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26 March 2019

The CJEU condemns the European Food Safety Agency’s lack of transparency in the glyphosate case

On 7 March, the Court of Justice of the European Union annulled the decisions of the European Food Safety Agency (EFSA) refusing access to toxicity and carcinogenicity studies on the active substance glyphosate in the context of the European regulatory system governing pesticides (“phytopharmaceuticals”).

The authorisation allowing the use of glyphosate had been renewed to a large extent on the basis of studies which had never been made public and which had not been subjected to peer assessments. Germany, the country with responsibility for this case, had produced an assessment in 2014, the main parts of which were simply a cut-and-paste of Monsanto documents.

In the case  T-716/14, Mr Anthony C. Tweedale submitted to EFSA a request for access to documents pursuant to the regulation regarding public access to European Parliament, Council and Commission documents, and to the regulation 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. This request related to two toxicity studies: “the two ‘key studies’ used in order to set glyphosate’s acceptable daily intake (ADI)".

In case T-329/17, MEPs Heidi Hautala, Michèle Rivasi, Benedek Jávor and Bart Staes submitted to EFSA a request for access to documents pursuant to the same regulations. Their request concerned the parts of the 75 unpublished studies on the carcinogenicity of glyphosate relating to ‘material, experimental conditions and methods’ and to ‘results and discussion’. In their request, the applicants stated that the International Agency for Research on Cancer (IARC) had, in March 2015, classified glyphosate as ‘probably carcinogenic to humans’ (Group 2 A), while the EFSA’s peer review had concluded that glyphosate was “unlikely to pose a carcinogenic hazard to humans".

 In both cases, EFSA had refused access, citing inter alia the following reasons: i) disclosure of that information might seriously harm the commercial and financial interests of the companies which had submitted the study reports; ii) there was no overriding public interest justifying disclosure; iii) there was no overriding public interest in disclosure of the parts of the studies to which the applicants sought access, since those parts do not constitute information which ‘relates to emissions into the environment’ for the purposes of the Aarhus Regulation; and iv) EFSA considered that access to the parts of those studies was not necessary for the purpose of verifying the scientific risk assessment carried out in accordance with the regulation concerning the placing of plant protection products on the market

 The Court rejected the EFSA arguments, pointing out that these were in breach of the Aarhus Regulation. The Court argued that CJEU case-law stated that the concept of information which ‘relates to emissions into the environment’ for the purposes of the Aarhus Regulation was not limited to information which made it possible to assess the emissions as such, but also covered information relating to the effects of those emissions.

The public should therefore 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 was specifically to know not only what was, or foreseeably would be, released into the environment, but also to understand the way in which the environment could be affected by the emissions in question.

It followed that the concept of information which ‘relates to emissions into the environment’ had to 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. The Court concluded that the requested studies had to be regarded as constituting information which ‘relates to emissions into the environment’ and that an overriding public interest in disclosing the studies was deemed to exist. The EFSA could not therefore EFSA 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.

In the view of ETUI researcher Laurent Vogel, this case shows the extent to which management of the dossier on renewing approval of glyphosate has been marked by breaches of EU legislation due to the stranglehold of the chemical industry – and Monsanto in particular – on the Community pesticide authorisation procedure. That same day, the CJEU also annulled the authorisation granted by the Commission to market lead chromates deemed to be carcinogens.

Reference : Judgment of the General Court T-716/14 Anthony C. Tweedale/(EFSA) and T-329/17 Hautala e.a/EFSA 

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