Judgment;Abstract — ECLI:EU:T:2019:141
Date: 2019-03-07
Language of the case: English
Court formation: Eighth Chamber
Subject matter: Provisions governing the Institutions;Access to documents
Procedure: Action for annulment - successful
Origin: Belgium

summary and a complete dossier as provided for in Article 8(1) and (2) of Regulation No 1107/2009. 68 Point 3.1 of Annex II to Regulation No 1107/2009 states, inter alia, that ‘the dossiers submitted pursuant to Article 7(1) shall contain the information needed to establish, where relevant, [ADI], Acceptable Operator Exposure Level (AOEL) and [ARfD]. 69 Secondly, the view should also be taken that the requested studies are intended to determine the effects of exposure to glyphosate on human health. 70 Under Article 3(23) of Regulation No 1107/2009, ‘tests and studies’ means ‘investigations or experiments whose purpose is to determine the properties and behaviour of an active substance or of plant protection products, predict exposure to active substances and/or their relevant metabolites, determine safe levels of exposure and establish conditions for the safe use of plant protection products’. 71 In addition, Article 3 of Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances in accordance with Regulation No 1107/2009 (OJ 2013 L 93, p. 1) provides that Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation No 1107/2009 (JO 2011 L 155, p. 1) is to apply to procedures concerning the renewal of approval of an active substance commenced before 31 December 2013. Therefore, Regulation No 544/2011 applies to the procedure concerning the renewal of approval of glyphosate (see paragraph 4 above). 72 The Annex to Regulation No 544/2011 sets out the data requirements for active substances, pursuant to Article 8(1)(b) of Regulation No 1107/2009. 73 With regard to the toxicological and metabolism studies, point 5 of the Annex to Regulation No 544/2011 provides, inter alia, in its introduction: ‘(i) The information provided, taken together with that provided for one or more preparations containing the active substance, must be sufficient to permit an evaluation to be made as to the risks for man, associated with the handling and use of plant protection products containing the active substance, and the risk for man arising from residual traces remaining in food and water. In addition, the information provided must be sufficient to: – decide whether, or not, the active substance can be approved, – specify appropriate conditions or restrictions to be associated with any approval, – classify the active substance as to hazard, – establish a [ADI] level for man, – establish [AOEL], – […]’ 74 More specifically, with regard to the developmental toxicity studies, of which the requested studies form part, point 5.6.2 of the Annex to Regulation No 544/2011 states: ‘The studies reported, taken together with other relevant data and information on the active substance, must be sufficient to permit effects on embryonic and foetal development, following repeated exposure to the active substance, to be assessed, and in particular must be sufficient: – to identify direct and indirect effects on embryonic and foetal development resulting from exposure to the active substance, […] – to establish the NOAEL.’ 75 It follows that, by making it possible to determine, inter alia, the ADI and ARfD for glyphosate, which represent the estimated quantity in food that may be ingested daily or over a lifetime without appreciable risk to the health of the consumer, the requested studies form part of the process of assessing the risks of the active substance for human health for the purposes of renewing the approval of glyphosate. 76 In the light of the foregoing considerations, it is necessary to examine whether the information contained in the requested studies constitutes information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006, which EFSA disputes. 77 In the first place, EFSA contends that the requested studies do not concern actual or foreseeable emissions into the environment or the effects of such emissions. 78 According to the case-law of the Court of Justice, it is apparent, in essence, from Article 1(1)(b) of Regulation No 1367/2006, read in conjunction with Article 2(1)(d), that the objective of that regulation is to ensure access to information concerning factors, such as emissions affecting or likely to affect elements of the environment, in particular air, water and soil. That is not the case as regards purely hypothetical emissions (see judgment of 23 November 2016, Commission v Stichting Greenpeace Nederland and PAN Europe, C‑673/13 P, EU:C:2016:889, paragraph 72 and the case-law cited). 79 However, the concept of information which ‘relates to emissions into the environment’ cannot be limited to information concerning emissions actually released into the environment when the plant protection product or active substance in question is used on plants or soil, where those emissions depend, inter alia, on the quantities of product actually used by farmers and the exact composition of the final product marketed (judgment of 23 November 2016, Commission v Stichting Greenpeace Nederland and PAN Europe, C‑673/13 P, EU:C:2016:889, paragraph 73). 80 Thus, that concept also covers information on foreseeable emissions into the environment from the plant protection product or active substance in question, under normal or realistic conditions of use of that product or substance, namely the conditions under which the authorisation to place that product or substance on the market was granted and which prevail in the area where that product or substance is intended to be used (see judgment of 23 November 2016, Commission v Stichting Greenpeace Nederland and PAN Europe, C‑673/13 P, EU:C:2016:889, paragraph 74 and the case-law cited). 