European Food Safety Authority and German risk assessment institute BfR are in contempt of the law in claiming glyphosate is unlikely to pose a cancer risk, say groups
In an open letter, thirty-one European environmental, health, trade union, consumer protection and medical organisations have called upon EU Commissioner Vytenis Andriukaitis, Commission President Jean-Claude Juncker and the Ambassadors of the member states to stop any further extension of glyphosate’s authorisation.
Signatories of the open letter include Pesticide Action Network Europe, Breast Cancer UK, Corporate Europe Observatory, the International Union of Food Workers, and GMWatch.
The letter points out that in assessing the carcinogenicity of glyphosate and concluding that it was unlikely to pose a cancer risk, the German Federal Institute for Risk Assessment (BfR) and the European Food Safety Authority (EFSA) ignored relevant OECD guidelines, falsely interpreted animal carcinogenicity studies, and systematically rejected relevant epidemiological studies by wrongly claiming them to be "unreliable”.
The letter also notes that both EFSA and BfR are in contempt of the European pesticides regulation in that they argue their case on a “risk assessment” basis, which takes exposure into account. European pesticides regulation specifies hazard-based cut-off criteria for carcinogenic substances. This means that the law only takes account of whether the chemical can cause cancer by virtue of its inherent properties, regardless of the extent of the carcinogenic risk to humans.
The text of the letter is below. A pdf of the actual letter sent to the EU authorities can be accessed here.
Open letter concerning phase-out of the pesticide glyphosate
10 June 2016
Dear Commission President Juncker,
Dear Health Commissioner Andriukaitis,
Concerning: Phase out of the pesticide Glyphosate
We – the thirty one signatories of European environmental, health, trade union, consumer protection and medical organisations – call on you to stop any further prolongation of the authorization of Glyphosate for the following reasons.
1. The BfR and EFSA assessment of Glyphosate is grossly flawed
In assessing the carcinogenicity of Glyphosate, the German Federal Institute for Risk Assessment (BfR) and the European Food Safety Authority (EFSA) have ignored relevant OECD guidelines, falsely interpreted animal carcinogenicity studies, and systematically rejected relevant epidemiological studies by wrongly claiming them to be "unreliable", as detailed in the expert statements accompanying this letter.
In writing this we join voices with the 96 leading international scientists who, in an open letter published at the end of 2015, expressed their serious reservations about the EFSA and BfR's assessments of carcinogenicity, describing them as "scientifically unacceptable", "fundamentally flawed" and "misleading". We therefore call on you to not rely on the erroneous conclusions drawn by BfR and EFSA.
2. Glyphosate qualifies as dangerous to human health and therefore cannot legally be authorised
We note that the EFSA and BfR evaluations are also unsuitable as a basis for decision-making because they mask the fact that since 2009 the European pesticides regulation specifies "hazard-based" cut-off criteria for carcinogenic substances.
In total disregard for this legal basis, the EFSA and BfR continue to argue on a "risk basis" and on the basis of exposure, when they come to the conclusion that "when used properly, according to the current data a carcinogenic risk to humans is unlikely".
In fact, Regulation (EC) 1107/2009 mandates to ban the use of active substances that pose a carcinogenic hazard (Categories 1A and 1B) regardless of the extent of the carcinogenic risk to humans.
According to the Regulation (EC) 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Glyphosate should be classified as carcinogenic substance Cat. 1B because of the following:
Category 1B classification applies where there is "sufficient evidence" of a carcinogenic effect on animals. The definition of "sufficient evidence" used in CLP Regulation is identical to that used by the International Agency for Research on Cancer (IARC).
The hazard-based evaluation of Glyphosate by the IARC determined that "sufficient evidence" had been presented by the animal studies. The key studies here are two long-term carcinogenicity studies with mice, which are also included in the current European Renewal Assessment Report.
As the classification process of the European Chemicals Agency (ECHA), scheduled for completion in 2017, follows the same criteria for “limited” and “sufficient” evidence as the IARC, we can expect that it will confirm the carcinogenic effect on animals and an EU classification as a Cat. 1B carcinogen.
Consequently, reapproving or technically extending the approval of Glyphosate would be a contravention of the hazard-based cut-off criteria for carcinogenic substances enshrined in the Regulation (EC) 1107/2009, Appendix II 3.6.3.
3. Further use of Glyphosate would pose an unacceptable health threat to Europeans
Last but not least, we should like to highlight the significant threat to public health as indicated by the IARC carcinogenicity assessment.
Epidemiological studies from Europe, the USA and Canada assessed by the IARC lead us to expect an increased incidence of non-Hodgkin's lymphoma for professional and private users of Glyphosate-based pesticides. This is a malignant cancer of the lymph glands for which the outcome is fatal in half of all cases.
Glyphosate residues in foods could also result in an increased risk of cancer incidence for the European population as a whole, as the IARC classifies Glyphosate as "genotoxic" (damaging to DNA) and for such substances no safe limits can be suggested.
Consequently, the fact that a majority of Europeans excrete Glyphosate in their urine and exposure has grown strongly in the past decade gives cause for great concern.
For the reasons outlined above, the undersigned environmental, health, trade union, consumer protection and medical organisations insist that if the European Commission renews or extends the Glyphosate authorisation, and national governments support this, despite of the evidence that it is a probable
carcinogen, they are legally and politically responsible for failing to fulfil the spirit and the letter of EU law on pesticides.
Apart from the unacceptable health risks, the use of Glyphosate also contributes to a massive loss of plant biodiversity, which has far reaching consequences for the food web, for amphibians, pollinators and birds in particular. These negative environmental impacts of Glyphosate also speak against further extension of its approval.
Finally, we do not agree with the Commission's wide use of Art. 17 technical extensions; these extensions are even used for active substances that have been classified by ECHA into hazard categories subject to the cut off criteria of Regulation (EC) 1107/2009. An example is Glufosinate, which has been classified as toxic for reproduction, Cat 1B. Another example is Linuron, classified as toxic for reproduction, Cat 1B and carcinogenic, Cat 2. This violates Art.4.1 (second part) of the Regulation.
In conclusion, we refer to the provisions of the European pesticides regulation and to the precautionary principle enshrined in the treaties of the Union, and strongly call on you to refuse the renewal or extension of the European licence for Glyphosate after 30 June 2016.
A. Lyssimachou, PAN Europe
Sources (see annexes):
Evidence in animal testing_PeterClausing
Differences between IARC and EFSA_Portier et al
Statement for the German parliament_IvanRusyn
Contradictions in the RAR
On behalf of the following organisations:
AEGU Ärzte ohne Grenzen (Austria)
Breast Cancer UK
Corporate Europe Observatory
Ecologistas en Acción (Spain)
European Environmental Bureau
Friends of the Earth Croatia
Friends of the Earth CzechRepublic
Friends of the Earth Europe
Friends of the Earth Hungary
Friends of the Earth Latvia/Zemes draugi
Friends of the Earth Malta
Genuk e. V.
GLOBAL 2000 (Austria)
Health and Environmental Alliance
International Union of Food workers (IUF)
Nature et Progrès Belgique
Pesticide Action Network Europe
Pesticide Action Network Germany
Pesticide Action Network Italia
Pesticide Action Network UK
Slow Food (International)
Umweltinstitut München (Germany)
Wemos (The Netherlands)