On Wednesday, MEPs heard expert testimony from scientists on the possible health effects of glyphosate use on humans and animals.

In an event organised by Pavel Poc, Vice-Chair of the European Parliament’s Environment Committee, speakers discussed the controversy which has surrounded the world’s most widely used herbicide. The debate on glyphosate is especially charged as the European Commission is set to make an announcement on re-appproval of the herbicide for use in the EU before June this year.

In March 2015, the World Health Organisation’s International Agency for Research against Cancer (IARC) classified glyphosate as ‘probably carcinogenic’ to humans. A few months after IARC published its hazard characterisation on glyphosate, the EU Commission’s science watchdog EFSA published the findings of its own review, which concluded that the herbicide is “unlikely” to cause cancer in humans. Assessors also said the legally permissible exposure levels to glyphosate could stand to be raised.

However, the two agencies have since argued over their differing conclusions, and green and pro-transparency groups have been critical of EFSA’s study, which looked at glyphosate in isolation whereas the IARC review studied glyphosate-containing herbicides. EFSA also had access to certain industry studies which IARC did not, as these were deemed to contain ‘trade secrets’. Pro-transparency group Corporate Europe Observatory has questioned this classification, as glyphosate is off-patent and most manufacturers belong to the Glyphosate Task Force, which supplied the studies to EFSA.

On Wednesday, MEPs heard presentations from speakers including Commission representatives, anti-pesticide campaigners, crop protection industry spokespeople and scientists from both IARC and EFSA. Member State Ministers were also invited to attend the event, as they are set to vote on the Commission’s proposal next week.

Andre Leu, president of international organic agriculture platform IFOAM, Prof Monica Kruger of the University of Leipzig and Robin Mesnage of King’s College London discussed health effects associated with glyphosate use in humans and animals, which include evidence of certain cancers, hormonal interference and damage to kidneys and liver in animals. Mesnage was a researcher who worked with Giles Seralini on his controversial research into GM crops, glyphosate and cancer in rats. He said there is a gap in the EU’s regulatory assessments to the extent that “The product which is used by and sold to consumers and farmers is not the product that has been assessed by EFSA in the regulatory assessment.”

Mensage added that adjuvants, which the French government is cracking down on following an assessment by state research agency ANSES, are not studied by EFSA in its tests and claimed this “Pesticide toxicity assessment is not coherent with the recommendations of the EU’s scientific committees.” He pointed to EU guidance which states that a “Whole mixture approach is recommended for any unidentified materials in the mixture and for any interactions among the mixture components.”  

Farmers, pesticide manufacturers concerned by EU risk assessments

However, Euros Jones, director of regulatory affairs at the European Crop Protection Association, which represents 21 pesticide manufacturers in Europe, disagreed with the other scientists’ suggestions of a link between glyphosate and a range of potential illnesses.  He said ECPA wants “Policies and legislation that foster innovation,” adding, “We need to give farmers the tools to help them to feed the world.” He said his organisation works to promote good farming practice and tries to promote a constructive dialogue on regulatory issues.

Although he said he wasn’t in Brussels to question the science behind the other speakers’ presentations, he did say he is confident that the EU has a “very robust” risk assessment system. He stressed the importance of glyphosate to farmers and said Europe’s is the most conservative and limiting evaluation system in the world. Farmers’ representatives from European lobby group Copa Cogeca and the British farm unions both expressed concern that changes to they way risk assessments are conducted could result in the loss of more active ingredients on which many farmers rely.

IARC and EFSA defend their positions

Dr Kate Guyton, from IARC discussed the Agency’s findings, pointing out that IARC uses data in the public domain and stringently vets scientists on its panels for vested interests to ensure the transparency and fairness of its assessments, which she said means “Once an IARC classification is made, it is often considered to be the most credible evaluation on which any risk assessment or action to support public health action can be based.”

