Commentaires de L'autorité Européenne de Sécurité Des Aliments (EFSA)

Intitulé de la section
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commentée
1.04 Data on application I support the proposed assessment: glyphosate is essential to a modern agriculture and greatly
Robert Durand
and efficacy contributes to saving energy and CO2 emissions
2.05 Long-term toxicity and
I support the proposed assessment as it it based on a solid scientific basis. Robert Durand
carcinogenicity
if your studies show that glyphosate is not a carcinogen, can you explain why the courts are in
1.07 Other comments catherine rosier
favour of complainants who suffers of cancer disease???!
Vol. 3, B.6.5.1. Long-term toxicity – rat, study 1, H. Heamatology, page 10
Is the significant increase in monocytes observed in the same males as in the males in which you
found a significant increase in haematocrit. If so, should you not reconsider incidentality?
Also, are we correct to assume that you haven’t assessed transgenerational toxicity?
Vol. 3, B.6.5.1. Long-term toxicity – rat, study 1, H. Heamatology, Clinical chemistry, page 11
Does stating that toxicological significance is questionable means you are not sure there is
toxicological significance but you also don’t know whether there isn’t? https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v0
carcinogenicity
Vol. 3, B.6.5.1. Long-term toxicity – rat, study 1, Heamatology, Necropsy, page 12
(Foucault, A., Vallet, N., Ravalet, N. et al. Occupational pesticide exposure increases risk of acute
myeloid leukemia: a meta-analysis of case–control studies including 3,955 cases and 9,948
controls. Sci Rep 11, 2007 (2021). https://doi.org/10.1038/s41598-021-81604-x)
If there only is the slightest possibility of myeoloid hypoplasia because of exposure to glyphosate
would that in itself not be enough to follow the precautionary principle? Especially since we are
talking about diseases progressing slowly?
Vol. 3, B.6.6.8.2.18. Public literature – Glyphosate based herbicide exposure affect gut microbiota,
anxiety and depression-like behaviour in mice page 420
You state: Relevance cannot be determined: Potential effects on gut microbes are not part of the
EU risk
assessments.
Q: Are you aware that relatively recent scientific research indicates that gut dysbiosis may be a
precursor to chronic inflammation and neuroinflammation, leading to neurodegenerative diseases
such as Parkinson's disease, among others (e.g. Santos, S. F., de Oliveira, H. L., Yamada, E. S.,
Neves, B. C., & Pereira, A., Jr (2019). The Gut and Parkinson’s Disease-A Bidirectional Pathway.
Frontiers in neurology, 10, 574. https://doi.org/10.3389/fneur.2019.00574)?
Disruption of the gut microbiota is one of those indications of neuroinflammation.

1.(Motta, E. V. S., Raymann, K., & Moran, N. A. (2018). Glyphosate perturbs the gut microbiota of
2.06 Reproductive toxicity honey bees. Proceedings of the National Academy of Sciences, 201803880. https://doi.org/10. https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
1073/pnas.1803880115)
2.(Mao, Q., Manservisi, F., Panzacchi, S. et al. The Ramazzini Institute. Environ Health 17, 50
(2018). https://doi.org/10.1186/s12940-018-0394-x).
3.(Shesheta, A.A., Schrödl, W., Aldin, A.A., Hafez, H.M., Krüger, M.(2012). The effect of glyphosate
on potential pathogens and beneficial members of poultry microbiota in vitro. Curr Microbiol 66:
350-358. https://doi.org/10.1007/s00284-012-0277-2
4.(Aitbali, Y., Ba-M’hamed, S., Elhidar, N., Nafis, A., Soraa, N., & Bennis, M. (2018). Glyphosate
based- herbicide exposure affects gut microbiota, anxiety and depression-like behaviors in mice.
Neurotoxicology and Teratology, 67, 44–49. https://doi.org/10.1016/j.ntt.2018.04.002), the study
you have excluded).
Q: Does the AGG reconsider scientific findings on how certain chronic diseases develop in their
assessments and – therefore - reconsider peer-reviewed literature on gut dysbiosis such as
abovementioned?
Vol. 3, B.6.7 – 6.10 (AS) – Non relevant articles, entry 1414, page 849
You consider the following article not to be relevant: Kubsad, D. et al. Assessment of Glyphosate
Induced Epigenetic Transgenerational Inheritance of Pathologies and Sperm Epimutations:
Generational Toxicology. Scientific Reports, volume 9, Article number: 6372 (2019). https://doi.
org/10.1038/s41598-019-42860-0)
Our questions:
Wouldn’t you agree that if any route of administration leads to transgenerational effects, this should
be taken very seriously, especially since the Principle of transgenerational equity is at stake?
Also, we argue that the IP route is valid. The authors used IP injection of doses lower than what you
would expect to have effects, so below the lowest adverse effect dose, and they got major effects.
Please reconsider adding this study and also Millissia 2021:
Millissia Ben Maamar, Daniel Beck, Eric E. Nilsson, Deepika Kubsad & Michael K. Skinner (2021)
Epigenome-wide association study for glyphosate induced transgenerational sperm DNA
2.07 Neurotoxicity https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
methylation and histone retention epigenetic biomarkers for disease, Epigenetics, 16:10, 1150-167,
DOI: 10.1080/15592294.2020.1853319
Vol. 3, B.6.7 – 6.10 (AS) – Non relevant articles, entry 1460 page 854
Questions:
How is the effect of mixtures with glyphosate on long term toxicity determined?
In real life, not only formulations are used but also mixtures with other pesticides. Would you not
agree that any knowledge about combined exposure – closer to real life – should therefore be
considered? Especially for long term toxicity and developing chronic and neurodegenerative
diseases such as Parkinson’s? (PD)
Can you please answer the question how disregarding literature with formulations with Roundup
protects our human rights and public health?
Vol. 3, B.9 (AS) B.9.2.5. Long-term and chronic toxicity to aquatic invertebrate page 246 and
onwards
1)Unacceptable impacts on biodiversity

The AGG says: Active substances can only be approved if, among others, plant protection products
containing them have no unacceptable impacts on biodiversity and the ecosystem (Article 4(3)(e)
(iii) of Regulation 1107/2009.)
Then the AGG writes: Glyphosate is “Toxic to aquatic life with long lasting effects”. Despite the two
statements above, the AGG states that glyphosate meets the approval criteria. Can the AGG
explain to its citizens in understandable language why 'a substance toxic to aquatic organisms with
long lasting effects' apparently has no unacceptable effects on biodiversity and the ecosystem?
5.02 Aquatic organisms https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
2)Lack of instruments to determine biodiversity
The AGG says: There is currently no validated tool nor a harmonized methodology for evaluating
biodiversity in the context of approval of active substances.
a)Is it true that the AGG has not provided a method for predicting the impact of biodiversity and
leaves the assessment to the individual Member States?
b)Is it true that, even though no prediction can be made, the AGG still recommends that the product
be re-authorized?
c)How can it be right that The AGG says 'glyphosate meets the approval criteria' if the AGG has not
been able to find this out due to the lack of a method for this, which has also not been supplied by a
party with an interest in 'not knowing'? Isn't it much more logical to err on the side of caution and
protect citizens? Why does the precautionary principle not apply in this context? If there is no
clarity, this does not mean that a drug is safe.
Vol. 3, B.9.(AS) B.9.9 Monitoring Data and other comments. Page 600
Reflections
Glyphosate is the most common broad-spectrum herbicide. It targets the key enzyme of the
shikimate pathway, 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS), which synthesises
three essential aromatic amino acids (phenylalanine, tyrosine and tryptophan) in plants. Because
the shikimate pathway is also found in many prokaryotes and fungi, the widespread use of
glyphosate may have unsuspected consequences for the diversity and composition of microbial
communities, including the human gut microbiome (Leino, 2021). This makes it clear that
glyphosate also affects non-target species such as even ourselves.
According to the AGG itself, it is (re)established that glyphosate is 'toxic to aquatic organisms with
long lasting effects'. It is these kinds of long-term effects that make the price of today's convenience
paid by others than those who benefit from it. Considering that neurodegenerative diseases only
5.09 Other comments incl.
show their full extent when much harm has already been done - and on a longer timescale than a https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
available monitoring data
five year renewal process - the omens - such as disturbances in the gut microbiota - are extremely
relevant to consider.
The Dutch Parkinson’s Foundation wants to prevent people from contracting a neurodegenerative
disease such as Parkinson’s from preventable causes such as chronic, sub exposure to (mixtures
of) pesticides. The question that needs to be answered before approval to glyphosate can be
extended is:
- Does glyphosate (or formulations thereof) affect the composition of intestinal bacteria towards a
more pro-inflammatory composition?
- Does glyphosate have a harmful effect on neurons (not only dopamine neurons, but also GABA
neurons etc. See also the EFSA report)
The literature presented in this response already shows that reasonable doubt is all around us.
Vol 3 B-3.1 Alain DELAGE, ingeneer et agriculturel advisor for 32 years. I represent the CETA de
Champagne Berrichonne, a technical agricultural study center which bring together more than 100
farmers who farm nearly 25000 hectares and are advised by 3 ingeneers or technicians.
My comment comes from the fielkd work we have doing on glyphosate for a few years, with other
1.04 Data on application
advisory structures in the Centre Val de Loire region. https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
and efficacy
The summary of this report is a bit short to comment on. In the other hand, we have worked on the
subject in the Centre Val de Loire region, setting up several field trials in which the glyphosate
solution was compared to alternative solutions involving tillage. The conclusions of these trials
clearly show the interest of glyphosate and the limits and short comings of alternative solutions.
Volume 3 – B.6.5 (AS) and Volume 3 – B.6.7 - B.6.10 (AS) page 433.
RMS: “Since investigation of the gut microbiota is currently not part of the European assessment
framework for pesticides, it is hard to assess the relevance of the findings”
Only few papers were cited on changes in the microbiomes after glyphosate addition. Microbiome
effects may actually be more important than potential direct toxic effects. It is an omission to ignore
effects on the microbiome, even though the relation between the gut microbiome and human/animal
health has been established
(https://www.frontiersin.org/articles/10.3389/fenvs.2021.763917/abstract):
“In the Ramazzini study with rats mentioned above (Mao et al., 2018), significant changes were
found in the bacterial composition in feces of young pups from mothers that had been exposed to
glyphosate or Roundup at the US Acceptable Daily Intake dose (1.75 mg/kg bw/day). Relative
2.06 Reproductive toxicity abundances of Bacteroidetes were increased while the Firmicutes were reduced by the glyphosate
treatments (Mao et al., 2018). The glyphosate concentrations in the urine increased with age,
suggesting accumulation, and were similar for pure glyphosate and Roundup (Panzacchi et al.,
2018). There were significant endocrine effects in female rats, which had higher testosterone levels
and delayed first estrous (Manservisi et al., 2019). In male rats, there were also significant
endocrine effects of glyphosate exposure at low concentrations (1 mg/L), but in this case,
testosterone levels were decreased by 35% (Clair et al., 2012a). In a human birth cohort study in
the midwestern USA, more than 90% of pregnant women had detectable glyphosate levels in their
urine (0.5–7.20 ng/mL), which correlated significantly with shortened pregnancy lengths but not with
fetal growth indicators (Parvez et al., 2018). Similarly, glyphosate and AMPA concentrations in the
urine of pregnant women were significantly correlated with pre-term births in Puerto Rico (Silver et
al., 2021)"
Volume 3, B.8.6.2, page 79. Predicted environmental concentrations from airborne transport.
“Due to the low volatilization potential and the fast degradation of glyphosate in air, glyphosate is
not expected to be subject of atmospheric long-range transport. Therefore calculations of
concentrations from airborne transport are not required and were not performed”
4.07 PEC from airborne
Long-range movement is especially important in agricultural production when dust particles with
transport and other routes
glyphosate are produced, for example during plowing fields, and then transported with the wind.
of exposure
(Chang et al., 2011; da Silva et al., 2021; Ramirez Haberkorn et al., 2020; Silva et al., 2018). For
example, high glyphosate concentrations were found in forest soil around no-till areas in Brazil (da
Silva et al., 2021). In addition, manure often contains glyphosate (Muola et al., 2021), which can
spread in the atmosphere when manure is used as fertilizer on agricultural land.
Citing from our paper-in-press (https://www.frontiersin.org/articles/10.3389/fenvs.2021.763917
/abstract)
“Under the auspices of the Food and Agriculture Organization of the United Nations (FAO),
residues of glyphosate and AMPA in plant products were determined in standard experiments
taking good agricultural practices (GAP) into account (FAO, 2005). These practices are focused on
strict recommendations about GBH use (FAO, 2005). Updated MRL values were suggested from
the highest residues obtained in trials that were carried out according to GAP requirements. When
trial practices did not match GAP requirements the obtained results were omitted. No trials were
conducted in Argentina where application rates and residues are exceptionally high (Cuhra, 2015).
The MRLs of glyphosate plus AMPA in farm products vary widely (Table S1), depending on
3.05 Residue trials in
commodity and regulatory agency, ranging from 0.05 mg/kg for most animal products (except for
plants and identification of
meat byproducts), 0.1 – 40 mg/kg in many plant products for human consumption, and up to 530
critical GAP
mg/kg in grass and fodder (Codex Alimentarius, 2013; Cuhra, 2015; EC, 2020; EPA, 2020). The
MRLs in animal feeds have been adjusted upwards over time when the original levels were
exceeded too frequently and lower levels did not seem practical (Benbrook, 2016). The MRLs for
most food and feed categories have been further increased (EC, 2020; EPA, 2020) since our
previous glyphosate review published in 2018 (van Bruggen et al., 2018).”
As far as I could see, van Bruggen et al. (2018) was not cited (https://pubmed.ncbi.nlm.nih.
gov/29117584/).
Raising the MRLs as environmental and plant residues increase, is not acceptable from a risk
analysis point of view
.
Please see Straw, Carpentier and Brown 2021. Finding that there are pertinent toxicity differences
among glyphosate-based herbicide formulations. Evidence that the representative formulation
approach to regulating glyphosate is inappropriate. Evidence suggests significant contact toxicity at
high exposure rates of surfactant co-formulants, which are not risk assessed at all by EFSA for
bees. The exposure scenario is not designed to be field-realistic, but given herbicides are applied
directly to flowering weeds, high contact exposure of pollinators is to be expected.
Compiles UK glyphosate formulations, finding 284 different formulations. Hard to imagine a single
representative formulation accurately portraying the hazard all these products possess.
OECD 214 is inappropriate to use as a measure of contact toxicity owing to the incredibly low
5.03 Bees and non-target exposure dose (2µL). Potter spray tower application would much more realistically mimick exposure
Edward Straw
arthropods for substances where product can be applied to flowering weeds/crops.
No evidence that glyphosate itself is detrimental to bees.
https://doi.org/10.1111/1365-2664.13867
https://besjournals.onlinelibrary.wiley.com/doi/10.1111/1365-2664.13867
Please see Straw 2021. Comprehensive rebuttal to Battisti et al. 2021 meta-analytical finding that
glyphosate causes lethality in bees.
https://doi.org/10.1016/j.scitotenv.2021.147556
https://www.sciencedirect.com/science/article/pii/S0048969721026279?via%3Dihub
Hello
I am a fruit producer and moderate user of glyphosate, which today is not classified as a proven
carcinogen unlike many other products like Diesel!
“Vol. 3, B.3.1, pages 6 to 9, Use of the active
substance: The use of this weedkiller is vital for the economic viability of my farm, the other Yvan GARIN
and efficacy
solutions being very time consuming and costly (carcinogenic fuel) and much less efficient. In the
necessary fight against global warming, and therefore against CO2 emissions, this weedkiller is
essential. 1 liter of glyphosate saves 50 liters of diesel necessary for mechanical weeding at the
foot of the trees, not to mention the cost of our fruits which would be even more expensive!
Vol.3, B.3.1 pages 6 to 9. Alain DELAGE, engineer and agricultural advisor for 32 years. I represent
the CETA de FRANCE association which brings together nearly 2700 farmers structures into CETA
groups representing 500 000 hectares of field crops in more than 20 french departments.
My comments are based on the expertise of the hundred or so engineers and technicians working
1.04 Data on application in these CETA structures.
https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
and efficacy The summary of this report is a bit short to comment on. On the other hand, our expertise in the
fields allows us to provide elements of interest. These elements are presented in the document
attached to this commentary. They highlight the impossibility of doing without glyphosate in many
situations, a withdrawal leading to the bankruptcy of farms that have become dependent on this
solution.
Präsident der
Seniorexperten
We herewith declare our consent to “5) Main findings” in the AGG-Document: “Procedure and Chemie der
1.01 Identity outcome of the draft Renewal Assessment Report on glyphosate, June 2021” with the Klaus-Peter Jaeckel Gesellschaft
understanding of Glyphosate as defined in Vol.1; 1.3 Identity Of The Active Substance. Deutscher
Chemiker,
Frankfurt/Main
2.3.4 Summary of observations on other undesirable or unintended side-effects
“There were no reported observations on other undesirable or unintended side-effects.”
A maximum of 900 g of glyphosate per ha may be used for the control of weeds. If 200 litres per ha
is sprayed, the glyphosate concentration is 4.5 mg/ml of liquid. It has long been known that
glyphosate is deadly not only to plants but also to many microorganisms sensitive to 0.15 mg/ml
and more. The natural composition of the microbiome can therefore be impaired by exposure to the
glyphosate concentrations used.
A recent review (https://www.frontiersin.org/articles/10.3389/fenvs.2021.763917/full) presents a
long list of minimum inhibitory concentrations (MICs) for bacteria (in the supplement). Until recently,
there was scientific 'bickering' about these numbers. Very low MIC values (such as 0.15 mg/ml)
2.13 Other comments,
would be due to aerobic incubation conditions. However, the authors of the review found that large Ariena van Bruggen https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
proposals for classification
differences in MIC values were due to the method of measuring bacteria concentrations rather than
the presence or absence of oxygen. Through this discovery, it is clear that the low glyphosate
concentrations that were identified as harmful to many beneficial bacteria were correct. It is now
also clear that many disease-causing bacteria can withstand higher concentrations of glyphosate
than beneficial bacteria (summarized in Table 1 of the review). Recent DNA research has shown
that up to 26% of the bacteria in the human intestines are sensitive to low glyphosate levels. Thus,
the microbiome composition can shift towards more pathogenic microorganisms.
This review shows unequivocally that there is a connection between glyphosate exposure, the
microbiomes of plants and animals, and the sensitivity to various pathogens, resulting in enhanced
disease development. Glyphosate effects on microbiomes should be taken into account when
taking a decision about re-authorization of glyphosate sale and use in the EU.
This comment does not concern a particular macro-organism, but any organism with its associated
microbioom.
It is based on a recent review on effects of glyphosate on plant- and animal-associated
microbiomes and the consequences for plant and animal health: https://www.frontiersin.
org/articles/10.3389/fenvs.2021.763917/full
Until recently, effects of relatively low residue levels on microbiomes in soil, on and in plants and in
animals did not seem unambiguous in the scientific literature. Some researchers found 'no effect',
while others clearly found negative effects on certain microorganisms. The authors of a recent
review paper (in the peer-reviewed journal Frontiers in Environmental Science) realized that the
5.09 Other comments incl. results of such studies depended on how detailed the microbial DNA data were analyzed.
Ariena van Bruggen
available monitoring data When only higher biological groups such as Orders, Classes and Families or biomass and diversity
were studied, the researchers usually found no glyphosate effects. More detailed analyses at the
level of genera and species or of specific processes did result in effects of regular glyphosate
concentrations on the microbiome. For example, nitrogen fixation by bacteria in legumes was
impaired. Also, the development of the immune system was negatively affected in bees that
became more susceptible to a parasite and a viral disease after challenge inoculations with these
pathogens.
“No-effects” scientific papers that analyzed potential effects on higher integration levels only are
now outdated and should not be viewed as panacea. More detailed analysis of deep-sequencing
data are currently the up-to-date standard and should be taken into account when judging potential
effects of glyphosate on the microbiome.
Vol. 3, B.3.5. p.16 - Seed production uses are part of minor uses of glyphosate. In seed production,
glyphosate can be used to control invasive, difficult, and harmful weeds within the crop
environment, when no other alternative is available, to avoid weed seed pollution in seed lots, as
some cannot be sorted, and it inevitably leads to weed spreading. In this context, the use of
glyphosate is necessary to maintain quality standards of seed production in Europe and to avoid
weed spreading across countries. Due to the diversity of species and situations, seed production
uses of glyphosate cannot be based on derogations, as it means for the authorities to deal with
1.04 Data on application multiple derogation dossiers. Plus, it still concerns only minor acreages.
and efficacy To provide examples, in alfalfas seed production, glyphosate can be sprayed on the whole field
surface using a low dose rate during the winter period to get free of non-frost sensitive perennial
damageable weeds. Then, the crop can grow in spring with no damage. There is no affordable
alternative identified in the situations of use in alfalfas seed crops. Glyphosate is also the only
reliable solution against Orobanche sp. issues – very occasional, but also very damageable issues
if untreated. In this situation, the substance is used at a low dose rate to control it, but it concerns
only few seed crop species - red clover and carrot seed crop - then only few plots among the total
surfaces of these minor crops of each year.
It is of little use to just scrutinize just the physical and chemical properties of pure Glyphosate
1.02 Physical and without taking into account the properties of the active substances of the ADDITIVES (adjuvant)
chemical properties of the which the herbicide producing industry adds to Glyphosate before it is used on the fields where our Sabine Ohm
active substance food is grown, on playgrounds and all sorts of other public spaces etc. Only with these adjuvants
can Glyphosate actually PENETRATE the plants and kill them.
The goal in this case cannot justify the means, as public health is put at risk. No matter how efficient
glyphosate would be in the eyes of a farmer who is just looking at his own benefit, with public health Sabine Ohm
and efficacy
at stake productivity is not the right criterion.
The original studies used by Monsanto and the FDA to legalize the use of glyphosate should be
closely revised including genuinely independent scientists. By spraying just pure Glyphosate
1.06 Methods of analysis without adjuvants on soy in a greenhouse and then using the harvested crop for only nine Sabine Ohm
generations on mice, the real effects of the commercially used herbicides containing Glyphosate
were never examined for all their toxic effects!
See above comments on the fallacy of studying Glyphosate without the adjurvants. These additives
2.01 Absorption,
help Glyphosate not only to penetrate and kill plants, but also allow it to penetrate our human cells
distribution, metabolism Sabine Ohm
and tissues, destroying our defenses and making way for the damage then provoked by all kinds of
and excretion in mammals
toxins on/in our food and water supplies, not only Glyphosate in itself..
All drinking water suppliers in the EU should be obliged to measure Glyphosate contamination in
4.06 PEC in surface water
their supplies and publish them. The contamination and public health risks will remain a hazard for Sabine Ohm
and ground water
decades due to the enormous contamination already present in soils and aquifers.
Séralini´s study in 2012 is a good lead on the kind of reproductive and other toxicity commercially
used Glyphosate-herbicides hold; instead of just dismissing it the study should be repeated NOT
2.06 Reproductive toxicity BY INDUSTRY / secretly funded scientists, but by genuinely independent scientists (hard to find Sabine Ohm
these days with the university system thouroughly corrupted through dependance on financial
means from the farmaceutical and chemical industries...).
I don't understand how anyone can question glyphosate on its danger. Enormous sums of money
are at stake in trying to find toxicity. Since there is none, or a very small one, and provided you "put
2.01 Absorption, glyphosate in your bathtub" or swallow it as an appetizer (although with its acidity it will quickly
distribution, metabolism attack your stomach) it is very expensive to prove what does not exist. This glyphosate is just a Dutet Fabrice
and excretion in mammals flagship product of the activists sponsored by the organic marketers. These are the same activists
who prefer to say no to nuclear power and consume polluting fossil fuels to replace wind turbines
when there is no wind.
The official analyses carried out by the basin organisations during the years 2015-2019 confirm the
high presence of glyphosate in our rivers and groundwater, as well as the continued presence in the
Ecologistas en
4.06 PEC in surface water aquatic environment of the most widely sold herbicide (glyphosate) in Spain. Hernández
Luis Ángel Acción https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultat
https://open.efsa.europa.eu/api/calendar/getConsultationCommentF
and ground water Lozano
(Spaien)
The attached report analyses the presence of glyphosate in the river basin districts that have
analysed this pollutant during the period 2015-2019.
Glyphosate
The active substance is very important in several work operations. Both before planting and during
the autumn, the active ingredient is important.
4.09 Other comments incl. It may be justifiable to take a closer look at the dosage of various weeds, but be aware that many
Lars Arne Høgetveit
available monitoring data countries have done a good job with low-drift nozzles, edge zones, etc.
The conclusion is that the active ingredient is important for maintaining food production in the time
ahead, at a time we see is already turbulent and we do not need a fall in more input factors that
drag food production down.
Higher estimated pesticide exposures linked to ALS risk
Quote: “A recent study sheds light on a potential contributor to the disease: pesticide exposure.
Pesticides linked to the disease include 2,4-D, glyphosate, carbaryl, and chlorpyrifos. 2,4-D and
glyphosate are used on herbicide-tolerant GM crops.”
Higher estimated pesticide exposures linked to ALS risk - EHN
Pesticides applied to crops and amyotrophic lateral sclerosis risk in the U.S
NeuroToxicology
Volume 87, December 2021, Pages 128-135
The European
2.08 Further toxicological lAngelineAndrewa et All
Miep Bos GMO-free
studies Received 21 May 2021, Revised 20 September 2021, Accepted 20 September 2021, Available
Citizens
online 22 September 2021.
Edited by Dr. P Lein and Dr. R Westerink
“Results
Pesticides with the largest positive statistically significant associations in both the discovery and the
validation studies and evidence of neurotoxicity in the literature were the herbicides 2,4-D (OR 1.25
95 % CI 1.17–1.34) and glyphosate (OR 1.29 95 %CI 1.19–1.39), and…” MORE: https://doi.org/10.
1016/j.neuro.2021.09.004 Pesticides applied to crops and amyotrophic lateral sclerosis risk in the
U.S - ScienceDirect
The European
2.13 Other comments, We, The European GMO-free Citizens want a total ban on glyphosate. See: https://www.
Miep Bos GMO-free
proposals for classification gentechvrij.nl/dossiers/glyfosaat-2/glyfosaat/
Citizens
In May 2019, the chemicals agencies of France, the Netherlands, Sweden and Hungary received a
mandate from the European Commission to conduct a joint scientific assessment of glyphosate.
This is necessary because the approval of glyphosate ends on December 15, 2022. At the request
of eight companies, the European Union must assess whether glyphosate may continue to be used.
The chemicals agencies ANSES (France), Ctgb (the Netherlands), Kemi (Sweden) and Nebih
(Hungary) conclude that glyphosate is:
-not carcinogenic,
-harmless to the genome,
-not toxic to reproduction,
-not harmful to organs and
-not dangerous for the hormonal balance.
Overall, France, the Netherlands, Sweden and Hungary conclude that the use of glyphosate
remains safe.
Marion Metzger
proposals for classification Die Pflanzenschutzbehörden von Frankreich, den Niederlanden, Schweden und Ungarn haben von
der Europäische Kommission im Mai 2019 den Auftrag erhalten, Glyphosat gemeinsam
wissenschaftlich zu bewerten. Dies ist notwendig, da die Zulassung von Glyphosat am 15.
Dezember 2022 endet. Auf Antrag von acht Unternehmen muss die Europäische Union prüfen, ob
Glyphosat weiterhin angewendet werden darf.
Die Behörden ANSES (Frankreich), Ctgb (die Niederlande), Kemi (Sweden) und Nebih (Ungarn)
kommen zu dem Ergebnsi, dass Glyphosat:
-nicht krebserregend,
-unschädlich für das Erbgut,
-nicht reproduktionstoxisch,
-nicht organschädigend und
-für den Hormonhaushalt nicht gefährlich
ist. Insgesamt kommen Frankreich, die Niederlande, Schweden und Ungarn zu dem Ergebnis, dass
die Anwendung von Glyphosat weiterhin sicher ist.
In May 2019, the chemicals agencies of France, the Netherlands, Sweden and Hungary received a
mandate from the European Commission to conduct a joint scientific assessment of glyphosate.
This is necessary because the approval of glyphosate ends on December 15, 2022. At the request
of eight companies, the European Union must assess whether glyphosate may continue to be used.
The chemicals agencies ANSES (France), Ctgb (the Netherlands), Kemi (Sweden) and Nebih
(Hungary) conclude that glyphosate is:
-not carcinogenic,
-harmless to the genome,
-not toxic to reproduction,
-not harmful to organs and
-not dangerous for the hormonal balance.
Overall, France, the Netherlands, Sweden and Hungary conclude that the use of glyphosate
remains safe.
Adrian Klose
proposals for classification Die Pflanzenschutzbehörden von Frankreich, den Niederlanden, Schweden und Ungarn haben von
der Europäische Kommission im Mai 2019 den Auftrag erhalten, Glyphosat gemeinsam
wissenschaftlich zu bewerten. Dies ist notwendig, da die Zulassung von Glyphosat am 15.
Dezember 2022 endet. Auf Antrag von acht Unternehmen muss die Europäische Union prüfen, ob
Glyphosat weiterhin angewendet werden darf.
Die Behörden ANSES (Frankreich), Ctgb (die Niederlande), Kemi (Sweden) und Nebih (Ungarn)
kommen zu dem Ergebnsi, dass Glyphosat:
-nicht krebserregend,
-unschädlich für das Erbgut,
-nicht reproduktionstoxisch,
-nicht organschädigend und
-für den Hormonhaushalt nicht gefährlich
ist. Insgesamt kommen Frankreich, die Niederlande, Schweden und Ungarn zu dem Ergebnis, dass
die Anwendung von Glyphosat weiterhin sicher ist.
Vol. 3, B.6.7, pages 6-70 "Neurotoxicity studies in rodents, delayed polyneuropathy studies and
publications on neurotoxicity":
Glyphosate was registered in Argentina by the end of the 70´s under the pesticides legislation in
2.07 Neurotoxicity force. Although no reevaluation was performed locally, Argentina has followed the most recent Federico Mertín Elorza
renewal processes in the US and UE and is aware of other agencies reevaluation (Australia,
Brazil).
CASAFE agrees with the assessments and conclusions achieved.
Vol. 3, B.6.2, pages 112-590 "Acute toxicity studies":
force. Although no reevaluation was performed locally, Argentina has followed the most recent
2.02 Acute toxicity Federico Mertín Elorza
Brazil).
Vol. 3, B.6.3, pages 5-280 "Short-term toxicity, oral 28-day studies, oral 90-day studies and other
routes":
2.03 Short-term toxicity force. Although no reevaluation was performed locally, Argentina has followed the most recent Federico Mertín Elorza
Brazil).
Vol. 3, B.6.4, pages 5-395 "Genotoxicity, in vitro studies, in vivo studies in somatic cells, in vivo
studies in germ cells and information from public literature":
2.04 Genotoxicity force. Although no reevaluation was performed locally, Argentina has followed the most recent Federico Mertín Elorza
Brazil).
Vol. 3, B.6.5, pages 5-360:
2.05 Long-term toxicity and force. Although no reevaluation was performed locally, Argentina has followed the most recent
Federico Mertín Elorza
carcinogenicity renewal processes in the US and UE and is aware of other agencies reevaluation (Australia,
Brazil).
Vol. 3, B.6.6, pages 6-449 "Generational studies, developmental toxicity studies and information
from public literature":
2.06 Reproductive toxicity force. Although no reevaluation was performed locally, Argentina has followed the most recent Federico Mertín Elorza
Brazil).
Vol. 3, B.6.8.3, pages 453-612 "Studies on endocrine disruption":
2.08 Further toxicological force. Although no reevaluation was performed locally, Argentina has followed the most recent
studies renewal processes in the US and UE and is aware of other agencies reevaluation (Australia,
Brazil).
Vol. 3, B.6.8.1, pages 6-321 "Toxicity studies on metabolites and relevant impurities":
2.09 Toxicological data on force. Although no reevaluation was performed locally, Argentina has followed the most recent
metabolites renewal processes in the US and UE and is aware of other agencies reevaluation (Australia,
Brazil).
Vol. 3, B.6.2, pages 112-590 "Acute toxicity studies" : Glyphosate was registered in Argentina by
the end of the 70´s under the pesticides legislation in force. Although no reevaluation was
2.02 Acute toxicity performed locally, Argentina has followed the most recent renewal processes in the US and UE and Nelson Illescas Fundación INAI
is aware of other agencies reevaluation (Australia, Brazil). Fundación INAI Agrees with the
assessments and conclusions achieved.
Vol. 3, B.6.8.1, pages 6-321 "Toxicity studies on metabolites and relevant impurities": Glyphosate
was registered in Argentina by the end of the 70´s under the pesticides legislation in force. Although
2.09 Toxicological data on
no reevaluation was performed locally, Argentina has followed the most recent renewal processes Nelson Illescas Fundación INAI
metabolites
in the US and UE and is aware of other agencies reevaluation (Australia, Brazil). Fundación INAI
Agrees with the assessments and conclusions achieved.
routes": Glyphosate was registered in Argentina by the end of the 70´s under the pesticides
2.03 Short-term toxicity legislation in force. Although no reevaluation was performed locally, Argentina has followed the Nelson Illescas Fundación INAI
most recent renewal processes in the US and UE and is aware of other agencies reevaluation
(Australia, Brazil). Fundación INAI Agrees with the assessments and conclusions achieved.
studies in germ cells and information from public literature": Glyphosate was registered in Argentina
by the end of the 70´s under the pesticides legislation in force. Although no reevaluation was
2.04 Genotoxicity Nelson Illescas Fundación INAI
performed locally, Argentina has followed the most recent renewal processes in the US and UE and
is aware of other agencies reevaluation (Australia, Brazil). Fundación INAI Agrees with the
Vol. 3, B.6.5, pages 5-360: Glyphosate was registered in Argentina by the end of the 70´s under the
pesticides legislation in force. Although no reevaluation was performed locally, Argentina has
followed the most recent renewal processes in the US and UE and is aware of other agencies Nelson Illescas Fundación INAI
carcinogenicity
reevaluation (Australia, Brazil). Fundación INAI Agrees with the assessments and conclusions
achieved.
publications on neurotoxicity": Glyphosate was registered in Argentina by the end of the 70´s under
the pesticides legislation in force. Although no reevaluation was performed locally, Argentina has
2.07 Neurotoxicity Nelson Illescas Fundación INAI
followed the most recent renewal processes in the US and UE and is aware of other agencies
achieved.
from public literature": Glyphosate was registered in Argentina by the end of the 70´s under the
2.06 Reproductive toxicity Nelson Illescas Fundación INAI
achieved.
Vol. 3, B.6.8.3, pages 453-612 "Studies on endocrine disruption": Glyphosate was registered in
Argentina by the end of the 70´s under the pesticides legislation in force. Although no reevaluation
2.08 Further toxicological
was performed locally, Argentina has followed the most recent renewal processes in the US and UE Nelson Illescas Fundación INAI
studies
and is aware of other agencies reevaluation (Australia, Brazil). Fundación INAI Agrees with the
Glyphosate is transported via aerial transport or attached to dust particles over long distances as
recently published studies from Germany and France show. Glyphosate is present in 100%
(Germany) and 56% (France) of the samples taken in a 2 large scale monitoring studies.
Glyphosate accumulates in the finest dust particles (Bento et al. 2018) that are directly long
relevant.
The health synergistic health risk caused by the inhalation of dust in combination with the adsorbed
attached Glyphosate/AMPA is not considered in the actual risk assessment procedure. This needs
urgently be considered as the
References:
ANSES/INERIS: Campagne Nationale Exploratoire des Pesticides
4.01 Route and rate of Glyphosate present in 56% of air samples taken across France in a monitoring campaign in 2019.
Violette Geissen https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
degradation in soil https://www.ineris.fr/fr/ineris/actualites/publication-resultats-campagne-exploratoire-nationale-
mesure-residus-pesticides
Kruse-Plass et al. 2020: Pesticide contamination in ambient air
Glyphosate present in 100% of air/dust samples taken across Germany in a monitoring campaign
in 2019.
http://www.umweltinstitut.org/fileadmin/Mediapool/Aktuelles_ab_2016/2020/2020_09_29_Pestizid-
Studie_Enkeltauglich/Englische_Zusammenfassung_Pestizidbelastung_der_Luft.pdf
Bento et al. 2018: https://www.researchgate.

