There has been a commotion in various media in recent years due to an announcement by the International Agency for Research on Cancer (IARC) that the weedkiller glyphosate was probably carcinogenic. In the meantime, a decision needed to be taken at the EU level on whether or not to renew the approval of glyphosate. High time then to report on the state of play (updated on February, 2020).
In the text below, the following questions are discussed:
- What is glyphosate?
- How was glyphosate assessed in the European Union?
- What has the IARC published?
- Was the IARC report taken into account in the EU assessment?
- Why have the IARC and the EFSA arrived at contradictory conclusions?
- Hasn't the French ANSES agency confirmed the IARC classification?
- Is the EU procedure for the assessment of glyphosate actually transparent?
- What is the situation regarding the independence of the experts who assessed glyphosate?
- Is glyphosate an endocrine disruptor?
- How dangerous is glyphosate for the environment?
- The standard for the "Admissible Daily Intake" (ADI) of glyphosate has been increased. Does this mean that more glyphosate residues will be present in food?
- Is it not the case that glyphosate is found everywhere?
- Is sufficient attention paid to co-formulants such as POE tallowamine, which is present in a plant protection product?
- Which studies are taken into account?
- Have the 'Monsanto Papers' not shown that the studies can be manipulated?
- How has the EU approval of glyphosate been renewed?
- Can the EU approval of glyphosate be renewed?
- At what stage is the assessment of the carcinogenic properties of glyphosate by the ECHA?
- What have the Belgian authorities been doing?
- Have other EU Member States already taken restrictive measures with regards to glyphosate?
1.What is glyphosate?
Glyphosate is a herbicide used to kill weeds which has already been authorised for decades. It is characterised by a short aftereffect. It has many applications, including:
- on agricultural soils for sowing or planting crops
- on railways
- in gardens for use by garden enthusiasts
You can find a full overview of all the applications authorised in Belgium via consult authorisations.
Glyphosate is generally associated with genetically modified crops. There are indeed crops which are genetically modified so that they are no longer sensitive to glyphosate. As a result, glyphosate can be used in these crops without harming them. In Belgium, such use of glyphosate is not authorised.
2.How was glyphosate assessed in the European Union?
In the EU, plant protection products have been subject to a double authorisation procedure since 1993. The active substance must first be approved at the EU level. Member States can then authorise plant protection products which contain such approved substances.
Glyphosate was first approved at the EU level on 01/07/2002. The procedure went as follows:
- Germany was designated as the Rapporteur Member State by the European Commission and produced the draft assessment report (DAR).
- experts from all Member States examined the German report; the experts also discussed the German DAR in a meeting.
- in consultation with the Member States, the European Commission decided to approve glyphosate. A Commission report is publicly available.
It was concluded inter alia that there were no indications that glyphosate was carcinogenic.
The EU approval is limited in time. An application to renew the approval was submitted. Germany was once again the rapporteur. The detailed German assessment report dates from December 2013. It is available via the website of the European Food Safety Authority (EFSA).
The dossier which was assessed by Germany contains not only studies carried out on behalf of the producer, but also all relevant studies published during the previous 10 years, including the one assessed by the IARC (see question 3). Germany assessed a larger number of studies into carcinogenic properties than the IARC did.
Germany decided that there are highly limited indications of carcinogenic properties in tests carried out on mice with extremely high doses, which nonetheless were insufficient to classify glyphosate as carcinogenic.
In response to the German report, the EFSA devoted a meeting with experts to the toxicological properties of glyphosate, in 2015. The EFSA, as an independent scientific organisation, published its Conclusion on 12 November 2015. The EFSA concluded that glyphosate does not need to be classified as carcinogenic.
3.What has the IARC published?
On 20 March 2015, the IARC published a paper, as well as a brief summary (each 2 pages) in the scientific journal 'The Lancet Oncology', which was published in 2015, in which a new classification with regards to carcinogenic properties was proposed for 5 active substances of plant protection products (including glyphosate, the only one of the 5 which is authorised in Belgium). The complete IARC assessment (containing the data which enable its assessment) was only published on 29 July 2015.
The IARC proposed that glyphosate must be classified in Class 2A as "probably carcinogenic for humans". The IARC specified that this classification is based on:
- studies published since 2001 regarding the exposure of humans to glyphosate and
- studies with laboratory animals
However, the IARC has no legal authority in Europe. Under European legislation, glyphosate is not currently deemed to be carcinogenic. Nonetheless, this new classification was a new element which could not just be ignored.
As such, European and national bodies, including the FPS Public health, Food Chain Safety and the Environment, evaluated this study as quickly as possible. Possible restrictive measures, or a prohibition of a substance, must be reasoned, and such reasoning can only be based on scientific grounds.
