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 the general requirements:
‘1. By way of derogation from Article 28, in special circumstances a Member State may authorise, for a period not exceeding 120 days, the placing on the market of plant protection products, for limited and controlled use, where such a measure appears necessary because of a danger which cannot be contained by any other reasonable means.
The Member State concerned shall immediately inform the other Member States and the Commission of the measure taken, providing detailed information about the situation and any measures taken to ensure consumer safety.
2. The Commission may ask the Authority for an opinion, or for scientific or technical assistance.
The Authority shall provide its opinion or the results of its work to the Commission within 1 month of the date of the request.
3. If necessary, a decision shall be taken, in accordance with the regulatory procedure referred to in Article 79(3), as to when and under what conditions the Member State:
(a) may or may not extend the duration of the measure or repeat it; or
(b) shall withdraw or amend its measure.
4. …’
III. Facts and request for a preliminary ruling
17. Thiamethoxam and clothianidin are insecticides in the neonicotinoid class which are used in agriculture to treat seeds. They were initially approved in the European Union. In 2018, the Commission revised the approvals for clothianidin (5) and thiamethoxam, (6) imposing very stringent restrictions due to the risks to bees. The implementing regulations revising those approvals prohibited, as of 19 December 2018, the use of plant protection products containing those active substances outside permanent greenhouses. In addition, seeds treated with those active substances may be used only in such greenhouses. As far as can be seen, those restricted approvals expired in 2019 without being replaced. (7) Therefore, plant protection products based on those active substances can no longer be approved in the European Union under the general approval procedure.
18. In autumn 2018, the État belge (Belgian State) nonetheless granted six authorisations for the use of plant protection products based on the active substances clothianidin and thiamethoxam, for the treatment of seeds of certain crops, including sugar beets, the placing on the market of those seeds and the sowing of those seeds in the field. The period of authorisation covered, in essence, the spring of 2019. Even before then, however, the products in question had been authorised and in use in Belgium for many years.
19. It is apparent from, in particular, the submissions of SESVanderHave S.A., an intervener in support of the Belgian State in the main proceedings, that the authorised use of the plant protection products serves to control aphids which transmit viruses which would damage the crops concerned, in particular sugar beets.
20. Two associations campaigning against pesticides and promoting biodiversity as well as a beekeeper (‘the applicants’) brought an action before the Conseil d’État (Council of State, Belgium). They claim that numerous scientific studies have shown that the use of such neonicotinoids entails significant risks to bees, bumblebees and other foraging insects. According to the applicants, the authorisation of the placing on the market of treated seeds and their use in the field is incompatible with EU law.
21. By contrast, the Belgian State takes the view that unacceptable risks to bees can be avoided by way of the conditions of use. It submits that, since the crops concerned are harvested before flowering, any contact between bees and the plant can be avoided. Various undertakings and representatives of the interests of the Belgian sugar beet industry and sugar producers have intervened in support of the Belgian State in the dispute.
22. In those circumstances, the Conseil d’État (Council of State) decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling:
‘(1) Is Article 53 of the Plant Protection Regulation to be interpreted as allowing a Member State to grant, in certain circumstances, an authorisation for the treatment, sale or sowing of seeds treated with plant protection products?
(2) If the answer to the first question is in the affirmative, can Article 53 of the Plant Protection Regulation be applied, in certain circumstances, to plant protection products containing active substances the marketing or use of which is restricted or prohibited in the territory of the European Union?
(3) Do the “special circumstances” required by Article 53 of the Plant Protection Regulation cover situations in which the occurrence of a danger is not certain but only plausible?
(4) Do the “special circumstances” required by Article 53 of the Plant Protection Regulation cover situations in which the occurrence of a danger is foreseeable, common and even cyclical?
(5) Is the expression “which cannot be contained by any other reasonable means”, as used in Article 53 of the Plant Protection Regulation, to be interpreted as giving equal importance, in the light of the wording of recital 8 of the regulation, on the one hand, to ensuring a high level of protection of both human and animal health and the environment and, on the other hand, to safeguarding the competitiveness of Community agriculture?’
23. The applicants, the Kingdom of Belgium and SESVanderHave S.A., an intervener in the main proceedings, as well as Finland, the French Republic, the Hellenic Republic, Hungary and the European Commission submitted written observations on those questions. The applicants, Belgium, Greece, France and the Commission participated in the hearing held on 17 March 2022.
