CELEX: 62018CJ0499
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

By 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.
I.

Legal context
A.

Directive 91/414/EEC
Before 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
).
Article 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).
2.   For inclusion of an active substance in Annex I, the following shall be taken into particular account:
(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.
…’
B.

Regulation (EC) No 1107/2009
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 (
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.’
Under 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.
…
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.
…
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:
(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.
2.   The Commission may ask the Member States and [EFSA] for an opinion, or for scientific or technical assistance. The Member States may provide their comments to the Commission within three months from the date of the request. [EFSA] shall provide its opinion or the results of its work to the Commission within three months of the date of the request.
3.   Where the 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).
…’
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.
IV.

Forms of order sought by the parties to the appeal
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.
V.

The 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.
A.

Admissibility of the appeal
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
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
). 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
, and of 17 September 2015, Mory and Others v Commission,
C‑33/14 P
,
EU:C:2015:609
, paragraph
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.
B.

Substance
1.

The first ground of appeal
(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.
…
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.
…
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
).
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
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.
2.

The second ground of appeal
(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.
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.
3.

The third and fifth grounds of appeal
Bayer CropScience complains that the General Court erred in law in the application of Article 21(3) of Regulation No 1107/2009 in that the General Court (i) failed to take account of the fact that EFSA was required to carry out an appropriate risk assessment; (ii) concluded that the Commission could adopt emergency measures on the basis of that provision; (iii) failed to give it the opportunity to submit the missing data, and (iv) was in breach of the principle of legal certainty in concluding that a change in the regulatory context of the approval criteria could be sufficient on its own to allow the Commission to discharge the burden of proof incumbent on it under that provision.
The Commission considers that the third and fifth grounds of appeal should be rejected.
(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.
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
). 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
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
and
).
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.
(b)

The second part of the third ground of appeal
(1)

Arguments of the parties
By 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.
The Commission disputes this line of argument.
(2)

Findings of the Court
It 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
According 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.
The Commission disputes those arguments.
(2)

Findings of the Court
Paragraph 142 of the judgment under appeal reads as follows:
‘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 …’
It 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.
In 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.
However, 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.
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 grounds that studies are underway which may call into question the available scientific and technical data.
Accordingly, 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
By 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.
According 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.
The Commission disputes those arguments.
(2)

Findings of the Court
As 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.
Bayer CropScience’s argument is based on a misinterpretation of paragraph 142 of the judgment under appeal.
In 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.
Contrary 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.
Consequently, 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
By 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.
The 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
Bayer 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.
The 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
It 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.
However, Bayer 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.
Indeed, 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.
In 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.
That 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.
Bayer 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.
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.
Even 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.
As 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.
Indeed, 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.
As 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.
Accordingly, 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
(1)

Arguments of the parties
In 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.
In 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.
Furthermore, 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.
The Commission disputes those arguments.
(2)

Findings of the Court
As 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.
As 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.
It 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.
However, 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.
As 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.
Furthermore, 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.
The 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
‘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.
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.’
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.
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.
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.
Therefore, no error of law was committed in that regard.
Consequently, 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
(1)

Arguments of the parties
In 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.
Finally, 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.
The Commission does not accept Bayer CropScience’s argument.
(2)

