EFSA Defends Conclusion to its Assessment of Glyphosate Safety

14 Jan 2016 --- EFSA has replied to criticism of the EU assessment of glyphosate that was overseen by the Authority last year.

In his eight page letter, Portier said: “The EFSA decision, based upon the Renewal Assessment Report provided by the German Federal Institute for Risk Assessment (BfR), runs counter to the finding earlier this year by the International Agency for Research on Cancer (IARC), the highly respected cancer arm of the World Health Organization that glyphosate is a probable human carcinogen. This IARC classification is based on a comprehensive assessment of the peer-reviewed toxicologic and epidemiologic literature undertaken over a 12-month period by a Working Group of 17 independent expert scientists. The IARC review linked glyphosate to dose-related increases in malignant tumors at multiple anatomical sites in experimental animals and to an increased incidence of non- Hodgkin lymphoma in exposed humans.

“We reviewed these two differing decisions on the human carcinogenicity of glyphosate and conclude that the IARC WG decision is by far the more credible. The IARC WG decision was reached relying on open and transparent procedures by independent scientists who completed thorough conflict-of-interest statements and were not affiliated or financially supported in any way by the chemical manufacturing industry. It is fully referenced and depends entirely on reports published in the open, peer-reviewed biomedical literature. It is part of a long tradition of deeply researched and highly credible reports on the carcinogenicity of hundreds of chemicals issued over the past four decades by IARC and used today by international agencies and regulatory bodies around the world as a basis for risk assessment, regulation and public health policy. In contrast, the BfR decision is not credible because it is not supported by the evidence and it was not reached in an open and transparent manner.

“Accordingly, we urge you and the European Commission to disregard the flawed EFSA finding on glyphosate in your formulation of glyphosate health and environmental policy for Europe and to call for a transparent, open and credible review of the scientific literature.”

Bernhard Url, EFSA’s Executive Director, sent a detailed reply to Prof. Portier that addresses the points raised in his letter, stating that glyphosate is currently a keenly debated issue, which makes it especially incumbent on those involved in its evaluation to describe clearly the legal frameworks [in which we work].

He further stated that, “IARC evaluations can represent a first step in carcinogen risk assessment to be considered - if available - by national and international authorities such as EFSA when carrying out their own assessments.

“I agree that IARC carries out an important role in the screening assessment of the carcinogenic potential of agents. However, we should not compare this first screening assessment with the more comprehensive hazard assessment done by authorities such as EFSA, which are designed to support the regulatory process for pesticides in close cooperation with the Member States in the EU.”

Url continues by stating that, in order to clarify certain differences of opinion, EFSA has agreed to meet with IARC in the early part of 2016 to discuss the different evidence and methodologies the two organisations have used. He highlighted that IARC’s broad screening covered both the active substance glyphosate and glyphosate-based pesticide formulations, whereas EFSA only covered the active substance as required by EU legislation.

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