IV. Legal assessment
24. Under Article 28(1) of the Plant Protection Regulation, a plant protection product requires authorisation by the Member State concerned. Pursuant to Article 29, that authorisation requires, inter alia, that the Commission has approved its active substances, safeners and synergists in accordance with Articles 4 to 13.
25. However, Article 53(1) of the Plant Protection Regulation allows Member States to authorise other plant protection products in emergencies.
26. The five questions referred for a preliminary ruling relate to various elements to be considered in such an emergency. I shall first address the fifth question, the answer to which makes the operation of that provision particularly clear. I shall then examine the second, the third and the fourth question and, lastly, the first question.
A. Fifth question: weighing up of interests
27. The fifth question seeks to clarify how the two objectives of recital 8, namely to ensure a high level of protection of both human and animal health and the environment, on the one hand, and to safeguard the competitiveness of Community agriculture, on the other hand, are to be weighted in the application of Article 53(1) of the Plant Protection Regulation.
28. That question is linked to the fact that an emergency authorisation under Article 53(1) of the Plant Protection Regulation is permissible only if it appears necessary because of a danger which cannot be contained by any other reasonable means. According to recital 32, in exceptional cases, Member States can authorise plant protection products 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.
29. The EU legislature has thus made the exercise of the power under Article 53(1) of the Plant Protection Regulation subject to a proportionality test.
30. According to the principle of proportionality, onerous measures are lawful only if they are appropriate and necessary in order to attain the objectives legitimately pursued. By virtue of that principle, when there is a choice between several (equally (8)) appropriate measures, recourse must be had to the least onerous measure and the disadvantages caused must not be disproportionate to the aims pursued. (9)
31. In the context of Article 53(1) of the Plant Protection Regulation, the ‘disadvantage’ does not consist in restricting the freedom or equality of holders of fundamental rights, but in reducing the scope of the protection of the environment and health which is ensured by the general provisions of that regulation. Although those objectives are set out in Articles 35 and 37 of the Charter of Fundamental Rights, and the Court, at least in relation to Article 37, has already referred to a ‘right’ within the meaning of Article 52(2) of the Charter for which provision is made in the Treaties, (10) the conditions for emergency authorisation are in fact unlikely to constitute a concrete manifestation of the limitations to fundamental rights as provided for in the second sentence of Article 52(1) of the Charter. However, in that respect also, the steps in the examination of the principle of proportionality facilitate a balancing of the conflicting interests.
32. In the application of Article 53(1) of the Plant Protection Regulation, it is first necessary to identify the danger or threat to plant production or ecosystems which is to be contained. That is the objective of the measure.
33. It must then be determined whether the use of a plant protection product to be authorised is suitable in the first place for containing such a danger.
34. If such suitability is established, it can be examined whether the authorisation of the plant protection product is necessary. In accordance with the wording of Article 53(1) of the Plant Protection Regulation, it must be examined whether the danger cannot be contained by any other reasonable means. Conceivable possibilities in that respect include, for example, other plant protection products based on active substances whose use for the relevant purposes has been approved by the Commission, the use of plant varieties that are resistant to the danger in question, or a switch of production to other products.
35. When examining different measures, it may be necessary, even at that stage, to weigh different legally protected interests against each other. In recital 32 of the Plant Protection Regulation, this is expressed by the fact that authorisation is possible only if the risk cannot be contained by any other reasonable means. Indeed, if the effectiveness of the other means is not manifestly equivalent or greater, it must be considered whether the lower degree of effectiveness is acceptable in view of the risks posed by the plant protection product to be authorised.
36. Lastly, if, on that basis, there are no other reasonable means of containing the danger, it must be considered, whether the risks associated with the plant protection product are proportionate to the objective of protecting the crops from the danger. This is because it is difficult to establish that the use of the product is ‘necessary’ within the meaning of Article 53(1) or ‘reasonable’ within the meaning of recital 32 if the risks of such use outweigh the benefits.