Findings of the Court
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.
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.
…
Second, as regards acropetal translocation, the Commission contended that foliar applications resulted in deposits of the product concerned on the soil, from where its active substances could be absorbed by the roots and dispersed throughout the plant.’
As regards Bayer CropScience’s argument that the General Court erred in law by accepting that the Commission could carry out the risk assessment itself instead of entrusting EFSA with that task, it should be noted that, as the Advocate General stated in point 155 of her Opinion, under Article 21(2) of Regulation No 1107/2009, referral to EFSA is a matter within the Commission’s discretion and therefore a risk assessment by EFSA is not necessarily required.
Thus, in accepting that the Commission could itself carry out the risk assessment for uses not yet specifically assessed by EFSA, such as foliar applications, the General Court did not err in law.
As to Bayer CropScience’s argument that the General Court erred in law in finding that foliar uses could be restricted in the absence of a scientific assessment and on the basis of assumptions that such uses could pose risks similar to those of the assessed uses, it is important to emphasise that the General Court accepted, in paragraph 534 of the judgment under appeal, that the Commission was also entitled to take precautionary measures for uses not yet specifically assessed by EFSA only if and in so far as the Commission could reasonably assume that those uses posed risks similar to those of the uses that had been assessed.
Thus, as regards basipetal translocation, the General Court held, in paragraph 542 of the judgment under appeal, that, in view of the weaknesses of the scientific studies relied on by both sides, it could not be concluded that the Commission could reasonably assume that foliar applications posed risks similar to those of the uses that had been assessed.
On the other hand, with regard to acropetal translocation, the General Court noted in paragraphs 543 and 544 of the judgment under appeal that, since the Commission had argued that foliar applications resulted in deposits of the product concerned on the soil, from which its active substances were likely to be absorbed by the roots and dispersed in the plant, those factors allowed the Commission reasonably to assume that foliar applications posed risks similar to those of the uses assessed by EFSA in its Conclusion.
It thus follows from the foregoing that, as the Advocate General observed in point 160 of her Opinion, in the context of the prohibition of foliar applications, the General Court, contrary to Bayer CropScience’s claim, did not accept a risk assessment based on purely hypothetical considerations and therefore did not err in law in that respect.
Secondly, as regards the prohibition of non-professional uses, paragraphs 553 to 558 of the judgment under appeal read as follows
‘553
Third, as regards the likelihood of plant protection products containing the substances covered being used inappropriately by non-professional users, neither the Commission nor the applicants have actually proved to what extent such a likelihood does or does not exist. However, Bayer [CropScience] referred to a 2011 survey requested by the Commission on “consumer understanding of labels and the safe use of chemicals”, which showed that some 80% of those responding read the labels on pesticide products “always” or “most of the time” and that a further 12% read them “sometimes”. Of those who read the instructions on the labels, almost 74% followed them “fully”, while 23% followed them “partially”. Those figures were confirmed by another survey, of which Bayer [CropScience] produced only excerpts.
It should be noted, first of all, that the figures stated by Bayer [CropScience] in respect of the first of those surveys do not correspond to those which appear in the copy it produced. In fact, the percentage of those responding who answered that they read the labels on plant protection products “always” or “most of the time” was 66% (50% “always” and 16% “most of the time”) and not the “some 80%” indicated by Bayer [CropScience].
Next, the excerpt of the second survey produced by Bayer [CropScience] does not show who carried out the survey, how the sample of those surveyed was made up and whether it was representative of the population of the seven countries in which it was carried out. In those circumstances, it can have only very limited evidential value.
Last, the first survey, conducted throughout all the Member States on the basis of a representative sample, reveals that 34% of those surveyed read the instructions for use on the labels of plant protection products only “sometimes” or “never”. It must be held, in those circumstances, and given, in particular, the high degree of toxicity of the substances covered, that the Commission was fully entitled to conclude that non-professional users were likely, more so than professional users, not to comply with the instructions for use.
Therefore, the prohibition of non-professional uses outdoors of the substances covered cannot be categorised as “manifestly inappropriate for the purpose of achieving the objective pursued” within the meaning of the case-law cited in paragraph 506 above.
Fourth, with regard specifically to non-professional uses indoors, it is true that it seems prima facie unlikely that bees will be put at risk, assuming that the instructions for use are followed. However, as has just been explained, misuse, by a failure to comply with the instructions for use, cannot be ruled out, particularly in the case of non-professional users. In that regard, the risk, mentioned by the Commission, of a plant being treated indoors and then being placed outdoors seems to be anecdotal and, in any event, occasional. By contrast, it seems likely, given the effectiveness as insecticides of the substances covered, that some users may be tempted to use the products containing them directly outdoors, even if they are sold for indoor use.’
Bayer CropScience complains, in essence, that the General Court found, in paragraph 558 of the judgment under appeal, that misuse, due to failure to comply with the instructions for use, could not be ruled out, particularly in relation to non-professional users, while at the same time the General Court acknowledged, in paragraph 553 of that judgment, that neither the applicants nor the Commission had demonstrated the extent to which the likelihood of misuse existed or did not exist.
In that regard, it must be recalled that, as is clear from paragraphs 551 and 552 of the judgment under appeal, it is for the institutions that are responsible for making political choices to determine the level of risk considered acceptable to society, that level of risk being determined not only on the basis of strictly scientific considerations but also taking account of social factors, such as the feasibility of controls.
The feasibility of controls may well constitute a relevant factor in determining the level of acceptable risk, since the controls are intended to ensure compliance with the instructions for the use of plant protection products containing active substances, compliance which, in turn, is likely to mitigate the impact of the use of such substances on the environment.
The General Court did find, in paragraph 553 of the judgment under appeal, that neither the Commission nor Bayer CropScience had demonstrated the exact likelihood of inappropriate use by non-professionals of plant protection products containing the substances covered. However, in view of the fact that non-professional users are not subject to any controls, it may be considered, as the General Court does in paragraph 556 of the judgment under appeal, that non-professional users were more likely than professional users to fail to comply with the instructions for use.
Taking into account the high degree of toxicity of the active substances at issue for bees, the General Court therefore did not commit an error of law in finding that the prohibition of non-professional uses of plant protection products containing those substances cannot be regarded as ‘manifestly inappropriate’ for achieving the objective pursued by the contested regulation.
It follows that the second part of the fourth ground of appeal is also unfounded.
Accordingly, the fourth ground of appeal must be rejected as being unfounded.
5.

