Arysta LifeScience Great Britain Ltd v European Commission.
| Jurisdiction | European Union |
| ECLI | ECLI:EU:C:2023:513 |
| Date | 22 June 2023 |
| Docket Number | C-259/22 |
| Celex Number | 62022CJ0259 |
| Court | Court of Justice (European Union) |
JUDGMENT OF THE COURT (Eighth Chamber)
22 June 2023 (*)
(Appeal – Plant protection products – Active substance – Regulation (EC) No 1107/2009 – Article 4(5) – Article 14(1) – Article 20(1) – Implementing Regulation (EU) No 844/2012 – Article 12(3) – Article 14(1) – Non-renewal of the approval of the active substance thiram for the purpose of placing it on the market – Rights of the defence – Precautionary principle – Equal treatment)
In Case C‑259/22 P,
APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 15 April 2022,
Arysta LifeScience Great Britain Ltd, established in Edinburgh (United Kingdom), represented by C. Mereu, avocat,
appellant,
the other parties to the proceedings being:
Taminco BVBA, established in Ghent (Belgium), represented by C. Mereu, avocat,
applicant at first instance,
European Commission, represented by G. Koleva and M. ter Haar, acting as Agents,
defendant at first instance,
THE COURT (Eighth Chamber),
composed of M. Safjan, President of the Chamber, N. Piçarra and M. Gavalec (Rapporteur), Judges,
Advocate General: P. Pikamäe,
Registrar: A. Calot Escobar,
having regard to the written procedure,
having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,
gives the following
Judgment
1 By its appeal, Arysta LifeScience Great Britain Ltd seeks to have set aside the judgment of the General Court of the European Union of 9 February 2022, Taminco and Arysta LifeScience Great Britain v Commission (T‑740/18, EU:T:2022:61) (‘the judgment under appeal’), by which the General Court dismissed its action for annulment of 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 regulation at issue’).
Legal context
European Union law
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) states in recitals 8, 10 and 14 thereof:
‘(8) The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and at the same time to safeguard the competitiveness of Community agriculture. Particular attention should be paid to the protection of vulnerable groups of the population, including pregnant women, infants and children. The precautionary principle should be applied and this Regulation should ensure that industry demonstrates that substances or products produced or placed on the market do not have any harmful effect on human or animal health or any unacceptable effects on the environment.
…
(10) Substances should only be included in plant protection products where it has been demonstrated that they present a clear benefit for plant production and they are not expected to have any harmful effect on human or animal health or any unacceptable effects on the environment. …
…
(14) To speed up the approval of active substances, strict deadlines should be established for the different procedural steps.’
3 Article 4 of that regulation, entitled ‘Approval criteria for active substances’, provides in paragraph 5 thereof:
‘For approval of an active substance, paragraphs 1, 2 and 3 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance.’
4 The first subparagraph of Article 7(1) of that regulation, entitled ‘Application’, provides:
‘An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to a Member State, (the rapporteur Member State), together with a summary and a complete dossier as provided for in Article 8(1) and (2) or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4.’
5 Article 13 of that regulation, entitled ‘Approval Regulation’, provides in paragraphs 2 and 4 thereof:
‘2. On the basis of the review report, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) 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)] are relevant, a Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), providing that:
(a) an active substance is approved, subject to conditions and restrictions, as referred to in Article 6, where appropriate;
(b) an active substance is not approved; or
(c) the conditions of the approval are amended.
…
4. Approved active substances shall be included in the Regulation referred to in Article 78(3) containing the list of active substances already approved. The [European] Commission shall maintain a list of approved active substances electronically available to the public.’
6 Article 14 of Regulation No 1107/2009, entitled ‘Renewal of approval’, states, in paragraph 1 thereof:
‘On application the approval of an active substance shall be renewed where it is established that the approval criteria provided for in Article 4 are satisfied.
Article 4 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance.
Such renewal of the approval may include conditions and restrictions, as referred to in Article 6.’
7 Article 15 of that regulation, entitled ‘Application for renewal’, provides in the first subparagraph of paragraph 2 thereof:
‘When applying for renewal, the applicant shall 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. The applicant shall at the same time submit a timetable of any new and ongoing studies.’
8 Article 17 of that regulation, entitled ‘Extension of approval period for the duration of the procedure’, states in the first paragraph thereof:
‘Where for reasons beyond the control of the applicant it appears that the approval is likely to expire before a decision has been taken on renewal, a decision shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), postponing the expiry of the approval period for that applicant for a period sufficient to examine the application.’
9 Under Article 20 of that regulation, entitled ‘Renewal Regulation’:
‘1. A Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), providing that:
(a) the approval of an active substance is renewed, subject to conditions and restrictions where appropriate; or
(b) the approval of an active substance is not renewed.
2. Where the reasons for not renewing the approval do not concern the protection of health or the environment, the Regulation referred to in paragraph 1 shall provide for a grace period not exceeding six months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. The grace period for the sale and distribution shall take into account the normal period of use of the plant protection product but the total grace period shall not exceed 18 months.
In the case of a withdrawal of the approval or if the approval is not renewed because of the immediate concerns for human health or animal health or the environment, the plant protection products concerned shall be withdrawn from the market immediately.
3. Article 13(4) shall apply.’
10 Article 29 of Regulation No 1107/2009, entitled ‘Requirements for the authorisation for placing on the market’, provides in paragraph (1)(a):
‘Without prejudice to Article 50 a plant protection product shall only be authorised where following the uniform principles referred to in paragraph 6 it complies with the following requirements:
(a) its active substances, safeners and synergists have been approved’.
11 Annex II to that regulation, entitled ‘Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II’, includes point 3.6 on ‘Impact on human health’, points 3.6.2 to 3.6.4 of which require the Commission to carry out a risk assessment, such as tests concerning genotoxicity, carcinogenicity or reproductive toxicity.
Implementing Regulation (EU) No 844/2012
12 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), contained an Article 12, entitled ‘Comments on the draft renewal assessment report’, paragraph 3 of which provides:
‘The [European Food Safety] Authority shall allow a period of 60 days from the date the report is made available to the public for the submission of written comments...
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