37. The weighing-up exercise must be carried out in the light of the precautionary principle, since, in accordance with recital 8 and Article 1(4), the provisions of the Plant Protection Regulation are, as a whole, based on that principle. (11) This presupposes, first, identification of the potentially negative consequences for health and the environment of the use of the active substances and plant protection products, (12) and, second, a comprehensive assessment of the risks based on the most reliable scientific data available and the most recent results of international research. (13)
38. In that respect, contrary to the view taken by the applicants, there can be no objection, in principle, if the applicant for emergency authorisation submits the information and expert reports required for such authorisation, this provision being also made for such an approach for the other procedures in the Plant Protection Regulation. (14)
39. However, the principle of good administration, which Member States must observe in the application of EU law, requires the competent authorities to conduct a diligent and impartial examination of all the relevant factors and to ensure that, when they adopt a decision, they have at their disposal the most complete and reliable information. (15) This means, in particular, that they must not simply accept information provided by the applicant without checking it, but must evaluate it critically and also take into account relevant information from other sources.
40. In the weighing-up exercise, the competent authorities must weigh the risks thus determined up against the benefits of the use in question, likewise identified on the basis of the best scientific evidence.
41. For the purposes of that balancing exercise, it is apparent at first glance from recital 8 of the Plant Protection Regulation that ensuring a high level of protection of both human and animal health and the environment, on the one hand, and safeguarding the competitiveness of agriculture, on the other hand, have the same level of importance, in abstract terms, in the application of that regulation and therefore, in particular, in the balancing exercise under Article 53(1). This is because both objectives are to be achieved ‘at the same time’.
42. However, recital 8 also states that the substances and products to be authorised in order to achieve those objectives must not have any harmful effect on human or animal health or any unacceptable effects on the environment. The industry, that is to say, the commercial operator making the application for authorisation in question, is required to prove that that is the case.
43. No other conclusion can be derived from recital 24 of the Plant Protection Regulation, discussed in the present proceedings. According to that recital, 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 (16) effects on the environment.
44. Moreover, the same objective of excluding harmful effects on human or animal health and unacceptable effects on the environment follows from recital 10 as well as from Article 4(2) and (3), Article 23(2), Article 27(1), Article 54(1) and Article 56(1) of the Plant Protection Regulation.
45. This shows, first, that ensuring a high level of protection of both human and animal health and the environment, on the one hand, and safeguarding the competitiveness of agriculture, on the other hand, do not have the same level of importance, in abstract terms, in the weighing-up exercise to be carried out in the application of Article 53(1) of the Plant Protection Regulation. Rather, in that weighing-up exercise also, the prevention of harmful effects on human or animal health or any unacceptable effects on the environment must, in principle, be given priority over economic considerations. This is also expressed in the heading of Article 53, in so far as it refers to emergency situations, as well as in recital 32, which limits application to exceptional cases.
46. Second, in the weighing-up exercise, significantly greater weight is attached to the prevention of harmful effects on human or animal health than to the prevention of harmful effects on the environment in the application of the Plant Protection Regulation. This is because that regulation is intended to exclude only unacceptable effects on the environment, but all harmful effects on human or animal health. Therefore, in the view of the legislature, it is also conceivable that there will be acceptable adverse consequences for the environment when authorising plant protection products.
47. Accordingly, if the use of a plant protection product is associated with harmful effects on human and animal health, an emergency authorisation under Article 53(1) of the Plant Protection Regulation may be granted only if it is necessary in order to contain particularly serious dangers. Such dangers could conceivably include, for example, real risks to the food security of the population, which are to be contained by way of the emergency authorisation. By contrast, mere economic considerations should not be sufficient.
48. However, the scope for weighing up is greater in the case of ‘merely’ adverse effects on the environment. Therefore, important economic interests may in certain circumstances outweigh minor adverse effects on the environment.
49. The distinction between the protection of animal health and the protection of the environment can be derived indirectly from the definition of ‘environment’ in Article 3(13) of the Plant Protection Regulation. In accordance with that definition, wild species of fauna, in particular, are attributable to the environment. Since certain wild species of fauna may constitute harmful organisms in accordance with Article 3(7), which are to be contained by way of plant protection products in accordance with Article 2(1)(a), for example the controlled aphids in the present case, it would also be contradictory to have to exclude any harmful effect on their health.
50. The concerns surrounding neonicotinoids relate to the effects on bees, including honeybees used in beekeeping. (17) The latter, unlike wild bees or bumblebees, are not wild species, with the result that, at least in this respect, the stronger protection objective of protecting animal health is affected.
