6 May 2021 (*1)

(Appeal – Regulation (EC) No 1107/2009 – Articles 4 and 21 – Criteria for approval – Review of approval – Plant protection products – Implementing Regulation (EU) No 485/2013 – Active substances clothianidin and imidacloprid – Seeds treated with plant protection products containing those active substances – Prohibition of non-professional use – Precautionary principle)

In Case C‑499/18 P,

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 27 July 2018,

Bayer CropScience AG,

Bayer AG, established in Monheim am Rhein (Germany),

represented by M. Zdzieborska, Solicitor, A. Robert, avocate, K. Nordlander, advokat, C. Zimmermann, avocat, and P. Harrison, Solicitor,

appellants,

the other parties to the proceedings being:

Association générale des producteurs de maïs et autres céréales cultivées de la sous-famille des panicoïdées (AGPM), established in Montardon (France),

The National Farmers’ Union (NFU), established in Stoneleigh (United Kingdom), represented initially by H. Mercer QC and J. Robb, Barrister, instructed by N. Winter, Solicitor, and subsequently by H. Mercer QC, J. Robb, Barrister, and K. Tandy, advocate,

Association européenne pour la protection des cultures (ECPA), established in Brussels (Belgium), represented initially by D. Abrahams, E. Mullier and I. de Seze, avocats, and subsequently by D. Abrahams and E. Mullier, avocats,

Rapool-Ring GmbH Qualitätsraps deutscher Züchter, established in Isernhagen (Germany),

European Seed Association (ESA), established in Brussels (Belgium), represented initially by P. de Jong, avocat, K. Claeyé, advocaat, and E. Bertolotto, avocate, and subsequently by P. de Jong, avocat, and K. Claeyé, advocaat,

Agricultural Industries Confederation Ltd, established in Peterborough (United Kingdom), represented initially by P. de Jong, avocat, K. Claeyé, advocaat, and E. Bertolotto, avocate, then by J. Gaul and P. de Jong, avocats, and by K. Claeyé, advocaat,

interveners at first instance,

European Commission, represented by B. Eggers, P. Ondrůšek, X. Lewis and I. Naglis, acting as Agents,

defendant at first instance,

supported by:

Stichting De Bijenstichting, established in Vorden (Netherlands), represented by L. Smale, advocate,

intervener in the appeal,

Union nationale de l’apiculture française (UNAF), established in Paris (France), represented by B. Fau and J.-F. Funke, avocats,

Deutscher Berufs- und Erwerbsimkerbund eV, established in Soltau (Germany),

Österreichischer Erwerbsimkerbund, established in Großebersdorf (Austria),

represented by B. Tschida and A. Willand, Rechtsanwälte,

Pesticide Action Network Europe (PAN Europe), established in Brussels,

Bee Life European Beekeeping Coordination (Bee Life), established in Louvain-la-Neuve (Belgium),

Buglife – The Invertebrate Conservation Trust, established in Peterborough,

Stichting Greenpeace Council (Greenpeace), established in Amsterdam (Netherlands),

represented by B. Kloostra, advocaat,

Kingdom of Sweden, represented initially C. Meyer-Seitz, A. Falk, H. Shev, J. Lundberg and E. Karlsson, and subsequently by C. Meyer-Seitz, H. Shev and E. Karlsson, acting as Agents,

interveners at first instance,

THE COURT (First Chamber),

composed of J.-C. Bonichot, President of the Chamber, K. Lenaerts, President of the Court, acting as a judge of the First Chamber, L. Bay Larsen (Rapporteur), M. Safjan and N. Jääskinen, Judges,

Advocate General: J. Kokott,

Registrar: M. Longar, Administrator,

having regard to the written procedure and further to the hearing on 3 June 2020,

after hearing the Opinion of the Advocate General at the sitting on 17 September 2020,

gives the following

1By their appeal, Bayer CropScience AG and Bayer AG ask, first, that the Court of Justice set aside the judgment of the General Court of the European Union of 17 May 2018, Bayer CropScience and Others v Commission (T‑429/13 and T‑451/13, the judgment under appeal, EU:T:2018:280), by which the General Court dismissed their action seeking the annulment of Commission Implementing Regulation (EU) No 485/2013 of 24 May 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions for the approval of the active substances clothianidin, thiamethoxam and imidacloprid, and prohibiting the use and sale of seeds treated with plant protection products containing those active substances (OJ 2013 L 139, p. 12, ‘the contested regulation’), and, second, that the Court annul the contested regulation in so far as it concerns the appellants.

2Before 14 June 2011 the placing of plant protection products on the market was governed by 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).

3Article 4(1) of Directive 91/414 provided that a plant protection product could not be authorised by a Member State unless, inter alia, its active substances were listed in Annex I to that directive.

Article 5 of that directive provided, inter alia:

‘1. In the light of current scientific and technical knowledge, an active substance shall be included in Annex I for an initial period not exceeding 10 years, if it may be expected that plant protection products containing the active substance will fulfil the following conditions:

(a) their residues, consequent on application consistent with good plant protection practice, do not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, and the said residues, in so far as they are of toxicological or environmental significance, can be measured by methods in general use;

(b) their use, consequent on application consistent with good plant protection practice, does not have any harmful effects on human or animal health or any unacceptable influence on the environment as provided for in Article 4(1)(b)(iv) and (v).

(a) where relevant, an acceptable daily intake (ADI) for man;

(b) an acceptable operator exposure level if necessary;

(c) where relevant, an estimate of its fate and distribution in the environment as well as its impact on non-target species.

…’

5Regulation (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 (OJ 2009 L 309, p. 1) entered into force on 14 June 2011.

Recitals 8 and 16 of that regulation are worded as follows:

‘(8) The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and at the same time to safeguard the competitiveness of Community agriculture. …

(16) The possibility of amending or withdrawing the approval of an active substance in cases where the criteria for approval are no longer satisfied, or where compliance with Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy is compromised [(OJ 2000 L 327, p. 1)], should be provided for under certain conditions.’

7Under Article 28(1) and Article 29(1)(a) of that regulation, 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 that regulation, the authorisation of that product by a Member State presupposing, inter alia, that its active substances have been approved at European Union level.

Article 4 of Regulation No 1107/2009, headed ‘Approval criteria for active substances’, sets out, in particular, the following criteria:

‘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.

…

(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.

…

(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:

(i) its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, groundwater, air and soil taking into account locations distant from its use following long-range environmental transportation;

(ii) its impact on non-target species, including on the ongoing behaviour of those species;

(iii) its impact on biodiversity and the ecosystem.

…

The first subparagraph of Article 7(1) of that regulation, that article being headed ‘Application’, provides:

‘An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to a Member State, (the rapporteur Member State), together with a summary and a complete dossier …, demonstrating that the active substance fulfils the approval criteria provided for in Article 4.’

The second subparagraph of Article 12(2) of that regulation, that article being headed ‘Conclusion by [EFSA]’, states:

‘Within 120 days of the end of the period provided for the submission of written comments, [EFSA] shall adopt a conclusion in the light of current scientific and technical knowledge using guidance documents available at the time of application on whether the active substance can be expected to meet the approval criteria provided for in Article 4 …’

Article 21 of that regulation, headed ‘Review of approval’, provides:

‘1. The Commission may review the approval of an active substance at any time. It shall take into account the request of a Member State to review, in the light of new scientific and technical knowledge and monitoring data, the approval of an active substance, including where, after the review of the authorisations pursuant to Article 44(1), there are indications that the achievement of the objectives established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC is compromised.

Where, in the light of new scientific and technical knowledge it considers that there are indications that the substance no longer satisfies the approval criteria provided for in Article 4, or further information required in accordance with Article 6(f) has not been provided, it shall inform the Member States, [EFSA] and the producer of the active substance, setting a period for the producer to submit its comments.

…’

Annex II to Regulation No 1107/2009, entitled ‘Procedure and criteria for the approval of active substances, safeners and synergists in accordance with Chapter II’, contains in its Section 3, headed ‘Criteria for the approval of an active substance’, point 3.8.3, which reads as follows

‘An active substance, safener or synergist shall be approved only if it is established following an appropriate risk assessment on the basis of [EU] or internationally agreed test guidelines, that the use under the proposed conditions of use of plant protection products containing this active substance, safener or synergist:

–will result in a negligible exposure of honeybees, or

–has no unacceptable acute or chronic effects on colony survival and development, taking into account effects on honeybee larvae and honeybee behaviour.’

