1 This request for a preliminary ruling concerns the interpretation of Article 53 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).
2 The request has been made in proceedings between, on the one hand, two anti-pesticide associations promoting biodiversity, Pesticide Action Network Europe ASBL and Nature et Progrès Belgique ASBL, and an apiarist, TN, and, on the other hand, the État Belge (Belgian State), represented by the ministre des Classes moyennes, des Indépendants, des PME, de l’Agriculture et de l’Intégration sociale, chargé des Grandes villes (Minister for Small Businesses, the Self-Employed, SMEs, Agriculture and Social Integration, with responsibility for the Large Cities), concerning national decisions authorising first, the placing on the market of plant protection products based on active substances that are prohibited in the European Union for seed treatment and, secondly, the sale and sowing of seeds treated with those products.
3 Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the use of pesticides (OJ 2009 L 309, p. 71) provides in Article 14(1): ‘Member States shall take all necessary measures to promote low pesticide-input pest management, giving wherever possible priority to non-chemical methods, so that professional users of pesticides switch to practices and products with the lowest risk to human health and the environment among those available for the same pest problem. Low pesticide-input pest management includes integrated pest management as well as organic farming …’
4 Recitals 8, 24, 32 and 33 of Regulation No 1107/2009 are worded as follows: ‘(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. … 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. … (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. … (32) 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. (33) Community seeds legislation provides for free movement of seeds within the Community but does not contain a specific provision concerning seeds treated with plant protection products. Such a provision should therefore be included in this Regulation. If treated seeds constitute a serious risk to human or animal health or to the environment, Member States should have the possibility of taking protective measures.’
5 Article 1(3) and (4) of that regulation provides: ‘3. The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production. 4. The provisions of this Regulation are underpinned by the precautionary principle in order to ensure that active substances or products placed on the market do not adversely affect human or animal health or the environment. …’
6 Article 2(1) of that regulation provides: ‘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 Article 3(5), (9), (10) and (17) of that regulation states: ‘For the purposes of this Regulation, the following definitions shall apply: … (5) “plants” means live plants and live parts of plants, including fresh fruit, vegetables and seeds; … (9) “placing on the market” means the holding for the purpose of sale within the Community, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves, but not the return to the previous seller. Release for free circulation into the territory of the Community shall constitute placing on the market for the purposes of this Regulation; (10) “authorisation of a plant protection product” means an administrative act by which the competent authority of a Member State authorises the placing on the market of a plant protection product in its territory; … (17) … For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment the zone means all zones defined in Annex I’.
8 Article 28 of Regulation No 1107/2009, headed ‘Authorisation for placing on the market and use’, provides in paragraph 1: ‘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.’
9 Article 29 of that regulation, headed ‘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’.
10 Under the heading ‘Application for authorisation or amendment of an authorisation’, Article 33 of that regulation refers, in paragraph 2(b), to seed treatment.
11 Article 40 of that regulation, relating to the mutual recognition of authorisations, refers, in paragraph 1(c), to seed treatment.
12 As set out in Article 49 of Regulation No 1107/2009, headed ‘Placing on the market of treated seeds’: ‘1. Member States shall not prohibit placing on the market and use of seeds treated with plant protection products authorised for that use in at least one Member State. 2. Where there are substantial concerns that treated seeds as referred to in paragraph 1 are likely to constitute a serious risk to human or animal health or to the environment and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, measures to restrict or prohibit the use and/or sale of such treated seeds shall be taken immediately in accordance with the regulatory procedure referred to in Article 79(3). Before taking such measures the [European] Commission shall examine the evidence and may request an opinion from the [European Food Safety] Authority [(EFSA)]. The Commission may set a time limit within which such an opinion shall be provided. 3. Articles 70 and 71 shall apply. 4. Without prejudice to other Community legislation concerning the labelling of seeds, the label and documents accompanying the treated seeds shall include the name of the plant protection product with which the seeds were treated, the name(s) of the active substance(s) in that product, standard phrases for safety precautions … and risk mitigation measures set out in the authorisation for that product where appropriate.’
