This week’s finding by the European Chemicals Agency (ECHA) that glyphosate, the world’s most widely used weed killer, is not a carcinogen has been welcomed by watchers. The assessment is based on extensive evaluation of all the available information, including human evidence and the weight of evidence of all the animal studies available, writes Martin Banks.
That scientific evidence was clear: it did not meet the criteria to classify glyphosate as a carcinogen, as a mutagen or as toxic for reproduction. The ECHA’s decision, which many argue means that “science has prevailed”, paves the way for Brussels to make a final decision on the chemical used in Monsanto’s key herbicide, Roundup.
The opinion follows more than a year of debate over glyphosate’s future in the EU, with many environmental groups like Health and Environment Alliance (HEAL), calling for it to be banned. In a bid to bring greater scientific clarity to the debate, ECHA was tasked with developing a harmonized classification on the carcinogenicity of glyphosate.
This came after the EU, last July, granted an 18-month temporary extension of its market approval for the weed killer after a proposal for full license renewal met opposition from member states and campaign groups. France and Malta opposed reapproval, while Germany was one of the seven nations to abstain.
So, why should glyphosate not be classified as carcinogenic agency? To begin with, and as the agency points out, the substance has not been found to cause genetic or reproductive defects. According to experts, the classification is entirely consistent with the existing 90,000 pages of evidence, 3,300 peer-reviewed studies, the opinions of the European Food Safety Authority (EFSA), the German Federal Institute for Risk Assessment (BfR), the US’ Environmental Protection Agency and other regulatory agencies worldwide. The ECHA study is also a wake up call for the World Health Organization’s International Agency for Research on Cancer (IARC), which classified glyphosate as a ‘probable carcinogen’ in 2015.
Until now, IARC was defending its finding by pointing out that its methodology takes into account hazard, while regulatory agencies look at risk. The difference is substantial: hazard assesses the potential of a substance to cause cancer, but it does not take into consideration exposure or how likely it is to catch the disease. Risk evaluations on the other hand do just that: they factor in dosage and how the substance is used in the real world. The catch is that ECHA conducted the same type of hazard assessment used by IARC, with one key difference: while the WHO agency combed through literature and rejected a large body of evidence, ECHA looked at everything available.
But is this the end of the process? Well, not necessarily so as the draft opinion will now be subjected to an “editorial check in” with the ECHA before being formally submitted to the Commission.
The pest-control industry is not alone in believing that the classification – that glyphosate is not carcinogenic – is entirely consistent with the existing 90,000 pages of evidence, 3,300 peer-reviewed studies, the opinions of the European Food Safety Authority (EFSA), the German Federal Institute for Risk Assessment (BfR), the US’ Environmental Protection Agency and other regulatory agencies worldwide. Despite what groups like HEAL may argue, this is an impressive body of evidence. The National Farmers’ Union (NFU) in the UK also welcomes the ECHA conclusions, pointing out that the overwhelming weight of evidence shows that glyphosate poses no risk to human health when used correctly.
But is this the end of the process? Well, not necessarily so as the draft opinion will now be subjected to an “editorial check in” with the ECHA before being formally submitted to the CommissionThe Commission services will then re-start their discussions with member states regarding the approval of glyphosate as an active substance in Plant Protection Products (PPPs).
Even so, many are hoping that ECHA’s opinion is a means to finally end the hysteria and start working on the basis of robust scientific evidence. They include British Tory MEP Julie Girling, her group’s spokesman on the Environment, and also a member of the Parliament’s Agriculture Committee, who says the opinion confirms what the EU and other scientific bodies have been saying since this debate began in 2015. She and others hope that, with positive opinions from ECHA and also the European Food Safety Authority, a full renewal of glyphosate’s authorisation is only a matter of time.
The importance of glyphosate should not be underestimated. Glyphosate products are widely used by gardeners and for weed control in forestry and aquatic environments, accounting for 25 per cent of the global herbicide market. More than 300 glyphosate herbicides from more than 40 different companies are currently registered for sale in Europe, many of which are available in gardening and hardware stores. A report last year by ADAS, the UK’s largest agricultural consultancy, estimated a total ban on glyphosate would reduce UK production of winter wheat and winter barley by 12% and oilseed rape by 10%, costing the industry €633 million a year.
But there is more to this story than just glyphosate. The long running saga also shines a light on the whole EU decision making process. In recent years the Commission has been regularly obliged to take decisions on very sensitive issues when member states have not been able to take a position, in particular on politically sensitive topics. Last year’s kerfuffle over the substance’s market authorization, which led the Commission to accuse some (unnamed) member states of “hiding behind” Brussels by failing to take an open stance, has pushed EC president Jean-Claude Juncker to revisit comitology rules.
In February, the Commission tabled several changes to the comitology regulation, which will make public the votes made by member states in technical committees, not counting abstentions when calculating the qualified majority needed for a measure to pass, and allowing national ministers to directly discuss with Commission experts on a political level.
The message is that if EU members can’t decide on thorny issues like this then Brussels will do it for them. It remains to be seen just how efficient the Commissions proposals will be – some industry groups have argued that the reforms could further politicize the process. But with ECHA’s positive decision, member states and concerned stakeholders have received yet another sign that the evidence against glyphosate is not scientifically sound.
In recent years the Commission has been regularly obliged to take decisions on very sensitive issues when member states have not been able to take a position, in particular with regards to topics like GMOs or glyphosate. Since the beginning of its mandate, the Juncker Commission has taken a number of internal measures to ensure that a political debate is held at the level of the College before submitting proposals for delegated or implementing acts on sensitive subjects.