Glyphosate is one of the most widely used active substances in pesticides to prevent unwanted plant growth around planted crops or to kill plants or parts of plants. These substances are often called ‘herbicides' or ‘weedkillers'.
Glyphosate is used in agriculture and horticulture to combat weeds before sowing. Where genetically modified plants with resistance to glyphosate are grown, the substance is also used after sowing to kill weeds growing amongst the crops. This practice does not, however, happen within the European Union.
ECHA manages the law on the classification and labelling of substances and mixtures. This law regulates the way in which substances are assessed and labelled, based on the hazardous properties they may have – for example poisons, flammable substances, corrosive substances and so on.
For certain substances, such as pesticides, a decision on the classification may be made at EU level to apply across the whole of Europe. In practice, this means that the relevant labelling will be required to warn consumers on every product containing the substance.
The German Federal Institute for Occupational Safety and Health (BAuA) proposed that glyphosate should have an additional harmonised classification for specific target organ toxicity after repeated exposure (in addition to existing harmonised classifications). As set out in the CLP legislation, ECHA invited parties concerned to comment on this proposal in a public consultation, which closed on 18 July 2016.
The comments ECHA received were responded to by the German authority. Subsequently, ECHA's Committee for Risk Assessment (RAC) discussed the proposal for harmonised classification during two consecutive meetings – in December 2016 and March 2017 and prepared its independent scientific opinion.
RAC is a scientific committee, made up of experts nominated by the Member States of the European Union and appointed by ECHA. They considered the relevant data – including that provided by third parties. RAC also took into account the key information that was previously analysed by other bodies and considered the differing views on how some of those studies had been evaluated.
On 15 March 2017, RAC agreed to maintain the harmonised classification of glyphosate as a substance causing serious eye damage and being toxic to aquatic life with long-lasting effects. On 15 June, RAC submitted their independent scientific opinion to the European Commission on whether the intrinsic properties of glyphosate meet the legal criteria for classification set out in the Classification, Labelling and Packaging (CLP) Regulation. The adopted opinion as well as further information on the harmonised classification process is provided at the links below.
RAC and ECHA's assessment is solely based on the hazardous properties of the substance – is the substance capable of causing harmful effects? It does not take account of the risk or the extent to which people and the environment are exposed to the substance. This, of course, depends on how the substance is used and how much of it is used. Those detailed risks are therefore considered on a case-by-case basis under the relevant legislation. For glyphosate, it is the legislation on pesticides. That legislation – known as the Plant Protection Products Regulation – is managed by the European Commission and the European Food Safety Authority (EFSA). Further information on risk and exposure-related issues is provided at the links below.
Decision by EU Member States
Following adoption, RAC’s opinion was sent to the European Commission, and the Commission together with the Member States decided to renew the approval of glyphosate’s use as an active substance in plant protection products for five years (until 15 December 2022).
The decision was taken by EU Member State experts on 27 November 2017 and adopted by the Commission on 12 December 2017.
When conducting their assessments, regulatory agencies like ECHA rely on a combination of data from toxicological studies whether they are published or not.
Under EU law, there is a requirement on industry to ensure the safe use of chemical substances that they place on the market. Industry, therefore, has to conduct (eco)toxicology studies to identify the hazardous properties of these substances. These studies are paid for by industry.
Specialised laboratories that usually conduct these studies for the industry have to follow strict guidelines, which are laid down in EU legislation and related guidance documents. The studies must be performed in accordance with agreed methodology and must meet quality requirements (OECD or equivalent technical guidelines and good laboratory practice). This is the same process used, for example, for medicines.
The complete reports from these studies have been made available to the relevant regulatory authorities, including ECHA's Committee for Risk Assessment, for their verification of the information.
RAC's opinion on the classification of glyphosate and the responses to comments received are available on ECHA's website. The CLH report (including summaries of the studies) submitted by the German competent authority as well as the comments received during the public consultation are also available.
There have been several recent reports on glyphosate. Depending on the approach taken and the way in which the data have been considered, different conclusions have been reached. This is not unusual – interpreting and weighing scientific data requires judgement. However, the data available to the authors of these recent reports has also been considered by ECHA's Committee for Risk Assessment of independent experts from the EU Member States.
ECHA adopted an independent scientific opinion on the need for a harmonised classification for glyphosate, based on the hazard criteria set out in the Classification, Labelling and Packaging Regulation. As mentioned earlier, ECHA assessed the intrinsic hazardousness of glyphosate and not the risks associated with its individual uses. Those risks, for example, of using products containing glyphosate, are assessed under the Plant Protection Products Regulation.
- Glyphosate not classified as a carcinogen by ECHA, 15 March 2017
- ECHA's role in assessing glyphosate, 7 July 2016
- Commission Implementing Regulation (EU) 2017/2324 of 12 December 2017
- Commission's glyphosate page
- Approval and use of active substances and pesticides in the EU
- Glyphosate: Commission responds to European Citizens' Initiative and announces more transparency in scientific assessments, 12 December 2017
- EFSA's glyphosate page
- Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate, 12 November 2015
Frequently asked questions on the assessment of the health risk of glyphosate by the German Federal Institute for Risk Assessment (BfR)
- Does glyphosate cause cancer?, BfR, 23 March 2015
- Frequently asked questions, Joint FAO/WHO Meeting on Pesticide Residues
- Q&A on Glyphosate, International Agency for Research on Cancer (IARC), 1 March 2016
- Glyphosate and cancer: why is there a difference in its classification by the IARC and EFSA? (GreenFacts)
- Video: Hazard, Risk & Safety - Understanding Risk Assessment, Management and Perception (GreenFacts)