4.Was the IARC report taken into account in the EU assessment?
The European Commission expressly mandated the EFSA to closely examine the findings of the IARC before publishing its Conclusion. The Commission specified, inter alia, that the EFSA needed to verify:
- whether the IARC had access to more information that what was in the possession of the Rapporteur Member State Germany.
- to what extent the IARC assessment is based on, firstly, information regarding the active substance glyphosate and, secondly, the data which pertain to formulations which contain other components in addition to glyphosate.
- whether there is a clear link between the phenomena as observed in the IARC report and the application of glyphosate-containing plant protection products in accordance with good plant protection practices in Europe.
- whether the toxicological classification as proposed by the Rapporteur Member State Germany should be adapted.
At the end of September 2015, the EFSA consulted with a number of European experts in toxicology. One Belgian expert took part in this consultation.
5.Why have the IARC and the EFSA arrived at contradictory conclusions?
Along with experts from the Member States and experts from the IARC, WHO, USEPA and ECHA, the EFSA discussed the IARC monograph in detail, and more generally the possible carcinogenic properties of glyphosate. The conclusion of the EU representatives was: "Based on a weight of evidence approach, the evidence does not support classification with regard to carcinogenicity, (one minority view)". This meeting also made it possible to better understand what underpinned the divergent visions of the EFSA and IARC. It relates to the following elements:
- The main element was that the number of animal studies in the EU dossier was much larger than in the IARC dossier, which therefore provided the opportunity to conduct more refined analysis.
- Moreover, the EU uses another strategy to statistically process the data. For example, in the EU review, a balance was made between, on the one hand, trends in tumour formation (which was deemed relevant by the IARC) and on the other hand all other available data, such as extreme toxicity, spontaneous tumour incidence ("historical controls"), and the absence of a consistent response in comparable long-term studies with glyphosate. Conversely, the IARC primarily focused on the trend in tumour formation.
- In assessing epidemiological studies, EU experts gave more weight to the outcome of the largest and, in their opinion, more relevant "Agricultural Health Study" than to other studies. On the other hand, the IARC believed that smaller, less detailed studies also provided conclusions which were just as important as those from the largest study. As was the case in the experimental animal studies, the existing epidemiological studies do not present a consistent picture concerning the carcinogenic capacity of glyphosate, also because the populations studied were exposed to multiple products, meaning that the effect of the share of glyphosate on human health is unclear.
- The mandate of the EFSA is mainly centred on studying the properties of the substance, and not of the multiple products (mixtures) which are placed on the market. Published data from studies carried out on products whose origin cannot always be traced, or which have an uncertain composition, do not provide a uniform picture of the hazard or risk for the user of the active substance itself.
This problem is covered in more detail in the scientific article 'Glyphosate toxicity and carcinogenicity: a review of the scientific basis of the European Union assessment and its differences with IARC'.
6.Hasn't the French ANSES agency confirmed the IARC classification?
The ANSES (Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail) looked into the question of the potentially carcinogenic properties of glyphosate. A group of experts studied the assessment reports of the IARC, the EFSA and the European Rapporteur Member State Germany. This group concluded that there is no reason to classify glyphosate as 1A (known human carcinogens) or 1B (presumed human carcinogens), in accordance with the criteria of the applicable EU legislation (Regulation (EC) no. 1272/2008). The group could not comment regarding a classification in category 2 (suspected human carcinogens) without having carried out a detailed analysis of the studies themselves.
The classification system used by the IARC differs from that of Regulation (EC) no. 1272/2008, but classification by the IARC in category 2A (presumably carcinogenic) is the closest to classification as 1B under Regulation (EC) no. 1272/2008. In other words, the opinion of the ANSES does not confirm the classification as established by the IARC. Nonetheless, given the uncertainty regarding a possible classification in category 2 (pursuant to Regulation (EC) no. 1107/2009), the French agency stated that it was necessary for the European Chemicals Agency (ECHA) to review the classification. Indeed, the process which must result in a review of EU classification by the ECHA has been finalized (see question 18). Belgium and the other EU Member States unequivocally supported the reassessment by the ECHA.
7.Is the EU procedure for the assessment of glyphosate actually transparent?
Transparency is the hallmark of the EU procedure. The following documents are available on the website of the EFSA:
- A summary of the dossier as submitted by the producers of this active substance.
- The complete report (excluding a section which contains confidential information such as the production process) of the Rapporteur Member State Germany, which consists of 3,945 pages, including 143 pages which list the assessed studies.
- The EFSA Conclusion.
