Provisional text
JUDGMENT OF THE COURT (Third Chamber)
25 April 2024 (*)
(Reference for a preliminary ruling – Approximation of laws – Regulation (EC) No 1107/2009 – Authorisation for placing plant protection products on the market – Examination for authorisation – Article 4 – Article 29 – Conditions – No harmful effect – Criteria – Endocrine disrupting properties – Regulation (EU) 2018/605 – Precautionary principle – Current scientific and technical knowledge)
In Joined Cases C‑309/22 and C‑310/22,
REQUESTS for a preliminary ruling under Article 267 TFEU from the College van Beroep voor het bedrijfsleven (Administrative Court of Appeal for Trade and Industry, Netherlands), made by decisions of 3 May 2022, received at the Court on 11 May 2022, in the proceedings
Pesticide Action Network Europe (PAN Europe)
v
College voor de toelating van gewasbeschermingsmiddelen en biociden
intervening parties:
Adama Registrations BV (Adama) (C‑309/22),
BASF Nederland BV (C‑310/22),
THE COURT (Third Chamber),
composed of K. Jürimäe, President of the Chamber, N. Piçarra and M. Gavalec (Rapporteur), Judges,
Advocate General: L. Medina,
Registrar: A. Calot Escobar,
having regard to the written procedure,
after considering the observations submitted on behalf of:
– Pesticide Action Network Europe (PAN Europe), by H. Muilerman and G. Simon, experts, and by M.R.J. Baneke, advocaat,
– Adama Registrations BV (Adama), by E. Broeren and A. Freriks, advocaten,
– BASF Nederland BV, by E. Broeren and A. Freriks, advocaten,
– the Netherlands Government, by M.K. Bulterman and J.M. Hoogveld, acting as Agents,
– the Czech Government, by S. Šindelková, M. Smolek and J. Vláčil, acting as Agents,
– the Greek Government, by K. Konsta, E.-E. Krompa, E. Leftheriotou and M. Tassopoulou, acting as Agents,
– the European Commission, by A.C. Becker and M. ter Haar, acting as Agents,
after hearing the Opinion of the Advocate General at the sitting on 28 September 2023,
gives the following
Judgment
1 These requests for a preliminary ruling concern the interpretation of Article 4(1) and (3) and of Article 29(1)(a) and (e) 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 79/711/EEC and 91/414/EEC (OJ 2009 L 309, p. 1), as amended by Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ 2018 L 101, p. 33, and corrigendum OJ 2018 L 111, p. 10) (‘Regulation No 1107/2009’), read in conjunction with point 3.6.5 of Annex II to that regulation, and the interpretation of Article 47 of the Charter of Fundamental Rights of the European Union and of Article 2 of Regulation 2018/605.
2 The requests have been made in proceedings between Pesticide Action Network Europe (PAN Europe) (‘PAN Europe’) and the College voor de toelating van gewasbeschermingsmiddelen en biociden (Plant Protection Products and Biocides Approval Board, Netherlands) (‘the CTGB’) concerning the rejection, by the latter, of (i) PAN Europe’s objection against the decision of the CTGB to authorise the placing on the Netherlands market of the plant protection product Pitcher, which contains the active substance fludioxonil, and (ii) PAN Europe’s objection to the decision of the CTGB to authorise the placing on the Netherlands market of the plant protection product Dagonis, which contains the active substance difenoconazole.
Legal context
Regulation No 1107/2009
3 Recitals 8, 24 and 29 of Regulation No 1107/2009 state:
‘(8) The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and at the same time to safeguard the competitiveness of Community agriculture. Particular attention should be paid to the protection of vulnerable groups of the population, including pregnant women, infants and children. The precautionary principle should be applied and this Regulation should ensure that industry demonstrates that substances or products produced or placed on the market do not have any harmful effect on human or animal health or any unacceptable effects on the environment.
…
(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)].’
4 Article 1 of that regulation, entitled ‘Subject matter and purpose’, provides, in paragraphs 3 and 4 thereof:
‘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. In particular, Member States shall not be prevented from applying the precautionary principle where there is scientific uncertainty as to the risks with regard to human or animal health or the environment posed by the plant protection products to be authorised in their territory.’
5 Under Chapter II of Regulation No 1107/2009, headed ‘Active substances, safeners, synergists and co-formulants’, Article 4 of that regulation, entitled ‘Approval criteria for active substances’, provides, in paragraphs 1 and 3 thereof:
‘1. An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3.
The assessment of the active substance shall first establish whether the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are satisfied. If these criteria are satisfied the assessment shall continue to establish whether the other approval criteria set out in points 2 and 3 of Annex II are satisfied.
…
3. A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements:
(a) it shall be sufficiently effective;
(b) it shall have no immediate or delayed harmful effect on human health, including that of vulnerable groups, or animal health, directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the scientific methods accepted by [the European Food Safety Agency (EFSA)] to assess such effects are available; or on groundwater;
(c) it shall not have any unacceptable effects on plants or plant products;
(d) it shall not cause unnecessary suffering and pain to vertebrates to be controlled;
(e) it shall have no unacceptable effects on the environment, having particular regard to the following considerations where the scientific methods accepted by [EFSA] to assess such effects are available:
…’
6 Chapter III of Regulation No 1107/2009, entitled ‘Plant protection products’, contains Section 1, on authorisation, which includes Subsection 1, headed ‘Requirements and contents’, comprising Articles 28 to 32 of that regulation.