13 Article 53 of that regulation, headed ‘Emergency situations in plant protection’, is worded as follows: ‘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. … 4. Paragraphs 1 to 3 shall not apply to plant protection products containing or consisting of genetically modified organisms, unless such release has been accepted in accordance with Directive 2001/18/EC [of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ 2001 L 106, p. 1)].’
14 Article 66(1) of that regulation states that the words ‘plant protection products’ may be replaced by a more precise description of the product type, such as, inter alia, ‘insecticide’.
15 Recitals 6, 11 and 13 of Commission Implementing Regulation (EU) 2018/784 of 29 May 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance clothianidin (OJ 2018 L 132, p. 35) state: ‘(6) The Commission consulted the [EFSA] which presented its conclusion on the risk assessment of clothianidin on 13 October 2016. … The [EFSA] identified for most crops high acute risks for bees from plant protection products containing the active substance clothianidin. In particular, as regards exposure via dust, the [EFSA] identified high acute risks for bees for winter cereals and high chronic risks to bees cannot be excluded for sugar beets. For the consumption of residues in contaminated pollen and nectar, high acute and chronic risks were identified or a high risk cannot be excluded for most field uses. Chronic and acute risks to bees were also identified in the succeeding crops for all field uses. For forestry nursery, no data was provided by the applicants and risks to bees can therefore not be excluded. Furthermore the [EFSA] identified a number of data gaps. (11) … Bearing in mind the need to ensure a level of safety and protection consistent with the high level of protection of animal health that is sought within the [European] Union, it is appropriate to prohibit all outdoor uses. Therefore, it is appropriate to limit the use of clothianidin to permanent greenhouses and to require that the resulting crop stays its entire life cycle within a permanent greenhouse, so that it is not replanted outside. … (13) Taking into account the risks for bees from treated seeds, the placing on the market and the use of seeds treated with plant protection products containing clothianidin should be subject to the same restrictions as the use of clothianidin. It is therefore appropriate to provide that seeds treated with plant protection products containing clothianidin shall not be placed on the market or used, except where the seeds are intended to be used only in permanent greenhouses and the resulting crop stays within a permanent greenhouse during its entire life cycle.’
16 As set out in Article 2 of that implementing regulation, headed ‘Prohibition of the placing on the market and use of treated seeds’: ‘Seeds treated with plant protection products containing clothianidin shall not be placed on the market or used, except where: (a) the seeds are intended to be used only in permanent greenhouses, and (b) the resulting crop stays within a permanent greenhouse during its entire life cycle.’
17 Recitals 11 and 13 and Article 2 of Commission Implementing Regulation (EU) 2018/785 of 29 May 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance thiamethoxam (OJ 2018 L 132, p. 40) are in identical terms to recitals 11 and 13 and Article 2 of Implementing Regulation 2018/784, with the exception of the reference to the active substance thiamethoxam instead of the reference to the active substance clothianidin in the latter provisions.
18 As is apparent from the order for reference, clothianidin and thiamethoxam are active substances in the neonicotinoids family, used as insecticides in agriculture for the purpose of seed coating.
19 Approved by the Commission in 1991, those substances, due to the risks to bees and bearing in mind the need to ensure a level of safety and protection consistent with the high level of protection of animal health that is sought within the European Union, have been subject to restrictions since 2013, first by Commission Implementing Regulation (EU) No 485/2013 of 24 May 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances clothianidin, thiamethoxam and imidacloprid, and prohibiting the use and sale of seeds treated with plant protection products containing those active substances (OJ 2013 L 139, p. 12), and subsequently by Implementing Regulations 2018/784 and 2018/785. The latter implementing regulations provide, inter alia, for a prohibition of the placing on the market and use of seeds treated with the active substances clothianidin and thiamethoxam, except for the purposes of crops that stay their entire life cycle in permanent greenhouses, so that the resulting crop is not replanted outside.
