From EFSA to ECHA: The long path to re-authorisation (2)
Glyphosate is an active substance used in herbicides that has been approved in the EU since 2002. EU legislation stipulates that active substances used in pesticides must be reassessed at regular intervals to check that they are safe for humans, animals and the environment. This ensures that new scientific findings, technological advances and experience gathered since the active substance was last assessed are taken into account. As part of the EU’s regular review of approvals for active pesticide substances, glyphosate has been undergoing assessment to renew its authorisation since 2010.
More than 150 original toxicology trials and over 900 new studies assessed
As the rapporteur member state, Germany was responsible for drawing up the draft assessment report. The authorities involved in the process evaluated all the studies, scientific publications and research in the light of the current state of research and technology. For the reassessment of glyphosate alone, the German Federal Institute for Risk Assessment (BfR) assessed more than 150 original toxicology trials conducted in line with internationally recognised standards, and over 900 new studies published in scientific journals. It came to the conclusion that glyphosate does not cause cancer, is not mutagenic or reprotoxic and does not pose any other kind of risk to human health.
The report was forwarded to the European Food Safety Authority (EFSA) at the end of 2013. EFSA made the assessment report publicly accessible in 2014 and started the peer review process, during which scientists working for the authorities of the member states and for EFSA critically reviewed the assessment report. In addition, a public consultation at EFSA gave every citizen the opportunity to express an opinion. At the end of this process, EFSA summarised the results of the peer review in a conclusion. EFSA confirmed that when the active substance glyphosate is used properly in accordance with regulations, it is not expected to have any adverse effects on human health or the environment.
Since the work by the participating authorities and the European Commission was delayed, the process was not completed by the end of 2015, as originally planned. For this reason, the Commission temporarily extended the existing approval to 30 June 2016.
The approval process stipulates that the member states have to vote on the renewal of the approval based on EFSA’s assessment. However, since European meetings of the member states in spring 2016 failed to achieve a sufficient majority for or against the approval, the European Commission extended the existing approval of glyphosate until the end of 2017, when the final decision will be taken.
IARC classification caused confusion
One reason for the hesitancy of some member states was an assessment of glyphosate by the IARC, the WHO’s cancer research agency, in 2015, which is still fiercely contested by experts. The IARC classified the active substance as a “probable carcinogen” (category 2A). It should be noted that the IARC also classifies e.g. yerba mate tea, shift work, working in hair salons and red meat as “probable carcinogens”. It also classifies sausages as “carcinogens”, but there has been no call to ban these products.
As a result of the IARC classification, some member states wanted to wait for glyphosate to be assessed by ECHA, the EU chemicals agency, before making a final decision to re-approve it in the EU. ECHA is responsible for ensuring harmonised classification and labelling of chemical substances (CLH process) in the European Union. It started its glyphosate assessment halfway through 2016.
ECHA removes any doubt
Finally, in March 2017, ECHA’s Committee for Risk Assessment (RAC) classified glyphosate as not carcinogenic, thereby confirming once again the assessments by other authorities and expert groups, including the European Food Safety Authority (EFSA), the German Federal Institute for Risk Assessment (BfR), the FAO/WHO Joint Meeting on Pesticide Residues (JMPR) and other authorising bodies. The agency came to a clear conclusion that glyphosate does not cause cancer and does not exhibit any mutagenic, reprotoxic or genotoxic properties. ECHA has sent its assessment to the European Commission for final approval.
A date for the final vote by member states on the re-approval of glyphosate is expected in summer/autumn 2017.
Last update: 03 July 2017