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 36 – Discretion of the Member State concerned, for the purposes of Article 36(2), with regard to the scientific risk assessment carried out by the Member State examining the application for authorisation under Article 36(1) – Article 44 – Withdrawal or amendment of an authorisation – Precautionary principle – Effective judicial remedy – Current scientific and technical knowledge)
In Case C‑308/22,
REQUEST 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 decision 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 party:
Corteva Agriscience Netherlands BV, formerly Dow AgroScience BV (Dow),
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,
– Corteva Agriscience Netherlands BV, by E.J.H. Gielen and N.E. Kuijer, advocaten,
– the Netherlands Government, by M.K. Bulterman and C.S. Schillemans, acting as Agents,
– the German Government, by J. Möller and R. Kanitz, acting as Agents,
– Ireland, by M. Browne, Chief State Solicitor, A. Joyce and M. Lane, acting as Agents, and by D. Fennelly, Barrister-at-Law,
– 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 This request for a preliminary ruling concerns the interpretation of Article 36(1) and (2) 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), and of Article 47 of the Charter of Fundamental Rights of the European Union (‘the Charter’).
2 The request has 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 PAN Europe’s objection against the decision of the CTGB to extend the authorisation for placing the plant protection product Closer, which contains the active substance sulfoxaflor, on the Netherlands market.
Legal context
Regulation No 1107/2009
3 Recitals 5, 8, 9, 24, 25, 28 and 29 of Regulation No 1107/2009 state:
‘(5) To simplify application of the new act and to ensure consistency throughout the Member States, it should take the form of a Regulation.
…
(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.
(9) In order to remove as far as possible obstacles to trade in plant protection products existing due to the different levels of protection in the Member States, this Regulation should also lay down harmonised rules for the approval of active substances and the placing on the market of plant protection products, including the rules on the mutual recognition of authorisations and on parallel trade. The purpose of this Regulation is thus to increase the free movement of such products and availability of these products in the Member States.
…
(24) The provisions governing authorisation must ensure a high standard of protection. In particular, when granting authorisations of plant protection products, the objective of protecting human and animal health and the environment should take priority over the objective of improving plant production. Therefore, it should be demonstrated, before plant protection products are placed on the market, that they present a clear benefit for plant production and do not have any harmful effect on human or animal health, including that of vulnerable groups, or any unacceptable effects on the environment.
(25) In the interest of predictability, efficiency and consistency, criteria, procedures and conditions for the authorisation of plant protection products should be harmonised, account being taken of the general principles of protection of human and animal health and the environment.
…
(28) Good administrative cooperation between Member States should be increased during all steps of the authorisation procedure.
(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 Article 4 of that regulation, under the heading ‘Approval criteria for active substances’, provides, in paragraphs 1 to 4 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.
2. The residues of the plant protection products, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements:
(a) they shall not have any harmful effects on human health, including that of vulnerable groups, or animal health, taking into account known cumulative and synergistic effects where the scientific methods accepted by the [European Food Safety Authority (EFSA)] to assess such effects are available, or on groundwater;
(b) they shall not have any unacceptable effect on the environment.
For residues which are of toxicological, ecotoxicological, environmental or drinking water relevance, there shall be methods in general use for measuring them. Analytical standards shall be commonly available.
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 [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:
…
4. The requirements of paragraphs 2 and 3 shall be evaluated in the light of uniform principles as referred to in Article 29(6).’
6 Article 6 of Regulation No 1107/2009 sets out the conditions and restrictions to which an approval may be subject.
7 Article 21 of that regulation, under the heading ‘Review of approval’, provides, in paragraph 3 thereof:
‘Where the [European] Commission concludes that the approval criteria provided for in Article 4 are no longer satisfied, or the further information required in accordance with Article 6(f) has not been provided, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure referred to in Article 79(3).
…’
8 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.
9 Article 28 of that regulation, headed ‘Authorisation for placing on the market and use’, provides, in paragraph 1 thereof, that a plant protection product is not to be placed on the market or used, subject to the situations provided for in paragraph 2 of that article, unless it has been authorised in the Member State concerned in accordance with that regulation.
10 Article 29 of Regulation No 1107/2009, headed ‘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.’
11 Article 31 of Regulation No 1107/2009, entitled ‘Contents of authorisations’, provides:
‘1. The authorisation shall define plants or plant products and non-agricultural areas (for example railways, public areas, storage rooms) on which and the purposes for which the plant protection product may be used.
2. The authorisation shall set out the requirements relating to the placing on the market and use of the plant protection product. Those requirements shall as a minimum include the conditions of use necessary to comply with the conditions and requirements provided for in the Regulation approving the active substances, safeners and synergists.
…
3. The requirements referred to in paragraph 2 shall also include where applicable:
(a) the maximum dose per hectare in each application;
(b) the period between the last application and harvest;
(c) the maximum number of applications per year.
4. The requirements referred to in paragraph 2 may include the following:
(a) a restriction with respect to the distribution and use of the plant protection product …
(b) the obligation before the product is used to inform any neighbours who could be exposed to the spray drift and who have requested to be informed;
(c) indications for proper use according to the principles of Integrated Pest Management …
(d) designation of categories of users, such as professional and non-professional;
(e) the approved label;
(f) the interval between applications;
(g) the period between the last application and consumption of the plant product where applicable;
(h) the re-entry interval;
(i) the packaging size and material.’
12 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.