20 It is apparent from the file before the Court that the approval of clothianidin expired on 31 January 2019 and the approval of thiamethoxam expired on 30 April 2019, since the applicants withdrew their respective applications for renewal of the approval of those active substances, with the result that their use is now prohibited in the European Union.
21 On 19 October 2018, the Belgian authorities, relying on the temporary derogation regime provided for in Article 53(1) of Regulation No 1107/2009, temporarily authorised the placing on the market of plant protection products containing clothianidin (‘Poncho Beta’ produced by Bayer AG) and thiamethoxam (‘Cruiser 600 FS’ produced by Syngenta) for the treatment of sugar beet seeds.
22 By letters of 7 December 2018, four other temporary authorisations for the placing on the market of plant protection products containing those active substances were granted for the sowing of seeds treated with those products, namely sugar beet, carrot, lettuce, endive, radicchio rosso and sugarloaf seeds.
23 On 21 January 2019, the applicants in the main proceedings brought an action before the referring court for the suspension and annulment of those authorisations.
24 The applicants in the main proceedings argue, in essence, that neonicotinoids have begun to be used increasingly through the seed coating technique in that, instead of being sprayed on crops, they are preventively applied to seeds before sowing. Farmers thus buy seeds which have already been treated with plant protection products containing those active substances, regardless of whether the presence of insects which those products are intended to eliminate is proven.
25 According to the applicants in the main proceedings, both the European Parliament and the Commission have expressed concerns as to the increasing use of the derogation provided for in Article 53(1) of Regulation No 1107/2009 by Member States, which wrongfully grant emergency authorisations for several years in a row without any proven danger to crops with the aim of regulating the growth of plants or facilitating their harvest or storage. In the light of new scientific data on the toxic effects of clothianidin and thiamethoxam on bees, the Commission prohibited the sale and outdoor use of seeds coated with plant protection products containing those active substances.
26 Before the referring court, the ministre des Classes moyennes, des Indépendants, des PME, de l’Agriculture et de l’Intégration sociale, chargé des Grandes villes submits, inter alia, that the applicants in the main proceedings have not demonstrated the relevance of the data on which they rely and have not, moreover, adduced any evidence justifying the prohibition of the use of those products under the conditions laid down by the authorisations at issue.
27 The referring court expresses doubts as to the scope of Article 53 of Regulation No 1107/2009 and the scope of the derogation for which it provides.
28 In those circumstances, the Conseil d’État (Belgium) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling: ‘(1) Is Article 53 of Regulation [No 1107/2009] 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 [Regulation No 1107/2009] 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 … Union? (3) Do the “special circumstances” required by Article 53 of [Regulation No 1107/2009] 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 [Regulation No 1107/2009] 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 [Regulation No 1107/2009] to be interpreted as giving equal importance, in the light of the wording of recital 8 of [that] 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?’
29 By its first and second questions, which it is appropriate to consider together, the referring court asks, in essence, whether Article 53(1) of Regulation No 1107/2009 must be interpreted as permitting a Member State, subject to compliance with the conditions laid down in that provision, to authorise the placing on the market of plant protection products for the treatment of seeds and the placing on the market and use of seeds treated with those products, even though the placing on the market and use of seeds treated with those products have been expressly prohibited by an implementing regulation.
30 It should be recalled, as stated in paragraphs 19 and 20 above, that the placing on the market and outdoor use of seeds treated with plant protection products containing, inter alia, the active substances clothianidin and thiamethoxam, which are the subject of the authorisations at issue in the main proceedings, were prohibited by Implementing Regulation 2018/784 and Implementing Regulation 2018/785, respectively.
