WP2 D.2.3 Glyphosate case study

Abstract

Contribution to the REconciling sCience, Innovation and Precaution through the Engagement of Stakeholders Project (RECIPES) funded by the Horizon 2020 Framework Programme of the European Union under Grant Agreement no. 824665.

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WP2 D.2.3 Glyphosate case
study
Sabrina Röttger-Wirtz
The RECIPES project has received funding from the European Union’s Horizon 2020
research and innovation programme under grant agreement No 824665

Glyphosate case study i
Acknowledgments & Disclaimer
This project has received funding from the European Union’s Horizon 2020 research and
innovation programme under grant agreement No 824665.
Neither the European Commission nor any person acting on behalf of the Commission is
responsible for the use which might be made of the following information. The views
expressed in this publication are the sole responsibility of the author and do not necessarily
reflect the views of the European Commission.
Reproduction and translation for non-commercial purposes are authorised, provided the source
is acknowledged and the publisher is given prior notice and sent a copy.
Authors
Sabrina Röttger-Wirtz, Maastricht University
With thanks to:
Laura Drivdal, Rosanne Edlenbosch, Tijs Sikma, Jeroen van der Sluijs, Siebe Rozendal,
Ellen Vos for their insightful comments on an earlier draft.
Manuscript completed in [April, 2020]
Document title
D.2.3. Glyphosate case study
Work Package
WP2
Document Type
Deliverable
Date
13 April 2020
Document Status
Final Draft

Glyphosate case study ii
Abstract
Glyphosate is the world’s most widely used herbicides and the debates surrounding
potential risks associated with it have dominated its recent re-approval in 2017 and will
continue to play a role in the ongoing renewal procedure which was applied for in December
2019.
Paying attention to the risk assessment and risk management phase at EU level as well as
the position of various stakeholders, this case study will analyse the role that the
precautionary principle played in the EU procedures for the re-approval of glyphosate. It
will also discuss how the application of the precautionary principle in this case interacts
with innovation and especially the ‘innovation principle’ which is recently gaining traction
in the EU discourse.

Glyphosate case study iii
Table of Contents
1 Introduction 1
1.1 Introduction 1
1.2 Key timeline 2
2 Glyphosate 4
3 Risks and scientific uncertainties 6
3.1 Risk/threat 6
3.1.1 Potential risks 6
3.2 Scientific analysis 9
3.3 Scientific uncertainty 11
3.3.1 Complexity 11
3.3.2 Uncertainty 12
3.3.3 3.3.3 Ambiguity 13
3.4 Relevance of the PP to the case 14
4 Risk governance and the precautionary principle 15
4.1 Political/juridical dynamics 15
4.2 Other governance dynamics 29
5 The precautionary principle and its future 30
5.1 Reflection on the PP in the literature 30
5.2 Effect of the PP on innovation pathways 33
5.3 Innovation principle 34
6 Synthesis 35
7 Conclusion 36
8 References 38
9 Appendix 45

Glyphosate case study iv
List of abbreviations
ADI
AMPA
BfR
BEUC
DAR
ECHA
EFSA
EU
ERF
GBH
GLP
GMO
IARC
NFU
NGO
OECD
PAFF
PEST
PPP
RMS
SAM
WHO
WP
Acceptable Daily Intake
Aminomethylphosphonic
Bundesinstitut für Risikobewertung /Federal Institute for Risk Assessment
Bureau Européen des Unions de Consommateurs
Draft Assessment Report
European Chemicals Agency
European Food Safety Authority
European Union
European Risk Forum
Glyphosate-based Herbicide
Good Laboratory Practice
Genetically Modified Organism
International Agency for Research on Cancer
National Farmers Union
Non-governmental organisation
Organisation for Economic Co-operation and Development
Standing Committee on Plants, Animals, Food and Feed
Special Committee on Pesticides (PEST)
Plant Protection Product
Rapporteur Member State
Scientific Advice Mechanism
World Health Organisation
Work Package

1
1 Introduction
1.1 Introduction
Glyphosate is used as active substance in herbicides (weedkillers) to control unwanted
plants and is marketed since the 1970s. Because glyphosate is effective on a very broad
range of weeds and not only kills the part of the plant above the surface, but also the plant
tissues below the ground level, it quickly became a widely used pesticide in agriculture,
landscaping, but also in private households. At the time of its introduction glyphosate was
deemed relatively safe to use and even had environmental benefits, as it reduces the need
for tillage, which has bad effects on the soil and releases CO2. However, increasingly
scientific studies and reports of NGOs questioned the safety of glyphosate and glyphosate-
based herbicides, raising concerns about risks to human health and the environment.
This case study will examine the complexities and controversies surrounding the
application of the precautionary principle in the approval of the active substance glyphosate
in the European Union. It will focus on the renewal of the approval of glyphosate as an
active substance in pesticides in the EU, which took place between 2012 and 2017.
The renewal of its approval beginning in 2012 was disrupted when the International Agency
for Research on Cancer (IARC) published a scientific monograph which presented grounds
for concern of carcinogenic potential of glyphosate. Although the European Food Safety
Authority, the European Chemicals Agency, as well as other regulatory bodies around the
world did not classify glyphosate as carcinogenic, the renewal process was accompanied
by public outrage and controversy. The debate concerned studies that have both proven
and disproven carcinogenic effects. Additionally concerns arose whether glyphosate might
act as endocrine disruptor. Moreover, recently also questions are raised if glyphosate poses
unacceptable risks to habitats and biodiversity in farmlands and aquatic ecosystems,
because it is non-selective and potentially harmful for a range of non-target organisms.
The glyphosate renewal procedure in 2017, after a long phase of risk assessment by the
EFSA and ECHA and contestation through the Member States in the comitology committee,
culminated in a renewal of the approval for 5 years. The risk governance in the renewal
procedure as well as the legal framework for pesticides will be analysed in this case study,
with a specific focus on the application of the precautionary principle.
The main goal of the research in this case study is to understand the complexities and
controversies around the application of the precautionary principle in the case of
glyphosate in the EU. Therefore, it will describe the specific context of the case study: legal
and/or policy discussions (environmental, economic, risk policy), as well as social and
cultural context. It will examine how precaution and innovation interact in the case of
glyphosate and if they in tension. It will analyse how the risk properties of complexity,
uncertainty and ambiguity add to this understanding, and how they been understood by
stakeholders (legal, policy makers, risk community). And finally, it will research how
glyphosate challenges the innovation/precaution juxtaposition.

Glyphosate case study 2
1.2 Key timeline
Political
Legal
Science/risk assessment
Public debate
Other
Year
Event
Relevance to case study
1950
Glyphosate creation
N-(phosphonomethyl) glycine, later called
glyphosate, was first synthesised by Dr.
Martin in Switzerland.
1960s
Glyphosate sold to Monsanto
Glyphosate is sold by Dr Martin to the
chemical company Aldrich in 1959 and resold
to Monsanto in 1960.
1970
Discovery of herbicidal
properties
Glyphosate is discovered to be an herbicide
by Monsanto chemist John E. Franz.
1973/7
4
First marketing of Roundup
The first glyphosate based herbicide is
marketed.
1991
Adoption of Council Directive
91/414/EEC
Plant protection products are subjected to a
harmonised authorisation procedures and a
EU level approval of active substances.
2002
Glyphosate approval
Adoption of Commission Directive
2001/99/EC. Glyphosate is now an approved
active substance for plant protection products
in the EU. Before it was authorised in the
Member Sates via national procedures.
2009
Adoption of Plant Protection
Product Regulation 1107/2009
The legal framework for plant protection
products is revised through the adoption of
Regulation 1107/2009. Glyphosate remains
approved and listed in Part A of the Annex of
Commission Implementing Regulation (EU)
540/2011.
2012
Start renewal of approval
procedure
Submission renewal application by the
Glyphosate Task Force. The regulatory
procedure for the renewal of the approval
starts.
2013
Friends of the Earth briefings
The NGO Friends of the Earth publish briefings
raising concerns about risks of glyphosate for
human health and the environment.
2013
BfR Renewal Assessment
Report
The BfR concluded that ‘glyphosate is devoid
of genotoxic potential’ and that ‘classification
and labelling for carcinogenicity is not
warranted’.
2015
IARC hazard assessment
The IARC classified glyphosate as ‘probably
carcinogenic to humans (Group 2A)’, which in
the evaluation scheme of the IARC means that
there was ‘limited evidence of cancer in
humans’ but ‘sufficient evidence of cancer in
animals’.
2015
EFSA risk assessment
Glyphosate is ‘unlikely to pose a carcinogenic
hazard to humans’. EFSA concluded that
glyphosate can be expected to meet the
approval criteria.