Article 69 of that regulation, headed ‘Emergency measures’, states

‘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.’

Article 78(3) of that regulation, that article being headed ‘Amendments and implementing measures’, provides that, following the repeal of Directive 91/414 and its replacement by Regulation No 1107/2009, the active substances included in Annex I to Directive 91/414 are deemed to be approved under Regulation No 1107/2009 and are now listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation No 1107/2009 as regards the list of approved active substances (OJ 2011 L 153, p. 1).

II. Background to the dispute

The active substances clothianidin and imidacloprid (‘the substances covered’), belonging to the neonicotinoid family, which had been included in Annex I to Directive 91/414, are listed in Part A of the Annex to Implementing Regulation No 540/2011.

Following incidents involving misuse of plant protection products, containing, inter alia, the substances covered, which have caused losses of honeybee colonies, the Commission asked EFSA on 18 March 2011 to review the existing scheme for assessing the risk of plant protection products to bees, established by the European and Mediterranean Plant Protection Organisation (EPPO), with regard to assessment of chronic risk to bees, low dose exposure, exposure through guttation and the cumulative risk assessment. The scheme was presented in a document entitled ‘Environmental risk assessment scheme for plant protection products’, bearing the reference PP 3/10 (‘the EPPO Guidance’).

On 30 March 2012 two studies on the sub-lethal effects on bees of substances in the neonicotinoid family were published in Science magazine. The first of those studies concerned products containing the active substance thiamethoxam (‘the Henry study’), the second study concerned products containing the active substance imidacloprid (together, ‘the March 2012 studies’). The authors of those studies concluded that ordinary levels of those two active substances could have a considerable effect on the stability and survival of colonies of honeybees and bumblebees.

On 3 April 2012 the Commission asked EFSA, pursuant to Article 21 of Regulation No 1107/2009, to assess the March 2012 studies and to verify whether the doses used in the experiments referred to in those studies were comparable to the doses to which bees were actually exposed in the European Union, taking into account the authorised uses at EU level and the authorisations granted by the Member States. The Commission also asked whether the results of those studies could be applied to other neonicotinoids used for the treatment of seeds, notably to clothianidin.

On 25 April 2012 the Commission asked EFSA to update, by 31 December 2012, the risk assessments for, inter alia, the substances covered, in particular as regards (i) the acute and chronic effects on bee colony development and survival, taking into account effects on bee larvae and bee behaviour, and (ii) the effects of sub-lethal doses on bee survival and behaviour.

On 23 May 2012, in response to the Commission’s request of 18 March 2011, EFSA published a scientific opinion on the science underpinning the assessment of risks posed by plant protection products to bees (‘the EFSA Opinion’). That document identified a number of areas in which future risk assessments as regards bees should be improved. The opinion drew attention, inter alia, to several weaknesses in the EPPO Guidance, which gave rise to uncertainty about the real extent of exposure of honeybees, and raised issues of relevance to bee health which had not previously been addressed by the EPPO Guidance.

On 1 June 2012, in response to the Commission’s request of 3 April 2012, EFSA presented a statement on the findings in recent studies on the sub-lethal effects on bees of some neonicotinoids in the light of the uses currently authorised in Europe. In that statement, EFSA assessed the March 2012 studies and a third study regarding clothianidin, published in January 2012 (‘the Schneider study’). Overall, EFSA concluded that further research needed to be carried out with different exposure levels or in other situations.

On 16 January 2013, EFSA published its conclusion on the assessment of risks for bees related to the substances covered and to thiamethoxam (‘EFSA’s Conclusion’), identifying:

–a high acute risk to honeybees from exposure via dust drift as a result of the sowing of maize and cereal seeds (clothianidin, imidacloprid, thiamethoxam), oilseed rape (clothianidin, imidacloprid and, except for uses at the lower rate authorised in the European Union, thiamethoxam) as well as cotton (imidacloprid, thiamethoxam),

–a high acute risk to bees from exposure to residues in nectar and pollen from the uses in oilseed rape (clothianidin, imidacloprid) as well as cotton and sunflowers (imidacloprid), and

–a high acute risk from exposure through guttation from the uses in maize (thiamethoxam).

In addition, EFSA’s Conclusion drew attention to numerous areas of uncertainty, owing to the lack of scientific data. These related, in particular, to the exposure of honeybees to dust, to ingestion of contaminated nectar and pollen and to guttation, the acute and long-term risk to honeybee colony survival and development, the risk to other pollinating insects, the risk posed by residues in honey dew and the risk posed by residues in succeeding crops.

In view of the risks identified by EFSA, the Commission adopted the contested regulation on 24 May 2013.

Article 1 of that regulation introduced, inter alia, the following restrictions for the substances covered:

–prohibition of any non-professional use, indoors or outdoors;

–prohibition of uses for seed treatment or soil treatment on the following cereals, when sown between January and June: barley, millet, oats, rice, rye, sorghum, triticale, wheat;

–prohibition of foliar treatments for the following cereals: barley, millet, oats, rice, rye, sorghum, triticale, wheat, and

–prohibition of uses as seed treatment, soil treatment or foliar application for around 100 crops, including oilseed rape, soya, sunflowers and maize, with the exception of uses in greenhouses and with the exception of foliar treatment after flowering.

Furthermore, Article 2 of the contested regulation prohibited the use and placing on the market of seeds of crops listed in Annex II to that regulation which were treated with plant protection products containing the substances covered, with the exception of seeds used in greenhouses.

III. The action before the General Court and the judgment under appeal

By application lodged at the Registry of the General Court on 19 August 2013, Bayer CropScience and Syngenta Crop Protection AG, supported by the Association générale des producteurs de maïs et autres céréales cultivées de la sous-famille des panicoïdées (AGPM), the National Farmers’ Union (NFU), the European Crop Protection Association (ECPA), Rapool-Ring GmbH Qualitätsraps deutscher Züchter, the European Seed Association (ESA) and Agricultural Industries Confederation Ltd brought an action seeking the annulment of the contested regulation.

In support of that action, Bayer CropScience and Syngenta Crop Protection mainly raised complaints relating to the application of Article 21(1) and (3) of Regulation No 1107/2009.

By the judgment under appeal, the General Court dismissed the action and ordered Bayer CropScience and Syngenta Crop Protection to pay the costs.

Bayer CropScience and Bayer claim that the Court of Justice should:

–set aside the judgment under appeal;

–annul the contested regulation in so far as it affects them, and

–order the Commission to pay the costs incurred both in the proceedings before the General Court and in the appeal.

The NFU and Agricultural Industries Confederation submit the same forms of order as Bayer CropScience and Bayer. ECPA supports the forms of order of the latter parties without making any arguments of its own.

The Commission asks the Court to dismiss the appeal and to order Bayer CropScience and Bayer to pay the costs.

The Union nationale de l’apiculture française (UNAF), Deutscher Berufs- und Erwerbsimkerbund eV, Österreichischer Erwerbsimkerbund, Pesticide Action Network Europe (PAN Europe), Bee Life European Beekeeping Coordination (Bee Life), Buglife – The Invertebrate Conservation Trust, Stichting Greenpeace Council (Greenpeace), and the Kingdom of Sweden, interveners at first instance, support the forms of order of the Commission.

The same applies to the Stichting De Bijenstichting, who were, by order of the President of the Court of Justice of 7 February 2019, granted leave to intervene in support of the Commission in the present appeal.

In support of its appeal, Bayer CropScience and Bayer rely on six grounds of appeal concerning, respectively, errors of law relating to the interpretation and application of Article 21(1) and (3) of Regulation No 1107/2009, and errors of law relating to the application of precautionary measures.

It should be recalled, first, that the existence of an interest in bringing an action on the part of an appellant presupposes that the appeal is likely, by its outcome, to benefit him or her (see, inter alia, order of the Vice-President of the Court of 16 January 2020, Highgate Capital Management v Commission, C‑605/19 P(R), not published, EU:C:2020:12, paragraph 49 and the case‑law cited).

In the present case, as the Advocate General states in point 58 of her Opinion, Bayer CropScience’s interest in bringing proceedings was not in doubt prior to the judgment under appeal being delivered, since the contested regulation considerably restricted the use of plant protection products based on the substances covered, which were produced by that company, and those restrictions would have ceased to exist if the action had been upheld.