7 Article 29 of that regulation, entitled ‘Requirements for the authorisation for placing on the market’, provides:
‘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;
…
(e) in the light of current scientific and technical knowledge, it complies with the requirements provided for in Article 4(3);
…
6. Uniform principles for evaluation and authorisation of plant protection products shall contain the requirements set out in Annex VI 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)] and shall be laid down in Regulations adopted in accordance with the advisory procedure referred to in Article 79(2) without any substantial modifications. Subsequent amendments to these Regulations shall be adopted in accordance with Article 78(1)(c).
Following these principles, interaction between the active substance, safeners, synergists and co-formulants shall be taken into account in the evaluation of plant protection products.’
8 Subsection 2, entitled ‘Procedure’, contained in Section 1, on authorisation, of Chapter III of Regulation No 1107/2009, comprises Articles 33 to 39 of that regulation.
9 Under Article 36 of that regulation, entitled ‘Examination for authorisation’:
‘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.
It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29(6), to establish, as far as possible, whether the plant protection product meets the requirements provided for in Article 29 in the same zone, where used in accordance with Article 55, and under realistic conditions of use.
The Member State examining the application shall make available its assessment to the other Member States within the same zone. The format of the assessment report shall be established in accordance with the advisory procedure referred to in Article 79(2).
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.
That Member State shall immediately inform the applicant and the [European] Commission of its decision and provide a technical or scientific justification therefor.
Member States shall provide for the possibility of challenging a decision refusing the authorisation of such products before national courts or other instances of appeal.’
10 Subsection 4, entitled ‘Renewal, withdrawal and amendment’, contained in Section 1 on authorisation, of Chapter III of Regulation No 1107/2009, comprises Articles 43 to 46 of that regulation.
11 Chapter IX of that regulation, entitled ‘Emergencies’, contains Articles 69 to 71 thereof.
12 Article 69 of that regulation, headed ‘Emergency measures’, is worded as follows:
‘Where it is clear that an approved active substance, safener, synergist or co-formulant or a plant protection product which has been authorised in accordance with this Regulation is likely to constitute a serious risk to human or animal health or 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 that substance or product shall be taken immediately in accordance with the regulatory procedure referred to in Article 79(3), either at the own initiative of the Commission or at the request of a Member State. Before taking such measures the Commission shall examine the evidence and may request an opinion from [EFSA]. The Commission may set a time limit within which such an opinion shall be provided.’
13 Annex I to Regulation No 1107/22009 establishes three zones for the authorisation of plant protection products (Zones A (North), B (Centre) and C (South)) and defines which Member States belong to each of those zones.
14 Annex II to that regulation concerns the procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II. Annex II contains Heading 3, ‘Criteria for the approval of an active substance’, sub-heading 3.6 of which is headed ‘Impact on human health’.
15 Point 3.6.5 of that Annex II lays down, with effect from 10 November 2018, the specific criteria on the basis of which an active substance, safener or synergist must be considered to have endocrine disrupting properties that may cause adverse effect in humans.
16 Point 3.8.2 of that Annex II lays down, with effect from 10 November 2018, the specific criteria on the basis of which an active substance, safener or synergist must be considered to have endocrine disrupting properties that may cause adverse effects on non-target organisms.
Regulation (EU) No 546/2011
17 Under Article 1 of Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (OJ 2011 L 155, p. 127), adopted pursuant to Article 29(6) and Article 84 of Regulation 1107/2009:
‘The uniform principles for evaluation and authorisation of plant protection products provided for in Article 29(6) of Regulation [No 1107/2009] shall be as set out in the Annex to this Regulation.’
18 Part I of the annex to Regulation No 546/2011, concerning the ‘uniform principles for evaluation and authorisation of chemical plant protection products’, comprises a heading A, ‘Introduction’, point 2 of which is worded as follows:
‘In evaluating applications for granting authorisations Member States shall:
…
(c) take into consideration other relevant technical or scientific information they can reasonably possess with regard to the performance of the plant protection product or to the potentially adverse effects of the plant protection product, its components or its residues.’
19 Part I also comprises a heading B, ‘Evaluation’, point 1.1 of which states:
‘Having regard to current scientific and technical knowledge, Member States shall evaluate the information referred to in point 2 of Part A and in particular:
(a) assess the performance in terms of efficacy and phytotoxicity of the plant protection product for each use for which authorisation is sought; and
(b) identify the hazard arising, assess their significance and make a judgment as to the likely risks to humans, animals or the environment.’
Regulation 2018/605
20 Recitals 1, 2, 5 and 8 of Regulation No 2018/605 state:
‘(1) Scientific criteria for the determination of endocrine disrupting properties of active substances, safeners and synergists, should be developed taking into account the objectives of [Regulation No 1107/2009], which are to ensure a high level of protection of both human and animal health and the environment, in particular ensuring that substances or products placed on the market have no harmful effect on human or animal health or unacceptable effects on the environment, and to improve the functioning of the internal market while improving agricultural production.
(2) In 2002, the World Health Organization (WHO) through its International Programme for Chemical Safety proposed a definition for endocrine disruptors … and in 2009 a definition of adverse effects … Those definitions have by now reached the widest consensus among scientists. [EFSA] endorsed those definitions in its Scientific Opinion on endocrine disruptors adopted on 28 February 2013 … Such is also the view of the Scientific Committee on Consumer Safety … It is therefore appropriate to base the criteria for the determination of endocrine disrupting properties on those WHO definitions.