The sixth ground of appeal
(a)

Arguments of the parties
By its sixth ground of appeal, Bayer CropScience complains that the General Court erred in law, in paragraphs 459 to 461 of the judgment under appeal, by incorrectly defining the scope of the impact assessment to be carried out prior to the adoption of the precautionary measures and by disregarding the requirements of that assessment. The General Court, Bayer CropScience claims, considered it sufficient that the Commission had acquainted itself with the effects likely to be induced by the proposed measure, and held that the scope and form of the impact assessment were within the Commission’s discretion, finding that a four bullet point summary of an impact assessment provided by the industry was sufficient, though the Commission did not have a complete overview of alternative plant protection products. According to Bayer CropScience, the obligation to carry out an impact assessment was thus rendered meaningless.
The Commission disputes those arguments.
(b)

Findings of the Court
The paragraphs of the judgment under appeal on which Bayer CropScience’s criticisms focus are as follows:
‘459
First, in that regard, it should be noted that point 6.3.4 of the Communication [on the precautionary principle of 2 February 2000 (COM(2000) 1 final) (“the communication of the precautionary principle”)] provides for an examination to be carried out of the benefits and costs of action and lack of action. However, the format and scope of that examination are not specified. In particular, it is not at all apparent that the authority concerned is obliged to initiate a specific assessment procedure culminating, for example, in a formal, written assessment report. In addition, it is apparent from the text that the authority applying the precautionary principle enjoys considerable discretion regarding methods of analysis. Although the communication indicates that the examination “should” include an economic analysis, the authority concerned must in any event also include non-economic considerations. Furthermore, it is expressly stated that it may be the case that, in certain circumstances, economic considerations must be considered less important than other interests which are given priority; interests such as the environment or health are expressly mentioned by way of example.
Moreover, it is not necessary for the economic analysis of the costs and benefits to be made on the basis of a precise calculation of the respective costs of the action proposed or of inaction. Such precise calculations will in most cases be impossible to make, given that, in the context of the application of the precautionary principle, their results depend on different variables which are, by definition, unknown. If all the consequences of inaction and of action were known, it would not be necessary to resort to the precautionary principle; it would be possible to decide on the basis of certainties. In conclusion, the requirements of the Communication on the precautionary principle are satisfied where the authority concerned – in the present case, the Commission – has in fact acquainted itself with the effects, positive and negative, economic and otherwise, to which the proposed action, as well as the failure to act, may lead, and has taken that into account in its decision. By contrast, it is not necessary for those effects to be estimated precisely, if that is not possible or would require disproportionate effort.
Second, it should be noted that the Commission has clearly drawn a comparison between the most likely positive or negative consequences of the action proposed and those of inaction in terms of the overall cost to the European Union, thereby satisfying the requirements of point 6.3.4 of the Communication on the precautionary principle. That is evident from the note dated 21 January 2013 for the attention of the Commissioner responsible at that time. The note sought to inform the Commissioner of the discussion under way on EFSA’s [Conclusion] and to request his approval for the measures proposed by the Commission’s services. In Annex V to the note, headed “Background information on EP, Industry, NGOs”, various circumstances were set out which had been considered in connection with the proposal. In particular, with regard to the fact that neonicotinoids are largely used in agriculture, Annex V mentioned the main results of the Humboldt study, produced to the Commission by the applicants, including the conclusions of that study as to the effects of a ban on neonicotinoids on the economy, the employment market and the environmental record of the European Union. Reference was also made to the fact that the Commission did not have a complete overview of the alternative plant protection products, since these were authorised at national level. Last, the note indicated that the [European] Parliament was going to discuss the matter three days later, on 24 January 2013, on the basis of a study it had commissioned on the risks posed by the substances covered and which recommended a total ban of neonicotinoids (rather than just a restriction on use) and the fact that environmental NGOs were also calling for a total ban. It follows from all these points that the Commission was aware of the challenges, both economic and environmental, linked to the use of the substances covered.’
In that regard, it should be recalled that, under Article 21(3) of Regulation No 1107/2009, where the Commission concludes that the approval criteria laid down in Article 4 of that regulation are no longer met, a regulation withdrawing or amending the approval is to be adopted.
Indeed, as stated in paragraph 69 of the present judgment, 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, provided that it is scientific or technical.
