Judgments nº T-725/15 of Tribunal General de la Unión Europea, December 14, 2018

• Resolution Date: December 14, 2018
• Issuing Organization: Tribunal General de la Unión Europea
• Decision Number: T-725/15

(Plant protection products - Procedure for reviewing the approval of the active substance diflubenzuron - Article 21 of Regulation (EC) No 1107/2009 - Conclusion of the EFSA review - Partial publication of that conclusion - Article 63 of Regulation No 1107/2009 - Request for confidential treatment of certain sections - Protection of commercial interests - Refusal to grant confidential treatment - Interest in bringing proceedings)

In Case T-725/15,

Arysta LifeScience Netherlands BV, formerly Chemtura Netherlands BV, established in Amsterdam (Netherlands), represented by C. Mereu and K. Van Maldegem, lawyers,

applicant,

v

European Food Safety Authority (EFSA), represented by D. Detken and S. Gabbi, acting as Agents, and by R. Van der Hout and C. Wagner, lawyers,

defendant,

supported by

European Commission, represented initially by F. Moro and P. Ondrůšek, and subsequently by P. Ondrůšek and G. Koleva, acting as Agents,

intervener,

APPLICATION under Article 263 TFEU for the annulment of the decision of EFSA of 10 December 2015 relating to the publication of certain sections of the EFSA peer review on the review of the approval of the active substance diflubenzuron concerning the metabolite PCA,

THE GENERAL COURT (Fourth Chamber),

composed of H. Kanninen, President, L. Calvo-Sotelo Ibáñez-Martín and I. Reine (Rapporteur), Judges,

Registrar: P. Cullen, Administrator,

having regard to the written part of the procedure and further to the hearing on 29 November 2017,

gives the following

Judgment

1. Legal framework

   A. EU legislation governing the procedure for the evaluation and approval of plant protection products and their active substances in the European Union

   1. 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) lays down the EU system for authorising the placing of plant protection products on the market and contains provisions applicable to plant protection products and to the active substances contained in those products.

      2 Under 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, a plant protection product is not authorised unless its active substances are listed in Annex I to the Directive and any conditions laid down in that annex are fulfilled. Articles 5 and 6 of that directive lay down the procedure for the inclusion of an active substance in the annex in question.

      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 Directives 79/117/EEC and 91/414 (OJ 2009 L 309, p. 1), with effect from 14 June 2011.

      4 In accordance with the transitional measures laid down in Article 80(1)(a) of Regulation No 1107/2009, Directive 91/414 was to continue to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision had been adopted before 14 June 2011 in accordance with Article 6(3) of that directive.

   2. Regulation (EC) No 1490/2002

      5 Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414 and amending Regulation (EC) No 451/2000 (OJ 2002 L 224, p. 23) concerns the continued evaluation of active substances.

      6 Articles 10 to 13 of Regulation No 1490/2002 define the procedure for evaluating active substances. In that regard, a rapporteur Member State designated for each substance conducts an evaluation and draws up a report in which it makes a recommendation to the European Commission either to include the active substance in Annex I to Directive 91/414 or not to include it. The rapporteur Member State sends a draft assessment report to the European Food Safety Authority (EFSA). Once it has received the draft assessment report sent to it by the rapporteur Member State, EFSA circulates it to the Member States. EFSA evaluates the draft report and delivers its opinion to the Commission on whether the active substance can be expected to meet the safety requirements of that directive. After receipt of that opinion, the Commission submits a draft review report to the Standing Committee on the Food Chain and Animal Health established by Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1).

      7 Article 11b of Regulation No 1490/2002 applies to active substances for which there are clear indications that they do not have any harmful effects.

   3. Regulation No 1107/2009

      8 According to recital 3 thereof, Regulation No 1107/2009 repealed and replaced Directive 91/414 with effect from 14 June 2011, in the light of the experience gained from the application of that directive and of recent scientific and technical developments.

      9 Article 4 of Regulation No 1107/2009 lays down approval criteria for active substances in plant protection products.

      10 Articles 7 to 13 of Regulation No 1107/2009 lay down the approval procedure for active substances. First of all, it is provided in Article 7 of that regulation that an application for the approval of an active substance or for an amendment to the conditions of an approval must be submitted by the producer of the active substance to a Member State, referred to as ‘the rapporteur Member State’. It must be demonstrated that the active substance fulfils the approval criteria provided for in Article 4. Next, pursuant to Article 11 of that regulation, the rapporteur Member State prepares and submits to the Commission, with a copy to EFSA, a report, referred to as the ‘draft assessment report’, assessing whether the active substance can be expected to meet the approval criteria provided for in Article 4. Moreover, according to Article 12 of the same regulation, having received the draft assessment report from the rapporteur Member State, EFSA circulates it to the applicant and the other Member States. After the expiry of the period for the submission of written comments, EFSA adopts a conclusion in the light of current scientific and technical knowledge using guidance documents available at the time of application on whether the active substance can be expected to meet the approval criteria provided for in Article 4. It communicated its conclusion to the applicant, the Member States and the Commission and made it available to the public. Last, in accordance with Article 13 of Regulation No 1107/2009, after receiving the conclusion from EFSA, the Commission presents a report, referred to as ‘the review report’, and a draft Regulation to the Standing Committee on the Food Chain and Animal Health, taking into account the draft assessment report by the rapporteur Member State and the conclusion of EFSA. The applicant shall be given the possibility to submit comments on the review report.

      11 Article 21 of Regulation No 1107/2009 concerns review of the approval of an active substance. Under that article, the Commission may review the approval of an active substance at any time. It must take into account the request of a Member State to review, in the light of new scientific and technical knowledge and monitoring data, the approval of an active substance. Where, in the light of new scientific and technical knowledge, it considers that there are indications that the substance no longer satisfies the approval criteria provided for in Article 4, or further information required has not been provided, it must inform the Member States, EFSA and the producer of the active substance, setting a period for the producer to submit its comments. In this review procedure, it may ask the Member States and EFSA for an opinion, and EFSA is required to provide its opinion or the results of its work to it. Where it concludes that an active substance no longer fulfils the approval criteria provided for in Article 4, a Regulation to withdraw or amend the approval must be adopted in accordance with the regulatory procedure referred to in Article 79(3) of Regulation No 1107/2009.

      B. EU legislation on the active substance diflubenzuron

      12 By Directive 2008/69/EC of 1 July 2008 amending Council Directive 91/414 to include clofentezine, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram and pyriproxyfen as active substances (OJ 2008 L 172, p. 9), the Commission included the active substance diflubenzuron in Annex I to Directive 91/414.

      13 Recital 5 of Directive 2008/69 reads as follows:

      ‘It has appeared from the various examinations made that plant protection products containing the active substances listed in the Annex to this Directive may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive [91/414], in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include in Annex I to that Directive the active substances listed in the Annex to this Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.’

      14 Considering that it was appropriate to obtain further information on certain specific points concerning diflubenzuron in particular, the Commission, on 22 June 2010, adopted Directive 2010/39/EU amending Annex I to Council Directive 91/414 as regards the specific provisions relating to the active substances clofentezine, diflubenzuron, lenacil...