Taminco BVBA and Arysta LifeScience Great Britain Ltd v European Commission.

• Jurisdiction: European Union
• ECLI: ECLI:EU:T:2022:61
• Date: 09 February 2022
• Docket Number: T-740/18
• Celex Number: 62018TJ0740
• Court: General Court (European Union)

JUDGMENT OF THE GENERAL COURT (Seventh Chamber)

9 February 2022 ( *1 )

(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),

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

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

applicants,

v

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

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

I. Legal framework

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.

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.

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.

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.

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

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.

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

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

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...