Where the Commission comes to such a conclusion, it should, in accordance with Article 21(3) of Regulation No 1107/2009, adopt a regulation withdrawing or amending the approval of the active substance concerned. Thus, by providing for the withdrawal or amendment of that approval, that provision expressly incorporates the principle of proportionality which, according to settled case-law, is one of the general principles of EU law and requires that acts of the EU institutions should not exceed the limits of what is appropriate and necessary to achieve the legitimate objectives pursued by the rules in question, it being understood that, where there is a choice between several appropriate measures, the least restrictive should be used and that the negative consequences must not be disproportionate to the aims pursued (judgment of 8 July 2010, Afton Chemical,
C‑343/09
,
EU:C:2010:419
, paragraph
and the case-law cited).
In the present case, as is apparent from paragraphs 22 to 24 of the present judgment and from the contested regulation itself, the Commission, by that regulation, amended the conditions for the approval of the substances covered, taking into account the fact that those substances presented certain high acute risks for bees and that unacceptable risks resulting from acute or chronic effects on the survival and development of colonies in several crops could not be ruled out.
It follows that the Commission considered that the approved uses of the active substances at issue in the present case no longer satisfied the approval criteria laid down in Article 4 of Regulation No 1107/2009 and, in particular, in point 3.8.3 of Annex II to that regulation, according to which an active substance is to be approved only if it is established 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.
As regards the principle of proportionality, it is important to note that Article 21(3) of Regulation No 1107/2009 does not impose any particular form or detailed rules to ensure compliance with it.
The finding of the General Court, that the scope and form of the examination of the positive and negative effects resulting from action or inaction are within the Commission’s discretion, does not infringe either Article 21(3) of Regulation No 1107/2009 or, moreover, the principle of proportionality which, as noted in paragraph 166 of the present judgment, is incorporated within that provision.
In that regard, it should be emphasised that the assessment carried out by the Commission in the context of a review based on Article 21 of Regulation No 1107/2009, read in conjunction with point 3.8.3 of Annex II to that regulation, concerns an analysis of the risks that the use of a plant protection product containing one of the substances covered will entail, inter alia, for the survival and development of bee colonies.
It follows that Bayer CropScience cannot claim that the General Court erred in law by referring to the wide margin of discretion enjoyed by the Commission when it decides also to carry out, in addition to that risk assessment – which alone is prescribed by the abovementioned regulatory framework – an examination of the positive and negative effects resulting from its action or inaction.
In any event, it should be noted that, contrary to what Bayer CropScience has argued, the General Court did not consider that it was sufficient that the Commission had acquainted itself with the effects likely to be caused by the proposed action. The Commission, as stated in paragraph 461 of the judgment under appeal, made a comparison between the most likely positive or negative consequences of the proposed action and those of inaction in terms of the overall cost to the European Union.
Furthermore, as is clear from paragraphs 463 to 466 of the judgment under appeal, the Commission had been able to assess the impact on agriculture and the environment of the measures which are the subject of the contested regulation, having regard, first, to the fact that it was possible, if it became necessary, to grant exemptions at national level for plant protection products containing the substances covered and, second, to the fact that, in certain Member States, agriculture had in the past been able to function satisfactorily without recourse to plant protection products containing the substances covered, and without that circumstance having adverse effects on the environment.
Finally, it is apparent from paragraphs 468 to 470 of the judgment under appeal that, while it is true that, given the system established by Regulation No 1107/2009 in which the Commission is competent to approve active substances at EU level, while the Member States are competent to authorise plant protection products containing the approved active substances, it was impossible for the Commission to determine, for the European Union as a whole, to what extent, for which uses and for which crops farmers had access to products other than those containing the substances covered, the fact remains that the Commission had an overview of active substances which could replace the substances covered by the contested regulation.
In those circumstances, and even assuming that the Commission has an independent obligation under Article 21(3) of Regulation No 1107/2009 to carry out an analysis specifically taking into account the positive and negative effects resulting from action or lack of action, it must be held that the arguments put forward by Bayer CropScience cannot, in any event, succeed.
Consequently, the sixth ground of appeal must be rejected as being unfounded.
Having regard to all the foregoing, the appeal must be dismissed.
VI.