13 Article 33 of that regulation, headed ‘Application for authorisation or amendment of an authorisation’, provides, in paragraph 1 thereof:
‘An applicant who wishes to place a plant protection product on the market shall apply for an authorisation or amendment of an authorisation himself, or through a representative, to each Member State where the plant protection product is intended to be placed on the market.’
14 Article 35 of that regulation, headed ‘Member State examining the application’, is worded as follows:
‘The application shall be examined by the Member State proposed by the applicant, unless another Member State in the same zone agrees to examine it. The Member State which will examine the application shall inform the applicant.
At the request of the Member State examining the application, the other Member States in the same zone to which an application has been submitted shall cooperate to ensure a fair division of the workload.
The other Member States within the zone to which an application has been submitted shall refrain from proceeding with the file pending assessment by the Member State examining the application.
Where an application has been made in more than one zone, Member States evaluating the application shall agree on the evaluation of data which are not related to the environmental and agricultural conditions.’
15 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 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.’
16 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.
17 Article 44 of that regulation, entitled ‘Withdrawal or amendment of an authorisation’, is worded as follows:
‘1. Member States may review an authorisation at any time where there are indications that a requirement referred to in Article 29 is no longer satisfied.
…
2. Where a Member State intends to withdraw or amend an authorisation, it shall inform the authorisation holder and give him the possibility to submit comments or further information.
3. The Member State shall withdraw or amend the authorisation, as appropriate, where:
(a) the requirements referred to in Article 29 are not or are no longer satisfied;
(b) false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted;
(c) a condition included in the authorisation has not been met;
(d) on the basis of developments in scientific and technical knowledge, the manner of use and amounts used can be modified; or
(e) the authorisation holder fails to comply with the obligations resulting from this Regulation.
4. Where a Member State withdraws or amends an authorisation in accordance with paragraph 3, it shall immediately inform the holder of the authorisation, the other Member States, the Commission and [EFSA]. The other Member States belonging to the same zone shall withdraw or amend the authorisation accordingly taking into account national conditions and risk mitigation measures except for cases where the second, third or fourth subparagraphs of Article 36(3) have been applied. Article 46 shall apply where appropriate.’
18 Under Article 56(1) of that regulation:
‘The holder of an authorisation for a plant protection product shall immediately notify the Member States that granted an authorisation of any new information concerning that plant protection product, the active substance, its metabolites, a safener, synergist or co-formulant contained in the plant protection product, which suggests that the plant protection product no longer complies with the criteria set out in Articles 29 and 4 respectively.’
19 Chapter IX of Regulation No 1107/2009, entitled ‘Emergencies’, contains Articles 69 to 71 of that regulation.
20 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.’
21 Chapter X of that regulation, entitled ‘Administrative and financial provisions’ contains, in particular, Article 77, headed ‘Guidance documents’, which provides:
‘The Commission may, in accordance with the advisory procedure referred to in Article 79(2), adopt or amend technical and other guidance documents such as explanatory notes or guidance documents on the content of the application concerning micro-organisms, pheromones and biological products, for the implementation of this Regulation. The Commission may ask [EFSA] to prepare or to contribute to such guidance documents.’
22 Under the second paragraph of Article 84 of that regulation:
‘By 14 June 2011, the Commission shall adopt the following:
…
(d) a Regulation on uniform principles for risk assessment for plant protection products, as referred to in Article 36’.
23 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.
24 Annex II of Regulation 1107/2009 lays down the procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II.
Regulation (EU) No 546/2011
25 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.’
26 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.’
27 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.’
The dispute in the main proceedings and the questions referred for a preliminary ruling
28 Closer is a plant protection product that contains the active substance sulfoxaflor.
29 Sulfoxaflor has been approved in the European Union, as an active substance, under Regulation No 1107/2009, by Commission Implementing Regulation (EU) 2015/1295 of 27 July 2015 approving the active substance sulfoxaflor, 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 2015 L 199, p. 8), subject to the conditions laid down in Annex I to Implementing Regulation 2015/1295.
30 On 30 April 2015, Dow AgroScience BV (‘Dow’), which has since become Corteva Agriscience Netherlands BV (‘Corteva’), submitted an application to the Kingdom of the Netherlands for the marketing authorisation in respect of Closer to be extended to use in the open cultivation of cabbages and potatoes. Corteva lodged the same application, in so far as concerns Zone B (Centre), which included Belgium, the Czech Republic, Germany, Ireland, Luxembourg, Hungary, the Netherlands, Austria, Poland, Romania, Slovenia, Slovakia and the United Kingdom.
31 Ireland, as the Member State examining the application for marketing authorisation under Article 36(1) of Regulation No 1107/2009, carried out the scientific risk assessment regarding Closer, in cooperation with the other Member States. In so far as concerns the effects on bees, that assessment was carried out on the basis of the EFSA Guidance Document on Terrestrial Ecotoxicology, published on 17 October 2002. Ireland completed its examination in 2016.
32 In the context of that scientific risk assessment, Ireland did not use the Guidance Document on the risk assessment of plant protection products on bees (‘the 2013 guidance document), published on 4 July 2013, which EFSA prepared further to a request made by the Commission in 2011.
33 On the basis of the scientific risk assessment carried out by Ireland, the CTGB extended, by decision of 5 April 2019, Closer’s authorisation for use in the open cultivation of cabbages and potatoes, whilst imposing a restriction worded as follows:
‘Dangerous to bees and bumblebees. In order to protect bees and other pollinating insects, do not apply this product during flowering of crops or on crops that are not in flower, when these are actively visited by bees and bumblebees. Application is only allowed after the flowering of potato crops. Do not use this product in proximity of self-propagating plants. Eliminate self-propagating plants before they flower.’