51. The answer to the fifth question is, therefore, that the application of Article 53(1) of the Plant Protection Regulation requires a specific weighing-up exercise in the light of the precautionary principle in order to determine whether the benefits in terms of safeguarding the competitiveness of agriculture which derive from the use of the plant protection product in question outweigh the risks associated with the use of that product. If the use of a plant protection product is associated with harmful effects on human and animal health, an emergency authorisation may be granted only if it is necessary in order to contain particularly serious dangers. However, the scope for weighing up ‘merely’ adverse effects on the environment is greater.
B. Second question: active substances the placing on the market or use of which is restricted or prohibited
52. The second question seeks to clarify whether, under Article 53(1) of the Plant Protection Regulation, Member States may authorise plant protection products containing active substances the placing on the market or use of which is restricted or prohibited. Although the Conseil d’État (Council of State) raises that question only in the event that the Court answers the first question in the affirmative, it seems appropriate to discuss it independently of that question.
53. Against the background of the case in the main proceedings, that question must be clarified to the effect that it asks whether Member States may authorise plant protection products in respect of uses which run counter to the restrictions laid down by the Commission in connection with the approval of the active substances used.
54. A measure under Article 53(1) of the Plant Protection Regulation may be taken by way of derogation from Article 28. Under that provision, a plant protection product requires authorisation by the Member State concerned. According to Article 29(1)(a), such authorisation presupposes, in particular, that its active substances have been approved. That approval, in turn, is granted by the Commission in cooperation with the Standing Committee on the Food Chain and Animal Health in accordance with Articles 13 and 79.
55. It follows that Article 53(1) of the Plant Protection Regulation does in fact allow Member States to authorise plant protection products the active substances of which have not been approved by the Commission.
56. According to the applicants, however, that applies only to active substances on which the Commission has not yet taken a decision. By contrast, plant protection products containing active substances the placing on the market or use of which has been restricted or prohibited by the Commission could not be authorised by Member States under that provision. The Belgian authorisations at issue would not be consistent with this. This is because the Commission approvals of the two neonicotinoids at issue expressly prohibit the use of treated seeds outside greenhouses, whereas the Belgian authorisations specifically permit the use of treated seeds in the field.
57. The wording of Article 53(1) and Article 28 of the Plant Protection Regulation would not force the interpretation given by the applicants, but would at least allow it. The Member States’ power under Article 53(1) would be limited to non-approved active substances, whereas active substances approved by the Commission subject to restrictive conditions would not be covered. Those restrictions could not be overcome on the basis of Article 53(1).
58. That interpretation is supported by the fact that the Commission already assesses the risks of an active substance when it approves it and thereby imposes conditions and restrictions that preclude certain uses in accordance with Article 6 of the Plant Protection Regulation.
59. However, recital 32 of the Plant Protection Regulation shows that Article 53(1) is intended to extend much further. According to that recital, Member States should be permitted to authorise plant protection products not complying with the conditions provided for in the regulation. This covers not only active substances which the Commission has not approved, but also uses of approved active substances which the Commission has excluded by way of a restriction or condition of approval. (18)
60. Consequently, according to Article 53(1) of the Plant Protection Regulation, Member States are to decide whether the specific plant-protection needs existing on the ground outweigh, on an exceptional basis, the risks associated with a plant protection product which led the Commission to impose conditions or restrictions, and therefore justify an emergency authorisation.
61. It is true that, on the basis of that interpretation, Article 53(1) of the Plant Protection Regulation allows Member States to accept certain risks which led the Commission to exclude the use in question. However, Member States must consider those risks when granting emergency authorisation, because – as stated above – they must base their decision on the most complete and reliable information. (19)
62. Moreover, the risk of the Commission’s concerns being neglected is limited by the fact that Member States are subject to the supervision of the Commission when issuing an emergency authorisation. In accordance with the second subparagraph of Article 53(1) of the Plant Protection Regulation, the Member State concerned must inform the Commission and the other Member States of the measure taken. Under Article 53(2) and (3), the Commission may review the emergency authorisation and, where appropriate, restrict or even prohibit it.
