The conclusion will be used by the European Commission in deciding whether or not to keep glyphosate on the EU list of approved active substances, and by EU Member States to re-assess the safety of pesticide products containing glyphosate that are used in their territories.
EFSA published its peer review of the active ingredient glyphosate as part of the EU renewal process. The review concludes that: "Glyphosate is unlikely to pose a carcinogenic hazard to humans and the evidence does not support classification with regard to its carcinogenic potential."
A peer review expert group made up of EFSA scientists and representatives from risk assessment bodies in EU Member States has set an acute reference dose (ARfD) for glyphosate of 0.5 mg per kg of body weight, the first time such an exposure threshold has been applied to the substance.
Jose Tarazona, head of EFSA’s Pesticides Unit, said: "This has been an exhaustive process – a full assessment that has taken into account a wealth of new studies and data. By introducing an acute reference dose we are further tightening the way potential risks from glyphosate will be assessed in the future. Regarding carcinogenicity, it is unlikely that this substance is carcinogenic."
The peer review group concluded that glyphosate is unlikely to be genotoxic (i.e. damaging to DNA) or to pose a carcinogenic threat to humans. Glyphosate is not proposed to be classified as carcinogenic under the EU regulation for classification, labelling and packaging of chemical substances. In particular, all the Member State experts but one agreed that neither the epidemiological data (i.e. on humans) nor the evidence from animal studies demonstrated causality between exposure to glyphosate and the development of cancer in humans.
EFSA also considered, at the request of the European Commission, the report published by the International Agency for Research on Cancer (IARC), which classified glyphosate as probably carcinogenic to humans.
The evaluation considered a large body of evidence, including a number of studies not assessed by the IARC which is one of the reasons for reaching different conclusions.
As well as introducing the ARfD, the review proposed other toxicological safety thresholds to guide risk assessors: the acceptable operator exposure level (AOEL) was set at 0.1 mg/kg body weight per day and an acceptable daily intake (ADI) for consumers was set in line with the ARfD at 0.5 mg/kg body weight per day.
Dr Tarazona added that EFSA will use the new toxicological values during its review of the maximum residue levels for glyphosate in food, which will be carried out in cooperation with Member States in 2016.
The EFSA conclusion will inform the European Commission in deciding whether or not to retain the substance on the EU’s list of approved active substances. This is a condition for enabling Member States to authorise its continued use in pesticides in the EU.
Crop Protection Association chief executive Nick von Westenholz said: "We are pleased to see that EFSA concurs with the numerous health assessments conducted by public authorities on glyphosate over the past 40 years which have all concluded that, when used correctly, it poses no meaningful risk to human health.
"As an industry we take pride in the fact that our products are demonstrably safe. Pesticides are amongst the most heavily regulated products in Europe and it currently takes about ten years, costing over £150m to bring an active ingredient to market. It is this process, backed by effective and independent regulatory scrutiny, that ensures the public can have absolute confidence in our products.
"Glyphosate is an important part of a farmer’s and gardener’s toolbox. It is particularly important in minimising food waste by controlling a broad spectrum of weeds and therefore reducing the need for ploughing of soils. This protects soils from degradation and reduces greenhouse gas emissions and energy consumption. This is just one example of how modern farming relies on innovations in crop protection such as glyphosate to protect soil whilst helping make our land as productive as possible."
"As is noted by the EFSA opinion, these robust and strong assessments by authoritative regulatory bodies are a significant and direct contrast to the classification of glyphosate as a 'probable carcinogen' by IARC earlier this year. The IARC classification selectively included and interpreted data, followed non-standard toxicological procedures, and only reflects the opinions of a select group of scientists. As concluded by EFSA and the Canadian PMRA, the overwhelming weight of evidence from decades of research on glyphosate does not provide any credible data to suggest a relationship between glyphosate and cancer.
"Based on this final EFSA conclusion, the Commission will now prepare a Review Report followed by a Regulation with a proposal that will be put to a vote by the representatives from the 28 member states at the Standing Committee for Food Chain and Animal Health in the coming months."
Soil Association policy director Peter Melchett said: "The EFSA decision is absolutely no surprise. Given that this review of glyphosate relies almost entirely on industry-funded, unpublished studies, it would be unthinkable for the EFSA to come to any conclusion other than that glyphosate is safe to use.
"The next serious scientific review of glyphosate will be carried out by the European Chemicals Agency (ECHA), the regulatory authority responsible for implementing the EU's chemicals legislation and protecting human health and the environment. The ECHA will be consulting on their findings at the end of this month. Their conclusions may still condemn glyphosate and prevent the weed killer being re-approved under EU law."