Judgments nº T-476/17 of Tribunal General de la Unión Europea, September 19, 2019

• Resolution Date: September 19, 2019
• Issuing Organization: Tribunal General de la Unión Europea
• Decision Number: T-476/17

(Plant protection products - Active substance diflubenzuron - Review of approval - Article 21 of Regulation (EC) No 1107/2009 - Rights of the defence - Ultra vires - Manifest error of assessment - Procedure for renewal of approval - Article 14 of Regulation No 1107/2009 - Imposition, in the context of the review procedure, of additional restrictions limiting the use of the active substance at issue without waiting for the outcome of the renewal procedure - Proportionality)

In Case T-476/17,

Arysta LifeScience Netherlands BV, established in Amsterdam (Netherlands), represented by C. Mereu and M. Grunchard, lawyers,

applicant,

v

European Commission, represented by A. Lewis, I. Naglis and G. Koleva, acting as Agents,

defendant,

APPLICATION under Article 263 TFEU for annulment of Commission Implementing Regulation (EU) 2017/855 of 18 May 2017 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance diflubenzuron (OJ 2017 L 128, p. 10),

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 12 February 2019,

gives the following

Judgment

Legal framework

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 rules governing authorisation for the placing of these products on the market. It contains provisions applicable to plant protection products and to the active substances 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 fulfil 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 that directive and any conditions laid down in that annex are satisfied. Articles 5 and 6 of Directive 91/414 lay down the procedure 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3 Directive 91/414 was repealed by Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the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 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 in accordance with Article 6(3) of that directive before 14 June 2011.

Regulation (EC) No 1 490/2002

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 Directive 91/414. 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 provides for the evaluation procedure for active substances with clear indications that they do not have any harmful effects.

Regulation No 1 107/2009

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 According to Article 1(3) thereof, the purpose of Regulation No 1107/2009 is to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production.

10 Article 4 of that regulation lays down approval criteria for active substances in plant protection products.

11 Under Article 5 of Regulation No 1107/2009, first approval is to be for a period not exceeding 10 years.

12 Articles 7 to 13 of Regulation No 1107/2009 set out the approval procedure for active substances. First of all, 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 (Article 7). Next, 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 (Article 11). 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 communicates its conclusion to the applicant, the Member States and the Commission and makes it available to the public (Article 12). Lastly, 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 must be given the possibility to submit comments on the review report (Article 13).

13 Articles 14 to 20 of Regulation No 1107/2009 concern the renewal of approval of active substances. The approval of an active substance is renewed on application by a producer of the active substance to a Member State no later than three years before the expiry of the approval where it is established that the approval criteria provided for in Article 4 are satisfied (Article 14(1) and Article 15(1)). When applying for renewal of approval, the applicant must identify new data he intends to submit and demonstrate that they are necessary, because of data requirements or criteria which were not applicable at the time of the last approval of the active substance or because his request is for an amended approval (Article 15(2)). At the same time the applicant must submit a timetable of any new and ongoing studies (Article 15(2)). A regulation is to be adopted in accordance with the regulatory procedure referred to in Article 79(3) of Regulation No 1107/2009, providing that the approval of an active substance is renewed, subject to conditions and restrictions where appropriate, or that the approval of an active substance is not renewed (Article 20(1)).

14 Article 21 of Regulation No 1107/2009 concerns the review of 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, the Commission 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 that review procedure the Commission 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 the Commission. Where the Commission 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.

Background to the dispute

15 The applicant, Arysta LifeScience Netherlands BV, is a company that develops, produces and sells agrochemical and specialty chemicals. Under the system provided for in Directive 91/414, it notified the active substance diflubenzuron, an insecticide used on pome fruit, citrus, cotton, mushrooms, ornamentals, forestry...