63. Although the applicants argue that the Commission exercises that power of review very cautiously, this would – at least in the Commission’s view – militate, rather, against the assertion that Member States exceed their powers under Article 53(1) of the Plant Protection Regulation. Moreover, were the Commission to infringe the Plant Protection Regulation and in particular Article 53 in that respect, environmental associations could, following the most recent amendments to the Aarhus Regulation, (20) request a review in addition to, or as an alternative to, proceedings such as those in the present case and, if necessary, refer the matter to the EU Courts.
64. The answer to the second question is, therefore, that, in the application of Article 53(1) of the Plant Protection Regulation, Member States must in particular consider whether the specific plant-protection needs existing on the ground outweigh, on an exceptional basis, the risks to human or animal health or to the environment associated with a plant protection product and therefore allow the emergency authorisation of a use which the Commission prohibited when approving the active substance concerned.
C. Third and fourth questions: interpretation of the concept of ‘special circumstances’
65. The third and fourth questions relate to the fact that, according to almost all language versions of Article 53(1) of the Plant Protection Regulation, a Member State may take measures in ‘special’ circumstances where such a measure appears necessary because of a danger which cannot be contained by any other reasonable means. Only the German version uses the term ‘bestimmten’ (certain) circumstances in that respect.
66. The Conseil d’État (Council of State) seeks to ascertain whether such circumstances cover situations in which the occurrence of a danger is not certain but only plausible (third question) or in which the occurrence of a danger is foreseeable, common and even cyclical (fourth question).
1. Third question: plausibility or certainty of the danger
67. The third question seeks clarification as to the degree of likelihood of a danger required to justify an emergency authorisation under Article 53(1) of the Plant Protection Regulation.
68. That question can be explained by the fact that, at the time of use of the plant protection product for the treatment of seeds in autumn and winter, it is hardly possible to assess how great the risk of adverse effects on the crops will actually be in the cultivation period in the spring and summer of the following year. The extent to which aphids will appear and transmit the viruses concerned may not be foreseeable with certainty at the time of either seed treatment or sowing.
69. The wording of Article 53(1) of the Plant Protection Regulation and, in particular, the term ‘special circumstances’ referred to in the question, do not actually help to answer that question.
70. Although recital 32 and the title of Article 53 show that such circumstances are intended to cover only derogations or emergency situations, a danger does not have to be ‘certain’ to constitute such a case. Moreover, contrary to the view taken by the applicants, no particular urgency or imminent danger is required to presume such a case.
71. Rather, the key lies in the abovementioned function of Article 53(1) of the Plant Protection Regulation to promote a proportionate balance between conflicting interests in an emergency or in special circumstances. (21)
72. From that perspective, the averting of a merely plausible danger may also be proportionate if no other reasonable means are available. Waiting until the danger is certain would, on the other hand, possibly prevent the danger from being contained at all by means of the plant protection product in question – as various parties argue. In that case, an emergency authorisation would no longer be suitable for achieving its objective, or at least not to the same extent. A delayed emergency authorisation would then not constitute a less burdensome alternative course of action within the meaning of the necessity test. (22)
73. However, the applicants’ reference to the practice in the United Kingdom (23) shows that it may be possible to attach appropriate conditions to an emergency authorisation granted at an early stage, which increase the likelihood that the plant protection product will be used only when it is actually necessary. Although an emergency authorisation for neonicotinoids had been granted in the autumn there, further developments were monitored and the use was dispensed with in the spring, as the risk at that time appeared less serious than originally expected.
74. As a general rule, however, it is the weighing up of the respective advantages and disadvantages that is decisive: it is true that a plausible danger carries less weight than a danger existing with certainty. However, the merely plausible danger of a particularly high degree of harm may carry similar weight to a danger of a lower degree of harm which exists with certainty. Therefore, neither scenario can be included in or excluded from, in abstract terms, the application of Article 53(1) of the Plant Protection Regulation. Rather, the question as to whether a merely plausible danger is sufficient to justify an emergency authorisation depends on whether it outweighs the dangers to human and animal health and to the environment which are associated with the use of the plant protection product.
