JUDGMENT OF THE GENERAL COURT (First Chamber, Extended Composition)

17 May 2018 ( *1 )

(Plant protection products — Active substances clothianidin, thiamethoxam and imidacloprid — Review of approval — Article 21 of Regulation (EC) No 1107/2009 — Prohibition of the use and sale of seeds treated with plant protection products containing the active substances in question — Article 49(2) of Regulation No 1107/2009 — Precautionary principle — Proportionality — Right to be heard — Non-contractual liability)

In Cases T‑429/13 and T‑451/13,

Bayer CropScience AG, established in Monheim am Rhein (Germany), represented by K. Nordlander, lawyer, and P. Harrison, Solicitor,

applicant in Case T‑429/13,

Syngenta Crop Protection AG, established in Basel (Switzerland), and the other applicants whose names appear in the annex, ( 1 ) represented initially by D. Waelbroek, I. Antypas, lawyers, and D. Slater, Solicitor, and subsequently by D. Waelbroek and I. Antypas,

applicants in Case T‑451/13,

supported by

Association générale des producteurs de maïs et autres céréales cultivées de la sous-famille des panicoïdées (AGPM), established in Montardon (France), represented by L. Verdier and B. Trouvé, lawyers,

by

The National Farmers’ Union (NFU), established in Stoneleigh (United Kingdom), represented by H. Mercer QC, and N. Winter, Solicitor,

by

Association européenne pour la protection des cultures (ECPA), established in Brussels (Belgium), represented by D. Abrahams, Barrister, I. de Seze and É. Mullier, lawyers,

by

Rapool-Ring GmbH Qualitätsraps deutscher Züchter, established in Isernhagen (Germany), represented initially by C. Stallberg and U. Reese, and subsequently by U. Reese and J. Szemjonneck, lawyers,

by

European Seed Association (ESA), established in Brussels, represented initially by P. de Jong, P. Vlaemminck and B. Van Vooren, and subsequently by P. de Jong, K. Claeyé and E. Bertolotto, lawyers,

and by

Agricultural Industries Confederation Ltd, established in Peterborough (United Kingdom), represented initially by P. de Jong, P. Vlaemminck and B. Van Vooren, and subsequently by P. de Jong, K. Claeyé and E. Bertolotto, lawyers,

interveners in Cases T‑429/13 and T‑451/13,

v

European Commission, represented by P. Ondrůšek and G. von Rintelen, acting as Agents,

defendant in Cases T‑429/13 and T‑451/13,

supported by

Kingdom of Sweden, represented by A. Falk, C. Meyer-Seitz, U. Persson, E. Karlsson, L. Swedenborg and C. Hagerman, acting as Agents,

by

Union nationale de l’apiculture française (UNAF), established in Paris (France), represented, in Case T‑429/13, by B. Fau and J.-F. Funke, lawyers, and, in Case T‑451/13, by B. Fau,

by

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

and

Österreichischer Erwerbsimkerbund, established in Großebersdorf (Austria),

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

by

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

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

and

Buglife — The Invertebrate Conservation Trust, established in Peterborough,

represented by B. Kloostra, lawyer,

and by

Stichting Greenpeace Council, established in Amsterdam (Netherlands), represented by B. Kloostra,

interveners in Cases T‑429/13 and T‑451/13,

APPLICATION (i) pursuant to Article 263 TFEU for annulment of Commission Implementing Regulation (EU) No 485/2013 of 24 May 2013 amending Implementing Regulation (EU) No 540/2011, as regards the conditions of approval of the active substances clothianidin, thiamethoxam and imidacloprid, and prohibiting the use and sale of seeds treated with plant protection products containing those active substances (OJ 2013 L 139, p. 12), and (ii) in Case T‑451/13, pursuant to Article 268 TFEU for compensation for the damage which the applicants claim to have suffered,

THE GENERAL COURT (First Chamber, Extended Composition)

composed of H. Kanninen, President, I. Pelikánová (Rapporteur), E. Buttigieg, S. Gervasoni and L. Calvo-Sotelo Ibáñez-Martín, Judges,

Registrar: S. Spyropoulos, Administrator,

having regard to the written part of the procedure and further to the hearings on 15 and 16 February 2017,

gives the following

Judgment

I. Legal Framework

A. Directive 91/414/EEC

1 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).

2 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 the directive.

3 Article 5(1) of Directive 91/414 stated, in particular: ‘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

4 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. It was adopted on the basis of Article 37(2) EC (now, after amendment, Article 43(1) TFEU) concerning the common agricultural policy, Article 95 EC (now Article 114 TFEU) concerning the approximation of laws which have as their object the internal market, in relation, notably, to the environment, and Article 152(4)(b) EC (now, after amendment, Article 168(4)(b) TFEU) concerning public health.

5 Under Article 28(1) of Regulation No 1107/2009, 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.

6 In accordance with Article 29(1)(a) of Regulation No 1107/2009, authorisation of a plant protection product by a Member State presupposes, inter alia, that its active substances have been approved at EU level.

7 Article 4 of Regulation No 1107/2009, entitled ‘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. The assessment of the active substance shall first establish whether the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are satisfied. If these criteria are satisfied the assessment shall continue to establish whether the other approval criteria set out in points 2 and 3 of Annex II are satisfied. 2. The residues of the plant protection products, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements: (a) they shall not have any harmful effects on human health, including that of vulnerable groups, or animal health, taking into account known cumulative and synergistic effects where the scientific methods accepted by the [European Food Safety Authority (EFSA)] to assess such effects are available, or on groundwater; (b) they shall not have any unacceptable effect on the environment. For residues which are of toxicological, ecotoxicological, environmental or drinking water relevance, there shall be methods in general use for measuring them. Analytical standards shall be commonly available. 3. A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements: (a) it shall be sufficiently effective; (b) it shall have no immediate or delayed harmful effect on human health, including that of vulnerable groups, or animal health, directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the scientific methods accepted by [EFSA] to assess such effects are available; or on groundwater; (c) it shall not have any unacceptable effects on plants or plant products; (d) it shall not cause unnecessary suffering and pain to vertebrates to be controlled; (e) it shall have no unacceptable effects on the environment, having particular regard to the following considerations where the scientific methods accepted by [EFSA] to assess such effects are available: (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. 4. The requirements of paragraphs 2 and 3 shall be evaluated in the light of uniform principles as referred to in Article 29(6). 5. For approval of an active substance, paragraphs 1, 2 and 3 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance. ...’

8 The uniform principles for evaluation mentioned in Article 4(4) of Regulation No 1107/2009 were defined in Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation No 1107/2009 as regards uniform principles for evaluation and authorisation of plant protection products (OJ 2011 L 155, p. 127), in accordance with Article 29(6) of Regulation No 1107/2009, without substantially modifying the version of those principles set out in Annex VI to Directive 91/414.

9 Article 21 of Regulation No 1107/2009, entitled ‘Review of approval’, is worded as follows: ‘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] 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). Article 13(4) and Article 20(2) shall apply.’

10 Annex II to Regulation No 1107/2009, entitled ‘Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II’, contains, in point 3 ‘Criteria for the approval of an active substance’, point 3.8 ‘Ecotoxicology’, a point 3.8.3 which is worded 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.’

11 Article 49 of Regulation No 1107/2009, entitled ‘Placing on the market of treated seeds’, provides in particular: ‘1. Member States shall not prohibit placing on the market and use of seeds treated with plant protection products authorised for that use in at least one Member State. 2. Where there are substantial concerns that treated seeds as referred to in paragraph 1 are likely to constitute a serious risk to human or animal health or to the environment and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, measures to restrict or prohibit the use and/or sale of such treated seeds shall be taken immediately in accordance with the regulatory procedure referred to in Article 79(3). Before taking such measures the 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. ...’

12 Under Article 78(3) of Regulation No 1107/2009, after 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 to be deemed to have been 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

13 The active substances clothianidin, thiamethoxam and imidacloprid (‘the substances covered’), which are part of the neonicotinoid family, were included in Annex I to Directive 91/414 by Commission Directive 2006/41/EC of 7 July 2006 amending Directive 91/414 to include clothianidin and pethoxamid as active substances (OJ 2006 L 187, p. 24), Commission Directive 2007/6/EC of 14 February 2007 amending Directive 91/414 to include metrafenone, Bacillus subtilis, spinosad and thiamethoxam as active substances (OJ 2007 L 43, p. 13) and Commission Directive 2008/116/EC of 15 December 2008 amending Directive 91/414 to include aclonifen, imidacloprid and metazachlor as active substances (OJ 2008 L 337, p. 86), respectively.

14 Within the European Union, imidacloprid and clothianidin are produced and marketed by the Bayer group and thiamethoxam is produced and marketed by the Syngenta group.