…
(5) As the specific scientific criteria laid down by this Regulation reflect the current scientific and technical knowledge and are to be applied instead of the criteria currently set out in point 3.6.5 of Annex II to [Regulation No 1107/2009], they should be provided for in that Annex.
…
(8) The criteria for the determination of endocrine disrupting properties reflect the current state of scientific and technical knowledge and allow identifying active substances having endocrine disrupting properties more accurately. The new criteria should therefore apply as soon as possible, while taking into account the time necessary for Member States and [EFSA] to prepare for applying those criteria. Therefore, from 10 November 2018, those criteria should apply except where the relevant Committee has voted on a draft Regulation by 10 November 2018. The Commission will consider the implications for each procedure pending under [Regulation No 1107/2009] and, where necessary, take appropriate measures with due respect for the rights of the applicants. This may include a request for additional information from the applicant and/or for additional scientific input from the rapporteur Member State and [EFSA].’
21 Article 2 of that regulation provides:
‘Points 3.6.5 and 3.8.2 of Annex II to [Regulation No 1107/2009], as amended by this Regulation, shall apply as of 10 November 2018, except for procedures where the Committee has voted on a draft Regulation by 10 November 2018.’
The dispute in the main proceedings, the questions referred for a preliminary ruling and the procedure before the Court
Case C‑309/22
22 Pitcher is a plant protection product, more specifically a fungicide for professional use intended for the immersion treatment of certain flower bulb and tuber crops and for the treatment of certain perennial and floricultural crops. It is composed of a mixture of the active substances fludioxonil and folpet and seven formulation auxiliaries.
23 The approval period of fludioxonil as an active substance, under Regulation No 1107/2009, was extended in the European Union until 31 October 2022 by Commission Implementing Regulation (EU) 2021/1449 of 3 September 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2-phenylphenol (including its salts such as the sodium salt), 8-hydroxyquinoline, amidosulfuron, bifenox, chlormequat, chlorotoluron, clofentezine, clomazone, cypermethrin, daminozide, deltamethrin, dicamba, difenoconazole, diflufenican, dimethachlor, etofenprox, fenoxaprop-P, fenpropidin, fludioxonil, flufenacet, fosthiazate, indoxacarb, lenacil, MCPA, MCPB, nicosulfuron, paraffin oils, paraffin oil, penconazole, picloram, propaquizafop, prosulfocarb, quizalofop-P-ethyl, quizalofop-P-tefuryl, sulphur, tetraconazole, tri-allate, triflusulfuron and tritosulfuron (OJ 2021 L 313, p. 20).
24 The approval period of folpet as an active substance, under Regulation No 1107/2009, was extended in the European Union until 31 July 2022, by Commission Implementing Regulation (EU) 2021/745 of 6 May 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances aluminium ammonium sulphate, aluminium silicate, beflubutamid, benthiavalicarb, bifenazate, boscalid, calcium carbonate, captan, carbon dioxide, cymoxanil, dimethomorph, ethephon, extract from tea tree, famoxadone, fat distillation residues, fatty acids C7 to C20, flumioxazine, fluoxastrobin, flurochloridone, folpet, formetanate, gibberellic acid, gibberellins, heptamaloxyloglucan, hydrolysed proteins, iron sulphate, metazachlor, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, plant oils/rape seed oil, potassium hydrogen carbonate, propamocarb, prothioconazole, quartz sand, fish oil, repellents by smell of animal or plant origin/sheep fat, S-metolachlor, Straight Chain Lepidopteran Pheromones, tebuconazole and urea (OJ 2021 L 160, p. 89).
25 Applications for renewal of the approval periods were made to which a response had yet to be given at the time when the request for a preliminary ruling was made.
26 On 15 September 2015, Adama Registrations BV (Adama) made, in the Netherlands, an application for a first marketing authorisation in respect of Pitcher.
27 By decision of 4 October 2019, the CTGB granted that authorisation until 31 July 2021.
28 PAN Europe lodged an objection against that decision. By decision of 2 September 2020, the CTGB declared that objection unfounded.
29 As a consequence, PAN Europe brought an action before the College van Beroep voor het bedrijfsleven (Administrative Court of Appeal for Trade and Industry, Netherlands), which is the referring court, seeking annulment of that decision of 2 September 2020.
30 Before the referring court, PAN Europe claims that the CTGB failed to assess the endocrine disrupting properties of the active substance fludioxonil. However, that substance, which the product Pitcher contains, has such properties, which ought to have led the CTGB to refuse to grant authorisation for placing Pitcher on the Netherlands market. According to PAN Europe, the CTGB must assess the endocrine disrupting properties of a plant protection product, as part of the examination of the application for marketing authorisation for that product, in the light of current scientific and technical knowledge at the time of the decision on that application.
31 The CTGB contends, before the referring court, that endocrine disrupting properties are not to be re-assessed as part of the examination of the application for authorisation of the plant protection product at issue, of which the approved active substance is a component. The CTGB takes the view that the new scientific criteria for the determination of endocrine disrupting properties, as laid down in Regulation 2018/605, concern only the approval of the active substance fludioxonil or the review of the approval of that active substance at EU level. Furthermore, it is current scientific and technical knowledge and the guidance documents available at the time of the application for authorisation for placing the plant protection product on the market that are decisive for the purposes of assessing the risks associated with that product.