81 Although the placing on the market of a product or substance is not sufficient in general for it to be concluded that that product or substance will necessarily be released into the environment and that information concerning the product or substance ‘relates to emissions into the environment’, the situation is different as regards a product such as a plant protection product, and the substances which that product contains, which, in the course of normal use, are intended to be released into the environment by virtue of their very function. In that case, foreseeable emissions, under normal or realistic conditions of use, from the product in question or from the substances which that product contains, into the environment are not hypothetical and are covered by the concept of ‘emissions into the environment’ for the purposes of the first sentence of Article 6(1) of Regulation No 1367/2006 (see judgment of 23 November 2016, Commission v Stichting Greenpeace Nederland and PAN Europe, C‑673/13 P, EU:C:2016:889, paragraph 75 and the case-law cited). 82 Consequently, an active substance contained in plant protection products, such as glyphosate, in the course of normal use, is intended to be discharged into the environment by virtue of its function, and its foreseeable emissions cannot, therefore, be regarded as purely hypothetical. 83 In any event, glyphosate emissions cannot be classified as merely foreseeable emissions. The requested studies formed part of the dossier for the renewal of approval of the active substance glyphosate. 84 It should be recalled, in that respect, that glyphosate has been listed as an active substance since 1 July 2002. Since that date, glyphosate has been authorised in Member States and has actually been used in plant protection products. As recital 19 of Implementing Regulation 2017/2324 states, glyphosate is one of the most widely used herbicides in the European Union. 85 Glyphosate emissions into the environment are therefore a reality. That active substance is present particularly as residues in plants, water and food. 86 Hence, the requested studies are studies which are intended to establish the toxicity of an active substance which is actually present in the environment. 87 Therefore, EFSA cannot argue that the requested studies do not concern actual emissions or the effects of actual emissions. 88 In the second place, EFSA contends that the requested studies were conducted in order to determine the dangerous properties of glyphosate and not to establish the level of emissions which might be authorised and that, therefore, their purpose is not to assess the actual or foreseeable emissions. A link with emissions into the environment is not sufficient for those studies to be covered by Article 6(1) of Regulation No 1367/2006. 89 It is true that the Court of Justice has already held that, although it was not necessary to apply a restrictive interpretation of the concept of information which ‘relates to emissions into the environment’, that concept may not, in any event, include information containing any kind of link, even direct, to emissions into the environment. If that concept were interpreted as covering such information, it would to a large extent deprive the concept of ‘environmental information’, as defined in Article 2(1)(d) of Regulation No 1367/2006, of any meaning. Such an interpretation would deprive of any practical effect the possibility, laid down in Article 4(2), first indent, of Regulation No 1049/2001, for the institutions to refuse to disclose environmental information on the ground, inter alia, that such disclosure would have an adverse effect on the protection of the commercial interests of a particular natural or legal person and would jeopardise the balance which the EU legislature intended to maintain between the objective of transparency and the protection of those interests. It would also constitute a disproportionate interference with the protection of business secrecy ensured by Article 339 TFEU (judgment of 23 November 2016, Commission v Stichting Greenpeace Nederland and PAN Europe, C‑673/13 P, EU:C:2016:889, paragraph 81). 90 However, it must be recalled that, according to the case-law cited in paragraph 57 above, the objective of Regulation No 1367/2006, according to Article 1, is to ensure the widest possible systematic availability and dissemination of environmental information. It is clear, in essence, from recital 2 of that regulation that the purpose of having access to environmental information guaranteed by that regulation is to promote more effective public participation in the decision-making process, thereby increasing, on the part of the competent bodies, the accountability of decision-making and contributing to public awareness and support for the decisions taken (judgments of 23 November 2016, Commission v Stichting Greenpeace Nederland and PAN Europe, C‑673/13 P, EU:C:2016:889, paragraph 80, and of 4 September 2018, ClientEarth v Commission, C‑57/16 P, EU:C:2018:660, paragraph 98). 91 In order to be able to ensure that the decisions taken by the competent authorities in environmental matters are justified and to participate effectively in decision-making in environmental matters, the public must have access to information enabling it to ascertain whether the emissions were correctly assessed and must be given the opportunity reasonably to understand how the environment could be affected by those emissions. The Court of Justice concluded that it was necessary to include in the concept of information which ‘relates to emissions into the environment’ information enabling the public to check whether the assessment of actual or foreseeable emissions, on the basis of which the competent authority authorised the product or substance in question, was correct, and the data relating to the effects of those emissions on the environment (judgment of 23 November 2016, Commission v Stichting Greenpeace Nederland and PAN Europe, C‑673/13 P, EU:C:2016:889, paragraph 80). 