15 In 2008 and 2009, a number of incidents involving the misuse of plant protection products containing the substances covered resulted in losses of honeybee colonies. The Member States affected reacted by taking various restrictive measures.

16 In 2010, in response to those incidents, the European Commission adopted Directive 2010/21/EU of 12 March 2010 amending Annex I to Directive 91/414 as regards the specific provisions relating to clothianidin, thiamethoxam, fipronil and imidacloprid (OJ 2010 L 65, p. 27). This measure strengthened the terms of approval of the substances in question as regards the protection of non-target organisms, in particular honeybees.

17 On 18 March 2011, the Commission asked EFSA to review the existing scheme for the assessment of risks posed by plant protection products to bees, drawn up by the European and Mediterranean Plant Protection Organisation (EPPO), in relation to the assessment of chronic risks to bees, exposure to low doses, exposure through guttation and the cumulative risk assessment. The scheme was presented in a document entitled ‘Environmental risk assessment scheme for plant protection products’ (reference PP 3/10; ‘the EPPO Guidance’).

18 Restrictive measures applying to the use of the products concerned continued to be applied in various Member States at national level. On the basis of the final report of October 2011 of the Apenet monitoring and research programme in Italy, which raised concerns about the use of seeds treated with plant protection products containing the substances covered, and after discussions with the Member States’ experts within the framework of the Standing Committee on the Food Chain and Animal Health (‘the Standing Committee’), the Commission decided, on 22 March 2012, in accordance with Article 49(2) of Regulation No 1107/2009, to request an opinion from EFSA on the subject.

19 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, products containing the active substance imidacloprid (‘the Whitehorn study’). The authors of these 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 bumble-bees.

20 On 3 April 2012, the Commission asked EFSA, under Article 21 of Regulation No 1107/2009, to assess the new studies and to verify, by 30 April 2012 (and, after extension, no later than 31 May 2012), whether the doses that served as the basis for the experiments reported in the Henry and Whitehorn studies (‘the March 2012 studies’) were comparable to the actual doses to which bees were exposed in the European Union, on the basis of the supported uses at EU level and the authorisations granted by Member States (‘the first mandate’). The Commission also asked whether the results of the studies could be applied to other neonicotinoids used for the treatment of seeds, notably to clothianidin.

21 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 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 (‘the second mandate’).

22 On 23 May 2012, in response to the Commission’s request of 18 March 2011 (see paragraph 17 above), EFSA published a scientific opinion on the science underpinning the assessment of risks posed by plant protection products to bees (‘the EFSA Opinion’). This 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, leading to uncertainties about the real exposure of honeybees, and raised issues of relevance to bee health which had not previously been addressed by the EPPO Guidance.

23 On 1 June 2012, in response to the first mandate, EFSA produced the ‘Statement on the findings in recent studies investigating sub-lethal effects in bees of some neonicotinoids in consideration of the uses currently authorised in Europe’ (‘EFSA’s Statement’). In that statement, EFSA evaluated the March 2012 studies and a third study regarding clothianidin, published in January 2012 (‘the Schneider study’).

24 It found, in particular, that the concentrations of the substances tested in those studies were higher than those normally found in nectar of the crops for which data were available. EFSA inferred from this that, hourly, the doses used were probably higher than those ingested by honeybees in the field (with the exception of some scenarios for clothianidin), but that, for clothianidin and thiamethoxam, they could be lower than the daily intake. At the same time, EFSA noted that, in the absence of certain additional data, estimates of intake had to be viewed with caution. Overall, EFSA concluded that further research needed to be carried out with different exposure levels or in other situations.

25 On 25 July 2012, as a result of concerns expressed by EFSA that it might not be able to fulfil the second mandate by the deadline set, the Commission — taking account of EFSA’s Statement while maintaining the deadline of 31 December 2012 — narrowed the second mandate so as to prioritise the review of only the substances covered, to the exclusion of two other neonicotinoids, and to focus on their use for seed treatment and in the form of granules.

26 On 16 January 2013, EFSA published its conclusions as regards the risk assessment for bees for the substances covered (‘EFSA’s Conclusions’), in which it identified: – a high acute risk for 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 for bees from exposure to residues in nectar and pollen for the uses in oilseed rape (clothianidin, imidacloprid) as well as cotton and sunflowers (imidacloprid), and – a high acute risk from exposure to guttation for uses in maize (thiamethoxam).

27 In addition, EFSA’s Conclusions identified 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 by residues in succeeding rotational crops.

28 In the light of the risks identified by EFSA, the Commission submitted a draft implementing regulation and an opinion to the Standing Committee at its meeting on 14 and 15 March 2013. Since no opinion was delivered either by the Standing Committee or the appeal committee, lacking a qualified majority, the Commission adopted, on 24 May 2013, Implementing Regulation (EU) No 485/2013 amending Implementing Regulation No 540/2011, as regards the conditions of approval of the active substances clothianidin, thiamethoxam and imidacloprid, and prohibiting the use and sale of seeds treated with plant protection products containing those active substances (OJ 2013 L 139, p. 12) (‘the contested measure’).

29 Article 1 of the contested measure in particular introduced, for the three substances covered, the following restrictions: – prohibition of any non-professional use, indoors or outdoors; – prohibition of uses for seed treatment or soil treatment on the following cereals when these are to be sown from January to 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; – prohibition of uses as seed treatment, soil treatment or foliar application for around 100 crops, including rapeseed, soya, sunflowers and maize, with the exception of uses in greenhouses and of foliar treatment after flowering.

30 Furthermore, Article 2 of the contested measure prohibited the use and placing on the market of seeds of crops listed in Annex II which have been treated with plant protection products containing the substances covered, with the exception of seeds used in greenhouses. That covered, inter alia, the seeds of summer cereals, rapeseed, soya, sunflowers and maize.

31 Under Article 3 of the contested measure, the Member States were required, in accordance with Regulation No 1107/2009, to amend or withdraw existing authorisations for plant protection products containing the substances covered, by 30 September 2013. Article 4 of the contested measure provided that any period of grace granted by Member States was required to be as short as possible and to expire on 30 November 2013 at the latest.

32 The contested measure was published in the Official Journal of the European Union on 25 May 2013 and entered into force the following day, in accordance with Article 5 thereof, except for Article 2 which was to apply as of 1 December 2013.

III. Procedure and forms of order sought

A. Procedure

33 Syngenta Crop Protection AG and the other applicants in Case T‑451/13 whose names are set out in the annex (together ‘Syngenta’) brought the action in Case T‑451/13 by application lodged at the General Court Registry on 14 August 2013.

34 Bayer CropScience AG (‘Bayer’) brought the action in Case T‑429/13 by application lodged at the General Court Registry on 19 August 2013.

35 By orders of the President of the First Chamber of the General Court of 21 October 2014, Bayer CropScience v Commission (T‑429/13, not published), and by order of 21 October 2014, Bayer CropScience v Commission (T‑429/13, EU:T:2014:920), the Association générale des producteurs de maïs et autres céréales cultivées de la sous-famille des panicoïdées (AGPM), the National Farmers’ Union (NFU), the Association européenne pour la protection des cultures (European Crop Protection Association) (ECPA), Rapool-Ring GmbH Qualitätsraps deutscher Züchter (‘Rapool-Ring’), the European Seed Association (ESA) and the Agricultural Industries Confederation Ltd (‘AIC’) were granted leave to intervene in support of the form of order sought by Syngenta, and the Kingdom of Sweden, the Union nationale de l’apiculture française (UNAF), Deutscher Berufs- und Erwerbsimkerbund eV (‘DBEB’), Österreichischer Erwerbsimkerbund (‘ÖEB’), Stichting Greenpeace Council (‘Greenpeace’), Pesticide Action Network Europe (PAN Europe), Bee Life — European Beekeeping Coordination (Bee Life) and Buglife — The Invertebrate Conservation Trust (‘Buglife’) were granted leave to intervene in support of the form of order sought by the Commission in Case T‑451/13.

36 By orders of the President of the First Chamber of the General Court of 20 October 2014, Syngenta Crop Protection and Others v Commission (T‑451/13, not published), and by order of 20 October 2014, Syngenta Crop Protection and Others v Commission (T‑451/13, not published, EU:T:2014:951), the AGPM, the NFU, the ECPA, Rapool-Ring, the ESA and the AIC were granted leave to intervene in support of the form of order sought by Bayer, and the Kingdom of Sweden, UNAF, the DBEB, the ÖEB, PAN Europe, Bee Life, Buglife and Greenpeace were granted leave to intervene in support of the form of order sought by the Commission in Case T‑429/13.

37 By orders of 27 March 2015, Bayer CropScience v Commission (T‑429/13, not published, EU:T:2015:199), of 1 April 2015, Syngenta Crop Protection and Others v Commission (T‑451/13, not published, EU:T:2015:204), and of 27 July 2015, Bayer CropScience v Commission (T‑429/13, EU:T:2015:578), the President of the First Chamber of the General Court ruled on the objections raised by some of the interveners to the requests for confidentiality submitted by the applicants.