Glyphosate case study 3
2016
European Parliament
Resolution
Referring to the precautionary principle the
Parliament called on the Commission the limit
the renewal to 7 years and asked for further
limiting conditions.
2017
ECHA hazard assessment
ECHA concluded that glyphosate is not to be
classified as carcinogenic, moreover it is not
mutagenic and also does not disrupt
reproduction.
2017
European Citizens Initiative
The European Commission received a
European Citizens’ Initiative which called for
the Commission to ban glyphosate, to reform
the regulatory framework for pesticides and to
set reduction target for pesticide use.
2017
European Parliament
Resolution
The Parliament again referred to the
precautionary principle and called for phasing
out the use of glyphosate.
2017
Glyphosate renewal of approval
Approval glyphosate renewal through
Commission Implementing Regulation (EU)
2017/2324.
2019
Start renewal of approval
procedure
The Glyphosate Renewal Group submitted a
renewal application for glyphosate. A new
regulatory procedure for the approval has
started.
2022
Expiry of approval
The renewal of approval granted in 2017
expires. The ongoing procedure will determine
if the approval is prolonged beyond that.

Glyphosate case study 4
2 Glyphosate
The chemical substance glyphosate [N-(phosphonomethyl) glycine] was first created
in the 1950s by the Swiss chemist Dr. Henri Martin (Dill et al 2016). Its herbicidal
properties were discovered by Monsanto (a former US agrochemical company that in 2018
has been acquired by the German chemical company Bayer), which had in the meantime
bought the compound, in 1970. Glyphosate is a pesticide, which are substances that
prevent, destroy, or control a disease or harmful organism, used on plant or plant products
during their production, storage or transport. Within pesticides, it classifies as herbicide
(or weedkiller), which are those pesticides that are used to control unwanted plants, like
weeds that would compete with the crops. In the EU, the term plant protection products
(PPPs) is used: PPPs are pesticides – including herbicides – which are applied to protect
crops or other useful plants in agriculture, forestry or home gardens.
1
Monsanto was the first to market glyphosate as active substance of its herbicide Roundup
in the early 1970s. The active substance glyphosate is the part of the chemical mixture of
the herbicide that acts against the unwanted plants, while the herbicide that is brought to
the market contains other chemicals - so-called co-formulants -, like in the herbicide
Roundup. Glyphosate was patented by Monsanto from 1971 until 2000, but after the
patents had expired, other companies started selling glyphosate-containing herbicides, for
example TouchdownTotal by Syngenta. Reportedly in the US alone 750 glyphosate
containing products are on the market (IARC 2015, p.322).
Glyphosate-based herbicides are used worldwide to remove unwanted weeds not only in
agriculture, but also forestry, gardening and use in public parks, and to remove unwanted
weeds from railways. In Europe, the agricultural use is mostly the application to fields
before a crop is planted, in order to remove weeds that would otherwise compete with the
crop and in some cases it is also sprayed on the crop before harvest to regulate growth.
2
Today, glyphosate is the most commonly used active substance in herbicides
around the world (Benbrook 2016). It also is the most widely used agrochemical in the
world, with a 2008 global sales of 620 000 MT and 8.3 billion US-Dollar (Pollack 2011,
p.116). According to a projection made by Benbrook, in the decade between 2005 and
2014, the global use of glyphosate amounted to 6133 million kg (Benbrook 2016, p.7). In
Germany, as survey carried out amongst farmers led to the estimation that in 2009,
glyphosate-based products were applied to 4.3 million hectares representing 39% of total
arable land (Steinmann et al 2012). Moreover, between 1999 and 2010 the use of
glyphosate in Germany increased by 100% (Steinmann et al 2012).
Glyphosate works through inhibiting an enzyme which plants (but not animals) need in
order to produce the amino acids necessary for the plant metabolism.
3
As this enzyme is
essential to the growth of most plants, applying glyphosate leads to the plant wilting and
dying. It’s wide-spread use is due to its “broad spectrum perennial weed control” (Dill et
al 2010, p.2), it works effectively on a very broad range of plants and not only kills the
part of the plant above the surface, but also the plant tissues below the ground level. At
first, as glyphosate kills all plants that it is applied to including the crops on a field, it first
had limited use in traditional agriculture, but began to be more commonly used before
planting and also pre-harvest for some crops to facilitate faster harvest.
1
See: https://ec.europa.eu/food/plant/pesticides_en, last accessed: 13/4/2020.
2
European Commission, Communication from the Commission on the European Citizens' Initiative
"Ban glyphosate and protect people and the environment from toxic pesticides", C(2017) 8414
final, p. 6.
3
Glyphosate inhibits the enzyme 5 - enolpyruvylshikimate - 3 - phosphate synthase (EPSPS).

Glyphosate case study 5
The use of glyphosate is also closely connected to biotechnology. Genetic modification
has been used to make crops like maize or soy resistant to the herbicidal effects of
glyphosate, which means that a field can be treated with glyphosate and all plants apart
from the herbicide resistant GMO crops will be destroyed.
4
This means, that in the US,
where glyphosate was already popular before the rise of biotechnology it has become even
more widely used, however, in the EU where GMOs are used far less it is a very popular
pesticide (Bozzini 2017). Especially in combination with GMOs, glyphosate was claimed to
have many advantages, the first being that it leads to a reduction of other chemical and
mechanical ways of killing weeds, which were said to be more harmful to the environment
(INGSA 2017). Glyphosate was presented as “relatively harmless because it bound tightly
to soil constituents with little movement through either soil or groundwater, and had a
short environmental half-life with no atmospheric contamination because it is not volatile”
(INGSA 2017, p.2).
Bayer presents glyphosate as environmentally friendly, claiming that as shown by
regulatory assessments it is not a threat to biodiversity, that it is contributing to conserving
land for wildlife by ensuring a productive harvest on the land currently used for agriculture
and that through reducing or eliminating the need for tillage it improves soil health and
reduces carbon emissions.
5
Bayer on its website presents glyphosate as a part of modern innovative farming:
“Introduced as the active ingredient in Roundup® in the 1970s,
glyphosate is a non-selective herbicide, which means that it can
eliminate almost any type of plant to which it is applied – even
desirable plants. It grew in prominence in modern agriculture as an
important tool in Integrated Weed Management after the introduction
of genetically modified crops, which allowed farmers to use the
herbicide in a way that eliminated weeds without harming desirable
plants. Today, glyphosate serves as an active ingredient in hundreds
of crop protection products currently registered and approved for use
in agriculture, vegetation management, lawn care, gardening and
more.
(…) From data gathered from drones, sensors and other digital
technologies to trusted herbicides like glyphosate, there are a host of
tools in the crop protection toolbox that are essential for farmers to
shape a healthy and sustainable future for agriculture.”
6
Farmer’s organisations like the British National Farmers’ Union (NFU) stress that
glyphosate is very important in agriculture and that a withdrawal of approval would have
many negative consequences, including the increased need for tillage leading to a decrease
in earthworms, a decrease in soil organic matter and increasing CO2 emission (NFU 2017).
According to the NFU, they would need 49% more labour per hectare without glyphosate
and would require 546,000 more hectares to grow the same amount of food (NFU 2017).
Finally, Bayer as well as the NFU argues that glyphosate is safe especially because such a
4
The application of the precautionary principle to GMO’s is discussed in a separate case study in the
RECIPES project.
5
https://www.bayer.com/en/about-glyphosate-based-herbicides-and-their-role-in-agriculture.aspx,
last accessed: 13/4/2020.
6
https://www.bayer.com/en/about-glyphosate-based-herbicides-and-their-role-in-agriculture.aspx,
last accessed: 13/4/2020.