- The background documents to the EFSA conclusion. In total, these amount to 1,730 pages, including the following elements:
- The comments which were made by various parties (Member States, producers, third parties) on the German report, and the way in which these comments were assessed (reporting tables and evaluation tables).
- The complete reports of the various expert meetings.
- The comments for the draft EFSA Conclusion.
All in all, there are almost 6,000 publicly available pages with information on the grounds and method in which glyphosate was assessed in the EU procedure.
The studies themselves, on which the assessment was based, have not been published. These studies contain confidential details, such as the names of the researchers. However, the published summaries are sufficiently extensive to allow a good understanding of the study results. Nonetheless, at the end of 2016, at the request of a number of members of the European Parliament, the EFSA handed over the complete studies on the genotoxicity and carcinogenic properties of glyphosate, including all raw data, to these members of Parliament.
8.What is the situation regarding the independence of the experts who assessed glyphosate?
Germany, as the Rapporteur Member State, entrusted the assessment to the Bundesinstitut für Risikobewertung (BfR), a scientific government institution. This institution adheres to approved guidelines in the area of good scientific practice.
The EFSA, which conducted a peer review of the German assessment and drew conclusions on the risk assessment, is an independent scientific institution of the European Union. During the peer review of glyphosate, the EFSA organised numerous meetings with experts from the Member States. The participating experts are appointed by the authorities of the Member States. They are invited by the EFSA to submit an annual declaration regarding their interests. These declarations are published by the EFSA on its website, if the experts agree. A list is also available on the EFSA website of the government institutions to which the experts belong, who take part in the peer review meetings.
Ultimately, the conclusions regarding the risk assessment are the full responsibility of the EFSA. These conclusions are drawn up by EFSA staff members. They also need to submit an annual declaration regarding their interests.
EFSA's independence was questioned with the allegation that the EFSA Conclusion would contain literal phrases from the original dossier from the producers of glyphosate. This is not correct: no fragment can be found in the EFSA Conclusion that would be copied from the original dossier. In the report of the Rapporteur Member State (RMS) Germany, there are fragments that literally match the summaries in the dossier prepared by the producers. But if these summaries match the conclusions of the RMS, then there is nothing wrong with this. The RMS has modified the summaries of several studies that were originally provided by the producers. These modifications were sometimes radical. This supports that the RMS has critically assessed the studies and the summaries. The fact that some summaries have not required modifications is not surprising at all. Moreover, the German report has been examined by experts from other Member States and EFSA. EFSA organized a public consultation of the report. All comments are publicly available (see question 7). For its Conclusion, EFSA relied upon all these elements: the original studies, the report of the RMS, the comments on the report and the discussion with the Member State experts during meetings.
There is no reason to doubt the independence of all the people involved in the assessment process.
9.Is glyphosate an endocrine disruptor?
To date at the EU level, no criteria have been definitively established which would make it possible to identify an endocrine disruptor. Nonetheless, it is always ascertained during an EU assessment of an active substance whether the currently known toxicological modes of action are related to a endocrine effect, which means that an evaluation of the endocrine properties always takes place. Regarding glyphosate, the EFSA has only quoted effects in one single study, for which it could not be ruled out that they were the result of an endocrine mode of action; in all other studies submitted, such effects were not however observed. In response to the EFSA conclusion, a glyphosate producer notified that it had recently conducted specific supplementary studies to demonstrate that there is no endocrine mode of action.
In September 2016, the European Commission mandated the EFSA to request all relevant information on the endocrine effects of glyphosate from the producers of this substance, and to formulate a scientific opinion on these data. This opinion was published on September 7, 2017. The conclusion is that there are no indication that glyphosate would be an endocrine disruptor.
Pending the definitive criteria for identifying endocrine disruptors, the so-called interim criteria currently apply, as laid down in Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market. According to this interim criteria, glyphosate is not an endocrine disruptor.
10.How dangerous is glyphosate for the environment?
Glyphosate has a relatively favourable profile regarding its impact on the environment: for most groups of non-target organisms, the EFSA has established that the risk is low. This applies to aquatic organisms, bees, non-target arthropods, earthworms, soil macro-organisms and soil micro-organisms. For birds and mammals, the picture is slightly more nuanced: for some of the scenarios, insufficient data were available to make a refined risk assessment, while the 'first tier' (i.e. the least refined) assessment did not allow the conclusion of a low risk. Nonetheless, the overall picture is rather favourable with regards to these groups, and the EFSA therefore identified 'no issue that could not be finalised' or 'critical area of concern' with regards to the environment, which would point to further investigation or problematic properties. That is the case for most approved substances. The EFSA conclusion is also reassuring regarding potential groundwater contamination.