38 On a proposal from the First Chamber, the Court decided, pursuant to Article 28 of its Rules of Procedure, to refer the case to the First Chamber sitting in extended composition.

39 Acting on a proposal from the Judge-Rapporteur, the Court (First Chamber, Extended Composition) decided to open the oral part of the procedure and, by way of measures of organisation of procedure provided for in Article 89 of the Rules of Procedure, put written questions to the parties, to which they replied within the prescribed period.

40 The parties presented oral argument and replied to the questions put by the Court at the hearings on 15 February 2017 in Case T‑429/13, and on 16 February 2017 in Case T‑451/13.

B. Forms of order sought

1. Case T‑429/13

41 Bayer, supported by the AGPM, the NFU, the ECPA, Rapool-Ring, the ESA and the AIC, claims that the Court should: – annul the contested measure in its entirety or, in the alternative, in so far as it concerns the active substances imidacloprid and clothianidin; – order the Commission to pay the costs.

42 The Commission, supported by UNAF, the DBEB and the ÖEB, contends that the Court should: – dismiss the action; – order the applicant to pay the costs.

43 The Kingdom of Sweden, PAN Europe, Bee Life, Buglife and Greenpeace contend that the Court should dismiss the action.

2. Case T‑451/13

44 Syngenta, supported by the ECPA and Rapool-Ring, claims, after rectification at the stage of the reply, that the Court should: – annul the contested measure in its entirety or, in the alternative, in so far as it imposes restrictions on thiamethoxam, seeds treated with thiamethoxam and products containing thiamethoxam; – order the European Union, represented by the Commission, to pay compensation for the damage it suffered as a result of the Commission’s breach of its legal obligations, and set the amount of compensation provisionally at EUR 367.9 million plus ongoing losses from July 2013 or at an amount to be determined by the Court, which amounts should be increased by interest from the date of delivery of the judgment until actual payment; – order that interest at the rate set by the European Central Bank (ECB) for main refinancing operations plus two percentage points, or any other appropriate rate to be determined by the Court, be paid on the amount payable as from the date of delivery of the judgment until actual payment; – order the Commission to pay the costs.

45 The NFU, the ESA and the AIC claim that the Court should: – annul the contested measure in its entirety or, in the alternative, in so far as it imposes restrictions on thiamethoxam, seeds treated with thiamethoxam and products containing thiamethoxam; – order the Commission to pay the costs.

46 The AGPM claims that the Court should: – annul the contested measure; – order the Commission to pay the costs.

47 The Commission, supported by UNAF, the DBEB and the ÖEB, contends that the Court should: – dismiss the actions; – order the applicants to pay the costs.

48 The Kingdom of Sweden, PAN Europe, Bee Life, Buglife and Greenpeace contend that the Court should dismiss the actions.

IV. Law

49 After hearing the views of the parties on the point, the Court finds that it is appropriate that these cases be joined for the purposes of the judgment, in accordance with Article 68(1) of the Rules of Procedure.

A. Admissibility of the applications for annulment

50 In both cases, the Commission has doubts as to the applicants’ standing to bring proceedings in relation to active substances of which they are not the notifiers. Furthermore, the Commission observes that the restrictions on use laid down in Article 1 of the contested measure entail implementing measures and that the applicants cannot therefore rely on the final limb of the fourth paragraph of Article 263 TFEU in that regard.

51 Bayer submits that the contested measure is a regulatory act that does not entail implementing measures, which is why Bayer is entitled to challenge it irrespective of any individual concern. It further submits that, as the applicant for approval of imidacloprid and as the holder of exclusive rights in relation to clothianidin, it is individually concerned by the contested measure.

52 Syngenta submits that it raised arguments challenging the legality of the contested measure in its entirety and that it does not appear that the parts of the contested measure relating to thiamethoxam (in respect of which it is the notifier) could be separated from the others and so capable of discrete annulment.

53 Under the fourth paragraph of Article 263 TFEU, any natural or legal person may, under the conditions laid down in the first and second paragraphs of that article, institute proceedings against an act addressed to that person or which is of direct and individual concern to them, and against a regulatory act which is of direct concern to them and does not entail implementing measures.

54 It must be noted, first of all, that the contested measure is a measure of general application in that it applies to objectively determined situations and entails legal effects for categories of persons envisaged in a general and abstract manner. Articles 1 to 4 of the contested measure concern three active substances and, in a general and abstract manner, anyone intending to produce, market or use those substances or seeds, listed in Annex II to the contested measure, treated with plant protection products containing those substances, and anyone holding authorisations for those plant protection products. Consequently, having regard to those provisions and without prejudice to the existence of additional characteristics peculiar to them, all those persons are affected by the contested measure in the same way and are in the same situation.

55 Since the contested measure was not addressed to the applicants, it is necessary therefore to consider whether, as the applicants claim, that measure is of direct and individual concern to them or whether it is a regulatory act which is of direct concern to them and which does not entail implementing measures.

56 Given that both alternatives presuppose that the applicants are directly concerned, that condition should be examined first.

1. Direct concern to the applicants

57 With regard to the condition of direct concern to the applicants, it should be noted that that condition requires that the measure at issue directly affect the legal situation of the individual and that it leave no discretion to the addressees of the measure who are entrusted with the task of implementing it, such implementation being purely automatic and resulting from the contested rules without the application of other intermediate rules (judgments of 5 May 1998, Dreyfus v Commission, C‑386/96 P, EU:C:1998:193, paragraph 43; of 10 September 2009, Commission v Ente per le Ville vesuviane and Ente per le Ville vesuviane v Commission, C‑445/07 P and C‑455/07 P, EU:C:2009:529, paragraph 45; and order of 9 July 2013, Regione Puglia v Commission, C‑586/11 P, not published, EU:C:2013:459, paragraph 31).

58 In the present case, Articles 1, 3 and 4 of the contested measure must be distinguished from Article 2 thereof.

(a) Articles 1, 3 and 4 of the contested measure

59 Article 1 of the contested measure amends the list of active substances approved for use in plant protection products that is set out in the Annex to Implementing Regulation No 540/2011. That amendment requires the Member States that have granted authorisations for plant protection products containing the substances covered, without any discretion, to amend or withdraw them by 30 November 2013 at the latest, in accordance with Article 4 of the contested measure.

60 Consequently, Article 1 of the contested measure directly affects the legal situation of Bayer and of Syngenta, in so far as they produce and market the substances covered, as well as plant protection products containing them. The same applies to Articles 3 and 4 of the contested measure, which are purely ancillary to Article 1, in that they specify the arrangements for its implementation by the Member States.

(b) Article 2 of the contested measure

61 Article 2 of the contested measure prohibits the sale and use of seeds of crops listed in Annex II to that measure which have been treated with plant protection products containing the substances covered (with the exception of seeds used in greenhouses). This prohibition is to apply from 1 December 2013, as stated in Article 5 of the contested measure. Article 2 of the contested measure is directly applicable.

62 It should, however, be noted in that regard that the persons concerned by the prohibition laid down in Article 2 of the contested measure are producers and traders of seeds which have been treated with the substances covered, and farmers who wish to use those seeds.

63 At the hearing on 16 February 2017 Syngenta stated, in reply to a question from the Court, and without being contradicted by the Commission, that the trade in seeds treated with plant protection products containing thiamethoxam accounted for a significant portion of the Syngenta group’s business. Accordingly, in so far as Article 2 of the contested measure concerns thiamethoxam, that provision directly affects the legal situation of Syngenta.

64 By contrast, Bayer indicated at the hearing on 15 February 2017 that it did not itself market seeds treated with plant protection products containing the active substances imidacloprid and clothianidin, which it does market. Admittedly the prohibition against using and marketing treated seeds has appreciable effects on Bayer’s economic situation, in that it will in fact no longer be possible for it to sell the products whose application to the seeds will result in the trade and the use of those seeds being prohibited. However, those effects are merely the economic consequence of a prohibition which, as a matter of law, affects only seed producers and farmers and not Bayer itself. Therefore, those effects must be characterised as being indirect — since they are relayed via independent decisions of Bayer’s customers — and economic, rather than direct and legal. Taken in isolation, that prohibition does not affect Bayer’s right to market plant protection products containing the active substances imidacloprid and clothianidin.

65 It should be noted in that regard that the mere fact that an act may have economic repercussions on an applicant’s activities is not sufficient to establish that that applicant is directly concerned by that act (orders of 18 February 1998, Comité d’entreprise de la Société française de production and Others v Commission, T‑189/97, EU:T:1998:38, paragraph 48, and of 1 June 2015, Polyelectrolyte Producers Group and SNF v Commission, T‑573/14, not published, EU:T:2015:365, paragraph 32; see also, to that effect, judgment of 27 June 2000, Salamander and Others v Parliament and Council, T‑172/98 and T‑175/98 to T‑177/98, EU:T:2000:168, paragraph 62).