32 Starting from the premiss that endocrine disrupting properties must be assessed as part of the examination, at national level, of an application for authorisation for placing a plant protection product on the market, the referring court seeks to ascertain, first of all, whether Article 2 of Regulation 2018/605 means that the competent national authority is required to apply the new criteria for the determination of endocrine disrupting properties, laid down by that regulation, including in the context of procedures initiated before 10 November 2018 – the date from which those new criteria became applicable – which are still pending as at that date.
33 In that connection, that court observes that the application for authorisation for placing Pitcher on the market was lodged before 10 November 2018 – that is, 15 September 2015 – and that the CTGB took a decision on that application after 10 November 2018, that is, on 4 October 2019. Regulation 2018/605 therefore entered into force while that application was ongoing.
34 Next, in the event that the new criteria for the determination of endocrine disrupting properties should not apply in the context of procedures initiated before 10 November 2018 and still pending at that date, the referring court asks whether those procedures should be suspended pending the Commission’s findings on the consequences of Regulation 2018/605, having regard to recital 8 thereof.
35 Lastly, should it not be necessary to suspend those procedures, the referring court asks whether it is sufficient that the competent national authority carry out an assessment of the endocrine disrupting properties of the plant protection product at issue on the sole basis of the data known at the time when the application for authorisation for the placing of that product on the market, even if the scientific and technical knowledge to which that application refers is no longer current at the time when the decision on that application is adopted.
36 In those circumstances the College van Beroep voor het bedrijfsleven (Administrative Court of Appeal for Trade and Industry) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:
‘(1) Does Article 2 of Regulation 2018/605 imply that the competent authority must also apply the new criteria for the determination of endocrine disrupting properties in the assessment and decision-making process relating to applications for authorisation which were still pending on 10 November 2018, also in view of Article 29(1)(e) in conjunction with Article 4(3) of Regulation [No] 1107/2009?
(2) If the answer to the first question is in the negative, is it incumbent on the competent authority to stay the assessment and decision-making process relating to applications for authorisation pending the findings of the [Commission] on the effects of Regulation 2018/605 on any proceedings pending under Regulation [No] 1107/2009, having regard to recital 8 of … Regulation 2018/605?
(3) If the answer to that second question is in the negative, is it sufficient for the competent authority to make an assessment solely on the basis of data known at the time of the application, even if the scientific and technical knowledge reflected therein is no longer current at the time when the contested decision is taken?’
Case C‑310/22
37 Dagonis is a plant protection product, more specifically a fungicide intended, inter alia, to combat powdery mildew and the septoria leaf spot. It contains the active substances difenoconazole and fluxapyroxad.
38 The active substance difenoconazole was included in Annex I to Directive 91/414 by Commission Directive 2008/69/EC of 1 July 2008 amending Council Directive 91/414 EEC to include clofentezine, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram and pyriproxyfen as active substances (OJ 2008 L 172, p. 9), as an active substance the inclusion of which is authorised in plant protection products, with effect from 1 January 2009.
39 Following the entry into force of Regulation No 1107/2009, that inclusion of difenoconazole was converted into an approval as an active substance, under that regulation, by Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ 2011 L 153, p. 1).
40 The approval period of difenoconazole was extended several times, inter alia by Implementing Regulation 2021/1449, until 31 December 2022.
41 The referring court states that Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution (OJ 2015 L 67, p. 18), designates difenoconazole as an active substance which is a candidate for substitution.
42 Fluxapyroxad has been approved as an active substance by Commission Implementing Regulation (EU) No 589/2012 of 4 July 2012 approving the active substance fluxapyroxad, 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 2012 L 175, p. 7), with effect from 1 January 2013, which approval was due to expire on 31 December 2022.
43 BASF Nederland BV applied for marketing authorisation in respect of Dagonis in several Member States.
44 In so far as the Kingdom of the Netherlands is concerned, that application was made on 22 January 2016, with the result that that Member State was to decide on the authorisation of that product, as the Member State concerned, for the purposes of Article 36(2) of Regulation No 1107/2009.
45 For Zone B (Centre), which includes the Kingdom of the Netherlands, the United Kingdom of Great Britain and Northern Ireland carried out a scientific risk assessment in respect of Dagonis, as the Member State examining the application under Article 36(1) of that regulation.
46 By decision of 3 May 2019, the CTGB granted Dagonis marketing authorisation in the Netherlands until 31 December 2020 for the treatment of potato, strawberry and various vegetable, herb and flower crops.
47 PAN Europe lodged an objection against that decision before the CTGB which, by decision of 13 November 2019, rejected that objection in part and confirmed that decision of 3 May 2019, whilst amending the grounds thereof.
48 PAN Europe brought an action before the referring court, seeking annulment of the decision of 13 November 2019.
49 Before the referring court, PAN Europe claims that the CTGB failed to assess the endocrine disrupting properties of Dagonis and therefore ought not to have authorised the placing of the product on the market in the Netherlands. In that connection, it argues that it is apparent from the file provided by BASF Nederland and from six studies submitted by PAN Europe that the active substance difenoconazole has such properties. According to PAN Europe, it follows from Article 29(1)(e), read in conjunction with Article 4(3) of Regulation No 1107/2009, and from the judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800), that the CTGB is required to assess the endocrine disrupting properties of a plant protection product, as part of the examination of the application for authorisation thereof, in the light of current scientific and technical knowledge at the time of the decision on that application. PAN Europe maintains that new criteria for assessing endocrine disrupting properties, which Dagonis does not meet, stem from Regulation 2018/605 and from the document ‘Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009’, prepared by EFSA.