net/publication/310749189_Glyphosate_and_AMPA_distribution_in_wind-
eroded_sediment_derived_from_loess_soil
1.04 Data on application Je suis agriculteur . L'utilisation à des doses faibles du Glyphosate ( 0.5 à 3L/ha) permet d'éviter la
and efficacy consommation de carburant ( 10à 20L/ha) par l'action mécanique des déchaumeurs
"Vol. 3, B.6.2, pages 112-590 ""Acute toxicity studies"": Glyphosate was registered in Argentina by
2.02 Acute toxicity performed locally, Argentina has followed the most recent renewal processes in the US and UE and Juan Perez
is aware of other agencies reevaluation (Australia, Brazil).
Juan Perez agrees with the assessments and conclusions achieved."
"Vol. 3, B.6.3, pages 5-280 ""Short-term toxicity, oral 28-day studies, oral 90-day studies and other
routes"": Glyphosate was registered in Argentina by the end of the 70´s under the pesticides
legislation in force. Although no reevaluation was performed locally, Argentina has followed the
2.03 Short-term toxicity Juan Perez
(Australia, Brazil).
"Vol. 3, B.6.4, pages 5-395 ""Genotoxicity, in vitro studies, in vivo studies in somatic cells, in vivo
studies in germ cells and information from public literature"": Glyphosate was registered in
2.04 Genotoxicity Juan Perez
was performed locally, Argentina has followed the most recent renewal processes in the US and UE
and is aware of other agencies reevaluation (Australia, Brazil).
"Vol. 3, B.6.5, pages 5-360: Glyphosate was registered in Argentina by the end of the 70´s under
followed the most recent renewal processes in the US and UE and is aware of other agencies Juan Perez
carcinogenicity
reevaluation (Australia, Brazil).
"Vol. 3, B.6.6, pages 6-449 ""Generational studies, developmental toxicity studies and information
from public literature"": Glyphosate was registered in Argentina by the end of the 70´s under the
2.06 Reproductive toxicity Juan Perez
"Vol. 3, B.6.7, pages 6-70 ""Neurotoxicity studies in rodents, delayed polyneuropathy studies and
publications on neurotoxicity"": Glyphosate was registered in Argentina by the end of the 70´s under
2.07 Neurotoxicity Juan Perez
"Vol. 3, B.6.8.3, pages 453-612 ""Studies on endocrine disruption"": Glyphosate was registered in
was performed locally, Argentina has followed the most recent renewal processes in the US and UE Juan Perez
studies
"Vol. 3, B.6.8.1, pages 6-321 ""Toxicity studies on metabolites and relevant impurities"": Glyphosate
no reevaluation was performed locally, Argentina has followed the most recent renewal processes Juan Perez
metabolites
in the US and UE and is aware of other agencies reevaluation (Australia, Brazil).
carcinogenicity
studies
metabolites
carcinogenicity
studies
metabolites
Juan Perz agrees with the assessments and conclusions achieved."
1.01 Identity test Goran - test Kumric - test EFSA - test
Impacts on aquatic organisms:
Glyphosate reaches aquatic systems, too. According to the assessment report (page 570/571 -
Summary of surface water monitoring data), the number of detections above LOQ (respectively
~40% and ~64% samples EU-wide for Glyphosate and AMPA) tends to indicate that the active
Bund für
substance and its main metabolite is widely and regularly found in surface water. Aquatic organisms
Umwelt und
are thus exposed to them. The following literature showing negative effects on a range of aquatic
Naturschutz
organisms should be taken into account:
5.02 Aquatic organisms Corinna Hölzel Deutschland e.
-Bonansea et al. 2017, The Fate of Glyphosate and AMPA in a Freshwater Endorheic Basin: An
V. (BUND) -
Ecotoxicological Risk Assessment. Toxics https://www.mdpi.com/2305-6304/6/1/3 .
Friends of the
-Tresnakova et al. 2021, Effects of glyphosate and their metabolite AMPA on aquatic organisms.
Earth Germany
Appl Sci, https://www.mdpi.com/2076-3417/11/19/9004
Also marine organisms can be negatively affected:
-Matozzo et al. (2020) The Effects of Glyphosate and Its Commercial Formulations to Marine
Invertebrates: A Review. J Mar Sci Eng 8:399; https://www.mdpi.com/2077-1312/8/6/399
Bund für
Umwelt und
In view of FoE Germany (BUND), due to the multitude of direct and indirect negative effects on
Naturschutz
5.09 Other comments incl. biodiversity, no further approval of glyphosate must be granted. Some of these negative impacts
Corinna Hölzel Deutschland e. https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
available monitoring data might perhaps partly be managed by complex risk mitigation measures, but in practice they would
V. (BUND) -
not be respected as past experience has shown.
Friends of the
Earth Germany
Vol. 3, B.3.1, pages 6 to 9, Use of the active substance : Sud amandes "In almond trees, many
orchards have their irrigation system installed on the ground (drip). The harvest is mechanical. The
opening of the corolla prevents producers from suspending their irrigation permanently. Mechanical
and efficacy
tillage, as an alternative to the use of glyphosate, is therefore very difficult and expensive to
implement."
2.02 Acute toxicity renewal processes in the US and UE and is aware of other agencies reevaluation (Australia,
Brazil). CIARA agrees with the assessments and conclusions achieved (RAR report Vol. 3, B.6.2,
pages 112-590 "Acute toxicity studies).
2.03 Short-term toxicity renewal processes in the US and UE and is aware of other agencies reevaluation (Australia,
pages 5-280 "Short-term toxicity, oral 28-day studies, oral 90-day studies and other routes).
2.04 Genotoxicity
pages 5-395 "Genotoxicity, in vitro studies, in vivo studies in somatic cells, in vivo studies in germ
cells and information from public literature).
2.07 Neurotoxicity
pages 6-70 "Neurotoxicity studies in rodents, delayed polyneuropathy studies and publications on
neurotoxicity).
studies
Brazil). CIARA agrees with the assessments and conclusions achieved (RAR report Vol. 3, B.6.8.3,
pages 453-612 "Studies on endocrine disruption).
metabolites
Brazil). CIARA agrees with the assessments and conclusions achieved (RAR report Vol. 3, B.6.8.1,
pages 6-321 "Toxicity studies on metabolites and relevant impurities).
carcinogenicity
pages 5-360).
2.06 Reproductive toxicity
pages 6-449 "Generational studies, developmental toxicity studies and information from public
literature).
force. Although no reevaluation was performed locally, Argentina has followed the most recent ACSOJA -
renewal processes in the US and UE and is aware of other agencies reevaluation (Australia, Argentine
2.04 Genotoxicity Luis Zubizarreta
Brazil). ACSOJA agrees with the assessments and conclusions achieved in the Vol. 3, B.6.4, Soybean Chain
pages 5-395 "Genotoxicity, in vitro studies, in vivo studies in somatic cells, in vivo studies in germ Association
cells and information from public literature" (RAR).
ACSOJA -
2.05 Long-term toxicity and Argentine
renewal processes in the US and UE and is aware of other agencies reevaluation (Australia, Luis Zubizarreta
carcinogenicity Soybean Chain
Brazil). ACSOJA agrees with the assessments and conclusions achieved in the Vol. 3, B.6.5,
Association
pages 5-360 (RAR).
2.06 Reproductive toxicity Luis Zubizarreta
pages 6-449 "Generational studies, developmental toxicity studies and information from public Association
literature" (RAR).
2.07 Neurotoxicity Luis Zubizarreta
pages 6-70 "Neurotoxicity studies in rodents, delayed polyneuropathy studies and publications on Association
neurotoxicity" (RAR).
ACSOJA -
2.08 Further toxicological Argentine
studies Soybean Chain
Brazil). ACSOJA agrees with the assessments and conclusions achieved in the Vol. 3, B.6.8.3,
Association
pages 453-612 "Studies on endocrine disruption" (RAR).
ACSOJA -
2.09 Toxicological data on Argentine
metabolites Soybean Chain
Brazil). ACSOJA agrees with the assessments and conclusions achieved in the Vol. 3, B.6.8.1,
Association
pages 6-321 "Toxicity studies on metabolites and relevant impurities" (RAR).
ACSOJA -
Argentine
2.02 Acute toxicity renewal processes in the US and UE and is aware of other agencies reevaluation (Australia, Luis Zubizarreta
Soybean Chain
Association
pages 112-590 "Acute toxicity studies" (RAR).
ACSOJA -
Argentine
2.03 Short-term toxicity renewal processes in the US and UE and is aware of other agencies reevaluation (Australia, Luis Zubizarreta
Soybean Chain
Association
pages 5-280 "Short-term toxicity, oral 28-day studies, oral 90-day studies and other routes" (RAR).
Vol. 3, B.6.2, pages 112-590 "Acute toxicity studies" . Glyphosate was registered in Argentina by
2.02 Acute toxicity performed locally, Argentina has followed the most recent renewal processes in the US and UE and
MAIZAR agrees with the assessments and conclusions achieved
routes". Glyphosate was registered in Argentina by the end of the 70´s under the pesticides
2.03 Short-term toxicity
studies in germ cells and information from public literature". Glyphosate was registered in Argentina
2.04 Genotoxicity
Vol. 3, B.6.5, pages 5-360. Glyphosate was registered in Argentina by the end of the 70´s under the
carcinogenicity
from public literature". Glyphosate was registered in Argentina by the end of the 70´s under the
publications on neurotoxicity". Glyphosate was registered in Argentina by the end of the 70´s under
2.07 Neurotoxicity
Vol. 3, B.6.8.3, pages 453-612 "Studies on endocrine disruption" . Glyphosate was registered in
studies
Vol. 3, B.6.8.1, pages 6-321 "Toxicity studies on metabolites and relevant impurities". Glyphosate
no reevaluation was performed locally, Argentina has followed the most recent renewal processes
metabolites
followed the most recent renewal processes in the US and UE and is aware of other agencies Federico Martín Elorza CASAFE
carcinogenicity
2.06 Reproductive toxicity Federico Martín Elorza CASAFE
2.07 Neurotoxicity followed the most recent renewal processes in the US and UE and is aware of other agencies Federico Martín Elorza CASAFE
CASAFE agrees with the assessments and conclusions achieved.CASAFE agrees with the
was performed locally, Argentina has followed the most recent renewal processes in the US and UE Federico Martín Elorza CASAFE
studies
no reevaluation was performed locally, Argentina has followed the most recent renewal processes Federico Martín Elorza CASAFE
metabolites
Vol. 3, B.6.2, pages 112-590 "Acute toxicity studies":
2.02 Acute toxicity Federico Martín Elorza CASAFE
Brazil).
2.03 Short-term toxicity Federico Martín Elorza CASAFE
2.04 Genotoxicity Federico Martín Elorza CASAFE
Vol. 3, B.3.4, pages 10-11, Field of use envisaged:
In our experience as an association of farmers involved in the development of Conservation
Agriculture*, we have not identified alternative solutions that would allow us to practice this farming
system (without tillage) without glyphosate.
The comparative evaluation carried out by ANSES in France (Reports 2019 and 2020) has shown
the absence of alternative solutions and the technical impasse in which the suppression of
glyphosate would leave European farmers practicing no-till and Conservation Agriculture. In France,
following this comparative evaluation of the ANSES, the use of glyphosate has been withdrawn in
September 2021 with the exception of a few orphan uses, including conservation agriculture. The
dose of 3l/ha/year is now authorized for this use.
It seems fundamental to us that EFSA and the different European agencies carry out comparative https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
and efficacy
evaluations in each agricultural area, to determine what would be the alternative solutions for no-till
farmers. Especially since the benefits of no-till, permanent soil cover and diversity of cultivated
species are recognized by all (cf. FAO reports) and completely in line with the European stakes (cf.
attached documents), i.e.: soil fertility, fight against erosion, fight against climate change, resilience
of farms, restoration of biodiversity.
*Conservation Agriculture (CA) is internationally acknowledged, by the FAO (FAO, 2014) and by the
Soil Conservation Project in Europe, as a system that guarantees the sustainable use of agricultural
soils. In France, the INRAe (National research Institute for Agriculture, Food and Environment)
promotes this system for its environmental benefits that ensure continuity in the quantity and quality
of the agricultural production.
Comments to
Vol. 1, 2.3.4. “undesirable or unintended side-effects”
Glyphosate causes high economic damages to organic farmers because of contaminated harvests.
The readmission of glyphosate may not be given because the European Union’s goal of
coexistence anchored in EC Basic Organic Regulation No. 834/2007 between conventional and
organic forms of production is to apply.
The peer-reviewed study “Kruse-Plaß, M., Hofmann, F., Wosniok, W. et al. Pesticides and
pesticide-related products in ambient air in Germany. Environ Sci Eur 33, 114 (2021). https://doi. Buendnis fuer
org/10.1186/s12302-021-00553-4“ proves an alarming long range transport of glyphosate. eine
Glyphosate was found miles away from the potential source – it was transported even to organic Johanna Baer enkeltaugliche
and efficacy
fields. The deposition of these pesticides on organic products may disqualify them from the market, Landwirtschaft
resulting in economic losses to organic farmers. e.V.
List of examples of contamination:
Letter from organic producers to the german ministry of agriculture: (german) https://taspo.
de/fileadmin/glasshouse/taspo/pdf/160607_Unternehmerbrief_an_BVL_BMEL_-_Pestizidschaeden.
pdf
Problem of honey contaminated with glyphosate in 2019: (german) https://www.aurelia-stiftung.
de/projekt/glyphosat-im-honig-seusing/
Problem of honey contaminated with glyphosate in 2016: (german) https://www.aurelia-stiftung.
de/wp-content/uploads/2020/11/Aurelia-PS-Glyphosat-im-Honig-Fall-A%C3%9Fmann.pdf
We would like to inform you that there is new data concerning the fate and behaviour of glyphosate
in air. The peer-reviewed study by Kruse-Plaß, M., Hofmann, F., Wosniok, W. et al. Pesticides and
pesticide-related products in ambient air in Germany. Environ Sci Eur 33, 114 (2021). https://doi.
org/10.1186/s12302-021-00553-4 (attached) proves an alarming long range transport of
glyphosate. Thus, glyphosate cannot longer be assessed as having “no potential for longe range
transport”.
We would like to call your attention to these results and request that they are taken into
consideration during the peer review. This relates to the following issues of the RAR:
Referring to Vol. 1, 2.8.4., page 569 “Further data would be necessary to confirm observations
about glyphosate in air.”
Buendnis fuer
Comment: Kruse-Plaß et al. (2021) present these data confirming these observations
eine
4.04 Fate and behaviour in Referring to Vol. 1,2.8.6., page 577: “Glyphosate estimated unlikely to undergo significant
Johanna Baer enkeltaugliche https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
air volatilisation and any residues reaching air will be rapidly degraded. Therefore, no significant
Landwirtschaft
concerns related to long range atmospheric transport and accumulation.”
e.V.
Comment: While it may be true that “glyphosate is unlikely to undergo significant volatilisation”, the
evidence provided by Kruse-Plaß et al. (2021) indicates that air transport of glyphosate is occurring
by other means (possibly via particulate matter). This should be reason for concern.
Referring to Vol. 1, 2.8.3., page 567: “long range transport is not expected.”
Comment: The fact that glyphosate was found in essentially all air samples collected by Kruse-Plaß
(2021) raises questions concerning this statement. Was the observation of a rapid degradation in
air performed under realistic conditions?
Referring to Vol. 1, 2.8.3., page 567: “the active substance is not considered volatile and has no
potential for long range transport.”
Comment: The publication by Kruse-Plaß et al. (2021) provides evidence that the opposite is true.
New data: behaviour in the environment (Vol. 1, 2.8 / especially in air Vol. 1, 2.8.3.)
Chang, F. S., MF und Capel, P. (2011). Occurrence and fate of the herbicide glyphosate and its
degradate aminomethylphosphonic acid in the atmosphere. Environ Toxicol Chem. 30(3): 548-555.
https://doi.org/10.1002/etc.431
de F. Sousa, M., da Silva, A., Araújo, R. und Rigotto, R. (2019). Evaluation of the atmospheric
contamination level for the use of herbicide glyphosate in the northeast region of Brazil. Environ
Monit Assess. 191(10): 604. https://doi.org/10.1007/s10661-019-7764-x
Humphries, D., Byrtus, G. und Anderson, A.-M. (2005). Glyphosate Residues in Alberta’s
Atmospheric Deposition, Soils, and Surface Waters. Pub No. T/806. A. Environment. Edmonton.
https://open.alberta.ca/dataset/a4381736-cd17-4be1-b8ed-16aee8073be9/resource/5744d27f-fce1-
43fd-a109-8ec6423929b4/download/6444.pdf Buendnis fuer
eine
Majewski, M., Coupe, R., Foreman, W. und Capel, P. (2014). Pesticides in Mississippi air and rain: Johanna Baer enkeltaugliche
A comparison between 1995 and 2007. Environ Toxicol Chem. 33(6): 1283-1293. https://doi.org/10. Landwirtschaft
1002/etc.2550 e.V.
Mendeza, M., Aimarb, S. A., VC, Ramirez Haberkona, N., E., D., Buschiazzoa, D. D. G., E und
Costac, J. (2017b). Glyphosate and Aminomethylphosphonic acid (AMPA) contents in the
respirable dust emitted by an agricultural soil of the central semiarid region of Argentina. Aeolian
Research. 29: 23–29. DOI: 10.1016/j.aeolia.2017.09.004. https://www.researchgate.
net/publication/320258359_Glyphosate_and_Aminomethylphosphonic_acid_AMPA_contents_in_th
e_respirable_dust_emitted_by_an_agricultural_soil_of_the_central_semiarid_region_of_Argentina
Prasanthi, Y., Ferguson, D., Kettleson, E., Schaeffer, C., Adhikari, A. und Loganathan, B. (2012).
Glyphosate levels in soil, water and air before and after application on agricultural farms.Organo
halogen compounds. 74: 316-319. https://www.researchgate.
net/publication/257873932_Glyphosate_levels_in_soil_water_and_air_before_and_after_applicatio
n_on_agricultu
Vol.3,B3.1, pages 6 to 9, use of the active substance As a farmer in the centre of France, I use
glyphosate, which is why I cannot do otherwise.
After cereals before rapeseed: multiple passes of tools between these two crops to destroy weeds
dries out the soil. In August with random rainfall, it is necessary to minimise tillage and therefore the
use of glyphosate to maximise soil moisture to favour the emergence of the rape.
In our areas with limited agronomic potential, farms have had to grow to a critical size (often several
hundred hectares) with little labour to maintain a decent income. Therefore, a lot of mechanical
stubble ploughing (4 to 5 ha/h each time) against a glyphosate (20 to 25 ha/h). In addition,
mechanical work is less efficient than glyphosate. If we let it go at sowing time, we have no solution
to catch up with vulpine and rye grass, which are resistant to many selective anti-gramins for
cereals.
For long intercrops, especially in our hydromorphic soils, the re-greening of the ploughing in the Denis Carroy
and efficacy
spring forces us to use a tool to destroy the weeds. However, at the time of sowing, time is often
limited and in these fragile soils, double passes damage the soil structure and therefore
compromise the yield.
The fight against perennial plants: if we are not careful, couch grass tend to come back very
quickly. Experience shows us that mechanical control methods involve 5 to 6 passes of tine tools to
limit proliferation, which brings us back to the problem of time and the carbon footprint of such
operations.
As for invasive species, we have ragweed in our area and we are now struggling to contain it by
combining glyphosate and tillage.
Finally, to successfully plant a summer crop behind a catch crop, an Intermediate Energy Crop
must be destroyed after the harvest to avoid regrowth in the following crop.
The eRcane Research Center has a pivotal role in the sugarcane sector in Reunion island while
being at the forefront of genetic and technological progress with a view to boosting sugarcane
production and ensuring its economic viability and sustainability. For more than 10 years,
experiments have been conducted on chemical and complementary weed control methods.
The summary of the study is too succinct to reflect the benefit and importance of the substance in
conservation agriculture and sustainable sugarcane production.
The sugarcane crop is semi-perennial and integrates two of the three concepts of Conservation
Agriculture: continuous no or minimum mechanical soil disturbance and quasi-permanent
maintenance of a vegetative mulch cover on the soil surface. To maintain these practices, the use
of glyphosate is an essential weapon to: (i) plough out the cane and make chemical false seeding
before replanting; (ii) control difficult and invasive species that have a high impact on yields; (iii)
and efficacy
weed the borders and farm roads.
The agricultural context of Reunion is subject to important constraints: tropical climate with very
important weed pressure, risk of water and wind erosion increased with slopes and cyclones, very
small and often very stony plots. This context strongly limits the use of mechanical weed control
with tillage.
Despite the experimentation of complementary methods to herbicides, the withdrawal of glyphosate
in our pedoclimatic conditions would have harmful consequences in mechanizable plots by a return
to ploughing and repeated tillage with the following impacts: an increase in erosive risk, a decrease
in soil biodiversity and organic matter on the surface, a destocking of carbon and thus an increase
in GHGs, an acceleration of soil evaporation, a rise in stones and a multiplication of weeds with
rhizomes, runners or tubers.
Vol. 3, B.3.5, pages 16-20, Harmful organisms controlled and crops or products protected or treated
:
The eRcane Research Center has a pivotal role in the sugarcane sector in Reunion island while
being at the forefront of genetic and technological progress with a view to boosting sugarcane
production and ensuring its economic viability and sustainability. For more than 10 years,
experiments have been conducted on chemical and complementary weed control methods.
The summary of the study is too succinct to reflect the benefit and importance of the substance in
the regulation of invasive species on the island.
The sugarcane crop represents more than 50% of the island's useful surface and the use of
glyphosate is an essential weapon to: (i) plough out the cane and make chemical false seeding
before replanting; (ii) control difficult and invasive species that have a high impact on yields; (iii)
1.04 Data on application weed the borders and farm roads.
and efficacy The agricultural context of Reunion is subject to important constraints: tropical climate with very
important weed pressure, risk of water and wind erosion increased with slopes and cyclones, very
small and often very stony plots. This context strongly limits the use of mechanical weed control
with tillage.
Despite the experimentation of complementary methods to herbicides, the withdrawal of glyphosate
would have harmful consequences by the proliferation of weeds registered on the list of invasive
species. Today 167 species on the list have been observed in sugarcane, 26 of which are known to
be aggressive. Of these species, 8 are targets of glyphosate (Paspalum paniculatum, Rottboellia
cochinchinensis, Setaria Barbata, etc.), and mechanical, manual or chemical weed control methods
(other than glyphosate) show little or no effectiveness. The withdrawal of glyphosate would
therefore create a risk for agricultural crops but also for the environment through a loss of
biodiversity and an alteration of the functioning of rural ecosystems.
Vol. 3, B.3.4, pages 10-11, Field of use envisaged : I am a farmer, I cannot judge this report
because it is too short but as a user I have things to say.
The use of glyphosate has allowed me to set up a no-tillage cropping system with plant cover and
diversification of the rotation. This system has brought me many benefits, direct effects such as a
drastic reduction in fuel consumption and equipment use, and the significant impact that this now
has on my CO2 emissions.
Not working the soil with glyphosate has also brought me agronomic benefits, an increase in the
rate of organic matter and therefore of the carbon stored in my soils. A better development of my
hydromorphic soils thanks to a better bearing capacity of the soils which facilitates the mechanized
interventions and thus an improved potential for its average soils.
No-tillage plant cover is established more quickly and therefore grows faster, stores more carbon
1.04 Data on application and improves my soils faster and therefore prepares me faster to face climate change.
CARNEL MAXIME
and efficacy No-tillage + glyphosate is also perfectly suited to more difficult climatic conditions, it is more resilient
and easier because it is cheaper to implement. It is, however, more technical and more difficult but
offers many opportunities.
Glyphosate is also a must because it is more effective than tillage in managing ragweed, a weed
that makes it unsuitable for selling cereals. Thanks to glyphosate, I can continue to supply
buckwheat of French origin to small French mills, for example.
Glyphosate can also ease the management of weeds over the entire 5/6 year rotation, and
therefore lighten or even sometimes reduce the use of other phytosanitary products, provided that
the work is well done and the weather is on our side.
The only fault I can see with glyphosate is that the product is not used properly, which would lead to
the appearance of weed resistance to the product and therefore an increase in the quantities
consumed. But we know today that spraying equipm
Your studies and reports are an insult to human kind, to intelligence, to nature and to biodiversity.
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chemical properties of the You will bury the death and the illness of thousands of people on your own shoulders for your all People Of the World
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points: ADI, ARfD, AOEL
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3.09 Summary of other
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3.12 Proposed import
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tolerances
Vol ; 3, B.3.1, pages 6 to 9, use of the active substance :
Weeding practices on walnuts orchards in France are as follows:
Only the plantation line of the trees is weeded on 50 cm to 1.5 m on each side of the trees, which
represents 10 to 30% of the orchard surface. This is to limit the mineral and water competition
between weeds and trees, and especially to facilitate mechanical harvesting on the ground. It also
allows to optimize the use of the irrigation equipment located on the row.
and efficacy
Only nuts falling on the weeded strip are potentially in contact with glyphosate.
One to three weedings are done per year. on adult orchards, the light enters less and so there are
less weeds on the row. There are more interventions in young orchards.
The doses used range from 180 to 2160 g of glyphosate per ha and per year. The last glyphosate
application is done more than 21 days before the harvest, so the pre-harvest interval is respected.
Volume 3. B3.1. p. 7. “Use of the active substance”. “Orchards and vines”.
Association Nationale des Producteurs de Noisettes
The mechanical harvesting of hazelnuts (between 12 and 26 mm in diameter) is done on the
ground after the natural fall of the fruit. The hazelnuts
are swathed in the middle of the row with specific brooms, then harvested with rotary pick-up
harvesters.
A levelled and stabilised soil is therefore essential for the harvesting process. Bare ground in the
bare ground in the inter-row areas is not recommended as it is impassable in rainy conditions at
harvest time and is subject to
at harvest time and are subject to a high risk of erosion. All of the inter-row areas of the planted
surfaces are therefore covered with
permanent grass cover. The hazelnuts are swathed and
harvested on this grassed area, which implies a specific weeding itinerary.
specific weeding itinerary.
The weed control operations are located under the row. The weed in the inter-row is maintained by
and efficacy
regular mowing or
or shredding, with the exception of the preparation of the orchard for harvest. These weed control
operations rely on the use of glyphosate.
Mechanical harvesting of hazelnuts from a grassy area requires grass cover to be kept as short as
possible so that all of the hazelnuts can be harvested.
The mechanical harvesting of hazelnuts from a grassy area requires that the grass cover be kept as
short as possible so that all the hazelnuts can be picked up by the pick-up of the harvester. The
only way to manage
of the grass cover becomes impossible as soon as the first fruits fall to the ground, as they would
then be destroyed.
as they would then be destroyed. A reduced dose of glyphosate is therefore applied to the weed in
compliance with the pre-harvest intervals in order to inhibit the growth of the fruit.
A reduced dose of glyphosate is therefore applied to the weed within the pre-harvest interval in
order to temporarily inhibit its growth without destroying it.
SCA UNICOQUE
Without the reduced-dose glyphosate weeding operation, a significant proportion of the fruit cannot
and efficacy
be harvested, representing a loss of product
of around 400 €/Ha (Observations 2020 of the Unicoque technical service).
In hazelnut orchards, glyphosate is mainly applied under the row, 1 metre on either side of the
trees, i.e. 30% of the orchard surface weeded for a 6 m inter-row.
of the trees, i.e. 30% of the orchard's surface area weeded for an inter-row distance of 6 m. Two
and efficacy
applications are necessary: in spring to manage the flora in place
necessary: in spring to manage the flora in place at the end of winter, then in June to manage the
summer weeds.
summer weeds. This reduces competition from weeds for water and fertilisers.
Hazelnuts: No risk of contamination of fruit on the ground. No application of glyphosate is made to
fruit already on the ground. For localized applications under the row, these are carried out well
before harvest and at the usual
In addition, 70% of the fruit is treated with glyphosate in the same way as the rest of the crop.
1.04 Data on application Moreover, 70% of the fruit is located in the periphery of the canopy of the
and efficacy periphery of the tree canopy and therefore fall onto the grassy area. The application on the grassed
area is
carried out at 25% of the registered "annual weeds" rate and at more than 21 days from the first
fruit falls
which occurs around 25 August for the earliest varieties. The pre-harvest interval is therefore
respected
for a greatly reduced rate.
With 8,000 ha planted (not all orchards are in production yet) with a potential of 15,000-20,000 t of
walnuts, the South East of France with the PDO Grenoble Walnut represents a large half of the
French walnut production. Coopenoix is the most important cooperative of walnut producers in
France. The production of this fruit has developed in the 80's thanks to the mechanization of the
harvest.
The walnut harvest is done on the ground from September, thanks to a natural fall and accentuated
1.04 Data on application by the shaking of the trees. The pickers are equipped with blowers and brooms to harvest all the
and efficacy nuts on the entire surface of the orchard.
A levelled and stabilized ground is thus essential for the good progress of the harvesting
operations. Only the orchards more sensitive to drought have their soil worked. This can generate
complications during harvesting in wet conditions. All the inter-rows of the plantations are
permanently grassed from the first years of the orchard. The up keep of the row allows to limit the
competition of the grass on the young trees and to facilitate the harvesting.
Weeding interventions are localized under the row. The inter row is maintained by crushing or
mowing the grass. The weed control on the row is mainly based on the use of glyphosate.
Weed control on walnut orchards in France is essentially based on the use of glyphosate. Currently,
1.04 Data on application pelargonic acid, Isoxaben, Fluazifop-P are still registered, these 3 molecules are not used on walnut
and efficacy trees because their spectrum of action is not sufficient. Glyphosate acts on grasses and broadleaf
weeds, its effectiveness is wider and more interesting for producers in a single passage. The other
molecules require several passes to alternate the efficacy on the different weeds.
The chemical weeding of walnut orchards in France can have an alternative: the maintenance of
the row with a mower. This requires more passes, up to 5 passes instead of 2 chemical weedings
on average. The equipment does not allow to go as fast as with a weeding ramp. For the producers,
the labor time is higher to have the same level of maintenance of the row. It also requires an
investment in equipment adapted to mowing on the row. Producers with limited acreage must make
a substantial investment in relation to the use they will make of it on their farm. Smaller farms often
do not have enough manpower to perform this alternative to chemical weed killers.
and efficacy
Moreover, the maintenance of the row by mowing requires that the irrigation system is not on the
ground and this is often the case in mature orchards. This incurs significant costs to raise the pipes
and sprinklers.
The use of the mower on the row generates a higher fuel consumption due to the equipment used
and the number of passes.
Currently, the investment in terms of equipment and time does not allow a majority of nut growers to
change their practices.
The harvest of walnuts in France is done from mid-September to the end of October in 2 to 4
passages. The mature nuts fall to the ground and the trees can also be shaken. The nuts fall to the
ground with or without the husk. The kernel is never in direct contact with possible traces of
glyphosate. It is always protected by the shell.
The nuts are then washed with water and brushed to remove the husk and soil. This step allows to
and efficacy
eliminate the possible traces of glyphosate. They are then dried.
The analysis of residues at the reception of the walnuts, which has been done at Coopenoix
cooperative as part of the quality control for many years, does not detect any traces of glyphosate
and AMPA. The whole nuts are provided for analysis. The fruits are crushed with the shell to make
the analysis of residues on the whole (shell and kernel) We can provide you the analysis on
request.
Sud amandes "In almond trees, ghyphosate is the leading molecule in chemical weed control
strategies. It allows an alternation with Fuazifop-p-butyl in the control of grasses and with
Carfentrazone-ethyl in the control of broadleaf weeds. Stopping the use of glyphosate will induce
resistance in the flora and will render the weed control strategies totally ineffective. The investments
and efficacy
necessary to switch to mechanical weed control will not be bearable for many farms. A mechanical
weeding tool costs about 10,000 €/farm, fuel consumption is higher, producers will have to replace
their irrigation system (3500 €/ha), work times will be higher and will require the search for qualified
personnel. These investments are important costs that small farms will not be able to finance."
force. Although no reevaluation was performed locally, Argentina has followed the most recent Bolsa de
2.02 Acute toxicity renewal processes in the US and UE and is aware of other agencies reevaluation (Australia, Brazil). Ramiro Costa Cereales de
Bolsa de Cereales de Buenos Aires agrees with the assessments and conclusions achieved. Vol. 3, Buenos Aires
B.6.2, pages 112-590 "Acute toxicity studies"
2.03 Short-term toxicity renewal processes in the US and UE and is aware of other agencies reevaluation (Australia, Brazil). Ramiro Costa Cereales de
B.6.3, pages 5-280 "Short-term toxicity, oral 28-day studies, oral 90-day studies and other routes"
Bolsa de
renewal processes in the US and UE and is aware of other agencies reevaluation (Australia, Brazil).
2.04 Genotoxicity Ramiro Costa Cereales de
Bolsa de Cereales de Buenos Aires agrees with the assessments and conclusions achieved. Vol. 3,
Buenos Aires
B.6.4, pages 5-395 "Genotoxicity, in vitro studies, in vivo studies in somatic cells, in vivo studies in
germ cells and information from public literature"
renewal processes in the US and UE and is aware of other agencies reevaluation (Australia, Brazil). Ramiro Costa Cereales de
carcinogenicity
B.6.5, pages 5-360
Bolsa de
2.06 Reproductive toxicity Ramiro Costa Cereales de
Buenos Aires
B.6.6, pages 6-449 "Generational studies, developmental toxicity studies and information from
public literature"
Bolsa de
2.07 Neurotoxicity Ramiro Costa Cereales de
Buenos Aires
B.6.7, pages 6-70 "Neurotoxicity studies in rodents, delayed polyneuropathy studies and
publications on neurotoxicity"
studies
B.6.8.3, pages 453-612 "Studies on endocrine disruption"
metabolites
B.6.8.1, pages 6-321 "Toxicity studies on metabolites and relevant impurities"
In Brazil, glyphosate went through the toxicological reassessment process, coordinated by the
National Health Surveillance Agency (ANVISA), which was completed in 2020 and made official by
the publication of Resolution RDC No. 441 (2020), which makes the final decision on risks to
human health. Thus, this Resolution establishes the maintenance of the active ingredient
Glyphosate in pesticide products in the country and determines measures to mitigate health risks
and changes in the registry resulting from its toxicological reassessment.
The following changes are defined in the Monograph of the active ingredient Glyphosate in Brazil:
Brazilian
I - inclusion of formaldehyde, at a concentration of 1.0 g/kg, among contaminants of toxicological
Institute of
importance for the active ingredient, maintaining N-nitrosoglyphosate at a concentration of 0.001
Toxicology
2.11 Toxicological end g/kg;
Flávio Zambrone (IBTox - https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
points: ADI, ARfD, AOEL II - inclusion of the definition of Glyphosate residues for compliance with the Maximum Residue
Instituto
Limit (MRL) as glyphosate;
Brasileiro de
III - inclusion of the definition of Glyphosate residues for dietary risk assessment as the sum of
Toxicologia)
Glyphosate and AMPA, expressed as Glyphosate;
IV - inclusion of the Acceptable Operator Exposure Level (AOEL) of 0.1 mg/kg of body weight per
day;
V - inclusion of the Acute Reference Dose (ARfD) of 0.5 mg/kg of body weight;
VI - change in Acceptable Daily Intake (ADI) to 0.5 mg/kg of body weight;
The component polyoxyethylene amine (POEA) in a concentration above 20% in Glyphosate-based
formulated products is prohibited.
1.04 Data on application SCA UNICOQUE
and efficacy No residues found in analyses from 2017 to 2020. AMPA and glypho.
(See attached analysis results)
carcinogenicity
JOSE SANCHEZ. agrees with the assessments and conclusions achieved."
2.04 Genotoxicity
metabolites
studies
2.07 Neurotoxicity
1.04 Data on application Association Nationale des Producteurs de Noisettes
and efficacy Hazelnuts - Washing the fruit removes any particles of treated soil that may be in contact with the
hazelnuts. The closed shell of the hazelnut protects the kernel from the outside environment.
I need to use Glyphosate at the bottom of my apple trees to control weeds. I need to have a place
75cm wide on each side of rows without weeds to be able to follow activity of mise which they eat
apple trees roots. Control weeds near to trees can help me save nutrients and water to the trees. I
1.04 Data on application can't use mechanical soil labor to kill weeds because of our soil is full of stones. And because of the
Julien Giraud
and efficacy slopes of our orchards, if me make the soil soft, each time it rains, we create erosion! And I don't
speak about mechanical weed killing need of fioul and so CO2 rejects, working at 2,5km/h working
only one side of the row, 4-5 times a year, despite of glyphosate 2 times a year working 2 sides at
one time at 6,5km/h
In Mulchsaaten ist Glyphosat erforderlich zur Verringerung der Beikrautkonkurrenz. Falls Glyphosat
nicht mehr zur Verfügung steht, nimmt der Einsatz alternativer selektiver Herbizide und die
Intensität der Bodenbearbeitung zu. Die Biodiversität des Bodens aber auch auf den Ackerflächen
wird durch die vermehrte Bodenbearbeitung z.B. Pflügen deutlich vermindert. Der Erosionsschutz
der Böden wird damit nachhaltig gefährdet.
1.03 Physical and L’utilisation de cette matière active permet de limiter l’utilisation d’autres matières active . D’autre
chemical properties of the part cela permet d’éviter le travail du sol donc érosion des sols économie de carburants restriction
plant protection product des rejets de carbone .
Autism Spectrum Disorder (ASD). In Vol 3, 25) CA B.6.10 the RMS required the applicant to
provide additional literature with autism as search term.
In the report, in RAR_14_Vol_3CA_B-6.7 - B-6.10_2021-08-10 p 861, Von Ehrenstein O. S. et al.
(2019) is cited and considered as non-relevant. In RAR_13_Vol_3CA_B-6.6_2021-08-10 p 442, the
applicant explained that this publication in non-relevant after assessment. This publication shows a
risk of autism spectrum disorder associated with prenatal exposure to glyphosate (odds ratio 1.16,
95% confidence interval 1.06 to 1.27). The applicant explains that the exposures in the study are
not documented, and it is irrelevant because the Farm Family Exposure Study (Acquavella et al.
2004) shows no exposure to glyphosate in spouses who lived on farm during the time of glyphosate
application.
The RMS must consider that this exposure study is old and conducted by one of the applicants
2.07 Neurotoxicity (Monsanto). Since then, several exposures studies to glyphosate in agriculture have been Olivier DELMAS
published. Ferreira C. et al., Environmental Research 198 (2021) 111294, shows higher levels of
glyphosate in urine of children living at less than 1 km to agriculture areas. These results are
consistent with four other previous studies cited in the paper. In a systematic review, Ongono, JS et
al. Env. Res. (2020) 109646 conclude that in the framework of environmental risk factors of ASD,
novel hypotheses can be formulated about early exposure to eight pesticides. Glyphosate
presented the most salient level of evidence.
Prevalence of ASD increases in many countries especially in America and Europe, and France in
particular (see santé publique France Trouble du spectre de l’autisme 2010-2017). Glyphosate use
increases in the same proportions. Underlying biological mechanisms become to be elucidated.
Today, glyphosate is the best candidate to explain ASD epidemic. Other studies are conducted (e.
g. PestiRive). Precautionary principle applies now, to all adverse effe
Vol 3, B.3.1 pages 6 to 9 : use of the activ substances
AOP CENALDI is the national association representing and defending producer organizations of
vegetables for processing (70 000 ha)
The use of glyphosate is not systematic prior our crops. As a non-selective herbicide and effective
on a large number of weeds, it is a complementary tool to manage weeds that are difficult to control
with the other techniques to be used in open fields (i.e : selective chemical control, mechanical
tillage...). We consider that it is important to take into account the specific interest of this molecule
for its evaluation.
Vegetables for processing are mostly sown or planted in spring, after long inter crops periods with
mandatory winter covercrop, rotating with field crops in farming systems
Being mechanically harvested, the vegetables quality may be impacted by weeds : because of an
excess of foreign parts, batches do not meet the compliance specifications. For this reason, manual
weeding is now often necessary before harvesting.
and efficacy
Clean fields at sowing matter particularly. However, spring soil conditions are often wet and unfit to
tillage before sowing. The chemical destruction of the cover crops may so be the only solution for a
correct degradation before incorporation of the vegetation in order to get the expected soil quality
for sowing.
Management of volunteers and weed emergence prior to crop establishment is particularly
necessary when there is a risk of toxic plants, such as datura.
A lack of weed control in the previous crops has all the more impact on the vegetable crop as the
approved active herbicides, whereas too few on vegetables, are continuously reduced. Mechanical
weed control, besides randomly affected by poor weather conditions, does not achieve complete
control, especially on the row.
Moreover, current technical development of localised treatments offers new interesting perspectives
for the use of glyphosate in our crops.
This comment refers to RAR §2.6.2.6 p.117, RAR §2.6.2.10.1 p. 129; RAR §2.6.3.1.3 p.177.
Conclusion RAR (p. 129):