66 Consequently, Article 2 of the contested measure does not directly affect the legal situation of Bayer.

67 In conclusion, Articles 1, 3 and 4 of the contested measure are of direct concern to Bayer, in so far as they relate to the active substances imidacloprid and clothianidin, and to Syngenta, in so far as they relate to the active substance thiamethoxam, whereas Article 2 is of direct concern only to Syngenta in so far as it relates to the active substance thiamethoxam. Bayer is not, therefore, entitled to seek annulment of Article 2 of the contested measure.

2. Individual concern to the applicants

68 In so far as Bayer and Syngenta are, in part, directly concerned by the contested measure, it is necessary, next, to examine whether they are individually concerned by it.

69 In that regard, it should be recalled that persons other than those to whom an act is addressed may claim to be individually concerned within the meaning of the fourth paragraph of Article 263 TFEU only if that act affects them, by reason of certain attributes which are peculiar to them or by reason of circumstances in which they are differentiated from all other persons, and thereby distinguishes them individually just as in the case of the person addressed (judgment of 15 July 1963, Plaumann v Commission, 25/62, EU:C:1963:17, p. 107, and order of 26 November 2009, Região autónoma dos Açores v Council, C‑444/08 P, not published, EU:C:2009:733, paragraph 36).

(a) The substances notified by the applicants

70 The Courts of the European Union have, on a number of occasions, held that a notifier of an active substance, having submitted the dossier and participated in the assessment procedure, is individually concerned as much by a measure authorising the active substance subject to conditions as by a measure refusing authorisation (see, to that effect, judgments of 3 September 2009, Cheminova and Others v Commission, T‑326/07, EU:T:2009:299, paragraph 66; of 7 October 2009, Vischim v Commission, T‑420/05, EU:T:2009:391, paragraph 72; and of 6 September 2013, Sepro Europe v Commission, T‑483/11, not published, EU:T:2013:407, paragraph 30). The same analysis must be considered to apply in principle where the measure in question withdraws or restricts the approval of the active substance covered.

71 In the present case, it is common ground that Bayer and Syngenta Crop Protection AG are the notifiers, respectively, of imidacloprid and of thiamethoxam, that they submitted the dossiers and participated in the assessment of those two substances and that they still have exclusive rights in respect of those substances. They are, therefore, individually concerned by the contested measure with regard, respectively, to imidacloprid and thiamethoxam, which the Commission has, moreover, expressly acknowledged.

72 Bayer is therefore entitled to challenge Articles 1, 3 and 4 of the contested measure in so far as they relate to imidacloprid, and Syngenta Crop Protection AG is entitled to challenge Articles 1, 2, 3 and 4 of the contested measure in so far as they relate to thiamethoxam.

(b) The substances in respect of which the applicants are not the notifiers

73 The Commission disputes that the applicants are individually concerned by the contested measure with respect to the active substances of which they are not the notifiers. This concerns, on the one hand, the standing of Bayer to bring proceedings with regard to the active substance clothianidin, and, on the other hand, Bayer and Syngenta Crop Protection AG with regard to the substances of which the other applicant is the notifier.

(1) Individual concern to Bayer, as regards clothianidin

74 The Commission contends that it is Sumitomo Chemicals SA and not Bayer that is the notifier of clothianidin, and that the contested measure is not, therefore, of individual concern to Bayer so far as that substance is concerned.

75 In the light of certain circumstances peculiar to Bayer, which are not disputed by the Commission, and which relate to Bayer’s role in the development of clothianidin and in the preparation of the regulatory dossier for approval of that substance, certain intellectual property rights in relation to clothianidin held by Bayer and its participation in the review procedure before EFSA on equal terms with the notifier, it must be concluded that Bayer is in a situation that is in fact comparable to that of the notifier. Consequently, for the same reasons as those set out in paragraph 70 above, Bayer must be regarded as being individually concerned by the contested measure with respect to clothianidin.

76 Accordingly, Bayer has standing to bring proceedings in the present action also in so far as it is challenging Articles 1, 3 and 4 of the contested measure, to the extent that they relate to clothianidin.

(2) Individual concern to the applicants in the case of the substances in respect of which the other applicant is the notifier

77 The applicants submit that their arguments are largely procedural in nature and apply equally to the three substances covered, and that it does not appear that the contested measure could be separated into different parts that apply to one of the substances but not to the others.

78 It is sufficient to observe in that regard that the applicants’ standing to bring proceedings is limited to those parts of the contested measure that are of direct and individual concern to them. As indicated above, the contested measure is of individual concern to the applicants only in so far as they are the notifiers of the substances covered or in so far as they can show that special circumstances apply, such as those identified in Bayer’s case with respect to clothianidin. By contrast, the contested measure is not of individual concern to Bayer in so far as it relates to thiamethoxam, nor is it of individual concern to Syngenta in so far as it relates to imidacloprid and clothianidin.

79 It must be added that, contrary to the view taken by the applicants, it is possible to separate the contested measure into different parts relating to the different active substances and, if necessary, to annul it with respect to one of the substances but not with respect to the others, in a situation where either the contested measure is challenged only by one party which does not have standing to bring proceedings in respect of all the substances, or the successful plea in favour of annulment relates to only one of the substances.

3. Characterisation of the contested measure as a regulatory act that does not entail implementing measures

80 Bayer submits that the contested measure constitutes a regulatory act that does not entail implementing measures within the meaning of the fourth paragraph of Article 263 TFEU, and that it is therefore entitled to challenge the measure, even in relation to substances in respect of which it is not the notifier, without being required to show that it is individually concerned.

81 In response to a written question from the Court, the Commission maintains that Article 1 of the contested measure, whether read in isolation or in conjunction with Articles 3 and 4 of that measure, entails implementing measures, while Article 2 does not.

(a) Characterisation as a regulatory act

82 According to the case-law, the concept of ‘regulatory act’ must be understood as covering acts of general application other than legislative acts (judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council, C‑583/11 P, EU:C:2013:625, paragraph 60).

83 First, as stated in paragraph 54 above, the contested measure is a measure of general application.

84 Second, Article 1 of the contested measure has as its legal basis Article 21(3) of Regulation No 1107/2009, which empowers the Commission to adopt, in accordance with the procedure referred to in Article 79(3) of that regulation, a regulation to withdraw or amend approval of the substances covered. Article 79(3) of Regulation No 1107/2009, in turn, refers in particular to Article 5 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ 1999 L 184, p. 23).

85 Since Decision 1999/468 was repealed and replaced, with effect from 1 March 2011, by Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ 2011 L 55, p. 13), the reference in Article 79(3) of Regulation No 1107/2009 must now be understood, in accordance with Article 13(1)(c) of Regulation No 182/2011, as referring to Article 5 of the latter regulation which, in accordance with Article 2(2) thereof, applies, in particular, to implementing acts of general application and to other implementing acts relating to the environment, security and safety or protection of the health or safety of humans, animals or plants.

86 It follows that Article 1 of the contested measure was adopted by the Commission in the exercise of its implementing powers under the review procedure, and that, consequently, it does not constitute a legislative act within the meaning of the case-law stemming from the judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council (C‑583/11 P, EU:C:2013:625). It should, moreover, be noted that Bayer does not claim that there were any procedural irregularities in that respect.

87 Consequently, Article 1 of the contested measure, which has general application and is not legislative in nature, is a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU.

(b) Absence of implementing measures

88 As the Court has already held, the question whether a regulatory act entails implementing measures should be assessed by reference to the position of the person pleading the right to bring proceedings under the final limb of the fourth paragraph of Article 263 TFEU. It is therefore irrelevant whether the act in question entails implementing measures with regard to other persons (judgment of 19 December 2013, Telefónica v Commission, C‑274/12 P, EU:C:2013:852, paragraph 30).

89 In the present case, as stated in paragraph 59 above, the amendment of the Annex to Implementing Regulation No 540/2011 provided for by Article 1 of the contested measure requires the Member States that have granted authorisations for plant protection products containing the substances covered to amend or withdraw them by 30 November 2013 at the latest, in accordance with Article 4 of the contested measure. Article 1 of the contested measure thus entails implementing measures.

90 That conclusion is not called into question by the mechanical nature of the measures taken at national level. That question is irrelevant in ascertaining whether a regulatory act entails implementing measures within the meaning of the final limb of the fourth paragraph of Article 263 TFEU (see, to that effect, judgment of 28 April 2015, T & L Sugars and Sidul Açúcares v Commission, C‑456/13 P, EU:C:2015:284, paragraphs 41 and 42).