50 The CTGB contends, before the referring court, that those properties are not to be re-assessed as part of the examination of the application for marketing authorisation for the plant protection product at issue, of which the approved active substance is a component. According to the CTGB, it follows inter alia from point 3.6.5 of Annex II to Regulation No 1107/2009, from Regulation 2018/605 and from the EFSA document referred to in the preceding paragraph of the present judgment that the new criteria for the determination of endocrine disrupting properties concern only the approval of the active substance or the review of the approval of that active substance at EU level. The CTGB claims that, in order for a marketing authorisation to be granted, it is sufficient that the condition laid down in Article 29(1)(a) of Regulation No 1107/2009 – according to which the active substance must be approved – be satisfied. Furthermore, Regulation 2018/605 applies only to approval decisions taken after 10 November 2018. In the present case, the decision to approve the active substance difenoconazole was adopted on 1 July 2008.
51 BASF Nederland, which supports the CTGB’s position before the referring court, contends that, during the examination of the application for authorisation of Dagonis, the endocrine disrupting properties of the active substance difenoconazole were taken into account, as is apparent from the Core Assessment carried out by the United Kingdom, which shows that the exposure of zebra fish to difenoconazole was examined in order to identify possible endocrine disrupting effects.
52 The referring court seeks to ascertain, first, whether the approach whereby it follows from the second subparagraph of Article 4(1), read in conjunction with point 3.6.5 of Annex II to Regulation No 1107/2009, that endocrine disrupting properties are not assessed as part of the examination, at national level, of an application for authorisation to place a plant protection product on the market, is well founded.
53 Second, it states that, if that approach is found to be correct, it would not be necessary to take account of scientific knowledge relating to endocrine disrupting properties as part of the examination of the application for authorisation for placing Dagonis on the market, such as that which underlies Commission Regulation No 283/2013 of 1 March 2013 setting out the data requirements for active substances, 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 (OJ 2013 L 93, p. 1), and Regulation 2018/605. However, it is apparent from Article 29(1)(e) of Regulation No 1107/2009 that such an assessment must be carried out on the basis of current scientific and technical knowledge.
54 Third, according to the referring court, while objections relating to the endocrine disrupting properties of an active substance may be raised only in the context of a procedure to approve such a substance, the question arises as to whether a non-governmental organisation such as PAN Europe can raise such objections. In that connection, it is apparent from the order of 28 September 2016, PAN Europe and Others v Commission (T‑600/15, EU:T:2016:601), and in particular from paragraph 62 thereof, that such an organisation cannot bring a direct legal challenge against the approval of an active substance and therefore does not have an effective remedy in so far as concerns the endocrine disrupting properties of approved active substances that are included in plant protection products in respect of which marketing authorisation is sought.
55 Fourth, in so far as, having regard to Article 29(1)(e) of Regulation No 1107/2009, endocrine disrupting properties may be assessed as part of the examination of an application for authorisation for placing a plant protection product containing the active substance concerned on the national market, the question arises as to whether the national authorities and courts are required to assess the pleas raised in opposition to the approval of the active substance on the basis of the scientific and technical knowledge in existence at the time of the decision to be adopted on that application for national authorisation or at the time of the approval of the active substance.
56 In those circumstances the College van Beroep voor het bedrijfsleven (Administrative Court of Appeal for Trade and Industry) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:
‘(1) Does it follow from the second subparagraph of Article 4(1) of Regulation [No] 1107/2009, in conjunction with point 3.6.5 of Annex II thereto, that the potential endocrine disrupting properties of an active substance need no longer be assessed during the assessment at national level of an application for authorisation of a plant protection product?
(2) If the answer to the first question is in the affirmative, does it mean that the scientific insights and technical knowledge relating to endocrine disrupting properties, which, for example, underpin Regulations [No] 283/2013 and 2018/605, need not be taken into account when assessing the authorisation of a plant protection product? How does that relate to the requirement of Article 29(1)(e) of Regulation [No] 1107/2009 that such an assessment must be conducted on the basis of current scientific and technical knowledge?
(3) If the answer to the first question is in the affirmative, how can a non-governmental organisation such as the appellant be said to have an effective remedy under Article 47 of the Charter [of Fundamental Rights of the European Union] to refer the approval of an active substance to a court of law?
(4) If the answer to the first question is in the negative, does it mean that, when assessing an application for authorisation, [it is the scientific and technical knowledge on those endocrine disrupting properties that is current at that time which is decisive]?’
57 By decision of 10 May 2023, Cases C‑309/22 and C‑310/22 were joined for the purposes of the oral part of the procedure and of the judgment.
The application to reopen the oral part of the procedure
58 Following the delivery of the Opinion of the Advocate General at the sitting on 28 September 2023, Adama and BASF Nederland, by document lodged at the Registry of the Court of Justice on 23 October 2023, applied for the oral part of the procedure to be reopened, pursuant to Article 83 of the Rules of Procedure of the Court of Justice.
59 Under that provision, the Court may at any time, after hearing the Advocate General, order the reopening of the oral part of the procedure, in particular if it considers that it lacks sufficient information or where a party has, after the close of that part of the procedure, submitted a new fact which is of such a nature as to be a decisive factor for the decision of the Court, or where the case must be decided on the basis of an argument which has not been debated between the parties or the interested persons referred to in Article 23 of the Statute of the Court of Justice of the European Union.