However, shortly after delivery of the judgment under appeal, Commission Implementing Regulation (EU) 2018/783 of 29 May 2018 amending Implementing Regulation No 540/2011 as regards the conditions for the approval of the active substance imidacloprid (OJ 2018 L 132, p. 31), and Commission Implementing Regulation (EU) 2018/784 of 29 May 2018 amending Implementing Regulation No 540/2011 as regards the conditions for the approval of the active substance clothianidin (OJ 2018 L 132, p. 35) were adopted.

Those regulations, as the Advocate General observes, in essence, in point 59 of her Opinion, although they redefine the conditions for approval of the substances covered, making those conditions even more restrictive than those previously laid down by the contested regulation, have not been challenged by the appellants.

In that respect, the Court has recognised that an applicant’s interest in bringing proceedings does not necessarily disappear by reason of the fact that the act contested by him or her has ceased to have effect in the course of the proceedings (judgment of 28 May 2013, Abdulrahim v Council and Commission, C‑239/12 P, EU:C:2013:331, paragraph 62). An applicant may retain an interest in obtaining a declaration that the act in question is unlawful for the period during which it was applicable and had effect, and such a declaration continues to be at least of interest as a basis for a possible action for damages (judgments of 27 June 2013, Xeda International and Pace International v Commission, C‑149/12 P, not published, EU:C:2013:433, paragraph 32, and of 17 September 2015, Mory and Others v Commission, C‑33/14 P, EU:C:2015:609, paragraph 69 and the case-law cited).

That is the situation in this case. In so far as Bayer CropScience produces and markets active substances covered by the contested regulation and plant protection products containing them, the appeal, if it were to be upheld, would be likely to be of benefit to Bayer CropScience in the context of a possible action for damages.

As regards the argument of UNAF that the appeal is inadmissible in its entirety since the appeal seeks a new assessment of the facts, it should be noted that, apart from the fact that, first, that argument is entirely general and does not identify any specific element of the appeal application in support of the claim that the appeal is inadmissible and, second, that argument has not been raised by the Commission, the defendant in support of whose forms of order UNAF has intervened, the appellants have, on the whole, identified the points in the judgment under appeal which are, in their view, vitiated by errors of law but have not, in addition, asked the Court to engage in a further general assessment of the facts.

Last, it must be noted that the appeal is brought on behalf of Bayer CropScience and Bayer, though only the former company was a party to the proceedings before the General Court. Under Article 56 of the Statute of the Court of Justice of the European Union, an appeal may be brought only by parties and interveners in the proceedings before the General Court and by Member States and the institutions of the European Union. Since Bayer did not take part in the proceedings before the General Court and has not invoked any particular circumstances which might, conceivably, entitle it to bring an appeal, the appeal is inadmissible in so far as it has been brought on behalf of that company.

Further, it should be noted that Syngenta Crop Protection has not brought an appeal against the judgment under appeal and therefore the active substance ‘thiamethoxam’ is not the subject of these proceedings.

(a) Arguments of the parties

Bayer CropScience submits that the General Court erred in law in concluding, in paragraphs 162 and 179 in particular of the judgment under appeal, that an increase in the level of certainty of the previous scientific knowledge could be classified as ‘new knowledge’, thereby authorising the Commission to review the approval concerned under Article 21(1) of Regulation No 1107/2009.

The Commission considers that this ground of appeal should be rejected.

(b) Findings of the Court

Paragraphs 162, 164 and 179 of the judgment under appeal read as follows

‘162… As the ECPA correctly noted, the concept of “new scientific and technical knowledge” cannot be understood as only temporal; it also has a qualitative component which applies, moreover, both to the term “new” and to the term “scientific”. It follows that the threshold for the application of Article 21(1) of Regulation No 1107/2009 is not reached if the “new knowledge” concerns mere repetition of what was previously known, new suppositions without a well-founded basis, or political considerations detached from science. Ultimately, the “new scientific and technical knowledge” must therefore be genuinely relevant to the assessment as to whether the conditions of approval under Article 4 of Regulation No 1107/2009 are still met.

…

164 In conclusion, in order for the Commission to be able to carry out a review of the approval of an active substance under Article 21(1) of Regulation No 1107/2009, it is therefore sufficient that there are new studies … the results of which, as compared with the knowledge available at the time of the earlier assessment, raise concerns as to whether the conditions for approval in Article 4 of Regulation No 1107/2009 are still satisfied, and it is not necessary, at that stage, to verify whether those concerns are well founded, such verification being reserved for the review itself.

…

179 However, to describe such confirmatory results as new scientific knowledge presupposes at the very least that the new methodologies are more reliable than those used previously. In such a situation, it would be the increase in the degree of certainty of the previous knowledge that would have to be described as new scientific knowledge. In the context of a risk management decision in accordance with the precautionary principle, such information must be considered relevant, contrary to [the assertions of Bayer CropScience].’

It is important to note that the import of paragraphs 162, 164 and 179 of the judgment under appeal is that the threshold for the application of the review procedure, provided for in Article 21(1) of Regulation No 1107/2009, presupposes the emergence of new scientific knowledge indicating that the substance concerned may no longer satisfy the approval criteria, and that that new scientific knowledge may consist of new methodologies that have provided results which increase the degree of certainty of the previous scientific knowledge.

However, in setting the threshold for the application of the review procedure in that way, the General Court erred in law.

The first sentence of the first subparagraph of Article 21(1) of Regulation No 1107/2009 permits the Commission to review the approval of an active substance at any time, without specifying further conditions. Only in the situations expressly defined in the second sentence of the first subparagraph of Article 21(1) does the initiation of a review procedure require the existence of new scientific and technical knowledge.

In that respect, the Court has already held that the existence of new scientific and technical knowledge is only one of the situations in which the Commission may re-examine the approval of an active substance (see, to that effect, judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 99).

As regards recital 16 of Regulation No 1107/2009, which Bayer CropScience invokes, that recital is irrelevant since the conditions to which it refers are, as the Advocate General states in point 80 of her Opinion, those which must be met in order to amend or withdraw an approval and not in order to initiate a review procedure.

That said, the error of law identified in paragraph 49 of the present judgment is not such as to require the judgment under appeal to be set aside.

In accordance with the Court of Justice’s settled case-law, if the grounds of a decision of the General Court contain an infringement of EU law but its operative part is shown to be well founded on other legal grounds, such an infringement is not one that should cause that decision to be set aside, and a substitution of grounds must be made (judgment of 23 January 2019, Deza v ECHA, C‑419/17 P, EU:C:2019:52, paragraph 87 and the case-law cited).

Although the General Court wrongly held that new scientific knowledge was necessary to permit the Commission to review the approval of an active substance within the meaning of the first sentence of the first subparagraph of Article 21(1) of Regulation No 1107/2009, the General Court nevertheless correctly found, in paragraph 217 of the judgment under appeal, that the Commission was entitled to consider, in this case, that a review of the approval of the substances covered should be undertaken.

In the light of those considerations, the first ground of appeal must be rejected as being ineffective.

(a) Arguments of the parties

Bayer CropScience complains that the General Court erred in law in its interpretation of Article 21(3) of Regulation No 1107/2009 by holding that, in carrying out the risk assessment, EFSA was entitled to rely on its own opinion and was not required to follow the official guidance document on risk assessments that was in force at the time of the review of the approval of the substances covered.

The Commission considers that this ground of appeal should be rejected.

According to Bayer CropScience, the General Court erred in basing its decision on the fact that it had argued that, in order to carry out the risk assessment, EFSA was obliged to apply the guidance document in force at the time of the granting of the initial approvals, whereas it had argued, as was clear from its initiating application and its reply, that EFSA was obliged to apply the guidance in force at the time of the review of the approval of the substances covered. Furthermore, the official risk assessment guidelines applicable at the time of that review were updated in the course of 2010, that is to say, after the adoption of Regulation No 1107/2009 and the approval criteria referred to in Article 4 of, and point 3.8.3 of Annex II to, that regulation.

The Commission considers that that ground of appeal should be rejected.

(b) Findings of the Court

As is apparent, inter alia, from paragraphs 228, 260 and 271 of the judgment under appeal, the General Court based its decision on the fact that Bayer CropScience argued that EFSA and the Commission were obliged, in the context of the review procedure under Article 21(3) of Regulation No 1107/2009, to base the risk assessment on a guidance document available at the time of the application for approval of an active substance, adopted either at EU or international level, whereas that company in fact, as is clear from the application lodged before the General Court, referred to the guidance document available at the time of the review of the approval of the substances covered.