“In humans, there is no evidence for respiratory tract irritation by the active substance […] Overall,
there is no sufficient evidence to classify glyphosate for respiratory tract irritation.”
Comment by Inserm:
(see also Inserm report, p. 30-1; https://www.inserm.fr/expertise-collective/pesticides-et-sante-
Inserm -
nouvelles-donnees-2021/)
French
National
The Inserm collective expert review concluded from epidemiological studies, that there is a weak
2.02 Acute toxicity Laurent FLEURY Institute of
presumption of a link (definition, Annex 2, Inserm report) between glyphosate exposure and
Health and
deleterious effects on respiratory health, and in particular with an excess risk of wheezing (allergic
Medical
or not) and asthma. It was noted, however, that this conclusion is based on the results of a limited
Research
number of epidemiological studies, most of which are from the AHS cohort.
This conclusion is supported by experimental toxicology studies that show glyphosate has pro-
oxidant and mitotoxic effects, two biological mechanisms likely to be involved in pathophysiology of
asthma and chronic obstructive pulmonary disease. Although the experimental models used involve
different species and cellular systems, and do not directly focus on the lung toxicity, the results
indicate a potential pro-inflammatory effect in the lung, which also depends on the duration and
intensity of exposure.
This comment refers to RAR § 2.6.4.3 ; Conclusion on classification and labelling for genotoxicity /
germ cell mutagenicity ; p. 228 "No classification for germ cell mutagenicity is warranted"
Comment by Inserm:
(see also Inserm report, p. 40-6 ; https://www.inserm.fr/expertise-collective/pesticides-et-sante-
Genotoxicity assays, which aim to detect DNA damage such as double-stranded breaks,
chromosomal aberrations or adducts, can be performed in different microbial, animal or plant
systems using in vitro or in vivo approaches.
Inserm -
French
The Inserm collective expert review analyzed some twenty studies in the academic literature using
National
these assays to explore the genotoxic potential of glyphosate or GBHs. Due to the large number of
2.04 Genotoxicity Laurent FLEURY Institute of
studies, the results appear discordant, which can be explained by the different protocols used that
Health and
vary in terms of models, dose and exposure times, and the types of products tested (glyphosate or
Medical
formulations). However, the studies showing that glyphosate has genotoxic effects are more
Research
important in terms of quality and quantity than those suggesting an absence of effect. A genotoxic
effect of glyphosate is consistent with the induction of oxidative stress, observed in different species
and cell systems, sometimes at exposure doses consistent with those encountered in the
environment.
The difference in opinion between the Inserm collective expert review and the RAR on the question
of genotoxicity stems from the fact that the Inserm collective review takes into account both the
results using non-standard models (i.e., non-mammalian models such as fish and crustaceans; not
considered for classification in the RAR), and those obtained with formulations (GBHs) that better
reflect the reality of exposure in humans.
This comment refers to RAR § 2.6.5.1.2 & § 2.6.5.1.2.2; p 300-6 & 311-2
Comment by Inserm (see also Inserm report, p. 22-6):
Inserm concluded on a moderate presumption of a link (definition, Annex 2, Inserm report) between
occupational exposure to glyphosate and increased risk of non-Hodgkin lymphoma (NHL) for
farmers or other employment categories, based on:
• the meta-analysis published by the consortium AGRICOH (Leon et al., 2019) which, combining the
AHS with two other agricultural cohorts (AGRICAN-France, CNAP-Norway) includes over 300,000
subjects and 2,430 cases of NHL, found a statistically significant association between glyphosate
and increased risk of diffuse large B-cell lymphoma. This result was primarily based on data from
the CNAP, while the risks were slightly elevated but not significant in the AHS and AGRICAN Inserm -
cohorts. French
• 3 recent pooled- or meta-analyses of earlier studies systematically show an increased risk National
(Chang and Delzell, 2016; Pahwa et al., 2019; Zhang et al., 2019), particularly among the most Laurent FLEURY Institute of
carcinogenicity
exposed farmers. Health and
Medical
In the RAR, 3 studies were considered as supplementary information or unreliable (Chang and Research
Delzell, 2016; Leon et al., 2019; and Zhang et al., 2019) while that of Schinasi & Leon, 2014 was
considered to be outdated (Appendix B.6.5.18.28-31).
As suggested by the RMS, we consider that all available meta-analyses published in international
peer-reviewed journals should be taken into account. Furthermore, the methodology of an updated
meta-analysis calculation, performed by the GRG and presented in an annex to the RAR, is not
described and the reference is missing (Table 1. Annex B.6.5.18.28-31) and should be provided.
Note also that this updated meta-analysis does not take into account the French and Norwegian
cohorts.
Our conclusion based on epidemiological studies is supported by experimental toxicology studies

as glyphosate shows pro-oxidant and genotoxic effects.
This comment refers both to reproductive effects (Vol. 1 §2.6.6.4; p. 432 & Vol. 3 §B.6.6.3 (AS); p.
364-450), as well as endocrine disruption (§2.10.4; p. 764).
Comment by Inserm:
Inserm analyzed the findings of a dozen academic studies using rodent models to investigate the
effects of glyphosate and GBHs on endocrine function (Walsh et al., 2000; Dallegrave et al., 2007;
Romano et al., 2012; De Liz Oliveira Cavalli et al., 2013; Cai et al., 2017; Guerrero Schimpf et al.,
Inserm -
2017 and 2018; Owagboriaye et al., 2017; Altamirano et al., 2018; Anifandis et al., 2018a and b;
French
Jiang et al., 2018; Milesi et al., 2018; Gomez et al., 2019; Manservisi et al., 2019; Pham et al.,
National
2019).
2.06 Reproductive toxicity Laurent FLEURY Institute of
Health and
The results are convergent and suggest an interaction of both GBHs and glyphosate with sex
Medical
hormone regulatory pathways. Specifically, the studies show that glyphosate and GBHs inhibit
Research
aromatase and can activate estrogen signaling pathways through mechanisms that may not involve
receptor binding and that exhibit complex dose-effect relationships. These changes are associated
with deleterious effects on reproductive function: for example, exposure of male rodents during the
prenatal period or in adult life is associated with disruption of spermatogenesis and mammary gland
anomalies, whereas early exposure to GBH in females is associated with uterine anomalies.
Our analysis suggests that both GBHs and glyphosate may exhibit endocrine disrupting properties
that impact reproductive function. The difference between the conclusions stems from the inclusion
or not of peer-reviewed academic studies by different groups that tested formulations (considered
not relevant in the RAR), and that better reflect the reality of exposure in humans.
This comment refers to RAR § 2.6.7 Summary of neurotoxicity.
Conclusion RAR (p. 436):

“Overall, the available information does not indicate a neurotoxic potential for glyphosate”
Comment by Inserm: Inserm -

(see Inserm report, p. 60-2; https://www.inserm.fr/expertise-collective/pesticides-et-sante- French
nouvelles-donnees-2021/) National
2.07 Neurotoxicity Laurent FLEURY Institute of
Recent academic studies have shown that GBHs as well as glyphosate alone alter the Health and
concentrations of several neurotransmitters in various regions of the brain in rodents (Hernandez- Medical
Plata et al., 2015; Cattani et al., 2017; Gallegos et al., 2018; Martinez et al, 2018; Yu et al., 2018). Research
This could explain the locomotor deficits and depressive behavior observed in rodents exposed to
glyphosate or formulations (Ait Bali et al., 2017 and 2018; Cattani et al., 2017; Gallegos et al.,
2018). This deserves to be analyzed and taken into consideration in the RAR. In addition, results
using non-standard models such as those in fish also merit consideration (Bridi et al., 2017; Pereira
et al., 2018).
This comment refers both to reproductive effects (Vol. 1 §2.6.6.4; p. 432 & Vol. 3 §B.6.6.3 (AS); p.
364-450), as well as endocrine disruption (§2.10.4; p. 764).
Comment by Inserm:
Inserm analyzed the findings of a dozen academic studies using rodent models to investigate the
effects of glyphosate and GBHs on endocrine function (Walsh et al., 2000; Dallegrave et al., 2007;
Romano et al., 2012; De Liz Oliveira Cavalli et al., 2013; Cai et al., 2017; Guerrero Schimpf et al.,
Inserm -
2017 and 2018; Owagboriaye et al., 2017; Altamirano et al., 2018; Anifandis et al., 2018a and b;
French
Jiang et al., 2018; Milesi et al., 2018; Gomez et al., 2019; Manservisi et al., 2019; Pham et al.,
National
2.13 Other comments, 2019).
Laurent FLEURY Institute of https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
Health and
The results are convergent and suggest an interaction of both GBHs and glyphosate with sex
Medical
hormone regulatory pathways. Specifically, the studies show that glyphosate and GBHs inhibit
Research
aromatase and can activate estrogen signaling pathways through mechanisms that may not involve
receptor binding and that exhibit complex dose-effect relationships. These changes are associated
with deleterious effects on reproductive function: for example, exposure of male rodents during the
prenatal period or in adult life is associated with disruption of spermatogenesis and mammary gland
anomalies, whereas early exposure to GBH in females is associated with uterine anomalies.
Our analysis suggests that both GBHs and glyphosate may exhibit endocrine disrupting properties
that impact reproductive function. The difference between the conclusions stems from the inclusion
or not of peer-reviewed academic studies by different groups that tested formulations (considered
not relevant in the RAR), and that better reflect the reality of exposure in humans.
Please find attached my report analyzing the 2021 draft glyphosate RAR's compliance with Art. 8(5)
of the PPP Regulation, the mandate to evaluate the toxicity findings published in the last 10 years.
This is the starting point for all re-authorizations...and it has utterly failed. I also analyze the role of
1.07 Other comments Anthhony Tweedale https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
EFSA's Guidance on complying with Art 8(5), which has a crucial loophole that allows users to
dismiss published toxicity findings by the bucket load before they have to even read them. In the
case of glyphosate, that means many hundreds of toxicity findings, dozens at low dose.
"vol.3,B.3.4,pages 10 to 11, use of the active substance" Controlling perennial plants: if we are not
careful, weeds tend to return very quickly. The experience of the pre-glyphosate past shows us that
mechanical control methods involve 5 to 6 passes of tools with teeth to limit proliferation. pulchérie fournier
and efficacy
- As for invasive species, we have ragweed in our area, which we are now struggling to contain by
combining glyphosate and tillage.
2.12 Product exposure and Campagne
risk assessment, including see attached file Daniel GRAU Glyphosate https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
dermal absorption France
Vol. 3, B.3.4, pages 10 to 11, Use of the active substance : Glyphosate allows me to grow crops
1.04 Data on application without ploughing, which leads to lower fuel consumption, less wear and tear on the equipment and
Martin Guilland
and efficacy therefore less consumption of natural resources. It also allows to sequester carbon in the soil. It is a
great tool to use sparingly for specific reasons such as no-till seeding and perennial management.
Vol. 3,
1.01 Identity philippe DECOENE
B.3.4, pages 10 to 11, Use of the active substance
Vol. 3,
B.3.4, pages 10 to 11, Use of the active substance :"
Removing glyphosate would be an agronomic and environmental nonsense.
Its use provides a significant number of advantages for the soil; erosion, water infiltration capacity in
shallow tillage techniques, concentration of organic matter on the surface, preservation of soil
porosity thanks to earthworm galleries that are no longer disturbed, very significant reduction in the
use of fuel (and therefore CO2) for weed control before sowing (multiple harrowing with low
1.04 Data on application efficiency), infinitely easier control of difficult weeds, thus avoiding the use of a multitude of other
philippe DECOENE
and efficacy active ingredients that are not always very effective and whose toxicological profile is sometimes
much more dangerous for humans and the environment. Finally, a clean field requires less
intervention during cultivation.
I have been using it for more than 40 years without any effect on my health or on the fauna; and this
shallow tillage technique has enabled me to increase the humus level in my soils significantly (--
>carbon sequestration).
In short, there are only advantages from an agronomic point of view, but also from a financial point
of view, as glyphosate allows a very significant reduction in costs.
COOPERATIVE DE PRODUCTEURS DE NOIX DU LIMOUSIN PERIGORD QUERCY - LIPEQU
If glyphosate is removed for wallnuts, only three herbicide molecules will remain: Pelargonic acid,
Isoxaben and Fluazifop-P.
Pelargonic acid is a defoliant that is only effective on weakly developed plants. With a maximum of
two applications per year, this product does not allow for the control of weeds in the row over the
1.04 Data on application season. Moreover, this molecule is more expensive than glyphosate.
and efficacy Isoxaben is an antigerminative molecule. To be effective, it must be applied to bare soil. To date,
only glyphosate allows you to obtain bare soil. Without glyphosate this molecule is therefore
unusable.
Fluazifop-P is a selective weedkiller for grasses. It has no effect on broadleaf weeds. Without
glyphosate, broadleaf weed control is not possible.
Without glyphosate we will be forced to multiply the number of passes, with much higher costs and
the IFT for much less efficiency.
COOPERATIVE DE PRODUCTEURS DE NOIX DU LIMOUSIN PERIGORD QUERCY - LIPEQU
In walnut production, the replacement of glyphosate by tillage would lead to numerous sanitary and
technical problems.
Return of root diseases such as phytophtora with high tree mortality.
and efficacy
High risk of erosion of the tilled area.
Difficulty of mechanical harvesting in wet years.
Decrease in the quality of nuts harvested from the soil: soiled shells and reduced market value of
the nuts.
Vol 3, B.3.1., pages 6 to 9, Use of the Active Substance, “Sovécopé, in agreement with AOP
Dynamic Noix”:
Glyphosate is a total weed killer used on walnut orchards in France, on young plantations after
lignification of the trunk (from 3 years), as well as on orchards in production. The weeding allows to
limit the competition in water and fertilizing elements by destroying all herbaceous competition. It is
used only on the row, the inter-row being exclusively grassed and maintained by mowing or
shredding. The width of the weeded strip depends on the diameter of the trunks and the plantation
and efficacy
density, but never exceeds 30% of the total surface of the orchard (50 cm to 1.5 m on each side of
the row). On average, there are 1 to 3 treatments per year in a walnut orchard. The last treatment is
carried out at the end of August, thus respecting the Pre-Harvest Period (harvesting starts at the
end of September, more than 21 days after the last treatment).
Translated with www.DeepL.com/Translator (free version)

Vol. 3,
B.3.4, pages 10 to 11, Use of the active substance
It is very necessary in the management of weeds, in order to limit the work of the soil to protect it as
much as possible. To avoid the phenomena of erosion, to keep a maximum of life and fertility.
Its removal would cause a sharp increase in the use of oil for tillage, more pollution! Dairon Aurélien
and efficacy
But also the abandonment of the least productive land. So a decrease of the production while the
consumption increases, and thus a rise of the prices.

