di Ludwig Krämer
Articolo pubblicato con il consenso dell’Autore. Orginariamente pubblicato su Environmental Law Network International 2/18 Kramer_contributo ELNI
The judgment in case T-545/11 RENV discusses once more the question, what constitutes an emission into the environment. This is of importance for environmental law, as the principle of transparency gives everybody the right to know, what “emissions, discharges and other releases” (1) are put into the environment. This principle of transparency sometimes enters into conflict with the wish of economic operators – and public authorities to keep information on emissions confidential.
The case which led to the judgment in case T-545/11 RENV started in 2010, when two environmental organizations, Greenpeace and Pesticide Action Network Europe (PAN), wanted to know the impurities of the substance glyphosate. Glyphosate is an active substance used in pesticides (herbicides). It was developed and patented by Monsanto company; the patent expired in the year 2000.
Present pesticide (2) legislation in the EU provides that an active substance of pesticides be approved by the EU. Further, pesticide products, which may only contain active substances that have previously been approved by the EU, are then authorized by the Member States.
Greenpeace and PAN addressed the European Commission, where requests had been submitted at the end of 1998 to include glyphosate in the list of approved active substances for pesticides, together with documentation to justify such an inclusion. Germany was asked to examine the application. Its review report of 1999 led to the Commission decision of 2001 which included glyphosate in the list of active substances for pesticides (3). The degree of purity was specified at “950g/kg” (4), meaning that the impurities were tolerated up to 50 g/kg (5 per cent).
Greenpeace and PAN asked for access to several documents of the authorizing file. After several discussions with the Commission, they clarified that they wanted to know the degree of purity of glyphosate, the identity and quantity of all the impurities and the exact composition of glyphosate. The General Court granted access upon this request (5). On appeal by the Commission, the Court of Justice set this judgment aside (6), arguing that the General Court had not differentiated clearly enough between the terms “access to environmental information” which allowed the public authorities to weigh any such request against the interests of economic operators to determine the commercial interests and intellectual property protected, and the term “emissions into the environment” which prevailed over the interests of economic operators (7).
Case T-545/11 RENV constitutes the new decision by the General Court in this matter (8). The General Court now holds that information on the impurities of glyphosate “does not relate to emissions whose release into the environment is foreseeable” (9). A competitor of the producer could deduce from the impurities the production method of glyphosate; this would lead to market share losses and an impairment of the intellectual property, impairing the commercial interests of the original glyphosate producer. Therefore the interests of the applicants to keep the exact composition of glyphosate and in particular the kind and quantity of impurities confidential prevail over the interest of the applicants to know the exact composition, including the impurities, of glyphosate.
First, the procedure before the European Courts has to be discussed. The judgment in case T-545/11 was issued by the Second Chamber of the General Court, and the judgment in case T-545/11 RENV by the Fourth Chamber. However, according to the heading of the two judgments, in both cases Judge Juraj Schwarcz acted as the rapporteur. The Statute of the Court of Justice of the EU, which also applies to the General Court, provides in this regard in Article 18: “No judge…may take part in the disposal of any case
… in which he has been called upon to pronounce as a member of a court or tribunal” (10). This means that Judge Schwarcz unduly acted as a judge in the second case. This judgment is thus defective and must, should the applicants appeal, be dismissed by the Court of Justice.
The substantive question turns once more to the problem of the term “emissions into the environment”. A closer examination of this term is important to understand the reasoning of the General Court and the problem which this reasoning raises.
The Aarhus Convention which was ratified by the EU (11) and is thus part of EU law (12) indicates that public authorities may refuse access to environmental information concerning the confidentiality of commercial and industrial information, but that “information on emissions which is relevant for the protection of the environment shall be disclosed” (13). The Convention does not include a definition of this term.
EU Regulation 1367/2006 (14) which, according to its title, has the objective to transpose the provisions of the Aarhus Convention into EU law (15), includes in the definition of “environmental information” also “emissions, discharges and other releases into the environment” (16). As regards the possibility for EU public authorities to refuse access to environmental information due to commercial interests or intellectual property, Article 6(1) of Regulation 1367/2006 states an irrefutable presumption in favour of disclosure: “an overriding public interest in disclosure shall be deemed to exist where the information requested relates to emissions into the environment”.