92 It is apparent from that case-law that the concept of information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006 is not limited to information which makes it possible to assess the emissions as such, but also covers information relating to the effects of those emissions. 93 In that regard, the Court of Justice has provided guidelines in its interpretation of the concept of ‘information on emissions into the environment’ for the purposes of the second subparagraph of Article 4(2) of Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ 2003 L 41, p. 26). 94 The second subparagraph of Article 4(2) of Directive 2003/4 is intended to transpose Article 4(4)(d) of the Aarhus Convention, the provisions of which form an integral part of the EU legal order (see judgment of 15 March 2018, North East Pylon Pressure Campaign and Sheehy, C‑470/16, EU:C:2018:185, paragraph 46 and the case-law cited). That convention has primacy over secondary EU legislation which must be interpreted, as far as possible, in accordance with it (see, by analogy, judgment of 11 July 2018, Bosphorus Queen Shipping, C‑15/17, EU:C:2018:557, paragraph 44). 95 Account must be taken of the Aarhus Convention for the purposes of interpreting Directive 2003/4 (judgment of 23 November 2016, Bayer CropScience and Stichting De Bijenstichting, C‑442/14, EU:C:2016:890, paragraph 54) and Regulation No 1367/2006 (judgment of 23 November 2016, Commission v Stichting Greenpeace Nederland and PAN Europe, C‑673/13 P, EU:C:2016:889, paragraph 61). 96 It should be pointed out that Article 4(2)(d) of Directive 2003/4 and Article 6(1) of Regulation No 1367/2006 are intended to implement the same provision of the Aarhus Convention. 97 As Advocate General Szpunar stated in point 40 of his Opinion in Saint-Gobain Glass Deutschland v Commission (C‑60/15 P, EU:C:2016:778), it is desirable to ensure consistency in the interpretation of those two acts (Directive 2003/4 and Regulation No 1367/2006) in so far as they implement the same provisions of the Aarhus Convention. In the absence of explicit indication to the contrary, it can be reasonably assumed that the EU legislature intended to implement the Aarhus Convention uniformly in EU law, both for Member States and for the EU institutions. 98 Therefore, the view should be taken that the interpretation adopted by the Court of Justice in the judgment of 23 November 2016, Bayer CropScience and Stichting De Bijenstichting (C‑442/14, EU:C:2016:890), of the concept of ‘information relating to emissions into the environment’ for the purposes of Article 4(2)(d) of Directive 2003/4, also applies to the concept of information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006. 99 The Court of Justice has held that the public must have access not only to information on emissions as such, but also to information concerning the medium to long-term consequences of those emissions on the state of the environment, such as the effects of those emissions on non-targeted organisms. The public interest in accessing information on emissions into the environment is specifically to know not only what is, or foreseeably will be, released into the environment, but also to understand the way in which the environment could be affected by the emissions in question (see, by analogy, judgment of 23 November 2016, Bayer CropScience and Stichting De Bijenstichting, C‑442/14, EU:C:2016:890, paragraph 86). 100 It follows that the concept of information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006 must be interpreted as covering not only information on emissions as such, namely information concerning the nature, composition, quantity, date and place of those emissions, but also data concerning the medium to long-term consequences of those emissions on the environment (see, by analogy, judgment of 23 November 2016, Bayer CropScience and Stichting De Bijenstichting, C‑442/14, EU:C:2016:890, paragraph 87). 101 In that regard, by making it possible to set the NOAEL and the ADI for glyphosate, that is to say, the maximum dose for exposure to the active substance for which no adverse effects are observed and the estimated quantity of the substance that may be ingested daily over a lifetime without appreciable risk to the consumer, the view must be taken that the requested studies, in accordance with the definition in Article 3(23) of Regulation No 1107/2009, made it possible to ‘determine safe levels of exposure’ and to ‘establish conditions for the safe use of plant protection products’. 102 In addition, it is apparent from point 5 of the Annex to Regulation No 544/2011 that the requested studies, by making it possible to set the ADI for glyphosate, constitute information which allows for an ‘evaluation to be made as to the risks for man, associated with the handling and use of the active substance’ and the ‘risk for man arising from residual traces remaining in food and water’. More specifically, the purpose of the requested studies, as developmental toxicity studies, according to point 5.6.2 of the Annex to Regulation No 544/2011, is ‘to permit effects on embryonic and foetal development, following repeated exposure to the active substance, to be assessed’. 