34 PAN Europe lodged an objection to that decision, which was rejected as unfounded by the CTGB by decision of 5 February 2020.
35 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 5 February 2020.
36 Before the referring court, PAN Europe claims that the CTGB should not have extended Closer’s authorisation to the use requested on the Netherlands market. It maintains that Ireland’s scientific risk assessment, which was followed by the CTGB, was not based on current scientific and technical knowledge. That risk assessment ought, in PAN Europe’s view, to have been based on the 2013 guidance document, which sets out new scientific knowledge. By failing to take that document into account, the CTGB compromised the high level of protection sought by Regulation No 1107/2009. PAN Europe adds that a scientific risk assessment of a product may be based on any new scientific or technical knowledge, irrespective of its source or the document in which it is contained. It argues, furthermore, that it follows from the precautionary principle that, in the event of uncertainty as to the effects of a product, additional research is necessary before that product can be authorised.
37 The CTGB contends, before the referring court, that an application for authorisation for placing a plant protection product on the market must be examined on the basis of the legislation in force at the time when that application is made, inasmuch as legal certainty requires that an applicant be able to ascertain the conditions to be satisfied when making such an application. It also contends that the 2013 guidance document was not ‘available’, within the meaning of Article 36(1) of Regulation No 1107/2009, since, when that application was made, that document had yet to be ‘adopted’ by the Commission, given the scientific uncertainty and the lack of consensus amongst the Member States. In any event, the risks associated with the use of Closer have been eliminated by the restriction included by the CTGB in the decision of 5 April 2019 referred to in paragraph 33 of the present judgment, since no authorisation was granted in respect of flowering crops.
38 The referring court seeks to ascertain, first, whether the Member State that decides on the authorisation for placing a plant protection product on the market (‘the Member State concerned’) may carry out its own risk assessment of such a product where the Member State examining the application under Article 36(1) of Regulation No 1107/2009 has already carried out such an assessment in accordance with that provision or whether, pursuant to Article 36(2) of that regulation, the Member State concerned is bound by that assessment for the purposes of authorising that product, without being able to carry out its own assessment.
39 In that connection, the referring court observes that, although Article 36(3) of Regulation No 1107/2009 provides that, by way of derogation from Article 36(2), appropriate conditions in so far as concerns compliance with the requirements referred to in Article 31(3) and (4) of that regulation and other risk mitigation measures may be imposed, those requirements must derive from specific conditions of use. That is not the case in the situation at issue in the main proceedings, in so far as the debate relates to the question whether the risk assessment at issue is to be carried out on the basis of the EFSA Guidance Document on Terrestrial Ecotoxicology, published on 17 October 2002, or on that of the 2013 guidance document. In any event, taking the view that an obligation to take account of the assessment carried out by the Member State examining the application under Article 36(1) of Regulation No 1107/2009 would be contrary to the precautionary principle, that court considers that the Member State concerned is not bound by such an assessment.
40 Second, the referring court asks whether, in the event that the Member State concerned is bound by that assessment, it may be considered that the right to an effective remedy under Article 47 of the Charter has been observed and, in particular, whether the assessment carried out by the Member State examining the application under Article 36(1) of Regulation No 1107/2009 may be challenged before the courts of the Member State concerned. In that regard, the referring court states that, under Netherlands law, if an administrative objection is directed against the risk assessment carried out by the Member State examining the application under Article 36(1) of Regulation No 1107/2009, the CTGB should conduct an in-depth review of that assessment. Should it find that that assessment is insufficiently reasoned, it ought to be able to substitute its own statement of reasons.
41 Third, the referring court seeks to ascertain whether, in the event that it should be found that the risk assessment carried out by the Member State examining the application under Article 36(1) of Regulation No 1107/2009 is not sufficiently reasoned, that Member State is required to review that assessment or whether it falls to the Member State concerned – in consultation or otherwise with the Member State examining the application under Article 36(1) of Regulation No 1107/2009 – to carry out a new assessment itself. Should the Member State concerned be entitled to carry out its own assessment, this raises the question whether that infringes the principles of uniformity and harmonisation that underpin Regulation No 1107/2009.
42 Fourth, the referring court questions, by reference to the adoption of the guidance documents referred to in Article 77 of Regulation No 1107/2009, the interpretation of the phrase ‘in the light of current scientific and technical knowledge using guidance documents available at the time of application’ in Article 36(1) of Regulation No 1107/2009. That court states that those terms can be interpreted as requiring the Member State examining the application under the latter provision to carry out its assessment by taking into account solely those guidance documents that have already been adopted by the Commission, whereas some of the scientific and technical knowledge contained in those documents may no longer be current.
43 Fifth, even if the Member State examining the application under Article 36(1) of Regulation No 1107/2009 cannot confine itself to basing its assessment on the guidance documents adopted by the Commission, the referring court is uncertain as to whether it is sufficient for that State to carry out that assessment on the basis of a guidance document containing data that are already available while that document has yet to be adopted by the Commission, or whether that State must also take into account all scientific and technical knowledge, including that which is not contained in the guidance documents. That court states, in that connection, that with a view to authorising the placing of a plant protection product on the market, Article 29(1)(e) of Regulation No 1107/2009 lays down the requirement that, in the light of current scientific and technical knowledge, that product is to comply with the requirements provided for in Article 4(3) of that regulation. No reference is made to the guidance documents in that provision. The referring court points out that the precautionary principle also militates in favour of taking into account all available scientific and technical knowledge, since that principle entails an overall assessment based on the most reliable scientific data available and the most recent results of international research.