31 More specifically, those implementing regulations provide, in Article 2, that seeds treated with plant protection products containing those active substances are not to be placed on the market or used, except where the seeds are intended to be used only in permanent greenhouses, and the resulting crop stays within a permanent greenhouse during its life cycle.
32 Such a restriction of the use of those active substances to permanent greenhouses, the effect of which is that the resulting crop may not be replanted outside, is justified, as is reflected in recitals 11 and 13 of those implementing regulations, by the risks to bees posed by seeds treated with plant protection products containing those active substances and by the need to ensure a level of safety and protection consistent with the high level of protection of animal health that is sought within the European Union.
33 The referring court’s questions thus relate to the ability to authorise the placing on the market of plant protection products for seed treatment and the placing on the market and use of seeds treated with those products by derogating from an express prohibition, adopted on the basis of Article 49(2) of Regulation No 1107/2009.
34 It should be noted at the outset that Article 53(1) of Regulation No 1107/2009 constitutes a derogation from the general rule laid down in Article 28(1) of that regulation pursuant to which a plant protection product may not be placed on the market or used unless it has been authorised in the Member State concerned in accordance with that regulation. Pursuant to established case-law, as this is a derogation, it must be interpreted strictly (see, to that effect, judgment of 4 March 2021, Agrimotion, C‑912/19, EU:C:2021:173, paragraph 28).
35 Furthermore, it should be borne in mind that, in accordance with settled case-law, for the purpose of interpreting a provision of EU law, it is necessary to consider not only its wording but also the context in which it occurs and the objectives pursued by the rules of which it is part (judgment of 25 July 2018, Confédération paysanne and Others, C‑528/16, EU:C:2018:583, paragraph 42 and the case-law cited).
36 As regards, first of all, the wording of Article 53(1) of Regulation No 1107/2009, it is clear from that wording that that provision applies ‘by way of derogation from Article 28’ of that regulation.
37 In that regard, it should be noted that Article 28(1) of that regulation states that a plant protection product may not be placed on the market or used unless it has been authorised in the Member State concerned in accordance with that regulation, and Article 28(2) of that regulation lists the cases in which no authorisation is required.
38 Pursuant to Article 29(1)(a) of Regulation No 1107/2009, the authorisation of a plant protection product, referred to in Article 28(1) of that regulation, is subject, inter alia, to the approval of its active substances.
39 It follows that Article 53(1) of Regulation No 1107/2009 permits Member States to authorise, subject to compliance with the conditions laid down in that provision, the placing on the market of plant protection products containing substances which are not covered by an approval regulation. In contrast, the wording of that provision does not support the conclusion that Member States may thus derogate from EU rules that are expressly intended to prohibit the placing on the market and use of seeds treated with plant protection products.
40 In that regard, it should be noted that, in accordance with recital 33 of Regulation No 1107/2009, the EU legislature dedicated a ‘specific provision’ of that regulation to seeds treated with plant protection products, namely Article 49 thereof. Under Article 49(2), where there are substantial concerns that seeds treated with plant protection products authorised for that use in a Member State are likely to present a serious risk to human or animal health or to the environment and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, measures to restrict or prohibit the use and/or sale of such treated seeds are to be taken immediately.
41 Measures adopted under Article 49 of Regulation No 1107/2009 are therefore specific measures concerning seeds treated with plant protection products. It is not apparent from the wording of Article 53(1) of Regulation No 1107/2009 that it derogates from Article 49(2) of that regulation or from measures adopted pursuant to Article 49(2), since Article 53(1) refers only to Article 28 of that regulation.
42 As regards, next, the context of Article 53(1) of Regulation No 1107/2009, it should be noted that the EU legislature referred, in recital 32 of that regulation, to the ability of Member States to authorise, in exceptional cases, plant protection products not complying with the conditions provided for in that regulation.
43 Although it is apparent from that recital that the legislature intended to permit Member States to authorise plant protection products, or, in the present case, seeds treated with such products, without complying with the conditions laid down by that regulation, that recital makes no reference to the legislature’s intention to permit Member States to derogate from an express prohibition of such seeds.