103 The view must therefore be taken that the requested studies, by establishing the NOAEL on the basis of which the ADI and the ARfD were calculated, made it possible to determine the limits within which glyphosate, when present in food, does not present any risk in the medium to long term for human health and therefore set the various values relating to the consequences of glyphosate emissions on human health. 104 Furthermore, as the Kingdom of Sweden points out, the ADI represents a threshold for long-term safe exposure for consumers. Thus, if the use or residues of a plant protection product cause the ADI to be exceeded, they will be regarded as harmful to human health. 105 In that regard, EFSA acknowledges that the ADI forms part of the risk assessment process for the approval of an active substance, which requires that the conditions set out in Article 4 of Regulation No 1107/2009 are satisfied. It states that, to that end, it is necessary to assess whether the active substance or its residues have harmful effects on human health. EFSA states that, in a first step, the toxicological reference value used to assess the long term exposure of humans is the ADI, calculated on the basis of the NOAEL, and that, in a second step, the exposure to the active substance and its residues is assessed and compared with the ADI. 106 It is apparent from the peer review and it is common ground between the parties that, on the basis of the requested studies, the ADI for glyphosate went from 0.3 mg/kg bw/day at the time of the first approval of glyphosate to 0.5 mg/kg bw/day at the time of the renewal of the approval of that active substance. 107 An increase in the ADI implies the possibility of an increase in the glyphosate residues regarded as not being harmful to health. As the Kingdom of Sweden points out, an increase in the ADI means that the relevant authorities will accept higher glyphosate levels in food. 108 In the third place, EFSA argues that the doses administered to vertebrate animals in a laboratory are not the same as the doses with which human beings will come into contact when using the substance and that those studies carried out in a laboratory are unrelated to the intended manner of use and do not correspond to realistic conditions. The conditions of exposure used in the laboratory studies are not comparable to the range of exposure of humans and the environment to spraying with glyphosate in accordance with good agricultural practice. 109 Admittedly, in the present case, there is no dispute that the requested studies were carried out in a laboratory on pregnant rabbits by gavage with high doses of glyphosate which do not correspond to those with which a human being is faced during normal use of that substance. 110 However, the Court of Justice has held that what mattered was not so much that the data in question come from studies performed entirely or in part in the field or in laboratories or even from a translocation examination, but that the purpose of those studies is to assess ‘emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006, that is to say, the actual or foreseeable emissions of the product or substance in question into the environment under circumstances representing normal or realistic conditions of use of that product or substance, or to analyse the effects of those emissions (see, by analogy, judgment of 23 November 2016, Bayer CropScience and Stichting De Bijenstichting, C‑442/14, EU:C:2016:890, paragraph 89). 111 Therefore, data from tests whose objective is to study the effects of the use of a dose of the product or substance in question which is significantly above the maximum dose for which the marketing authorisation is granted and which is to be used in practice, or a dose in a much higher concentration, do not, in particular, constitute information which ‘relates to emissions into the environment’, since that information relates to emissions which are not foreseeable under normal or realistic conditions of use (see, by analogy, judgment of 23 November 2016, Bayer CropScience and Stichting De Bijenstichting, C‑442/14, EU:C:2016:890, paragraph 90). 112 By contrast, information which ‘relates to emissions into the environment’ covers studies which seek to establish the toxicity, effects and other aspects of a product or substance under the most unfavourable realistic conditions which could possibly occur, and studies carried out in conditions as close as possible to normal agricultural practice and conditions which prevail in the area where that product or substance is to be used (see, by analogy, judgment of 23 November 2016, Bayer CropScience and Stichting De Bijenstichting, C‑442/14, EU:C:2016:890, paragraph 91). 113 It follows that, for the studies to be classified as information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006, what matters is not so much the conditions in which those studies were carried out, in particular whether or not they were carried out in a laboratory, but their purpose. 114 Thus, EFSA cannot validly argue that the requested studies are not related to the intended uses and are purely theoretical on the basis that the high doses used in the requested studies in order to set the ADI do not correspond to those actually released into the environment. 115 That would mean that the requested studies set the NOAEL for human beings, from which the ADI was calculated using purely hypothetical data which have nothing to do with the manner in which human beings will be exposed to glyphosate when using it. 116 Thus, EFSA’s argument that the conditions in which the requested studies were carried out are not linked to emissions is irrelevant. What matters is not the conditions in which the requested studies were carried out, but their purpose, which is to define the NOAEL, used as a basis for establishing the ADI and the ARfD. It follows that the purpose of the requested studies is to determine the limits beyond which exposure to the active substance glyphosate presents risks to human health. 