It follows that the General Court distorted the clear sense of what Bayer CropScience claimed that EFSA and the Commission had done and what allegedly vitiated the procedure for the review of the approval of the substances covered.

While that distortion led the General Court to find, in essence, in paragraphs 266 and 271 of the judgment under appeal, that, in the context of the review procedure under Article 21 of Regulation No 1107/2009, the risk assessment for an approved active substance cannot be based on the guidance documents available at the date of the application for approval of that substance, that distortion did not, however, contrary to what Bayer CropScience claims, lead the General Court to find that such an assessment should not be based on the guidance document in force at the time of the review.

In fact, as is apparent from paragraphs 16, 17, 223 to 235 and 238 of the judgment under appeal, the Commission’s request to EFSA on 18 March 2011 to review the existing scheme, established by EPPO during 2010, for the risk assessment of plant protection products on bees with regard to the assessment of chronic risk to bees, low dose exposure, exposure through guttation and the cumulative risk assessment, followed the adoption of a directive strengthening the conditions for approval, inter alia, of the substances covered, with regard to the protection, in particular, of bees, and, thereafter, EFSA delivered its opinion, which was based on a very thorough use of the available studies, in which (i) the different routes of exposure of the different categories of bees are analysed in detail; (ii) the existing test guidelines are evaluated; (iii) certain weaknesses of these guidelines are identified with regard to the tests used to date, and (iv) it is recommended that the existing guidelines be developed with a view to incorporating the current state of scientific knowledge on certain points, and, where appropriate, new guidelines developed.

The General Court inferred therefrom, in paragraphs 239 and 240 of the judgment under appeal, that, although the EFSA Opinion, which provides a scientific basis for the development of guidance documents and guidelines for the tests to be carried out, does not itself constitute such a document, EFSA could rely on its opinion in the context of the risk assessment, since, as a document analysing in detail the different routes of exposure of the different categories of bees and assessing the existing test guidelines, that opinion could serve to indicate areas where there were deficiencies in the assessments made up to that time that could hide risks which had not yet been assessed and which had not been taken into account in the previous decisions on risk management relating to the active substances covered.

Accordingly, Bayer CropScience submits that the General Court departed from the requirement, laid down in point 3.8.3 of Annex II to Regulation No 1107/2009 and in Article 12(2) thereof, to base the risk assessment on guidelines.

In that respect, it should be recalled that, first, point 3.8.3 of Annex II to Regulation No 1107/2009 provides that an active substance is only to be approved if it is established, after an appropriate risk assessment on the basis of EU or internationally agreed test guidelines, that the use of plant protection products containing that active substance, under the proposed conditions of use, will result in negligible exposure of bees, or will have no unacceptable acute or chronic effects on colony survival and development, taking into account effects on bee larvae and bee behaviour.

Second, the second subparagraph of Article 12(2) of that regulation provides that within 120 days from the expiry of the period for submission of written comments, EFSA must, taking into account the current state of scientific and technical knowledge, and using the guidance documents available at the date of the application for approval of an active substance, adopt a conclusion in which EFSA is to state whether that active substance can be expected to meet the approval criteria provided for in Article 4 of that regulation.

On the other hand, in the context of the review of the approval of an active substance, Article 21(3) of Regulation No 1107/2009, read in conjunction with the second subparagraph of paragraph (1) of that article, provides that, where the Commission, in the light of new scientific and technical knowledge, comes to the conclusion that the approval criteria laid down in Article 4 of that regulation are no longer satisfied, a regulation withdrawing or amending the approval is to be adopted.

It follows from the foregoing that, in the context of the review of the approval of an active substance, the conclusion that the approval criteria laid down in Article 4 of Regulation No 1107/2009 are no longer satisfied may be based on any new knowledge, in so far as it is scientific or technical, regardless of the source or document from which it comes.

Such an interpretation of Article 21(3) of that regulation, which implies that, in the course of that review, account is to be taken of the best scientific and technical knowledge available, is, moreover, consistent with the objective, referred to in recital 8 of that regulation, of ensuring a high level of protection of human and animal health and of the environment.

It follows from all the foregoing that, although the General Court distorted the arguments put forward by Bayer CropScience in support of its plea in law, as noted in paragraphs 60 and 61 of the present judgment, the General Court did not err in law in holding, in paragraph 240 of the judgment under appeal, that EFSA, having identified weaknesses in the EPPO guidelines, could rely on its opinion in the context of the risk assessment. As a document that analyses in detail the different routes of exposure for different categories of bees and assesses the existing test guidelines, the EFSA Opinion could serve to highlight the areas where there were deficiencies in the assessments made to date that could hide risks that had not yet been assessed and which had not been taken into account in the previous risk management decisions relating to the substances covered.

In those circumstances, the second ground of appeal must be rejected as being ineffective.

(a) The first part of the third ground of appeal and the fifth ground of appeal

(1) Arguments of the parties

Bayer CropScience complains that the General Court failed, in paragraphs 309 and 310 of the judgment under appeal, to examine whether the risk assessment and scientific evaluation were sufficiently exhaustive and well informed to justify the adoption of the contested regulation. According to Bayer CropScience, it is contrary to the procedural safeguards contained in Regulation No 1107/2009 for the Commission to rush through a review procedure before hurriedly adopting a decision amending or withdrawing an approval without, at any stage, having carried out or relied on a comprehensive risk assessment.

The Commission contests those arguments.

(2) Findings of the Court

Paragraphs 309 and 310 of the judgment under appeal, on which Bayer CropScience’s complaints in the first part of the third ground of appeal are focused, are worded as follows:

‘309 However, such an extension would necessarily have delayed the Commission’s becoming aware, however imprecisely, as risk manager, of the level of risk posed by the substances covered and, as a result, the taking of a decision on the need to amend the approval requirements for those substances and on the usefulness of doing so. The Commission therefore had conflicting goals: on the one hand, the promptness of the risk assessment and, on the other, its comprehensiveness and accuracy.'

‘310 The question that arises in the present case is not therefore whether, in the abstract and with no time constraints, a more comprehensive and accurate scientific evaluation would have been possible. It follows from the above that the answer to that question will probably be in the affirmative. It is, however, necessary to examine initially whether the deadline for the risk assessment was lawfully selected by the Commission … and, if it was, whether that assessment was conducted taking into account the state of scientific knowledge available on the chosen date …’

It is apparent from paragraphs 307 and 308 of the judgment under appeal that it was accepted that postponing the deadline for EFSA’s risk assessment in order, first, to await the finalisation of a test guidance document and, second, to allow Bayer CropScience to take that guidance document into account, would have made it possible to take into consideration a state of scientific knowledge which was even more up to date than that reflected in EFSA’s Opinion. It was concluded that the fact of the risk assessment’s being completed by 31 December 2012 might mean that certain risks could not be ruled out, even though they did not in fact exist, and that such a situation could be avoided by extending the deadline to a later date.

In that regard, it should be recalled that the provisions of Regulation No 1107/2009 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 (judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 44). The Commission is in the same position where there is scientific uncertainty concerning risks of that sort posed by active substances which are subject to review in accordance with Article 21 of Regulation No 1107/2009.

The precautionary principle means that where there is uncertainty as to the existence or extent of risks, including risks to the environment, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent. Where it proves to be impossible to determine with certainty the existence or extent of the alleged risk, because the results of studies conducted are inconclusive, but the likelihood of real harm to the environment persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures (see, to that effect, judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 43 and the case-law cited).

Thus, contrary to what Bayer CropScience claims, an exhaustive risk assessment cannot be required in a situation where the precautionary principle is applied, which equates to a situation in which there is scientific uncertainty.

Furthermore, the precautionary principle does not require that the adoption of measures under Article 21(3) of Regulation No 1107/2009 be deferred solely on the grounds that studies are underway which may call into question the available scientific and technical data (see, by analogy, judgment of 21 July 2011, Etimine (C‑15/10, EU:C:2011:504, paragraphs 128 and 129).

In the light of the foregoing, it must be held that paragraphs 309 and 310 of the judgment under appeal are not vitiated by the error of law claimed by Bayer CropScience.

Consequently, the first part of the third ground of appeal and the fifth ground of appeal must be rejected as being unfounded.

The second part of the third ground of appeal

(1) Arguments of the parties

85By the second part of the third ground of appeal, Bayer CropScience argues that, by accepting that the Commission could rely on a risk assessment carried out in haste by EFSA and rush its own review by invoking strict time limits, the General Court held, in reality, that the Commission could adopt, on the basis of Article 21(3) of Regulation No 1107/2009, emergency measures falling within the scope of Article 69 of that regulation.

