Judgments nº T-67/18 of Tribunal General de la Unión Europea, December 19, 2019

• Resolution Date: December 19, 2019
• Issuing Organization: Tribunal General de la Unión Europea
• Decision Number: T-67/18

(Plant protection products - Active substance 8-hydroxyquinoline - Request for amendment of the conditions of approval - Procedure for harmonised classification and labelling - Right to be heard - Legitimate expectations - Manifest error of assessment)

In Case T-67/18,

Probelte, SA, established in Murcia (Spain), represented by C. Mereu and S. Saez Moreno, lawyers,

applicant,

v

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

defendant,

APPLICATION based on Article 263 TFEU seeking annulment of Commission Implementing Regulation (EU) 2017/2065 of 13 November 2017 confirming the conditions of approval of the active substance 8-hydroxyquinoline, as set out in Implementing Regulation (EU) No 540/2011 and modifying Implementing Regulation (EU) 2015/408 as regards the inclusion of the active substance 8-hydroxyquinoline in the list of candidates for substitution (OJ 2017 L 295, p. 40),

THE GENERAL COURT (Fifth Chamber),

composed of D. Gratsias (Rapporteur), President, K. Kowalik-Bańczyk and R. Frendo, Judges,

Registrar: E. Artemiou, Administrator,

having regard to the written part of the procedure and further to the hearing on 21 June 2019,

gives the following

Judgment

Background to the dispute

1 The applicant, Probelte, SA, produces and sells plant protection products made using the active substance 8-hydroxyquinoline.

2 That active substance was approved for a duration of 10 years under Commission Implementing Regulation (EU) No 993/2011 of 6 October 2011 approving the active substance 8-hydroxyquinoline, 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 2011 L 263, p. 1).

3 According to Annex I to Implementing Regulation No 993/2011, which lays down the conditions of approval of 8-hydroxyquinoline, only uses as fungicide and bactericide in greenhouses may be authorised. Those conditions are now set out in Row 18 of Part B of 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).

4 On 31 January 2014, the applicant, on the basis of Article 7 of 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), made a request for amendment of the conditions of approval of 8-hydroxyquinoline with a view to having the restriction on its use in greenhouses lifted. That request was made to the competent Spanish authority, as the Kingdom of Spain was the designated rapporteur Member State for that active substance under Annex I to 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 Council Directive 91/414/EEC and amending Regulation (EC) No 451/2000 (OJ 2002 L 224, p. 23).

5 Furthermore, in September 2014, the Kingdom of Spain submitted to the European Chemicals Agency (ECHA) a report relating to a proposal for a harmonised classification and labelling of 8-hydroxyquinoline. The proposal was introduced in accordance with Article 37 of 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). According to the conclusion set out in paragraph 4.11.6 of the report in question, 8-hydroxyquinoline was to be classified as toxic for reproduction category 2, that is to say, as a substance suspected of being toxic for human reproduction.

6 It is apparent from what is set out in paragraphs 4 and 5 above that two procedures were initiated, one for the amendment of the conditions of approval of 8-hydroxyquinoline with a view to having the restriction on its use in greenhouses lifted and the other concerning the harmonised classification and labelling of that active substance.

Procedure for harmonised classification and labelling of 8-hydroxyquinoline

7 By an opinion of 5 June 2015, issued following the public consultation during which the applicant submitted its observations, ECHA’s Risk Assessment Committee stated that it was in favour of classifying 8-hydroxyquinoline as a toxic substance for reproduction category 1B, on the basis, in particular, of a study which had shown malformation (omphalocele) in rabbits.

8 On 10 March 2016, the applicant requested the competent Spanish authority’s permission, inter alia, to carry out new studies on developmental toxicity in rabbits and to complete the observations made in a 2006 study. By letter of 14 March 2016, the competent Spanish authority acceded to that request. That authority drew the applicant’s attention, in that regard, to Article 62(1) of Regulation No 1107/2009, pursuant to which testing on vertebrate animals may be undertaken only where no other methods are available.