Looking at Non-Hodgkin Lymphoma, one of the illnesses linked to glyphosate exposure, she said one of the key studies on the subject - a meta-analysis by IARC scientists - did find evidence of a link, that could not be explained by other factors. However she qualified the findings, saying, “Not every study [in the analysis] was positive, this is not a case like smoking or asbestos, this is a case of limited evidence.”

Discussing the unpublished toxicology studies conducted on mice that have led to contention, Dr Guyton said IARC reviewers only looked at studies that were in the the public domain, with sufficient information available for their review. She said in the case of these studies, full data would be needed to judge them properly, adding, “We’ve requested full public access to these data.”

In turn, Jose Vicente Tarazona, head of the pesticides unit at EFSA, defended the EU Watchdog’s process of review, claiming, “At least a hundred people are involved in the assessment of every pesticide. On top of that we hold public consultations.”

The EFSA spokesperson said, “I think it’s important to put glyphosate in context, as well as the use of industry-sponsored studies.” He gave examples of recent EFSA conclusions, which showed that, even in cases where they relied exclusively on industry studies, EFSA assessments had reached different conclusion. Pointing to neonicotinoids, which were heavily restricted by the European Commission in light of their potential environmental effects, he said these conclusions were the result of the same process as the glyphosate review.

Commission and EFSA spokespeople were keen to point out that, though active substances alone are assessed at EU level by EFSA, member state governments are responsible for looking at each new product containing these actives as they enter the market. However, campaigners challenged this state of affairs, suggesting the process would cost member states millions, and that these assessments are often not carried out.

Change in EU risk assessments on the horizon?

Groups in the Parliament have stated that they wish to reject plans for glyphosate, highlighting the precautionary principle as it is understood in EU law (that where there is a risk of harm to humans, but no clear scientific conclusion, the Commission may take provisional risk management measures, as was the case with three neonicotinoids in 2013). Representatives from environment organisations who questioned speakers also pointed out that the Commission’s pesticide regulation procedures had been found lacking in a ruling by the European Ombudsperson late in February.

One green parliamentarian even suggested that the Commission had become a “A mere rubber stamper for EFSA.”

Recognising the criticism the executive has faced, Commission spokesperson Nathalie Chaze, who was representing the office of health and food safety, said changes for the risk assessment regime could be on the horizon. She said the EU executive plans to work with member states to look at co-formulants in pesticides. Chase elaborated, "We are aware… that looking at the [active] substance alone is only part of the picture, this was really made very obvious in the case of glyphosate. We know that people do not buy an active substance, they buy a formulation. This is what is used. In the case of glyphosate, at the beginning we had some concern. We had asked EFSA to look at tallowamine.

“The conclusion from EFSA was really clear for this co-formulant. This is why we are going to propose a ban on this co-formulant when it’s associated with glyphosate.”

She added, “In the context of the regulatory system we are opening a new area of work. This is not something we have done a lot before, looking at the co-formulant, looking at the end product, looking at something that IARC has done probably more [of], looking at the formulation and end product.

“That is why we are inviting member states to launch an identification of the co-formulants they use at home. We would like to launch together with them on defining the list of unacceptable co-formulants. It’s a new area of work, it will probably be resource-intensive, it’s something we need to put in place. It’s the result of lot of concerns we have heard, including from MEPs and civil society.”

Drawing together the arguments, MEP Dr Poc, who hosted the event, said, “Yes, we have the best pesticide regulation system in the world… but there is still room for advancement.”

Dr Poc said he would push for publication of three “key” studies that were available to EFSA but not to IARC. He said he would also support a change to make the European regulatory process more transparent, and said of the current situation in Europe, “Those who are benefitting from the outcomes of the current regulatory process deliver the studies at the beginning of the process. It looks strange. Even if it is legal, it looks strange… We call it… conflict of interest. When I’m financed by industry, it’s conflict of interest.”

A stream of the four hour presentation can be viewed here, and speakers’ presentations are also expected to be made available on Dr Poc’s website.