86The Commission disputes this line of argument.

(2) Findings of the Court

87It is important to note that there is no indication in the present case that the conditions for the application of Article 21 of Regulation No 1107/2009 were not met. In particular, it is apparent from paragraphs 312 and 313 of the judgment under appeal, which have not been contested, that, since the deadline for the assessment of the risks posed by the active substances covered was set at 31 December 2012, EFSA was given more time than was legally provided for in Article 21(2) of that regulation to reach its conclusion. Moreover, it is common ground that the Commission did not adopt the contested regulation until 24 May 2013.

The second part of the third ground of appeal must therefore be rejected as being unfounded.

(c) The third part of the third ground of appeal

(1) Arguments of the parties

89According to Bayer CropScience, the General Court erred in law in holding, in paragraph 142 of the judgment under appeal, that since the data generated by the studies carried out for the purposes of the original approval was insufficient, in the light of the amended approval criteria, to account for the totality of the risks to bees associated with the substances covered, the Commission could withdraw the approval granted to those substances. In such circumstances, Bayer CropScience maintains that the Commission had an obligation, first, to put the interested party in a position to produce updated data. The risk assessment carried out by EFSA should have been based on that updated data, when the Commission would have been obliged to assess, on the basis of that updated data, whether the amended approval criteria were met.

90The Commission disputes those arguments.

(2) Findings of the Court

Paragraph 142 of the judgment under appeal reads as follows:

91‘Thus, the Commission will discharge to the requisite legal standard its burden of proof, in the light of Article 21(3) of Regulation No 1107/2009, if it is able to demonstrate that, in the light of a legislative change involving a strengthening of the conditions of approval, the data generated by studies carried out for the purposes of the initial approval were insufficient to identify all the risks for bees linked to the active substance concerned … The precautionary principle requires the withdrawal or amendment of an approval of an active substance where new data invalidate the earlier conclusion that that substance satisfies the approval criteria provided for in Article 4 of Regulation No 1107/2009. Against that background, the Commission need do no more than provide, in accordance with the general rules of evidence, solid and convincing evidence which, while not resolving the scientific uncertainty, may reasonably raise doubts as to the fact that the active substance in question satisfies the approval criteria …’

92It should be emphasised that paragraph 142 of the judgment under appeal concerns only the burden of proof incumbent on the Commission in the review procedure pursuant to Article 21(3) of Regulation No 1107/2009, and not specifically the question whether a producer such as Bayer CropScience was entitled to submit comments or new data on that occasion.

93In any event, with regard to Bayer CropScience’s claim that it should have been given the opportunity to produce updated data in the approval review procedure, it is not disputed that, as is apparent from paragraph 435 of the judgment under appeal, Bayer CropScience was given several opportunities to submit comments in the course of that procedure pursuant to Article 21 of Regulation No 1107/2009.

94However, as the Advocate General states in point 119 of her Opinion, the right to be heard does not oblige the Commission, in the context of a review under Article 21 of Regulation No 1107/2009, to give the producer the opportunity to carry out new studies in order to fill any gaps identified in the available data.

95As stated in paragraph 82 of the present judgment, the precautionary principle does not require that the adoption of measures under Article 21(3) of Regulation No 1107/2009 be deferred solely on the grounds that studies are underway which may call into question the available scientific and technical data.

96Accordingly, the General Court, having regard in particular to the precautionary principle recalled in paragraph 442 of the judgment under appeal, was entitled to hold, in paragraph 446 of that judgment, that Bayer CropScience, in particular, was not entitled to have the Commission postpone the amendment of the approval of the substances covered in order to give it the opportunity to generate the data necessary to fill the gaps identified in EFSA’s Conclusion.

Consequently, the third part of the third ground of appeal must be rejected as being unfounded.

(d) The fourth part of the third ground of appeal

(1) Arguments of the parties

98By the fourth part of its third ground of appeal, Bayer CropScience submits that the General Court infringed the principle of legal certainty in paragraph 142 of the judgment under appeal by concluding that a legislative change in respect of the approval criteria was sufficient in itself to enable the Commission to discharge its burden of proof under Article 21(3) of Regulation No 1107/2009.

99According to Bayer CropScience, if the threshold for the application of Article 21(3) of Regulation No 1107/2009 is higher than that of Article 21(1) of that regulation and the threshold for the application of the latter provision requires new scientific and technical knowledge giving reason to believe that the approval criteria are no longer met, the threshold for the application of Article 21(3) of that regulation must logically require the existence of new scientific and technical knowledge that goes further, supporting the conclusion that the approval criteria are not met.

100The Commission disputes those arguments.

(2) Findings of the Court

101As the General Court stated in paragraph 285 of the judgment under appeal, it is settled case-law that the principle of legal certainty requires that the rules of law be clear, precise and predictable in their effect, so that the persons concerned can ascertain their positions in situations and legal relationships governed by EU law.

102Bayer CropScience’s argument is based on a misinterpretation of paragraph 142 of the judgment under appeal.

103In that regard, while it is true that, as found in paragraph 49 of the present judgment, the General Court erred in law in holding that the threshold for the application of the review procedure, provided for in Article 21(1) of Regulation No 1107/2009, requires the emergence of new scientific knowledge indicating that the substance concerned may no longer satisfy the approval criteria, such an error is of no consequence in the present case.

104Contrary to what Bayer CropScience submits, the General Court did not hold, in paragraph 142 of the judgment under appeal, that a mere legislative change with respect to the approval criteria was sufficient in itself to enable the Commission to discharge its burden of proof under Article 21(3) of Regulation No 1107/2009, but made it clear that the withdrawal or amendment of the approval of an active substance requires the existence of new data that invalidates the previous conclusion that that substance fulfils the approval criteria provided for in Article 4 of that regulation.

105Consequently, notwithstanding the General Court’s error of law, referred to in paragraph 103 of the present judgment, it does not appear, in the context of this part of the third ground of appeal, that the rule contained in Article 21(3) of Regulation No 1107/2009, as interpreted by the General Court, is at odds with the principle of legal certainty.

Consequently, the fourth part of the third ground of appeal must be rejected as being unfounded.

In the light of all the foregoing, the third ground of appeal must be rejected as being unfounded.

(4) The fourth ground of appeal

108By its fourth ground of appeal, Bayer CropScience complains that the General Court erred in law by failing to establish the appropriate level of scientific certainty in relation to the materialisation of the alleged risk required for the application of precautionary measures, first, by misinterpreting and misapplying the standard of proof required for the adoption of precautionary measures, second, by concluding that purely hypothetical risks could justify the adoption of precautionary measures, and, third, by failing to comply with the legal rules governing the burden of proof.

109The Commission considers that the fourth ground of appeal must be rejected as being inadmissible or, at the very least, unfounded.

(a) The first part of the fourth ground of appeal

(1) Arguments of the parties

110Bayer CropScience complains that (i) the General Court failed to recognise that the substances covered had already been authorised following a comprehensive scientific assessment and that it failed to apply an appropriate standard of proof, which is higher for such substances than for those which have not yet been authorised; (ii) the General Court contradicted itself by allowing the Commission to adopt precautionary measures in the absence of any new scientific knowledge of relevance and wrongly considered that it was sufficient for the Commission to amend the applicant’s approvals on the basis of largely incomplete data, and (iii) the General Court in fact allowed the Commission to have recourse to the precautionary principle in order to adopt emergency measures under Article 21(3) of Regulation No 1107/2009, instead of Article 69 of that regulation.

111The Commission pleads, primarily, that this part of the fourth ground of appeal is inadmissible and, in the alternative, that it is unfounded.

(2) Findings of the Court

112It should be noted that Bayer CropScience does not dispute the finding in paragraph 142 of the judgment under appeal that, in the context of the application of Article 21(3) of Regulation No 1107/2009, the Commission need do no more than provide, in accordance with the general rules of evidence, solid and convincing evidence which, without resolving scientific uncertainty, gives rise to reasonable doubt as to whether the active substance in question satisfies the approval criteria laid down in Article 4 of that regulation.

113Bayer CropScience argues that the General Court misapplied the standard of proof thus required by not insisting that, in order to adopt precautionary measures, the Commission must, in accordance with a higher evidence requirement for substances already approved than for non-approved substances, demonstrate, on the basis of new data, the existence of serious doubts as to the safety of the active substance concerned.