The Court of Justice had already in the past had the opportunity to discuss the meaning of the term “emissions into the environment”. In case C- 442/14 (17), a Dutch court posed some preliminary questions in a case between the company Bayer CropScience and an organization for the protection of bees. The NGO wanted access to information on the active substance imidacloprid which was contained in pesticides and biocides and which the NGO suspected to be harmful to bees. Bayer CropScience, which had obtained authorization from the Dutch authorities to put pesticides and biocides on the market which contained that substance, opposed the request, invoking its copyright and the fact that disclosure would adversely affect the confidentiality of its commercial and industrial information.
The Court of Justice held (18): “although the placing of a product on the market alone is not sufficient in general to consider that that product must necessarily be released into the environment and that information concerning it relates to ‘emissions into the environment’, the situation is different as regards a product, such as a plant protection product or biocide, which is in the context of normal use, intended to be released into the environment under normal or realistic conditions of use of that product of substance”. The term “information on emissions into the environment” covered, according to the Court, information concerning the nature, composition, quantity, date and place of the emission, as well as data concerning the medium to long-term consequences of such emissions. The Court concluded: “’emissions into the environment’ covers the release into the environment of products or substances such as plant protection products or biocides and substances contained in those products, to the extent that that release is actual or foreseeable under normal or realistic conditions of use”.
As can be seen, in case C-442/14 the issue of impurities of an active substance of a pesticide was not discussed. In the present case T-545/11, the first judgment of the General Court concluded that there was a sufficiently direct link between the information on the environment and the information on emissions into the environment. Therefore, the information on the impurities of glyphosate should be disclosed. On appeal, the Court of Justice held that this “sufficiently direct link” was too vague a formula and did not allow to clearly differentiate between “information on the environment” and information on emissions into the environment”. Thus, it sent the case back to the General Court.
1. The judgment in case T-545/11 RENV
In its new judgment of 21 November 2018, the General Court found that the active substance glyphosate has only been released into the environment in the form of a pesticide product, not as a pure substance. However, pesticide products are authorized by the EU Member States, whereas the European Union only authorizes the active substances in pesticide products. When a Member State was appointed, under EU law, to act as a rapporteur in order to assess a new active substance, it did not assess the impurities of that substance. Rather, such impurities were only assessed when a Member State was going to evaluate the pesticide as a whole in a later stage of the procedure (19). This is due to the fact that the production methods of the pesticide products containing glyphosate are different in different regions or Member States. The General Court thus concluded that it is not foreseeable that the impurities of the active substance glyphosate will be released into the environment, but that such a release is – this must be deduced from its arguments- hypothetical. Hypothetical emissions into the environment, though, do not come under the notion “emissions into the environment”, according to consistent case- law of the Court of Justice (20).
2. Emissions from an active substance – theoretical emissions?
However, the reasoning of the General Court is not correct. According to Article 4 of Regulation 1107/2009, the rapporteur Member State has to examine an application for authorization of an active substance according to Annex II to Regulation 1107/2009. Annex II no. 3.4.1 requires the additional examination of impurities in the active substance, in particular as regards toxicological, ecotoxicological or environmental concerns. And it follows from the requirement of Annex II no. 3.5.1 that any impurity which is present in the active substance “as manufactured”, shall be assessed. The same conclusion follows from Annex II no. 3.6 to no. 3.8. According to these provisions, an active substance shall only be approved where it is not a mutagen, carcinogen, toxic for reproduction, where it is not a persistent organic pollutant, and where it has neither endocrine disrupting nor ecotoxicological adverse properties. As follows furthermore from no. 3.5.1, these approval conditions also apply to impurities. Indeed, it is not possible to believe that these conditions only apply to the pure active substance, but that the impurities – up to 50 g per kg – could also be carcinogenic, etc.