91 It follows that Article 1 of the contested measure, whether read in isolation or in conjunction with Articles 3 and 4 (see paragraph 60 above), does not constitute an act of general application that does not entail implementing measures within the meaning of the final limb of the fourth paragraph of Article 263 TFEU.

92 The admissibility of the present actions, to the extent that they concern Articles 1, 3 and 4 of the contested measure with regard to the substances in respect of which Bayer and Syngenta Crop Protection AG are not the notifiers, cannot, therefore, be founded on that provision.

4. Admissibility of the action in Case T‑451/13, in so far as it was brought by the applicants other than Syngenta Crop Protection AG

93 In case T‑451/13, the Commission has doubts as to whether the applicants other than Syngenta Crop Protection AG, which are not the notifiers of the active substance thiamethoxam and which, at most, are holders of national authorisations to place plant protection products on the market, are individually concerned by the contested measure. Given that the restrictions on use laid down in Article 1 of the contested measure entail implementing measures, they cannot, on any view, rely on the final limb of the fourth paragraph of Article 263 TFEU.

94 Syngenta has not commented on those arguments.

95 It should be observed in that regard that, as has been noted in paragraph 72 above, Syngenta Crop Protection AG has standing to bring proceedings with respect to the application for annulment of Articles 1 to 4 of the contested measure, in so far as they relate to the active substance thiamethoxam.

96 In those circumstances, since one and the same application is involved, there is no need to consider whether the other applicants are entitled to bring proceedings (see, to that effect, judgments of 24 March 1993, CIRFS and Others v Commission, C‑313/90, EU:C:1993:111, paragraph 31; of 6 July 1995, AITEC and Others v Commission, T‑447/93 to T‑449/93, EU:T:1995:130, paragraph 82; and of 8 July 2003, Verband der freien Rohrwerke and Others v Commission, T‑374/00, EU:T:2003:188, paragraph 57).

97 Furthermore, it is not apparent from the file that, from the point of view of the applicants other than Syngenta Crop Protection AG, the admissibility of their application would extend beyond that of the application brought by Syngenta Crop Protection AG.

98 Consequently, in Case T‑451/13, there is no need to consider whether the applicants other than Syngenta Crop Protection AG are entitled to bring proceedings.

5. Summary with regard to admissibility

99 In conclusion, the action in Case T‑429/13 is admissible to the extent that Bayer seeks annulment of Articles 1, 3 and 4 of the contested measure with respect to the active substances imidacloprid and clothianidin. As to the remainder, the action is inadmissible.

100 The action in Case T‑451/13 is admissible to the extent that Syngenta seeks annulment of Articles 1 to 4 of the contested measure with respect to the active substance thiamethoxam. As to the remainder, the action is inadmissible.

B. The applications for annulment of Articles 1, 3 and 4 of the contested measure

1. Preliminary observations

101 In both cases, the applicants raise complaints alleging infringement of Article 4, Article 12(2), Articles 21 and 49 and point 3.8.3 of Annex II to Regulation No 1107/2009, breach of the principles of legal certainty, protection of legitimate expectations and respect for the rights of the defence, breach of the precautionary principle and of the principles of proportionality and of good administration, and infringement of the right to property and of the freedom to conduct a business.

102 In addition, in Case T‑451/13, Syngenta alleges, as a preliminary point, a ‘[lack of] scientific basis for the contested [measure]’. In the context of that complaint, it argues that there are a number of fundamental problems with the scientific basis for the contested measure. In its opinion, these flaws amount to manifest errors and result in the infringement of numerous provisions of EU law, set out in the other pleas it raises.

103 It must be noted in that regard that this complaint by Syngenta is of a cross-cutting nature, in that it could be relevant to some of the other pleas in law on which it relies and, in particular, to those alleging infringement of provisions of Regulation No 1107/2009 and to those alleging breach of the precautionary principle and of the principle of proportionality. This complaint does no more, therefore, than set out separately and as a preliminary point certain arguments advanced by Syngenta in relation to the scientific basis of the contested measure and which are relevant to a number of the pleas invoked.

104 In those circumstances, this complaint will not be dealt with separately and as a preliminary point below, but will be taken into account in the context of the other pleas raised by Syngenta to which it relates.

2. General considerations

105 According to Article 1(3) of Regulation No 1107/2009, the purpose of the regulation is to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production.

106 In requiring that a high level of protection of the environment be maintained, Regulation No 1107/2009 is applying Article 11 and Article 114(3) TFEU. Article 11 TFEU provides that environmental protection requirements must be integrated into the definition and implementation of the European Union’s policies and activities, in particular with a view to promoting sustainable development. Giving concrete expression to that obligation, Article 114(3) TFEU provides that, in its proposals concerning, inter alia, environmental protection, made on the basis of the approximation of laws which have as their object the establishment and functioning of the internal market, the Commission will take as a base a high level of protection, taking account in particular of any new development based on scientific facts, and that, within their respective powers, the European Parliament and the Council of the European Union will also seek to achieve this objective. The protection of the environment takes precedence over economic considerations, with the result that it may justify adverse economic consequences, even those which are substantial, for certain traders (see, to that effect, judgments of 9 September 2011, Dow AgroSciences and Others v Commission, T‑475/07, EU:T:2011:445, paragraph 143; of 6 September 2013, Sepro Europe v Commission, T‑483/11, not published, EU:T:2013:407, paragraph 85; and of 12 December 2014, Xeda International v Commission, T‑269/11, not published, EU:T:2014:1069, paragraph 138).

107 Moreover, recital 8 of Regulation No 1107/2009 states that the precautionary principle should be applied and that the regulation seeks to ensure that industry demonstrate that substances or products produced or placed on the market do not have any harmful effect on human or animal health or any unacceptable effects on the environment.

108 In that regard, it should be noted that the prior authorisation and approval procedures put in place by Regulation No 1107/2009 (and, previously, by Directive 91/414) for plant protection products and their active substances emanate from the general principle of EU law that is the precautionary principle (see, to that effect, judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 133).

(a) The precautionary principle

(1) Definition

109 The precautionary principle is a general principle of EU law requiring the authorities in question, in the particular context of the exercise of the powers conferred on them by the relevant rules, to take appropriate measures to prevent specific potential risks to public health, safety and the environment, by giving precedence to the requirements related to the protection of those interests over economic interests (see judgments of 21 October 2003, Solvay Pharmaceuticals v Council, T‑392/02, EU:T:2003:277, paragraph 121 and the case-law cited, and of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 134 and the case-law cited; see also, to that effect, judgment of 26 November 2002, Artegodan and Others v Commission, T‑74/00, T‑76/00, T‑83/00 to T‑85/00, T‑132/00, T‑137/00 and T‑141/00, EU:T:2002:283, paragraphs 183 and 184).

110 Where there is scientific uncertainty as to the existence or extent of risks to human health or to the environment, the precautionary principle allows the institutions to take protective measures without having to wait until the reality and seriousness of those risks become fully apparent or until the adverse health effects materialise (see judgments of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 135 and the case-law cited, and of 6 September 2013, Sepro Europe v Commission, T‑483/11, not published, EU:T:2013:407, paragraph 44 and the case-law cited).

111 Within the process leading to the adoption by an institution of appropriate measures to prevent specific potential risks to public health, safety and the environment by reason of the precautionary principle, three successive stages can be identified: first, identification of the potentially adverse effects arising from a phenomenon; second, assessment of the risks to public health, safety and the environment which are related to that phenomenon; and, third, when the potential risks identified exceed the threshold of what is acceptable for society, risk management by the adoption of appropriate protective measures. Although the first of those stages does not require further explanation, the two subsequent stages call for clarification.

(2) Risk assessment

112 Assessment of the risks to public health, safety and the environment consists, for the institution required to consider potentially adverse effects arising from a phenomenon, in scientifically assessing those risks and in determining whether they exceed the level of risk deemed acceptable for society. Thus, in order for the institutions to be able to carry out a risk assessment, it is important for them, first, to have a scientific assessment of the risks and, second, to determine what level of risk is deemed unacceptable for society (see judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 137 and the case-law cited).

(i) The scientific assessment

113 A scientific risk assessment is a scientific process consisting, in so far as possible, in the identification and characterisation of a hazard, the assessment of exposure to that hazard and the characterisation of the risk (see judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 138 and the case-law cited).

114 In its communication COM(2000) 1 final of 2 February 2000 on the precautionary principle (‘the Communication on the precautionary principle’), the Commission defined those four components of a scientific risk assessment as follows (see Annex III to that communication): ‘Hazard identification means identifying the biological, chemical or physical agents that may have adverse effects … Hazard characterisation consists of determining, in quantitative and/or qualitative terms, the nature and severity of the adverse effects associated with the causal agents or activity ... Appraisal of exposure consists of quantitatively or qualitatively evaluating the probability of exposure to the agent under study … Risk characterisation corresponds to the qualitative and/or quantitative estimation, taking account of inherent uncertainties, of the probability, of the frequency and severity of the known or potential adverse environmental or health effects liable to occur. It is established on the basis of the three preceding and closely depends on the uncertainties, variations, working hypotheses and conjectures made at each stage of the process. When the available data are inadequate or non-conclusive, a prudent and cautious approach to environmental protection, health or safety could be to opt for the worst-case hypothesis. When such hypotheses are accumulated, this will lead to an exaggeration of the real risk but gives a certain assurance that it will not be underestimated.’