44 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 the Member State concerned, which decides on the authorisation of a plant protection product under Article 36(2) of Regulation [No 1107/2009], have any discretion to depart from the assessment of the zonal rapporteur Member State that examined the application under Article 36(1) of [that regulation] and, if so, what is the margin of that discretion?
(2) If the answer to the first question is that the Member State concerned has no or limited discretion, how is the right to an effective remedy under Article 47 of the Charter given effect? Is it then possible for the correctness of the zonal rapporteur Member State’s assessment to be fully challenged before the national court of the Member State concerned?
(3) If the Member State concerned, or the court of that Member State, concludes that the zonal rapporteur Member State’s assessment is based on insufficient grounds, to what extent is the Member State concerned required to involve the zonal rapporteur Member State in preparing an adequately reasoned assessment?
(4) Can the zonal rapporteur Member State confine itself to an assessment based exclusively on adopted guidance documents, even if the scientific and technical knowledge contained therein is no longer fully up to date?
(5) If the answer to the previous question is in the negative, can the Member State carrying out the zonal assessment additionally rely on scientific and technical knowledge contained in guidance documents which have already been drawn up but not yet adopted, or must the Member State carrying out the zonal assessment take account of all scientific and technical knowledge available even outside of the guidance documents?’
The application to reopen the oral part of the procedure
45 Following the delivery of the Opinion of the Advocate General on 28 September 2023, Corteva, by document lodged at the Registry of the Court of Justice on 23 October 2023, asked the Court to order the reopening of the oral part of the procedure, pursuant to Article 83 of the Rules of Procedure of the Court of Justice.
46 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.
47 In its application, Corteva claims that the Opinion of the Advocate General is not impartial, that it contains a contra legem interpretation of the provisions of EU law and a misinterpretation of the case-law of the Court, and that the answers provided in that Opinion do not serve to answer the questions referred for a preliminary ruling in the present case.
48 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.
49 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).
50 In the present case, since Corteva merely disputes certain passages of the Advocate General’s Opinion and submits observations on the content thereof, there is no need to order the reopening of the oral part of the procedure.
Consideration of the questions referred
The first question
51 By its first question, the referring court is asking, in essence, whether Article 36 of Regulation No 1107/2009 must be interpreted as meaning that the Member State that makes a decision concerning authorisation for placing a plant protection product on the market, under Article 36(2) and (3) of that regulation, may depart from the scientific risk assessment of that product carried out by the Member State examining the application for such authorisation, under Article 36(1) of that regulation.
52 Chapter III of Regulation No 1107/2009 is devoted to ‘Plant protection products’. Section 1 of that chapter regulates authorisations for such products. Subsection 1 of that section, which comprises Articles 28 to 32 of that regulation, sets out the requirements to which those authorisations are subject and the content thereof. Subsection 2 of that section, which comprises Articles 33 to 39 of that regulation, governs the procedure to be followed.
53 It is clear from Article 33(1) of Regulation No 1107/2009 that an applicant is required to make an application for authorisation to each Member State where the plant protection product is intended to be placed on the market. Under the first paragraph of Article 35 of that regulation, the application is to be examined by a single Member State, namely that proposed by the applicant, unless another Member State in the same zone agrees to examine it.
54 In accordance with the second paragraph of Article 35 and the second sentence of the first subparagraph of Article 36(1) of that regulation, the other Member States in the zone concerned are to cooperate to ensure a fair division of the workload. Those Member States are also to have the opportunity to submit comments to be considered in the risk assessment of such a product.
55 However, the risk assessment under the first and second subparagraphs of Article 36(1) of Regulation No 1107/2009 is to be carried out exclusively by the Member State examining the application for authorisation under Article 36(1) of that regulation, without that assessment having to be approved by the other Member States in that same zone.
56 In accordance with Article 36(2) of that regulation, it is on the basis of that assessment that the Member States concerned – that is to say, the Member States to which an application for marketing authorisation on their territory has been submitted – are to grant or refuse such authorisation.
57 In that context, it is not ruled out that a Member State concerned may not concur with the conclusions of the risk assessment which has been carried out pursuant to the first and second subparagraphs of Article 36(1) of Regulation No 1107/2009. Such a situation may arise irrespective of whether that Member State has or has not submitted its observations as part of the procedure for that risk assessment.
58 In that connection, the first subparagraph of Article 36(3) of that regulation provides for the possibility, for the Member State concerned, to impose (i) appropriate conditions with respect to the content and duration of the authorisation granted on its territory and (ii) other risk mitigation measures deriving from specific conditions of use.
59 Furthermore, where the concerns of the Member State concerned relating to human or animal health or the environment cannot be controlled by the establishment of the national risk mitigation measures, that Member State may refuse authorisation of the plant protection product in its territory, in accordance with the second subparagraph of Article 36(3) of Regulation No 1107/2009, if, due to its specific environmental or agricultural circumstances, the product in question still poses an unacceptable risk to human or animal health or the environment.
60 It follows from the foregoing that the Member States concerned, within the meaning of Article 36(2) of Regulation No 1107/2009, which have available to them an assessment carried out by another Member State, pursuant to paragraph 1 of that article, can, within the limits laid down in paragraph 3 of that article, impose risk mitigation measures, or even refuse to authorise such a product in their territory, with a view to ruling out an unacceptable risk to human or animal health or the environment.