Thus, it is submitted that the General Court erred, when it found that Member States only assess the impurities of an active substance if they have to assess a pesticide product as a whole. Rather, the findings of the rapporteur Member State of an active substance on the substance are shared with all other Member States and the EU Commission and are the basis for the EU-wide approval of the active substance. Thus they must carefully assess all the conditions of the active substance when an application for an EU-approval according to Regulation 1107/2009 is submitted. This includes an assessment of the impurities, at least in cases where, as with glyphosate the impurities comprise more than 1g/kg of the weight of the active substance.
This result does not yet answer the question whether at the stage of the approval of the active substance, the assessment of the impurities is hypothetical. It is only at the stage of the approval of a pesticide product as a whole that it becomes relevant whether there are still impurities which may be released into the environment. This was the assumption of the General Court.
However, the General Court failed to discuss the consideration of impurities found in the active substance in the assessment of the pesticide product as a whole. It assumed that this was irrelevant, as the manufacturing process of the active substance may be very different (21). In the opinion of the General Court, the assessment of the active substance and its impurities at EU level at the moment of approval is a “theoretical assessment” (22). This led the General Court to conclude that the emissions into the environment which might emanate from an active substance and its impurities are hypothetical, as long as the active substance is not reassessed as part of a pesticide product as a whole.
The applicants’ argument that the active substance is not, as such, considered a second time during the assessment of the pesticide product as a whole was pushed aside by the General Court. It repeated its argument that the assessment of the pesticide as a whole takes place at Member State, not EU level (23).
Until now, it seems that nobody has ever argued that the assessment of an active substance for later use in pesticide products at EU level was a theoretical assessment. After all, why must all the details for the assessment process of the active substance, laid down in Annex II to Regulation 1107/2009, have to be scrupulously respected when the assessment is only of theoretical value and without practical use? This would deprive all these detailed provisions of any useful effect. Why should Regulation 1107/2009 require the detailed assessment of the active substance and its impurities if the Member States have to make this detailed assessment again? Rather, the detailed requirements of assessment suggest that the EU legislature considered it foreseeable and not only hypothetical that the active substance, including its impurities, would be released into the environment.
Several other arguments plead in favour of this understanding of the EU assessment procedure. The first is the requirement of Annex II, no. 3.5.1 to Regulation 1107/2009 which imposes this detailed assessment also of impurities exceeding 1g/kg of the active substance. This requirement indicates that the legislature quite clearly foresaw the release of the active substance into the environment, as it considered that there might also be risks for humans or the environment which stem from impurities exceeding quantities of 1g/kg or more.
Furthermore, the assessment of an active substance, including its impurities, at EU level attaches a great importance to its effects on the environment. This would be completely superfluous if the EU assessment were only of a theoretical nature, as then the evaluation of the effect of the active substance could be left to the assessment of the pesticide as a whole by the different Member States.
3. The approval of a pesticide product as a whole
The decisive argument comes, in this author’s opinion, from a consideration of the provisions on the approval of a pesticide product as a whole which are laid down in Regulation 1107/2009, Articles 28ss. Article 28(a) determines: “No authorisation [of a pesticide product] shall be required in the following cases: (a) use of products containing exclusively one or more basic substances”. The term “basic substances” is not defined in Regulation 1107/2009, which only defines “substances”. In view of the context, “basic substances” must be synonymous with “active substances”. This means that the appropriate Member State need not examine a pesticide product which exclusively contains one or more active substances. Such a provision makes sense, as the active substance or substances are already examined and approved at EU level, so that a second assessment would be unnecessary. Already this provision shows that the General Court’s assumption that an active substance is always examined a second time during the approval procedure of a pesticide product, is wrong.
This is confirmed by Article 29 of Regulation which is to be used for the pesticide had been approved by the EU. Article 29 (1)(b) to (i) contain a number of further requirements. Article 29(2) then requests that the Member State in question verify compliance with Article 29 (1)(b) and (e) to (i) by “official or officially recognized tests and analysis”. The Member State thus does not have to test or analyze the active substance itself, as that substance is mentioned in Article 29(1)(a)! It may therefore assume, as regards the active substance, the results from the approval procedure of the active substance at EU level. Confirmation of this conclusion is found in the fact that Article 29 never refers to Annex II to Regulation 1107/2009, which according to its heading contains the detailed test requirements for active substances but not for pesticide products.
