Opinion of Advocate General Kokott delivered on 8 September 2022.

• Jurisdiction: European Union
• ECLI: ECLI:EU:C:2022:650
• Date: 08 September 2022
• Celex Number: 62021CC0162
• Court: Court of Justice (European Union)

Provisional text

OPINION OF ADVOCATE GENERAL

KOKOTT

delivered on 8 September 2022 (1)

Case C‑162/21

Pesticide Action Network Europe and Others

(Request for a preliminary ruling from the Conseil d’État (Council of State, Belgium))

(Agriculture – Internal market – Protection of health – Regulation (EC) No 1107/2009 – Plant protection products – Neonicotinoids – Protection of bees – Active substances the use of which has been prohibited by the Commission in respect of certain applications – Article 53 – Approval by the Member State for placing on the market for a limited and controlled use due to a danger which cannot be contained by any other reasonable means – Proportionality – Exceptional cases)

I. Introduction

1. The Court has repeatedly addressed the use of ‘neonicotinoids’ in plant protection products. On the one hand, these active substances are particularly well suited to certain uses; on the other hand, there is reason to believe that they are harmful to bees, in particular. Therefore, the Court examined, first, a national prohibition of these active substances (2) and, subsequently, significant restrictions on their use imposed by the Commission. (3) By virtue of the present request for a preliminary ruling, the Court is called on to clarify, for the first time, the extent to which a Member State may nevertheless derogate from such restrictions by way of an ‘emergency authorisation’ in order to contain a danger to certain agricultural crops through the use of neonicotinoids.

2. The legal basis for such an emergency authorisation is Article 53(1) of the Plant Protection Regulation. (4) That provision requires a proportionality test, such that it is necessary to weigh the risks of using a plant protection product against its benefits, which is the subject of one of the questions referred. The other questions concern the possibility to treat seeds with the plant protection product and to place on the market and sow such seeds, the possibility to derogate from restrictions expressly imposed by the Commission when it approved an active substance and the requisite nature of the danger which the emergency authorisation is intended to contain. The answers to those questions make clear that certain limits must be observed in the weighing-up exercise.

II. Legal framework

3. Recital 8 of the Plant Protection Regulation describes the fundamental objectives of the regime:

‘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.’

4. Recital 24 of the Plant Protection Regulation describes the requirements for the authorisation of a plant protection product:

‘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.’

5. Recital 32 of the Plant Protection Regulation explains the emergency powers of the Member States under Article 53:

‘In exceptional cases, Member States should be permitted to authorise plant protection products not complying with the conditions provided for in this Regulation, where it is necessary to do so because of a danger or threat to plant production or ecosystems which cannot be contained by any other reasonable means. Such temporary authorisations should be reviewed at Community level.’

6. Article 2(1) of the Plant Protection Regulation contains a definition of the term ‘plant protection products’:

‘This Regulation shall apply to products, in the form in which they are supplied to the user, consisting of or containing active substances, safeners or synergists, and intended for one of the following uses:

(a) protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products;

…’

These products are referred to as “plant protection products”.’

7. The definitions of the terms ‘harmful organisms’ and ‘environment’ in Article 3 of the Plant Protection Regulation are also of interest:

‘For the purposes of this Regulation, the following definitions shall apply:

…

7. “harmful organisms” means any species, strain or biotype belonging to the animal kingdom or plant kingdom or pathogenic agent injurious to plants or plant products;

…

13. “environment” means waters (including ground, surface, transitional, coastal and marine), sediment, soil, air, land, wild species of fauna and flora, and any interrelationship between them, and any relationship with other living organisms’.

8. The approval of active substances is regulated in Subsections 1 and 2 of Section 1 of Chapter II of the Plant Protection Regulation (Articles 4 to 13).

9. Article 4 of the Plant Protection Regulation sets out the approval criteria. In particular, under Article 4(2) and (3), harmful effects on human and animal health as well as unacceptable effects on the environment are to be excluded.

10. Article 4(7) of the Plant Protection Regulation allows, under certain conditions, the approval of active substances not complying with the general requirements:

‘By way of derogation from paragraph 1, where on the basis of documented evidence included in the application an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years even if it does not satisfy the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. …

…

Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control that serious danger to plant health in their territory.

At the same time, they shall draw up a phasing out plan concerning the control of the serious danger by other means, including non-chemical methods, and shall without delay transmit that plan to the Commission.’

11. Article 6 of the Plant Protection Regulation allows for conditions and restrictions on the approval:

‘Approval may be subject to conditions and restrictions including:

…

(c) restrictions arising from the evaluation of the information referred to in Article 8 taking account of the agricultural, plant health and environmental, including climatic, conditions in question;

…

(e) manner and conditions of application;

…

(h) designation of areas where the use of plant protection products, including soil treatment products, containing the active substance may not be authorised or where the use may be authorised under specific conditions;

…

(j) any other particular conditions that result from the evaluation of information made available in the context of this Regulation.’

12. The content of an approval of active substances results from Article 13(2) of the Plant Protection Regulation:

‘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 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.’

13. Under Article 28(1) of the Plant Protection Regulation, a plant protection product requires authorisation by the Member State concerned:

‘A plant protection product shall not be placed on the market or used unless it has been authorised in the Member State concerned in accordance with this Regulation.’

14. The requirements for authorisation arise from Article 29 of the Plant Protection Regulation:

‘1. 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;

(b) …’

15. According to Article 49(1) of the Plant Protection Regulation, Member States are not to prohibit placing on the market and use of seeds treated with plant protection products authorised for that use in at least one Member State. Article 49(2) provides for the adoption of measures to address substantial concerns that treated seeds are likely to constitute a serious risk to human or animal health or to the environment.

16. Under the heading ‘Emergency situations in plant protection’, Article 53 of the Plant Protection Regulation allows Member States to authorise, on an exceptional basis, plant protection products not complying with...