Dynamic Noix”:
The walnut is a fruit harvested on the ground, using a picker, which passes between 2 and 5 times
in the season (beginning autumn) on the orchard. To obtain quality fruit, the walnut trees are
1.04 Data on application vibrated before being picked. The fruits fall to the ground protected by the husk and the shell. The
and efficacy kernel, the edible part, is never in contact with the ground. Thus, the kernels don’t come into contact
with any traces of glyphosate when the fruits fall onto the chemically weeded strip. Moreover, after
collection, the nuts are washed with clean water, removing any traces of glyphosate from the shells.

Dynamic Noix”:
The application of weed killer, such as glyphosate, is carried out using a weeding ramp. The ramp
is very low: spraying is done downwards, to be as close as possible to the target (weeds) and to
limit any drift towards the immediate environment. However, walnut trees are tall, between 6 and 15
metres. Moreover, they have a very erect growth bearing, the low branches being regularly cut to
and efficacy
facilitate the passage of the machines. Thus, the risk of drift during a weed killer treatment on the
plant or on the nuts is nil. On younger trees, smaller in size, a plastic bell is added to the weeding
ramp to limit any contact with the plant.

Dynamic Noix”:
Alternative solutions to chemical weed control exist for walnut groves: tillage on the one hand and
shredding of weeds on the other. In the first case, the weeds are completely destroyed by
uprooting, leaving the soil bare. In the second case, the weeds are controlled by shredding. To
chemically weed an orchard (glyphosate), 1 to 3 passes are necessary per year. To weed an
orchard mechanically (tillage or shredding), 3 to 6 passes are necessary per year (Enjeux et impact
technico-économique du retrait du glyphosate et du changement de pratiques de désherbage,
Enquête CTIFL 2019 sur les pratiques de désherbage en arboriculture fruitière, Ctifl, Mai 2020 ;
Rapport d’évaluation comparative, Cas des produits à base de glyphosate, Examen des
1.04 Data on application alternatives en arboriculture, ANSES, 15/09/2020 ; Alternatives au glyphosate en arboriculture :
and efficacy évaluation économique des pratiques de désherbage, Rapport de l’INRAE, publication février
2020). The increase in the number of tools passes therefore leads to an increase in soil compaction
in mechanically weeded orchards compared to chemically weeded orchards. However, walnut is a
very sensitive crop to soil compaction. The installation of a winter plant cover, based on legumes,
grasses and crucifers and destroyed at the end of spring, allows to limit this compaction biologically.
For this technique to be effective, it is essential to limit the number of tools passes during the cover
growth period and also throughout the growing season. Mechanical weeding is therefore
counterproductive to this agronomic measure: increased compaction and early destruction of the
cover on wheel passes.

substance: I am a farmer, apple producer. The loss of use of glyphosate will result in a minimum
yield loss of 30%. Glyphosate is never found in the residue analysis we do on apples. We only use Marine Fraissinet
and efficacy
it on 20% of the gross surface of our orchard. We are against the suppression of the use of
glyphosate.
Dynamic Noix”:
Depending on the soil and climate conditions, some orchards may be impassable for a certain
period (e.g. an orchard with a high clay content following heavy spring rainfall), thus delaying
weeding of the rows. The resulting water and mineral competition can have a negative impact on
production depending on the vegetative stage of the walnut trees (flowering, fruiting, enlargement
and filling of the fruit). Chemical weed control is relatively flexible in use, as glyphosate can be
applied on very developed weeds. However, mechanical weed control, by tillage or shredding, is
and efficacy
not effective beyond a certain height of grass on the row. In fact, tillage tools can only manage
seedlings that are not very developed. Shredding tools, such as satellites, will fade away when they
encounter well-developed weeds or will flatten them without shredding them. Thus, alternative
solutions may be difficult to use in certain conditions, whereas the flexibility of using glyphosate
makes it possible to intervene more quickly, with shorter climatic intervention windows.

Dynamic Noix”:
Mechanical weeding requires a slower speed of advance than chemical weeding, depending on the
tool used as well as the weediness of the row and the height of the weeds. Moreover, these tools
require a particular skill on the part of the tractor operator: more fragile tools and risk of significant
injury to the trunks. On average, the speed of progress during mechanical weeding is between 1
and 6 km/h, whereas that for chemical weeding is 6 km/h (Le désherbage des cultures fruitières :
enjeux et perspectives. Pratiques en vergers installés, jeunes plantations et cultures de petits fruits.
Evolutions réglementaires. Bilan de l’enquête CTIFL 2019 sur les pratiques de désherbage en
arboriculture fruitière, Ctifl, Juin 2021). This means that for a single intervention, 111 hours of work
1.04 Data on application are required to shred the rows of a 30-hectare farm, i.e. 3.2 weeks of work. In the case of weeding
and efficacy by tillage, up to 160 hours are needed to maintain the same area, i.e. 4.6 weeks (Enjeux et impact
technico-économique du retrait du glyphosate et du changement de pratiques de désherbage,
Enquête CTIFL 2019 sur les pratiques de désherbage en arboriculture fruitière, Ctifl, Mai 2020).
According to this survey and the INRAE report in 2020 (Alternatives au glyphosate en arboriculture :
évaluation économique des pratiques de désherbage, Rapport de l’INRAE, publication février
2020), one row shredding equipment can only cover 20 hectares and one tillage equipment only
covers 15 hectares. Thus, farms of more than 20 hectares must invest in a second mechanical
weeding tool, a second tractor of the arboriculture type but also hire a second competent tractor
operator. This material constraint can therefore have a financial impact on large farms.

Dynamic Noix”:
If glyphosate is abolished, walnut farms that include glyphosate in their weed control plan will have
to quickly equip themselves with mechanical weed control tools (the other molecules approved in
France for walnut are less effective and more expensive, and therefore of little interest to
producers). However, at present, the Union of agro-equipment manufacturers in France (AXEMA)
estimates that agri-equipment companies are not able to respond to the estimated demand in a
very short period of time (Solutions alternatives au glyphosate en Viti & Arbo – étude de la capacité
industrielle, Note de synthèse présentée en juin 2020, Union des Industriels de l’Agroéquipement).
In 2020, the production in France of mechanical weeding equipment under the row was 3600 units.
However, approximately 50,000 vineyard and tree farms (including walnut producers) would require
mechanical weed control equipment under the row. It would take about 15 years for agro
and efficacy
equipment companies to be able to supply all arboriculture and viticulture producers (Alternatives
au glyphosate en arboriculture : évaluation économique des pratiques de désherbage, Rapport de l’
INRAE, publication février 2020). The AXEMA report was unfortunately produced before Covid and
does not consider the current shortage of raw materials, such as steel, that the whole world is
experiencing. Thus, the cessation of glyphosate use cannot be sudden and will require time, in
order to allow all farmers to equip themselves with alternate weed control tools, while keeping in
mind that not all nut farms will be able to use alternative methods (technical and agronomic
impasses, financial cost, labour cost, fuel consumption, longer working times, higher number of
passes, yield loss, distortion of competition on the world market).

yield loss of 30%. Glyphosate is never found in the residue analysis we do on apples. We only use Arielle Fraissinet
and efficacy
it on 20% of the gross surface of our orchards. To date, no study has shown the extreme danger of
the product. I am against the suppression of the use of glyphosate.
yield loss of 30%. Glyphosate is never found in the residue analysis we do on apples. We only use Yannick Fraissinet
and efficacy
it on 20% of the gross surface of our orchards. To date, no study has shown the extreme danger of
the product. I am against the suppression of the use of glyphosate.
I support farmers for the use of glyphosate. I prefer to eat healthy, French food. The removal of
glyphosate will lead to an increase in imports. Transporting foreign food will increase pollution. Our Mathieu Darenes
and efficacy
food sovereignty is in question. Therefore I am against the suppression of glyphosate.
I support farmers for the use of glyphosate. I prefer to eat healthy, French food. The removal of
glyphosate will lead to an increase in imports. Transporting foreign food will increase pollution. Our Maxime Bely
and efficacy
food sovereignty is in question. Therefore I am against the suppression of glyphosate.
Submitted as Chemical Group Leader for pesticides in HBM4EU:
Three recent epidemiological studies based on human biomonitering (HMB) for exposure
assessment found adverse associations between maternal urinary concentrations of glyphosate
(Gly) and AMPA in pregnancy and increased risk of preterm birth (Silver et al. 2021) and shorter
gestational length (Lesseur et al. 2021a; Parvez et al. 2018). An additional study found associations
between urinary Gly/AMPA in pregnancy and prolonged Ano-Genital- Distance (AGD) in girl infants
(Lesseur et al. 2021b). None of these studies are included in the RAR (Vol 3, B.6.7-B.6.10). Since
preterm birth is a major public health issue that contributes to potential long-term health effects, and
potential endocrine effects are of major health concern, these studies deserve to be included in the
risk assessment of glyphosate.
The findings are supported by data from some of the reproduction toxicity studies described and
2.06 Reproductive toxicity assessed in Vol 1, p. 316-, Vol 2, and Vol 3 B6.7-6.10. However, AGD in offspring was only Helle Raun Andersen https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
included in one of the regulatory studies (Vol 1, Table p. 342) and the results were not reported
normalized to a measure in pup size as recommended in the OECD guideline 421.
In a study, included from “Published literature” (Table 59, vol 1, p. 356), low glyphosate doses of
1.75 mg/kg/day administered to rats from gestational Day (GD) 6 caused significantly increased
AGD on post-natal day (PND) 4 in male offspring, as well as increased TSH in males dosed with
glyphosate (same dose) for 6 weeks after weaning (Manservisi et al. 2019). Another included study
found lower number of implantation sites in F1 females after administration of a glyphosate-based
herbicide (GBH) through food (2 or 200 mg/kg/day) to pregnant rats from GD9 to weaning. F2
offspring showed lower foetal weight and length and some other effects at the high dose (Milesi et
al. 2018) (Vol 1, p. 366-67).
See more information and references in the attached fil
VOLUME 3. B3.1. page 7 "Use of the active substance" / "Orchards and vines"
COOPERATIVE DES PRODUCTEURS DE NOIX LIMOUSIN PERIGORD QUERCY - LIPEQU :
"On a farm scale, the use of mechanical weeding methods has an impact on energy consumption.
and efficacy
For example in walnut : for one producer following a conversion to organic farming, the complete
cutting of his orchard resulted in an increase of about 30% in fuel consumption."
Vol. 3, B.6.8.1, pages 6-321 "Toxicity studies on metabolites and relevant impurities": Glyphosate CIAFA
was registered in Argentina by the end of the 70´s under the pesticides legislation in force. Although (Chamber of
2.09 Toxicological data on no reevaluation was performed locally, Argentina has followed the most recent renewal processes the Argentine
Alejandro Trezeguet
metabolites in the US and UE and is aware of other agencies reevaluation (Australia, Brazil). Industry of
CIAFA (Chamber of the Argentine Industry of Fertilizers and Agrochemicals) agrees with the Fertilizers and
assessments and conclusions achieved. Agrochemicals)
"Vol. 3, B.6.2, pages 112-590 ""Acute toxicity studies"": Glyphosate was registered in Argentina by CIAFA
the end of the 70´s under the pesticides legislation in force. Although no reevaluation was (Chamber of
performed locally, Argentina has followed the most recent renewal processes in the US and UE and the Argentine
2.02 Acute toxicity Alejandro Trezeguet
is aware of other agencies reevaluation (Australia, Brazil). Industry of
assessments and conclusions achieved." Agrochemicals)
CIAFA
(Chamber of
the Argentine
2.03 Short-term toxicity most recent renewal processes in the US and UE and is aware of other agencies reevaluation Alejandro Trezeguet
Industry of
Fertilizers and
CIAFA (Chamber of the Argentine Industry of Fertilizers and Agrochemicals) agrees with the
Agrochemicals)
CIAFA
(Chamber of
the Argentine
2.04 Genotoxicity performed locally, Argentina has followed the most recent renewal processes in the US and UE and Alejandro Trezeguet
Industry of
Fertilizers and
Agrochemicals)
Vol. 3, B.6.5, pages 5-360: Glyphosate was registered in Argentina by the end of the 70´s under the CIAFA
pesticides legislation in force. Although no reevaluation was performed locally, Argentina has (Chamber of
2.05 Long-term toxicity and followed the most recent renewal processes in the US and UE and is aware of other agencies the Argentine
Alejandro Trezeguet
carcinogenicity reevaluation (Australia, Brazil). Industry of
CIAFA
(Chamber of
the Argentine
2.06 Reproductive toxicity followed the most recent renewal processes in the US and UE and is aware of other agencies Alejandro Trezeguet
Industry of
Fertilizers and
Agrochemicals)
CIAFA
(Chamber of
the Argentine
2.07 Neurotoxicity followed the most recent renewal processes in the US and UE and is aware of other agencies Alejandro Trezeguet
Industry of
Fertilizers and
Agrochemicals)
Vol. 3, B.6.8.3, pages 453-612 "Studies on endocrine disruption": Glyphosate was registered in CIAFA
Argentina by the end of the 70´s under the pesticides legislation in force. Although no reevaluation (Chamber of
2.08 Further toxicological was performed locally, Argentina has followed the most recent renewal processes in the US and UE the Argentine
Alejandro Trezeguet
studies and is aware of other agencies reevaluation (Australia, Brazil). Industry of
VOLUME 3 B3.1. page 7 "Use of the active substance"/ "Orchards and vines"
COOPERATIVE DES PRODUCTEURS DE NOIX LIMOUSIN PERIGORD QUERCY : "The non-
approval of glyphosate in Europe could increase a distorsion of competition on the world walnut
market. Currently, there is a gap between countries, linked to differences in production systems :
and efficacy
American walnuts are sold on average 30% cheaper than French walnuts. The increase in
production costs, if there is an end of the use of glyphosate, would widen this gap and weaken the
European sector."
VOLUME 3 B3.1. page 7 "Use of the active substance" / "Orchards and vines"
1.04 Data on application COOPERATIVE DES PRODUCTEURS DE NOIX LIMOUSIN PERIGORD QUERCY - LIPEQU :
and efficacy "Weed and grass control limits water competition on the row and, therefore, allows better
management of water resources."
The Indre and Loire (I&L) Chamber of Agricultural, is commited in the drive for new and innovative
agricultural practices in order to answer societal needs for healthy and environmental friendly
products. Since 1992, the I&L region is a pilot site for substainable development programmes wich
are pionners of agrienvironmental measures. In a region with fragile soils and intermediate
agricural economy, farmers adopted conservation agriculture practices wich includes the use of
glyphosate.
Glyphosate is currently used at the approved rates and enables the removal of intercrop covers,
the renewal of grasslands and weed management in vineyards without using mechanical solutions.
Mechanical weeding consummes fuel wich is a source of GES and has a negative impact on the
Chambre
soil structure (erosion and GES). Research studies on the destruction of grassland in 2019 and the
d'Agriculture
destruction intercrop covers in 2020 and 2021, at the INRAe institute in Nouzilly , have shown that
d'Indre et Loire
1.07 Other comments mechanical weeding needs multiple tractors crossings are never as good as chemical weeding. Christophe Bersonnet
- President :
Indeed there are additional costs from fuel consumption (31 l/ha, INRAe 2020) and from time
Henry Fremont
consumption (an hour and a half more, INRAe 2020). The 2020 INRAe study shows an extra cost of
www.cda37.fr
80 €/ha without the use of glyphosate. This consequences will impact the economical balance of
farms and will compromise the continuity of conservation agriculture practices.
Conservation agriculture practices are suitable techniques for soil erosion control. This type of
agriculture stores carbon in the soil and improves the chemical, physical and biological properties of
the soil wich which reduces nitrate leaching.
In the current context of global warming and the steps taken to reduce the carbon footprint, the end
the use of glyphosate is incoherent.
Environmental, economical and social (pillars of sustainable development) conclusions will be
negative.
General criticism:
There is no room for general criticism in the consultation process. However, this could help to
democratize and improve the process. That is why we would like to add general criticisms for which
there is no classification and we ask for your attention.
1. Form of the documents provided, which were incorporated into the re-authorization procedure for
glyphosate: Confusing presentation of the individual documents (with the enormous number of
pages, this makes it extremely difficult to view and assess the data submitted); 2. In several cases,
the documents are not machine-readable (in documents with a very large number of pages, there
are always individual pages that are not machine-readable and therefore cannot be found in a
Umweltinstitut
1.07 Other comments keyword search, for example.) Christine Vogt
München e.V.
Selection of the public literature on the effects of glyphosate:
The selection method of the public literature (non-industrial studies) and its classification as relevant
or not relevant for the evaluation process must be viewed extremely critically. A study by the French
NGO Generation Futures has shown that in the RAR only a negligibly small proportion of public
studies on glyphosate were simultaneously classified as relevant and without restriction as reliable
for the assessment of the herbicide, namely only 0.4% (30 of around 7,000) of the listed public
studies. At the same time, industry studies that do not meet the requirements of the OECD
guidelines were classified as acceptable. https://www.generations-futures.fr/wp-
content/uploads/2021/11/evaluation-du-glyphosate-un-rapport-biaise-v4.pdf
Vol. 1, 2.8.3 Summary of fate and behaviour in air, p. 567
The results of the German study “Pesticide pollution of the air” prove that glyphosate is transported
through air for miles. The analysis was initially published in 2020 and has now been peer-reviewed
by independent scientists and published in the journal "Environmental Sciences Europe".
Glyphosate was detected at every single one of the total 69 measuring points distributed throughout
Germany in both passive air samplers and filter mats. It was found far away from potential fields of
origin, even in national parks like the Bavarian Forest or on the Harzer Brocken. Concentrations
peaked at 3176.8 ng/sample (median: 98.4 ng/ sample). In Vol. 1 of the RAR is recored: „Based on
4.04 Fate and behaviour in Umweltinstitut
glyphosate properties, the active substance is not considered volatile and has no potential for long Christine Vogt
air München e.V.
range transport according to FOCUS guidance Air (2008). However, it should be noted that
glyphosate is quantified in a national exploratory pesticide campaign in air in France.“" The fact that
glyphosate spreads through the air must not only be noted in the approval process. These findings
show that the previous assumptions were wrong and under these conditions a reapproval of
glyphosate cannot be an option.
The comparable monitorings cited in the study mentioned should also be taken into account.
https://enveurope.springeropen.com/articles/10.1186/s12302-021-00553-4
Vol. 3, B.6.4. GENOTOXICITY, p. 5 ff
The experts on genotoxicity (DNA damage) at the Institute for Cancer Research at the Medical
University of Vienna Prof. Dr. Siegfried Knasmüller and Dr. Armen Nersesyan examined 53 studies
of glyphosate DNA damage that were submitted by manufacturers as part of the previous approval
process. Based on these studies, the European Food Safety Authority (EFSA) came to the
conclusion that glyphosate is not genotoxic and with this classification contradicted the Cancer
Research Agency of the World Health Organization (IARC), which classified glyphosate as
Umweltinstitut
2.04 Genotoxicity genotoxic. In reviewing these studies, the professors also came to a different conclusion. Only 2 of Christine Vogt
München e.V.
the 53 studies that were used for the current EU approval of glyphosate can be classified as
"reliable" according to their analysis. The majority (34 of 53 studies) rated them as “not reliable”
and the remaining 17 as only “partially reliable”. It should not be repeated that studies have
classified glyphosate as Non-DNA Damaging. The report of the Viennese experts must absolutely
be taken into account and the studies submitted by the industry should be critically examined when
in the last detail. Inadequate studies should not be accepted as reliable.
https://www.global2000.at/sites/global/files/Analyse-Glyphosat-Studien.pdf
Vol. 3, B.6.5. LONG-TERM TOXICITY AND CARCINOGENESIS, p. 5 ff
The International Agency for Research on Cancer (IARC) of the World Health Organization (WHO),
tested the active ingredient glyphosate based on what was available to it (only publicly available
studies) in 2015 and came to the conclusion that
- Glyphosate is "probably carcinogenic in humans" (carcinogen group 2A)
2.05 Long-term toxicity and Umweltinstitut
- there is sufficient evidence available that glyphosate is carcinogenic in laboratory animals Christine Vogt
carcinogenicity München e.V.
Furthermore, the IARC found a positive relationship between glyphosate and
the occurrence of non-Hodgkin lymphoma (malignant lymph gland cancer that occurs in all
Organs of the human body).
IARC: Carcinogenicity of tetrachlorvinphos, parathion, malathion, diazinon, and glyphosate. Lancet
Oncology, March 20, 2015, http://monographs.iarc.fr/ENG/Monographs/vol112/mono112-09.pdf
Vol 1 2.9.1.1 Acute toxicity to birds p. 577 ff,
Vol 1 2.9.1.2 Short-term dietary toxicity to birds p. 579 ff
Vol 1 2.9.1.3 Sub-chronic and reproductive toxicity to birds p. 580 ff
Vol 19 B.9.1.1. Effects on birds p. 4 ff
Vol 19 B.9.1.4. Other data on effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and
5.01 Birds and other amphibians) p. 55 ff Umweltinstitut
Christine Vogt
terrestrial vertebrates München e.V.
The studies submitted were each carried out with only 10 birds instead of the required 20. In
addition, these 10 were kept in a very small space (in some cases less than half as much as
prescribed). Despite these conditions, the RMS tolerates the studies submitted by the applicant.
The birds tested belonged exclusively to the order Galliformes and Anseriformes. Drawing
conclusions from these larger birds to small songbirds does not seem feasible.
Vol 3, B.9.3. EFFECTS ON ARTHROPODS pp. 468
The negative effects of glyphosate (GLY) and GLY-based herbicides (GHB) on non-target
arthropods is mainly related to the disturbed or fully inhibited symbiosis with their microbiota. The
consequences of morbidity must be assessed with time frames exceeding the 72h mark in Vol 3, B.
9.3. Longer time frames are needed to gain a full understanding of the long-term effects of GLY on
crucial pollinators. Studies related to indirect effects must be considered when assessing the
renewal of GLY for their far-reaching implications, not only direct effects as in MON 52276.
One study by Motta et al. (2020) on oral and topical exposure to GLY of honeybees found a
disturbance of bee health and increased morbidity and mortality. The inhibition of the shikimate
pathway via GLY and GHB changed the bee's gut microbial community via a reduction of beneficial
5.03 Bees and non-target bacteria. This was observed in a dose-dependent way and left these arthropods more vulnerable to Umweltinstitut
Christine Vogt https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
arthropods infections due to a compromised immune response. Increased susceptibility to infection in insects München e.V.
after GLY/GHB exposition is also brought forward in a study by Smith et al. (2021) who further point
out the relevance of melanin for arthropod immunity. Its production is also inhibited by GLY/GHB in
addition to the adverse health effects from disturbed microbial symbiosis. Increased mortality has
been observed in GLY/GHB-exposed caterpillars when faced with fungus infection. Kiefer et al.
(2021) present another study on adverse effects of GLY/GHB on arthropod's nutritional
endosymbionts: symbiont establishment in the host beetle was inhibited by GLY/GHB and
negatively impacted cuticle growth and melanization, leaving arthropods with a weakened immune
response. Overall, the adverse effects on endosymbionts of arthropods highlight an indirect but
highly worrisome effect on non-target arthropods. Given accelerated declines in insect populations,
glyphosate must not be granted reapproval in the EU
Vol. 3, B.9.4. EFFECTS ON NON-TARGET SOIL MESO- AND MACROFAUNA p. 531 ff/Vol. 1,
2.9.9.4.1 Summary of risk assessment for earthworms p.703
For the conclusion of the RMS that an acceptable risk to earthworms when using MON 52276 can
be expected, only three studies were used, two of which are not related to MON 52276, but on
AMPA or to the active ingredient glyphosate itself. For the studies that have been submitted by the
applicant, two different earthworm species were studied, both of which are among the so-called
compost worms that live epigeal. In the studies, the compost worms were not fed dead plant
material treated with glyphosate, but rather the animals were kept in substrate treated with
5.04 Earthworms and other glyphosate for the study. No negative effects could be found. There are 3,000 different earthworm
Umweltinstitut
non-target soil macro- and species worldwide, 400 in Europe and almost 50 in Germany alone. Compost worms, as used in Christine Vogt https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
München e.V.
mesofauna the studies, hardly occur in arable soils. Other species are found here. However, according to the
results of the studies mentioned, the applicants do not even have to submit further tests under more
realistic conditions. The studies carried out and required in this form by the competent authorities
are not sufficient to determine the real risk that glyphosate poses for earthworms.There are
numerous studies that show that glyphosate-containing agents do pose a risk to earthworms. In
view of the great importance that earthworms have for maintaining soil fertility, among other things,
they must be taken into account in the risk assessment. Furthermore, a revision of the requirements
of the approval procedure for the direct and indirect effects of pesticides on earthworms is urgently
needed.
Vol 1, 2.9.6 Summary of effects on terrestrial non-target higher plants p. 664 ff;Vol 1, 2.9.9.6
Summary of risk assessment for terrestrial non-target higher plants p 704 ff;Vol 29, B.9.11. Effects
on terrestrial non-target higher plants p 328 ff;Vol 30, Part 7 References for assessment of indirect
effects via trophic interactions for non-target terrestrial plants discussion p 84 ff
The studies that have been submitted by the applicant only investigate crop-plants. In this section,
the risk for non-target higher plants in off-field situations is evaluated. It is therefore questionable
why no studies concerning non-target plants have been submitted or included. In addition, studies
concerning the off-field situation are completely missing. The submitted studies only investigate
effects of GLY on crop-plants. Ferreira et al. (2017) determine GLY effects on over 20 native
species, showing that some plant species die with very low rates while others are herbicide tolerant.
5.06 Terrestrial non-target Umweltinstitut
These herbicide tolerant non-target plants could become established as new weeds. Glyphosate Christine Vogt https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
higher plants München e.V.
off-target drift could therefore promote the loss of biodiversity and the selection of new weeds. The
risk to non-target plants is considered acceptable, when risk mitigations are implemented. These
calculations regarding buffer zones did not take in account the influence of wind and rain for
example (see point 4.04 Fate and behaviour in air). The German study “Pesticide pollution of the
air” prove that glyphosate is transported through air for miles. As studies are missing, it is doubtful
that the buffer zones provide sufficient protection. The effect of GLYin a forest was completely
excluded from the evaluation. Here, glyphosate is used in order to reduce populations of plants
competing with merchantable conifers. Golt et al. (2021) showed, that GLY has severe effects on
reproductive morphology of Rosa acicularis, a highly prevalent understory shrub. Effects still
detected 2 years after GLY application.
Vol. 3, B.9.6. EFFECTS ON TERRESTRIAL NON-TARGET HIGHER PLANTS, p. 581ff
Glyphosate acts as a broad spectrum herbicide against all monocotyledonous and dicotyledonous
5.07 Other non-target
plants. Broad spectrum herbicides not only destroy undesirable weeds, but also uncompetitive and Umweltinstitut
terrestrial organisms (flora Christine Vogt
rare wild herb species. The accompanying flora, which plays a key role in biodiversity in agricultural München e.V.
and fauna)
landscapes represents, is one of the most endangered species groups in Europe today. https:
//www.bfn.de/sites/default/files/2021-04/20180131_BfN-Papier_Glyphosat.pdf
Glyphosate is the most widespread herbicide not only in Germany, but worldwide. The use of
glyphosate is associated with massive negative effects on biodiversity. These are difficult to
measure. Nevertheless, particularly due to the immense extinction of species, they must be given a
particularly high level of attention. In view of the ongoing extinction of species, especially insects,
and the associated consequences for humans and the environment, further approval of glyphosate
cannot be regarded as acceptable. The disadvantages associated with the application of
glyphosate far outweigh any advantages.The German Federal Agency for Nature Conservation has
described indirect effects on a large number of wild animals in agricultural landscapes. Through the
use of glyphosate and the associated reduction in flowering wild herbs, the supply of flowers for
5.09 Other comments incl. Umweltinstitut
insects in already cleared agricultural landscapes is further restricted. The food supply of Christine Vogt
available monitoring data München e.V.
herbivorous insects is also reduced in this way. The office also names negative indirect effects on
earthworms with regard to their activity and reproduction. The decline in insects and earthworms, in
turn, leads to a decline in the number of birds and small mammals that use these as a source of
food. Mitigation measures such as buffer strips on bodies of water are not sufficient to reduce the
risk to biodiversity to an acceptable level. The statements of the Federal Office including sources
can be found here: https://www.bfn.de/sites/default/files/2021-04/20180131_BfN-Papier_Glyphosat.
pdf A current study also shows how glyphosate also indirectly harms insects: It can inhibit symbiotic
bacteria that are necessary for the formation of the exoskeleton of some species. This is evident
from studies on beetles. https://www.nature.com/articles/s42003-021-02057-6#Sec7
Vol. 3, B.3.1, pages 6 to 9, Use of the active substance
Hello,
I am a technician in fruit growing.
In addition to all the practical and competitive aspects of glyphosate in fruit growing, I have come to
bring an element concerning the impact of glyphosate on global warming.
If glyphosate is stopped, the most relevant solution seems to be the mechanical working of the soil
on the row. The following comparison can be made:
Starting hypothesis: the orchard rows are planted at 4 meters, that is 2500 linear meters per
hectare. We suppose a device that passes only on one side of the row, that is to say 5000 meters
to be accomplished for 1 hectare.
In chemical weeding with glyphosate: 3 passages per year are necessary to obtain a correct result.
The applications are done at 6 km/h, with an hourly fuel consumption of 4 liters/hour. That is to say: Jean-Michel SERRE
and efficacy
3 passages X 5/6 X 4 = 10 liters of fuel/hectare/year.
With mechanical weeding, 5 passes per year will be necessary to achieve the same result. These
mechanical passages would require the displacement of the irrigation of the ground in air for
approximately ¾ of the orchard which is equipped in this way.
Mechanical weeding is done at an average of 2.5 km/h. The fuel consumption with this type of
device is 10 liters/hour. That is 5 passages X 5/2.5 X 10 = 100 liters fuel/hectare/year.
We should add :
- for weeding with glyphosate: the cost (economic and ecological) of glyphosate.
- for mechanical weeding: the depreciation of the equipment, the replacement of wearing parts, the
cost of the few trees that will inevitably be affected.
Conclusion: the ratio of the carbon footprint in case of abandonment of glyphosate is 1 to 10, i.e.
900% of additional carbon dioxide emissions in case of abandonment of glyphosate!
Hello,
I am a technician in fruit growing.
I propose to evaluate the impact of the end of glyphosate on the consequences in fruit growing. In
addition to all the economic and practical aspects, which have certainly already been widely
developed, I will focus on the impacts on the final fruit.
If glyphosate is stopped, the preferred method appears to be tillage in the row.
In walnut cultivation, the fruit is swept to the ground. On a tilled soil, the shell will be much dirtier
and darker, which leads to more washing afterwards. Despite this, the shell remains darker,
resulting in a lower market value of about 5%.
In fresh fruit (apple, pear, peach, apricot, cherry, ...), soil projections on the fruit, during rain or
1.04 Data on application irrigation, create more favourable conditions for the germination of rot fungi. This would lead to
Jean-Michel SERRE
and efficacy more fungicide treatments, and would nevertheless lead to more commercial disputes, the retailer
and the consumer being very vigilant on this aspect of conservation. Depending on the weather
conditions, the type of fruit and the shape of the trees, we can estimate a loss of value of 0 to 30%,
with an average of 10%.
The average income in arboriculture is 5 to 15% of the gross product. If glyphosate is phased out,
income may become negative, which will lead to orchard grubbing, with all the social and
environmental consequences. Moreover, we will then have to import fruit from less regulated
countries, with a much less controlled quality of fruit, and a CO2 impact for transport.
In conclusion, the abandonment of glyphosate would lead us to carry out more treatments on the
tree and would in fact lead to a lesser value of the fruit produced, even to the abandonment of
production on the local territory.
The hypothesis of the end of glyphosate would have the following consequences for walnut
producers:
- The purchase of row maintenance equipment for an amount of 7,000 to 15,000 €, to be amortized
over 30 ha and 7 years, i.e. a charge of 33 € to 71 € per hectare per year.
- The increase in annual working time is as follows: maintaining the row with glyphosate requires 3
passes at 30 minutes per hectare, i.e. 90 minutes per year. If a row maintenance tool is used,
1.04 Data on application depending on the equipment, it takes 1 hour per hectare and 3 passes to do the same work. It is
and efficacy also necessary to finish the work manually with a backpack brushcutter for 10 minutes per hectare
per year. The total working time is therefore 3 hours, i.e. a doubling of the working time.
- With regard to fuel consumption, the use of glyphosate leads to a consumption of 10 litres per
hour, i.e. 15 litres per hectare per year. The use of a tool, which requires more power, leads to a
consumption of 15 litres per hour or 45 litres of diesel per hectare per year.
The importance of conserving glyphosate is no longer in question in terms of investment, working
time and additional costs.
Paragraph concerned : Vol 3, B3.1, pages 6 to 9
The organisation I represent is responsible for representing the agricultural profession.
If glyphosate were to be phased out, this would have the following consequences for nut growers:
- The purchase of line maintenance equipment for an amount of 7,000 to 15,000 €, to be amortised
over 30 ha and over 7 years, i.e. a charge of 33 € to 71 € per hectare per year.
- The increase in annual working time is as follows: maintaining the row with glyphosate requires 3
passes at 30 minutes per hectare, i.e. 90 minutes per year. If a row maintenance tool is used,
1.04 Data on application depending on the equipment, it takes 1 hour per hectare and 3 passes to do the same work. It is
and efficacy also necessary to finish the work manually with a backpack brushcutter for 10 minutes per hectare
per year. The total working time is therefore 3 hours, i.e. a doubling of the working time.
- With regard to fuel consumption, the use of glyphosate leads to a consumption of 10 litres per
hour, i.e. 15 litres per hectare per year. The use of a tool, which requires more power, leads to a
consumption of 15 litres per hour or 45 litres of diesel per hectare per year.
The importance of conserving glyphosate is no longer in question in terms of investment, working
time and additional costs.