Glyphosate case study 6
thorough hazard and risk assessment has taken place and because of the sheer volume of
studies carried out for this active substance.
7
However, the benefits presented in the context of glyphosate may be relativized. The
weeds which glyphosate is supposed to kill will, over time, become increasingly resistant
to it. In turn this leads to an increase in the use of glyphosate-based pesticides, the return
to tillage, and an increase in combining the use of glyphosate-based pesticides with other
pesticides (Benbrook 2016). Thus, the development of glyphosate-resistant weeds might
ultimately take away some of the initial benefits of using glyphosate.
3 Risks and scientific uncertainties
Generally speaking, the use of pesticides can entail risks to human health (where humans
come in contact with the substance either directly or for example through residues in food)
and to the environment (including ecosystems, biodiversity, as well as water and soil
quality) (European Court of Auditors 2020). The risks posed by the plant protection
products will vary according to the active substance used, the co-formulation with other
substances and also when, how and where as well as in which amount they are used
(European Court of Auditors 2020). Glyphosate was for the longest time seen as a safe
pesticide and used in large quantities all over the world. However, as will be shown in this
section, in the last decade concerns with regard to risks for human health and the
environment have arisen and were simultaneously subject to scientific controversies, as
will be discussed in the following.
3.1 Risk/threat
3.1.1 Potential risks
From its invention in the 1970s until the 2000s there was little concern over the use of
glyphosate-based pesticides and the general public’s exposure to them in the scientific and
regulatory community. However, in the EU especially in the time surrounding the start of
renewal of approval procedure for glyphosate in 2012, concerns about risks of glyphosate
to human health and the environment were voiced by scientist and non-governmental
organisations (NGOs). The NGO Friends of the Earth Europe for example in July 2013
published a series of briefings raising concerns about risks for human health and the
environment.
8
Exposure
Due to the popularity of glyphosate and glyphosate-based herbicides (GBHs), humans are
exposed to it in various ways. First of all, obviously the application of a glyphosate based-
herbicides exposes humans to it: there is the occupational exposure to glyphosate
(farmers, workers in garden and landscape maintenance, forestry workers etc.), but also
exposure through household use, as weedkiller on private properties (IARC 2015).
Furthermore, the continuously increasing use of glyphosate has resulted in the fact that
glyphosate and aminomethylphosphonic (AMPA, the product into which glyphosate is
metabolised) can be detected in air, water, soil and also food (Benbrook 2016). This
7
https://www.bayer.com/en/is-glyphosate-safe.aspx, last accessed:13/4/2020.
8
https://www.foeeurope.org/glyphosate-reasons-for-concern-briefing-130613, last accessed:
13/4/2020.

Glyphosate case study 7
means that even the average citizen that has never applied glyphosate-based herbicides
is exposed to it.
In 2013, the fact that glyphosate residues were found in the urine of European citizens
from 18 Member States through a study commissioned by Friends of the Earth caused a
public outcry.
9
However, the German competent authority BfR clarified that these
concentration levels were not at a level that would cause a risk to human health.
10
In 2016,
Benbrook argued that the human exposure estimates through water, soil, air and food
remained below the Acceptable Daily Intake (ADI), thus not giving rise to concern
(Benbrook 2016, p.11). However, with regard to exposure caused by applying the
pesticide, in a more recent article Benbrook claims that the risks that might follow
occupational exposure for those mixing and applying the substance, especially through
hand held application by sprayers, are higher (Benbrook 2019). In this regard, the
application through handheld and backpack sprayers leads to a far higher exposure then
the application by tractors with cabins and air filtration systems (Benbrook 2020).
Risks: Human Health
In June 2011 the NGO Earth Open Source published a report ‘Roundup and birth defects;
Is the public being kept in the dark?’, referring to a study (Paganelli et al 2010), which
linked glyphosate and glyphosate-based pesticides to birth defects. In 2013 the NGO
Friends of the Earth published a media briefing, in which they pointed to the toxicity of
the substance.
11
The briefing, mostly referring to data from Latin America, also cited
studies pointing to birth defects, an increased rate of miscarriages and a risk of
genotoxicity (leading to genetic mutation and an increased cancer risk). Furthermore,
according to other research, it is estimated that glyphosate exposure poses risks to the
kidney and the liver (Myers et al 2016).
However, the focal point of the public debate surrounding glyphosate approval was the
potential carcinogenicity of glyphosate, i.e. the potential of the substance to cause
cancer. Although publications by individual scientists began to raise concerns about the
potential carcinogenicity of glyphosate and glyphosate-based pesticides (Myers et al 2016),
the publication of Monograph 112 by the International Agency for Research on Cancer
(IARC) in 2015 accelerated the debate concerning carcinogenicity. The IARC classified
glyphosate as ‘probably carcinogenic to humans (Group 2A)’, which in the evaluation
scheme of the IARC means that there was ‘limited evidence of cancer in humans’ but
‘sufficient evidence of cancer in animals’ (IARC 2015).
Next to the carcinogenicity of glyphosate, other concerns that glyphosate may be an
endocrine disruptor emerged (Gasnier et al 2009; Krass et al 2020). Endocrine
disruptors are chemicals that interfere with the hormonal system and thereby cause cancer
and other harms such as birth defects or developmental disorders.
12
A question that is debated in the scientific analysis of the risks of glyphosate is whether
the health risks of glyphosate are the same for all humans or if they differ according to the
9
https://www.foeeurope.org/weed-killer-glyphosate-found-human-urine-across-Europe-130613,
last accessed: 13/4/2020.
10
Bundesinstitut für Risikobewertung, Glyphosate in Urine - Concentrations are far below the range
indicating a potential health hazard, BfR Opinion No. 014/2013, 14 June 2013.
11
https://www.foeeurope.org/sites/default/files/press_releases/foee_media_briefing_glyphosate.pd
f, last accessed: 13/4/2020.
12
Please see the separate case study on endocrine disruptors in the RECIPES project.

Glyphosate case study 8
gender of the exposed person. Many of the case-controlled cancer studies that are used
in the IARC assessment were conducted amongst male farmworkers, excluding women
from the studies (IARC 2015). Also the EU risk assessment of glyphosate has been
criticised for lacking attention to vulnerable groups, for example through not examining
the risk of exposure for pregnant women (Arcuri & Hendlin 2019). With regard to the risk
of endocrine disruption, a study in 2013 found that glyphosate stimulates breast cancer
via the receptors for the hormone estrogen (Thongprakaisang et al 2013). Generally as
the male and female hormonal system differ, the harm caused by endocrine disruptors can
differ, but currently there is still limited knowledge especially about the effects on
females.
13
With regard to animal studies, differences in the impact of glyphosate on
animals according to gender have been researched. For example, in the animal studies
conducted concerning carcinogenicity the IARC notes a difference in two studies which
reported tumours for male but not for female rats (IARC 2015, p.396). A French study
reported risks for the gut microbiome specifically of female rats (Lozano et al 2018).
Overall, further research is needed to reach more clarity on gender related risks of
glyphosate both in humans and animal.
Risks: Environmental
As nowadays, glyphosate is present in soil, water and air it might cause risk to non-target
organisms and whole ecosystems. The European Parliament for example in its resolution
of April 2016 pointed to: “a high long-term risk found for almost all uses of glyphosate for
non-target terrestrial vertebrates, including mammals and birds; whereas use of the non-
selective herbicide glyphosate kills not only unwanted weeds, but all plants, as well as
algae, bacteria and fungi, thereby having an unacceptable impact on biodiversity and the
ecosystem”.
14
Thus, the environmental risks are twofold: first, specific species are harmed by
glyphosate and, second, it might endanger the whole ecosystem through its negative
effects on biodiversity, which in turn harms many species forming part of the ecosystem.
Regarding specific species that are affected by glyphosate, Benbrook for example refers to
studies which point to potential harm for microbial communities in the soil as well as for
several species (earthworms, monarch butterflies, honeybees, crustaceans) (Benbrook
2016).
With regard to the risks to the ecosystems and biodiversity, the risk assessment on the EU
level so far did not point to risks to ecosystems, provided that the substance is used within
good agricultural practice and under the conditions under which it was approved.
15
The
Commission in this regard points to the possibility of the Member States to impose
conditions such as no spray zones or drift reduction technology in the authorisation of
glyphosate-based pesticide. Nonetheless, as glyphosate - and any herbicide for that matter
– removes unwanted plants, this could disturb interlinked food chains in the relationship
13
Please see the separate case study on endocrine disruptors in the RECIPES project.
14
European Parliament resolution of 13 April 2016 on the draft Commission implementing regulation
renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No
1107/2009 of the European Parliament and of the Council concerning the placing of plant protection
products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011,
P8_TA(2016)0119, Point R of the resolution.
15
European Commission, Communication from the Commission on the European Citizens' Initiative
"Ban glyphosate and protect people and the environment from toxic pesticides", C(2017) 8414
final, p. 8.