117 Therefore, by making it possible to define the maximum dose for exposure to glyphosate beyond which the residues of the active substance will be regarded as harmful to human health, the requested studies are studies which seek to determine the toxicity of glyphosate under the most unfavourable realistic conditions which could possibly occur. 118 In addition, under the case-law cited in paragraph 91 above, according to which the public must be given the opportunity reasonably to understand how the environment could be affected by those emissions, the view must be taken that the applicant’s access to the requested studies would enable him to understand the manner in which human health could be affected by glyphosate being released into the environment. 119 It follows from the foregoing that the requested studies must be regarded as constituting information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006. 120 Therefore, pursuant to that provision, an overriding public interest in disclosing the studies is deemed to exist, and EFSA could not refuse to disclose them on the ground that that would have an adverse effect on the protection of the commercial interests of the owners of the requested studies for the purposes of Article 4(2), first indent, of Regulation No 1049/2001. 121 Consequently, EFSA’s argument that access to the complete studies is not necessary, since the parts of the requested studies that were disclosed make it possible to verify the result of the studies or the assessment carried out, is irrelevant. 122 Moreover, in the contested decision, in the context of the exception laid down in Article 4(2), first indent, of Regulation No 1049/2001, EFSA stated that Article 63(2) of Regulation No 1107/2009 contained a non-exhaustive list of sensitive information the disclosure of which was in principle deemed to undermine the protection of the commercial interests of the persons concerned. It considered that the parts of the studies identified as coming under that list had to be protected in accordance with Article 4(2), first indent, of Regulation No 1049/2001. 123 First, it is apparent from the contested decision that EFSA does not specify which parts of the requested studies were identified as coming under the list in Article 63(2) of Regulation No 1107/2009. 124 In that regard, it should be pointed out that, with regard to the information relating to the names and addresses of persons involved in testing on vertebrate animals, referred to in Article 63(2)(g) of Regulation No 1107/2009, EFSA expressly stated that they were protected by virtue of the exception provided for in Article 4(1)(b) of Regulation No 1049/2001. It should be recalled that that information is not the subject of the present action. 125 However, EFSA does not indicate which information in the requested studies comes under one of the other exceptions contained in the list in Article 63(2) of Regulation No 1107/2009. In that regard it should be pointed out that the table annexed to the contested decision, setting out which parts of the requested studies were or were not disclosed and for what reason, refers to Article 63(2) of Regulation No 1107/2009 only with regard to the parts of those studies which were disclosed, that is to say, the title, the table of contents and the tables, figures and annexes containing raw data from the studies. 126 Secondly, EFSA expressly states in the contested decision that it applied Article 63(2) of Regulation No 1107/2009 in the context of the exception provided for in Article 4(2), first indent, of Regulation No 1049/2001, that is to say, the protection of commercial interests. 127 It follows from the foregoing that the exception relating to the protection of commercial interests, provided for in Article 4(2), first indent, of Regulation No 1049/2001, cannot be relied upon in order to object to the disclosure of the requested studies which are regarded as information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006. 128 Therefore, the view should be taken that EFSA has not justified the application of Article 63(2) of Regulation No 1107/2009. 129 In the light of all of the foregoing, the first plea in law should be upheld, and therefore the contested decision should be annulled in so far as it refused to disclose the whole of the requested studies, with the exception of the names and signatures of the persons mentioned therein. Costs 130 Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. 131 Since EFSA has been unsuccessful, it must be ordered to bear its own costs and to pay those incurred by the applicant, in accordance with the form of order sought by the applicant. 132 Under Article 138(1) of the Rules of Procedure, Member States which intervene in the proceedings are to bear their own costs. For that reason, the Kingdom of Sweden must bear its own costs. On those grounds, THE GENERAL COURT (Eighth Chamber) hereby: 1. Annuls the decision of the European Food Safety Authority (EFSA) of 16 October 2017, annulling and replacing the decision of 30 July 2014 and granting partial access to two toxicity studies on the active substance glyphosate, conducted in connection with the procedure to renew approval of that active substance, in so far as EFSA refuses to disclose the whole of those studies, with the exception of the names and signatures of the persons mentioned therein; 2. Orders EFSA to bear its own costs and pay the costs incurred by Mr Anthony Tweedale; 3. Orders the Kingdom of Sweden to bear its own costs. Collins Kancheva De Baere Delivered in open court in Luxembourg on 7 March 2019. E. Coulon A.M. Collins Registrar President * Language of the case: English.