1. What is glyphosate?
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 known as ‘herbicides' or ‘weedkillers'.
2. What is it used for?
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 crop. This practice however does not happen within the European Union.
3. What is ECHA doing on glyphosate?
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) has proposed that glyphosate should have an additional harmonised classification (it already has several). As foreseen by 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 are responded to by the German authority. Subsequently, ECHA's Committee for Risk Assessment (RAC) will prepare the 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 will consider all the relevant data – including that provided by third parties. RAC will also take into account the key information that was previously analysed by other bodies and will also consider the differing views on how some of those studies have been evaluated.
RAC will give 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 Commission will make the final decision. 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. In the case of 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.
4. Where does the scientific data come from and can I see it?
When conducting their assessments, regulatory agencies like ECHA rely on a combination of data from toxicological studies that are either published or not.Under EU law, there is a legal 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 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 are made available to the relevant regulatory authorities, including ECHA's Committee for Risk Assessment, for their evaluation.
The results of the studies included in the classification process, the responses to comments received and RAC's opinion on the classification of glyphosate will be published on ECHA's website once the opinion has been adopted. The dossier submitted by the German competent authority as well as the comments provided during the public consultation are already available there.
5. What happens next?
ECHA's Committee for Risk Assessment (RAC) is currently developing its opinion on the classification of the substance, also taking into account information provided during the public consultation on glyphosate during the early summer 2016. RAC will adopt the final opinion on harmonised classification for glyphosate by the end of November 2017. ECHA will submit the opinion to the Commission, which takes the final decision on the classification of glyphosate. The Commission takes the classification into account when deciding on the renewal of the approval of glyphosate under the Plant Protection Products Regulation.
6. I've heard about different scientific evaluations of glyphosate – why don't they agree?
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 recent reporters is also now to be considered by ECHA's Committee for Risk Assessment of independent experts from the EU Member States.ECHA will adopt 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 is assessing the intrinsic hazardousness of glyphosate and not the risks associated with its individual uses. Those risks, for example the risks of using products containing glyphosate, are assessed under the Plant Protection Products Regulation.
CLH report submitted by German competent authority
Presentations given at the RAC meeting on 7 December 2016
European Food Safety Authority (EFSA) [PDF] [EN]
Industry’s Glyphosate task force (GTF) [PDF] [EN]
Civil society (HEAL) [PDF] [EN]
- RAC starts discussing the harmonised classification of glyphosate (ECHA's news item - 7 December 2016)
- ECHA's role in assessing glyphosate (ECHA's news item – 7 July 2016)
- Substance information - glyphosate
- Substance details, public consultation and comments received on the harmonised classification and labelling proposal for Glyphosate
- Harmonised classification and labelling
- Committee for Risk Assessment (RAC) and RAC Members' declarations of interest
- ECHA Executive Director's response to messages on glyphosate from the public:
- Glyphosate: Commission proposes the way forward - Statement by Commissioner for Health and Food Safety, Vytenis Andriukaitis, European Commission – press release (1 June 2016), Commission's Daily news and fact sheet (29 June 2016)
- Approval and use of active substances and pesticides in the EU
- Frequently asked questions on the assessment of the health risk of glyphosate by the Federal Institute for Risk Assessment (BfR) [EN] [DE]
- Does glyphosate cause cancer?, BfR Communication No 007/2015, 23 March 2015
- Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate, European Food Safety Authority, 12 November 2015
- Frequently asked questions, JMPR secretariat – 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)