Vol. 3, B.6.2, pages 112-590 "Acute toxicity studies": Glyphosate was registered in Argentina by the
end of the 70´s under the pesticides legislation in force.
Asociación
Although no reevaluation was performed locally, Argentina has followed the most recent renewal
2.02 Acute toxicity Miguel Cané Argentina de
processes in the US and UE and is aware of other agencies reevaluation (Australia, Brazil).
Trigo
ArgenTrigo agrees with the assessments and conclusions achieved
Asociación
2.03 Short-term toxicity Miguel Cané Argentina de
routes":
Trigo
studies in germ cells and information from public literature":Glyphosate was registered in Argentina
by the end of the 70´s under the pesticides legislation in force. Asociación
2.04 Genotoxicity Although no reevaluation was performed locally, Argentina has followed the most recent renewal Miguel Cané Argentina de
processes in the US and UE and is aware of other agencies reevaluation (Australia, Brazil). Trigo

pesticides legislation in force.
Asociación
2.05 Long-term toxicity and Although no reevaluation was performed locally, Argentina has followed the most recent renewal
Miguel Cané Argentina de
carcinogenicity processes in the US and UE and is aware of other agencies reevaluation (Australia, Brazil).
Trigo
pesticides legislation in force. Asociación
2.06 Reproductive toxicity Although no reevaluation was performed locally, Argentina has followed the most recent renewal Miguel Cané Argentina de

the pesticides legislation in force. Asociación
2.07 Neurotoxicity Although no reevaluation was performed locally, Argentina has followed the most recent renewal Miguel Cané Argentina de

Vol. 3, B.6.8.3, pages 453-612 "Studies on endocrine disruption" : Glyphosate was registered in
Argentina by the end of the 70´s under the pesticides legislation in force.
Asociación
2.08 Further toxicological Although no reevaluation was performed locally, Argentina has followed the most recent renewal
studies processes in the US and UE and is aware of other agencies reevaluation (Australia, Brazil).
Trigo
was registered in Argentina by the end of the 70´s under the pesticides legislation in force.
Asociación
2.09 Toxicological data on Although no reevaluation was performed locally, Argentina has followed the most recent renewal
metabolites processes in the US and UE and is aware of other agencies reevaluation (Australia, Brazil).
Trigo
Glyphosate is very important as a tool for regenerative agriculture and conservation agriculture. If it
would be banned 2 thinks would happen. 1. Farmers will need way more other herbicides that do
not degrade so quick in the soil. 2. farmers will do more tillage with all it's negative effects: - pushing
weed to emerge -> more herbizides - destroy homes of beneficial insects -> more insecticides
necessary because of a lack of beneficial insects - high mineralisation of nitrogen what leads to
double the nitrate leaks - mineralisation of soil organic matter means burning of humus, so
producing CO2 while loosing soil health. Not tilling the soil instead leads to using the soil as a
carbon sink - destroyed soil structure leads to 500 times more soil erosion that in notill. Wind
erosion, soil erosion and trouble of water infiltration what can cause wore floods As one of Alexander Klümper
Germanys leading notill farmers (and educator to 5.000 other farmers) I could reduce my fertilizer
demand by 30% and the use of chemicals by 40-50%, the use of Diesel by 40% while having a lot
more wildlife (insects, birds, deers) on my farm and increasing my soil organic matter, be more
resiliant to climate change and produce healthier food just by following the rules on notill and
regenerative agriculture. If glyphosate get banned, in my climate on a latitude of 52 this system will
no more working. Here are 2 more interesting studies about the low toxicity https://www.ncbi.nlm.
nih.gov/pubmed/29110579 https://geneticliteracyproject.org/2020/01/23/glyphosate-harms-soil-
microbes-usda-research-challenges-common-criticism-of-monsantos-roundup-herbicide/
All hazardous substances mut be prohibited everywhere and forever; for our safety and the one of
1.07 Other comments Alexandra MAUDUIT
futures generations. It is a matter of consciousness and responsibility.
It is well known that glyphosate is a dangerous chemical that have been proven to cause cancer in
1.07 Other comments human beings. It is not good for the environment either and should be banned from the market Anders Dreyer
completely. Health and safety comes first.
CIRC 2015: glyphosate = probable carcinogen; M. E. et al., International Journal of Epidemiology
48, 5, p. 1519-1535 + L. Zhang et al., Mutation Research, 781, p. 186-206: highly increased risk of
NHL ; Hoy et al., Poultry, fisheries & wildlife Sciences 2015,3:132: toxicity /wild animals; E. V.. S. Francis Gautier
Motta et al., PNAS oct 2018, 115 (41), p. 10305-10310: increased mortality of honey bees.
Conclusion: Glyphosate is a danger for humans, wild animals and bees.
I am a private person with no scientific background. Living in a rural area, I know, though, that cows
5.09 Other comments incl. have a risen risk of illness with Clostridia. Clostridia are the only microbiota surviving glyphosate.
Ilona Mennerich
available monitoring data The role of microbiota in gut and illnesses is still to be researched. We should not kill microbiota
before knowing them. Glyphosate is killing them. Thanks and Regards, Ilona Mennerich
i PREFER SPRAYING ONCE PER YEAR UNDER THE ROW OF MY WINEYARDS THAN USING
1.07 Other comments BRUN philippe
MUCH MORE FOSSEL FUEL TO DO UNEFFICIANT MECHANICAL WORKS
1.07 Other comments Pour la prolongation du glyphosate Cuisinier Guillaume
Aktuelle Untersuchungen zeigen, dass Glyphosat nicht krebserregend (Kanzerogenität),
unschädlich für das Erbgut (Keimzellenmutagenität), nicht reproduktionstoxisch
(Reproduktionstoxizität) nicht organschädigend (Zielorgan-Toxizität) und für den Hormonhaushalt
nicht gefährlich (kein endogener Disruptor) ist. Die Anwendung als Streifenherbizid in Obstbau-
2.13 Other comments, Dauerkulturen hat im Vergleich zu mechanischen Verfahren der Beikrautregulierung wesentliche
proposals for classification Vorteile : - Maschineninvestition 80 % günstiger - je nach Witterung bis zu 80 % Einsparung von
Arbeitszeit und Kraftstoff (200 l Diesel / ha) - dadurch nachhaltig, energiesparend, klimafreundlich
mit enormer CO2 Einsparung - Schonung von Bodenflora und -fauna, Bodenstruktur und
Feinwurzeln der Obstbäume - mechanische Bodenbearbeitung führt durch oberflächennahe
Feinwurzelschädigung zum Trockenstress bei geringen Niederschlägen.
As a R&D chemist working on developing fertilisers, I am studying a new herbicide based on natural
substances. Briefly, I have discovered that some substances may have activity and they have low
concern on toxicology an ecotoxicology, as stated on ECHA studies. Moreover, bibliography shows
1.07 Other comments many natural substances that may have herbicide activity. By following the precautionary principle,
any dangerouse substance (glyphosate) should be substituted by other alternatives with low risk.
New natural solutions should be marketed in order to be aligned to the new green deal and its
sustainability demand.
For reduce CO2 , using glyphosate is necessary For competivity , using glyphosate is necessary
1.07 Other comments
For biodiversité, using glyphosate is necessary
Jag ser med oro att odlingssystem nu grundar sig på årlig användning av glyfosat på hela arealer.
Med reducerad jordbearbetning och nästan enbart höstsäd bygger man i stor skala upp ett
1.07 Other comments beroende av glyfosat som kraftigt kommer att öka användningen. Idag finns teknik som klara odling
utan glyfosat och det skulle egentligen kunna förbjudas. Om det över huvud taget ska fortsätta
användas behövs en kraftig begränsning per gård och år.
Je suis pour une utilisation renouvelée du glyphosate au delà de 2022 en le réservant aux
1.07 Other comments
professionnels compétents.
Om ett Glyfosat förbud införs i lantbruket är det så gott som omöjligt att bruka små och stenrika
1.07 Other comments åkrar på ett miljövänligt och ekonomiskt vettigt sätt. Ett förbud skulle innebära nedläggning av
dessa åkrar. Detta gynnar inte den biologiska mångfalden i odlingslandskapet.
1.07 Other comments Sono contraria all'utilizzo dei pesticidi.
Vol. 1, level 2, 2.7.10, page 559 Proposed MRLs and compliance with existing MRLs Table 2.7.10-
1: Overview of the proposed MRLs and compliance with existing MRLs for glyphosate “Animals
liver, kidney, fat: “No residues above the LOQ are expected in animal commodities: liver, kidney
and fat when exposed to diet including the (by-products) of intended uses.” This conclusion is not in
agreement with published data. I will cite text from a paper by van Bruggen et al. that is currently in
print in Frontiers in Environmental Science (https://www.frontiersin.org/articles/10.3389/fenvs.
2021.763917/abstract) “Relatively high concentrations (5 - 20 mg/kg) of glyphosate were found in
several other organs of malformed pigs, dairy cows and fattening rabbits (Krüger et al., 2014a;
Krüger et al., 2014b). On average, 2 mg/kg were detected in the livers of malformed pigs in
3.11 Proposed MRLs and
Denmark (Krüger et al., 2014b). However, 5-16 mg/kg were registered in the livers of experimental
compliance with existing
pigs that had received glyphosate amended feed (10-40 mg/kg, the maximum tolerable
MRLs
concentration) in China, while glyphosate was not found in the livers of the control group (Fu et al.,
2020).” All current MRLs and observed glyphosate concentrations are listed in table S1 in the
appendix of this paper in-press. (https://www.frontiersin.org/articles/10.3389/fenvs.2021.763917
/abstract) “The current MRLS for edible offal are 0.5-5.0 mg/kg (EFSA, 2019; EPA, 2020), while the
observed values are 0.0-16.0 mg/kg (EFSA, 2019; FAO, 2005; FAO and WHO, 2016; Fu et al.,
2020; Stephenson and Harris, 2016; van Eenennaam and Young, 2017).“ “Also, the MRLs of fodder
and forage are extremely high: 50-530 mg/kg (Codex Alimentarius, 2013; EPA, 2020), and those
are exceeded sometimes, 1099 mg/kg (FAO, 2005).” Thus, it is extremely unlikely that no residues
above the LOQ are expected in livers or kidneys.
Maintaining the use of glyphosate, Why?
In flinty soils the use of mechanical equipment is very expensive, the management of weeds such
as ryegrass is complicated to bury or destroy mechanically.
The use of glyphosate is an essential alternative for successful oilseed rape planting. In summer,
this success is very much linked to the presence of moisture in the first few centimetres of the soil,
1.04 Data on application as multiple mechanical passes cause this moisture to evaporate. A glyphosate pass without tilling
Pascal ROBERT
and efficacy the soil combined with a simplified or direct seeding allows a successful emergence while
minimising the tilling of the soil which generates human and mechanical costs, diesel consumption
and carbon emissions.
The management of weeds such as thistle is an obvious issue, especially as their presence is
increasing with the growing presence of wasteland and poor management on some organic farms.

it is not classified as carcinogenic, mutagenic or toxic to reproduction, as recognised by several
1.07 Other comments Pascal ROBERT
world agencies
CPIA agrees with the assessments and conclusions achieved.
2.07 Neurotoxicity
carcinogenicity
2.04 Genotoxicity
metabolites
end of the 70´s under the pesticides legislation in force. Although no reevaluation was performed
2.02 Acute toxicity locally, Argentina has followed the most recent renewal processes in the US and UE and is aware
of other agencies reevaluation (Australia, Brazil).
CPIA agrees with the assessments and conclusions achieved
studies
was performed locally, Argentina has followed the most recent renewal processes in the US and UE Ricardo Etienot
studies
ng. Agr. Ricardo Cesar Etienot agrees with the assessments and conclusions achieved."
no reevaluation was performed locally, Argentina has followed the most recent renewal processes Ricardo Etienot
metabolites
2.07 Neurotoxicity Ricardo Etienot
2.03 Short-term toxicity Ricardo Etienot
Ing. Agr. Ricardo Cesar Etienot agrees with the assessments and conclusions achieved."
2.04 Genotoxicity Ricardo Etienot
followed the most recent renewal processes in the US and UE and is aware of other agencies Ricardo Etienot
carcinogenicity
2.06 Reproductive toxicity Ricardo Etienot
end of the 70´s under the pesticides legislation in force. Although no reevaluation was performed
2.02 Acute toxicity locally, Argentina has followed the most recent renewal processes in the US and UE and is aware Ricardo Etienot
Ing. Agr. Ricardo Cesar Etienot agrees with the assessments and conclusions achieved.
Vol.3,B.3.4, pages 10 to 11, Use of the active substance : I’m a farmer, I practice regenerative
1.04 Data on application agriculture and direct drilling, without glyphosate it’s impossible. My farm is in a heavy clay area,
and efficacy without glyphosate and direct drilling, my farm is in bankrupt because it will be impossible to face
multiresistant weeds.
ASOCIACION
ARGENTINA
DE
Vol. 3, B.6.7, pages 6-70 "Neurotoxicity studies in rodents, delayed polyneuropathy studies and CONSORCIOS
publications on neurotoxicity": Glyphosate was registered in Argentina by the end of the '70s under REGIONALES
the pesticides legislation in force. Although no reevaluation was performed locally, Argentina has DE
2.07 Neurotoxicity Eugenia Magnasco
followed the most recent renewal processes in the US and UE and is aware of other agencies EXPERIMENT
reevaluation (Australia, Brazil). ACIÓN
AACREA agrees with the assessments and conclusions achieved. AGRICOLA
(AACREA)-
https://www.
crea.org.ar/
ASOCIACION
ARGENTINA
DE
Vol. 3, B.6.4, pages 5-395 "Genotoxicity, in vitro studies, in vivo studies in somatic cells, in vivo CONSORCIOS
studies in germ cells and information from public literature": Glyphosate was registered in Argentina REGIONALES
by the end of the '70s under the pesticides legislation in force. Although no reevaluation was DE
2.04 Genotoxicity Eugenia Magnasco
performed locally, Argentina has followed the most recent renewal processes in the US and UE and EXPERIMENT
is aware of other agencies reevaluation (Australia, Brazil). ACIÓN
(AACREA)-
https://www.
crea.org.ar/
ASOCIACION
ARGENTINA
DE
CONSORCIOS
Vol. 3, B.6.5, pages 5-360: Glyphosate was registered in Argentina by the end of the '70s under the
REGIONALES
2.05 Long-term toxicity and DE
followed the most recent renewal processes in the US and UE and is aware of other agencies Eugenia Magnasco
carcinogenicity EXPERIMENT
ACIÓN
AACREA agrees with the assessments and conclusions achieved.
AGRICOLA
(AACREA)-
https://www.
crea.org.ar/
ASOCIACION
ARGENTINA
DE
CONSORCIOS
REGIONALES
Argentina by the end of the '70s under the pesticides legislation in force. Although no reevaluation
2.08 Further toxicological DE
was performed locally, Argentina has followed the most recent renewal processes in the US and UE Eugenia Magnasco
studies EXPERIMENT
ACIÓN
AGRICOLA
(AACREA)-
https://www.
crea.org.ar/
ASOCIACION
ARGENTINA
DE
CONSORCIOS
REGIONALES
was registered in Argentina by the end of the '70s under the pesticides legislation in force. Although
2.09 Toxicological data on DE
no reevaluation was performed locally, Argentina has followed the most recent renewal processes Eugenia Magnasco
metabolites EXPERIMENT
ACIÓN
AGRICOLA
(AACREA)-
https://www.
crea.org.ar/
ASOCIACION
ARGENTINA
DE
Vol. 3, B.6.6, pages 6-449 "Generational studies, developmental toxicity studies and information CONSORCIOS
from public literature": Glyphosate was registered in Argentina by the end of the '70s under the REGIONALES
pesticides legislation in force. Although no reevaluation was performed locally, Argentina has DE
2.06 Reproductive toxicity Eugenia Magnasco
followed the most recent renewal processes in the US and UE and is aware of other agencies EXPERIMENT
reevaluation (Australia, Brazil). ACIÓN
(AACREA)-
https://www.
crea.org.ar/
ASOCIACION
ARGENTINA
DE
CONSORCIOS
REGIONALES
end of the '70s under the pesticides legislation in force. Although no reevaluation was performed
DE
2.02 Acute toxicity locally, Argentina has followed the most recent renewal processes in the US and UE and is aware Eugenia Magnasco
EXPERIMENT
ACIÓN
AGRICOLA
(AACREA)-
https://www.
crea.org.ar/
ASOCIACION
ARGENTINA
DE
Vol. 3, B.6.3, pages 5-280 "Short-term toxicity, oral 28-day studies, oral 90-day studies and other CONSORCIOS
routes": Glyphosate was registered in Argentina by the end of the '70s under the pesticides REGIONALES
legislation in force. Although no reevaluation was performed locally, Argentina has followed the DE
2.03 Short-term toxicity Eugenia Magnasco
most recent renewal processes in the US and UE and is aware of other agencies reevaluation EXPERIMENT
(Australia, Brazil). ACIÓN
(AACREA)-
https://www.
crea.org.ar/
Re: RAR Vol 1 - 2.6.1, p67-73 and Vol 3 - B.6.1, p7-102: absorption, distribution, metabolism and
excretion.
Compounds chemically-similar to glyphosate, including methylene diphosphonate and 1-amino-2-