Glyphosate case study 9
between different species (so called foodwebs).
16
Two examples in this regard are
mentioned by the NGO Friends of the Earth:
17
First of all, the weeds which are removed
through the application of glyphosate constitute an important food source for insects, which
in turn are the main feed of birds such as the skylark. Second, the use of glyphosate-based
herbicides is linked to the decline of Monarch butterflies in the US, not because it would be
directly toxic to the butterflies, but because it removes the common milkweed on which
the caterpillars of the butterfly are dependent as food source.
More and more, the risk of glyphosate for the environment and, specifically the risks to
wildlife in meadows and rivers, is the focus of attention.
18
In an interview by the webportal
Politico, Jeroen van der Sluijs (RECIPES partner) warned, concerning the risks of
glyphosate, that it leads to an agricultural practice where you have monoculture with no
wild plants left in the fields and thus no floral resources for bees and other pollinators, that
it harms non-target plants and that it poses risks to aquatic organisms and especially
amphibians.
19
3.2 Scientific analysis
Individual scientific studies
Glyphosate has been the focus of a large and still growing number of scientific studies.
20
Initially, the toxicological testing of glyphosate-based herbicides pointed to a low risk of
the substance for non-target species (Myers et al 2016). For example, in 2000 Williams et
al. in a review of the safety of glyphosate, based on industry performed regulatory studies
as well as published studies, concluded that they found no indication of human health
concerns for glyphosate as well as the Roundup formulation (Williams et al 2000). At the
time, studies were often carried out by laboratories owned or commissioned by the
industry, and also the review of Williams et al. is based on these unpublished studies, while
the authors were consultants associated with the industry (Myers et al 2016).
However, since the mid-2000s several animal and epidemiology studies published by non-
industry associated scientist seem to call the safety of glyphosate into question (Myers et
al 2016). A review of such studies led to a consensus statement of several scientist
concerning glyphosate-based herbicides (GBHs) from 2016 which expressed that:
“Collectively, studies from laboratory animals, human populations,
and domesticated animals suggest that current levels of exposure to
GBHs can induce adverse health outcomes.” (Myers et al 2016, p.3).
16
European Commission, Communication from the Commission on the European Citizens' Initiative
"Ban glyphosate and protect people and the environment from toxic pesticides", C(2017) 8414
final, p. 8.
17
https://www.foeeurope.org/sites/default/files/publications/foee_5_environmental_impacts_glyph
osate.pdf, last accessed: 13/4/2020.
18
https://www.politico.eu/article/battle-over-glyphosate-shifts-to-the-environmental-front-
pesticides-herbicides/, last accessed: 13/4/2020.
19
https://www.politico.eu/article/battle-over-glyphosate-shifts-to-the-environmental-front-
pesticides-herbicides/, last accessed: 13/4/2020.
20
In its assessment the BfR reviewed over 1,000 studies, including epidemiolocal studies on
glyphosate carcinogenicity.

Glyphosate case study 10
According to this consensus-statement, further studies of the causal link between the
exposure to glyphosate-based pesticides and cancer (specifically non-Hodgkin’s
Lymphoma) are required, while the epidemiological data does provide evidence of
heightened cancer risk (Myers et al 2016). They also state that several studies have
“reported effects indicative of endocrine disruption.” (Myers et al 2016, p.6).
The scientific assessment of glyphosate carcinogenicity: The International
Agency for Research of Cancer (IARC)
The IARC is the specialized cancer agency of the Wold Health Organisation (WHO), which
focusses on the carcinogenic properties of different substances. They do not perform their
own studies, but base their assessment on compiling publicly available information, the
IARC experts critically review and evaluate peer-reviewed and published studies, which
they assess in terms of strength-of-evidence (of carcinogenic properties of a substance).
The IARC was the first international scientific body identifying carcinogenic properties of
glyphosate (Arcuri 2019). The findings are summarised in an article in The Lancet in the
following way:
“There was limited evidence in humans for the carcinogenicity of
glyphosate. Case-control studies of occupational exposure in the USA,
Canada, and Sweden reported increased risks for non-Hodgkin
lymphoma that persisted after adjustment for other pesticides. (…)
In male CD-1 mice, glyphosate induced a positive trend in the
incidence of a rare tumour, renal tubule carcinoma. A second study
reported a positive trend for haemangiosarcoma in male mice.
Glyphosate increased pancreatic islet-cell adenoma in male rats in two
studies. A glyphosate formulation promoted skin tumours in an
initiation-promotion study in mice.” (Guyton et. al 2015, pp. 490-491)
The scientific assessment of glyphosate carcinogenicity in EU Agencies: ECHA and
EFSA
In the context of the EU procedures, glyphosate as an active substance was subject to
scientific assessment by:
- the Federal Institute for Risk Assessment (BfR) (as rapporteur for EFSA)
- the European Food Safety Authority (EFSA)
- the European Chemicals Agency (ECHA)
In its assessment the BfR reviewed over 1,000 studies, including epidemiolocal studies on
glyphosate carcinogenicity.
21
The BfR also found that there is ‘limited’ evidence for
carcinogenicity in humans based on the epidemiological studies that the IARC also referred
to. However, the BfR concluded that the studies in question have certain flaws and do not
provide evidence for a link between the exposure to glyphosate and cancer (non-Hodgkin
lymphoma).
22
21
Bundesinstitut für Risikobewertung, Assessment of the BfR concerning epidemiological studies on
carcinogenic effects of glyphosate in the context of the EU active substance review BfR background
information No. 034/2015, 28 September 2015.
22
Ibid.

Glyphosate case study 11
In October 2015, based on the assessment of the BfR and the subsequently carried out
peer review, EFSA published its ‘Conclusion on the peer review of the pesticide risk
assessment of the active substance glyphosate’ in which it concluded that “glyphosate is
unlikely to pose a carcinogenic hazard to humans and the evidence does not support
classification with regard to its carcinogenic potential according to Regulation (EC) No
1272/2008.”
23
In its opinion of 15 March 2017, ECHA concluded that glyphosate is not to be classified as
carcinogenic, moreover it is not mutagenic and also does not disrupt reproduction.
24
However, it did classify glyphosate with: Eye Damage (class 1, Causes serious eye
damage) and Aquatic Chronic (class 2; Toxic to aquatic life with long lasting effects). The
hazard classifications with regard to eye damage and aquatic toxicity were already in place
before the renewed evaluation in 2016.
25
3.3 Scientific uncertainty
This section is about the scientific uncertainty about the risks associated with your
case.
3.3.1 Complexity
Generally, pesticide risk assessment is complex as they span over a wide range of products
from naturally occurring ones to synthetic chemicals (Bozzini 2017). Moreover, pesticides
are used in the whole food production chain from farming to trading, as well as in
landscaping and forestry (Bozzini 2017). Their use has drastically increased since the
1950s due to the progressive shift towards “the agro-industrial model of farming” (Bozzini
2017, p.2).
A large source of complexity in the risk assessment of glyphosate-based pesticides is that
next to glyphosate as active substance they contain other chemicals as well, and this
formulation will be different for the over 750 different products on the market (IARC
2015, p. 322). For example, concerns were raised regarding the high toxicity of a co-
formulant of glyphosate, POE-tallowamine (Mesagne et al 2013). After a request from the
Commission to EFSA to investigate this further and EFSA concluded that: “Compared to
glyphosate, a higher toxicity of the POE-tallowamine was observed on all endpoints
investigated.”
26
The formulation of the plant protection products are commercial secrets
and therefore not accessible to independent scientists (Myers et al 2016).
While the formulation of the different products causes a first level of complexity, this is
enhanced through complexities regarding the accumulation and mixing of pesticides that
the current scientific methods and regulatory framework is not able to comprehensively
address. Myers et al. explain that glyphosate-based pesticides are increasingly applied
together with other pesticides, while the safety levels for the active ingredients are
calculated separately and without taking into account these mixtures (Myers et al 2016).
As stated in a report for the European Parliament, Europe risk assessors also struggle with
this issue: “(…) less attention is given to unintentional mixtures – like the ones that are
formed during the handling of different products on the part of users – or coincidental –
23
EFSA, Conclusion on the peer review of the pesticide risk assessment of the active substance
glyphosate, 13(11) 4302 EFSA Journal (2015),pp. 1-107.
24
ECHA, Committee for Risk Assessment (RAC) Opinion proposing harmonised classification and
labelling at EU level of glyphosate (ISO); N-(phosphonomethyl)glycine, CLH-O-0000001412-86-
149/F, 15 March 2017.
25
ECHA, How ECHA is assessing glyphosate, ECHA Newsletter 3/2016, p. 3.
26
EFSA, Statement of EFSA on the request for the evaluation of the toxicological assessment of the
co-formulant POE-tallowamine, 13(11) 4303 EFSA Journal (2015), pp. 1-13.