115 As a scientific process, the scientific risk assessment must be entrusted by the institution to scientific experts (judgments of 11 September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraph 157; of 11 September 2002, Alpharma v Council, T‑70/99, EU:T:2002:210, paragraph 170; and of 9 September 2011, France v Commission, T‑257/07, EU:T:2011:444, paragraph 73).

116 The scientific risk assessment is not required to provide the institutions with conclusive scientific evidence of the reality of the risk and the seriousness of the potential adverse effects were that risk to become a reality. A situation in which the precautionary principle is applied by definition coincides with a situation in which there is scientific uncertainty. Furthermore, the adoption of a preventive measure, or, conversely, its withdrawal or relaxation, cannot be made subject to proof of the lack of any risk, in so far as such proof is generally impossible to give in scientific terms since zero risk does not exist in practice (judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 140; see also, to that effect, judgment of 21 October 2003, Solvay Pharmaceuticals v Council, T‑392/02, EU:T:2003:277, paragraph 130). However, a preventive measure cannot properly be based on a purely hypothetical approach to the risk, founded on mere conjecture which has not been scientifically verified (judgments of 11 September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraphs 142 and 143, and of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 140; see also, to that effect, judgment of 11 July 2007, Sweden v Commission, T‑229/04, EU:T:2007:217, paragraph 161).

117 Indeed, the scientific risk assessment should be based on the best scientific data available and should be undertaken in an independent, objective and transparent manner (see judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 141 and the case-law cited).

118 In addition, it must be noted that it may prove impossible to carry out a full scientific risk assessment because of the inadequate nature of the available scientific data. However, that does not prevent the competent public authority from taking preventive measures in accordance with the precautionary principle. It is important, in such a situation, that scientific experts carry out a scientific risk assessment notwithstanding the existing scientific uncertainty, so that the competent public authority has available to it sufficiently reliable and cogent information to allow it to understand the ramifications of the scientific question raised and decide upon a policy in full knowledge of the facts (judgment of 9 September 2011, France v Commission, T‑257/07, EU:T:2011:444, paragraph 77; see also, to that effect, judgments of 11 September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraphs 160 to 163, and of 11 September 2002, Alpharma v Council, T‑70/99, EU:T:2002:210, paragraphs 173 to 176).

119 Where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the insufficiency, inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures, provided they are non-discriminatory and objective (judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 142 and the case-law cited, and judgment of the EFTA Court of 5 April 2001, EFTA Surveillance Authority v Norway, E–3/00, EFTA Court Report 2000-2001, p. 73, paragraph 31).

120 It follows that a preventive measure may be taken only if the risk, although the reality and extent thereof have not been ‘fully’ demonstrated by conclusive scientific evidence, appears nevertheless to be adequately backed up by the scientific data available at the time when the measure was taken (see judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 143 and the case-law cited).

121 In such a situation, ‘risk’ thus constitutes the degree of probability that the acceptance of certain measures or practices will adversely affect the interests safeguarded by the legal order. ‘Hazard’ (‘danger’) is commonly used in a broader sense and describes any product or procedure capable of having an adverse effect on human health or any other interest safeguarded by the legal order (judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 144; see also, to that effect, judgments of 11 September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraph 147, and of 9 September 2011, Dow AgroSciences and Others v Commission, T‑475/07, EU:T:2011:445, paragraph 147).

(ii) The determination of the level of risk deemed unacceptable

122 The responsibility for determining the level of risk which is deemed unacceptable for society lies, provided that the applicable rules are observed, with the institutions responsible for the political choice of determining an appropriate level of protection for society. It is for those institutions to determine the critical probability threshold for adverse effects on public health, safety and the environment and for the degree of those potential effects which, in their judgment, is no longer acceptable for society and above which it is necessary, in the interests of protecting public health, safety and the environment, to take preventive measures in spite of the existing scientific uncertainty (judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 145; see also, to that effect, judgments of 11 July 2000, Toolex, C‑473/98, EU:C:2000:379, paragraph 45, and of 11 September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraphs 150 and 151).

123 In determining the level of risk deemed unacceptable for society, the institutions are bound by their obligation to ensure a high level of protection of public health, safety and the environment. That high level of protection does not necessarily have to be the highest that is technically possible, in order to be compatible with Article 114(3) TFEU (judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 146; see also, to that effect, judgment of 14 July 1998, Safety Hi-Tech, C‑284/95, EU:C:1998:352, paragraph 49). Moreover, those institutions may not take a purely hypothetical approach to risk and may not base their decisions on a ‘zero risk’ (judgments of 11 September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraph 152, and of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 146).

124 The level of risk deemed unacceptable for society will depend on the assessment made by the competent public authority of the particular circumstances of each individual case. In that regard, the authority may take account, inter alia, of the severity of the impact on public health, safety and the environment were the risk to occur, including the extent of possible adverse effects, the persistency or reversibility of those effects and the possibility of delayed effects as well as of the more or less concrete perception of the risk based on available scientific knowledge (judgment 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 147; see also, to that effect, judgment of 11 September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraph 153).

(3) Risk management

125 Risk management corresponds to the body of actions taken by an institution faced with a risk in order to reduce it to a level deemed acceptable for society having regard to its obligation, in accordance with the precautionary principle, to ensure a high level of protection of public health, safety and the environment (judgment 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 148).

126 Those actions include the adoption of provisional measures, which must be proportionate, non-discriminatory, transparent, and consistent with similar measures already taken (judgment 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 149; see also, to that effect, judgment of 1 April 2004, Bellio F.lli, C‑286/02, EU:C:2004:212, paragraph 59).

(b) Review of an active substance included in Part A of the Annex to Implementing Regulation No 540/2011

127 As explained in paragraphs 12 and 13 above, the substances covered by the contested measure were approved under the rules laid down by Directive 91/414, in accordance with the conditions that applied at the time, and are now listed in Part A of the Annex to Implementing Regulation No 540/2011.

128 Since the review of their approval by the Commission was carried out pursuant to Regulation No 1107/2009, it should be noted in that regard that the specific requirements for the approval of active substances changed when that regulation was adopted.

(1) The original conditions for inclusion under Directive 91/414

129 Article 5(1) of Directive 91/414 provided that, in order for a substance to be included in Annex I thereto, it had to be the case that it could be expected that, in the light of then current scientific and technical knowledge, the use of, and residues from, plant protection products containing that active substance, consequent on application consistent with good plant protection practice, would not have any harmful effects on human or animal health or any unacceptable influence on the environment.

130 It has been held that it followed from Article 5(1) of Directive 91/414, interpreted in conjunction with the precautionary principle, that, in the domain of human health, the existence of solid evidence which, while not resolving scientific uncertainty, could reasonably raise doubts as to the safety of a substance, justified, in principle, the refusal to include that substance in Annex I thereto (judgment of 11 July 2007, Sweden v Commission, T‑229/04, EU:T:2007:217, paragraph 161). Those considerations apply, by analogy, in respect of the other interests protected by Article 4 of Regulation No 1107/2009 (identical to those protected by Article 5(1) of Directive 91/414), namely, in particular, animal health and the environment.

131 However, it is also apparent from the case-law that the effect of Article 5(4) of Directive 91/414, which provides that inclusion of an active substance in Annex I to that directive may be subject to restrictions on use, is to permit inclusion of substances which do not fulfil the requirements of Article 5(1) of the directive subject to certain restrictions which exclude problematic uses of the substance involved. Since Article 5(4) of Directive 91/414 is to be regarded as a limitation on Article 5(1) of that directive, it must be interpreted in the light of the precautionary principle. Consequently, before including a substance in that annex, it must be established beyond a reasonable doubt that the restrictions on the use of the substance involved make it possible to ensure that use of that substance will be in accordance with the requirements laid down in Article 5(1) of the directive (judgment of 11 July 2007, Sweden v Commission, T‑229/04, EU:T:2007:217, paragraphs 169 and 170).

132 Last, it has been held that, under the rules laid down by Directive 91/414, it is the notifier who has to demonstrate that, on the basis of the information submitted for one or more preparations for a limited range of representative uses, the conditions for approval are met (judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 154).