60 In their application, Adama and BASF Nederland claim that the Court does not have sufficient information to hand down a decision in Joined Cases C‑309/22 and C‑310/22, that their written observations were not sufficiently taken into consideration in the Advocate General’s Opinion, and that the latter contains elements on which Adama and BASF Nederland have not been able to submit their views.
61 In that connection, it should be recalled that, pursuant to the second paragraph of Article 252 TFEU, the role of the Advocate General is to make, in open court, acting with complete impartiality and independence, reasoned submissions on cases which, in accordance with the Statute of the Court of Justice of the European Union, require the Advocate General’s involvement in order to assist the Court in the performance of the task assigned to it, which is to ensure that in the interpretation and application of the Treaties the law is observed.
62 The Court is not bound either by the Advocate General’s Opinion or by the reasoning on which it is based. Furthermore, neither the Statute of the Court of Justice of the European Union nor the Rules of Procedure make provision for the parties to submit observations in response to the Advocate General’s Opinion. Consequently, an interested party’s disagreement with the Opinion of the Advocate General cannot in itself constitute grounds justifying the reopening of the oral part of the procedure (judgment of 28 September 2023, LACD, C‑133/22, EU:C:2023:710, paragraph 22 and the case-law cited).
63 In the present case, since, on the one hand, Adama and BASF Nederland essentially confine themselves to disputing certain passages of the Advocate General’s Opinion and submitting observations on the content thereof and, on the other hand, the Court is not bound by the description of the legal arguments set out in that Opinion, there is no need to order the reopening of the oral part of the procedure.
Consideration of the questions referred
First question referred in Case C‑309/22 and first and fourth questions referred in Case C‑310/22
64 As a preliminary point, it should be noted that the first question in Case C‑309/22 refers, in particular, to Article 2 of Regulation 2018/605. Under that article, point 3.6.5 of Annex II to Regulation No 1107/2009, as amended by Regulation 2018/605, applies from 10 November 2018, except for procedures in which the committee referred to in Article 79(1) of Regulation No 1107/2009 has voted on a draft regulation by 10 November 2018 at the latest. While Article 2 of Regulation 2018/605 is part of the regulatory context into which the first question in Case C‑309/22 and the first and fourth questions in Case C‑310/22 fit, that article does not apply, however, to the dispute in the main proceedings in Case C‑309/22.
65 In fact, first, that article sets the date of the entry into force of the criteria for the determination of active substances with endocrine disrupting properties for the purposes of the approval of an active substance. It does not govern the taking into account, by a Member State, in the examination of an application for authorisation to place a plant protection product containing such a substance on the market, of the harmful effects that that product may have.
66 Second, the exception that that article contains applies only to procedures in which the committee referred to in Article 79(1) of Regulation No 1107/2009 has voted on a draft regulation by 10 November 2018 at the latest, which is not the case here.
67 Furthermore, even if it were appropriate to apply, by analogy, the six-month period, granted by the EU legislature to the Member States and EFSA in order to allow them to prepare for the application of the new criteria laid down in point 3.6.5 of Annex II to Regulation No 1107/2009, to procedures for authorisation for placing plant protection products on the market, it is clear that it was following that period that the CTGB, in the context of the cases in the main proceedings, issued marketing authorisations for Dagonis and Pitcher, respectively.
68 In those circumstances, it must be held that, by its first question in Case C‑309/22 and its first and fourth questions in Case C‑310/22, the referring court is asking, in essence, whether Article 29(1)(a) and (e), the second subparagraph of Article 4(1), and Article 4(3) of Regulation No 1107/2009, read in conjunction with point 3.6.5 of Annex II to that regulation, must be interpreted as meaning that the competent authority of a Member State charged with the task of assessing an application for authorisation to place a plant protection market on the market is required, as part of the examination of that application, to take into account the adverse effects that the endocrine disrupting properties of an active substance contained in that product may cause for human beings, having regard to the relevant and reliable scientific or technical knowledge available at the time of that examination and which are, in particular, reproduced in the criteria laid down in point 3.6.5.
69 In the first place, in so far as concerns the wording of Article 29 of Regulation No 1107/2009, it should be recalled that that article, which concerns the requirements for the authorisation for placing plant protection products on the market, provides, in paragraph 1 thereof, that, without prejudice to Article 50 of that regulation, a plant protection product is only to be authorised where it complies with the various requirements set out therein.
70 It therefore follows from Article 29(1)(a) and (e) of that regulation that such a product may be authorised only if its active substances have been approved and if, in the light of current scientific and technical knowledge, it complies with the requirements provided for in Article 4(3) of that regulation.
71 According to the latter provision, a plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, is to meet, inter alia, the condition, laid down in point (b), that it have no immediate or delayed harmful effect on human health.
72 Accordingly, on the basis of the wording of Article 29(1)(a) and (e) and that of Article 4(3)(b) of Regulation No 1107/2009, it appears that a plant protection product may be authorised by a competent national authority where, in particular, all the active substances that that product contains are approved, and that product has no immediate or delayed harmful effect, in the light of current scientific and technical knowledge, on human health.
73 As to point 3.6.5 of Annex II to Regulation No 1107/2009, it should be borne in mind that this lays down, with effect from 10 November 2018, the specific criteria that determine, in particular, whether an active substance is to be considered as having endocrine disrupting properties that may cause adverse effect in humans.