75. Moreover, the same question may arise with regard to the latter dangers, since they too may be plausible or certain. The extent to which they must be taken into account follows from the case-law on the precautionary principle. That principle justifies the adoption of restrictive measures where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the inconclusiveness of the results of studies conducted, but the likelihood of real harm to the environment persists should the risk materialise. (24) This refers to dangers which, although not certain, appear to be sufficiently documented, that is to say, there is solid and convincing evidence. (25)
76. Moreover, in order to be able to compare the dangers to human or animal health or to the environment thus determined with the danger to agriculture which the emergency authorisation is intended to contain, the same method of assessment must be applied to determine the latter as that applied to determine the former. In practice, this means that the danger to agriculture must also be assessed on the basis of the available studies and that emergency authorisation can be permitted only if there is solid and convincing evidence.
77. The answer to the third question is, therefore, that the authorisation of the use of a plant protection product under Article 53(1) of the Plant Protection Regulation does not depend on whether the occurrence of the danger to be averted is certain or plausible, but on whether the advantages of that use outweigh the associated disadvantages. In that respect, the advantages and disadvantages of the use in question, including the degree of likelihood of the danger concerned, must be sufficiently documented and therefore derived from solid and convincing evidence.
2. Fourth question: foreseeable, common and cyclical danger
78. The fourth question also concerns the danger on the basis of which the emergency authorisation is to be justified. The Conseil d’État (Council of State) seeks to ascertain whether a danger which is foreseeable, common and even cyclical is also sufficient for that purpose.
79. The background to that question is the fact that, according to the submissions of SESVanderHave in particular, the danger posed by aphids and viral diseases appears to be foreseeable and common in Belgium. Therefore, similar authorisations to avert the same dangers have been granted in the past and are also expected to be granted in the future.
80. From the mere point of view of the weighing up of the advantages and disadvantages of the use of the active substances in question, it could be concluded that it does not matter whether the danger is foreseeable, common and even cyclical. Such dangers may even outweigh the dangers associated with the use of the plant protection product in question. They could therefore constitute special circumstances within the meaning of Article 53(1) of the Plant Protection Regulation.
81. The legislative history of Article 53(1) of the Plant Protection Regulation, highlighted by the Commission, confirms that assessment at first sight. Indeed, the European Parliament Committee on the Environment, Public Health and Food Safety was unsuccessful with its proposal to make such power conditional – in a manner similar to what was previously the case under Article 8(4) and recital 18 of the previously applicable Plant Protection Directive (26) – on an unforeseeable danger or other emergency. (27)
82. On that point, however, recital 32 of the Plant Protection Regulation contains a clarification that limits the scope of the weighing-up exercise. According to that recital, the application of Article 53(1) should cover ‘exceptional cases’ only. Foreseeable or cyclical dangers may also constitute exceptional cases if they occur rarely, that is to say only exceptionally. By contrast, a common danger, that is to say one which occurs frequently, is not an exceptional case on the basis of the meaning of the word alone. Nor is it an ‘emergency situation’ as referred to in the heading of Article 53.
83. Furthermore, the restriction to rare exceptional or emergency cases is in line with the requirement of Article 53(1) of the Plant Protection Regulation to allow the use in question on a ‘limited’ basis. If, on the other hand, the use is intended to contain a common danger, it must be authorised on a virtually permanent – that is to say indefinite – basis.
84. The comparison with the Plant Protection Directive underlines the importance of the concepts of ‘exception’ and ‘emergency situation’, as they were not yet included in that directive. Their use in the Plant Protection Regulation must therefore be regarded as a deliberate restriction of the power of authorisation under Article 53.
85. The consequence of such an interpretation is not that common dangers must necessarily be accepted. If no other means are found to avert the danger even after an intensive search, the Commission must take such dangers into account when deciding on the approval of active substances and may, in application of Article 6 of the Plant Protection Regulation, designate areas where the active substances may be used to a greater extent than they are in other areas of the European Union because of the dangers that usually occur there. Article 6(h) shows that such territorially applicable restrictions on active substance authorisations are possible. If the general conditions for approval preclude this, it should at least be possible to have recourse to Article 4(7) of the Plant Protection Regulation.
86. The answer to the fourth question is, therefore, that an emergency authorisation under Article 53(1) of the Plant Protection Regulation may be granted only on an exceptional basis. A common danger, which occurs frequently, does not constitute an exceptional case and is therefore not sufficient.
