62018TJ0740_RES
Case T‑740/18
Taminco BVBAandArysta LifeScience Great Britain Ltd
v
European Commission
Judgment of the General Court (Seventh Chamber), 9 February 2022
(Plant protection products – Active substance thiram – Non-renewal of approval – Regulation (EC) No 1107/2009 and Implementing Regulation (EU) No 844/2012 – Rights of the defence – Procedural irregularity – Manifest error of assessment – Competence of EFSA – Proportionality – Precautionary principle – Equal treatment)
Agriculture – Approximation of laws – Placing of plant protection products on the market – Regulation No 1107/2009 – Renewal of the approval – Discretion of the Commission – Judicial review – Scope
(European Parliament and Council Regulation No 1107/2009)
(see paragraphs 52-56, 166)
Agriculture – Approximation of laws – Placing of plant protection products on the market – Regulation No 1107/2009 – Approval of an active substance – Burden of proof on the applicant – Applicability in the context of a procedure for the renewal of an approval of an active substance
(European Parliament and Council Regulation No 1107/2009, Art. 4(1) to (3))
(see paragraphs 57, 58, 131)
Acts of institutions – Implementing Regulation refusing the renewal of the approval of thiram, prohibiting the use and sale of seeds treated with plant protection products containing thiram – Act of general application – Obligation to allow the participation of the persons affected – Absence – Express provision of the relevant legal framework – Right to be heard – Scope
(Charter of Fundamental Rights of the European Union, Art. 41; European Parliament and Council Regulation No 1107/2009; Commission Regulation No 844/2012)
(see paragraphs 68-71, 84)
Agriculture – Approximation of laws – Placing of plant protection products on the market – Regulation No 1107/2009 – Renewal of the approval – Partial withdrawal of the application for renewal – Effects
(European Parliament and Council Regulation No 1107/2009, recital 12 and Art 6)
(see paragraphs 100, 103-105)
Agriculture – Approximation of laws – Placing of plant protection products on the market – Regulation No 1107/2009 – Renewal of the approval – Obligation for the Commission to follow the conclusions of the rapporteur Member State – Absence
(European Parliament and Council Regulation No 1107/2009; Commission Regulation No 844/2012, Art. 14(1))
(see paragraph 141)
Approximation of laws – Classification, packaging and labelling of substances and mixtures – Regulation No 1272/2008 – Hazard classification for plant protection product substances – Competence of the European Food Safety Authority (EFSA) – Absence – Classification of an active substance in a particular hazard class – Relevance for the purposes of the identification and communication of the hazards of substances, in accordance with Regulation No 1272/2008, and of the identification of compliance with the approval criteria provided for by Regulation No 1107/2009
(European Parliament and Council Regulations No 1272/2008 and No 1107/2009)
(see paragraphs 152, 154)
Agriculture – Approximation of laws – Placing of plant protection products on the market – Regulation No 1107/2009 – Application of the precautionary principle – Scope – Renewal of the approval – Inclusion – Judicial review – Limits – Manifest error of assessment
(Arts 9 and 168(1) TFEU; Charter of Fundamental Rights of the European Union, Art. 35; European Parliament and Council Regulation No 1107/2009, recital 8 and Art. 1(2) and (4))
(see paragraphs 178-183, 189, 192, 193, 200)
EU law – Principles – Precautionary principle – Scope – Guidelines for applying the precautionary principle – Procedures for examining the benefits and costs of action or lack of action
(Art. 191(2) TFEU)
(see paragraphs 195, 196, 201)
Agriculture – Approximation of laws – Placing of plant protection products on the market – Regulation No 1107/2009 – Renewal of the approval – Implementation of the renewal procedure for active substances – Thiram – Other active substances subjected to a review having been treated more favourably – Breach of the principle of equal treatment – None
(European Parliament and Council Regulation No 1107/2009)
(see paragraphs 203-205)
Résumé
The active substance thiram (‘thiram’), used for fungicidal purposes on various fruits and vegetables, was first approved on 1 August 2004. (
1
) Taminco BVBA and Arysta LifeScience Great Britain Ltd (‘the applicants’), companies marketing thiram and plant protection products containing thiram, applied, in accordance with Regulation No 1107/2009, (
2
) for its renewal in 2014. (
3
) During the renewal procedure, the applicants limited their application, which initially concerned the use of thiram as a foliar spray and its use as a seed treatment, to seed treatment only.
By implementing regulation of 9 October 2018, (
4
) the European Commission refused to renew the approval of thiram and prohibited the use and sale of seeds treated with plant protection products containing thiram. In that regard, the recitals of the contested implementing regulation refer, inter alia, to the conclusions of the European Food Safety Authority (EFSA), which identified, inter alia, the existence of a high acute risk to consumers and workers from the application of thiram as a foliar spray and the existence of a high risk to birds and mammals, arising from all representative uses assessed, including seed treatment.
The applicants brought an action for annulment of the contested implementing regulation. That action was dismissed by the General Court.