11.The standard for the "Admissible Daily Intake" (ADI) of glyphosate has been increased. Does this mean that more glyphosate residues will be present in food?
The EFSA does indeed propose increasing the ADI of glyphosate from 0.3 to 0.5 mg/kg body weight/day. The ADI is a toxicological reference value that indicates how much glyphosate we can consume daily (for our entire lives) with food, without any effect on our body. The ADI is generally 100 times smaller than the highest dose administered to test animals in toxicity studies, for which no harmful effect was observed. As such (and rightly so) a very broad margin of safety has been maintained. The maximum residue limit in food is not derived from the ADI. They are determined on the basis of residue tests carried out in accordance with the requested good agricultural practice for the application of the plant protection product. It is then ascertained whether or not the residues obtained in this way lead to an intake that exceeds the ADI. A maximum residue limit is only laid down in law after it has been demonstrated that there is no risk of exceeding the ADI. In other words: the sum of all residues in food is always smaller than the admissible daily intake (ADI). In the case of glyphosate it is not even 50% (see below).
An increase of the ADI therefore does not mean that more residues in food is tolerated. In theory, an increase of the ADI leaves space to establish higher maximum residue limits, and therefore the authorisation of agricultural practices which result in higher levels of residues in food (e.g. a higher dose). But from the latest reasoned opinion of the EFSA in which a calculation is made of the theoretical intake of residues of glyphosate, it appears that in the most unfavourable case, not even 50% of the ADI is reached. In other words, the current ADI of 0.3 mg/kg of body weight per day is not at all a limiting factor for increasing the maximum residue limits. As such, an increase of the ADI will not have any effect on residue levels.
More relevant than the modest increase in the ADI is the establishment by the EFSA of a second (relatively recent) toxicological reference value which is important for the risk assessment of maximum residue limits, namely the acute reference dose (ARfD). This value indicates how much glyphosate we can consume in one time with food without any effect on the body, and was established by the EFSA at 0.5 mg/kg body weight. From now on, a test on the acute effects will also take place, in addition to the ADI test (which considers the chronic intake of residues). For the applications that were assessed in the context of the application to renew the approval of glyphosate, no problems were observed regarding the possible exceedance of the ARfD (the estimated intake was still less than 10% of the ARfD). The EFSA is currently testing all existing maximum residue limits against the newly established toxicological reference values. As such, the application of the new toxicological reference values will not result in the establishment of higher maximum residue limits. If anything changes, it will more likely be a reduction or a scrapping of certain limits, which will result in less glyphosate being present in food.
12.Is it not the case that glyphosate is found everywhere?
Studies have shown that glyphosate can be found in e.g. beer and urine, which appears to point to the ubiquity of this much used substance. The concentrations found in the studies are often compared with the standard which applies for drinking water. An exceedance of the standard is presented as problematic by some people.
This standard is arbitrarily fixed at 0.1 µg/l for any active substance (and for the relevant metabolites of these active substances), and means in essence that no presence in drinking water is tolerated (assuming that the analytical determination limit for any active substance must be at least 0.1 µg/l). For food originating from crops treated with plant protection products, such zero tolerance cannot be applied. In most cases, the treatment results in the presence of residues. The question is whether or not the level of these residue concentrations can have an adverse impact on health. To this end, residue tests are carried out in accordance with good agricultural practice, and it is ascertained whether the identified residue levels can result in an intake of residues which exceeds the toxicological reference values (ADI and ARfD; see also question 11). If there is no risk for exceeding these values, a maximum residue limit (MRL) is established in the context of Regulation (EC) No 396/2005. Consequently, there is inevitably a limited but toxicologically irrelevant intake of glyphosate residues via food.
In European legislation, the legal maximum residue limit for glyphosate in barley, one of the basic components of beer, is established at 20 mg/kg. For beer, no maximum residue limit is established, but for processed products such as beer, Regulation (EC) No 396/2005 specifies that the maximum residue limit of the basic components apply, provided that account is taken of changes in the residue levels as a result of processing. In response to a study on the presence of glyphosate in beer, the German Bundesinstitut für Risikobewertung carried out a risk assessment and concluded that an adult would need to drink about 1000 litres of beer with the highest found concentration of 30 µg/l in one day to exceed the toxicological reference value for glyphosate. But perhaps before the consumer has consumed these 1000 litres, the consequences of another ingredient in the beer will have been felt, which received an even less favourable classification than glyphosate as a carcinogenic substance by the IARC, i.e. category 1 instead of category 2A. Moreover, it is a substance which occurs in concentrations 1.5 million times higher than the 30 µg/L of glyphosate. This substance is alcohol.