hydroxyethane phosphonic acid analog of serine (see PMID 3712097), have high affinity for bone
matrix due to their phosphonic acid moiety(ies) and accumulate at sites of mineralization, properties
exploited for their use as bone imaging agents.
Industry studies described in the RAR as well as the open literature (see PMID 1916078)
consistently demonstrate that the highest residual levels of glyphosate are present in bone, with up
to ~1% of the administered oral dose remaining associated with the tissue at 1 week post-exposure.
All repeat-dose studies analyzed involve daily oral exposure of animals to unlabeled glyphosate
over 14 days, followed by administration of a single radiolabeled dose, then sacrifice and analysis
2.01 Absorption,
typically 3 days thereafter.
distribution, metabolism
and excretion in mammals
A document made public through court proceedings* reveals GRG members were aware in 2011
that such a "repeat-dose procedure is designed primarily to determine if there are changes in
metabolism (e.g., due to enzyme induction) with repeated dosing", and that "It doesn't really
address the acumulation issue - for this, repeated dosing with 14C material would be required."
Thus, the GRG by their own admission recognizes that repeat-dose studies with labeled test
material, as outlined in the current OECD TG 417, are necessary to evaluate the accumulation and
persistence of glyphosate in bone - yet these studies are lacking.
In summary, the affinity of glyphosate for bone has been shown in nuerous toxicokinetic studies
over the past 30 years, yet its potential for accumulation in the skeleton and the possible health
consequences in humans have yet to be carefully evaluated by regulatory authorities.
*https://www.docketbird.com/court-documents/In-re-Roundup-Products-Liaqbility-
Litigation/Exhibit/cand-3:2016-md-02741-12878-005
1.07 Other comments aucune preuve que le glyphosate est classee cancerigene
Vol. 3, B.3.4, pages 10 to 11, Use of the active substance :
I am a farmer, I practice soil conservation agriculture.
I use glyphosate in a multi-weed control.
Notably :
- Before the late planting of my late sowing crops. Without it I can no longer sow directly in the
intercrop cover which would then have to be destroyed by mechanical means using equipment not
present on my farm such as a plow, harrow ... .So that would require me to have a high re-
investment.
1.04 Data on application - The use of glyphosate allows me to fight effectively on grass weeds resistant to herbicides with an
Julien NAUT
and efficacy efficiency greater than 90%. Today is the only one capable of doing so.
- The use of this single molecule at 360g of active material / ha saves me the use of cocktails of
various molecules in much greater quantities for the same efficiency.
Glyphosate is currently the only molecule allowing me to practice agriculture based on the
biodiversity of my soil, year-round coverage of this soil, crop rotation, and above all the non-working
of the soil by being able to sow directly. The carbon balance of such a practice stores carbon in the
soil and straightens the level of organic matter in the soil. Its ban without an alternative solution
would jeopardize my agronomic system and force me to return to mechanically and chemically
more intensive agriculture.
Use of the active substance. I am a farmer and use glyphosate as an intercrop for fast and efficient
1.04 Data on application weed control. It allows me to do minimal work on the soil before sowing. In some situations I sow
Louis HENAULT
and efficacy directly into the residue from the previous crop in a single pass.
Glyphosate allows me to save fuel and reduce my carbon footprint.
I am a tillage farmer practising Conservation Agriculture principles on my farm in Ireland, these
principles include minimum soil disturbance, cover crops, companion crops, rotation soil testing,
leaf sap analysis straw, chopping, organic manures and composts. All these practices are part of
the system of Conservation Agriculture with the aim of increasing soil health, improving water
quality, reducing emissions, improving food quality, reducing pesticide and fertiliser usage and
improving CO2 sequestration in our soils. BASE Ireland is a group of approximately 90 farmers
from all sectors in Agriculture, the main objective of the group is to promote knowledge and
experience of CA principles. Over the years our members have been able reduce their usage of
herbicides on their farms, including reducing rates of glyphosate (540g/ha). The use of cover crops,
no til and rotation have reduced the reliance on herbicides, however the termination of cover crops Gareth Culligan Base Ireland
and efficacy
is reliant on glyphosate in Ireland as we don’t get the hard frosts to take out the cover crop before
the cash crop is established. Some of the BASE farmers are just using glyphosate (540g/ha) and
no other herbicides on their crops, if glyphosate is banned then more herbicides will have to be
used on crops. As Farmers we have to become more responsible with the use of glyphosate on
our farms and look at the bigger picture of reducing overall pesticide use on farms. Again if
glyphosate is banned it will make it harder for a Farmer to change from conventional farming to
Conservation Agriculture. In Irish conditions no til or min til establishment systems would not work
without glyphosate so there would a switch back to plough based systems and so losing all the
benefits that Conservation Agriculture offer for the environment.
Vol 3,b.3.1 page 6 to 9 , use of the active substance .Hello, I am a farmer, user of glyphosate
because I have been practicing direct seeding for 20 years. I think that the banning of glyphosate
would be a mistake in view of the climatic challenges to come. Indeed, it takes 25 liters of fuel per
ha with direct seeding and glyphosate, against 95 liters with ploughing , to go from preparation to Denis Philippon
and efficacy
harvest. Moreover, to this day, no study could prove a real danger to the use of this chemical , as
long as it is used in reasonable conditions of uses. I think it would be more reasonable to restrict its
use than to ban it.
Volume 3.B-3(AS), B.3.1. “Use of the active substance”, p. 7. “Orchards and Vines”.
CTIFL: we would like to emphasize that a correct weeding of fruit crops is an essential condition for
their competitiveness, and this, whatever the stage of the orchard (and not only in the first 3 to 5
years). The competition for nutrients and water in the soil results in trees that do not grow
sufficiently, do not develop their production volume, and are more subject to alternate bearing. This
results in reduced yields and, for some species, lower fruit size. Competition between weed and
tree is documented by several publications (e.g., DE MONTARD, 1998; GIGLEUX, 2010; BREITH,
2014; ATAY, 2016; FOREY, 2016). The most competitive weed species for fruit crops are those
that grow high with a strong biomass. These can be perennials (a thistle can grow as tall as a
mature apple tree) or annuals (crabgrass, foxtail, barnyard grass, etc.). Perennials with rhizomes
and efficacy
can settle very long in the orchard, and their spread is further amplified by mechanical weeding
methods.
Weeds that are not well controlled also favor the spread of pests and diseases on the fruit crop
(bugs, leafhoppers, plum rust, etc.), the risks of frost damage, and rodent outbreaks. Rodents are
harmful as they nibble the bark and the collar of trees, but also because they eat the tree roots
underground. They can cause the death of a whole plantation. Glyphosate has a very wide action
spectrum (broadleaf and monocotyledonous weeds, annuals, biennials and perennials) and is very
flexible of use (effective also on already tall weeds), which allows to apply it even after a long rainy
period.
Volume 3.B-3(AS), B.3.1. “Use of the active substance”, p. 7. “Orchards and Vines”
CTIFL: Glyphosate is widely used by French fruit growers in IPM orchards: more than 91% of the
farmers use it, and 72% of them only weed their adult orchards with the two active substances
glyphosate and 2,4-D (without any other herbicide). In France, the most common weed control
practice is to spray glyphosate along the rows of the trees, from the age when the trunks are
lignified, and this during the whole life of the orchard.
But in some cases, fruit growers may also need to use glyphosate on the inter-rows: either on the
whole inter-row surface (to prepare the ground before harvesting, especially for some nut species),
or by spot spraying to eliminate weed patches or to enable irrigation sprinklers to rotate, or else in
conditions where the inter-row cannot be mowed (on very stony soils). These practices may
1.04 Data on application concern 31% of French fruit growers.
and efficacy Glyphosate can also be used before planting or on the inter-rows of the very young orchard, in case
of weeds particularly difficult to eliminate by tillage (this concerns 19% of young orchards). Lastly,
with the accelerating ban in France of many herbicidal PPPs based on other a.s. acting by contact,
glyphosate is sometimes used today even on young plantations (with the tree trunks protected from
spraying), to avoid the invasion of young plots by weeds, at a stage of the tree's life when
competition is most critical.
Moreover, fruit growers may also need to use glyphosate for tree stump removal, either as a
prophylactic measure in case of mortality due to dieback pathogens, or in case of tree removal to
recreate light in the orchard for very fast growing plantations (walnut, chestnut, hazelnut, etc.) (cf. «
CTIFL, 2021. Fruit crop weed control: issues and perspectives. Weed management in established
orchards, young plantations and berry crops. Regulatory changes. Ed. CTIFL, 28 p. »).
CTIFL: some physical weeding methods exist and are commonly used in organic orchards. But it is
difficult to generalize them to all IPM orchards: 1) first because the park of machinery is currently
insufficient to supply all French orchards (cf. « AXEMA, 2020. Solutions alternatives au glyphosate
en Viti. & Arbo - Etude de la capacité industrielle. Union des Industriels de l'Agroéquipement »); 2)
second, because these alternative methods are much more expensive to use than herbicides,
which may make French productions lose their competitiveness to imports, and no longer allow
farmers to get an income from their orchard. Moreover, these methods, such as tillage or mowing,
require much more frequent passes, with a consequent increase in GHG emissions and in the use https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
and efficacy
of fossil fuels. Finally, these methods have a series of negative impacts on agronomic aspects: 1)
tillage: injury to roots and trees, faster mineralization and nutrients losses through leaching,
disturbance of earthworms, multiplication of perennial weeds with rhizomes; 2) mowing: tree
breakage, rodent shelter supply, competition; 3) thermal: fleeting effectiveness, plus fire hazard; 4)
ground tarps: insufficient effectiveness, plus a big problem with replacing the perforated films once
the orchard is planted, and then with eliminating the plastics. (« CTIFL, 2020. Issues and technical
and economic impacts of a withdrawal of glyphosate and a change in weed control practices. CTIFL
survey 2019 on weed management in fruit crops. Ed. CTIFL, 57 p. »).
CTIFL: we would like to emphasize that it is important to take into consideration that besides
glyphosate, the choice of authorized herbicidal active substances for weed control in fruit crops has
been greatly reduced in France over the last decade, and has accelerated since 2015. Withdrawal
of Marketing Authorizations for PPPs based on amitrole in 2015, glufosinate and quizalofop-P-ethyl
in 2017, pendimethalin in 2018, pyraflufen-ethyl in 2019, oryzalin, propyzamide and 2,4-D in 2021
(source: ephy-anses website). The active substances that remain authorized for the moment for
weed control on fruit crops have restrictions on their use, with a limit of one application per year,
1.04 Data on application and often only at an early stage of the vegetation cycle of the fruit crop. In the absence of
and efficacy glyphosate, this would no longer enable controlling many weed species (especially perennial
grasses) and implementing rational weeding strategies, by targeting weeds according to their own
annual development cycle. Glyphosate is the only active substance that allows a very good quality
of weed control with a minimum number of applications, thanks to its excellent efficiency if correctly
used, and its ability to leave the tree rows free of weeds for several months. Glyphosate was used
in 2019 at a rate of one to three applications per year by French fruit growers, depending on the
annual rainfall and the specific requirements of the crop. (cf. « CTIFL, 2021. Fruit crop weed
control: issues and perspectives. Weed management in established orchards, young plantations
and berry crops. Regulatory changes. Ed. CTIFL, 28 p. »).
CTIFL: if mechanical weeding devices are used today in organic orchards, it is important to note
that it is totally impossible to apply these methods in some IPM orchards situations, that were
precisely characterized by CTIFL.
Thus, they are not suitable for sloping grounds, stony soils, orchards planted in terrace or trees
planted on mounds, or even in orchards with on-the-ground irrigation systems. Moreover,
mechanical methods are totally incompatible with nut crops in French economic production
systems, which are based on mechanized harvesting of the fruits on the ground. Similarly,
mechanical weeding tools are incompatible with low bush fruit crops (berries species), or with citrus,
whose trees have a large canopy and a down falling port. For these situations and species,
1.04 Data on application abandoning herbicides could lead to the cessation of these fruit productions. It should also be noted
and efficacy that several of the species concerned are minor crops, which have even fewer registered active
substances than other crops representing larger surfaces. For example, nut crops and berry crops
will only have quizalofop-p-buthyl and isoxaben available from 2022 onwards (and, in the case of
berry crops, pelargonic acid whose effectiveness is highly uncertain). In berry orchards, this will be
very insufficient to control weeds and could lead to risks of poisoning by black nightshade, whose
toxic berries could be mixed with the harvested fruits. In the case of nut crops, a perfect weed
control is also required, since the fruits cannot be picked up on the ground by harvesting equipment
if they are caught in clumps of grass. We point out that, even if berry crops represent low
superficies, their production is particularly recognized at the European level, and that nut crops are
part of the fastest growing fruit sectors in France today. As for other fruit sectors, reapproval of
glyphosate is essential for these crops.
Volume 1. 1.5.1. p. 26-27 (4a, 4b, 4c). “Details on representative uses. Post-emergence of weeds.
Orchard crops”
CTIFL: we draw attention to the fact that in the representative uses chosen for the drafting of the
dRAR, in the "fruit crops" section, small fruit crops (blackcurrant, raspberry, redcurrant, blackberry,
1.07 Other comments blueberry) are not mentioned, and neither are olive oil crops. It is important not to forget them in the
uses to be maintained for glyphosate, especially since in France, very few other herbicide
molecules are authorized on these crops. On the other hand, the "small fruit" species, which are
characterized by a bushy habit, are very poorly adapted to the application of mechanical weed
control methods
Volume 1. 1.5.1. p. 26-28 (4a, 4b, 4c, 5a, 5b, 5c). “Details on representative uses. Post-emergence
of weeds. Orchard crops. Vines.”
CTIFL: we would like to point out that in the 23 representative uses mentioned, in the lines
concerning fruit crops, the maximum rate per application mentioned seems to be lower than the
effective rates for the targeted weed categories. Today, the effective rates are: 1) against
perennials: 2880 g a.s. per treated area, in one application; 2) against annual and biennial
broadleaf weeds: 2160 g a.s. per treated area, in one application; 3) against annual grasses: 1440
g a.s. per treated area, in one application. However, Section 4a indicates a maximum of 1440 g a.s.
1.07 Other comments per hectare, Section 4b a maximum of 1080 g a.s. per hectare, and Section 4c a maximum of 720 g
a.s. per hectare. However, studies show that reductions in glyphosate rates are risky, with
insufficient efficacy and risk of developing resistance ("Arvalis 2015. Low volumes are possible, but
dose reductions are risky. Arvalis Infos"). If, in adult orchards and in the most common cases, the
treated area concerns 20 to 50% of the orchard, it seems important to us to underline that the
effective doses, at the treated area, must be maintained. The same is true for table grapes (which
are related to the uses listed in headings 5a, 5b and 5c). Moreover, in certain situations identified as
technical impasses, the possibility of spraying 100% of the surface should be maintained. This has
been highlighted in the comparative evaluation realized by ANSES for France in 2020.
Volume 1. 1.5.1. p. 22-25 (1a, 1b, 1c, 2a, 2b, 2c). “Details on representative uses. Pre-sowing, pre-
planting, pre-emergence; Post-harvest, pre-sowing, pre-planting”
CTIFL: we would like to point out that the representative uses selected in the dRAR, in the "pre-
planting" sections, do not mention the use of glyphosate in pre-planting of fruit crops. However, the
use of glyphosate before planting an orchard is sometimes necessary, especially when the previous
1.07 Other comments crop makes the land available too late in relation to the date of planting trees, or in the case of a
previous crop that is particularly infested by perennial weeds, which must then be treated with
glyphosate to prevent their spread in the future orchard. In both cases, the main targets are
perennial weeds. This type of use of glyphosate is currently authorized in France under the
following uses: "General treatments*Weed control*Cultivated areas before planting" and "General
treatments*Weed control*Before planting".
Volume 1. 1.5.1. p. 22-31. “Details on representative uses”
CTIFL: we note that the 23 representative uses selected in the dRAR do not include the use of
glyphosate for stump removal. It seems to us that it is important to maintain this possibility of using
glyphosate, which is necessary in fruit crops in the following two types of situations: 1) elimination of
1.07 Other comments suppressed tree stumps in case of dieback caused by quarantine organisms (Plum Pox Virus,
European Stone Fruit Yellows phytoplasma, Pear decline, etc.); 2) removal of trees in case of
clearing of tree plantations for tall fruit species (walnut, chestnut, hazelnut, etc.). This use is
currently authorized in France in the use "General treatments*Devitalization*Stands and stumps"
and "General treatments*Stump destruction".
Vol. 3, B.3.1, pages 6 to 9, Use of the active
substance: I am a farmer and I practice soil conservation
Indeed, the choice of not tilling the soil but having a permanent cover, implies to be able to destroy
this cover in an efficient way. For this, there are no other methods than glyphosate. philippe demiot
and efficacy
To fight against invasive plants such as quackgrass or ragweed, we do not know of any chemical
method more effective than glyphosate. If we use the mechanical method, we will need five to six
passes of tools, which will be more expensive and will take much longer to implement.
Volume 1. 1.5.4. p. 33-50 (4a, 4b, 4c, 5a, 5b, 5c). “Overview on authorisations in EU Member
States.”
CTIFL: We point out that the authorized uses of glyphosate in France are not listed in these tables,
as they are based on the formulation MON 52276, which has no registered use in France. In
1.07 Other comments France, fruit crops use glyphosate for the following six authorized uses: Fruit crops*Weed
control*Installed crops, Grapevine*Weed control*Installed crops, General treatments*Weed
control*Installed crops, General treatments*Weed control*Before planting, General
treatments*Weed control*Cultivated areas before planting, General
treatments*Devitalization*Standing trees and stumps.
Le juge administratif français s’est prononcé à de nombreuses reprises sur la dangerosité du
glyphosate, estimant qu’il existait une « présomption suffisamment établie de dangerosité et de
persistance dans le temps des effets néfastes pour la santé publique et l’environnement des
produits » (Tribunal administratif de Cergy-Pontoise, 8 novembre 2019, n°1912597 ; Tribunal
administratif de Cergy-Pontoise, 8 novembre 2019, n°1912597).
A la lumière du principe de précaution tel que défini par le juge européen (CJUE National Farmers’
Union et autres du 5 mai 1998, C-157/96, Royaume-Uni c. Commission du 5 mai 1998, C-180/96 et
Commission c. France du 28 janvier 2010, C-333/08), le juge administratif français a annulé les
autorisations de mise sur le marché français des produits phytopharmaceutiques « Transform » et «
Closer » en prenant le soin de rappeler la jurisprudence européenne en matière d’application du
principe de précaution, qui prévoit que « lorsque des incertitudes subsistent quant à l’existence ou
1.07 Other comments
à la portée de risques, des mesures de protection peuvent être prises sans avoir à attendre que la
réalité et la gravité de ces risques soient pleinement démontrées » (Tribunal administratif de Nice,
29 novembre 2019, n° 1704687, 1704689, 1705145 et 1705146, Association Générations Futures
et autres).
Le juge administratif français n’hésite pas non plus à valider les annulations de mises sur le marché
de certains produits comme le Roundup Pro 360, en application du principe de précaution (Cour
administrative d’appel de Lyon, 29 juin 2021, n°19LY01031).
En effet, l’ANSES par une décision du 6 mars 2017 avait décidé d’autoriser la mise sur le marché
du Roundup Pro 360, produit phytopharmaceutique contenant du glyphosate. Or, le juge
administratif relève que le principe de précaution n’a pas été respecté en l’absence de mise en
œuvre d’une procédure d’évaluation des « risques suspectés » depuis 2013 pour le glyphosate.
les pesticides polluent l’air que nous respirons.
L’étude « Pesticides et effets sur la santé » de 2021 de l’INSERM, évoquée ci-avant, indique que «
(…) les résidus de pesticides sont présents dans les différents compartiments environnementaux (l’
air, le sol, l’eau, les denrées alimentaires) qui peuvent être des sources d’exposition pour la
population générale ».
De son côté, Airparif, l'association de surveillance de la qualité de l'air en Île-de-France, a publié le

11 mai 2016 une étude sur la présence de pesticides dans l'air, à la campagne et en ville.
4.04 Fate and behaviour in Or, un air pollué est vecteur de maladie et notamment de maladies respiratoires comme le Covid.
air
En 2003 déjà, une étude chinoise montrait le lien entre la pollution de l’air et les cas létaux de
Syndrome Respiratoire Aigu Sévère (SRAS) (un virus de la famille de celui qui est responsable du
COVID-19). Les patients contaminés vivant dans des régions modérément polluées avaient 84%
plus de risques de mourir que les patients de régions peu polluées. Ceux vivant dans les régions
avec des niveaux de pollution élevés avaient, quant à eux, deux fois plus de risques de mourir du
SRAS (Yan Cui et al., « Air Pollution and Case Fatality of SARS in the People’s Republic of China:
An Ecologic Study », décembre 2003, Environmental Health 2, no 1).
Par suite, le rôle de la pollution de l’air a été évoqué pour expliquer l’explosion des cas de Covid-19
comme l’indiquent le Guardian du 7 avril 2020 ou le Monde du 30 mars 2020.
Une étude de 2021 de l’Institut national de la santé et de la recherche médicale (INSERM),
établissement public à caractère scientifique et technologique français spécialisé dans la recherche
médicale, intitulée « Pesticides et effets sur la santé », affirme : « Le glyphosate et son métabolite l’
AMPA sont des contaminants retrouvés dans les produits alimentaires, des produits agricoles bruts
ou des produits transformés ». -S’agissant de la génotoxicité, « les différents modèles
expérimentaux montrent des résultats positifs in vitro et in vivo (…).En comparaison des niveaux d’
exposition, plusieurs tests in vitro observent des effets génotoxiques à des concentrations proches
2.04 Genotoxicity
de celles qui peuvent être détectées dans l’environnement. À titre d’exemple, en France, les
concentrations de glyphosate ne dépassent pas 0,07 mg dans les eaux de surface ; cette valeur est
donc proche de celle induisant des effets génotoxiques sur A sur Oreochromis niloticus. » Le
rapport souligne que les nombreux travaux publiés expriment des résultats plutôt positifs quant à un
effet génotoxique ; en revanche les deux essais sont négatifs en ce qui concerne les effets sur la
mutagenèse.Le rapport met également en lumière des effets en terme de cytotoxicité et de mito
toxicité.
ou des produits transformés ». Le rapport conclut ainsi : « en résumé des nouvelles données
renforcent la présomption d’un lien entre glyphosate et le risque de LNH dans les populations d’
agriculteurs (présomption moyenne). Cette conclusion repose d’une part sur la méta-analyse
récemment publiée par le consortium de cohorte d’agriculteurs Agricoh (…) et sur les trois méta-
2.05 Long-term toxicity and analyses analyses récentes réalisées à partir d’études anciennes montrant systématiquement un
carcinogenicity risque augmenté. »
En dehors du lymphome non-hodgkinien sont évoqués également :
- le myélome multiple qui qualifie de faible la présomption du lien entre risque de myélome multiple
et exposition au glyphosate, cette faiblesse s’expliquant par la faiblesse des cohortes.
-le lymphome de Hodgkin : Risque élevé mais à la limite de la signification statistique. Les données
n’existaient pas dans les conditions de l’expertise collective de 2013. Aujourd’hui, il existe une
présomption de lien entre l’exposition au glyphosate et la leucémie sur la base des résultats de la
cohorte AHS.
Il en va de même des cancers de la vessie.
ou des produits transformés ». Le rapport met également en lumière des effets pro œstrogéniques
via des récepteurs aux œstrogènes constatés à de fortes mais aussi à de faibles doses. Le rapport
considère que le glyphosate pourrait être un perturbateur endocrinien agissant au niveau des
fonctions de développement ou/et de reproduction.
Le 18 mars 2019, une méta-étude réalisée par une quinzaine d’épidémiologistes issus d’une
dizaine d’institutions de recherche internationale a été publiée dans la revue International Journal of
Epidemiology. Cette méta-analyse, « Pesticide use and risk of non-Hodgkin lymphoid malignancies
in agricultural cohorts from France, Norway and the USA: a pooled analysis from the AGRICOH
consortium », a combiné les données de trois grandes cohortes constituées en France, en Norvège
et aux Etats-Unis.
Les chercheurs ont évalué l’exposition de plus de 300.000 agriculteurs ou travailleurs agricoles de
ces trois Etats, pendant plus de dix ans, avec pour objectif de calculer le surrisque de lymphome
pour les agriculteurs utilisant un pesticide donné, et ce par rapport à ceux n’y ayant pas recours.
L’étude concernait trente-trois pesticides différents, dont le glyphosate, qui avait été utilisé par 36 %
2.10 Medical data and
des agriculteurs français, 38 % des agriculteurs norvégiens et 83 % des agriculteurs américains
information
des études de cohorte. Il en ressort que 2.545 premiers cancers lymphoïdes incidents ont été
observés dont 434 cas étaient des lymphomes diffus à grandes cellules B (DLBCL), le plus courant
des lymphome non hodgkinien (LNH), cancer du système lymphatique, caractérisé par une
prolifération anormale des lymphocytes B ou T, entraînant une baisse globale du système
immunitaire. D’après les résultats de cette méta-analyse, le glyphosate est associé à un surrisque
de 36% de ces DLBCL.
Deux études menées aux Etats-Unis, l’une dans l’Etat de Washington (Caballero et coll., 2018) et l’
autre dans le Nebraska (Wan et Lin, 2016), mettent en exergue une augmentation significative du
risque de développer la maladie de Parkinson avec l’exposition environnementale au glyphosate.
Une étude cas-témoins réalisée en Californie (Von Ehrenstein et coll., 2019), a montré une
augmentation du risque de troubles du spectre autistiques chez les enfants en lien avec une
exposition prénatale à certains pesticides
Du point de vue de la jurisprudence européenne, autoriser la mise sur le marché d’un produit tel
que le glyphosate, en se contentant de balayer les centaines d’études produites et affirmant la
dangerosité du produit serait parfaitement illégal.
En effet, il est rappelé que dans la décision précitée du 1er octobre 2019, le juge européen
considère que si le règlement 1107/2009 ne détaille pas la nature des essais et des analyses et
des études auxquelles les produits phytopharmaceutiques doivent être soumis avant de pouvoir
bénéficier d’une autorisation (point 113) :
« (…) il ne saurait être conclu que le règlement 1007/2009 dispense le demandeur de fournir des
tests de carcinogénicité et de toxicité à long terme portant sur le produit phytopharmaceutique visé
par la demande d’autorisation.
2.13 Other comments, (114) Dans ce contexte, il convient de rappeler que conformément à l’article 4 paragraphe 3 sous
proposals for classification b), et à l’article 29 paragraphe 1, sous e), de ce règlement, un tel produit ne peut être autorisé que
s’il est établi qu’il n’a pas d’effet nocif immédiat et différé sur la santé humaine, une telle preuve
devant, conformément à l’article 29 paragraphe 2 dudit règlement, être apportée par le demandeur.
(115) Or, un produit phytopharmaceutique ne saurait être considéré comme satisfaisant à cette
condition lorsqu’il présente une forme de carcinogénicité ou de toxicité à long terme ».
Le produit ne peut donc être autorisé que si les doutes sont levés et que différentes données
scientifiques permettent d’écarter tout risque de génotoxicité.
A défaut, le produit doit être interdit. C’est la raisons pour laquelle, en France, comme évoqué
précédemment, l’ANSES a décidé de retirer du marché 36 produits à base de glyphosate, en raison
de « l’absence ou de l’insuffisances de données scientifiques permettant d’écarter tout risque
génotoxique ».
The assessment on neurotoxicity in the RAR is flawed. It is designed to put industry's studies on a
platform of reliability, while the studies of independent scientists are disregarded and dismissed as
a standard procedure.
On neurotoxicity, we could easily identify 20 important independent studies that demonstrated that
Glyphosate is a neurotoxicant while the RAR only captured 3 or 4. The way these 3 or 4 are
evaluated is scientific misconduct. They are dismissed because they are not following OECD
protocols. And because they have no GLP certificate. And don't include HCD data. This is putting
the scientific world upside-down.
Industry studies have a massive conflict of interest and it was no coincidence that there have been
high numbers of fraud in the past with test labs. That's why OECD and GLP came around in an
attempt to stop the fraud. WE however still have no good data to demonstrate if the fraud and
manipulation has stopped, In the case of Glyphosate (Monsanto) it clearly hasn't. So why this 100%
2.07 Neurotoxicity
confidence in industry studies?
At the same time independent academic studies are disqualified by you because not being OECD
and GLP. This is crazy. Independent scientists have no interest in the pesticide and their studies
are protected by peer review. Independent studies therefore should be put at the highest level of
confidence and not at the lowest as you do.
Asking for HCD as a condition is only revealing that the RAR assessment is done with a certain
ideology. HCD after all is an industry invention! Just to widen the control limit and to increase the
chance of harmful effects being dismissed. No independent scientist would ever use HCD. It is a
violation of the precautionary principle. Concurent controls should be the only way to analyse
outcome,.
A full chronic neurotoxicity test shall be ordered from the applicants given the weight of the
evidence on neurotoxicity in independent studies, before a decision on the renewal can be taken.
Attached is PortierComments.zip containing two separate pdf documents.
PortierChronicCarcinogenicityStudies.pdf provides comments on the animal carcinogenicity data
evaluated by the Assessment Group on Glyphosate (AGG) (14 sections, 2 appendices).
The first 5 sections deal with: S1 - failure to use one-sided statistical p-values (tumour protection is
not an interest in this risk evaluation); S2 – the lack of a consistent analysis plan creating bias in the
overall evaluation; S3 – incorrect use of historical control data to exclude positive findings; S4 – a
failure to use an objective, quantitative evaluation of consistency of response across the same
tumor in multiple studies; and S5 – incorrectly excluding findings at top doses in several studies.
The next 8 sections deal with tumour types: S6– malignant lymphomas, S7– kidney tumours, S8–
haemangiosarcomas, S9– hemangiomas, S10– skin keratoacanthomas, S11– skin basal cell
tumors, S12– hepatocellular adenomas, S13– other tumours.
Section 14 summarizes overall findings and rejects the AGG conclusions.
App. 1 addresses reduction in the probability of detecting a true positive finding. Christopher Portier https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
carcinogenicity
App. 2 contains technical corrections.
PortierEpidemiology.pdf addresses the epidemiological studies included in the AGG draft
evaluation.
The first section addresses direct evidence (see Appendix 1) of exposure misclassification in the
imputed exposures and indirect evidence of exposure misclassification in the respondents to the
most recent update by Andreotti et al. (2018).
The second section addresses the differences between the North American Pooled Project (NAPP)
study population and the original study populations.
The third section describes three publications not mentioned in the original draft review.
The fourth section comments on the study by Leon et al. (2019).
In the last section (five), argues that the correct category for the epidemiological literature is limited
evidence in humans.
the pesticides legislation in force. Although no reevaluation was performed locally, Argentina has Cazenave y
2.07 Neurotoxicity Santiago M. Casares
followed the most recent renewal processes in the US and UE and is aware of other agencies Asociados SA
Cazenave y Asociados agrees with the assessments and conclusions achieved."
2.08 Further toxicological Cazenave y
was performed locally, Argentina has followed the most recent renewal processes in the US and UE Santiago M. Casares
studies Asociados SA
legislation in force. Although no reevaluation was performed locally, Argentina has followed the Cazenave y
2.03 Short-term toxicity Santiago M. Casares
most recent renewal processes in the US and UE and is aware of other agencies reevaluation Asociados SA
Argentina by the end of the 70´s under the pesticides legislation in force. Although no reevaluation Cazenave y
2.04 Genotoxicity Santiago M. Casares
was performed locally, Argentina has followed the most recent renewal processes in the US and UE Asociados SA
2.09 Toxicological data on Cazenave y
no reevaluation was performed locally, Argentina has followed the most recent renewal processes Santiago M. Casares
metabolites Asociados SA
Cazenave y
2.02 Acute toxicity performed locally, Argentina has followed the most recent renewal processes in the US and UE and Santiago M. Casares
Asociados SA
pesticides legislation in force. Although no reevaluation was performed locally, Argentina has Cazenave y
2.06 Reproductive toxicity Santiago M. Casares
followed the most recent renewal processes in the US and UE and is aware of other agencies Asociados SA
2.05 Long-term toxicity and Cazenave y
followed the most recent renewal processes in the US and UE and is aware of other agencies Santiago M. Casares
carcinogenicity Asociados SA
Hello,
I am a technician in fruit growing
In addition to all the practical and competitive aspects of glyphosate in fruit growing, I have come to
bring an element concerning the impact of glyphosate on global warming.
If glyphosate is stopped, the most relevant solution seems to be the mechanical working of the soil
on the row. The following comparison can be made:
Starting hypothesis: the orchard rows are planted at 4 meters, that is 2500 linear meters per
hectare. We suppose a device that passes only on one side of the row, that is to say 5000 meters
to be accomplished for 1 hectare.
In chemical weeding with glyphosate: 3 passages per year are necessary to obtain a correct result.
The applications are done at 6 km/h, with an hourly fuel consumption of 4 liters/hour. That is to say:
3 passages X 5/6 X 4 = 10 liters of fuel/hectare/year. Jean-Michel SERRE
and efficacy
With mechanical weeding, 5 passes per year will be necessary to achieve the same result. These
mechanical passages would require the displacement of the irrigation of the ground in air for
approximately ¾ of the orchard which is equipped in this way.
Mechanical weeding is done at an average of 2.5 km/h. The fuel consumption with this type of
device is 10 liters/hour. That is 5 passages X 5/2.5 X 10 = 100 liters fuel/hectare/year.
We should add :
- for weeding with glyphosate: the cost (economic and ecological) of glyphosate.
- for mechanical weeding: the depreciation of the equipment, the replacement of wearing parts, the
cost of the few trees that will inevitably be affected.
Conclusion: the ratio of the carbon footprint in case of abandonment of glyphosate is 1 to 10, i.e.
900% of additional carbon dioxide emissions in case of abandonment of glyphosate!
(Note: I repeat this comment, because I did not receive an acknowledgment of receipt on November
19)
Vol.3, B.3.1, pages 6 to 9, Use of the active substance, orchards and vines.
France Pistache : Pistachio cultivation is not currently authorized in France to use glyphosate. As in
any orchard, the weeding of the row allows to limit the hydric and mineral competition of the weeds
on the row, which is particularly important for the young trees. Moreover, since pistachio trees are
sensitive to humid situations, strict weed management at the base of the tree is a key factor for
success. In these situations, the usefulness of glyphosate is obvious because the other existing
and efficacy
active substances lack efficiency and/or are too selective and more expensive. The current
alternative to glyphosate is row tillage, which is not always an ideal technique that can be
transferred to all orchards: its cost is very high (specific material and work time) and its carbon
footprint is not very relevant. Finally, it requires the suspension of the irrigation equipment, which is
difficult to reconcile with mechanical harvesting.
EFFAT supports an harmonised classification of glyphosate (CAS 1071-83-6) as a minimum as
carcinogenic category 1B according to the CLP criteria because of the evidence provided in the
following studies:
1)The International Agency of Research on Cancer (IARC) classified glyphosate as “probably

