Région de Bruxelles-Capitale v European Commission.

• Jurisdiction: European Union
• ECLI: ECLI:EU:C:2020:978
• Docket Number: C-352/19
• Date: 03 December 2020
• Celex Number: 62019CJ0352
• Court: Court of Justice (European Union)

Provisional text

JUDGMENT OF THE COURT (First Chamber)

3 December 2020 (*)

(Appeal – Regulation (EC) No 1107/2009 – Placing of plant protection products on the market – Implementing Regulation (EU) 2017/2324 – Renewal of the approval of the active substance glyphosate – Article 263 TFEU – Standing to bring proceedings of a regional body – Whether directly concerned)

In Case C–352/19 P,

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 1 May 2019,

Région de Bruxelles-Capitale (Belgium), represented by A. Bailleux, avocat,

appellant,

the other party to the proceedings being:

European Commission, represented by X. Lewis, F. Castillo de la Torre, I. Naglis and F. Castilla Contreras, acting as Agents,

defendant at first instance,

THE COURT (First Chamber),

composed of J.-C. Bonichot (Rapporteur), President of the Chamber, L. Bay Larsen, C. Toader, M. Safjan and N. Jääskinen, Judges,

Advocate General: M. Bobek,

Registrar: A. Calot Escobar,

having regard to the written procedure,

after hearing the Opinion of the Advocate General at the sitting on 16 July 2020,

gives the following

Judgment

1 By its appeal, the Région de Bruxelles-Capitale (the Brussels Capital Region, Belgium) asks the Court to set aside the order of the General Court of the European Union of 28 February 2019, Région de Bruxelles-Capitale v Commission (T–178/18, not published, ‘the order under appeal’, EU:T:2019:130), whereby the General Court dismissed as inadmissible its action for 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 act at issue’).

Legal context

2 Recitals 10, 23, 24 and 29 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) state:

‘(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. In order to achieve the same level of protection in all Member States, the decision on acceptability or non-acceptability of such substances should be taken at Community level on the basis of harmonised criteria. These criteria should be applied for the first approval of an active substance under this Regulation. For active substances already approved, the criteria should be applied at the time of renewal or review of their approval.

…

(23) Plant protection products containing active substances can be formulated in many ways and used on a variety of plants and plant products, under different agricultural, plant health and environmental (including climatic) conditions. Authorisations for plant protection products should therefore be granted by Member States.

(24) The provisions governing authorisation must ensure a high standard of protection. In particular, when granting authorisations of plant protection products, the objective of protecting human and animal health and the environment should take priority over the objective of improving plant production. Therefore, it should be demonstrated, before plant protection products are placed on the market, that they present a clear benefit for plant production and do not have any harmful effect on human or animal health, including that of vulnerable groups, or any unacceptable effects on the environment.

…

(29) The principle of mutual recognition is one of the means of ensuring the free movement of goods within the Community. To avoid any duplication of work, to reduce the administrative burden for industry and for Member States and to provide for more harmonised availability of plant protection products, authorisations granted by one Member State should be accepted by other Member States where agricultural, plant health and environmental (including climatic) conditions are comparable. Therefore, the Community should be divided into zones with such comparable conditions in order to facilitate such mutual recognition. However, environmental or agricultural circumstances specific to the territory of one or more Member States might require that, on application, Member States recognise or amend an authorisation issued by another Member State, or refuse to authorise the plant protection product in their territory, where justified as a result of specific environmental or agricultural circumstances or where the high level of protection of both human and animal health and the environment required by this Regulation cannot be achieved. It should also be possible to impose appropriate conditions having regard to the objectives laid down in the National Action Plan adopted in accordance with Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve a sustainable use of pesticides [(OJ 2009 L 309, p. 71)].’

3 Article 20(1) and (2) of that regulation provides:

‘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. …

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.’

4 Article 36 of that regulation provides:

‘1. The Member State examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge using guidance documents available at the time of application. It shall give all Member States in the same zone the opportunity to submit comments to be considered in the assessment.

…

2. The Member States concerned shall grant or refuse authorisations accordingly on the basis of the conclusions of the assessment of the Member State examining the application as provided for in Articles 31 and 32.

3. By way of derogation from paragraph 2 and subject to Community law, appropriate conditions may be imposed with respect to the requirements referred to in Article 31(3) and (4) and other risk mitigation measures deriving from specific conditions of use.

Where the concerns of a Member State relating to human or animal health or the environment cannot be controlled by the establishment of the national risk mitigation measures referred to in the first subparagraph, a Member State may refuse authorisation of the plant protection product in its territory if, due to its specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question still poses an unacceptable risk to human or animal health or the environment.

…’

5 Article 40 of that regulation, under the heading ‘Mutual recognition,’ provides, under the conditions set out therein, for the opportunity for the holder of an authorisation granted in accordance with Article 29 to apply for an authorisation for the same plant protection product in another Member State.

6 Article 41(1) of Regulation No 1107/2009 provides:

‘The Member State to which an application under Article 40 is submitted shall, having examined the application and the accompanying documents referred to in Article 42(1), as appropriate with regard to the circumstances in its territory, authorise the plant protection product concerned under the same conditions as the Member State examining the application, except where Article 36(3) applies.’

7 Article 43 of that regulation provides:

‘1. An authorisation shall be renewed upon application by the authorisation holder, provided that the requirements referred to in Article 29 are still met.

2. Within 3 months from the renewal of the approval of an active substance, safener or synergist contained in the plant protection product, the applicant shall submit the following information:

…

5. Member States shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the renewal of the approval of the active substance, safener or synergist contained therein.

6. Where, for reasons beyond the control of the holder of the authorisation, no decision is taken on the renewal of the authorisation before its expiry, the Member State in question shall extend the authorisation for the period necessary to complete the examination and adopt a decision on the renewal.’

8 Article 78(3) of that regulation provides that a regulation is to be adopted containing the list of active substances 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), since those substances are deemed to have been approved under that regulation.

Background to the dispute

The approval of the active substance glyphosate by the European Union

9 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) adopted the list provided for in Article 78(3) of Regulation No 1107/2009. Glyphosate appeared on that list, with an expiry date for the approval period of 31 December 2015.

10 By its Implementing Regulations (EU) 2015/1885 of 20 October 2015 amending Implementing Regulation...