As such, there is indeed an intake of glyphosate residues via food, but in quantities whereby the toxicological reference values are not exceeded. Using metabolism studies, it was examined what happens with glyphosate which is absorbed into the body of test animals. The results of these studies show that glyphosate is barely metabolised. In other words, it is excreted by the body largely unchanged, mainly via faeces, and around 20% via urine. It is therefore not at all surprising, and even less problematic, that traces of glyphosate are found in urine.
The alleged presence of glyphosate in breast milk, as was reported in the media in June 2015 on the basis of non-verifiable analysis results for sixteen samples of breast milk, was not, incidentally, confirmed in a recent study commissioned by the German Bundesinstitut für Risikobewertung (BfR). In this study, the results of which were published in January 2016 in a scientific journal, highly sensitive measurement techniques were used, and glyphosate was not found in any of the 114 examined samples of breast milk.
13.Is sufficient attention paid to co-formulants such as POE tallowamine, which is present in a plant protection product?
The EU system for assessing plant protection products involves 2 stages:
- An evaluation of the active substance at the EU level, which may or may not lead to EU approval; together with the dossier for the active substance, at least one dossier for a representative plant protection product containing the active substance is also assessed at that level.
- An evaluation of the plant protection products containing an active substance approved at the national level, with a view to granting, or not, a national authorisation.
It is especially at the second stage that the co-formulants come into play, but nevertheless it can be ascertained from the German assessment report for glyphosate that the co-formulant POE-tallowamine, which appears in a number of plant protection products on the basis of glyphosate, can impact the toxicological mode of action of glyphosate. That is why the European Commission has instructed the EFSA to consider the toxicological properties of this co-formulant. The EFSA has published a statement in this respect. The EFSA concluded that there is insufficient information on this co-formulant to carry out a risk assessment. In the Conclusion on glyphosate, the EFSA also pointed to the need to pay sufficient attention to the potential genotoxic properties of plant protection products based on glyphosate. This also relates to the possible impact of the co-formulants.
In response, the European Commission has imposed a ban on plant protection products which, in addition to containing the active substance glyphosate, also contain the co-formulant POE-tallowamine. You can find more information regarding this ban, and its implementation in Belgium, in questions 16 and 18.
Moreover, Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market, provides for the possibility of placing certain co-formulants on a negative list. Substances which appear on this list can no longer be used as a co-formulant in a plant protection product. To date, no substances have been added to this list (although a number of co-formulants have long been banned in Belgium), but the European Commission has set up a working group whose purpose is to work out a proposal for a uniform EU procedure to include co-formulants in the negative list.
14.Which studies are taken into account?
Worldwide, the rule applies that whoever wishes to place a substance on the market must also make the necessary costs and effort, to prove that this substance does not constitute an unacceptable risk to human health and the environment.
The European assessment is therefore based on a dossier submitted by the producer. This dossier mainly contains studies carried out on behalf of the producer. A system whereby the competent authorities are responsible for carrying out these studies does not exist in any country: such a way of working would require huge public resources and civil servants, and would not generate any added value in relation to the current system, and is therefore not feasible. It would mean in essence that the development of new and safer plant protection products was seriously slowed down.
As such, it has been decided that producers finance the studies, but that the laboratories which carry out the studies must comply with very strict criteria in terms of transparency and quality. This quality is closely monitored by the government:
- only GLP (good laboratory practice) laboratories can carry out such tests. This means that every stage of preparation, execution and reporting is meticulously described, and each component is also traceable. In other words, the executing laboratories must demonstrate that they 'say what they do, and do what they say'. Such accreditation is awarded by national GLP inspectorates, and regularly inspected.
- During submission of these GLP reports, the national authorities check in turn whether the studies carried out are consistent with the study protocols that are required by law ('form'), and whether the interpretation of their results are scientifically ('substance') robust.
In addition to the studies financed by producers, the European dossier must also contain the most recent and relevant literature studies. All published studies of independent laboratories are therefore also included in the assessment.
It is important to stress that the studies financed by the producers must comply with extensive legal conditions. They contain much more information than the other studies. Excluding these studies and only basing the assessment on publish studies would result in an extremely incomplete and skewed picture of all the possible effects of the plant protection products.
Contrary to what is often claimed, the assessment of the IARC is also only based on several studies from industry.
15.Have the 'Monsanto Papers' not shown that the studies can be manipulated?
The following can be ascertained from the 'Monsanto Papers':
- In 1999, Monsanto approached Prof. Parry of the University of Swansea with a request to carry out an assessment of the available data regarding the possible genotoxicity of glyphosate (formulations). Prof. Parry advised Monsanto to carry out a whole range of studies in order to demonstrate that glyphosate is not genotoxic. Parry's report was not submitted with the authorities. The question is what the impact was of this non-submission.