61 It is appropriate, nonetheless, also to take account of the context into which Article 36 of Regulation No 1107/2009 fits. In that regard, it should be recalled, first, that Article 28 of that regulation expressly states, in paragraph 1 thereof, that a plant protection product is not to be placed on the market or used unless it has been authorised in the Member State concerned ‘in accordance with this Regulation’, which means compliance with the procedure laid down in Article 36 of Regulation No 1107/2009.
62 Compliance with the details of that procedure makes it possible – as the Advocate General essentially observes in point 37 of her Opinion – to ensure a fair division of the workload between the Member States. It is for the Member State examining the application to carry out the risk assessment, while the Member States concerned are responsible for risk management by making the final decision as to authorisation in their respective territories.
63 Such a framework for the leeway afforded to the Member States in the procedures for authorising plant protection products stems from the harmonisation of the applicable rules, with a view to simplifying those procedures and ensuring consistency across all of the Member States, as is clear, in respect of plant protection products, from Article 1(3) of Regulation No 1107/2009, read in the light of recitals 5, 9, 25 and 29 of that regulation.
64 Second, in the context of a case concerning the provisions on mutual recognition of authorisations for plant protection products, set out in Subsection 3, Section 1 of Chapter III of Regulation No 1107/2009, the Court has observed that, where a Member State received an application for authorisation for placing on the market a plant protection product already authorised for that use by another Member State, it is not required to grant it where the conditions under Article 36(3) of that regulation apply due to its specific environmental or agricultural circumstances (see, to that effect, judgment of 3 December 2020, Région de Bruxelles-Capitale v Commission, C‑352/19 P, EU:C:2020:978, paragraphs 51 and 53).
65 Third, it is undeniable that the Member States can, under Article 44(1) and (3) of Regulation No 1107/2009, (i) review an authorisation at any time where there are indications that a requirement referred to in Article 29(1) of that regulation is no longer satisfied, and (ii) withdraw or amend that authorisation where those requirements are no longer satisfied.
66 Thus, a Member State is, in particular, required to withdraw an authorisation, in accordance with Article 29(1)(e) and Article 44(3)(a) of Regulation No 1107/2009, where it finds, in the light of current scientific and technical knowledge, that the plant protection product has a harmful effect on human or animal health or unacceptable effects on the environment, within the meaning of Article 4(3)(b) and/or (e) of that regulation (see, to that effect, judgment delivered today, PAN Europe (Assessment of endocrine disrupting properties), C‑309/22 and C‑310/22, paragraph 81 and the case-law cited).
67 As the Advocate General essentially observes in point 52 of her Opinion, a Member State may withdraw an authorisation where the most reliable scientific or technical knowledge available to that Member State indicates that there may be immediate or delayed harmful effects on human or animal health or unacceptable effects on the environment. Accordingly, a Member State concerned, within the meaning of Article 36(2) of Regulation No 1107/2009, also cannot be required to authorise the placing of a plant protection product on the market if there is scientific or technical knowledge identifying an unacceptable risk to human or animal health or to the environment associated with the use of that product (see, to that effect, judgment delivered today, PAN Europe (Assessment of endocrine disrupting properties), C‑309/22 and C‑310/22, paragraph 83).
68 That interpretation of Article 36 of Regulation No 1107/2009 is borne out by the purpose of that regulation which, as is stated in Article 1(3) and reflected in recital 8 thereof, is in particular to ensure a high level of protection of human and animal health and the environment. In that connection, the Court, making reference to recital 24 of Regulation No 1107/2009, has already ruled that 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 (judgment of 19 January 2023, Pesticide Action Network Europe and Others, C‑162/21, EU:C:2023:30, paragraphs 46 and 48 and the case-law cited).
69 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 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.
70 In the light of the foregoing, the answer to the first question is that Article 36 of Regulation No 1107/2009 must be interpreted as meaning that the Member State that takes a decision concerning the authorisation for placing a plant protection product on the market, under Article 36(2) of that regulation, may depart from the scientific risk assessment of that product carried out by the Member State examining the application for such an authorisation, under Article 36(1) of that regulation, in the situations referred to in the second subparagraph of Article 36(3) of that regulation, in particular where it has available the most reliable scientific and technical data – which the latter Member State did not take into account when preparing its assessment – which identifies an unacceptable risk to human or animal health or to the environment.
The second question
71 By its second question, the referring court is asking, in essence, whether Article 36 of Regulation No 1107/2009, read in the light of the principle of effective judicial protection, must be interpreted as meaning that the conclusions of the assessment carried out by the competent Member State pursuant to Article 36(1) of that regulation, may be subject to review by a court of the Member State concerned, within the meaning of Article 36(2) of that regulation, hearing an action brought against a decision adopted under Article 36(2) or (3) of that regulation.
72 In order to answer that question, it should be observed, as a preliminary point, that the fourth subparagraph of Article 36(3) of Regulation No 1107/2009 requires only that Member States provide for the possibility of challenging a decision refusing the authorisation of plant protection products before national courts or other instances of appeal. However, it follows from the judgment of 28 October 2020, Associazione GranoSalus v Commission (C‑313/19 P, EU:C:2020:869), that it is also incumbent on the Member States to provide for a system of remedies and procedures which also ensure compliance with the fundamental right to an effective remedy of third parties demonstrating an interest in the context of the implementation, by the national authorities of those States, of that regulation.