114Indeed, in paragraphs 177 and 180 of the judgment under appeal, the General Court accepted that the Commission could adopt precautionary measures in the absence of any relevant scientific knowledge and, in paragraph 442 of the judgment under appeal, the General Court considered that it was appropriate that the Commission amend Bayer CropScience’s approvals on the basis of largely incomplete data.

115In that regard, as follows from paragraph 79 of the present judgment, the provisions of Regulation No 1107/2009, which are based on the precautionary principle, do not prevent the Commission from applying that principle where there is scientific uncertainty as to the risks to human or animal health or the environment posed by the active substances that are subject to review pursuant to Article 21 of Regulation No 1107/2009.

116That principle means, as recalled in paragraph 80 of the present judgment, that where there is uncertainty as to the existence or extent of risks, in particular to the environment, protective measures may be taken without having to wait until the reality and seriousness of those risks have been fully demonstrated. Where it proves to be impossible to determine with certainty the existence or extent of the alleged risk, because the results of studies conducted are inconclusive, but the likelihood of real harm to the environment persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures. In this context, in accordance with Regulation No 1107/2009, the Commission is not subject to a higher proof requirement with respect to active substances already approved than with respect to non-approved substances.

117Bayer CropScience’s argument that the General Court accepted that the Commission could adopt precautionary measures in the absence of any relevant scientific knowledge cannot succeed.

119In that regard, it is important to note that paragraphs 177 to 180 of the judgment under appeal deal, in essence, with the question whether, in the light of the March 2012 studies and the Schneider study, the Commission had at its disposal, at the time of the initiation of the review procedure, ‘new scientific and technical knowledge’ within the meaning of Article 21(1) of Regulation No 1107/2009.

In that regard, it is important to note that paragraphs 177 to 180 of the judgment under appeal deal, in essence, with the question whether, in the light of the March 2012 studies and the Schneider study, the Commission had at its disposal, at the time of the initiation of the review procedure, ‘new scientific and technical knowledge’ within the meaning of Article 21(1) of Regulation No 1107/2009.

119Even though the General Court wrongly considered that such new knowledge was necessary for the purposes of undertaking a review under Article 21(1) of Regulation No 1107/2009, the fact remains that that part of the judgment under appeal relates to the initiation of the review procedure and does not take a position on the precautionary measures which the Commission adopted under Article 21(3) of Regulation No 1107/2009.

120Even though the General Court wrongly considered that such new knowledge was necessary for the purposes of undertaking a review under Article 21(1) of Regulation No 1107/2009, the fact remains that that part of the judgment under appeal relates to the initiation of the review procedure and does not take a position on the precautionary measures which the Commission adopted under Article 21(3) of Regulation No 1107/2009.

121As regards paragraph 442 of the judgment under appeal, the General Court recalled that it had been held, in paragraph 325 of that judgment, that the precautionary principle justified, in the circumstances of the case, the approval of the substances covered being amended without waiting for data to be available to fill the gaps identified in EFSA’s Conclusion.

120As regards paragraph 442 of the judgment under appeal, the General Court recalled that it had been held, in paragraph 325 of that judgment, that the precautionary principle justified, in the circumstances of the case, the approval of the substances covered being amended without waiting for data to be available to fill the gaps identified in EFSA’s Conclusion.

122Indeed, as stated in paragraph 82 of the present judgment, the precautionary principle does not require that the adoption of measures under Article 21(3) of Regulation No 1107/2009 be deferred solely on the ground that studies are underway which may call into question the available scientific and technical data. As the General Court rightly found in paragraph 116 of the judgment under appeal, a situation in which the precautionary principle is applied equates, by definition, to a situation in which there is scientific uncertainty.

121Indeed, as stated in paragraph 82 of the present judgment, the precautionary principle does not require that the adoption of measures under Article 21(3) of Regulation No 1107/2009 be deferred solely on the ground that studies are underway which may call into question the available scientific and technical data. As the General Court rightly found in paragraph 116 of the judgment under appeal, a situation in which the precautionary principle is applied equates, by definition, to a situation in which there is scientific uncertainty.

123As regards Bayer CropScience’s argument that the General Court in fact allowed the Commission to have recourse to the precautionary principle in order to adopt emergency measures under Article 21(3) of Regulation No 1107/2009 instead of under Article 69 of that regulation, it is important to note that, quite apart from what is held in paragraphs 87 and 88 of the present judgment, Bayer CropScience has not, contrary to what is required by Article 169(2) of the Rules of Procedure of the Court of Justice, identified in that respect the points in the grounds of the judgment under appeal which are contested. That argument is therefore inadmissible.

122As regards Bayer CropScience’s argument that the General Court in fact allowed the Commission to have recourse to the precautionary principle in order to adopt emergency measures under Article 21(3) of Regulation No 1107/2009 instead of under Article 69 of that regulation, it is important to note that, quite apart from what is held in paragraphs 87 and 88 of the present judgment, Bayer CropScience has not, contrary to what is required by Article 169(2) of the Rules of Procedure of the Court of Justice, identified in that respect the points in the grounds of the judgment under appeal which are contested. That argument is therefore inadmissible.

123Accordingly, the first part of the fourth ground of appeal must be rejected as being partly inadmissible and partly unfounded.

124Accordingly, the first part of the fourth ground of appeal must be rejected as being partly inadmissible and partly unfounded.

(b) The third part of the fourth ground of appeal

(b) The third part of the fourth ground of appeal

(1) Arguments of the parties

(1) Arguments of the parties

124In the third part of its fourth ground of appeal, Bayer CropScience complains that the General Court erred in law by failing to comply with the legal rules on the burden of proof.

124In the third part of its fourth ground of appeal, Bayer CropScience complains that the General Court erred in law by failing to comply with the legal rules on the burden of proof.

125In the present case, according to Bayer CropScience, the General Court effectively reversed the burden of proof by requiring the applicant to show, in paragraphs 546, 184, 216 and 499 to 500 of the judgment under appeal respectively, that (i) the prohibition of foliar uses was manifestly inappropriate; (ii) the March 2012 studies and the Schneider study did not provide new scientific and technical knowledge; (iii) the concerns that increased bee mortality or colony collapse coincided with the use of plant protection products containing the substances covered were unfounded, and (iv) the assumption that there was a correlation between the effects on individual honey bees and the impact at colony level was unfounded.

125In the present case, according to Bayer CropScience, the General Court effectively reversed the burden of proof by requiring the applicant to show, in paragraphs 546, 184, 216 and 499 to 500 of the judgment under appeal respectively, that (i) the prohibition of foliar uses was manifestly inappropriate; (ii) the March 2012 studies and the Schneider study did not provide new scientific and technical knowledge; (iii) the concerns that increased bee mortality or colony collapse coincided with the use of plant protection products containing the substances covered were unfounded, and (iv) the assumption that there was a correlation between the effects on individual honey bees and the impact at colony level was unfounded.

126Furthermore, Bayer CropScience claims that the General Court, by finding, solely on the basis of certain risks to individual honey bees and an alleged correlation between those risks and an impact at colony level, that a risk to colonies could not be ruled out, erred in law in so far as it absolved the Commission of its obligation to meet the applicable legal criterion, which focuses on the maintenance of the health of honey bee colonies, and not of individual bees, as enshrined in Regulation No 1107/2009.

126Furthermore, Bayer CropScience claims that the General Court, by finding, solely on the basis of certain risks to individual honey bees and an alleged correlation between those risks and an impact at colony level, that a risk to colonies could not be ruled out, erred in law in so far as it absolved the Commission of its obligation to meet the applicable legal criterion, which focuses on the maintenance of the health of honey bee colonies, and not of individual bees, as enshrined in Regulation No 1107/2009.

127The Commission disputes those arguments.

127The Commission disputes those arguments.

(2) Findings of the Court

(2) Findings of the Court

128As regards, first, the alleged error of law in requiring the applicant to show that the prohibition of foliar uses was manifestly inappropriate, it is important to recall that, in paragraph 546 of the judgment under appeal, it was held that Bayer CropScience, in particular, had not demonstrated that the prohibition of foliar uses was manifestly inappropriate for the purposes of achieving the objectives of the contested regulation, namely the protection of the environment and, in particular, the protection of bees.

128As regards, first, the alleged error of law in requiring the applicant to show that the prohibition of foliar uses was manifestly inappropriate, it is important to recall that, in paragraph 546 of the judgment under appeal, it was held that Bayer CropScience, in particular, had not demonstrated that the prohibition of foliar uses was manifestly inappropriate for the purposes of achieving the objectives of the contested regulation, namely the protection of the environment and, in particular, the protection of bees.

