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Glyphosate, the controversial herbicide, is expected to be re-approved at EU level for another ten years following a vote scheduled for October. This became possible after the Food Safety Authority (EFSA) presented its final report at the beginning of July. On Wednesday, Global 2000 announced a new statement of facts due to possible failures by the manufacturer. Bayer responded to the allegations in a statement.
Possible connection with cancer
Again it’s about a possible connection between cancer and glyphosate: lawyer Josef Unterweger, who has previously worked on behalf of Global 2000, PAN Europe, Générations Futures and PAN Germany, said at today’s online press conference that Bayer would be like it was in 2019 now Withhold studies that were therefore classified as negative. An initial statement of the facts was received by the Vienna public prosecutor’s office in March 2016 and was supplemented twice (December 2017 and July 2019). In each case it was about suspicion of serious fraud (Section 146 ff of the Criminal Code). Bayer and a manufacturer consortium led by the group are currently being accused of failing to submit unfavorable studies and data on the carcinogenic and neurotoxic effects of glyphosate when applying for re-approval.
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Bayer responded to the allegations in a statement and saw them as a further attempt “to discredit the scientific dossier that was submitted with the application for renewal of the EU approval of glyphosate and to undermine trust in the approval authorities.” to prevent approval. The press conference conveyed the allegations that have been known for years and which the regulatory authorities in the EU and other countries have investigated. “Bayer has not concealed any scientific study or withheld it from the relevant authorities. The company has always acted with complete transparency and complied with applicable EU regulations. We have submitted all relevant studies that were required for the scientific dossier.”
Criticism of studies
Global 2000 particularly drew attention to one publication, a DNT study on glyphosate commissioned by the agricultural group Syngenta. It was also withheld from the EU authorities. According to the NGO, this developmental neurotoxicity study found “severely impaired motor function” in baby rats when their mothers were given glyphosate during pregnancy. In addition, the study was classified by the US Environmental Protection Agency (US EPA) as “acceptable for regulatory purposes” and the doses corresponded to a quantity currently classified as safe by the EU authorities.
Helmut Burtscher, chemistry expert at Global 2000, said that EFSA had confirmed that the current study was not submitted by the applicant – as were other previously published studies. When asked by the APA, it was also said that some of the studies had been made known through the public consultation and that the EU authority had then requested Syngenta to transmit them.
Syngenta rejected the criticism of the APA. “Syngenta has not withheld any studies from EU regulators. All developmental neurotoxicity studies conducted for Syngenta-specific agents, which are significantly different from glyphosate in terms of human safety profile, have been requested by US regulators and their existence has been made public. Even though Syngenta’s study concerns an active ingredient other than glyphosate, it was included in the current EFSA reassessment,” it said in a statement.
Bayer specified that on the subject of neurotoxicity, regulatory authorities around the world, including, among others, the EU authorities EFSA and ECHA, the US EPA and the Canadian PMRA, evaluated the relevant data and determined that glyphosate is not neurotoxic. “Developmental neurotoxicity (DNT) is a separate issue from neurotoxicity.” The 2001 study on glyphosate trimesium cited by Global 2000 has nothing to do with the active ingredient glyphosate. Incidentally, glyphosate trimesium is not a Bayer molecule.”
Data gap
In a dossier published in July, the EFSA referred to DNT studies, stating that a data gap had been identified for the applicants and that the cause of the DNT effects needed to be clarified. However, the EFSA also found that “the pesticide formulation submitted for evaluation” based on glyphosate did not show any evidence of acute toxicity or genotoxicity. “There is no evidence that glyphosate as an active ingredient has neurotoxic potential,” wrote the EU authority after a peer review after almost three years of evaluating around 2,400 studies – which would involve two to four times the amount of a usual such procedure.
If the survey of member states on October 12th and 13th does not find a qualified majority in favor of re-approving glyphosate, the EU Commission would have to decide on this. The NGOs appeal to all EU member states to vote “no”. Due to a decision made by the SPÖ, FPÖ and the Greens in the EU subcommittee of the National Council in 2017, Austria will not be in favor of extending the approval, which expires on December 15th.
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