This case raises two questions that are new to the Court’s case-law, concerning, first, the possible failure of the Commission to take into account the partial withdrawal of the application for renewal of the approval of an active substance and, second, the Commission’s obligation, in the application of the precautionary principle, to carry out an examination of the benefits and costs (
5
) within the framework of a procedure for renewal of such an approval.
Findings of the Court
First of all, the Court points out that the principle that it is the applicant which must prove that the conditions for approval of an active substance are satisfied, in order to obtain approval, also applies in the context of the procedure for renewal of the approval of such a substance.
With regard, in the first place, to the applicants’ complaints that they were not given the opportunity to express their views on two proposals arising from a meeting of experts within EFSA, namely the reduction of the reference value used in the assessment of the long-term risk to mammals and the proposal for a new classification of thiram as a category 2 carcinogen, (
6
) the Court observes that the contested implementing regulation constitutes an act of general application. Neither the process of drafting such an act nor those acts themselves require, under the general principles of EU law, such as the right to be heard, consulted or informed, the participation of the persons affected. In such a context, the procedural rights enjoyed by the applicants in the renewal procedure are those explicitly provided for by Regulation No 1107/2009 and by Implementing Regulation No 844/2012. In that respect, the Court finds no irregularity which could constitute a breach of the applicants’ right to be heard.
The Court considers, in the second place, the procedural irregularity relied on by the applicants, in that the Commission did not take account of the withdrawal of the application for renewal of the approval of thiram for use as a foliar spray and did not make any distinction between that use and use as a seed treatment.
In that regard, the Court points out, first of all, that Regulation No 1107/2009 does not provide for the situation in which an applicant for renewal of an approval of an active substance withdraws its application for one of the representative uses which it has previously designated. Next, it finds that the recitals of the contested implementing regulation do refer to that partial withdrawal. Finally, the Court analyses the effects of the partial withdrawal of the application for renewal of the approval of thiram. It notes that that partial withdrawal took place after the completion of the risk assessment process evidenced by the adoption of the EFSA conclusions, which raise several risks associated with the application of thiram by foliar spraying and, in particular, a high acute risk to consumers and users. The existence of those risks was not contested by the applicants in the present action. Moreover, they were real and not hypothetical, in that they concerned products already placed on the market. In those circumstances, the Court considers that a new assessment on the basis of the seed treatment alone would have had the effect of delaying the adoption of a position on the renewal of thiram.
Having regard also to the Commission’s risk management role and the fact that the contested implementing regulation is an act of general application, the Court concludes that the Commission was not required to base that regulation solely on grounds relating to the use of thiram as a seed treatment. Nor was the Commission required to carry out or have carried out a new risk assessment limited to that use.
In the third place, the Court answers in the negative whether EFSA acted ultra vires in proposing the classification of thiram as a category 2 carcinogen. It is true that EFSA is not competent to propose or decide on the classification of the hazards associated with substances incorporated in plant protection products under Regulation No 1272/2008. However, it did not make such a proposal, but merely referred in its conclusions to the unanimous opinion of the experts consulted in the renewal procedure to that effect. Moreover, such an opinion did not in itself prevent the renewal of the approval of thiram. Furthermore, although the procedures provided for in Regulations No 1272/2008 and No 1107/2009 are distinct, the question of whether an active substance is or should be classified in a particular hazard class may be relevant in the context of both procedures, namely both in relation to the identification and communication of the hazards of a substance and in relation to whether it fulfils the criteria for approval under Regulation No 1107/2009.
Finally, with regard to the application of the precautionary principle, the Court considers whether the Commission was obliged to carry out an examination of the benefits and costs in a renewal procedure. That examination is part of the process leading to the adoption of appropriate measures to prevent certain potential risks to public health, safety and the environment under the precautionary principle and is part of the stage of that process aimed at managing the risks identified. The Court concludes that the Commission was required to carry out that examination and that it did in fact fulfil that obligation. To that end, it is sufficient to note that the Commission took cognisance of the effects, positive and negative, economic and otherwise, likely to be induced by the proposed action and by the failure to act, and that it took them into account in its decision, without it being necessary for those effects to be estimated precisely, if that is not possible or would require disproportionate effort.
(
1
)	By Commission Directive 2003/81/EC of 5 September 2003 amending Council Directive 91/414/EEC to include molinate, thiram and ziram as active substances (OJ 2003 L 224, p. 29).
(
2
)	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).
(
3
)	That renewal application was submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ 2012 L 252, p. 26).
(
4
)	Commission Implementing Regulation (EU) 2018/1500 of 9 October 2018 concerning the non-renewal of approval of the active substance thiram, and prohibiting the use and sale of seeds treated with plant protection products containing thiram, 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 Commission Implementing Regulation (EU) No 540/2011 (OJ 2018 L 254, p. 1) (‘the contested implementing regulation’).
(
5
)	For the purposes of point 6.3.4 of the Communication from the Commission on the precautionary principle (COM(2000) 1 final).
(
6
)	In the light of the criteria laid down in 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).