D. First question: seeds treated with plant protection products
87. The first question seeks clarification as to whether Article 53(1) of the Plant Protection Regulation allows a Member State to grant, in certain circumstances, an authorisation for the treatment, sale or sowing of seeds treated with plant protection products.
88. Since Article 53(1) of the Plant Protection Regulation allows Member States to authorise the use of a plant protection product, that power includes, according to its very wording, the authorisation to treat seeds with the authorised plant protection product, because that would be a use of the product.
89. Moreover, the Plant Protection Regulation is based on the assumption that plant protection products are used in that manner, as it refers to the treatment of seeds on various occasions and even regulates the placing of treated seeds on the market in Article 49.
90. Contrary to the view taken by the applicants, the objective of Article 53(1) of the Plant Protection Regulation does not preclude an extension to the treatment of seeds, which by its nature occurs much earlier than a possible infestation with harmful organisms at a later stage. This is because, as explained above, (28) that regime is not aimed exclusively at containing imminent dangers.
91. Although the authorisation to place on the market or sow seeds treated with plant protection products is not expressly referred to in Article 53(1) of the Plant Protection Regulation, it is ultimately also indirectly a use of the plant protection product. This is because it is only through the sowing of the treated seed that the product can perform its function. Placing on the market, that is to say, distribution to farmers, is intended to make such sowing possible.
92. That outcome is also supported by the line of reasoning put forward by France and Belgium that treated seeds could themselves be regarded as plant protection products within the meaning of Article 2(1) of the Plant Protection Regulation.
93. However, the Member State must restrict both the placing on the market and the sowing to the region of its territory in which the danger to be contained occurs. This is because a more extensive use of the treated seed cannot be justified by that danger. Rather, the very wording of Article 53(1) of the Plant Protection Regulation only allows authorisation for limited and controlled use. That necessary limitation must also define the area in which the use is possible.
94. It follows, moreover, that the authorisation to place treated seed on the market under Article 53(1) of the Plant Protection Regulation does not produce the effect of the EU regime on the placing on the market of treated seeds under Article 49. This is because Article 49 allows free trade throughout the European Union in seeds treated with a plant protection product authorised under Article 28. However, this would not in fact constitute a limited and controlled use.
95. The answer to the first question is, therefore, that the emergency authorisation of a plant protection product under Article 53(1) of the Plant Protection Regulation may include the treatment of seeds with the plant protection product as well as the sale or sowing of seeds treated with the plant protection product in the area covered by the authorisation.
V. Conclusion
96. I therefore propose that the Court answer the request for a preliminary ruling as follows:
(1) The answer to the fifth question is that the application of Article 53(1) 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 requires a specific weighing-up exercise in the light of the precautionary principle in order to determine whether the benefits in terms of safeguarding the competitiveness of agriculture which derive from the use of the plant protection product in question outweigh the risks associated with the use of that product. If the use of a plant protection product is associated with harmful effects on human and animal health, an emergency authorisation may be granted only if it is necessary in order to contain particularly serious dangers. However, the scope for weighing up is greater in the case of ‘merely’ adverse effects on the environment.
(2) The answer to the second question is that, in the application of Article 53(1) of Regulation No 1107/2009, Member States must in particular consider whether the specific plant-protection needs existing on the ground outweigh, on an exceptional basis, the risks to human or animal health or to the environment associated with a plant protection product and therefore allow the emergency authorisation of a use which the Commission prohibited when approving the active substance concerned.
(3) The answer to the third question is that the emergency authorisation of the use of a plant protection product under Article 53(1) of Regulation No 1107/2009 does not depend on whether the occurrence of the danger to be averted is certain or plausible, but on whether the advantages of that use outweigh the associated disadvantages. In that respect, the advantages and disadvantages of the use in question, including the degree of likelihood of the danger concerned, must be sufficiently documented and therefore derived from solid and convincing evidence.
(4) The answer to the fourth question is that an emergency authorisation under Article 53(1) of Regulation No 1107/2009 may be granted only on an exceptional basis. A common danger, which occurs frequently, does not constitute an exceptional case and is therefore not sufficient.
(5) The answer to the first question is that the emergency authorisation of a plant protection product under Article 53(1) of Regulation No 1107/2009 may include the treatment of seeds with the plant protection product as well as the sale or sowing of seeds treated with the plant protection product in the area covered by the authorisation.