73 In that regard, since the decisions adopted under Article 36(2) or (3) of Regulation No 1107/2009 are taken on the basis of the conclusions of the assessment carried out by the competent Member State pursuant to Article 36(1) of that regulation, those conclusions are necessarily part of the relevant factors of the situation that those decisions are intended to regulate. Such conclusions must therefore be taken into consideration by the courts of the Member State concerned, within the meaning of Article 36(2) of Regulation No 1107/2009 where they are ruling on the merits of such decisions (see, to that effect, judgment of 8 July 2010, Afton Chemical, C‑343/09, EU:C:2010:419, paragraph 34).
74 However, since the decisions referred to in the preceding paragraph of the present judgment are the result of assessments of highly complex scientific and technical facts, such national courts cannot substitute their own assessment of those facts for that of the competent national authorities (see, to that effect, judgment of 21 January 1999, Upjohn, C‑120/97, EU:C:1999:14, paragraphs 33 to 35).
75 It follows that the courts of the Member State concerned, within the meaning of Article 36(2) of Regulation No 1107/2009, called upon to rule on the merits of the decisions adopted under Article 36(2) or (3) of that regulation, have jurisdiction to assess the lawfulness of those decisions in the light of the substantive and procedural conditions laid down in those provisions (see, by analogy, judgment of 8 September 2011, Monsanto and Others, C‑58/10 to C‑68/10, EU:C:2011:553, paragraph 79), it being understood that those courts may, on the one hand, take into consideration the conclusions of the assessment carried out by the competent Member State under Article 36(1) of that regulation but that, on the other hand, they cannot substitute their assessment of the scientific and technical facts for that of the competent national authorities.
76 In the light of the foregoing, the answer to the second question is that Article 36 of Regulation No 1107/2009, read in the light of the principle of effective judicial protection, must be interpreted as meaning that the conclusions of the assessment carried out by the competent Member State, pursuant to Article 36(1) of that regulation, may be taken into consideration by the court of the Member State concerned, within the meaning of Article 36(2) of that regulation, called upon to rule on the lawfulness of a decision adopted under Article 36(2) or (3) of that regulation, in the light of the substantive and procedural conditions laid down in those provisions, it being understood that that court cannot substitute its assessment of the scientific and technical facts for that of the competent national authorities.
The third question
77 By its third question, the referring court is asking, in essence, whether Article 36(2) and (3) of Regulation No 1107/2009 must be interpreted as meaning that, where the Member State taking a decision as to the authorisation for placing a plant protection product on the market under those provisions takes the view that the scientific risk assessment carried out by the Member State examining the application under Article 36(1) of that regulation is insufficiently reasoned, the former Member State is required to involve the latter Member State in carrying out a fresh assessment on the basis of which the authorisation for placing a plant protection product on the market may be granted.
78 As a preliminary point, it should be recalled that the national authorities called upon to intervene pursuant to Article 36 of Regulation No 1107/2009 must comply with the general principle of EU law of sound administration, which entails requirements which the Member States must observe when implementing EU law. Among those requirements, the obligation to state reasons for decisions adopted by the national authorities is particularly important, since it puts the addressees of such decisions in a position to defend their rights and decide in full knowledge of the circumstances whether it is worthwhile to bring an action against those decisions (see, to that effect, judgments of 15 October 1987, Heylens and Others, 222/86, EU:C:1987:442, paragraph 15, and of 21 December 2023, Infraestruturas de Portugal and Futrifer Indústrias Ferroviárias, C‑66/22, EU:C:2023:1016, paragraph 87).
79 That said, and as the Commission states in its written observations, Regulation No 1107/2009 does not lay down any specific arrangements for settling differences of opinion between the Member States in the event that the Member State concerned considers, when dealing with an application for authorisation for placing a plant protection product on the market, that a scientific risk assessment carried out by the Member State examining the application under Article 36(1) of that regulation has provided an insufficient statement of reasons for the concerns of the Member State concerned relating to human or animal health or the environment, in connection with the environmental or agricultural circumstances specific to its territory.
80 However, it is clear from the third subparagraph of Article 36(3) of Regulation No 1107/2009 that the Member State concerned, which refuses to authorise the plant protection product in its territory under the second subparagraph of Article 36(3) of that regulation, notwithstanding the risk assessment carried out by the Member State examining the application under Article 36(1) of that regulation, is immediately to inform the applicant and the Commission of its decision and provide a technical or scientific justification therefor.
81 Furthermore, as has been recalled in paragraph 65 of the present judgment, as regards the provisions relating to the renewal, withdrawal and amendment of authorisations for placing plant protection products on the market, set out in Subsection 4 of Section 1 of Chapter III of Regulation No 1107/2009, the Members States can, in accordance with Article 44(1) of that regulation, review a marketing authorisation at any time where there are indications that a requirement referred to in Article 29 is no longer satisfied.
82 However, in the context of the review conducted pursuant to Article 44 of Regulation No 1107/2009, the withdrawal or amendment of a marketing authorisation is in no way contingent on the prior amendment of the assessment carried out by the Member State that examined the application for authorisation under Article 36(1) of that regulation. By contrast, in accordance with Article 44(4) of that regulation, where a Member State withdraws or amends an authorisation in accordance with Article 44(3) of the regulation, it is immediately to inform, inter alia, the holder of the authorisation, the other Member States and the Commission.
