Glyphosate Facts

Transparency on safety aspects and use of glyphosate-containing herbicides in Europe



  • What is the nature of the EU renewal process?
    EU legislation governing the regulation of pesticides dictates that the “active substances” present in these products must be assessed in terms of their safety for humans, animals and the environment at least once every decade. The review of the approval is necessary to take account of progress in science and technology and experience gained since the active substance was last reviewed.
  • What is the timeframe for the renewal process?
    Current estimates suggest that the decision to renew approval for glyphosate will take approximately 3 years from submission of the applicant dossier. The process should therefore be completed by the end of 2015.
  • What stages are involved in the renewal process?
    Companies manufacturing products containing an active substance (applicants) apply for renewal to a designated competent authority (Rapporteur Member State (RMS)) as publically appointed by the European Commission in advance. For Glyphosate, the Rapporteur is Germany. The RMS verifies the admissibility of each application, followed by an independent, objective and transparent assessment of the submitted dossier and prepares a draft assessment report (DAR) based on the information submitted. This report is sent to the European Food Safety Authority (EFSA) and is circulated to all Member States and the applicant. It is published on the EFSA website making it available to all interested parties for comment. EFSA then conducts its own review. The Commission may decide to ask EFSA to carry out a detailed risk assessment involving peer review by scientists from Member States. Based on the final EFSA conclusion, the Commission prepares a Review Report followed by a Regulation that proposes approval, non-approval or amended conditions of approval to the Standing Committee for Food Chain and Animal Health. SCFCAH consists of representatives from relevant ministries of all EU Member States and delivers its opinion by means of qualified majority voting. In the case of a non-approval decision, Member States are required to withdraw authorisation for products containing the active substance within a defined schedule.
  • What data is required for the renewal application?
    The range of data required includes that on: 1) physical-chemical properties, 2) impact on human health following single, multiple or lifetime exposure, whether for workers, consumers or the general public, and includes consideration of neurotoxtic, mutagenic, carcinogenic and reproductive effects; 3) the nature and amounts of residual traces remaining in food; fate and behaviour in soil, surface, ground and drinking water and air; 4) impact on birds and mammals, aquatic species, earthworms and other soil borne organisms, bees and other invertebrate insects, micro-organisms and non-target plants. Furthermore, data on efficacy is requested and peer-reviewed publications have to be searched systematically for evidence of potentially adverse effects.
  • Does the European Parliament have a role to play?
    The renewal process is legislated for by means of a Commission Regulation (No. 1107/2009). Therefore, the European Parliament has no legislative function within the framework of the approval process.
  • How can stakeholders engage with the process?
    The process for the review of the approval of glyphosate outlined by Commission Regulation (EC) 1141/2010 offers the possibility for to “any person wishing to submit information which might contribute to the assessment, in particular with regard to potentially dangerous effect”, to do so. Any public party can provide comments on the draft assessment report (DAR) prepared by the Rapporteur Member State and during the commenting period managed by EFSA.
  • How can citizens be assured of the quality and reliability of the data used for the renewal decision?
    The prescribed experimental designs have been developed by leading scientists in the fields concerned. They have been subjected to international scientific scrutiny and have been validated by means of an internationally agreed testing procedure involving laboratories around the world, to verify the reliability of the test methods used. All safety tests must be conducted in accordance with the OECD Principles of Good Laboratory Practice (GLP) a system that ensures that tests are conducted by properly trained personnel, that they follow correct procedures and that the procedures used are documented. GLP rules require that audits of tests and testing facilities are conducted.
  • What has been the outcome of Regulatory Reviews conducted to date?
    The comprehensive health assessments conducted by public authorities over the past 40 years have consistently concluded that glyphosate does not pose any unacceptable risk to human health. In the European Union, glyphosate was approved in 2002 for a period of ten years. The human health evaluation was based on the results of over 200 toxicology studies. The conclusion reached was that glyphosate meets all the safety requirements laid down by EU legislation on herbicides.
  • What data and information is examined by the Regulatory Authorities when the safety for human health of glyphosate is assessed?
    For human safety evaluation the results of oral, dermal and inhalation toxicity studies following single, repeat and lifetime exposure in rats, mice, rabbits and dogs are assessed. Additionally, there are specific tests that evaluate whether glyphosate has any impact on genotoxicity, neurotoxicity, reproductive and developmental parameters and to assess if glyphosate has any carcinogenicity potential following long term exposure.
  • What is an active substance?
    An active substance refers to the biologically active component that produces the intended effects in plant protection products. Glyphosate is the active substance in a range of herbicides which are widely used in both agricultural and non-agricultural situations in order to protect crops and manage weeds.
  • Does glyphosate alter human DNA?
    The several authoritative toxicology reviews of glyphosate conducted have consistently concluded that glyphosate is not genotoxic. Some published papers reporting adverse effects when scrutinized for data integrity and reliability have been found to suffer from a number of deficiencies and/or deviations from internationally validated test methods. On the basis of the studies considered reliable and suitable for hazard and risk assessment, glyphosate is clearly shown not to have genotoxic properties under conditions relevant to humans.
  • Is glyphosate detrimental to reproduction and development?
    Regulatory requirements dictate that reproduction and developmental toxicity tests be carried out on two mammalian species (rats and rabbits), and include a multi-generation reproduction study. Based on the several studies conducted, the EU, WHO and US-EPA have concluded that glyphosate is not detrimental to reproduction or development in mammals.
  • Is there a link between exposure to glyphosate and Parkinson’s disease?
    Multiple studies with glyphosate have failed to demonstrate any evidence of neurotoxicity, including any evidence of Parkinson’s-like abnormalities. In the largest epidemiology study to date, which surveyed US farmers (Agricultural Health Study), no increased risk of Parkinson’s disease was found. Considering the widespread use of glyphosate, a significant number of cases associated with either acute and/or chronic exposure would be evident if glyphosate was a causative agent of this fairly common disease.