Glyphosate case study 12
mixtures that get formed in the environment after the use of a variety of active substances.
At present there is no systematic and integrated approach across different pieces of
legislation. In the pesticide sector, guidelines are currently under development.”
27
However, not only the mixture of glyphosate with other chemicals poses risk assessment
problems. The physicochemical properties, make it very difficult to analyse (Huhn
2018). Huhn concluded an article calling for more and enhanced analysis of glyphosate
with the statement that: “our understanding of the fate of glyphosate in the environment
and its impact on ecosystems and human health are still not fully understood.” (Huhn
2018, p.3043). It is also pointed out that currently studies can only address individual
aspects of the fate of glyphosate in the environment and that questions regarding the
bioavailability when it is absorbed into the soil are unclear, this also leads to gaps in the
understanding of its ecotoxicology (Huhn 2018).
3.3.2 Uncertainty
Added to the complexities as elaborated in the previous section, is the uncertainty of the
ever-evolving scientific methods. Since glyphosate is already a relatively old product, it
is worth reminding the reader that toxicology as a scientific discipline has rapidly evolved
and has become increasingly refined, which means that today scientists are able to conduct
a far more sophisticated risk assessment when it comes to toxic, ecotoxic and endocrine
disruption risks of a substance (Bozzini 2017). This also influenced the regulatory
framework of pesticides which reflects the increasing ability to identify these risks (Bozzini
2017). It should also be taken into account that the science of toxicology will certainly
progress further and findings which are now in accordance with the most up-to-date
science will be overhauled. Even in an area such as carcinogenicity testing, where a testing
standard is already established since the 1960s, the assessment is complex and has been
progressively refined, still causing debate.
28
Another factor that contributes to the scientific uncertainty with regard to glyphosate
relates to the absence of reliable data on the use of glyphosate-based herbicides
(Myers et al 2016). As Benbrook explains, the quantification of risks to human health and
the environment is dependent on knowing how much of the substances is applied in a
certain region, on which crops and in which other areas (forests, parks, industrial
properties etc.), the timing of application and which method was used (Benbrook 2016).
However, such a comprehensive dataset is hardly available (Benbrook 2016). Also the
Scientific Advice Mechanism (SAM)
29
of the European Commission has noted that:
“[i]nformation on non-dietary health risks (e.g. agricultural worker safety) and
environmental risks of PPPs is commonly not fully available to all risk assessors and risk
managers due to lack of systematic monitoring and data sharing.”(SAM 2018, p.33).
Currently, a lot of uncertainty with regard to glyphosate thus originates in a lack of data
concerning the exposure to it. This applies to the exposure of citizens through food, water
and air; the exposure of people that use glyphosate professionally (often in combination
27
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668, April 2018,
Annex II p. 8.
28
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668, April 2018,
Annex II p. 37-41.
29
The Scientific Advice Mechanisms (SAM) provides independent scientific advice to the European
Commission. It is constituted of 7 Chief Scientific Advisors who work closely with the Scientific
Advice for Policy by European Academies (SAPEA) a consortium of over 100 academies and societies
across Europe.

Glyphosate case study 13
with other pesticides); and the exposure of the environment to glyphosate under real world
conditions.
3.3.3 Ambiguity
Especially regarding the question of carcinogenic risks, ambiguity – difference in
interpretation of the scientific data - is a core characteristic of the risk assessment process
concerning glyphosate. Next to disputes over the interpretation and methodology of single
studies,
30
the different assessment of the scientific evidence regarding
carcinogenicity between the IARC on the one hand and the regulatory agencies
in the EU on the other hand dominated the public and scientific debate.
While the IARC only takes into account publicly available studies, but does not limit its
assessment to only the active substance, the regulatory authorities in the EU also use raw
data from industry conducted studies but limit their assessment to the active substance.
Nonetheless, this is not to say that the IARC and EFSA/ECHA would have carried out their
assessment on completely different data sets, on the contrary, the information at their
disposal to a large degree was overlapping.
31
What might be surprising given the divergent
assessments is that in its 2015 assessment, the IARC did not only take into account peer-
reviewed scientific articles but also regulatory reports from the EU and US (IARC 2015).
However, what does differ significantly is how the bodies judged the quality, reliability and
importance of the different studies.
The IARC, in accordance with its procedures, bases its assessment exclusively on publicly
available data, mostly on scientific literature, which is identified by the Agency through
systematic literature review and a public call for data. The EFSA conclusion (as well as the
ECHA classification), on the other hand, takes into account published studies, but is based
on the data submitted by the approval applicant, which contains studies commissioned by
the applicants and therefore not publicly available. In examining the submitted studies,
EFSA (and the BfR as rapporteur) used a so-called weight-of evidence assessment.
According to EFSA guidance, the weight of evidence approach is: “a process in which
evidence is integrated to determine the relative support for possible answers to a
question.”
32
In essence for the weight of evidence assessment, one asks whether the studies are
reproducible, how many studies support a conclusion and also how these studies are
designed and conducted.
33
The reason why regulatory authorities, place a big emphasis on
the studies submitted by the applicant is that those are performed according to the
Organisation for Economic Co-operation and Development (OECD) standards of Good
Laboratory Practice (GLP). GLP is a quality system concerned with the organisational
process and the conditions under which non-clinical health and environmental safety
studies are planned, performed, monitored, recorded, archived and reported. It reduces
30
For example the article ‘Long term toxicity of a Roundup herbicide and a Roundup-tolerant
genetically modified maize’ by Séralini et al. (in Volume 50 of Food and Chemical Toxicology) was
retracted and then republished (in 26(14) Environmental Sciences Europe), after controversy about
its findings.
31
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668, April 2018,
Annex IV p. 89 ff.
32
EFSA, Guidance on the use of the weight of evidence approach in scientific assessments, 15(8)
4971 EFSA Journal (2017), pp. 1-69.
33
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668, April 2018,
p. 87.

Glyphosate case study 14
the possibilities for fraud and fabrication but it is argued that it does not guarantee that a
study has been designed correctly (Maxim & van der Sluijs 2013; Myers et al 2009).
Academic studies, on the other hand, are often designed and carried out according to more
original and less standardised designs. Most academic labs do not have GLP certificates
because this is a standard for industry labs and academic studies rely on the system of
peer review for the quality control of the studies. As regulatory authorities apply the so-
called Klimisch criteria to assess the reliability of toxicological studies, academic studies
are excluded or deemed less reliable as they usually lack the GLP certificate (Myers et al
2016).
While the EU agencies relied on the weight of evidence approach, the IARC uses a so-called
strength of evidence approach, which led to different weighting of the studies in question.
This is explained by Bozzini:
“IRAC concludes that three studies (out of 14) present evidence of a
weak/dubious – but still existent- correlation and classifies such
evidence as limited. As a consequence, according to IARC criteria,
glyphosate can be classified as ‘probably carcinogenic’. Whereas the
IARC relies almost exclusively on this evidence, EFSA places it in the
context of a much broader set of (unpublished) papers and employs a
weight of evidence approach to reach its conclusion. Eventually, EFSA
concluded that the evidence is very limited and that, therefore,
glyphosate cannot be categorized as carcinogenic.” (Bozzini 2017,
p.89)
Thus, the ambiguity in the assessment of glyphosate follows from the “trade-off between
regulatory science’ and ‘research science’, that is between the need for standard testing
criteria (…) and the need for research designs that are innovative (...).”(Bozzini 2017,
p.89)
3.4 Relevance of the PP to the case
Glyphosate might be one of the most intensely studied pesticides on the market,
however as the sections above have shown this does not exclude scientific
uncertainty. First of all, the discussion in the previous sections has shown that not only
people that apply glyphosate-based herbicides, but also average citizens are exposed to
the substance. Nonetheless, the absence of systematic monitoring of its herbicide use as
well as the exposure via food and water, poses significant uncertainty challenges for the
assessment of its risks. These risks concern human health risks, such as carcinogenicity
and endocrine disruption, as well as risks to the environment, regarding specific species
as well as whole ecosystems. However, the main controversy and source of ambiguity
surrounding the risk(s) associated with glyphosate in the recently concluded renewal
procedure was the diverging scientific assessment of the substance in terms of its
carcinogenic potential: while in its 2015 monograph the IARC classified glyphosate as
probably carcinogenic to humans (Group 2A), EFSA and ECHA did not classify glyphosate
as carcinogen.
The causes for this divergence in assessment have been addressed in the literature. From
these sources, several factors for the diverging carcinogenicity classification can be
identified (Paskalev 2019; Leonelli 2018; Arcuri 2018):

