The European Agency for Food Safety EFSA and risk assessors from the European Member States have reassessed the active substance glyphosate. They conclude that it is unlikely that glyphosate is a carcinogenic substance or that it damages the genetic material of humans. No causal link (link between cause and effect) between glyphosate exposure and cancer in humans is shown in epidemiologic data regarding humans, nor in the results of studies conducted on animals. Glyphosate causes no harm to human reproduction and has no neurotoxic effects.
All available and published scientific studies were used in the reassessment of glyphosate. These studies include original studies, which must be provided by applicants as part of licensing procedures, and studies conducted and published by research institutes on a worldwide basis. These studies also include the studies used by the International Agency for Research on Cancer (IARC) for its assessment. Furthermore, there are assessment reports by various non-European authorities, which consider glyphosate – in unison with the EFSA and ECHA - as non-carcinogenic:
- the US Environmental Protection Agency EPA
- the Canadian assessment body Pest Management Regulatory Agency (PMRA)
- the Australian assessment body Australian Pesticides and Veterinary Medicines Authority (APVMA)
- the Japanese Food Safety Commission
- the New Zealand EPA
- the Joint FAO/WHO Meeting on Pesticide Residues (JMPR)
Thus, the classification of glyphosate as “probably carcinogenic to humans” by the International Agency for Research on Cancer (IARC) is in clear contradiction to the assessments provided by other authorities and committees.
EFSA Risk Assessment: Glyphosate Safe to Use
The European Agency for Food Safety EFSA and risk assessors of the European Member States have reassessed the active substance glyphosate. They conclude that it is unlikely that glyphosate is carcinogenic or that it damages the genetic material of humans. No causal link between glyphosate exposure and cancer in humans has been shown in epidemiologic data regarding humans, nor in the results of studies conducted on animals. Glyphosate causes no harm to human reproduction and has no neurotoxic effects. This view is similar to that of the group of risk assessment experts for plant protection product residues at the World Health Organization WHO, the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). Whereas the International Agency for Research on Cancer (IARC) of the WHO classifies the substance as probably carcinogenic to humans. However, the IARC evaluates the body of evidence that glyphosate could cause cancer, and not the risk of actually developing cancer. On top of that, the IARC did not have access to all the data used by the EFSA and ECHA as a basis for their assessment. The classification by the International Agency for Research on Cancer (IARC) as probably carcinogenic to humans is unjustified, according to the EFSA and ECHA.
EFSA Conclusion
EFSA Explains Risk Assessment: Glyphosate
EFSA: Peer Review Background Documents
Federal Institute for Risk Assessment (BfR) on Glyphosate
New Health-Related Limit
A so-called acute reference dosage (ARfD) has been defined for glyphosate for the very first time: this is the quantity of a substance in a food product that can be ingested on a short-term basis – usually within a day or during a meal – without any risk to health.
This reference dose is 0.5 milligram per kilogram bodyweight per day for glyphosate. This means that a person weighing 70 kilos can ingest a one-time dose of 35 milligrams of glyphosate without any health risk. Additionally, the same dosage of 0.5 milligrams (at present: 0.3) per kilogram bodyweight per day was suggested as the acceptable daily intake – the amount of a substance that can be ingested on a daily basis over a person’s lifetime without suffering any adverse health effects.
A separate health-related limit (AOEL = acceptable operator exposure level) was defined for individuals working with glyphosate: this limit has been set to 0.1 milligrams (currently 0.2) per kilogram bodyweight per day. This means that a person weighing 70 kilos working with this active substance can ingest 7 milligrams of glyphosate per day without risking adverse health effects.
Why do the EFSA and national risk assessment agencies in Europe contradict the International Agency for Research on Cancer (IARC) and say that glyphosate is probably not carcinogenic to humans?
All the available and published scientific studies were used for the latest reassessment of glyphosate at the European level. These studies include original studies, which must be provided by applicants as part of licensing procedures, and studies conducted and published by research institutes on a worldwide basis. They also include the studies used by the International Agency for Research on Cancer (IARC) for its assessment. In other words, the European authorities have assessed more studies and data than the IARC.
The European scientists participating in this reassessment evaluated more studies on rats and mice than the IARC scientists: three out of five studies on mice and three out of nine long-term studies on rats were not assessed by the IARC. Additionally, the statistical evaluations that were carried out were interpreted differently. The EFSA and the European Member States also included biological plausibility and relevant historic control data providing information on the spontaneous cancer rate in their conclusions.
Such research uses specially bred laboratory mice and rats so that the results of different studies are comparable. These animals ingest the tested chemical substance in different dosages with their food over their entire lifespan. Cancer development at the end of their lives must be compared to the “natural” cancer rate in untreated animals. The IARC did not carry out this comparison.
EFSA and ECHA Answer IARC (Joint Statement English)
EFSA and ECHA Answer Christopher Portier (BfR in German)
IARC Monography Glyphosate
ECHA Hazard and Labelling Classification
The hazard and labelling classification of glyphosate is carried out by the European Chemicals Agency ECHA. The assessment by the Committee for Risk Assessment (RAC) of the ECHA is based solely on the dangerous properties of the substance and the question whether the substance may cause damaging effects. The risk or extent to which individuals and the environment are exposed to this substance is not taken into account. The German Federal Institute for Risk Assessment (BfR) sent the data of their tests on the active substance to ECHA in 2016.
The ECHA Risk Assessment Committee (RAC) confirmed the existing classification of glyphosate as eye-damaging and chronically toxic for bodies of water (Eye dam 1, H318; aquatic chronic 2, H411) in a press statement released on 15th March, 2016. The classification of the substance as having mutagenic, carcinogenic or reproduction-toxic properties or specific toxicity for organs is considered unjustified in line with Regulation (EU) 1272/2008.
Details on the ECHA Assessment