Costs
Under Article 184(2) of the Rules of Procedure, where the appeal is unfounded, the Court is to make a decision as to the costs.
Under Article 138(1) of those rules, applicable to appeal proceedings by virtue of Article 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.
Since the Commission, UNAF, Deutscher Berufs- und Erwerbsimkerbund eV, Österreichischer Erwerbsimkerbund, PAN Europe, Bee Life, Buglife and Greenpeace have applied for costs against the appellants and since the appellants have been unsuccessful in their appeal, the appellants should be ordered to pay the costs of those parties. Since the Kingdom of Sweden has not applied for costs, it shall bear its own costs.
Under Article 184(4) of the Rules of Procedure, where the appeal has not been brought by an intervener at first instance, he or she may not be ordered to pay costs in the appeal proceedings unless he or she participated in the written or oral part of the proceedings before the Court. Where an intervener at first instance takes part in the proceedings, the Court may decide that that party shall bear its own costs.
AGPM, ECPA, Rapool-Ring Qualitätsraps deutscher Züchter and ESA, which had the status of interveners at first instance, did not participate in the proceedings before the Court. However, the NFU and Agricultural Industries Confederation Ltd, having participated in the appeal proceedings and having been unsuccessful in their claims, shall bear their own costs.
Pursuant to Article 140(3) of the Rules of Procedure, which is applicable to the appeal proceedings under Article 184(1) thereof, the Court may decide that an intervener other than the Member States, the institutions, the States who are parties to the Agreement on the European Economic Area of 2 May 1994 (
OJ 1994 L 1, p. 3
) other than the Member States or the EFTA Surveillance Authority shall bear its own costs.
That provision should be applied and Stichting De Bijenstichting should be ordered to bear its own costs.

On those grounds, the Court (First Chamber) hereby:

1.
Declares that the appeal is inadmissible in so far as it was brought on behalf of Bayer AG;

2.
Dismisses the appeal, in so far as it was brought by Bayer CropScience AG;

3.
Orders Bayer CropScience AG and Bayer AG to bear their own costs and to pay those incurred by the European Commission, 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 and Stichting Greenpeace Council (Greenpeace);

4.
Orders the National Farmers’ Union (NFU) and Agricultural Industries Confederation Ltd, and also Stichting De Bijenstichting to bear their own costs;

5.
Orders the Kingdom of Sweden to bear its own costs.

Bonichot
Lenaerts
Bay Larsen
Safjan
Jääskinen
Delivered in open court in Luxembourg on 6 May 2021.
A. Calot Escobar
Registrar
J.-C. Bonichot
President of the First Chamber
(
*1
)	Language of the case: English.