When an active substance is produced by a different manufacturer or by the original manufacturer with a change in the manufacturing process, the Member State which intends to approve the pesticide product as a whole must check whether the elements of the active substance “deviate significantly” from the elements that had previously been approved for the active substance at EU level (Article 29). The Member State in question has to establish this equivalence through tests and analyses. But there is no stipulation in Article 29 that the Member State has to repeat the whole approval procedure for the active substance in each case. This could at best be necessary when the active substance deviates significantly from the active substance that had been originally approved by the EU. In conclusion, the impact of an active substance and its impurities is normally assessed one time – at the moment of the approval of the active substance by the EU. There is no provision in Regulation 1107/2009 requiring the assessment of the active substance to be systematically repeated at the stage of approval of a pesticide product. The General Court let itself be persuaded by the Commission and the opposed vested industry representatives (24), without analyzing in detail Article 29 of Regulation 1107/2009.
4. Confidentiality and disclosure of environmental information
Article 63 of Regulation 1107/2009 stipulates that information on the impurities of an active substance which are considered to be toxicologically, ecotoxicologically or environmentally relevant, may normally not be kept confidential. It further indicates that this provision is without prejudice to the provisions on right of access to environmental 1107/2009 which contains the requirements for a Member State when a pesticide product as a whole shall be approved. Article 29(1)(a) requires the Member State to ensure that the active substance information (25). Article 63 thus expresses the clear opinion of the EU legislature that impurities of an active substance are foreseeably emitted into the environment. The methods of manufacturing for a pesticide product and also for an active substance such as glyphosate may differ. Thus it is possible that the impurities of glyphosate which existed at the moment when the EU approval of glyphosate was requested disappeared during the manufacturing process of the pesticide as a whole. However, this is a theoretical consideration. The Member State which looks at the approval of a pesticide product containing glyphosate need only examine whether the glyphosate contained in the pesticide product deviates significantly from the glyphosate that had been approved at EU level, including its impurities. Normally, no reassessment of glyphosate or its impurities has to be made. During the Court procedure, the European Commission had argued that disclosure of the content, composition, etc. of the impurities would reveal the manufacturing process and would thus harm the commercial interests of the glyphosate manufacturer as well as his intellectual property. The General Court followed this reasoning. As it considered the presumption of Article 6 of Regulation 1367/2006, quoted above, to be inapplicable, it limited itself to weighing the interests of confidentiality of the EU applicant of the glyphosate substance against the interest of the public in disclosure. Without discussing Article 63 of Regulation 1107/2009, it concluded that the Commission had weighed the different arguments correctly. In this author’s opinion, Article 63, in particular its paragraph 3, clearly indicates that the interests of the public in disclosure of information on the environment prevail over the economic interests of the manufacturer of an active substance. This is in particular true when the protection of the intellectual property has already elapsed; this was the case for glyphosate, where the patent ended in 2000, while the request for disclosure was introduced in 2010. Even when it concluded that the information on impurities of the active substance glyphosate only regards a theoretical and not a foreseeable emission into the environment, the General Court should have granted access to the information on the impurities. Its judgment is a regrettable attempt to let economic interests prevail over the right of the public to be informed on releases into the environment.
In conclusion: Contrary to the General Court
(I) Information on impurities of the active substance glyphosate is information about foreseeable, not only theoretical emissions into the environment;
(II) The interests of the public to access information on the nature, composition and quantity of glyphosate impurities disclosed prevail over the commercial or industrial interests and intellectual property rights of the glyphosate manufacturer, who had asked for the authorization of glyphosate at EU level in 1999, in precluding the disclosure of such information.