129As stated in paragraphs 79 and 80 of the present judgment, the precautionary principle implies that, where there is uncertainty as to the existence or extent of risks, in particular to the environment, protective measures may be taken, under the review procedure provided for in Article 21 of Regulation No 1107/2009, without waiting for the reality and seriousness of those risks to be fully demonstrated and that, where it is not possible to determine with certainty the existence or extent of the alleged risk, because the results of the studies carried out are inconclusive, but the likelihood of actual damage to the environment persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures.

129As stated in paragraphs 79 and 80 of the present judgment, the precautionary principle implies that, where there is uncertainty as to the existence or extent of risks, in particular to the environment, protective measures may be taken, under the review procedure provided for in Article 21 of Regulation No 1107/2009, without waiting for the reality and seriousness of those risks to be fully demonstrated and that, where it is not possible to determine with certainty the existence or extent of the alleged risk, because the results of the studies carried out are inconclusive, but the likelihood of actual damage to the environment persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures.

130It follows that, where the Commission has to adopt a restrictive measure, within the meaning of Article 21(3) of Regulation No 1107/2009, to counter a risk the existence or extent of which is not certain but which nevertheless appears to be sufficiently documented, it is incumbent on the party concerned, in accordance with Article 7(1) of that regulation, to demonstrate that the active substance concerned satisfies the approval criteria laid down in Article 4 of that regulation. As the Advocate General pointed out in point 150 of her Opinion, if the Commission provides solid and convincing evidence which gives rise to reasonable doubt as to whether those criteria have been met, the initial burden of proof reverts to the party concerned.

130It follows that, where the Commission has to adopt a restrictive measure, within the meaning of Article 21(3) of Regulation No 1107/2009, to counter a risk the existence or extent of which is not certain but which nevertheless appears to be sufficiently documented, it is incumbent on the party concerned, in accordance with Article 7(1) of that regulation, to demonstrate that the active substance concerned satisfies the approval criteria laid down in Article 4 of that regulation. As the Advocate General pointed out in point 150 of her Opinion, if the Commission provides solid and convincing evidence which gives rise to reasonable doubt as to whether those criteria have been met, the initial burden of proof reverts to the party concerned.

131However, in the context of a complaint such as the one in the present case, which is based solely on the fact that the General Court reversed the burden of proof, and not on an alleged lack of solid and conclusive evidence casting doubt on compliance with the approval criteria laid down in Article 4 of Regulation No 1107/2009, the finding in paragraph 546 of the judgment under appeal, that Bayer CropScience failed to demonstrate that the prohibition of foliar uses was manifestly inappropriate to achieve the objective pursued by the contested regulation of protecting bees, does not in itself constitute an error of law.

131However, in the context of a complaint such as the one in the present case, which is based solely on the fact that the General Court reversed the burden of proof, and not on an alleged lack of solid and conclusive evidence casting doubt on compliance with the approval criteria laid down in Article 4 of Regulation No 1107/2009, the finding in paragraph 546 of the judgment under appeal, that Bayer CropScience failed to demonstrate that the prohibition of foliar uses was manifestly inappropriate to achieve the objective pursued by the contested regulation of protecting bees, does not in itself constitute an error of law.

132As regards paragraph 184 of the judgment under appeal, where it was held that the study commissioned by Bayer CropScience, finalised on 24 May 2013, on whether the results of the Henry study and the Schneider study deviated from previous knowledge in this area, is not such as to demonstrate that the March 2012 studies and the Schneider study failed to provide ‘new scientific and technical knowledge’, within the meaning of Article 21(1) of Regulation No 1107/2009, the argument that that finding does not comply with the legal rules governing the burden of proof is, in any event, inoperative since, as noted in paragraph 50 of the present judgment, the first sentence of the first subparagraph of Article 21(1) of Regulation No 1107/2009 authorises the Commission to review the approval of an active substance at any time, without any further conditions.

132As regards paragraph 184 of the judgment under appeal, where it was held that the study commissioned by Bayer CropScience, finalised on 24 May 2013, on whether the results of the Henry study and the Schneider study deviated from previous knowledge in this area, is not such as to demonstrate that the March 2012 studies and the Schneider study failed to provide ‘new scientific and technical knowledge’, within the meaning of Article 21(1) of Regulation No 1107/2009, the argument that that finding does not comply with the legal rules governing the burden of proof is, in any event, inoperative since, as noted in paragraph 50 of the present judgment, the first sentence of the first subparagraph of Article 21(1) of Regulation No 1107/2009 authorises the Commission to review the approval of an active substance at any time, without any further conditions.

133Furthermore, in paragraph 55 of the present judgment, it is noted that the General Court rightly found, in paragraph 217 of the judgment under appeal, that the Commission was entitled to consider, in this case, that a review should be undertaken of the approval of the substances covered.

133Furthermore, in paragraph 55 of the present judgment, it is noted that the General Court rightly found, in paragraph 217 of the judgment under appeal, that the Commission was entitled to consider, in this case, that a review should be undertaken of the approval of the substances covered.

134The same applies to the argument that the finding in paragraph 216 of the judgment under appeal does not comply with the legal rules governing the burden of proof. That paragraph, according to which the monitoring data relied on by the applicants was indeed capable of casting doubt on the concerns raised by the March 2012 studies and the Schneider study, but on the other hand was not capable of demonstrating that those concerns were unfounded, does raise an issue relating to the burden of proof in respect of scientific knowledge, but in the context of a decision to undertake a review under Article 21(1) of Regulation No 1107/2009.

134The same applies to the argument that the finding in paragraph 216 of the judgment under appeal does not comply with the legal rules governing the burden of proof. That paragraph, according to which the monitoring data relied on by the applicants was indeed capable of casting doubt on the concerns raised by the March 2012 studies and the Schneider study, but on the other hand was not capable of demonstrating that those concerns were unfounded, does raise an issue relating to the burden of proof in respect of scientific knowledge, but in the context of a decision to undertake a review under Article 21(1) of Regulation No 1107/2009.

Paragraphs 499 and 500 of the judgment under appeal, which Bayer CropScience claims infringe the legal rules on the burden of proof, read as follows

135Paragraphs 499 and 500 of the judgment under appeal, which Bayer CropScience claims infringe the legal rules on the burden of proof, read as follows

‘499 It is therefore common ground that there is a correlation between the risk to individual bees and the risk to the colony. By contrast, there is at this stage scientific uncertainty as to the individual bee mortality rate threshold above which “unacceptable acute or chronic effects” on colony survival and development are likely to arise. That uncertainty is due in particular to the difficulties of measuring under field conditions the extent of individual losses and their impact on the colony.

‘499 It is therefore common ground that there is a correlation between the risk to individual bees and the risk to the colony. By contrast, there is at this stage scientific uncertainty as to the individual bee mortality rate threshold above which “unacceptable acute or chronic effects” on colony survival and development are likely to arise. That uncertainty is due in particular to the difficulties of measuring under field conditions the extent of individual losses and their impact on the colony.

500 In those circumstances, it must be concluded that the Commission was fully entitled to find that, in the light of the hazard quotient values identified in respect of the substances covered in EFSA’s [Conclusion], a risk to the colonies could not be ruled out, and that it was therefore for the Commission, on the basis of the precautionary principle, to adopt protective measures without having to wait for the conditions under which, and the mortality rate threshold above which, the loss of individual bees was likely to endanger colony survival or development to be established.’

500 In those circumstances, it must be concluded that the Commission was fully entitled to find that, in the light of the hazard quotient values identified in respect of the substances covered in EFSA’s [Conclusion], a risk to the colonies could not be ruled out, and that it was therefore for the Commission, on the basis of the precautionary principle, to adopt protective measures without having to wait for the conditions under which, and the mortality rate threshold above which, the loss of individual bees was likely to endanger colony survival or development to be established.’

136However, those paragraphs, as such, are merely an application to a specific case of the precautionary principle as recalled, inter alia, in paragraph 129 of the present judgment, according to which, where there is uncertainty as to the existence or extent of risks, in particular for the environment, protective measures may be taken, under the review procedure provided for in Article 21 of Regulation No 1107/2009, without having to wait for the reality and seriousness of those risks to be fully demonstrated, and where it proves impossible to determine with certainty the existence or extent of the alleged risk, because the results of the studies carried out are inconclusive, but the likelihood of actual damage to the environment persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures.