Glyphosate case study 15
• the mandates and procedures of the bodies in question (regulatory vs non-
regulatory);
• hazard identification vs risk assessment;
• approach concerning the data taken into account (published/peer reviewed vs
industry composed dossiers);
• assessment of active substance and/or co-formulation;
• diverging methods/interpretations in the ‘weight of evidence approach’.
What makes the glyphosate case especially interesting as a case study for the application
of the precautionary principle is that not only is the science contested or at least interpreted
ambiguously, but that the EU regulators have been criticised for failing to “give any
substantial weight to the margins of scientific uncertainty surrounding the glyphosate
case”(Leonelli 2018, p.594). For example, the President of BfR in an article in the ZLR,
explaining that the precautionary principle does not apply to the risk assessment of
glyphosate as there was no unknown risk and no lack of knowledge (Hensel 2016). Concern
has been voiced, for example by the Executive Director of EFSA Bernhard Url in Nature,
that the public debate surrounding the scientific findings concerning carcinogenicity in the
EU risk assessment was driven by political agenda rather than scientific uncertainty. He
states that: “It seems to us that some campaigners contest the science of safety
assessments in pursuit of greater political arguments. These arguments deserve airing —
but they belong with policymaker.”(Url 2018, p.381)
Thus, glyphosate represents a case not only of contestation of science, but also of
contestation of scientific uncertainty. This also warrants the close analysis of the
application of the precautionary principle in the EU risk governance concerning glyphosate
as discussed in the following section.
4 Risk governance and the precautionary
principle
The scope of this case study is largely limited to renewal of glyphosate as an active
substance in pesticides in the EU, which took place between 2012 and 2017. The
glyphosate approval was renewed at the time, however, the precautionary principle still
played an important role in the risk governance process as this section will show. First, the
political and legal dynamics of the risk governance process will be discussed, including an
analysis of the regulatory framework as well as a detailed description of the risk analysis
process. In section 4.2. the societal dynamic in the glyphosate risk governance will be
introduced.
4.1 Political/juridical dynamics
Glyphosate and glyphosate-based pesticides are subject to an extensive regulatory
framework in the EU. Plant Protection Products have to be approved/authorised before
they can be placed on the internal market.
34
The active substance, such as glyphosate,
34
For a comprehensive discussion of the regulatory framework for pesticides in the EU see: Bozzini
2017.

Glyphosate case study 16
is subject to an approval granted on EU level by the Commission. However, the actual
plant protection products, thus the commercial formulation of the active substance with
other co-formulants, like the glyphosate containing herbicide Roundup, have to be
authorised on Member State level.
Pesticides are subject to harmonised European legislation only since the 1990s. A first
proposal for a Directive in 1976 was not adopted due to resistance of the Member States.
35
Only with the adoption of Council Directive 91/414/EEC a common procedure for an
approval of active substances and the authorisation of plant protection products in the
Member States was established.
36
However, the Directive proved unsuccessful in
establishing a coherent framework and was inefficient.
37
This led to the adoption of the
pesticide package establishing the current regulatory framework: Regulation (EC) No
1107/2009 concerning the placing of plant protection products on the market,
38
and Directive 2009/128/EC establishing a framework for Community action to
achieve the sustainable use of pesticides.
39
The following section will examine how
the precautionary principle is integrated in the Pesticides Regulation 1107/2009, which
applied to the glyphosate renewal.
The precautionary principle and the regulation of pesticides in the EU
Although in the Treaties the precautionary principle is only mentioned Article 191(2) TFEU
on environmental policy, it applies also to other policies especially where they are aimed
at the protection of public health and human health, which includes the Pesticides
Regulation.
40
Therefore, it is not surprising that also Regulation 1107/2009 refers to the
principle. First of all, the precautionary principle is mentioned in Recital 8:
“(8) The purpose of this Regulation is to ensure a high level of
protection of both human and animal health and the environment and
at the same time to safeguard the competitiveness of Community
agriculture. Particular attention should be paid to the protection
of vulnerable groups of the population, including pregnant
women, infants and children. The precautionary principle
should be applied and this Regulation should ensure that industry
demonstrates that substances or products produced or placed on the
35
European Commission, Proposal for a Council Directive concerning the placing of EEC-accepted
plant protection products on the market, COM (1976) 427 final, OJ C 212, 9.9.1976, p. 3–20.
36
Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products
on the market, OJ L 230, 19.8.1991, pp. 1–32.
37
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668, April 2018,
p. 19.
38
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the market and repealing Council Directives
79/117/EEC and 91/414/EEC, OJ L 309, 24.11.2009, pp. 1–50.
39
Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009
establishing a framework for Community action to achieve the sustainable use of pesticide OJ L
309, 24.11.2009, pp.71-86.
40
See e.g.: C-616/17 Criminal proceedings against Mathieu Blaise and Others, ECLI:EU:C:2019:800,
paras. 41and 42.

Glyphosate case study 17
market do not have any harmful effect on human or animal health or
any unacceptable effects on the environment.”(emphasis added)
This is then included in Article 1 of the Regulation and specifically paraphs 3 and 4 which
state:
‘3. The purpose of this Regulation is to ensure a high level of
protection of both human and animal health and the environment and
to improve the functioning of the internal market through the
harmonisation of the rules on the placing on the market of plant
protection products, while improving agricultural production.
4. The provisions of this Regulation are underpinned by the
precautionary principle in order to ensure that active substances or
products placed on the market do not adversely affect human or
animal health or the environment. In particular, Member States shall
not be prevented from applying the precautionary principle where
there is scientific uncertainty as to the risks with regard to human or
animal health or the environment posed by the plant protection
products to be authorised in their territory.’ (emphasis added)
The regulation aims at the protection of humans, animals and the environment, expressing
the precautionary principle in various ways:
• The prior approval scheme: Plant protection products can only be placed on
the market when they have been authorised by the Member States, and any active
substance contained in the PPPs has to be approved on EU level. As stated by
Advocate General Sharpston, such a prior approval scheme is in itself an expression
of the precautionary principle: “The PPP Regulation is itself a precautionary measure
because it establishes a system of prior approval affecting a generic product
category (plant protection products).”
41
Comparable prior approval schemes are
used in several policy areas in the EU, including food, chemicals, and
pharmaceuticals.
42
In accordance with the Commission Communication on the
precautionary principle, such authorisation schemes are used exceptionally with
regard to “substances deemed ‘a priori’ hazardous”
43
.
• The shift in the burden of proof: The prior approval scheme also introduces
a shift in the burden of proof: in the approval and authorisation procedures the
safety of the product had to be proven, and this responsibility is placed on the
company that wants to market the product (Bozzini 2017). Such a shift in the
41
Opinion of Advocate General Sharpston in case C-616/17 Criminal proceedings against Mathieu
Blaise and Others, ECLI:EU:C:2019:190.
42
See also: European Commission, Communication from the Commission on the European Citizens’
Initiative “Ban Glyphosate and Protect People and the Environment from Toxic Pesticides”, C(2017)
8414 final, p. 11.
43
European Commission, Communication from the Commission on the precautionary principle,
COM(2000)0001 final, p.20.

Glyphosate case study 18
burden of proof is exceptional and not the general rule for all risks.
44
In the case of
pesticide approvals, the manufacturers are required to provide scientific evidence
of the safety of their product. Next to performing own tests, manufacturers are
required to also compile peer-reviewed scientific literature for the active substance
in question (Bozzini 2017).
• The authorisation criteria: With the adoption of Regulation 1107/2009, the
EU introduced a hazard-based approach as opposed to a risk-based approach.
45
This entails that a substance is first examined for certain intrinsic hazardous
characteristics, the so-called ‘cut-off criteria’. If in the hazard identification stage,
it becomes evident that a pesticide meets one of the cut-off criteria, for example as
it is carcinogenic, a risk assessment concerning the likelihood of the harm to occur
is not necessary to take precautionary measures. With regard to the approval of
active substances, the hazard-based approach is enshrined in Article 4(1) of
Regulation 1107/2009 and the cut-off criteria are listed in Annex II points 3.6.2 to
3.6.4 and 3.7. According to this cut-off criteria system, an active substance will be
banned if it is: carcinogenic; mutagenic; toxic for reproduction; persistent,
bioaccumulative and toxic for the environment; a persistent organic pollutant; very
persistent and very bioaccumulative; or an endocrine disruptor.
• The limited approval periods: In accordance with Article 5 of the Pesticide
Regulation, if an active substance is approved for the first time, the approval cannot
be granted for a longer period than 10 years. If the approval of an active substance
is subsequently renewed, the maximum period is 15 years (Article 14(2)). This
ensures that the scientific evidence for the safety of the substance is reviewed
regularly, considering new scientific findings and evolving technology.
• The review of approval: In accordance with Article 21 the Commission can
review the approval at any time should new scientific findings and technical
knowledge point to doubts that the approval criteria are still fulfilled.
• Emergency measures: If an authorised product (or a substance contained in
it) or approved active substance is likely to cause serious risks to human or animal
health or the environment, the Commission – also on proposal of a Member State
– can immediately take measures to restrict the use/sale as an emergency measure
(Article 69).
Thus, the precautionary principle is integrated in the regulatory framework
applicable to pesticides. Especially the use of a hazard-based approach is quite unusual,
not only compared to pesticide regulation around the world, but also compared to other
risk regulation areas in the EU, which generally are risk based (Bozzini 2017). It is argued
that the hazard-based approach is not only an expression of the precautionary principle,
but that choosing a hazard, rather than risk based approach is “a strong version of the
principle by calling for precautions to avoid serious and possibly irreversible harm”.
46
As
was stated before, already the existence of the prior-approval scheme in the regulatory
44
European Commission, Communication from the Commission on the precautionary principle,
COM(2000)0001 final, p. 4.
45
For a discussion of the hazard-based approach see: Bozzini 2017, p. 29 ff.; SAM 2018,. p. 42;
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668, April 2018,
p.43.
46
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668, April 2018,
p. 21.