(2) Amendment of the approval criteria by Regulation No 1107/2009

133 It is apparent, when Article 5 of Directive 91/414 (see paragraph 3 above) is compared with Article 4 of Regulation No 1107/2009 (see paragraph 7 above), that, in the replacement of Directive 91/414 by Regulation No 1107/2009, the general approval criteria and conditions were reformulated in greater detail, although that did not necessarily lead to any substantive strengthening of those criteria and conditions.

134 In addition, the uniform principles for evaluation and authorisation of plant protection products, defining in particular the thresholds for hazard quotients for oral and contact exposure, did not change substantially when Regulation No 1107/2009 entered into force (see paragraph 8 above).

135 However, Regulation No 1107/2009 introduced specific new requirements for the approval of active substances, including, in particular, point 3.8.3 of Annex II to that regulation (see paragraph 10 above), which contains special requirements in relation to the exposure of honeybees and acute or chronic effects on colony survival and development. It follows from a comparison of that criterion with the earlier legislation and, in particular, Article 5(1) of Directive 91/414, that the requirements relating to the absence of unacceptable effects on bees were substantially strengthened when Regulation No 1107/2009 entered into force, in so far as it is now expressly required that exposure of honeybees to the active substance in question be only ‘negligible’ or that its use not have ‘unacceptable acute or chronic effects on colony survival and development, taking into account effects on honeybee larvae and honeybee behaviour’.

136 Recital 10 of Regulation No 1107/2009 states that, for active substances already approved prior to entry into force of the regulation, criteria harmonised by Regulation No 1107/2009 are to be applied at the time of renewal or review of their approval. It follows that, in the present case, the review of the approval of the substances covered, approved under Directive 91/414, must proceed according to the criteria and conditions set out by Regulation No 1107/2009.

(3) The burden of proof

137 Last, it is evident from the wording and the organisation of the relevant provisions of Regulation No 1107/2009 that the burden of proving that the conditions for approval under Article 4 of Regulation No 1107/2009 are met lies, in principle, with the notifier, as was expressly provided for in Directive 91/414 (see paragraph 132 above).

138 In particular, recital 8 of Regulation No 1107/2009 states that the regulation ‘should ensure that industry demonstrates that substances or products produced or placed on the market do not have … any unacceptable effects on the environment’. Similarly, according to recital 10, substances should be included in plant protection products ‘only ... where it has been demonstrated’, in particular, that they are not expected to have any unacceptable effects on the environment.

139 Furthermore, Article 4(1) of Regulation No 1107/2009, which sets out the conditions for approval of active substances (see paragraph 7 above), requires that it may be ‘expected’ that the plant protection products containing an active substance meet the requirements provided for in paragraphs 2 and 3 of that article, which, in turn, require that those products and their residues meet the requirements that are then set out. In accordance with the principle that a party who relies on a legal provision must prove that the conditions of application of that provision are met, it follows from the wording above that it is the person seeking approval who must prove that the conditions of such approval are met in order to obtain it, and not the Commission that must prove that the conditions of approval are not met in order to be able to refuse it.

140 However, as the applicants submitted at the hearings, in the context of a review taking place before the end of the approval period, it is for the Commission to demonstrate that the conditions of approval are no longer met. It is the party that relies on a legal provision — in this instance, Article 21(3) of Regulation No 1107/2009 — that must prove that the conditions of its application are met. It should be pointed out in that regard that acceptance that in cases of scientific uncertainty reasonable doubts as to the safety of an active substance approved at EU level are capable of justifying a precautionary measure cannot be treated as equivalent to a reversal of the burden of proof (see, by analogy, judgment of 26 November 2002, Artegodan and Others v Commission, T‑74/00, T‑76/00, T‑83/00 to T‑85/00, T‑132/00, T‑137/00 and T‑141/00, EU:T:2002:283, paragraph 191).

141 Nevertheless, the Commission discharges the burden of proof if it establishes that the conclusion, at the time of the initial approval, that the approval criteria provided for in Article 4 of Regulation No 1107/2009 were satisfied is invalidated by subsequent regulatory or technical developments.

142 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, as regards, for example, certain routes of exposure. 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 (see, to that effect and by analogy, judgment of 26 November 2002, Artegodan and Others v Commission, T‑74/00, T‑76/00, T‑83/00 to T‑85/00, T‑132/00, T‑137/00 and T‑141/00, EU:T:2002:283, paragraph 192).

(c) Scope of judicial review

143 If the Commission is to be able to pursue effectively the objectives assigned to it by Regulation No 1107/2009 (see paragraphs 105 to 107 above), account being taken of the complex technical assessments which it must undertake, it must be recognised as enjoying a broad discretion (see, to that effect, judgments of 18 July 2007, Industrias Químicas del Vallés v Commission, C‑326/05 P, EU:C:2007:443, paragraphs 74 and 75, and of 6 September 2013, Sepro Europe v Commission, T‑483/11, not published, EU:T:2013:407, paragraph 38). That applies, in particular, to risk management decisions which it must take pursuant to that regulation.

144 The exercise of that discretion is not, however, excluded from judicial review. In that regard, according to settled case-law, in the context of such a review, the Courts of the European Union must verify whether the relevant procedural rules have been complied with, whether the facts admitted by the Commission have been accurately stated and whether there has been a manifest error of assessment or a misuse of powers (judgments of 25 January 1979, Racke, 98/78, EU:C:1979:14, paragraph 5; of 22 October 1991, Nölle, C‑16/90, EU:C:1991:402, paragraph 12; and of 9 September 2008, Bayer CropScience and Others v Commission, T‑75/06, EU:T:2008:317, paragraph 83).

145 As regards the assessment by the Courts of the European Union as to whether there has been a manifest error of assessment, it must be stated that, in order to establish that the Commission made a manifest error in assessing complex facts such as to justify the annulment of the contested measure, the evidence adduced by the applicant must be sufficient to make the factual assessments used in that measure implausible (see, to that effect, judgments of 12 December 1996, AIUFFASS and AKT v Commission, T‑380/94, EU:T:1996:195, paragraph 59, and of 1 July 2004, Salzgitter v Commission, T‑308/00, EU:T:2004:199, paragraph 138, not set aside on that point by the judgment of 22 April 2008, Commission v Salzgitter, C‑408/04 P, EU:C:2008:236). Without prejudice to that examination of plausibility, it is not for the General Court to substitute its assessment of complex facts for that of the institution which adopted the measure (judgment of 9 September 2011, Dow AgroSciences and Others v Commission, T‑475/07, EU:T:2011:445, paragraph 152; see also, to that effect, judgment of 15 October 2009, Enviro Tech (Europe), C‑425/08, EU:C:2009:635, paragraph 47).

146 Moreover, it must be recalled that, where an institution has a wide discretion, the review of observance of guarantees conferred by the EU legal order in administrative procedures is of fundamental importance. The Court of Justice has had occasion to specify that those guarantees include, in particular for the competent institution, the obligations to examine carefully and impartially all the relevant elements of the individual case and to give an adequate statement of the reasons for its decision (judgments of 21 November 1991, Technische Universität München, C‑269/90, EU:C:1991:438, paragraph 14; of 7 May 1992, Pesquerias de Bermeo and Naviera Laida v Commission, C‑258/90 and C‑259/90, EU:C:1992:199, paragraph 26; and of 6 November 2008, Netherlands v Commission, C‑405/07 P, EU:C:2008:613, paragraph 56).

147 Thus, it has already been held that a scientific risk assessment carried out as thoroughly as possible on the basis of scientific advice founded on the principles of excellence, transparency and independence is an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures (judgment of 11 September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraph 172).

3. Complaints relating to the application of Article 21(1) of Regulation No 1107/2009

148 The applicants submit, in essence, that the Commission was not entitled to review the approval of the substances covered, since the requirements set out in that respect in Article 21(1) of Regulation No 1107/2009 were not met.

149 The Commission contests the applicants’ arguments.

150 Article 21 of Regulation No 1107/2009 (cited in paragraph 9 above) is structured as follows.

151 Paragraph 1 provides that the Commission may at any time review the approval of an active substance, either on its own initiative or at the request of a Member State. In accordance with the second subparagraph of paragraph 1, where the Commission decides to carry out a review, it is to inform the Member States, EFSA and the producer of the substance in question and set a period for the producer to submit its comments.

152 Paragraph 2 provides that, in the context of the review, the Commission may ask the Member States and EFSA for an opinion, or for scientific or technical assistance, and prescribes the time limits with which they must comply.

153 Last, paragraph 3 provides that, where the Commission concludes that the approval criteria are no longer satisfied, it is to propose the adoption of a regulation to withdraw or amend the approval, under the committee procedure, in accordance with Article 79(3) of Regulation No 1107/2009.

