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No new cancer study, yet EU authorities want to extend approval

Six years after glyphosate was classified as carcinogenic by the WHO's cancer research agency IARC, the EU authorities want to extend the approval of glyphosate again. This is despite the fact that the glyphosate manufacturers have not submitted a new (and exonerating) cancer study for the new approval procedure. The authorities are therefore stating, on the basis of the scientifically highly controversial old manufacturer studies from the previous approval procedure, that the existing regulatory classification of glyphosate as non-carcinogenic should be maintained. This is according to a communication from the European Food Safety Authority (EFSA) and a review of the Glyphosate Renewal Group's application for approval.

"This is incredibly irresponsible and negligent," explains Helmut Burtscher-Schaden, environmental chemist at GLOBAL 2000: "The law requires that pesticide manufacturers demonstrate that their pesticide meets the requirements for approval based on studies conducted on the current state of science. Yet despite the unresolved controversy surrounding the carcinogenicity of glyphosate, the glyphosate manufacturers have not submitted a single new cancer study. Therefore the authorities are now once again declaring that glyphosate is not carcinogenic, based on the same old manufacturer studies that according to IARC provide "sufficient evidence" of glyphosate's carcinogenicity in animal experiments. This is so absurd and will not boost Europeans' confidence in their authorities."

Background

The WHO classification of glyphosate as "probably carcinogenic to humans" is based in large part on studies conducted by glyphosate manufacturers Monsanto and Cheminova in 1983 and 1993, respectively, in which significant increases in tumour incidence with increasing doses of glyphosate had been found (as well as in three other cancer studies with mice and six with rats). Yet the same studies had previously been used by the EU authorities as evidence for the safety of glyphosate. They subsequently tried to dismiss the increasing tumour incidence as artefacts and incidental findings. The authorities argued that too high glyphosate doses, diseases of test animals, or simply statistical fluctuations were responsible for the cancer findings in the manufacturer's studies. As we now know, according to a peer-reviewed evaluation by former IARC consultant Chris Portier, a total of 37 significant tumour findings can be identified in the 13 valid cancer studies with rodents submitted by the applicants so far (the most recent dates from 2009). According to the current EU Pesticides Regulation (EC) No 1107/2009, pesticide active substances may only be authorised if the applicant demonstrates, on the basis of reliable state-of-the-art scientific studies, that its pesticide active substance does not cause cancer in animal experiments.

"Although the concrete arguments used by the EU authorities to justify their renewed green bill of health for glyphosate will not be available until the beginning of September, when EFSA publishes the interim report of the glyphosate assessment as part of a public consultation," explains Burtscher-Schaden, "we can already look forward to the reactions from the independent scientific community.

EFSA plans to make a final recommendation on whether to renew the authorisation of glyphosate in the summer of 2022.

Source of comment: GLOBAL 2000