Orders nº T-125/18 of Tribunal General de la Unión Europea, February 14, 2019

• Resolution Date: February 14, 2019
• Issuing Organization: Tribunal General de la Unión Europea
• Decision Number: T-125/18

(Actions for annulment - Plant-protection products - Substance active ‘glyphosate’ - Renewal of inclusion in the annex to Implementing Regulation (EU) No 540/2011 - Act not of individual concern - Regulatory act entailing implementing measures - Inadmissibility)

In Case T-125/18,

Associazione Nazionale Granosalus - Liberi Cerealicoltori & Consumatori (Associazione GranoSalus), established in Foggia (Italy), represented by G. Dalfino, lawyer,

applicant,

v

European Commission, represented by F. Castillo de la Torre, D. Bianchi, G. Koleva and I. Naglis, acting as Agents,

defendant,

APPLICATION pursuant to Article 263 TFEU seeking the annulment of Commission Implementing Regulation (EU) 2017/2324 of 12 December 2017 renewing the approval of the active substance glyphosate 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 the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ 2017 L 333, p. 10),

THE GENERAL COURT (First Chamber),

composed of I. Pelikánová, President, P. Nihoul (Rapporteur) and J. Svenningsen, Judges,

Registrar: E. Coulon,

makes the following

Order

Background to the dispute

1 Glyphosate is an active substance used, in particular, as a herbicide.

2 Glyphosate was ‘approved’ for the use referred to in paragraph 1 above for the first time in the European Union by its inclusion on the list of active substances 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).

3 Glyphosate was added to the end of the table in Annex I to Directive 91/414 by Commission Directive 2001/99/EC of 20 November 2001 amending Annex I to Directive 91/414 to include glyphosate and thifensulfuron-methyl as active substances (OJ 2001 L 304, p. 14).

4 Pursuant to Directive 2001/99, the glyphosate was ‘approved’ as an active substance from 1 July 2002 to 30 June 2012.

5 Article 5(5) of Directive 91/414 provided that the inclusion of an active substance could be renewed, upon request, provided an application was made at the latest two years before the inclusion period was due to lapse.

6 The European Commission received a renewal request for glyphosate within the period prescribed.

7 However, it appeared that the detailed rules concerning the submission and evaluation of further information necessary for the renewal of active substances had yet to be adopted.

8 The inclusion of glyphosate was therefore extended until 31 December 2015 by Commission Directive 2010/77/EU of 10 November 2010 amending Directive 91/414 as regards the expiry dates for inclusion in Annex I of certain active substances (OJ 2010 L 293, p. 48).

9 Subsequently, Directive 91/414 was replaced with effect from 14 June 2011 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).

10 The active substances deemed to have been approved under Regulation No 1107/2009 are listed in 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).

11 Glyphosate is on the list in the annex to Implementing Regulation No 540/2011. The expiry date of the approval period for that active substance was fixed at 31 December 2015.

12 On 20 December 2013, the Federal Republic of Germany, as the rapporteur Member State, submitted, in collaboration with the Slovak Republic as the co-rapporteur Member State, the renewal assessment report for the renewal of the approval of glyphosate.

13 The European Food Safety Authority (EFSA) sent the renewal assessment report to the applicant and to the Member States for their comments. It forwarded the comments received to the Commission and made the supplementary summary dossier available to the public.

14 On 20 March 2015, the International Agency for Research on Cancer (IARC) published its findings concerning the carcinogenicity of glyphosate. On the basis of those findings it was classified on the list of substances probably carcinogenic to humans.

15 On 29 April 2015, the Commission mandated the Authority to review the information in the IARC’s findings on glyphosate’s carcinogenic potential and to include those findings in its conclusion by 30 October 2015.

16 In the meantime, the Commission extended the period of the validity of the approval of glyphosate until 30 June 2016 by its Implementing Regulation (EU) 2015/1885 of 20 October 2015 amending Implementing Regulation No 540/2011 as regards the extension of the approval periods of the active substances 2,4-D, acibenzolar-s-methyl, amitrole, bentazone, cyhalofop butyl, diquat, esfenvalerate, famoxadone, flumioxazine, DPX KE 459 (flupyrsulfuron-methyl), glyphosate, iprovalicarb, isoproturon, lambda-cyhalothrin, metalaxyl-M, metsulfuron methyl, picolinafen, prosulfuron, pymetrozine, pyraflufen-ethyl, thiabendazole, thifensulfuron-methyl and triasulfuron (OJ 2015 L 276, p. 48).

17 Implementing Regulation 2015/1885 was based on Article 17, first paragraph, of Regulation No 1107/2009, which provides that the Commission may postpone the expiry of the approval period of an active substance if it appears that the approval is likely to expire before a decision has been taken on renewal, for reasons beyond the control of the applicant.

18 On 30 October 2015, the EFSA sent its conclusion on whether glyphosate could be expected to meet the approval criteria provided for in Article 4 of Regulation No 1107/2009.

19 In its findings, the EFSA stated that ‘glyphosate is unlikely to pose a carcinogenic hazard to humans and the evidence [did] not support classification [of that active substance] with regard to its carcinogenic potential according to 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)]’.

20 The Commission presented the draft review report to the Standing Committee on Plants, Animals, Food and Feed on 28 May 2015. The applicant was given an opportunity to comment.

21 At the Standing Committee on Plants, Animals, Food and Feed several Member States deemed it appropriate to seek the opinion of another body, namely the Committee for Risk Assessment of the European Chemicals Agency (ECHA) on the harmonised classification of glyphosate with regard to its carcenogenic potential, before taking a decision on the new approval.

22 Taking account of the time necessary for the Committee for Risk Assessment of the ECHA to adopt an opinion, the approval period for glyphosate was extended a third time, this time until 15 December 2017, by Commission Implementing Regulation (EU) 2016/1056 of 29 June 2016 amending Implementing Regulation No 540/2011 as regards the extension of the approval period of the active substance glyphosate (OJ 2016 L 173, p. 52).

23 The Committee for Risk Assessment of the ECHA forwarded its opinion to the Commission on 15 June 2017. In its opinion, it concluded by consensus that, on the basis of the information currently available, no hazard classification for...