Glyphosate case study 19
framework for pesticides in based on the precautionary principle. In the following section
the approval procedure will be introduced, before examining the approval procedure of
glyphosate.
The approval procedure for active substances
Active substances like glyphosate have to be approved before they can be used in plant
protection products in the EU. An application will have to be submitted to a competent
authority of a Member State, which becomes the Rapporteur Member State (RMS).
47
The
RMS together with another co-rapporteur from another Member State, produces a draft
assessment report (DAR), carrying out an “independent, objective and transparent
assessment in the light of current scientific and technical knowledge” of the documents
submitted by the applicant.
48
The purpose of these assessments is to establish ‘whether
the active substance can be expected to meet the approval criteria, as provided for in
Article 4 of Regulation (EC) No 1107/2009.’
49
The following risk assessment steps are
coordinated by EFSA Panel on Plant Protection Products and their Residues, including a
peer review of the application by the other Member States and a public consultation.
50
EFSA’s Conclusion is subsequently sent to the Commission, which has the decision-making
power concerning the approval of active substances.
Taking into account the EFSA Conclusion, the European Commission will draft a review
report and a Draft Implementing Regulation.
51
This Draft Implementing Regulation will
approve or not approve the active substance, based on “the review report, other factors
legitimate to the matter under consideration and the precautionary principle”.
52
However, the European Commission’s decision-making power is still subject to control by
the Member States through comitology, as the comitology committees are composed of
representatives of the Member States (van den Brink 2020), often being employees of
national ministries. This means that the Member States will vote on the Commission
proposal to approve a substance in the Standing Committee on Plants, Animals, Food and
Feed (PAFF Committee), and more specifically in the PAFFs section on
phytopharmaceuticals. In case of a positive opinion of the committee, the Commission
adopts an Implementing Regulation approving the substance, it will be included in the list
of approved active substances in the Annex of Commission Implementing Regulation (EU)
No 540/2011.
53
47
Regulation (EC) No 1107/2009, Art. 7.
48
Regulation (EC) No 1107/2009, Art.11(2).
49
Regulation (EC) No 1107/2009, Art 11. Commission Implementing Regulation (EU) No 844/2012
of 18 September 2012 setting out the provisions necessary for the implementation of the renewal
procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European
Parliament and of the Council concerning the placing of plant protection products on the market OJ
L 252, 19.9.2012, pp. 26–32.
50
Regulation (EC) No 1107/2009, Art. 12. See also: European Parliament Research Service,
Regulation (EC) 1107/2009 on the Placing of Plant Protection Products on the Market – European
Implementation Assessment, PE 615.668, April 2018, p. 21.
51
Regulation (EC) No 1107/2009, Art. 13.
52
Regulation (EC) No 1107/2009, Art. 13(2). Emphasis added.
53
In case of approval of active substances the examination procedure is followed in accordance with
Article 5 of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16
February 2011 laying down the rules and general principles concerning mechanisms for control by

Glyphosate case study 20
In case of glyphosate, the procedure applicable in this case study was not an initial
approval, but a renewal of an existing approval, which is governed by Articles 14 until 21
and further detailed in Commission Implementing Regulation (EU) No 844/2012.
54
As the
first approval of an active substance is only granted for a maximum of 10 years,
55
while
the maximum renewal period is 15 years,
56
such renewals are reoccurring regularly. The
procedure follows similar steps as the approval procedure with an assessment by a
Rapporteur MS and a subsequent peer review by EFSA. However, a core difference is that
the Rapporteur Member State is not chosen by the applicant but has been assigned in the
Commission Implementing Regulation.
57
Like in the case of an initial approval, the
applicant company will have to provide scientific evidence that the approval criteria are
fulfilled given the current scientifically and technical knowledge. The Commission again is
the final decision-maker, together with the comitology committee.
Glyphosate in the EU: the timeline of glyphosate approval procedures
Glyphosate was first approved in the EU in 2002, after the introduction of the harmonised
procedures through Council Directive 91/414/EEC. Before, glyphosate was used in the
European Union in products authorized in Member States under their national regulatory
framework. With the adoption of the Directive, a gradual work programme was set up in
order to examine and approve the active substances on the market.
58
In the context of
this work programme glyphosate was approved in 2002,
59
based on the scientific and
technical knowledge of human health and environmental risks at the time.
In 2009, after a revision of the Plant Protection Product legislation in the EU, a new general
legislative framework was introduced through the adoption of Regulation (EC) 1107/2009.
The previously granted approval of glyphosate remained valid.
60
This approval originally
expired in 2012 but, together with other approval dates, was prolonged to 31 December
2015,
61
in order to clarify the framework for and carry out the renewals under the new
Regulation. In accordance with the applicable procedure,
62
the renewal was applied for on
Member States of the Commission’s exercise of implementing powers, OJ L 55, 28.2.2011, pp. 13–
18.
54
Commission Implementing Regulation (EU) No 844/2012.
55
Regulation (EC) No 1107/2009, Art. 5.
56
Regulation (EC) No 1107/2009, Art. 14(2).
57
Annex of Commission Implementing Regulation (EU) No 844/2012.
58
Council Directive 91/414/EEC, art 8(2).
59
Commission Directive 2001/99/EC of 20 November 2001 amending Annex I to Council Directive
91/414/EEC concerning the placing of plant protection products on the market to include glyphosate
and thifensulfuron-methyl as active substances OJ L 304, 21.11.2001, pp. 14–16.
60
All the active substances included in Annex I to Directive 91/414/EEC were also deemed to be
approved under Regulation (EC) No 1107/2009.
61
Commission Directive 2010/77/EU of 10 November 2010 amending Council Directive 91/414/EEC
as regards the expiry dates for inclusion in Annex I of certain active substances Text with EEA
relevance OJ L 293, 11.11.2010, pp. 48–57.
62
Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for
the renewal of the inclusion of a second group of active substances in Annex I to Council Directive
91/414/EEC and establishing the list of those substances, OJ L 322, 8.12.2010, pp. 10-19.

