Judgments nº T-584/13 of Tribunal General de la Unión Europea, May 17, 2018

• Resolution Date: May 17, 2018
• Issuing Organization: Tribunal General de la Unión Europea
• Decision Number: T-584/13

(Plant protection products - Active substance fipronil - Review of approval - Article 21 of Regulation (EC) No 1107/2009 - Prohibition of the use and sale of seeds treated with plant protection products containing the active substance in question - Article 49(2) of Regulation No 1107/2009 - Precautionary principle - Impact assessment)

In Case T-584/13,

BASF Agro BV, established in Arnhem (Netherlands), and the other applicants whose names appear in the annex, (1) represented by J.-P. Montfort and M. Peristeraki, lawyers,

applicants,

supported by

Association européenne pour la protection des cultures (ECPA), established in Brussels (Belgium), represented by I. de Seze and É. Mullier, lawyers, and D. Abrahams, Barrister,

and by

European Seed Association (ESA), established in Brussels, represented initially by P. de Jong, P. Vlaemminck and B. Van Vooren, and subsequently by P. de Jong, K. Claeyé and E. Bertolotto, lawyers,

interveners,

v

European Commission, represented by P. Ondrůšek and G. von Rintelen, acting as Agents,

defendant,

supported by

Deutscher Berufs- und Erwerbsimkerbund eV, established in Soltau (Germany),

Österreichischer Erwerbsimkerbund, established in Grof‌lebersdorf (Austria),

and

Österreichischer Imkerbund (ÖIB), established in Vienna (Austria)

represented by A. Willand and B. Tschida, lawyers,

interveners,

APPLICATION pursuant to Article 263 TFEU for annulment of Commission Implementing Regulation (EU) No 781/2013 of 14 August 2013 amending Implementing Regulation (EU) No 540/2011, as regards the conditions of approval of the active substance fipronil, and prohibiting the use and sale of seeds treated with plant protection products containing this active substance (OJ 2013 L 219, p. 22),

THE GENERAL COURT (First Chamber, Extended Composition),

composed of H. Kanninen, President, I. Pelikánová (Rapporteur), E. Buttigieg, S. Gervasoni and L. Calvo-Sotelo Ibáñez-Martín, Judges,

Registrar: P. Cullen, Administrator,

having regard to the written part of the procedure and further to the hearing on 17 February 2017,

gives the following

Judgment

1. Background to the dispute

   1 The active substance fipronil, which is part of the phenylpyrazole family, was included in Annex I to 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) by Commission Directive 2007/52/EC of 16 August 2007 amending Directive 91/414 to include ethoprophos, pirimiphos-methyl and fipronil as active substances (OJ 2007 L 214, p. 3).

   2 Within the European Union, fipronil is produced and marketed by the BASF group.

   3 Following the replacement of Directive 91/414 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 (OJ 2009 L 309, p. 1), the active substances included in Annex I to Directive 91/414 were deemed to be approved under Regulation No 1107/2009, pursuant to Article 78(3) thereof, and are now listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation No 1107/2009 as regards the list of approved active substances (OJ 2011 L 153, p. 1).

   4 In 2008 and 2009, a number of incidents involving the misuse of plant protection products containing active substances belonging to the neonicotinoid family resulted in losses of honeybee colonies. The Member States affected reacted by taking various restrictive measures.

   5 In 2010, in response to those incidents, the European Commission adopted Directive 2010/21/EU of 12 March 2010 amending Annex I to Directive 91/414 as regards the specific provisions relating to clothianidin, thiamethoxam, fipronil and imidacloprid (OJ 2010 L 65, p. 27). This measure strengthened the terms of approval of the substances in question as regards the protection of non-target organisms, in particular honeybees.

   6 On 18 March 2011, the Commission asked the European Food Safety Authority (EFSA) to review the existing scheme for the assessment of risks posed by plant protection products to bees, drawn up by the European and Mediterranean Plant Protection Organisation (EPPO), in relation to the assessment of chronic risks to bees, exposure to low doses, exposure through guttation and the cumulative risk assessment. The scheme was presented in a document entitled ‘Environmental risk assessment scheme for plant protection products’ (reference PP 3/10; ‘the EPPO Guidance’).