74 In the disputes in the main proceedings, the question arises as to whether the competent authority of a Member State, to which an application has been made for authorisation to place a plant protection product on the market, must take those criteria into account as part of the assessment of the potential effects of that product on human health.
75 According to the stance taken by Adama, BASF Nederland, the Netherlands and Greek Governments as well as the Commission, the endocrine disrupting properties that an active substance may present are not to be assessed as part of the examination at national level of an application for authorisation to place on the market a plant protection product containing that active substance. Such an examination would disregard the scheme of Regulation No 1107/2009, the distinction between the assessment, at EU level, of the intrinsic properties of active substances and the examination, at Member State level, of applications for authorisation for placing plant protection products on the market, as well as the division of powers between the European Union and the Member States established by that regulation.
76 By contrast, PAN Europe and the Czech Government take the view that, where a competent national authority, which is to decide on an application for authorisation for placing a plant protection product on the market, has at its disposal current and relevant scientific and technical knowledge establishing that there is a risk that a plant protection product carries with it adverse effects on human beings on account of the endocrine disrupting properties of an active substance contained in that product, that authority is required to assess such a risk and draw the appropriate conclusions therefrom.
77 In that connection, it should be observed that it follows from neither the wording of Article 29(1)(a) and (e) nor that of Article 4(3)(b) of Regulation No 1107/2009, referred to in paragraphs 69 to 71 of the present judgment, that where a decision is to be adopted as to the authorisation to place a plant protection product on its national market, the competent authorities of the Member State concerned must take into account only certain categories of scientific or technical knowledge, according to the source thereof or the time when that knowledge became available.
78 It follows that, on the basis of a literal interpretation of those provisions, there is nothing to prevent the competent national authorities, when examining an application for authorisation to place a plant protection product on the market, under Article 29 of Regulation No 1107/2009, from checking that, in the light of current scientific and technical knowledge, that product has no immediate or delayed harmful effect on human health, within the meaning of Article 4(3)(b) of that regulation, having regard to the criteria laid down, in particular, in point 3.6.5 of Annex II to that regulation and to the properties of an active substance contained in that product.
79 In the second place, that literal interpretation is borne out by the context into which those provisions fit.
80 First, it should be noted that Regulation No 1107/2009 makes the distinction between the approval of active substances at EU level and authorisations for the placing on the market and use of plant protection products. While the approval of active substances is governed by the provisions of Chapter II of that regulation, which include Article 4 thereof, and falls within the scope of the Commission’s competence, authorisations for the placing on the market and use of plant protection products are covered by Chapter III of that regulation and adopted by the Member States.
81 However, it should be observed that, in the context of applications for authorisation for placing a plant protection product on the market, Article 29(1)(e) of Regulation No 1107/2009 requires that the Member State ensure that the conditions laid down in Article 4(3) of that regulation are complied with. The Court has already had occasion to state that, pursuant to Article 29(1)(e) of Regulation No 1107/2009, one of the requirements imposed if the placing of a plant protection product on the market is to be authorised is that it must, in the light of current scientific and technical knowledge, comply with the conditions laid down in Article 4(3) of that regulation. In accordance with those provisions, such a product may be authorised only if it is established that it has no immediate or delayed harmful effect on human health (see, to that effect, judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraphs 71 and 114).
82 Accordingly, while the approval, by the Commission, of the active substance cannot be reviewed by the Member States when examining an application for authorisation to place on the market a plant protection product containing that substance, the authorisation of such a product cannot, however, be regarded as constituting a purely automatic implementation of the approval, by the Commission, of an active substance contained in that product (see, to that effect, judgment of 28 October 2020, Associazione GranoSalus v Commission, C‑313/19 P, EU:C:2020:869, paragraphs 55 and 58).
83 Consequently, as the Advocate General observes in point 58 of her Opinion, while Regulation No 1107/2009 prevents a Member State from granting an authorisation to place on the market a plant protection product containing an active substance which has not been approved, a Member State is not required to authorise the placing on the market of a plant protection product containing active substances all of which have been approved, if there is scientific or technical knowledge that identifies an unacceptable risk to human or animal health or the environment from the use of that product.
84 Second, it is also necessary to have regard to the uniform principles for evaluation and authorisation of plant protection products to which Article 29(1) of Regulation No 1107/2009 refers and which are set out in the annex to Regulation No 546/2011.
85 Thus, in accordance with point 2(c) under heading A of Part I of that annex, in examining applications and granting authorisations, Member States are to take into consideration other relevant technical or scientific information they can reasonably possess with regard to the potentially adverse effects of the plant protection product or its components. There is no doubt that the criteria set out in point 3.6.5 of Annex II to Regulation No 1107/2009 constitute such scientific information.
86 On the one hand, it is clear from recital 2 of Regulation 2018/605 that those criteria are based on the definitions of endocrine disruptors and of their adverse effects proposed by the WHO, which are the subject of a very broad consensus amongst scientists and which have been approved by EFSA in its Scientific Opinion of 28 February 2013 on endocrine disruptors.
87 On the other hand, the identification of an active substance with endocrine disrupting properties that can have adverse effects on human beings must, in particular, be based, according to the sixth paragraph of point 3.6.5 of Annex II to Regulation No 1107/2009, on all available relevant scientific data and on an assessment of those data based on a weight of evidence approach.