However, those paragraphs, as such, are merely an application to a specific case of the precautionary principle as recalled, inter alia, in paragraph 129 of the present judgment, according to which, where there is uncertainty as to the existence or extent of risks, in particular for the environment, protective measures may be taken, under the review procedure provided for in Article 21 of Regulation No 1107/2009, without having to wait for the reality and seriousness of those risks to be fully demonstrated, and where it proves impossible to determine with certainty the existence or extent of the alleged risk, because the results of the studies carried out are inconclusive, but the likelihood of actual damage to the environment persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures.

Last, as regards Bayer CropScience’s argument that the General Court, by finding, solely on the basis of certain risks to individual honeybees and an alleged correlation between those risks and an impact at colony level, that a risk to colonies could not be ruled out, erred in law by absolving the Commission of its obligation to meet the applicable legal criterion, which focuses on the maintenance of the health of honey bee colonies and not individual bees, as laid down in Regulation No 1107/2009, the following points should be made.

137Last, as regards Bayer CropScience’s argument that the General Court, by finding, solely on the basis of certain risks to individual honeybees and an alleged correlation between those risks and an impact at colony level, that a risk to colonies could not be ruled out, erred in law by absolving the Commission of its obligation to meet the applicable legal criterion, which focuses on the maintenance of the health of honey bee colonies and not individual bees, as laid down in Regulation No 1107/2009, the following points should be made.

138According to point 3.8.3 of Annex II to Regulation No 1107/2009, an active substance is to be approved only if it is established, inter alia, that the use of plant protection products containing this active substance, under the proposed conditions of use, will not have unacceptable acute or chronic effects on colony survival and development, taking into account the effects on bee larvae and bee behaviour.

According to point 3.8.3 of Annex II to Regulation No 1107/2009, an active substance is to be approved only if it is established, inter alia, that the use of plant protection products containing this active substance, under the proposed conditions of use, will not have unacceptable acute or chronic effects on colony survival and development, taking into account the effects on bee larvae and bee behaviour.

139According to paragraphs 499 and 500 of the judgment under appeal, reproduced in paragraph 135 of the present judgment, in circumstances where it is common ground that a correlation exists between the risk to individual bees and the risk to the colony, but where there is scientific uncertainty at this stage as to the rate of mortality of individual bees above which ‘unacceptable acute or chronic effects’ on the survival and development of the colony are likely to occur, the Commission was entitled to consider that a risk to the colonies could not be ruled out and that it was therefore incumbent on the Commission, on the basis of the precautionary principle, to take protective measures.

According to paragraphs 499 and 500 of the judgment under appeal, reproduced in paragraph 135 of the present judgment, in circumstances where it is common ground that a correlation exists between the risk to individual bees and the risk to the colony, but where there is scientific uncertainty at this stage as to the rate of mortality of individual bees above which ‘unacceptable acute or chronic effects’ on the survival and development of the colony are likely to occur, the Commission was entitled to consider that a risk to the colonies could not be ruled out and that it was therefore incumbent on the Commission, on the basis of the precautionary principle, to take protective measures.

Thus, contrary to what Bayer CropScience has claimed, the General Court, in noting that it is common ground that there is a correlation between the risk to individual bees and the risk to the colony, where the scientific uncertainty in this respect concerns only the level of mortality of individual bees above which ‘unacceptable acute or chronic effects’ on the survival and development of the colony are likely to occur, did not absolve the Commission of its obligation to satisfy the legal criterion relating to the maintenance of the health of honey bee colonies, laid down in point 3.8.3 of Annex II to Regulation No 1107/2009.

140Thus, contrary to what Bayer CropScience has claimed, the General Court, in noting that it is common ground that there is a correlation between the risk to individual bees and the risk to the colony, where the scientific uncertainty in this respect concerns only the level of mortality of individual bees above which ‘unacceptable acute or chronic effects’ on the survival and development of the colony are likely to occur, did not absolve the Commission of its obligation to satisfy the legal criterion relating to the maintenance of the health of honey bee colonies, laid down in point 3.8.3 of Annex II to Regulation No 1107/2009.

141Therefore, no error of law was committed in that regard.

Therefore, no error of law was committed in that regard.

142Consequently, the third part of the fourth ground of appeal must be rejected as being unfounded.

142Consequently, the third part of the fourth ground of appeal must be rejected as being unfounded.

(c) The second part of the fourth ground of appeal

(c) The second part of the fourth ground of appeal

(1) Arguments of the parties

(1) Arguments of the parties

143In the second part of its fourth ground of appeal, Bayer CropScience complains that the General Court erred in law in concluding that purely hypothetical risks could justify the adoption of precautionary measures. According to Bayer CropScience, the General Court wrongly found that both foliar and non-professional uses could be restricted in the absence of a scientific assessment and on the basis of assumptions that, first, foliar uses not yet assessed by EFSA could, as stated in paragraphs 533 and 534 of the judgment under appeal, pose risks similar to those of the assessed uses and, second, that non-professional users were, as stated in paragraphs 556 and 558 of the judgment under appeal, likely not to comply with the instructions for use.

143In the second part of its fourth ground of appeal, Bayer CropScience complains that the General Court erred in law in concluding that purely hypothetical risks could justify the adoption of precautionary measures. According to Bayer CropScience, the General Court wrongly found that both foliar and non-professional uses could be restricted in the absence of a scientific assessment and on the basis of assumptions that, first, foliar uses not yet assessed by EFSA could, as stated in paragraphs 533 and 534 of the judgment under appeal, pose risks similar to those of the assessed uses and, second, that non-professional users were, as stated in paragraphs 556 and 558 of the judgment under appeal, likely not to comply with the instructions for use.

144Finally, Bayer CropScience claims that the General Court also erred in law, in paragraph 543 of the judgment under appeal, by allowing the Commission itself to argue that foliar applications resulted in deposits of the product concerned in the soil and to rely on its own hypothetical conclusions instead of entrusting the scientific risk assessment to EFSA.

144Finally, Bayer CropScience claims that the General Court also erred in law, in paragraph 543 of the judgment under appeal, by allowing the Commission itself to argue that foliar applications resulted in deposits of the product concerned in the soil and to rely on its own hypothetical conclusions instead of entrusting the scientific risk assessment to EFSA.

145The Commission does not accept Bayer CropScience’s argument.

145The Commission does not accept Bayer CropScience’s argument.

(2) Findings of the Court

(2) Findings of the Court

146As regards, first, the prohibition of foliar applications, the paragraphs of the judgment under appeal criticised by Bayer CropScience are worded as follows

As regards, first, the prohibition of foliar applications, the paragraphs of the judgment under appeal criticised by Bayer CropScience are worded as follows

‘533 In the second place, it should be pointed out that the second mandate issued to EFSA by the Commission, as revised on 25 July 2012 …, was expressly limited to “authorised uses of those substances for seed treatment and granules”. Consequently, the risk assessment carried out by EFSA did not relate to other authorised uses and EFSA’s [Conclusion] on the three substances covered did not contain any indication of the risk associated with foliar applications.

‘533 In the second place, it should be pointed out that the second mandate issued to EFSA by the Commission, as revised on 25 July 2012 …, was expressly limited to “authorised uses of those substances for seed treatment and granules”. Consequently, the risk assessment carried out by EFSA did not relate to other authorised uses and EFSA’s [Conclusion] on the three substances covered did not contain any indication of the risk associated with foliar applications.

534 In the third place, it should be borne in mind that the measures adopted in [the contested regulation] are based on the application of the precautionary principle, in that there was solid evidence that some of the uses of the substances covered which had been approved until then could entail unacceptable risks to bees, even though there was not yet any scientific certainty in that respect. In that situation, the Commission was entitled to adopt preventive measures also in respect of uses that had not yet been specifically assessed by EFSA, if and in so far as it could reasonably assume that these posed similar risks to those posed by uses that had been assessed.

534 In the third place, it should be borne in mind that the measures adopted in [the contested regulation] are based on the application of the precautionary principle, in that there was solid evidence that some of the uses of the substances covered which had been approved until then could entail unacceptable risks to bees, even though there was not yet any scientific certainty in that respect. In that situation, the Commission was entitled to adopt preventive measures also in respect of uses that had not yet been specifically assessed by EFSA, if and in so far as it could reasonably assume that these posed similar risks to those posed by uses that had been assessed.