   7 On the basis of the final report of October 2011 of the Apenet monitoring and research programme in Italy, which raised concerns about the use of seeds treated with plant protection products containing, inter alia, fipronil, and after discussions with the Member States’ experts within the framework of the Standing Committee on the Food Chain and Animal Health (‘the Standing Committee’), the Commission decided, on 22 March 2012, in accordance with Article 49(2) of Regulation No 1107/2009, to request an opinion from EFSA on the subject.

   8 On 23 May 2012, in response to the Commission’s request of 18 March 2011 (see paragraph 6 above), EFSA published a scientific opinion on the science underpinning the assessment of risks posed by plant protection products to bees (‘the EFSA Opinion’). This document identified a number of areas in which future risk assessments as regards bees should be improved. The opinion drew attention, inter alia, to several weaknesses in the EPPO Guidance, leading to uncertainties about the real exposure of honeybees, and raised issues of relevance to bee health which had not previously been addressed by the EPPO Guidance.

   9 In June 2012, in response to the Commission’s request of 22 March 2012 (see paragraph 7 above), EFSA produced a statement on the assessment of the scientific information from the Italian Apenet research project on the effects on bees of maize seeds coated with certain neonicotinoids and fipronil. In that statement, EFSA noted that, due to certain deficiencies and certain weaknesses in the Apenet project, it had not been possible for it to draw a definitive conclusion, but that a number of potential concerns had nevertheless been identified in the context of the project, suggesting that a change might be required in the assessment of some neonicotinoids and fipronil as regards their effects on bees.

   10 On 6 August 2012, the Commission asked EFSA to conduct, by 31 March 2013, a thorough risk assessment of fipronil as regards its impact on bee health, pursuant to Article 21 of Regulation No 1107/2009.

   11 On 27 May 2013, EFSA published its conclusions on the peer review of the assessment of risks posed to bees by the active substance fipronil, used as a pesticide (‘EFSA’s Conclusions’). It identified, in particular, a high acute risk to honeybees from exposure to dust drift during the sowing of maize. It was unable to rule out the existence of a similarly high risk in respect of other field crops.

   12 EFSA’s Conclusions also highlighted several issues which it had not been possible to finalise on the basis of the data available and which related, inter alia, to the exposure of honeybees via dust, from consumption of contaminated nectar and pollen, and from exposure via guttation.

   13 In the light of the issues noted by EFSA, the Commission submitted a draft implementing regulation and an opinion to the Standing Committee at its meeting on 15 and 16 July 2013. Since the draft was supported by a qualified majority of Member States, on 14 August 2013 the Commission adopted Implementing Regulation (EU) No 781/2013 amending Implementing Regulation No 540/2011, as regards the conditions of approval of the active substance fipronil, and prohibiting the use and sale of seeds treated with plant protection products containing this active substance (OJ 2013 L 219, p. 22; ‘the contested measure’).

   14 Article 1 of the contested measure restricted the use of plant protection products containing fipronil to crops in greenhouses and to seeds of leek, onions, shallots and the group of Brassica vegetables intended to be sown in fields and harvested before flowering.

   15 In addition, by Article 2, the contested measure prohibited the use and placing on the market of seeds treated with plant protection products containing fipronil, with the exception of seeds intended to be sown in greenhouses and seeds of leek, onions, shallots and the group of Brassica vegetables intended to be sown in fields and harvested before flowering.

   16 Under Article 3 of the contested measure, the Member States were required, in accordance with Regulation No 1107/2009, to amend or withdraw existing authorisations for plant protection products containing fipronil by 31 December 2013. Article 4 of the contested measure provided that any period of grace granted by Member States was required to be as short as possible and to expire on 28 February 2014 at the latest.

   17 The contested measure was published in the Official Journal of the European Union on 15 August 2013 and entered into force the following day, in accordance with Article 5 thereof, except for Article 2 which was to apply from 1 March 2014.

2. Procedure and forms of order sought

   18 BASF Agro BV and the other applicants whose names are set out in the annex (together ‘BASF’) brought the present action by application lodged at the General Court Registry on 4 November 2013.

   19 By order of the President of the First Chamber of the General Court of 9 October 2014, BASF Agro and Others v Commission (T-584/13, not published), and by order of 9 October 2014, BASF Agro and Others v Commission (T-584/13, not published, EU:T:2014:907), the European Seed Association (ESA) and the Association européenne pour la protection des cultures (European Crop Protection Association) (ECPA) were granted leave to intervene in support of the form of order sought by the applicants, and Deutscher...