- In Monsanto emails from 2015, a strategy is discussed to have scientific articles published which are favourable to glyphosate. It was suggested having these articles drafted by Monsanto themselves, and then approaching independent scientists so that they could associate their names with the articles. In this respect, reference is made to the William, Kroes and Munro study from 2000, which was apparently drafted using this approach. The question is how the authorities dealt with the latter article (Safety evaluation and risk assessment of the herbicide Roundup and its active ingredient, glyphosate, for humans; Regulatory Toxicology and Pharmacology).
- In these Monsanto emails from 2015, it is proposed that the following scientists should be approached: Greim, Kier and Kirkland. In 2016, an article did indeed appear in the scientific journal Critical Reviews in Toxicology under the title 'A review of the carcinogenic potential of glyphosate by four independent expert panels and comparison to the IARC assessment', with the above-mentioned scientists as co-authors (in addition to numerous others). Once again the question is how the authorities dealt with this article.
It must therefore be ascertained what impact these studies had on the decision-shaping by the authorities.
First and foremost, it should be stressed that the 3 studies are not toxicological studies but assessments of existing toxicological studies. The authorities, both at the EU level and the national level, themselves carried out an independent assessment of the toxicological studies. These toxicological studies must be carried out by laboratories which are approved as GLP laboratories (Good Laboratory Practice) and which are inspected by the authorities (see question 14). These studies contain all the necessary raw data to enable a thorough and independent assessment of the toxicological effects. The 'Monsanto Papers' do not contain any indication that Monsanto attempted, or even considered attempting, to interfere in the execution of the toxicological GLP studies.
a. The Parry rapport
In his report, Parry provides an overview of all the available studies into the genotoxicity of glyphosate, and formulations based on glyphosate. The results of the studies are briefly shown. Parry recommends conducting further research.
Parry identifies a number of studies which provide positive results which could possible point to genotoxic effects. Each of these studies were assessed by the Rapporteur Member State Germany in the Renewal Assessment Report. Since 1999, numerous studies have been conducted in this respect. Germany has thoroughly assessed all studies, and decided on a weight of evidence basis that glyphosate is not genotoxic. There is no reason whatsoever to assume that Parry's report would have given Germany a different insight.
b. The Williams, Kroes and Munro study of 2000
In the acknowledgements at the end of the study, the following is mentioned: "Second, we thank the toxicologists and other scientists at Monsanto who made significant contributions to the development of exposure assessments and through many other discussions". The authors therefore state with transparency that there was cooperation with Monsanto, and the German evaluators and the EFSA were aware of this fact.
This study amounts to 48 pages and provides an overview into the effects of glyphosate, the co-formulant POE tallowamine, the metabolite AMPA, and Roundup formulations. The final conclusion is that glyphosate does not pose any risk to human health. The study appears on the reference list of Germany's Renewal Assessment Report (RAR).
From the EFSA's Peer Review Report it appears that this study did not play any role in the stages following the submission of the RAR by Germany. No Member State referred to this study in their comments, and not once did the study come up for discussion in the expert meeting.
The study was not included in the reference list of the CLH report which Germany drafted in the context of the classification of glyphosate, pursuant to Regulation (EC) no. 1272/2008 (see question 19). In its CLH report, Germany comes to the same conclusions as in the RAR, from which it can be deduced that the study was not a decisive factor in Germany's final conclusions.
In response to the 'Monsanto Papers', the EFSA investigated what the impact may have been of studies which were possibly influenced by Monsanto. The EFSA concluded that there are no grounds to suggest that the producers of glyphosate might have influenced the assessment process. The EFSA has published a statement in this respect.
c. The study published in Critical Reviews in Toxicology in 2016
The study was published on 28 September 2016. The basis for the assessment by the ECHA was the CLH report drawn up by Germany. Germany submitted this report in May 2016, and therefore could not have been influenced in any way by the study. In the report, Germany proposes not classifying glyphosate as carcinogenic.
The Committee for Risk Assessment (RAC) of the ECHA agreed with the German proposal not to classify glyphosate as carcinogenic.
16.How has the EU approval of glyphosate been renewed?
In consultation with the Member States, the European Commission proposed a decision in 2016 for the renewal of the approval of glyphosate. In this initial proposal, the Commission had linked certain new conditions to the renewal:
- A ban on the co-formulant POE-tallowamine in plant protection products based on glyphosate (see question 13).
- An obligation to review the approval of glyphosate as soon as it appears that glyphosate, pursuant to Regulation (EC) no. 1272/2008, must be classified as a carcinogenic substance in category 1A or 1B (see question 18).