Note:
1) This is the term used in Directive 2003/4 on public access to environmental information, OJ 2003, L41 p. 26, Article 2(1)(b), and Regulation 1367/2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision- Making and Access to Justice in Environmental Matters to Community institutions and bodies, OJ 2006, L 264 p. 13, Article 2(1)(d)(ii).
2) The terms “pesticide” and “plant protection product” are used interchangeably in EU law, see for example Regulation 1107/2009 on plant protection products, OJ 2009, L 309 p. 1 and Directive 2009/128 on the sustainable use of pesticides, OJ 2009, L 309 p. 71. Both legal acts were adopted on the same day.
3) Commission Directive 2001/99, OJ 2001, L 304 p. 14.
4) Ibidem, Annex. This specification was followed by the note: “Further details on identity and specifications of active substances are provided in the review report”. The review report was not made public, though.
5) General Court case T-545/11, Greenpeace and PAN v. Commission, ECLI:EU:T:2013.523.
6) Court of Justice case C-673/13P, Commission v. Greenpeace and PAN, ECLI:EU:C:2016:889.
7) See case C-673/13 L. Krämer, Emissions into the environment and disclosure of information. Comments on ECJ C-442/14 and C-673/13P. elni-Review 2017, n. 1 p. 25. B. Wegener, “Kein Mund auf – Augen zu” – der freie Zugang zu Informationen über Emissionen in die Umwelt, Zeitschrift für Umweltrecht 2017, p. 146.
8) General Court, case T-545/11 RENV, ECLI:EU:T:2018:817.
9) Ibidem, paragraph 90.
10) Statute of the Court of Justice of the European Union, OJ 2008, C 115 p. 210.
11) Decision 2005/370, OJ 2004, L 124 p. 1. The Convention is reproduced in the annex to that decision.
12) Court of Justice, case C-240/09 Lesoochranárske zoskupenie, ECLI:EU:C:2011:125, paragraph 30: “the provisions of that convention [the Aarhus Convention] now form an integral part of the legal order of the European Union”.
13) Aarhus Convention (fn. 11), Article 4(4)(d).
14) Regulation 1367/2006 (fn. 1, above).
15) This aspect was not considered by the Court of Justice in joined cases C- 401/12P and C-403/12P, Council a.o. v. Milieudefensie and Stichting Stop Luchtverontreiniguíng Utrecht, ECLI:EU:C:2015:4, paragraphs 56ss, where the Court held that Article 9 of Regulation 1367/2006 could not be invoked by the NGOs, because that Article did not explicitly indicate that it meant to transpose the Aarhus Convention into EU law; in this author’s opinion, in view of the title of Regulation 1367/2006, this was not necessary.
16) See fn. 1, above.
17) Court of Justice, case C-442/14, Bayer CropScience, ECLI:EU:C:2019:890.
18) The Court had to interpret not Regulation 1367/2006, but the corresponding provisions of Directive 2003/4 (fn. 1, above). However, the term “information on emissions into the environment” and the other provisional requirements of relevance for the present discussion are identical in Directive 2003/4 and Regulation 1367/2006.
19) General Court, case T-545/11 RENV (fn.8, above), paragraph 88: “it is only at the stage of the national authorisation procedure to place a specific plant protection product on the market that the Member State assesses any emission into the environment… from the active substance”.
20) See in particular Court of Justice, case C-442/14 (fn. 17, above).
21) General Court, case T-545/11 RENV (fn.8, above) paragraph 85.
22) Ibidem, paragraph 83.
23) Ibidem, paragraph 92.
24) See case T-545/11 RENV, paragraph 92: “… as noted by the Commission, Cefic and ECPA”. Cefic is the EU umbrella organization of the chemical industry; ECPA is the Association Européenne de la Protection des Cultures.
25) Article 63 only refers to Directive 2003/4 on public access to environmental information at the level of Member States (fn. 1, above). However, as the provisions concerning access to environmental information at EU level, as laid down in Regulation 1367/2006 for the EU- level, are substantially equivalent, Article 63 is also applicable to requests for access to environmental information which are addressed at an EU institution.