(a) The threshold for the application of Article 21(1) of Regulation No 1107/2009

154 The applicants have not specifically expressed a view on the threshold for the application of Article 21(1) of Regulation No 1107/2009, since, in their arguments, they do not maintain a strict distinction between the respective conditions for applying paragraph 1 and paragraph 3 of that article. Syngenta nevertheless concedes that Article 21(1) allows the Commission to investigate new information that may be of concern. However, Bayer and Syngenta dispute that the March 2012 studies constitute such information. They contend, in particular, that there was no new scientific and technical knowledge within the meaning of Article 21(1) of Regulation No 1107/2009 indicating that the substances concerned no longer met the approval criteria.

155 The ECPA, intervening in support of the applicants, submits inter alia that the requirement for the scientific and technical knowledge in question to be ‘new’ should not be understood primarily as being temporal, but rather as a qualitative requirement.

156 The Commission contests those arguments.

157 In the first place, it must be noted that it is evident from the actual wording of Article 21 of Regulation No 1107/2009 that the threshold for the application of paragraph 1 thereof is lower than that of paragraph 3.

158 First of all, the first sentence of Article 21(1) provides that the Commission may review the approval of an active substance ‘at any time’. Although the implementation of that very general power is subsequently made subject to certain conditions, the legislature’s choice of wording indicates that it did not consider that the approval of an active substance must give the notifier special protection against the initiation of a review procedure.

159 In addition, whereas the second subparagraph of Article 21(1) provides for a review, in particular, where the Commission ‘considers that there are indications that the substance no longer satisfies the approval criteria provided for in Article 4’, paragraph 3 of that article requires the Commission to have ‘conclude[d] that the approval criteria provided for in Article 4 are no longer satisfied’, if a regulation to withdraw or amend the approval is to be adopted. The wording of Article 21 itself therefore indicates that the threshold for the application of paragraph 1 is lower than that of paragraph 3.

160 That is consistent with the structure of Article 21, outlined in paragraphs 150 to 153 above. The review procedure is precisely required to enable the Commission, in the event of new scientific knowledge emerging to suggest that the substance in question might no longer satisfy the approval criteria, to verify whether that is indeed the case. It would therefore be entirely illogical to require the same degree of certainty for initiation of the review procedure as for the withdrawal or amendment of the approval.

161 In the second place, as regards the specific definition of the threshold for the application of Article 21(1) of Regulation No 1107/2009, it should be noted that the interests of the notifiers of the substances in question are protected by the fact that an approval can actually be amended or withdrawn only if, at the end of the review procedure, it is concluded that the conditions of Article 4 of Regulation No 1107/2009 are no longer satisfied. Moreover, in order to be able to establish whether that is indeed the case, taking account, in particular, of the objective of protection pursued by Regulation No 1107/2009 (see paragraphs 105 to 107 above), the Commission must be able to initiate a review even if the degree of doubt raised by the new scientific and technical knowledge is only relatively small.

162 Nonetheless, that does not mean that the Commission is entirely free in making its assessment. 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.

163 Last, in the third place, the definition of the level of previous scientific and technical knowledge should also be clarified, since the newness of new knowledge can only be assessed in relation to a previous level. It must be concluded in that regard that the previous level of knowledge cannot be that which immediately precedes publication of the new knowledge, but rather that which obtained at the time of the previous risk assessment of the substance concerned. First, that previous assessment represents a stable benchmark since it contains a summary of the knowledge available at the time. Second, if the novelty of the knowledge related to the level of knowledge immediately preceding its publication, it would not be possible to take account of the gradual development of scientific and technical knowledge, each stage of which may not necessarily in itself raise concerns, but which, as a whole, may give rise to concern.

164 In conclusion, in order for the Commission to be able to carry out a review of the approval of an active substance under Article 21(1) of Regulation No 1107/2009, it is therefore sufficient that there are new studies (that is to say, studies which have not yet been taken into account by EFSA or the Commission in an earlier assessment of the substance concerned) the results of which, as compared with the knowledge available at the time of the earlier assessment, raise concerns as to whether the conditions of 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 a matter for the review itself.

(b) The information relied on by the Commission in order to justify initiation of the review procedure

165 In order to identify which information the Commission was entitled or, as the case may be, was required to take into account in its decision to review the approval of the substances covered, in the first place, it is necessary to determine when that decision was taken.

166 It should be noted that, in the second mandate (see paragraph 21 above), the Commission instructed EFSA, on 25 April 2012, to update the risk assessment of neonicotinoids with regard to bees, in particular as regards (i) the acute and chronic effects on colony development and survival, and (ii) the effects of sub-lethal doses on bee survival and behaviour. Such an ‘update’ cannot but be interpreted as the first stage of the review of the approval of the substances in question, within the meaning of Article 21 of Regulation No 1107/2009, namely that of identifying and assessing (or reassessing) the risks posed by those substances, a task which Regulation No 1107/2009 confers on EFSA (the second stage, risk management, being the Commission’s responsibility). The date of 25 April 2012 must therefore be accepted as being the date on which, at the latest, the Commission decided to carry out the review.

167 In reply to a written question from the Court, the Commission essentially confirmed that date, while emphasising that, since Article 21(1) of Regulation No 1107/2009 does not require a formal decision to be adopted in order for a review to be initiated, the date of 25 April 2012 merely represented the temporal limit of a decision-making process that extended over a certain period of time.

168 Consequently, the ‘new scientific and technical knowledge’ within the meaning of Article 21(1) of Regulation No 1107/2009 had to pre-date 25 April 2012 in order to be capable of justifying the initiation of the review procedure.

169 In the second place, it should be noted that the contested measure does not precisely identify the new scientific and technical knowledge that led the Commission to carry out a review of the approval of the substances covered. Recital 4 of that measure states in general terms that, ‘in spring 2012, new scientific information on the sub-lethal effects of neonicotinoids on bees was published’. That general description may include, in addition to the March 2012 studies (see paragraph 19 above), the Schneider study, published on 11 January 2012 (see paragraph 23 above), and the EFSA Opinion (see paragraph 22 above). Although the final version of that opinion — on which the Commission also relies in its defence statements, with regard to new scientific information — was not published until 23 May 2012, an initial version had been sent to the Commission on 29 February 2012, as is evident from an email from EFSA to the Commission.

170 Nevertheless, it appears that the new knowledge which the Commission was able to acquire on reading the EFSA Opinion (or, more specifically, the preliminary version of it; see paragraph 169 above) in fact played no more than a minor part in its decision to review the approval of the substances covered. Thus, for example, the discussion paper dated 28 January 2013 for the Standing Committee’s meeting on 31 January and 1 February 2013, in which the Commission set out the inferences it considered should be drawn from EFSA’s Conclusions published on 16 January 2013, mentioned only the Henry, Whitehorn and Schneider studies as ‘new scientific evidence’ that had led the Commission to carry out a review, and not the EFSA Opinion.

171 Accordingly, the Court considers it appropriate to confine itself to the March 2012 studies and the Schneider study for the purpose of determining whether the new scientific and technical knowledge available on 25 April 2012 warranted initiation of the review.

(c) Whether the Commission had new scientific and technical knowledge, within the meaning of Article 21(1) of Regulation No 1107/2009, at the time of the initiation of the review procedure

172 The March 2012 studies were published in the science journal Science on 30 March 2012. The Schneider study was published in January 2012 in the online science journal PLoS ONE. In accordance with the guidance set out in paragraph 164 above, it is appropriate therefore to note at the outset that those three studies were new, in the sense that they had not previously been taken into account by EFSA or the Commission for the purposes of assessing the risks posed by the substances covered.

173 According to the summary provided in EFSA’s Statement (see paragraph 23 above), the Henry study concerned research conducted in France on the plant protection product Cruiser, marketed by Syngenta, which contains the active substance thiamethoxam. Specifically, that study highlighted research indicating that exposure to non-lethal but field-realistic doses of thiamethoxam caused high mortalities in honeybees due to homing failure at levels that increased the risk that a colony could collapse. A new technology, radiofrequency identification (RFID), was used in the Henry study to follow individual bees as they entered and exited the hive.

174 The Whitehorn study concerned research conducted in the United Kingdom on bumble-bees and the plant protection product Gaucho, marketed by Bayer, containing the active substance imidacloprid. This study concluded that the growth rate and the production of new queens were significantly reduced in colonies of bumble-bees exposed to various sub-lethal doses of imidacloprid.

175 The Schneider study identified effects on the behaviour of bees exposed to sub-lethal doses of imidacloprid and of clothianidin. In particular, a reduction in foraging activity and in the duration of foraging flights was observed. Like the Henry study, the Schneider study used RFID technology to monitor bee movement.

176 The applicants have a certain number of criticisms of the Henry, Whitehorn and Schneider studies, which are capable, in their view, of calling into question the new scientific and technical knowledge the Commission claims to draw from them.

(1) The newness of the results of the March 2012 studies

177 In the first place, Bayer submits that neither the Henry study nor the Whitehorn study nor yet the Schneider study contained new scientific information of relevance for honeybee risk managem