carcinogenic to humans” in 2015.
2)Zhang et al, Exposure to glyphosate-based herbicides and risk for non-Hodgkin lymphoma: A
meta-analysis and supporting evidence. Mutat Res. 2019 Jul - Sep; 781:186-206. doi: 10.1016/j.
mrrev.2019.02.001. EFFAT -
3)Maria E Leon et al. Pesticide use and risk of non-Hodgkin lymphoid malignancies in agricultural European
cohorts from France, Norway and the USA: a pooled analysis from the AGRICOH consortium. Int J Federation of
Epidemiol. 2019 Oct 1;48(5):1519-1535. doi: 10.1093/ije/dyz017 Enrico Somaglia Food, https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
carcinogenicity
4)Portier, C.J. A comprehensive analysis of the animal carcinogenicity data for glyphosate from Agriculture and
chronic exposure rodent carcinogenicity studies. Environ Health 19, 18 (2020). https://doi.org/10. Tourism Trade
1186/s12940-020-00574-1 Unions
5)Denis D. Weisenburger. A Review and Update with Perspective of Evidence that the Herbicide
Glyphosate (Roundup) is a Cause of Non-Hodgkin Lymphoma. Clinical Lymphoma, Myeloma and
Leukemia, 2021,Vol. 21, No. 9, 621–630. https://doi.org/10.1016/j.clml.2021.04.007
Given the evidence of the carcinogenicity of glyphosate in animal studies and the compelling link
between exposure to glyphosate-based herbicides and increased risk for non-Hodgkin lymphoma in
human epidemiological studies, EFFAT therefore calls on EFSA to apply the cut-off criteria of
Regulation (EU) No 1107/2009 and ban glyphosate as an active substance in herbicide products in
the renewal process which is expected to end in 2022
EFSA should consider the 13-week pilot study run by the Ramazzini Institute in Bologna in 2019.
This study demonstrates that exposure to glyphosate-based herbicides from prenatal period to
adulthood induced endocrine disruptive effects and altered reproductive developmental parameters
EFFAT -
in male and female rats:
European
Manservisi et al, The Ramazzini Institute 13-week pilot study glyphosate-based herbicides
Federation of
2.13 Other comments, administered at humanequivalent dose to Sprague Dawley rats: effects on development and
Enrico Somaglia Food,
proposals for classification endocrine system; Environ Health. 2019 Mar 12;18(1):15. doi: 10.1186/s12940-019-0453-y.
Agriculture and
Another recent study has proven glyphosate acts as an endocrine disruptor in the case of exposure
Tourism Trade
during pregnancy:
Unions
Lesseur et al. Maternal urinary levels of glyphosate during pregnancy and anogenital distance in
newborns in a US multicenter pregnancy cohort. Environ. Pollution. Volume 280, 1 July 2021,
117002. https://doi.org/10.1016/j.envpol.2021.117002
EFFAT notes that in the glyphosate renewal dossier submitted by the applicants in 2019, all 38
genotoxicity studies on “pure” glyphosate that were previously accepted as valid or supplementary EFFAT -
have been re-submitted for the purpose of the current evaluation. However, the following scientific European
report indicates that these studies cannot be considered as reliable: Federation of
2.04 Genotoxicity Armen Nersesyan and Siegfried Knasmueller “Evaluation of the scientific quality of studies Enrico Somaglia Food,
concerning genotoxic properties of glyphosate” available at Agriculture and
https://s3.amazonaws.com/s3.sumofus. Tourism Trade
org/images/Evaluation_scientific_quality_studies_genotoxic_glyphosate.pdf Unions
EFFAT is therefore of the opinion that these studies should not be considered by EFSA.
"Vol. 3, B.3.1, pages 6 to9, Use of the active substance:I am a farmer. Glyphosate is essential for
1.01 Identity the management of dangerous, toxic, allergenic and invasive plants. mechanical solutions are not Malou Claude
sufficient and consume a lot of diesel
Vol. 1, 2.8.1 Summary of fate and behaviour in soil. Rate of degradation in soil. Assessment in
relation to the P-criteria (pages 561-562). Please review, there’s a mistake in the following
paragraph: “When considering DT90/3.32 when degradation was best described by biphasic model,
estimated DT50 values at 20ºC for glyphosate are > 120 days in 1 soil over 10 (18 Acres, DFOP
DT90/3.32=177 d) and >180 days in 2 soils over 10 (18 Acres, DFOP DT90/3.32=177 d and Arrow, Spanish
FMOC DT90/3.32=500 d).” DT50 values of 177 d and 500 d are both > 120 d and only the second Ministry for
4.01 Route and rate of is > 180 d. Ovejas Ecological
Almudena
degradation in soil Zapata Transition and
Vol. 3, B.8.1.1.4.2, page 548, Field studies. “RMS highlights that for AMPA the two field DT50 Demographic
would only cover a pH of 7.8. Since AMPA was shown to be more persistent in laboratory under Challenge
acidic conditions, this range of pH investigated in field would not be sufficient. In any case, a data
gap for additional field data is identified”. Just to point out that this data gap was already required in
EFSA Peer review 2015: “degradation of the major soil metabolite AMPA needs to be investigated
in acidic soils (pH = 5–6)”
Spanish
Vol. 3, B.8.2.2.3, page 1004, Water/sediment studies with AMPA as test item. Please review, in Ministry for
water and sediment and
“Table 8.2.2.3-34: List of existing and new water/Sediment studies on AMPA” the year reported for Ovejas Ecological
effect of water treatment Almudena
Annex point CA 7.2.2.2.3/021 is 1991, but the Report year in page 1022 is 1999, one of these data Zapata Transition and
procedures on the nature
is not correct. Demographic
of residues
Challenge
Vol. 3, B.8.3.1.3, page 1285, Summary of route and rate of degradation in air. It is concluded:
“Based on glyphosate properties, the active substance is not considered volatile and has no
potential for long range transport according to FOCUS guidance Air (2008). However, it should be
Spanish
noted that glyphosate is quantified in a national exploratory pesticide campaign in air in France”. In
Ministry for
the referred guidance, regarding the values to consider a substance as volatile, the FOCUS air
4.04 Fate and behaviour in Ovejas Ecological
group points out the potential uncertainties of measurements: “The determination of vapour Almudena
air Zapata Transition and
pressures especially of older compounds may still have uncertainties today”. Glyphosate acid
Demographic
vapour pressure study was conducted 30 years ago (1991) and result is below the trigger to
Challenge
consider the substances as volatile. The more recent study (2012, using the K salt) results in a
vapour pressure of <1,5 x 10-3 Pa (20ºC) indicating the potential to reach the air from soil and from
plants. A more recent glyphosate acid study should be required.
Vol. 3, B.8.5.3, data point CA 7.5/002, page 101, Assessment and conclusion by RMS. The highest
value of exceedances is 8,9% in Spain (Table 8.5-30). The concern increases considering that
those results cannot be related to any use pattern of glyphosate, and that the proportion of false
negative linked to a total absence of glyphosate containing product use cannot be evaluated in the
whole data set.
Spanish
Regulation (EU) 546/2011 prevents authorisation of products when the concentration of the active
Ministry for
substance in groundwater may be expected to exceed 0.1ug/l, unless it is demonstrated
4.09 Other comments incl. Ovejas Ecological
scientifically that under relevant field conditions it is not exceeded. The data clearly demonstrates Almudena
available monitoring data Zapata Transition and
that exceedances may be expected.
Demographic
Challenge
Vol. 3, B.8.5.8, page 733, Monitoring data in air. New studies/assessments. The RMS concludes:
“Although the frequency of quantification for glyphosate is quite high and unexpected when
considering its intrinsic properties (vapour pressure, DT50 in air), further data would be necessary
to confirm these observations”. Please, see our comment about the potential uncertainties of
volatilisation and vapour pressure measurements for older compounds (4.04. Vol. 3, B.8.3.1.3)
Please consider for this section the following cohort studies that we recently published:
Lesseur C, Pathak KV, Pirrotte P, Martinez MN, Ferguson KK, Barrett ES, Nguyen RHN,
Sathyanarayana S, Mandrioli D, Swan SH, Chen J. Urinary glyphosate concentration in pregnant
women in relation to length of gestation. Environ Res. 2021 Jul 30;203:111811. doi: 10.1016/j.
Ramazzini
2.06 Reproductive toxicity envres.2021.111811 Daniele Mandrioli
Institute
Lesseur C, Pirrotte P, Pathak KV, Manservisi F, Mandrioli D, Belpoggi F, Panzacchi S, Li Q, Barrett
ES, Nguyen RHN, Sathyanarayana S, Swan SH, Chen J. Maternal urinary levels of glyphosate
during pregnancy and anogenital distance in newborns in a US multicenter pregnancy cohort.
Environ Pollut. 2021 Jul 1;280:117002. doi: 10.1016/j.envpol.2021.
Please consider for this section the following studies that we recently published:
Truzzi F, Mandrioli D, Gnudi F, Scheepers PTJ, Silbergeld EK, Belpoggi F, Dinelli G. Comparative
Evaluation of the Cytotoxicity of Glyphosate-Based Herbicides and Glycine in L929 and Caco2
Cells. Front Public Health. 2021 May 7;9:643898. doi: 10.3389/fpubh.2021.643898.
Robin Mesnage, Simona Panzacchi, Emma Bourne, Charles A Mein, Melissa Perry, Jianzhong Hu,
Jia Chen, Daniele Mandrioli, Fiorella Belpoggi, Michael N Antoniou. Glyphosate and its formulations
2.08 Further toxicological Ramazzini
Roundup Bioflow and RangerPro alter bacterial and fungal community composition in the rat Daniele Mandrioli
studies Institute
caecum microbiome bioRxiv 2021.11.19.468976; doi: https://doi.org/10.1101/2021.11.19.468976
Mesnage R, Teixeira M, Mandrioli D, Falcioni L, Ducarmon QR, Zwittink RD, Mazzacuva F,
Caldwell A, Halket J, Amiel C, Panoff JM, Belpoggi F, Antoniou MN. Use of Shotgun Metagenomics
and Metabolomics to Evaluate the Impact of Glyphosate or Roundup MON 52276 on the Gut
Microbiota and Serum Metabolome of Sprague-Dawley Rats. Environ Health Perspect. 2021 Jan;
129(1):17005. doi: 10.1289/EHP6990.
The attached ZIP contains three reports by renowned experts in genetic toxicology, commissioned
by SumOfUs. They show that glyphosate manufacturers have provided EU authorities with
unreliable and incomplete genotoxicity studies that fail to prove their pesticide is safe. The most
2.04 Genotoxicity Eoin Dubsky SumOfUs https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
important knowledge gaps concern the questions if glyphosate causes DNA-damage in
metabolically competent human-derived liver cells and in inner organs of rodents other than the
bone marrow. Studies which have been published in scientific journals indicate that this is the case.
2.10 Medical data and There are 5 books which declare that Roundup is toxic to human health and the environment, 4
Rosemary Mason https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
information written in 2021.
The Risk Assessment Committee of ECHA's harmonised classification says that glyphosate a
5.02 Aquatic organisms substance that causes toxicity to aquatic life with long lasting effects. A substance that causes this Rosemary Mason
damage to the environment should not have its licence renewed.
Vol. 3, B.3.4, pages 10-11, Field of use envisaged. The use of glyphosate is essential for the
implementation and practice of Conservation Agriculture. In this type of management system, as
tillage is eliminated, weed control is carried out through the application of herbicides, usually
glyphosate, in pre-sowing and pre-emergence, with an average dose of 1 kg/ha of active
substance. There is currently no viable alternative that can replace the use of this herbicide if this
management system is to continue, so not renewing the use of glyphosate would in most cases
lead to the abandonment of this practice and, with it, the loss of all the environmental benefits that it Asociación
brings and that science supports. Española
The report "Conservation Agriculture and the tools for its implementation in the context of the Óscar Veroz Agricultura de
and efficacy
European Green Deal", available at www.agriculturaypactoverde.com, provides an extensive Conservación
analysis of the use of glyphosate in both Conservation Agriculture and conventional agriculture, and Suelos Vivos
the socio-economic impact it would have on the sector in the event of not renewing it and, more
specifically, in the case of Conservation Agriculture practices. The report reveals that in the case of
using alternative products to glyphosate, the cost would be multiplied by 4.3 in the case of a cereal
crop and by 1.9 in the case of a woody crop. Moreover, some of these active substances that could
be an alternative to glyphosate (more expensive) cannot be used in all cases, as some of these
herbicides are not authorised for use on certain crops.
metabolites
in the US and UE and is aware of other agencies reevaluation (Australia, Brazil)
Hugo Oscar Ferreyra agrees with the assessments and conclusions achieved."
2.02 Acute toxicity
Hugo Oscar ferreyra agrees with the assessments and conclusions achieved."
agrees with the assessments and conclusions achieved."
2.07 Neurotoxicity
2.04 Genotoxicity
carcinogenicity
studies
and is aware of other agencies reevaluation (Australia, Brazi Hugo Oscar Ferreyra with the
assessments and conclusions achieved."
Intervention on RAR_06_Volume_3CA_B-3_2021-08-10 page 6
For reasons of agronomy and income, cereal farmers in intermediate zones have stopped
ploughing and practice TCS, simplified cultivation techniques: shallow tillage with destruction of
intercultural weeds by glyphosate. Its ban would lead to a return to ploughing. The impact has been
estimated by INRAE but only in terms of mechanisation costs without integrating the impact of the
farming system and its feasibility. INRA researchers agree (summer 2020 exchanges).
In the summer of 2020, with the support of the Centre de Gestion Agricole, I carried out an estimate
of the organisation of our no-till farm (summary in PJ and detailed study in French available).
The current system, GAEC with 3 partners in an intermediate zone with 330 ha in TCS and 60 ha of
rapeseed in direct seeding with destruction of weeds between crops by using glyphosate, is
compared to 390 ha in ploughing without glyphosate. Balance sheet
Cost of seeding and weeding (1)
Equipment: Ploughing system: 54 824 €, My TCS system: 32 553 €. https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
and efficacy
Glyphosate savings: - 4 678 €.
Loss of sunflower margin versus wheat : 7320 €.
Balance sheet: 24 913 € = 64 €/ha
The difference corresponds to 80% of the income + social charges of one of the three partners.
(1) Comparison based on the mutual aid scale.
(2) Work time (343 h + in ploughing) including 268 h during sowing: obligation to replace 30 ha of
wheat by 30 ha of sunflower, with a lower margin of 244 €/ha.
The data was established on the basis of 2019-2020. Since the increase in the cost of fuel: 950
€/1000 l against 600 € retained for the study with 7800 additional litres consumed in fuel in
ploughing (+36%).
In addition, on the farm's sandy soils, yields have improved by 5-8 quintals and the loamy soils are
more stable.
Michel Vaudour, cereal farmer, partner in the GAEC, has been using TCS for 30 years.
Vol. 3, B.3.4, pages 10-11, Field of use envisaged: I am a farmer in Austria. I practice Conservation
Agriculture on my farm. With a lot of biodiverse cover crops and direct seeding methods it is
possible to produce my products like wheat, rape seed, potatoes or even sugar beets in a CO2
neutral way. I currently store more CO2 in my fields than my products emit. By growing a lot of
diffent cover crops on my fields, weed control is not so easy. I am planting them shortly after the
harvest in summer. In some places on the fields you become weeds. Therefore it is nessesary to
spray something, I use Glyphosate, in spring to get the weeds away. Otherwise it is not possible to
grow biodiverse cover crops and become CO2 neutral. If you have no chemical chance to do
something against weeds, I must do more soil preparation. Soil preparation is more harmfull to the
life in the soil (esp. different fungus and rainworms) than the use of Glyphosate. With direct seeding
methods I have no erosion any more. With soil preparation you have a lot of erosion during heavy Hans Gnauer https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
and efficacy
rains. With a lot of soil preparation it is not possible anymore to produce my farm products CO2
neutral because of the loss of humus caused by erosion. Another aspect is water. In my region we
have an average of 470 mm rainfall per year. Saving water is very important. That is not possible
with soil preparation. Saving water is only possible with direct seeding methods in combination with
good cover crops with a lot of biomass. I use Glyphosate before seeding the crops with 3 l per ha
for normal weeds. For root weeds I use up to 5 l per ha (360 g per liter). In Austria we have the so
called Innovation Farm. There exists 2 years of trails in maize with and without Glyphosate, with
other substances which should substitute Glyphosate and different cover crops and different
methods of soil preparation and also notill. The report is writen in German. I will add the file. Let us
use Gly. in a sustainable way in the future!
Générations makes comments regarding the genotoxicity assessment of glyphosate in the attached
document “Comments of Générations Futures on the genotoxicity endpoint”. These comments are
made in a very detailed way and using EFSA and ECHA guidelines as references. We thank in
advance ECHA and EFSA for reading this document and respond to the questions we have.
The conclusion of our analysis is the following:
Générations Futures asks for not taking any decision regarding the genotoxicity assessment and
the renewal of glyphosate without taking into account all the followings:
1/ All actual relevant studies must be included in the literature search (see the document
“Comments of Générations Futures on the literature search”) Générations
2.04 Genotoxicity Pauline Cervan https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
2/ All available data obtained in fishes should be taken into account in the genotoxicity assessment Futures
3/ Applicant data and public literature studies must be assessed for their reliability in a transparent
and equitable way. A clear method for the reliability assessment of both industry and public studies
and a clear method of the weight of evidence assessment must be provided.
4/ The reliability of applicant studies, especially clastogenicity studies, must be re-considered,
taking into account their major deviations (not meting the acceptability criteria of OECD guideline).
The relevance of the in vivo micronucleus studies without any convincing demonstration of bone
marrow exposure must be questioned.
5/ An in vivo comet assay must be conducted on target organs such as kidney or liver.
Générations Futures maked the count of the percentage of the public literature studies taken into
account in the RAR/CLH report of glyphosate. The results, are detailed in a report (https://www.
generations-futures.fr/wp-content/uploads/2021/11/evaluation-du-glyphosate-un-rapport-biaise-v4.
pdf ). If we consider the whole toxicity and ecotoxicity studies and the studies used for the ED
assessment, only 0.4% (30) of the total number of studies found in the literature search (7188) are
considered as relevant and reliable without restriction.
In consequence, the public literature had no weight in the whole studies weight of evidence
assessment.
These numbers are facts and raise many questions. Is it normal that the differences between
academic science and regulatory science being so huge? What is the purpose of the academic
science and knowledge if it can’t be applied? Are the OECD compliant studies the only ones who
2.13 Other comments, can be used for regulatory purpose? Générations
Pauline Cervan https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
proposals for classification Futures
Beyond these figures, Générations Futures also has specific comments and questions regarding
the document “Glyphosate_RAR_14_Volume_3CA_B6.7 - B6.10_2021-08-10”, section B.6.10.1
Literature search. These comments are detailed in the attached document named “Comments of
Générations Futures on the literature search”. In this document, many flaws regarding the rapid and
detailed assessment and the reliability assessment are described in details and using references to
EFSA and ECHA guidelines.
Considering all the flaws described in the attached document regarding the selection of relevant
studies and the lack of transparency of the reliability assessment of the studies, Générations
Futures considers that the legal requirements regarding the literature search (article 8.5 of the
Regulation 1107/2009) are not met.
No decision regarding the classification of glyphosate and its renewal can be made without taking
into account all the actual relevant available studies.
Vol. 3, B.3.4, pages 10-11, Field of use envisaged:According to FAO Conservation Agriculture (CA)
is a farming system that can prevent losses of arable land while regenerating degraded lands. It
promotes maintenance of a permanent soil cover, minimum soil tillage/disturbance, and
diversification of plant species. It enhances biodiversity and natural biological processes above and
below the ground surface, which contribute to increased water and nutrient use efficiency and to
improved and sustained crop production.
A study of AEAV.SV explains that the change of paradigm that CA implies in land management
systems and the application of the 3 fundamental principles on which its practice is based represent
a method of weed control. Even so, CA faces significant challenges with respect to weeds and their
control. Therefore, the use of plant protection products in CA continues to be a necessary tool to
1.04 Data on application control weeds and numerous studies show how, in addition, the environmental benefits provided by
and efficacy these practices allow an optimization in the use of these products. However, the chemical control of
weeds in CA is necessary for its implementation and development, and it has to respect regulations
currently in force, what guarantees the safe use of these products
Among the products used in the pre-seeding period of the crop, glyphosate alone or in a mixture
with other types of herbicides, such as hormonal ones, is the most common choice among farmers.
Glyphosate controls many of the weeds in the fields under CA. Since glyphosate makes the field
weed-free prior to cultivation, fewer sprayings with other herbicides have to be carried out during
cultivation. To date farmers have no capable alternatives to the use of glyphosate.
Banning glyphosate will not only stop farmers to adopt CA but also send back to tillage – that
increases soil erosion - farmers already practicing CA undermining the benefits of this type of
agriculture in the urgent protection of soil, water, air & biod
Volume 1, 2.6.5.1.1. Short summary and overall relevance of the provided information on long-term
toxicity and carcinogenicity, pages 250-298
Health an
Chapter 2.6.5.1.1 contains a numerous flaws. Some are due to the wrong use of guideline criteria
Environment
others due to mis-interpretation of the data presented. Details with reference to page number and
Alliance
quote from the text are explained in the attachment.
(HEAL),
Furthermore, on page 256 it is stated: “A ‘weight of evidence’ approach should and may be applied,
2.05 Long-term toxicity and Brussels, and
therefore, as a general principle.” However, this approach is not followed. An appropriate weight of Peter Clausing https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
carcinogenicity Pesticide
evidence needs to integrate findings of the rodent carcinogenicity bioassays (tumour incidences)
Action Network
and mechanistic evidence (mode of action). The latter was completely ignored. Potential mode of
(PAN
action was taken into consideration – although not in an integrated manner – by RMS Germany
Germany),
during the 2015 assessment. Since then at least 15 papers using analytical grade glyphosate or
Hamburg
AMPA have been published addressing oxidative stress (a recognized mechanism of
carcinogenicity). Details are explained in the attachment.
Also in Denmark and Sweden we have seen large interest in applying conservation agriculture (CA)
practises.
Already within the first years new CA farmers experience many positive impacts of not tilling their
soils. Erosion by water and wind is avoided. Farmers experience more soil life activity (earth worms
and microbiology, the soil looks and smells healthier!).
CA has a large potential to increase carbon sequestration and hereby making a positive climate
impact by reducing greenhouse gas emissions or by increasing the immissions of CO2 from the
atmosphere into the soil. FRDK,
The important application of glyphosate is for withering weeds prior to seeding or prior to emerging Foreningen for
of a newly seeded crop. At present the only real alternative for weed control is mechanical weeding. Reduceret
1.04 Data on application If glyphosate is banned most conservation agriculture land will be ploughed or tilled with great jordbearbejdnin
Hans Henrik Pedersen
and efficacy negative impacts on soil biodiversity, on climate gas emissions and surface water pollution. g i DanmarK
CA farmers would much dislike to again mechanical cultivating their soils. (The Danish
CA farmers are much aware of not misusing glyphosate. In Denmark farmers have many years of MinTill
experience in applying adapted dosages depending on the weed that are to be controlled (“Use as association)
much as needed and not more”). A recent study of pesticide use among Danish farmers indicated
that the glyphosate use were similar between CA farmers and conventional farmers. Due to
improved biological control, the used of insecticides and fungicides were a bit lower among CA
farmers. These pesticide categories are considered to have larger environmental impact than
glyphosate has.
From FRDK we consider it will have incredible large negative environmental impact if pre-
emergence application of glyphosate is banned for conservation agriculture and for farmer who
wish to reduce tillage to a minimum.
Volume 3.B-3(AS), B.3.1. "Use of the active substance", p7. "Orchard and Vine"
Glyphosate is of particular importance in the weed control strategy for fruit production. Its
withdrawal could lead to technical impasses and considerable agronomic risks. Furthermore, https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
and efficacy
existing alternatives, in particular mechanical weeding, are not sufficiently effective to replace the
use of glyphosate. You will find attached more precise information on these different points.
Volume 1. 1.5.1 p. 26-27 (4a, 4b, 4c)
Small fruits which, due to their agronomic specificity, require the use of glyphosate. In France, the
production of blackcurrants and redcurrants, harvested mechanically, requires weed control in the
heart of the bushes in order to avoid the presence of certain weeds producing toxic berries likely to
be confused with blackcurrant berries (bitter-sweet nightshade (Solanum dulcamara), Bryone
dioica, Belladonna (Atropa belladonna)) In the case of blueberries and raspberries, the planting of
several hectares is underway for industrial outlets. This requires mechanical harvesting, so grass
management has become the main issue that conditions the future of this sector. Therefore, it
seems important to us to maintain the use of glyphosate.
1.07 Other comments Volume 1 1.5.1 p. 22-25 (1a, 1b, 1c, 2a, 2b, 2c) "Details on representative uses. Pre-sowing, pre-
emergence; post-harvest, pre-sowing, pre-planting
The DRAR does not mention the use of glyphosate in pre-planting fruit orchards. However, the soil,
before planting, may be covered with weeds. The use of glyphosate is therefore necessary, as it is
the most efficient active substance to eliminate them.
Volume 1. 1.5.1 p.22-31 "Details on representative uses"