88 It follows from the foregoing that the context of Article 29(1), the second subparagraph of Article 4(1), and Article 4(3), together with point 3.6.5 of Annex II to Regulation No 1107/2009, confirms the literal interpretation of those provisions as set out in paragraph 78 of the present judgment.
89 In the third place, that interpretation is similarly borne out by the purpose of Regulation No 1107/2009 which is, as stated in Article 1(3) 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 (judgment of 19 January 2023, Pesticide Action Network Europe and Others, C‑162/21, EU:C:2023:30, paragraph 46).
90 In that connection, by referring to recital 24 of Regulation No 1107/2009, the Court has already ruled that the provisions governing the granting of authorisations for the placing of plant protection products on the market must ensure a high level of protection and, when granting such authorisations, the objective of protecting human and animal health and the environment should ‘take priority’ over the objective of improving plant production (judgment of 19 January 2023, Pesticide Action Network Europe and Others, C‑162/21, EU:C:2023:30, paragraph 48 and the case-law cited).
91 Similarly, recital 29 of Regulation No 1107/2009, while stressing the need to provide for more harmonised availability of plant protection products, acknowledges that environmental or agricultural circumstances specific to the territory of one or more Member States might require that that Member State or those Member States 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 cannot be achieved.
92 Furthermore, it should be recalled that the provisions of that regulation are based, in accordance with Article 1(4) of that regulation, read in the light of recital 8 thereof, on the precautionary principle, in order to prevent active substances or products placed on the market from adversely affecting human health.
93 The taking into account, when assessing the potential harmful effects of a plant protection product in respect of which a marketing authorisation is sought, of the scientific criteria set out in point 3.6.5 of Annex II to Regulation No 1107/2009 contributes, in keeping with the precautionary principle, to the attainment of the objective recalled in paragraph 89 of the present judgment.
94 It should be added that the considerations set out in the preceding paragraphs of the present judgment are not called into question by the requirement of compliance with the principle of legal certainty.
95 In their written observations, Adama and the Greek Government claim in essence that that principle requires that the examination of an application for authorisation for the placing of a plant protection product on the market be carried out by reference to the scientific and technical knowledge in existence at the time when that application was made.
96 It is settled case-law that the principle of legal certainty requires that rules of law be clear and precise and predictable in their effect, so that interested parties can ascertain their position in situations and legal relationships governed by EU law (judgment of 6 May 2021, Bayer CropScience and Bayer v Commission, C‑499/18 P, EU:C:2021:367, paragraph 101).
97 That principle must, however, in the specific field of authorisations for the placing of plant protection products on the market, be weighed up against the precautionary principle on which Regulation No 1107/2009 is based and the aim of which is – as recalled in paragraph 89 of the present judgment – to ensure a high level of protection for human and animal health and the environment. Thus, in the event that information should emerge demonstrating that an active substance or a plant protection product has a harmful effect on human or animal health or an unacceptable effect on the environment, the Commission and/or the Member States may be required to withdraw the approval of that active substance or the authorisation for the placing on the market of that plant protection product and, where necessary, take emergency measures.
98 It follows that, in the context of that regulation, any applicant wishing to place a plant protection product on the market can expect that scientific or technical knowledge should change during the authorisation procedure or over the course of the period for which an active substance is approved or a plant protection product is authorised. Furthermore, it is apparent from Article 46 and Articles 69 to 71 of that regulation that the withdrawal of authorisation or the taking of emergency measures can take effect immediately, no longer permitting the placing on the market or the use of existing stocks of the product at issue.
99 Consequently, the taking into account of relevant and reliable scientific or technical knowledge which was not yet available at the time when the application for authorisation for the placing on the market of a plant protection product was made cannot be regarded as being contrary to the principle of legal certainty.
100 In the light of all of the foregoing, the answer to the first question in Case C‑309/22 and the first and fourth questions in Case C‑310/22 is that Article 29(1)(a) and (e), the second subparagraph of Article 4(1), and Article 4(3) of Regulation No 1107/2009, read in conjunction with point 3.6.5 of Annex II to that regulation, must be interpreted as meaning that the competent authority of a Member State charged with the task of assessing an application for authorisation to place a plant protection market on the market is required, as part of the examination of that application, to take into account the adverse effects that the endocrine disrupting properties of an active substance contained in that product may cause for human beings, having regard to the relevant and reliable scientific or technical knowledge available at the time of that examination and which is, in particular, reproduced in the criteria laid down in point 3.6.5.
The second and third questions in Case C‑309/22 and the second and third questions in Case C‑310/22
101 Having regard to the answer given to the first question in Case 309/22 and the first and fourth questions in Case C‑310/22, there is no need to answer the second and third questions in Case C‑309/22 or the second and third questions in C‑310/22.
Costs
102 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring 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.
On those grounds, the Court (Third Chamber) hereby rules:
Article 29(1)(a) and (e), the second subparagraph of Article 4(1), and Article 4(3) 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, as amended by Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties, read in conjunction with point 3.6.5 of Annex II to Regulation No 1107/2009, as amended,
must be interpreted as meaning that the competent authority of a Member State charged with the task of assessing an application for authorisation to place a plant protection market on the market is required, as part of the examination of that application, to take into account the adverse effects that the endocrine disrupting properties of an active substance contained in that product may cause for human beings, having regard to the relevant and reliable scientific or technical knowledge available at the time of that examination and which is, in particular, reproduced in the criteria laid down in point 3.6.5.
[Signatures]