9 On 14 December 2016, the applicant asked ECHA for clarification on the interaction between the procedure for classification and labelling, on the one hand, and the procedure for amendment of the conditions of approval of 8-hydroxyquinoline, on the other. The applicant also asked ECHA to set out for it the procedure to be followed for the purposes of triggering a new assessment by ECHA’s Risk Assessment Committee, in the light of the new studies which, at that stage, had not yet been completed.

10 On 9 January 2017, ECHA informed the applicant that the European Commission had already taken a decision, not yet published, on the harmonised classification and labelling of 8-hydroxyquinoline and that, therefore, a new request for harmonised classification had to be introduced by the competent Spanish authority, in accordance with Article 37 of Regulation No 1272/2008, in order that the classification of the substance as a toxic substance for reproduction category 1B could be re-examined by ECHA’s Risk Assessment Committee.

11 On 20 January 2017, the applicant requested the competent Spanish authority to propose to ECHA the amendment of the harmonised classification and labelling of 8-hydroxyquinoline. On 4 April 2017, that authority asked the applicant to inform it of the date on which the final results of the studies, referred to in paragraph 8 above, would be available. On 19 May 2017, the applicant replied that the new classification proposal file and the final results in question would be available at the end of May 2017.

12 On 4 May 2017, the Commission adopted Regulation (EU) 2017/776 amending, for the purposes of its adaptation to technical and scientific progress, Regulation No 1272/2008 (OJ 2017 L 116, p. 1). Under Article 1 of that regulation, Annex VI to Regulation No 1272/2008 was amended to include, inter alia, 8-hydroxyquinoline in the harmonised classification and labelling table. It is clear from that inclusion that 8-hydroxyquinoline is now classified, inter alia, as toxic for reproduction category 1B.

13 On 31 May 2017, the applicant sent to the Commission the documentation relating to the studies referred to in paragraph 8 above, forwarded on the same day to the competent Spanish authority for the purposes of reopening the harmonised classification and labelling procedure.

14 By letter of 28 September 2017, the competent Spanish authority explained to the applicant the reasons why it considered that the evidence from the studies in question was not sufficient to call into question the harmonised classification and labelling in force and that they therefore did not justify a new proposal in that regard.

Procedure for amendment of the conditions of approval of 8-hydroxyquinoline

15 In the meantime, following the applicant’s request for amendment of the conditions of approval of 8-hydroxyquinoline, referred to in paragraph 4 above, the competent Spanish authority proposed to the European Food Safety Authority (EFSA), in accordance with Article 11 of Regulation No 1107/2009, the amendment of the conditions of approval of that active substance so that its outdoor use would be permitted from then onwards. To that end, the competent Spanish authority submitted to EFSA, on 25 March 2015, an addendum to the initial draft assessment report, which had served as the basis for the initial approval of that active substance.

16 EFSA sent the addendum to the Member States and to the applicant, and also made it publicly available, setting a period of 60 days for the submission of written observations.

17 By document dated 9 June 2015, the applicant submitted its observations on the addendum to the draft assessment report.

18 On 4 September 2015, EFSA asked the applicant to provide additional information within 90 days, in accordance with Article 12(3) of Regulation No 1107/2009. The applicant acceded to that request by letter of 3 December 2015.

19 On 2 May 2016, EFSA sent to the applicant its conclusions on the request for amendment of the conditions of approval of 8-hydroxyquinoline and requested the applicant to indicate any confidential information that should not be disclosed to the public. On 24 June 2016, the applicant shared its observations on those conclusions. In its conclusions, EFSA set out the assessment by ECHA’s Risk Assessment Committee, according to which 8-hydroxyquinoline was to be classified as a toxic substance for reproduction category 1B (see paragraph 7 above). In addition, EFSA pointed out that 8-hydroxyquinoline has endocrine-disrupting properties, within the meaning of point 3.6.5 of Annex II to Regulation No...