The DRAR mentions representative uses of glyphosate. However, stump removal is not mentioned.
However, this is a fundamental use which allows the elimination of trees contaminated by harmful
organisms and which, in France, are regulated. This use makes it possible to limit the spread of
these organisms (e.g. Sharka).
I am a no till farmer in Greece. In writing this i assume the reader has a minimal understanding of
conservation agriculture and no till farming. Glyphosate is indispensable for the following: 1.
Controlling crabgrass or Digitaria. Nothing grows on crabgrass, it has a hard wire like root and does
not allow any other species to set root even in winter. It spreads via its roots as well as seeds that
form in the middle of our summer. Controlling this weed is a matter of spraying in summer
10ltr/hectare which is necessary only in the infested areas not the whole field. Once sprayed it is
eliminated but may appear in other areas. This practice has not damaged my yields at all but has
1.07 Other comments allowed me to farm infested areas without plowing. 2. The practice of no till requires a chemical Vassilis Christoforakis
burnout of weeds or volunteer seeds in order to give the planted seed a headstart. This is achieved
by spraying 3ltr/hectare and some years even less. 3. The price of glyphosate is uncomprably low
(3 times lower) meaning that in times of global financial uncertainty and unpredictable weather
patterns we can keep producing food in a sustainable way. Banning glyphosate would put me back
to what i call the dark ages. Plowing fields, burning diesel, releasing carbon into the atmosphere,
watching my topsoil runoff, adding more chemical fertilizers to compensate for the loss of organic
matter, looking at my bills and thinking that this is not financially sustainable. Thank you.
Autism Spectrum Disorder (ASD).
In the report, in RAR_14_Vol_3CA_B-6.7 - B-6.10_2021-08-10 p 861, Von Ehrenstein O. S. et al.
(2019) is cited and considered as non-relevant. In RAR_13_Vol_3CA_B-6.6_2021-08-10 p 442, the
applicant explained that this publication in non-relevant after assessment. This publication shows a
risk of autism spectrum disorder associated with prenatal exposure to glyphosate (odds ratio 1.16,
95% confidence interval 1.06 to 1.27). The applicant explains that the exposures in the study are
not documented, and it is irrelevant because the Farm Family Exposure Study (Acquavella et al.
2004) shows no exposure to glyphosate in spouses who lived on farm during the time of glyphosate
application. The RMS must consider that this exposure study is old and conducted by one of the
applicants (Monsanto). Since then, several exposures studies to glyphosate in agriculture have
been published. Ferreira C. et al., Environmental Research 198 (2021) 111294, shows higher levels
2.07 Neurotoxicity Olivier Delmas
of glyphosate in urine of children living at less than 1 km to agriculture areas. These results are
consistent with four other previous studies cited in the paper (two of them are considered relevant
by the AGG). Underlying biological mechanisms of ASD induced by glyphosate become to be
elucidated. In Vol 3, 25) CA B.6.10 the RMS give example and required the applicant to provide
additional literature with autism as search term.
In a systematic review, Ongono, JS et al. Env. Res. (2020) 109646 conclude that in the framework
of environmental risk factors of ASD, novel hypotheses can be formulated about early exposure to
eight pesticides. Glyphosate presented the most salient level of evidence.
Prevalence of ASD increases in many countries especially in America and Europe, and France in
particular. Glyphosate use increases in the same proportions (x2).
Today, glyphosate is the most valuable candidate to develop ASD epidemic.
Vol. 3-CA B.2.15, page 21, and B.5.3, page 740, References Relied On: Reg 1107/2009 under Art
59(3) states that data protection shall only be granted where the applicant has claimed data
protection and have provided for each test and study report the reasons why they are necessary for
the regulatory decision.
The applicants Glyphosate Renewal Group justify the necessity of all the studies included on this
dossier, for which data protection is claimed, with the sentence: “First submission in EU”.
1.07 Other comments
The applicants fail to fulfill the requirements of point (f) of Art 8(1). Stating “First submission in EU”
does not fulfill the requirement to provide the reasons why the study is necessary. The fact that it is
the first time that the study is submitted in EU, does not mean it is necessary. The fact that the
study has not previously been submitted makes it eligible, but it is not a reason or justification why it
is necessary. Without a proper justification on why the studies are necessary, no data protection
should be granted.
Vol. 3-CA B.7.8.8., page 383, References Relied On, reference list: Reg 1107/2009 under Art 59(3)
states that data protection shall only be granted where the applicant has claimed data protection
and have provided for each test and study report the reasons why they are necessary for the
regulatory decision.
3.13 Other comments
should be granted.
Vol. 3-CA B.7.8.8., page 402, References Relied On, reference list: Data protection is claimed for 1
non GLP study (KCA 6.10.1-002). According to Article 59 of Regulation 1107/2009, in order to be
eligible for data protection, a study need to be certified as compliant with the principles of GLP. No
data protection should be granted to this study and the RMS should correct this claim.
Vol. 3-CA B.8.7., page 1328, References Relied On: Reg 1107/2009 under Art 59(3) states that
data protection shall only be granted where the applicant has claimed data protection and have
provided for each test and study report the reasons why they are necessary for the regulatory
decision.
4.09 Other comments incl. does not fulfill the requirement to provide the reasons why the study is necessary. The fact that it is
available monitoring data the first time that the study is submitted in EU, does not mean it is necessary. The fact that the
should be granted.
Vol. 3-CA B.8.7., page 1333, References Relied On: Data protection is claimed for 1 non GLP study
(KCA 7.1.3.1.1-002). According to Article 59 of Regulation 1107/2009, in order to be eligible for data
protection, a study need to be certified as compliant with the principles of GLP. No data protection
should be granted to this study and the RMS should correct this claim.
Vol. 3-CA B.6.10.2, page 923, Reference list: Reg 1107/2009 under Art 59(3) states that data
protection shall only be granted where the applicant has claimed data protection and have provided
for each test and study report the reasons why they are necessary for the regulatory decision.
should be granted.
Vol. 3-CA B.9.11.2., page 821, Reference Relied On: Reg 1107/2009 under Art 59(3) states that
data protection shall only be granted where the applicant has claimed data protection and have
provided for each test and study report the reasons why they are necessary for the regulatory
decision.
5.09 Other comments incl. dossier, for which data protection is claimed, with the sentence: “First submission in EU”.
available monitoring data The applicants fail to fulfill the requirements of point (f) of Art 8(1). Stating “First submission in EU”
should be granted.
Générations Futures maked comments regarding the genotoxicity assessment of glyphosate in the
attached document “Comments of Générations Futures on the genotoxicity endpoint”. These
comments are made in a very detailed way and using EFSA and ECHA guidelines as references.
We thank in advance ECHA and EFSA for reading this document and respond to the questions we
have.
The conclusion of our analysis is the following:
Générations Futures asks for not taking any decision regarding the genotoxicity assessment and
the renewal of glyphosate without taking into account all the followings:
1/ All actual relevant studies must be included in the literature search (see the document
2.04 Genotoxicity “Comments of Générations Futures on the literature search” https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
2/ All available data obtained in fishes should be taken into account in the genotoxicity assessment
3/ Applicant data and public literature studies must be assessed for their reliability in a transparent
and equitable way. A clear method for the reliability assessment of both industry and public studies
and a clear method of the weight of evidence assessment must be provided.
4/ The reliability of applicant studies, especially clastogenicity studies, must be re-considered,
taking into account their major deviations (not meting the acceptability criteria of OECD guideline).
The relevance of the in vivo micronucleus without any convincing demonstration of bone marrow
exposure must be questioned.
5/ An in vivo comet assay must be conducted on target organs such as kidney or liver.
Générations Futures maked the count of the percentage of the public literature studies taken into
account in the RAR/CLH report of glyphosate. The results are detailed in a report (https://www.
generations-futures.fr/wp-content/uploads/2021/11/evaluation-du-glyphosate-un-rapport-biaise-v4.
pdf )
If we consider the whole toxicity and ecotoxicity studies and the studies used for the ED
assessment, only 0.4% (30) of the total number of studies found in the literature search (7188) are
considered as relevant and reliable without restriction.
In consequence, the public literature had no weight in the whole studies weight of evidence
assessment.
These numbers are facts and raise many questions. Is it normal that the differences between
academic science and regulatory science being so huge? What is the purpose of the academic
2.13 Other comments, science and knowledge if it can’t be applied? Are the OECD compliant studies the only ones who
proposals for classification can be used for regulatory purpose?
Beyond these figures, Générations Futures also have specific comments and questions regarding
the document “Glyphosate_RAR_14_Volume_3CA_B6.7 - B6.10_2021-08-10”, section B.6.10.1
Literature search. These comments are detailed in the attached document named “Comments of
Générations Futures on the literature search”. In this document, many flaws regarding the rapid and
detailed assessment and the reliability assessment are described in details and using references to
EFSA and ECHA guidelines.
Considering all the flaws described in the attached document regarding the selection of relevant
studies and the lack of transparency of the reliability assessment of the studies, Générations
Futures considers that the legal requirements regarding the literature search (article 8.5 of the
Regulation 1107/2009) are not met.
No decision regarding the classification of glyphosate and its renewal can be made without taking
into account all the actual relevant available studies.
Je suis agriculteur en système polyculture élevage et pratique le semis direct essentiellement. Le
glyphosate est un atout essentiel dans la gestion des adventices avant toutes mises en place d'une
culture. Depuis 20 ans, j'ai testé des solutions alternatives tels binage, faux semis, labour (solutions
qui assassinent la macrofaune et la microbiologie du sol et ses capacités fertilisantes), rotation
longue...et je n'ai pas trouvé de solutions miracles et surtout pas celle qui détrônera le glyphosate
en terme de gestion d'adventices. J'ai suivi des formations en agriculture biologique( solution qui
1.07 Other comments sylvain rey
présente des atouts environnementaux évidents mais qui ne répondra pas à la demande
alimentaire mondiale à long terme) et dans mon système de production, ce style d'agriculture laisse
planer l'incertitude de récolte 1 année sur 3( le problème est que nous mangeons matin, midi et
soir...). Je ne suis pas adepte des solutions chimiques à outrance et sensible aux problèmes de la
qualité de l'eau mais néanmoins pour garder une certaine viabilité de nos entreprises agricoles,
certaines molécules dont le glyphosate présentent de solides arguments.
Le glyphosate doit être conservé si nous voulons réussir la séquestration du carbone et la baisse
des gaz à effet de serre. Tant qu'il n'aura pas une alternative aussi efficace et aussi peu impactante LABRUNIE Fabien
sur l'environnement, il est indispensable.
Bonjour le glyphosate n'est classé cancérigéne . s'il est supprimé de l'agriculture il sera remplacé
par d'autres phytosanitaires qui seront peu etre pires ça fait 40 ans que j'utilise le glyphosate et je
n'ai pas de problémes de santé
Etant producteur de grains, l'usage du glyphosate est réservé à l'interculture. Il permet de détruire
les vivaces et graminées résistantes avant le semis, ce qui réduit fortement l'utilisation d'autres
matières actives tout en limitant le travail du sol, donc de passages outils répétés, de fioul, de
1.07 Other comments carbone donc. Il est indispensable dans la voie de la conservation des sols avec maîtrise des
couverts et travail minimum du sol. Son interdiction serait synonyme de retour en arrière avec
lessivage et perte de fertilité du sol et plus globalement perte de compétitivité dans les régions
intermédiaires et aux sols fragiles.
Je suis agriculteur et pratique le non labour a 95% sur mon exploitation agricole. Le non labour me
permet de laisser la terre se structurer et me permet aussi d'economiser du temps et du carburant.
Les adventices doivent toutefois etre supprimées avant le semis car une fois les surfaces
encemencées, les produits sont peu nombreux, extrêmement couteux et ne garantissent pas 100%
de reussite. Lorsque je ne laboure pas, j'utilise du glypgosate pour stopper les adventices avant de
1.07 Other comments semer. Ainsi, les champs restent propre et je ne suis pas contraint d'utiliser des produits de
désherbage sélectif a pleine dose. Le glyphosate m'apporte donc une grande sécurité pour mes
cultures. Je pratique aussi de plus en plus le semis direct; sans aucun travail du sol Dans ce cas, le
glyphosate est le moyen le plus judicieux (techniquement et économiquement) de cultiver. Le semis
direct est une technique tres vertueuse du sol, de sa faune et flore, vertueuse pour l'environnement
également.
1.07 Other comments le glyphosate doit rester une molécule utilisable pour maintenir une agriculture compétitive .
For the the General Confederation of Beet growers (CGB), Glyphosate must be renewed. The
reasoned use of this active ingredient can enable sustainable and environmental weed
management.
A non-renewal of Glyphosate would lead farmers into situations of impasse and/or additional costs
in their agricultural practices.
The work carried out by INRAe also highlights situations of technical impasses, where no
alternative in current use can meet the needs of professionals in the short term, without requiring a
substantial change in practices, which would have a strong impact on agricultural activity.
Among these technical impasses, where Glyphosate cannot be replaced by another technique,
whether mechanical or chemical, we can cite
-The case of conservation agriculture and no-till farms
1.04 Data on application -Control of perennial weeds and invasive plants
and efficacy -Mandatory regulated control
-Managing the establishment of spring crops after summer or early autumn ploughing in
hydromorphic and clay soils.
Other situations of complementary impasses are also identified:
-in stony or rocky soils, on steep slopes, when the use of mechanical tools is not feasible
-for the management of perennials/thistles, the use of glyphosate cannot be substituted by an
alternative non-chemical method
-for the management of weeds before sowing, when mechanical tillage is impossible due to the
weather for example or when the use of other herbicides is ineffective or useless, in situations of
resistance for example: without glyphosate, there would no longer be any possibility of destroying
annual weeds, regrowth and plant cover during intercropping.
Also, the use of glyphosate is often an adaptation to a constraint rather than a choice.
The end of glyphosate would generate large additional costs for no-till field crops.
“Vol. 3, B.3.1, pages 6 to 9, Use of the active substance : We are in an era of climate change and
1.04 Data on application the mechanical weeding we practice today is a disaster! We spend more time and diesel, not to
Etienne SAGNE
and efficacy mention all the wearing parts, metal and plastic transmitted into the soil ... Chemical weed control
must continue, glyphosate is part of the solution.
I am a professional user for the destruction of species classified as dangerous and invasive.
ambrosia thistles vulpine are very present on my territory. The mechanical solution alone does not
1.07 Other comments Malou Claude
work because these plants are very resistant. It should also be noted that the mechanical method
consumes a lot of time and fuel because of the need to multiply the passages.
I'm new and young french growers. I practice the no till pratice, without plouwing. For me and for
the futur on my farm, the glyphosate (little dose per hectare arounds 1 or 1.5L/ha max per years) i'ts
essential for the global weeds management. Without glyphosate i would be obliger to use plow and
1.07 Other comments more tillage tools with more diesiel comsumption and more ersosion plroblem. I think that in all vassort antonin
practices it is essential to have all the possible solutions to reduce our impact on the environment
but without losing efficiency and without increasing our environmental impact in another area
(consumption of fossil energy)
There is no other place for this statement so I put it here: Some of the analyses were conducted to
develop expert opinions for court cases and were supported by funding from attorneys involved in
1.07 Other comments Christopher Portier
these litigations. Some of the text in these comments are duplicative of written expert testimony for
these court cases. These funders had no role in the opinions expressed in my comments.
aucune preuve que le glyphosate est cancerigene
Je suis pour le glyphosate, je l'utilise régulièrement car je suis en sans labour depuis de
1.07 Other comments
nombreuses années et j'ai fait 10ans de langue allemande ,je ne comprend rien à l'anglais
Mesdames, Messieurs, Comme vous le savez, le processus de ré-autorisation du glyphosate –
substance cancérigène probable d’après le CIRC – est en cours. Or, un travail minutieux mené par
Générations Futures montre de graves biais dans le dossier d’évaluation réalisé par les états
membres rapporteurs et soumis à la consultation du public. Vous pouvez consulter ce rapport ici :
https://www.generations-futures.fr/actualites/evaluation-glyphosate-biais/ Les conclusions de ce
rapport sont inquiétantes et nous obligent à prendre des mesures immédiates en faisant adopter
une méthode garantissant la prise en compte de toutes les connaissances scientifiques disponibles
1.07 Other comments
de manière équitable et transparente. Dans l’attente de cette réforme nous vous demandons de
vous opposer à la ré-autorisation de cette substance. En effet, comment garantir à vos concitoyens
que cette substance est sans danger, alors même que le dossier censé l’évaluer présente de tels
biais et de telles carences ? Il en va de la crédibilité des instances européennes et de la confiance
à accorder à nos règlementations. Je compte sur vous pour empêcher la ré-autorisation de cet
intrant chimique dévastateur, au nom de notre biodiversité fragilisée et de la santé des citoyens et
citoyennes de ce monde. Bien cordialement
I am plant heatlh manager at Technical Tropical Institute (IT2). IT2 is an agricultural research
Institut
institute approved by French Authorities for tropical and vegetables crops in Martinique and
Technique
Guadeloupe. The principal aim of the institute is to provide efficients and sustainables solutions for
1.04 Data on application Le Moullec- Tropical -
producers issues trough agro-ecologicals pathways. The IT2 actions are articulated around plant Thomas https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
and efficacy Rieu Technical
breeding, bio-agressors integrated management, regulatory support to producers, cropping systems
Tropical
and environment viability.
Institute
Study abstract is too brief to reflect active substance benefits and importance in banana plantations
in Guadeloupe and Martinique. IT2 comments are provided in attachment.
Vol. 3, B.3.1, pages 6 to 9, Use of the active substance: The walnut orchard is the second largest
orchard in France after the apple. It is represented by two production basins in the South-East and
South-West of France.
The surface of the French orchard is 18 000 ha divided for half in each basin.
The two production areas are PDO (PDO Grenoble walnuts and PDO Perigord walnuts).
The annual production is about 38 000 T of walnuts, 30 000 T are marketed in shell and 8 000 T
transformed into kernels (that is to say 2 500 T).
The annual turnover is about 100 million euros for the walnut in shell and 20 million euros for the
kernels.
Depending on the climatic year, the global turnover of the walnut sector can be estimated at 120 to
150 million euros.
and efficacy
The maintenance of the row with glyphosate requires 3 passages at 30 minutes per hectare, that is
to say 90 minutes per year. If a row maintenance tool is used, depending on the equipment, it takes
1 hour per hectare and 3 passes to do the same work. It is also necessary to finish the work
manually with a backpack brushcutter for 10 minutes per hectare and per year. The total working
time is therefore 3 hours, which is double the annual working time.
The average surface of the French nucicultural exploitations does not exceed 10ha. Concerning the
use of glyphosate, a change in row maintenance practices with the suppression of glyphosate
would entail an additional cost that could not be supported by most of them.
I represent Technical Tropical Institute (IT2). Technical Tropical Institute (IT2) is an agricultural
research institute approved by French Authorities for tropical and vegetables crops in Martinique
and Guadeloupe. The principal aim of the institute is to provide efficients and sustainables solutions
for producers issues trough agro-ecologicals pathways. The IT2 actions are articulated around plant
breeding, bio-agressors integrated management, regulatory support to producers, cropping systems
and environment viability.
Banana is one of the most cultivated crop in Martinique and Guadeloupe for a total of 7040
hectares in 2020 with a production of 212 000 tons. It represents 13 percent of utilised agricultural
Institut
area and around 550 farms (AGRESTE from Food and Agricultural Department of France).
Technique
Banana in Guadeloupe and Martinique is one of the onliest agricultural sectors in France that have
1.04 Data on application Le Moullec- Tropical -
successively respect the differents nationals plans ECOPHYTO, ECOPHYTO II and ECOPHYTO Thomas https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
and efficacy Rieu Technical
II+. These plans leaded to a reduction of 50 percent in the use of phytopharmaceuticals products
Tropical
(PPP) in agriculture in France. Control pest in banana is completely integrated with prophylactic
Institute
measures and PPP are used as a last resort.
IT2 is monitoring PPP use in bananas. This sector has drastically reduced the use of PPP since 15
years, in particular for herbicides with a decrease of 70 percent on active substance amount per
hectare and per year. Glyphosate represents 95 percent of herbicides active substance amount per
hectare and per year with around 2 kg/ha/an (internal data – IT2).
Glyphosate-based products are used for banana plantation devitilisation and plant cover seedling
(before set-aside), plant cover destruction (before cultivation) or weeds management. Alternatives
measures are mechanical with machinery or human with small tooling for destruction and weeds
management.
These alternatives involve an higher time spent-o
Ratio AMPA vs glyphosate and relevance of AMPA for risk assessment
Feedback from HBM4EU
Vol. 1, 2.6.9, Summary of medical data and information, p. 473-474.

Vol. 1, 2.6.10, Toxicological end point for assessment of risk following long-term dietary exposure –
ADI (acceptable daily intake), p.487.
Vol. 3, B.6.9.8, Literature data – medical data / treatment / poisoning / exposure, p. 645-707.
Statistical analysis of individual data of very recent human biomonitoring (HBM) studies on internal
exposure of glyphosate (GLY) and AMPA supports the existence of GLY-independent sources of
AMPA. The relevance and impact of which has been recently discussed by Lemke (2021), referring European
to Grandcoin (2017) and JMPR (2011), but is largely missing from the draft Renewal Assessment Human
Report. Biomonitoring
Initiative
2.12 Product exposure and In HBM4EU, GLY and AMPA were determined in children's urine collected recently in Cyprus, HBM4EU -
risk assessment, including Germany, Belgium and Slovenia. The preliminary (unpublished) results combined with recently Jos BESSEMS Horizon 2020 https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
dermal absorption published studies from Germany (Lemke, 2021), Sweden (Faniband, 2021), Spain (Ruiz, 2021) and R&I
Slovenia (Stajnko, 2020) indicate a low but widespread exposure among children with GLY and Programme
AMPA concentrations above 0.1 µg/L in up to 54% of the participants. These internal exposures for under grant
GLY as well as AMPA should be considered separately in the risk assessment, especially agreement No
considering the reduction in ADI from 0.5 to 0.1 mg/kg bw/d and AMPA having a similar 733032.
toxicological profile to GLY (EFSA, 2015). The combined exposure to both GLY and AMPA should
be considered as suggested by the JMPR, proposing a group-ADI for GLY+AMPA (JMPR, 2011).
When regressing AMPA (Y-axis) against GLY (X-axis), the slope of the linear fit is less than 1. At
lower GLY concentrations, AMPA generally exceeds GLY, vice versa at higher concentrations.
This suggests a GLY-independent source of AMPA in the environment, such as environmental

metabolites of amino-polyphosphonates (Grandcoin, 2017).
Details + references in uploaded file.

Pesticide
5.01 Birds and other We would like to bring to your attention the attached list of relevant studies (sections birds and
Martin Dermine Action Network https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
terrestrial vertebrates rodents).
(PAN) Europe
Pesticide
We would like to bring to your attention the attached list of relevant studies (sections Amphibians
5.02 Aquatic organisms Martin Dermine Action Network https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
and aquatic environment).
(PAN) Europe
We consider that the risk assessment on bees has not been complete and that a series of data
gaps must be identified, new studies shall be submitted by the applicant.
We also consider that the studies provided by the applicant are in general of poor quality and that
Pesticide
5.03 Bees and non-target the few ones valid point at major toxicity on non-target non-bees arthropods, in particular those
Martin Dermine Action Network https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
arthropods where glyphosate formulation is directly sprayed on the insects where 100% toxicity is observed.
(PAN) Europe
This is very worrying, considering the current collapse of insect diversity in Europe and that the
conclusions should point at an identified high acute toxicity as well as numerous data gaps.
Please read our comments in the file entitled "Bees and non-target arthropods".
5.04 Earthworms and other Pesticide
We would like to bring to your attention the attached list of relevant studies (sections Terrrestrial
non-target soil macro- and Martin Dermine Action Network https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
environment and Soil microbiota).
mesofauna (PAN) Europe
Vol. 3, B.3.1, pages 6 to 9, Use of the active substance : I'm farmer and doing blackcurrant and
mixed farming.
For me the use of glyphosate is indispansible to my settlements of blackcurrant and to my fields of Patrick Soreau
and efficacy
crop, against weedy; since anyother can't remplace him.
Mr. SOREAU Patrick
From Internal exposure to PDI and comparison to ADI
Feedback from HBM4EU
Vol. 1, 2.6.5.2. Comparison with the CLP criteria regarding carcinogenicity, p. 311.
Vol. 1, 2.6.9. Summary of medical data and information, p. 473-474.
Vol. 1, 2.6.10.1. Toxicological end point for assessment of risk following long-term dietary exposure
– ADI (acceptable daily intake), p.487.
Vol. 3, B.6.1. Absorption, distribution, metabolism and excretion in mammals.
Vol. 3, B.6.9.8. Literature data – medical data / treatment / poisoning / exposure, p. 645-707.
Recent papers on human biomonitoring (HBM) as well as volunteer studies (GLY) have not been
European
included in Vol. 3, B.6.9.8 and Vol. 3, B.6.1, respectively, and so are missing from the risk
Human
assessment (RA) (Vol. 1, 2.6.10). Also, the project HBM4EU has determined GLY in urine collected
Biomonitoring
from four studies.
Initiative
2.12 Product exposure and HBM4EU.
Results indicate widespread GLY exposure, also in children (concentrations >0.1 µg/L in 8-54% of
risk assessment, including Jos BESSEMS Horizon 2020 https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
the samples). High detection rates advocate use of internal exposure levels in RA by using reverse
dermal absorption R&I
dosimetry calculations to predict daily intake (PDI) and then use PDI to verify RA based on TMDI. In
Programme
addition, they support inclusion of HBM in epidemiological studies as indicated in Vol. 1, 2.6.5.2, p.
under grant
311.
agreement No
733032.
Using urinary P95 values (reasonable worst case) we have calculated PDI values and compared to
the ADI. Then the proposed ADI of 0.1 mg/kg bw/d (Vol. 1, 2.6.10.1, p.487) is not exceeded but
actual exposure is certainly not two orders of magnitude below ADI (suggested in Vol. 1, 2.6.9, p.
473). Considering that workers were not specifically included in the HBM studies and that worker
exposure is in general higher than the exposure of the ‘general population’, the margins for safety
might even be smaller for that subpopulation.
It is suggested taking internal exposure information into account in the RA for consumers including
children as well as workers and bystanders.
References, calculations + assumptions uploaded.

CONINAGRO agrees with the assessments and conclusions achieved."
2.04 Genotoxicity
carcinogenicity
2.07 Neurotoxicity
studies
metabolites
The reproductive toxicity analysis appears to exclude several of the adverse effects reported in
scientific literature. The attachment "reproduction" provides an analysis on the adverse effects that
Health and
were observed in the studies submitted by the industry and have not been adequately reported as
2.06 Reproductive toxicity Angeliki Lyssimachou Environment https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
well as a short review (Annex R) on the available scientific literature that clearly report effects of
Alliance
glyphosate on reproduction that could also be endocrine mediated. The conclusion of AGG that
glyphosate does not cause adverse effects on reproduction is incorrect.
The endocrine disruption of glyphosate has not been adequately investigated in the RAR, and the
conclusion that glyphosate is not an endocrine disruptor is not justified by the evidence. The
Health and
2.08 Further toxicological attachment (Endocrine disruption) provides an analysis on the assessment of the endocrine
Angeliki Lyssimachou Environment https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
studies potential of glyphosate carried out by the applicants and AGG, the studies used and the evidence
Alliance
from the available scientific literature that glyphosate causes adverse effects via the endocrine
system.
HEAL supports the IARC classification of glyphosate as “probably carcinogenic to humans”
(equivalent to Cat1B in EU). Pesticide active substances that fall under this category do not meet
the criteria to be approved for market use. IARC's classification was based on “limited” evidence of
cancer in humans and “sufficient” evidence of cancer in experimental animals. IARC also concluded
Health and
that there was “strong” evidence for genotoxicity, both for “pure” glyphosate and for glyphosate
2.04 Genotoxicity Angeliki Lyssimachou Environment https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
formulations. In the attachment "Genotoxicity" we provide an analysis of the studies summited by
Alliance
the industry that according to a recent analysis (Annex G evaluation) only two of these studies were
reliable in terms of methodology. The attachment also provides an analysis of the use of the public
literature were almost all studies were considered unreliable for the assessment. Overall we
disagree with the conclusion that glyphosate does not have a genotoxic potential.
The scientific literature provides evidence that exposure to glyphosate is linked to cancer in
humans, particularly to non-Hodgkin lymphoma. The attachment (carcinogenicity) provides an Health and
analysis of the epidemiology studies, and particularly the Agricultural Health Study, used by AGG to Angeliki Lyssimachou Environment https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
carcinogenicity
assess the link between exposure to glyphosate and development of NHL. We disagree with the Alliance
AGG that there is not enough evidence.
Dynamic Noix”:
The alternatives to chemical weed control in walnut orchards are tillage and shredding. Using these
techniques represents a significant cost for producers. According to the survey carried out in 2019
by Ctifl (Enjeux et impact technico-économique du retrait du glyphosate et du changement de
pratiques de désherbage, Enquête CTIFL 2019 sur les pratiques de désherbage en arboriculture
fruitière, Ctifl, Mai 2020), in the context of walnut orchards, the extra cost of shredding the row is 62
to 206 €/ha/year, compared to two chemical weed control operations per year (glyphosate) The
extra cost of tilling the row is 193 to 473 €/ha/year. The additional costs are attributable to the extra
working time, the investment in mechanical weeding tools and the extra labour costs. The loss of
1.04 Data on application yield is not included in the analysis. Similarly, the values are based on averages (e.g. labour costs
and efficacy and investment rates) and therefore do not represent all the situations and do not indicate optimal
weed control quality. The need to invest in a second mechanical weeding tool for large farms also
increases the additional costs significantly. In a complementary survey by Ctifl in 2019, 47% of
Organic Agriculture arboriculturists (all fruits combined) who shred the row and 62% of Organic
arboriculturists who till the row indicate that these weeding methods would not be economically
viable if they did not value their production as Organic (Le désherbage des cultures fruitières :
enjeux et perspectives. Pratiques en vergers installés, jeunes plantations et cultures de petits fruits.
Evolutions réglementaires. Bilan de l’enquête CTIFL 2019 sur les pratiques de désherbage en
arboriculture fruitière, Ctifl, Juin 2021).

In the chapter 2.6.5.1.1, the same rodent carcinogenicity studies that in 2015 the IARC and more
recenty U.S. courts have taken as evidence of glyphosate carcinogenicity, are taken by the
Glyposate Assessment Group (AGG) as evidence that glyposate is not carcinogenic.
This (false) conclusion had also been drawn by ECHA in 2017. Given the large number of
statistically significant tumor findings in the studies in question (see: B.6.5.18.2. Supporting
publications – Portier, 2020), such a conclusion was only possible through violation of applicable
guidance and guidelines for the assessment of long-term carcinogenicity studies.
In the peer-reviewed essay "Pesticides and public health: An analysis of the regulatory approach to
assessing the carcinogenicity of glyphosate in the European Union" (Clausing et al, 2018), in which
I participated together with Caire Robinson and Peter Clausing, we explain these breaches of GLOBAL 2000,
2.05 Long-term toxicity and Burtscher-
regulations in detail. These include in particular an arbitrary weakening of the significance of Helmut Friends of the https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
carcinogenicity Schaden
statistical analyses; ignoring dose-response relationships; unjustified claims that doses in mouse Earth Austria
carcinogenicity studies were too high, unjustified claims that carcinogenic effects were not
reproducible; and the improper use of historical control data.
Unfortunately, the Glyposate Assessment Group (AGG) seems to have ignored or dismissed our
publication. This is particularly regrettable because the current AGG assessment reiterated most of
the regulatory violations described therein.
With a view to the upcoming peer review process, I would therefore like to recommend that ECHA
examine the arguments in this publication.
Attachment: Clausing P, Robinson C, Burtscher-Schaden. H. J Epidemiol Community Health, Epub
ahead of print: doi:10.1136/jech-2017-209776
Dynamic Noix”: T
The alternatives to chemical weed control in walnut orchards are tillage and shredding. According to
the survey carried out in 2019 by Ctifl (Enjeux et impact technico-économique du retrait du
glyphosate et du changement de pratiques de désherbage, Enquête CTIFL 2019 sur les pratiques
de désherbage en arboriculture fruitière, Ctifl, Mai 2020), these practices are responsible for
significant yield losses linked to hydric and mineral competition from grass on the one hand, and to
1.04 Data on application the destruction of the superficial root system of the walnut trees on the other. These yield losses on
and efficacy walnut trees are estimated at between 587 and 1173 euros / ha / year, for at least 3 years.
However, the decrease in yield can be sustained over time and represent 30% of losses every year.
The losses were calculated by expert opinion (based on organic farms, which use mechanical
weeding) and according to an average valuation price of 2.55 euros / kg of walnuts in conventional
farming. The loss of production can strongly affect the sustainability and resilience of the farm and
make it economically fragile.

In the chapter 2.6.5.1.1, the same rodent carcinogenicity studies that in 2015 the IARC and more
recenty U.S. courts have taken as evidence of glyphosate carcinogenicity, are taken by the
Glyposate Assessment Group (AGG) as evidence that glyposate is not carcinogenic.
This (false) conclusion had also been drawn by EFSA in 2015. Given the large number of
statistically significant tumor findings in the studies in question (see: B.6.5.18.2. Supporting
publications – Portier, 2020), such a conclusion was only possible through violation of applicable
guidance and guidelines for the assessment of long-term carcinogenicity studies.
In the peer-reviewed essay "Pesticides and public health: An analysis of the regulatory approach to
assessing the carcinogenicity of glyphosate in the European Union" (Clausing et al, 2018), in which
I participated together with Caire Robinson and Peter Clausing, we explain these breaches of GLOBAL 2000
2.05 Long-term toxicity and Burtscher-
regulations in detail. These include in particular an arbitrary weakening of the significance of Helmut - Friends of the https://open.efsa.europa.eu/api/calendar/getConsultationCommentFile?consultationId=a0c1v00000HePrzA
carcinogenicity Schaden
statistical analyses; ignoring dose-response relationships; unjustified claims that doses in mouse Earth Austria
carcinogenicity studies were too high, unjustified claims that carcinogenic effects were not
reproducible; and the improper use of historical control data.
Unfortunately, the Glyposate Assessment Group (AGG) seems to have ignored or dismissed our
publication. This is particularly regrettable because the current AGG assessment reiterated most of
the regulatory violations described therein.
With a view to the upcoming peer review process, I would therefore like to recommend that EFSA
examine the arguments in this publication.
Attachment: Clausing P, Robinson C, Burtscher-Schaden. H. J Epidemiol Community Health, Epub
ahead of print: doi:10.1136/jech-2017-209776
Dynamic Noix”:
On walnut orchards with a high presence of stones, the only alternative to glyphosate is to till the
soil in the row. Indeed, the stones limit the natural retention of water in the soil. Competition from
grass would have an even greater impact on the yield, but also on the durability of the trees and
1.04 Data on application their survival, hence the need to pull up the weeds and not to grind them. However, the presence of
and efficacy stones in the soil leads to premature wear of mechanical weeding tools, which need to be regularly
repaired or replaced. The additional cost of maintaining these tools is relatively high, and can
represent a burden that puts farms at risk. Alternative methods to glyphosate are therefore not
technically and economically suitable for all situations and farms.

Commentaires de L'autorité Européenne de Sécurité Des Aliments (EFSA)

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Disruption of the gut microbiota is one of those indications of neuroinflammation.

1)Unacceptable impacts on biodiversity

No evidence that glyphosate itself is detrimental to bees.

Edited by Dr. P Lein and Dr. R Westerink

Bento et al. 2018: https://www.researchgate.

Conclusion RAR (p. 129):

Comment by Inserm (see also Inserm report, p. 22-6):

Our conclusion based on epidemiological studies is supported by experimental toxicology studies

Conclusion RAR (p. 436):

Comment by Inserm: Inserm -

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ArgenTrigo agrees with the assessments and conclusions achieved

ArgenTrigo agrees with the assessments and conclusions achieved

ArgenTrigo agrees with the assessments and conclusions achieved

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Compounds chemically-similar to glyphosate, including methylene diphosphonate and 1-amino-2-

De son côté, Airparif, l'association de surveillance de la qualité de l'air en Île-de-France, a publié le

1)The International Agency of Research on Cancer (IARC) classified glyphosate as “probably

Volume 1. 1.5.1 p.22-31 "Details on representative uses"

Vol. 1, 2.6.9, Summary of medical data and information, p. 473-474.

This suggests a GLY-independent source of AMPA in the environment, such as environmental

Details + references in uploaded file.

References, calculations + assumptions uploaded.

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