44 In addition, it should be noted that the interpretation of Article 53(1) of Regulation No 1107/2009 in paragraph 39 above is supported by the obligation on the Member States, under Article 14(1) of Directive 2009/128, to take all necessary measures to promote low pesticide-input pest management, giving wherever possible priority to non-chemical methods, so that professional users of pesticides switch to practices and products with the lowest risk to human health and the environment among those available for the same pest problem.
45 Lastly, it should be noted that the prohibitory measures laid down by Implementing Regulations 2018/784 and 2018/785 were adopted bearing in mind the need to ensure a level of safety and protection consistent with the high level of protection of animal health that is sought within the European Union, as stated in recital 11 of those implementing regulations.
46 Such prohibitions thus meet the objective of Regulation No 1107/2009 which is, as stated in Article 1(3) and (4) of that regulation and reflected in recital 8 thereof, in particular to ensure a high level of protection of human and animal health and the environment.
47 In that regard, it should be borne in mind that those provisions are based on the precautionary principle, which is one of the bases of the policy of a high level of protection pursued by the European Union in the field of the environment, in accordance with the first subparagraph of Article 191(2) TFEU, in order to prevent active substances or products placed on the market from harming human or animal health or the environment.
48 Furthermore, it is clear, as stated in recital 24 of Regulation No 1107/2009, that the provisions governing authorisations must ensure a high standard of protection and that, 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 (see, by analogy, judgment of 5 May 2022, R. en R. (Agricultural use of an unauthorised product), C‑189/21, EU:C:2022:360, paragraphs 42 and 43).
49 Consequently, as stated in that recital, it should be demonstrated, before they are placed on the market, not only that plant protection products present a clear benefit for plant production but also that they do not have any harmful effect on human or animal health.
50 If Article 53(1) of Regulation No 1107/2009 were to be interpreted as authorising the placing on the market and use of seeds treated with plant protection products, even though that placing on the market and use have been expressly prohibited following evaluation by the European Food Safety Authority (‘the Authority’), such an interpretation would, first, run counter to the objective of that regulation, as set out in paragraphs 46 and 47 above. Secondly, that interpretation would give priority to improving plant production over the prevention of risks to human and animal health and the environment which the use of seeds treated with plant protection products - the harmfulness of which has been proved - could entail, contrary to the considerations set out in paragraph 48 above.
51 In that regard, it should be pointed out that prohibitory measures such as those laid down by Implementing Regulations 2018/784 and 2018/785 are taken by the Commission in compliance with strict conditions since seeds treated with such plant protection products are capable of posing a serious risk to the environment and to human or animal health.
52 As stated in recital 6 of Implementing Regulation 2018/784, the European Food Safety Authority identified for most crops high acute and chronic risks for bees from the use of plant protection products containing the active substance clothianidin, in particular from exposure via dust and the consumption of residues in contaminated pollen and nectar. Recital 13 of Implementing Regulation 2018/785 also highlights the risks to bees from seeds treated with plant protection products containing thiamethoxam.
53 It should also be added that the interpretation of Article 53(1) of Regulation No 1107/2009 that has been adopted applies not only to the placing on the market and use of seeds treated with plant protection products which have been expressly prohibited by implementing regulations, in the present case for the sowing of such seeds, but also applies to the placing on the market of those plant protection products for the treatment of such seeds.
54 In the light of all the foregoing considerations, the answer to the first and second questions is that Article 53(1) of Regulation No 1107/2009 must be interpreted as not permitting a Member State to authorise the placing on the market of plant protection products for seed treatment, or the placing on the market and use of seeds treated with those products, where the placing on the market and use of seeds treated with those products have been expressly prohibited by an implementing regulation.
55 In the light of the reply given to the first and second questions, there is no need to reply to the third to fifth questions.
56 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.