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Päivi Jokiniemi and Paul Trouth
Article related to: CLP
Glyphosate opinion – what was taken into account?
Based on the scientific evidence available, ECHA’s Committee for Risk Assessment (RAC) says that glyphosate is not a human carcinogen according to the Classification, Labelling and Packaging (CLP) Regulation’s criteria. But what exactly did they take into account?
The committee's task was to review all the available information on the hazards of the chemical. They concluded by consensus that glyphosate's existing hazard classification (causing serious eye damage and being toxic to aquatic life with long-lasting effects) should be retained. In doing so, it agreed that the substance should not be classified as a carcinogen, a mutagen or as toxic to reproduction.
Proposal for harmonised classification
In 2016, the Federal Institute for Occupational Safety and Health of Germany (BAuA) submitted a proposal to revise the existing EU-wide harmonised classification of glyphosate. They proposed to classify glyphosate as a substance that:
- causes serious eye damage (Eye damage 1),
- is toxic to the aquatic environment with long lasting effects (Aquatic Chronic 2), and
- may cause damage to organs through prolonged or repeated exposure (Specific target organ toxicity – repeated exposure 2).
What about carcinogenicity?
However, the main debate with glyphosate has concerned its possible carcinogenicity. This was largely triggered by the International Agency for Research on Cancer’s (IARC) evaluation which concluded that “glyphosate is probably carcinogenic in humans”.
When the IARC conclusion was published, the European Food Safety Authority (EFSA) was also conducting a risk assessment and peer review of glyphosate. EFSA concluded that glyphosate is unlikely to be a carcinogenic threat to humans. The rapporteur Member State for that review, Germany, also submitted a proposal for classification and labelling to ECHA for evaluation by RAC.
What was assessed?
As a basis for its assessment, RAC considered the available scientific data, including scientifically relevant information received during the public consultation conducted in summer 2016.
An unusually large amount of study data was considered by the committee. The usual number of studies for carcinogenicity would be one or two. In this case, to assess the carcinogenicity of glyphosate, 12 long-term studies conducted on animals were evaluated – seven using rats and five using mice as the test species. In addition to study summaries, RAC had full access to all of the original study reports.
The review concluded that there was no significant increase in tumour incidence in any of the treated groups of animals in the long-term rat studies. Similarly, with the mouse studies, RAC’s assessment is that the trends observed were not biologically significant.
These studies were all sponsored by industry, which is usually the case with chemicals in the EU. All but one of the 12 studies were conducted in accordance with good laboratory practice (GLP) and the applicable OECD (Organisation for Economic Cooperation and Development) test guidelines, which provide the global testing standards. These two standards give confidence in the reliability and reproducibility of the findings.
Additionally, a number of epidemiological studies were assessed. These included the United States Agricultural Health Study which is the only prospective cohort study available and a number of case control studies.
The findings of the epidemiology studies were weighed together with the findings in long-term animal studies and led to the conclusion that no hazard classification for carcinogenicity was justified for glyphosate according to the CLP criteria.
Keeping the existing classification
The proposal for harmonised classification was discussed during two consecutive RAC meetings – in December 2016 and March 2017. Overall, preparing the opinion took more than six months.
RAC agreed with the dossier submitter that the existing hazard classifications should be retained. However, for the specific target organ toxicity, the committee concluded that it is not justified for glyphosate. This decision was based on a weight-of-evidence approach and considered the available study data.
Furthermore, RAC also assessed other hazard classes according to the requirements of the CLP Regulation. They concluded that the available scientific evidence for these was also insufficient for classification.
This scientific opinion considered the hazardous properties of the substance. The assessment based on the CLP Regulation does not evaluate the likelihood of exposure or the risks associated with exposure to the substance – that is done during the risk assessment process, which EFSA performed in 2015.
The adopted opinion, which will also be available on ECHA’s website shortly, will be sent to the European Commission. The Commission will consider it with the Member States. They will decide whether to renew the approval of glyphosate as an active substance in plant protection products later this year.
Acute toxicity – adverse effects, particularly those leading to death arising from a single or relatively brief exposure.
Carcinogenicity – tendency to induce cancer or increase its incidence.
Cohort study – people are prospectively followed with a view to determine whether those exposed to a substance develop a disease more frequently that those who have not been exposed.
Epidemiological study – how often and where diseases occur in different groups of people and why. This information is used to evaluate strategies to prevent illness.
Eye damage – damage to the eye or serious physical decay of vision after the substance has entered the anterior surface of the eye, which is not reversible within a relatively lengthy period of time.
Good laboratory practice (GLP) – ensures that the test data generated is reliable and of high quality. The principles have been developed by the OECD.
Mutagenicity – capacity to cause direct or indirect damage to DNA that results in mutations.
Reproductive toxicity – the toxic effects that can affect the reproductive ability of an organism or the development of its offspring.
Weight-of-evidence approach – all available information that could determine a hazard is considered together, giving appropriate weight to the quality and consistency of the data.
Did you know?
ECHA’s Committee for Risk Assessment currently has about 50 members, nominated by the Member State competent authorities but appointed in their personal capacity as scientists by the Management Board of ECHA.
RAC has given opinions on about 250 classification and labelling dossiers to date.
Text by Nedyu Yasenov
Top image: iStockphoto
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
Committee for Socio-Economic
18-22 March (tentative)
Management Board meeting:
Member State Committee:
13-17 May (tentative)