- A requirement to submit data in the short term (by 01/08/16) which need to confirm that glyphosate does not exhibit any endocrine modes of action (see question 9).
- A requirement that the Member States, in the context of the national authorisation procedure, ascertain that the plant protection products which contain glyphosate do not exhibit any genotoxic properties (see question 13).
- A requirement that the Member States, in the context of the national authorisation procedure, must pay particular attention to the effects on terrestrial vertebrates (see question 10).
Upon discussing the proposal, the Commission observed that there was inadequate support on the part of the Member States. As such, the Commission abandoned the proposal.
Since the current approval of glyphosate would expire on 30 June 2016, the Commission made a proposal to extend this by a maximum of 1.5 years. Thanks to this extension, it will become clear at the moment the decision regarding the renewal of the approval needs to be taken (end 2017) what the ECHA proposal will look like, regarding the classification of glyphosate as carcinogenic or not (see question 6 and question 18). The Commission has adopted this proposal for extension (as Implementing Regulation (EU) 2016/1056, published in the Official Journal of the EU on 30 June 2016). As such, the current approval was therefore extended in good time, and the decision to renew the approval was postponed.
Secondly, the Commission presented a proposal to Member States to adapt the current authorisation conditions of glyphosate. This contains the following elements:
- A ban on the co-formulant POE-tallowamine in plant protection products based on glyphosate.
- The Member States are reminded, when authorising plant protection products which contain glyphosate, to pay particular attention to the risks arising from the use in areas frequented by the general public or by vulnerable groups, such as parks, public gardens, sports and recreation areas, school areas and play areas, and areas in the vicinity of care institutions.
- The Member States must also pay special attention to pre-harvest applications of glyphosate and ensure that these applications do not conflict with good agricultural practices; in an accompanying report, the Commission specifies that applications to facilitate harvests are targeted, and not its use as weedkiller.
This proposal obtained sufficient support from the Member States. Belgium also supported this proposal. It was adopted by the Commission on 1 August 2016, and published in the Official Journal of the EU on 2 August 2016 as Implementing Regulation (EU) 2016/1313.
Now that the ECHA has published its assessment (see question 18), the European Commission has drafted a proposal for the renewal of glyphosate for a period of 10 years. Due to insufficient support for this proposal, the Commission presented a modified proposal with an approval period of only 5 years (from 16 December 2017 until 15 December 2022). This proposal has received sufficient support from the Member States. It has been adopted by the Commission and published as Implementing Regulation (EU) 2017/2324 on 15 December 2017.
17.Can the EU approval of glyphosate be renewed?
The approval of glyphosate was renewed for a period of 5 years, i.e. until 15 December 2022 (see question 16). This does not mean that the approval expires definitively on that date: after all, an approval can be renewed again if it is shown that the conditions for approval are still met. The procedure to that end is laid down in Regulation (EU) No 844/2012 laying down the necessary provisions to implement the renewal procedure for active substances provided for in Regulation (EC) No 1107/2009. The provisions of this regulation require the producer of an active substance to apply for its renewal at least three years before the expiry date of the approval. Thus, for glyphosate, this application was made on 15 December 2019. The application can be consulted in EFSA's Register of Questions (go to 'Pesticides Dossier' and select 'glyphosate' in the 'List of available Substances'). In this application, the producer has to indicate which studies he intends to submit. If the application is found admissible, the producer must submit the dossier at the latest 30 months before the expiry date of the approval. In the case of glyphosate, this deadline would therefore be 15 June 2020 at the latest.
Originally, Regulation (EU) No 844/2012 required for each active substance one Member State to be designated as rapporteur and one Member State to be designated as co-rapporteur. However, in the case of glyphosate, the European Commission considered it appropriate to appoint a group of Member States as rapporteur. This allows for a sharing of the expected significant workload and an increased exchange of expertise during the preparation of the assessment report. Regulation (EU) 2019/724 amended Regulation (EU) No 844/2012 to allow for the designation of a group of rapporteurs and appointed France, Hungary, the Netherlands and Sweden as a group of rapporteurs for glyphosate.
18.At what stage is the assessment of the carcinogenic properties of glyphosate by the ECHA?
In the EU, chemical substances are classified based on their intrinsic properties, pursuant to Regulation (EC) No 1272/2008 concerning the classification, labelling and packaging of substances and mixtures. It is the European Commission which establishes the classification, but this occurs on the basis of an opinion from the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA).
