissible and well-founded;

| — | annul the contested act (1); and |
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annul the contested act (1); and

| — | order the defendant to pay the costs of these proceedings. |
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order the defendant to pay the costs of these proceedings.

Pleas in law and main arguments

In support of the action, the applicants rely on nine pleas in law.

| 1. | First plea in law, alleging infringement of an essential procedural requirement since the defendant failed to comply with all the mandatory requirements set out in Commission Implementing Regulation No 844/2012 (2) (Articles 12 and 13) and adopted the contested act on the basis of an incomplete risk assessment. This means that the contested act is not supported by the full, legally required scientific basis. |
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1.

First plea in law, alleging infringement of an essential procedural requirement since the defendant failed to comply with all the mandatory requirements set out in Commission Implementing Regulation No 844/2012 (2) (Articles 12 and 13) and adopted the contested act on the basis of an incomplete risk assessment. This means that the contested act is not supported by the full, legally required scientific basis.

| 2. | Second plea in law, alleging infringement of the principle of transparency vis-à-vis the first applicant since at no time during the renewal process, the first applicant received indication that there were concerns other than those commented during the public consultation period or raised in EFSA’s Article 13(3) request for additional information. |
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2.

Second plea in law, alleging infringement of the principle of transparency vis-à-vis the first applicant since at no time during the renewal process, the first applicant received indication that there were concerns other than those commented during the public consultation period or raised in EFSA’s Article 13(3) request for additional information.

| 3. | Third plea in law, alleging infringement of an essential procedural requirement as the bases of the contested act are two EFSA Statements, opposed to a standard EFSA Peer Review Report and that the first applicant was not able to provide scientific comments that could address the defendant’s concerns. |
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3.

Third plea in law, alleging infringement of an essential procedural requirement as the bases of the contested act are two EFSA Statements, opposed to a standard EFSA Peer Review Report and that the first applicant was not able to provide scientific comments that could address the defendant’s concerns.

| 4. | Fourth plea in law, alleging infringement of the precautionary principle: the contested act is underpinned by the precautionary principle, which, for the substance chlorpyrifos-methyl, was unlawfully applied because the first applicant had submitted a relevant data set that, after having been assessed, showed negative results, therefore exhausting the requirements of the precautionary principle. In addition, the precautionary principle can only be applied when a risk assessment is conducted and concluded. In the present case, however, the risk assessment was not completed and the precautionary principle itself formed the basis of the risk assessment conclusion. |
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4.

Fourth plea in law, alleging infringement of the precautionary principle: the contested act is underpinned by the precautionary principle, which, for the substance chlorpyrifos-methyl, was unlawfully applied because the first applicant had submitted a relevant data set that, after having been assessed, showed negative results, therefore exhausting the requirements of the precautionary principle. In addition, the precautionary principle can only be applied when a risk assessment is conducted and concluded. In the present case, however, the risk assessment was not completed and the precautionary principle itself formed the basis of the risk assessment conclusion.

| 5. | Fifth plea in law, alleging manifest error of assessment since the defendant took into account an irrelevant factor to adopt the contested act. The latter was adopted following the regulatory committee procedure, requiring a qualified majority vote within the SCoPAFF. Because of the impending exit of the UK from the EU (‘Brexit’), the UK representative did not participate in the 6 December 2019 SCoPAFF meeting and, instead, gave a proxy vote to Finland. The UK representative did not participate because the UK Government announced, at the end of August 2019, a new policy regarding the country’s attendance to the meetings of the EU Scientific Committees. That Finland — and by extension the defendant — took into account the Brexit-motivated policy means that an irrelevant factor was taken into account in the adoption of the contested act. |
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5.

Fifth plea in law, alleging manifest error of assessment since the defendant took into account an irrelevant factor to adopt the contested act. The latter was adopted following the regulatory committee procedure, requiring a qualified majority vote within the SCoPAFF. Because of the impending exit of the UK from the EU (‘Brexit’), the UK representative did not participate in the 6 December 2019 SCoPAFF meeting and, instead, gave a proxy vote to Finland. The UK representative did not participate because the UK Government announced, at the end of August 2019, a new policy regarding the country’s attendance to the meetings of the EU Scientific Committees. That Finland — and by extension the defendant — took into account the Brexit-motivated policy means that an irrelevant factor was taken into account in the adoption of the contested act.

| 6. | Sixth plea in law, alleging infringement of the principle of sound administration: the defendant and EFSA perceived that the chlorpyrifos-methyl could present health concerns and, for that purpose, they organised an expert meeting, after which the Rapporteur Member State was asked to carry out a further literature search to confirm those concerns. That search led to a decision being taken on the basis of non-compliant studies and without providing the first applicant an opportunity to make its views known. |
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6.

Sixth plea in law, alleging infringement of the principle of sound administration: the defendant and EFSA perceived that the chlorpyrifos-methyl could present health concerns and, for that purpose, they organised an expert meeting, after which the Rapporteur Member State was asked to carry out a further literature search to confirm those concerns. That search led to a decision being taken on the basis of non-compliant studies and without providing the first applicant an opportunity to make its views known.

| 7. | Seventh plea in law, alleging that the conclusion on genotoxicity is unstainable as a matter of law: the defendant reached the conclusion that chlorpyrifos-methyl showed a potential for genotoxicity based on an unlawful misapplication of the read-across and the weight of evidence approaches. |
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7.

Seventh plea in law, alleging that the conclusion on genotoxicity is unstainable as a matter of law: the defendant reached the conclusion that chlorpyrifos-methyl showed a potential for genotoxicity based on an unlawful misapplication of the read-across and the weight of evidence approaches.

| 8. | Eighth plea in law, alleging that the conclusion on developmental neurotixicity is unsustainable as a matter of law: the defendant identified concerns related to the developmental neurotoxicity of chlorpyrifos-mehtyl based on a read-across from chlorpyrifos-ethyl and organophosphates substances to chlopyrifos-methyl without providing any indication as to how and why that read-across was scientifically and legally appropriate. |
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8.

Eighth plea in law, alleging that the conclusion on developmental neurotixicity is unsustainable as a matter of law: the defendant identified concerns related to the developmental neurotoxicity of chlorpyrifos-mehtyl based on a read-across from chlorpyrifos-ethyl and organophosphates substances to chlopyrifos-methyl without providing any indication as to how and why that read-across was scientifically and legally appropriate.

| 9. | Ninth plea in law, alleging infringement of the rules on classification as toxic to reproductive toxicity, Category 1B: the defendant infringed the rules laid down in Regulation (EC) 1272/2008 (3) when it indicated that the classification of chlorpyrifos-methyl as toxic for reproduction category 1B may be appropriate. That opinion was indeed based on an unlawful and not substantiated application of read-across. |
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9.

Ninth plea in law, alleging infringement of the rules on classification as toxic to reproductive toxicity, Category 1B: the defendant infringed the rules laid down in Regulation (EC) 1272/2008 (3) when it indicated that the classification of chlorpyrifos-methyl as toxic for reproduction category 1B may be appropriate. That opinion was indeed based on an unlawful and not substantiated application of read-across.

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(1)  Commission Implementing Regulation (EU) 2020/17 of 10 January 2020 concerning the non-renewal of the approval of the active substance chlorpyrifos-methyl, in accordance with Regulation (EC) No 107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ 2020 L 7, p. 11).

(2)  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 (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ 2012 L 252, p. 26).

(3)  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).

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