83 It is clear from the considerations above that the Member State concerned, within the meaning of Article 36(2) of Regulation No 1107/2009, cannot be required to involve, on the sole basis of that regulation, the Member State examining the application under Article 36(1) of that regulation, or the other Member States belonging to the same zone, where that Member State carries out its own risk assessment in the context of the procedure for authorising the placing of a plant protection product on the market in its territory, under Article 36(2) and (3) of that regulation.
84 In the light of the foregoing, the answer to the third question is that Article 36(2) and (3) of Regulation No 1107/2009 must be interpreted as meaning that where the Member State taking a decision as to the authorisation for placing a plant protection product on the market under those provisions takes the view that the scientific risk assessment carried out by the Member State examining the application under Article 36(1) of that regulation is insufficiently reasoned in the light of the concerns of the Member State concerned relating to human or animal health or the environment, in connection with the environmental or agricultural circumstances specific to its territory, the former Member State is not required to involve the latter Member State in carrying out a fresh assessment on the basis of which the authorisation for placing a plant protection product on the market may be granted.
The fourth and fifth questions
85 As a preliminary point, it should be recalled that, according to settled case-law, in the procedure laid down by Article 267 TFEU providing for cooperation between national courts and the Court of Justice, it is for the latter to provide the national court with an answer which will be of use to it and enable it to decide the case before it. To that end, the Court should, where necessary, reformulate the questions referred to it (judgments of 17 July 1997, Krüger, C‑334/95, EU:C:1997:378, paragraphs 22 and 23, and of 18 November 2021, A. S.A., C‑212/20, EU:C:2021:934, paragraph 36).
86 To those ends, the Court may extract from all the information provided by the national court, in particular from the reasons in the order for reference, the points of EU law which require interpretation in view of the subject matter of the dispute in the main proceedings. The Court may also decide to take into consideration rules of EU law to which the national court has made no reference in the wording of its question (see, to that effect, judgments of 13 December 1984, Haug-Adrion, 251/83, EU:C:1984:397, paragraph 9; of 20 March 1986, Tissier, 35/85, EU:C:1986:143, paragraph 9; and of 29 April 2021, Banco de Portugal and Others, C‑504/19, EU:C:2021:335, paragraph 30).
87 In the present case, it should be noted that the fourth and fifth questions refer to the Member State examining the application for authorisation under Article 36(1) of Regulation No 1107/2009 – namely, Ireland – whereas the subject matter of the dispute before the referring court is the rejection, by the CTGB, of the objection lodged with it by PAN Europe concerning its decision approving the extension of the authorisation for placing the plant protection product at issue on the market in the Netherlands.
88 In those circumstances, in order to give the referring court an answer which will be of use to it, it must be held that, by its fourth and fifth questions, that court is asking, in essence, whether Article 29(1)(e) and Article 36(2) of Regulation No 1107/2009 must be interpreted as meaning that, in order to challenge the authorisation for placing a plant protection product on the market in the territory of the Member State taking a decision concerning such authorisation under the latter provision, the most reliable scientific and technical data available may be raised before the authorities or the courts of that Member State with a view to demonstrating that the scientific risk assessment of that plant protection product, carried out by the Member State examining the application under Article 36(1) of that regulation, is insufficiently reasoned.
89 First, as regards the wording of those provisions, it should be recalled, in the first place, that Article 29 of Regulation No 1107/2009, which concerns the requirements for the authorisation for placing plant protection products on the market, provides, in paragraph 1(e) thereof, that without prejudice to Article 50 of that regulation, a plant protection product is only to be authorised where it complies with the requirement that ‘in the light of current scientific and technical knowledge, it complies with the requirements provided for in Article 4(3)’ of that regulation.
90 In the second place, the Court has stated that, in accordance with Article 36(1) of Regulation No 1107/2009, the Member State dealing with an application for authorisation of a plant protection product must undertake an independent, objective and transparent assessment of that application in the light of current scientific and technical knowledge. With that in mind, it is the duty of the competent authorities, in particular, to take account of the most reliable scientific data available and the most recent results of international research and not to give in all cases preponderant weight to the studies provided by the applicant (see, to that effect, judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraphs 66 and 94).
91 It follows that neither the wording of Article 29(1)(e) nor that of Article 36(2) of Regulation No 1107/2009 indicates that, where an administrative or judicial decision is to be adopted in the Member State concerned as to the authorisation for placing a plant protection product on its national market, the authorities and the courts 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.
92 The wording of Article 29(1)(e) and of Article 36(2) of Regulation No 1107/2009 therefore does not preclude the most reliable scientific and technical information available being raised, before those authorities and courts, with a view to challenging the authorisation of such a product in the territory of the Member State concerned, irrespective of the source of that information or the time when it became available.
93 The reference made, in Article 36(1) of that regulation, to the use of guidance documents available at the time of application does not call that interpretation into question. It cannot, in fact, be inferred from that provision that the Member State examining that application must limit itself to basing its risk assessment solely on the guidance documents available, where it considers that such documents do not sufficiently reflect current scientific and technical knowledge in the light of which it is required to carry out its assessment.
94 Aside from the fact that such an interpretation would be contrary to the case-law cited in paragraph 90 of the present judgment, the non-binding nature of those documents must also be taken into account. As the Advocate General essentially observes in point 74 of her Opinion, since Article 77 of Regulation No 1107/2009 provides only that the Commission may adopt such documents, the Member State examining the application referred to in the preceding paragraph of the present judgment must, in turn, also be able, in the absence of such documents, to carry out its risk assessment on the basis of the most reliable scientific information available and of the most recent results of international research.