On Germany's initiative, the procedure to review the existing classification of glyphosate (not classified as carcinogenic) has been initiated. Germany has produced a so-called CLH report and submitted it to the RAC. The RAC has now started to formulate its opinion. On 15 March 2017, the ECHA communicated via a press release that the RAC had decided that there was no reason to modify the current classification of glyphosate. In other words, the RAC has confirmed that, based on the available scientific data, there is no reason to classify glyphosate as carcinogenic.
Following an editorial audit (as is the case for all opinions of the RAC) the ECHA published the opinion on 15 June 2017.
As is the case for the EFSA, transparency and independence are key elements for the ECHA. The curricula vitae and the declarations regarding interests of all members of the RAC are published by the ECHA. The Rules of Procedure of the RAC encompass all the necessary elements to ensure independent and transparent functioning.
19.What have the Belgian authorities been doing?
For the Belgian authorities, the IARC classification was not a trigger to take steps with regards to authorisations for plant protection products containing glyphosate, for the following reasons:
- The classification of the IARC does not correspond with previous classifications, nor with those proposed in the context of the application to renew the EU approval.
- There is no legal basis to simply apply the conclusions of the IARC.
- The detailed German assessment report, which does not propose classification as carcinogenic, is based on a larger number of studies than the IARC assessment and is therefore more comprehensive.
- The European Commission mandated the EFSA to assess the IARC report, along with the German report; the EFSA concluded that there is currently no sufficient reason to classify glyphosate as carcinogenic.
- A decision regarding the renewal of the EU approval must be taken at the EU level. As a dutiful Member State, Belgium does not intend to take any unilateral decisions which go against the principles of a harmonised EU approach with regards to plant protection products.
Naturally, Belgium took account of the modified approval conditions for glyphosate (see question 16). In the first instance, this entails the revocation of all authorisations for plant protection products based on glyphosate which contain POE-tallowamine as a co-formulant. The following periods apply:
- Placing these products on the market and storing them by the authorisation holder was authorised until 22/08/2016.
- The stocks present on the market may be sold and stored by third parties until 22/02/2017.
- Use is still authorised until 22/02/2018.
Next, the Belgian Approval Committee for pesticides for agricultural use examined whether measures should be taken to limit the risks arising from the use in areas frequented by the general public or by vulnerable groups. The Committee established that the accidental exposure of vulnerable groups to plant protection products based on glyphosate is acceptable in accordance with the theoretical calculation models if these products are applied in accordance with the conditions in the authorisation certificate.
The Committee also assessed whether the authorised applications are actually in accordance with good agricultural practices. The pre-harvest applications authorised in Belgium are only approved only for controlling weeds, and therefore do not relate to use to facilitate harvests as targeted by the Commission. The Committee has nonetheless observed that when these applications were authorised in the past, the range of available herbicides against weeds was significantly smaller than today. Good agricultural practices have evolved and the herbicides authorised to control weeds in sowed crops are now sufficiently varied. A glyphosate treatment is more suitable after the harvest, against the regrowth of stubble and developing weeds, which is not a treatment on a crop, but between 2 crops. That is why the Committee decided to revoke authorisations for pre-harvest applications. This decision concerns the following crops:
- field peas (dry harvest)
- field beans (field beans, pigeon peas, garden beans, etc.) (dry harvest)
- summer/winter wheat
- summer/winter barley
- summer/winter rye
- summer/winter oats
The renewal of the EU-approval of glyphosate from 16 December 2017 (see question 16) will lead to the revision of all authorisations for national plant protection product that contain this active substance. Authorisation holders will have to submit a new application within 3 months after the renewal demonstrating that their product still meets the authorisation criteria, taken into account:
- the new data requirements from 2013 (Regulation (EU) nr. 284/2013);
- the conditions included in the Regulation for the renewal of glyphosate.
The Member States need to decide on the prolongation of the national authorisations by 15 December 2018.
20.Have other EU Member States already taken restrictive measures with regards to glyphosate?
All Member States must implement the approved conditions for glyphosate (see question 16). No strict timing or methodology is imposed in this respect, which means that this can be applied differently in each Member State.
Reports which appeared in the press before the European modification of the authorisation conditions, that countries such as France and the Netherlands had banned the sale of glyphosate-containing products to amateurs, were incorrect. In France, a horizontal measure was taken which will enter into force on 1 January 2019, and whereby the sale of plant protection products to amateurs will be restricted to products which can be used in organic production methods, products which meet the definition of 'low-risk plant protection product' and 'organic means of control'. Naturally, this measure will also have an impact on the products which contain glyphosate, but in no way is it a measure which specifically targets these products. It is also a general measure in the Netherlands, namely regarding the use of herbicides on paved areas and therefore not a measure which specifically applies to products based on glyphosate.