  • Is there evidence to suggest that glyphosate can cause cancer?
    In the course of glyphosate’s 40-year history, glyphosate has been subjected to safety assessments by many regulatory experts and authoritative review panels. None of these reviews involving assessment of long-term studies with rats and mice have suggested any carcinogenic effects linked to glyphosate. A recent review article concluded that no relationship between glyphosate and any cancer outcome can be drawn from the considerable volume of published epidemiology data.
  • Can glyphosate impair the quality of drinking water?
    Numerous studies have demonstrated that the traces of glyphosate and AMPA that can occur are reliably removed by standard water treatment processes used for water drinking production. Moreover, available monitoring data demonstrates that glyphosate and AMPA are generally not a problem for drinking water producers. A study of nine European countries showed that in most samples analysed, the 0.1µg/L drinking water limit was not exceeded. While a few results exceeded that limit, these were attributed to analytical errors or localised short-term contamination.
  • What effect does glyphosate have on groundwater and surface water?
    With its combination of degradability and ability to bind strongly to soil, glyphosate does not leach through soil to groundwater. Although glyphosate and AMPA have occasionally been found in groundwater, extensive monitoring data from 14 countries has provided no evidence of any persistent contamination. Intensive use and wide application means that there is potential for glyphosate to reach surface water as a result of spray drift, run off or lack of good agricultural practices. Studies have demonstrated that higher levels of AMPA rather than of glyphosate are found in surface water. Other sources of AMPA in surface water are detergent additives and sequestering agents. These agents are discharged directly into the environment through drains and effluent and contribute significantly to the presence of AMPA in surface water. The risks to the aquatic environment as a consequence of the observed levels found in surface water monitoring programmes are negligible.
  • Is glyphosate harmful to frog populations?
    The effects of a dozen different glyphosate based formulations have been evaluated on almost 30 species of amphibians in both acute and chronic toxicity studies. Several chronic exposure studies have been conducted to investigate the impact of formulated glyphosate on growth development and survival of frog species using testing methods that have been validated by means of an internationally agreed testing procedure involving laboratories around the world, to verify the reliability of the test methods used. No adverse effects at predicted environmental concentrations were found. The absence of chronic effects is believed to reflect the rapid dissipation of glyphosate from the water column. Studies linking glyphosate usage to a decline in amphibian populations have been largely discredited.
  • What about fish and aquatic organisms?
    Some recent studies have indicated that polyethoxylated tallow amine surfactants (which are contained in some glyphosate based herbicides) could be harmful to aquatic organisms by impairing the integrity of cellular membranes. It is widely accepted that the potential risks are mild or negligible if glyphosate is used in accordance with label instructions and good agricultural practices are observed. Since glyphosate does not bio-accumulate in fish or in other animals, it does not pose a risk to the food chain. Because of its favourable safety profile, glyphosate products have been used in protected habitats such as the Galapagos Islands and the Florida Everglades to protect the native flora from invasive weed species.
  • Are bees at risk from glyphosate?
    Glyphosate and glyphosate-based formulations have been extensively tested in both the laboratory and in the field to evaluate their potential toxicity to honeybees. When glyphosate was sprayed on large areas of vegetation directly adjacent to beehives it was found to have neither acute nor chronic effects on adult honeybees or on brood production, even at concentrations three times higher than normal application rates. Despite considerable media speculation, it must be concluded that glyphosate based formulations do not harm bees and other beneficial insect populations at field exposure levels.
  • Are insects and soil dwelling organisms at risk from glyphosate?
    Extensive tests have been conducted to assess the toxicity of glyphosate on beneficial insects and other non-target organisms - such as spiders, beetles, springtails and mites. A study in which the organisms were forced to remain in contact with the pesticide film for several days showed that glyphosate was harmless for most species and moderately harmful to one species, the carabid beetle. When testing was conducted under more realistic field conditions, there were no adverse effects on carabid beetles.
  • What is the environmental fate and behaviour of glyphosate?
    The behaviour of glyphosate and its impact on the environment and wildlife has been studied extensively. Glyphosate binds tightly to clay and organic matter in soils and sediments, such that it is not available for uptake by roots of non-target plants. In addition, glyphosate degrades rapidly into AMPA (aminomethylphosphonic acid) and then into naturally occurring substances such as carbon dioxide and phosphate. The fact that glyphosate binds strongly to soil and that it degrades rapidly are significant factors that contribute to its favourable environmental safety profile.
  • Did the organisation Earth Open Source establish a link between glyphosate exposure and birth defects?
    A report published by Earth Open Source contains criticisms of risk assessments for glyphosate conducted by official authorities and highlights certain in vitro studies that reported developmental toxicity. The Regulatory Authorities have found these in vitro studies to be of limited use for regulatory decisions, as they do not reflect realistic exposure conditions for animals and humans and do not take into account the physiological barriers (absorption, metabolism and excretion) that limit exposure. In vitro studies, in which substances are artificially administered directly to embryos, are considered to be less reliable and less relevant for human risk assessments than studies on animals.
  • What did the study by Professor Séralini and colleagues establish?
    The study conducted by a French university team led by Gilles-Eric Séralini claimed to have found effects including tumour development and a shortened life time in laboratory rats fed a diet containing a glyphosate and genetically modified NK603 maize. Regulatory Agencies and individual scientists have examined the study and criticised its validity, pointing out that the findings are not supported by the data presented; that the conclusions are not relevant for the purpose of safety assessment; that there are fundamental problems with the study design; that critical information on methodology was absent; and that the data presented does not support the author’s interpretations.