95 Second, as to the context of which Article 29(1) and Article 36(2) of Regulation No 1107/2009 form part, regard must be had to the uniform principles for evaluation and authorisation of plant protection products, to which the first of those provisions refers and which are set out in the annex to Regulation No 546/2011.
96 However, according to point 2(c) under heading A of Part I of that annex, in evaluating 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.
97 It should also be noted that Articles 44 and 56 of Regulation No 1107/2009 also make reference to the taking into consideration of developments in scientific and technical knowledge.
98 In fact, on the one hand, as has been held in paragraph 65 of the present judgment, it is clear from Article 44(1) of that regulation that the Member States may review an authorisation for the placing of a plant protection product on the market at any time where there are indications that a requirement referred to in Article 29 is no longer satisfied. To that end, it is expressly provided in Article 44(3)(d) of that regulation that the Member State concerned is to withdraw or amend the authorisation previously granted where, on the basis of developments in scientific and technical knowledge, the manner of use and amounts used can be modified.
99 On the other hand, Article 56 of Regulation No 1107/2009 provides that the holder of an authorisation for the placing on the market of a plant protection product is immediately to notify the Member States that granted an authorisation of any new information concerning that plant protection product which suggests that the plant protection product no longer complies with the criteria set out in Articles 4 and 29 of that regulation.
100 The obligation to notify includes, under the fourth subparagraph of Article 56(1) of that regulation, relevant information on decisions or assessments by international organisations or by public bodies which authorise plant protection products or active substances in third countries.
101 Third, the interpretation in paragraph 92 of the present judgment is also borne out by the objective of Regulation No 1107/2009.
102 As has been stated in paragraph 68 of the present judgment, that regulation seeks to ensure a high level of protection of human and animal health and the environment. Furthermore, as is stated in Article 1(4) of that regulation, the provisions thereof are based on the precautionary principle and do not prevent Member States from applying that principle where there is scientific uncertainty as to the risks to human or animal health or the environment posed by plant protection products to be authorised in their territory.
103 The possibility of raising any scientific or technical knowledge that is relevant, reliable and current before the authorities and courts of the Member State concerned, within the meaning of Article 36(2) of that regulation, with a view to challenging the authorisation of a plant protection product in the territory of that Member State, contributes, in line with the precautionary principle, to the attainment of that objective.
104 Moreover, the findings set out in the preceding paragraphs are not called into question by the requirement of compliance with the principle of legal certainty.
105 In its written observations, Corteva claims in essence that that principle requires that the examination of an application for authorisation for placing a plant protection product on the market be carried out by reference to the scientific and technical knowledge existing at the time when that application was made.
106 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).
107 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 paragraphs 68 and 102 of the present judgment – to ensure a high level of protection of 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.
108 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.
109 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 placing a plant protection product on the market was made cannot be regarded as being contrary to the principle of legal certainty.
110 In the light of the foregoing, the answer to the fourth and fifth questions is that Article 29(1)(e) and Article 36(2) of Regulation No 1107/2009 must be interpreted as meaning that, in order to challenge the authorisation for placing a plant protection product on the market in the territory of the Member State taking a decision concerning such authorisation under the latter provision, the most reliable scientific and technical data available may be raised before the authorities or the courts of that Member State with a view to demonstrating that the scientific risk assessment of that plant protection product, carried out by the Member State examining the application under Article 36(1) of that regulation, is insufficiently reasoned.
Costs
111 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:
1. Article 36 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
must be interpreted as meaning that the Member State that takes a decision concerning the authorisation for placing a plant protection product on the market, under Article 36(2) of that regulation, may depart from the scientific risk assessment of that product carried out by the Member State examining the application for such an authorisation, under Article 36(1) of that regulation, in the situations referred to in the second subparagraph of Article 36(3) of that regulation, in particular where it has available the most reliable scientific and technical data – which the latter Member State did not take into account when preparing its assessment – which identifies an unacceptable risk to human or animal health or to the environment.
2. Article 36 of Regulation No 1107/2009, read in the light of the principle of effective judicial protection,
must be interpreted as meaning that the conclusions of the assessment carried out by the competent Member State, pursuant to Article 36(1) of that regulation, may be taken into consideration by the court of the Member State concerned, within the meaning of Article 36(2) of that regulation, called upon to rule on the lawfulness of a decision adopted under Article 36(2) or (3) of that regulation, in the light of the substantive and procedural conditions laid down in those provisions, it being understood that that court cannot substitute its assessment of the scientific and technical facts for that of the competent national authorities.
3. Article 36(2) and (3) of Regulation No 1107/2009
must be interpreted as meaning that where the Member State taking a decision as to the authorisation for placing a plant protection product on the market under those provisions takes the view that the scientific risk assessment carried out by the Member State examining the application under Article 36(1) of that regulation is insufficiently reasoned in the light of the concerns of the Member State concerned relating to human or animal health or the environment, in connection with the environmental or agricultural circumstances specific to its territory, the former Member State is not required to involve the latter Member State in carrying out a fresh assessment on the basis of which the authorisation for placing a plant protection product on the market may be granted.
4. Article 29(1)(e) and Article 36(2) of Regulation No 1107/2009
must be interpreted as meaning that in order to challenge the authorisation for placing a plant protection product on the market in the territory of the Member State taking a decision concerning such authorisation under the latter provision, the most reliable scientific and technical data available may be raised before the authorities or the courts of that Member State with a view to demonstrating that the scientific risk assessment of that plant protection product, carried out by the Member State examining the application under Article 36(1) of that regulation, is insufficiently reasoned.
[Signatures]