Glyphosate case study 21
25 May 2012 by the so-called Glyphosate Task Force, a collective of 24 glyphosate
producing companies which included Monsanto Europe.
63
The Rapporteur Member State (RMS) was Germany and its German Bundesinstitut
für Risikobewertung (BfR), which was supported by Slovakia as co-rapporteur. The
Renewal Assessment Report (RAR) will form the basis of the risk assessment. On 20
December 2013 the BfR provided the Renewal Assessment Report to EFSA, in which it
stated that “glyphosate is devoid of genotoxic potential” and that “classification and
labelling for carcinogenicity is not warranted”.
64
Upon receiving the RAR, EFSA sent
it out for consultation to the Member State and the applicant – the Glyphosate Task Force.
Based on the comments received, EFSA identified “that expert consultation in the areas of
mammalian toxicology, residues, environmental fate and behaviour and ecotoxicology”
should be carried out.
65
After consultation with experts from other Member States and the
approval applicants as well as a public consultation, the BfR incorporated the comments
and additional studies and submitted a revised report in December 2014.
66
While the assessment in the EU was ongoing, on 20 March 2015 the International
Agency for Research on Cancer (IARC) published a monograph which contained
findings of a carcinogenic potential of glyphosate. Based on a mandate by the
European Commission, the BfR made an addendum to the RAR on 31 August 2015 to
evaluate the IARC Monograph. The BfR reassessed the studies taken into account by the
IARC, but did not change its conclusion.
67
Therefore, EFSA in October 2015 published
its Conclusion, stating that “glyphosate is unlikely to pose a carcinogenic hazard
to humans and the evidence does not support classification with regard to its carcinogenic
potential according to Regulation (EC) No 1272/2008.”
68
Overall, EFSA concluded that
glyphosate can be expected to meet the approval criteria.
69
However, the EFSA Conclusion mentioned a data gap concerning the fate and behaviour in
the environment, stating that further information is required to assess the “contamination
route through run off (especially in situations where application to hard surfaces might
occur) and subsequent surface water contamination and bank infiltration to
groundwater”.
70
Also concerning “ecotoxicology, two data gaps were identified to
provide an assessment to address the long-term risk for small herbivorous mammals and
for insectivorous birds.”
71
The ecotoxic risk for aquatic organisms as well as bees,
63
Bundesinstitut für Risikobewertung, Renewal Assement Report, Glyphosate, Volume 1 Report and
Proposed Decision, Volume 1, p.3.
64
Bundesinstitut für Risikobewertung, Renewal Assement Report, Glyphosate, Volume 1 Report and
Proposed Decision, Volume 1, p.139.
65
EFSA, Conclusion on the peer review of the pesticide risk assessment of the active substance
glyphosate, 13(11) 4302 EFSA Journal (2015), pp. 1-107, p. 2.
66
This Renewal Assessment Report was revised twice (29 January 2015 and 31 March 2015).
Bundesinstitut für Risikobewertung, Frequently asked questions on the procedure for the re-
assessment of glyphosate within the framework of the EU active substance review, BfR FAQ, 12
November 2015.
67
Bundesinstitut für Risikobewertung, The BfR has made a comprehensive check of the
epidemiological studies on glyphosate, BfR Background Information No. 033/2015, 22 September
2015.
68
EFSA, Conclusion on the peer review of the pesticide risk assessment of the active substance
glyphosate, 13(11) 4302 EFSA Journal (2015), pp. 1-107.
69
Ibid.
70
Ibid., p.3.
71
Ibid.

Glyphosate case study 22
arthropods and soil micro- and macro-organisms was considered low.
72
The risk for non-
target plants was considered low, given that mitigation measures are taken.
73
The EFSA
opinion had also pointed out that one study showed potential endocrine activity and
that, while data had become available there was no time to assess this information. This
led the Commission to ask for an assessment of the endocrine disruption potential through
EFSA.
However, when the EFSA Conclusion was presented to the Member States, as represented
in the comitology committee, they considered it was appropriate to have an opinion of
the Committee for Risk Assessment of the European Chemicals Agency.
74
ECHA and more
specifically its Committee for Risk Assessment was asked to form an opinion on the hazard
classification of glyphosate.
75
In April 2016 the European Parliament adopted a resolution concerning ongoing
glyphosate approval.
76
At the time the European Commission had drafted a proposal for
the maximum period of 15 years. In its resolution the Parliament stated that the
Commission proposals “fails to apply the precautionary principle”
77
and called on the
Commission to limit the renewal to 7 years.
78
In the meantime, in August 2016, the conditions of approval of the active substance
were amended in the light of new scientific and technical knowledge by Commission
Implementing Regulation (EU) 2016/1313, which the PAFF has agreed to.
79
In its opinion
from October 2015 the EFSA had voiced concerns regarding the toxicity co-formulant POE-
tallowamine, which is often used in plant protection products containing glyphosate. Based
on these findings, the conditions of approval for glyphosate were changed and Member
States had to ensure that pesticides containing glyphosate do not contain POE-
tallowamine. Moreover, the changed conditions of approval now stated that Member States
in their assessment of PPPS should pay particular attention to (i) the protection of
groundwater in vulnerable areas (particularly regarding non-crop use); (ii) risks from use
72
Ibid.
73
Ibid.
74
In January 2016, the EFSA report was presented to the PAFF and in May the PAFF asked for an
opinion of the Committee for Risk Assessment of the European Chemicals Agency on the
carcinogenic potential of glyphosate. When the Commission in June 2016 called for a vote on the
renewal proposal, neither a qualified majority for nor against the renewal could be reached. See:
https://ec.europa.eu/food/plant/pesticides/glyphosate/earlier-assessment_en, last accessed:
13/4/2020.
75
Such a hazard assessment is carried out in accordance with Article 37 of Regulation (EC) No
1272/2008. With regard to pesticides, the Pesticides Regulation 1107/2009 prohibits the placing
on the market of a hazardous pesticide that is classified as human carcinogen or as mutagen, and
this classification is carried out through the procedure prescribed by the CLP Regulation 1272/2008.
See Annex II Regulation 1107/2009.
76
European Parliament resolution of 13 April 2016 on the draft Commission implementing regulation
renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No
1107/2009 of the European Parliament and of the Council concerning the placing of plant protection
products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011,
P8_TA(2016)0119.
77
European Parliament resolution of 13 April 2016, Point 1.
78
Ibid., Point 3.
79
Commission Implementing Regulation (EU) 2016/1313 of 1 August 2016 amending
Implementation Regulation (EU) No 540/2011 as regards the conditions of approval of the active
substance glyphosate, OJ L 208, 2.8.2016, pp. 1–3.

Glyphosate case study 23
in areas used by the general public and vulnerable groups (like parks, playgrounds etc.);
and (iii) compliance of the pre-harvest use with good agricultural practice.
In its opinion of 15 March 2017, ECHA concluded that glyphosate is not to be
classified as carcinogenic, moreover it is not mutagenic and also does not disrupt
reproduction.
80
However, it did classify glyphosate with: Eye Damage (class 1, Causes
serious eye damage) and Aquatic Chronic (class 2; Toxic to aquatic life with long lasting
effects). The hazard classifications with regard to eye damage and aquatic toxicity were
already in place before the renewed evaluation in 2016.
81
It should be stressed that the
ECHA carries out a hazard assessment, which does not consider the exposure.
In May 2017 the Commission, therefore, restarted the discussion, which also took into
account the EFSA opinion published on 7 September 2017, that concluded that on the
basis of the data assessed, weight of evidence indicates that glyphosate is not an
endocrine disrupter.
82
The Commission proposed the renewal for glyphosate for 10
years, and the proposal also included certain conditions of approval.
83
A second European
Parliament resolution was adopted on 24 October 2017, one day before the meeting of
the PAFF Committee, in which the Commission proposal foreseeing a renewal for 10 years
was to be discussed.
84
In this resolution the Parliament again referred to a breach of the
precautionary principle,
85
and also called for phasing out the use of glyphosate in the EU
until 15 December 2022.
86
In the comitology committee, some Member States questioned why the renewal period
was shortened to 10 years and the meeting ended with the Commission requesting written
comments. The discussions in the comitology committee continued throughout October,
however, no majority for or against could be found.
87
On 9 November 2017, the PAFF was
asked again to vote, this time the Commission had proposed a renewal for 5 years. Again,
no majority could be found and the Committee delivered no opinion. The division in the
position of the Member States becomes visible in the summary report:
‘Several Member States voting in favour indicated that they would
have preferred a longer period of renewal but agreed to the shorter
period of renewal in the spirit of compromise. (…) Two Member States
voted against as they wanted a renewal or extension of approval for
80
ECHA, Committee for Risk Assessment (RAC) Opinion proposing harmonised classification and
labelling at EU level of glyphosate (ISO); N-(phosphonomethyl)glycine, CLH-O-0000001412-86-
149/F, 15 March 2017.
81
ECHA, How ECHA is assessing glyphosate, ECHA Newsletter 3/2016, p. 3.
82
EFSA, Conclusion on the peer review of the pesticide risk assessment of the potential endocrine
disrupting properties of glyphosate’, 15(9) 4979 EFSA Journal (2017), pp.1-20.
83
See: https://ec.europa.eu/food/plant/pesticides/glyphosate/earlier-assessment_en, last
accessed: 13/4/2020.
84
European Parliament resolution of 24 October 2017 on the draft Commission implementing
regulation renewing the approval of the active substance glyphosate in accordance with Regulation
(EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant
protection products on the market, and amending the Annex to Implementing Regulation (EU) No
540/2011 (D053565-01 – 2017/2904(RSP)), P8_TA(2017)0395.
85
Ibid., Point 1.
86
Ibid., Point 6.
87
See: https://ec.europa.eu/food/plant/pesticides/glyphosate/earlier-assessment_en, last
accessed: 13/4/2020.

Glyphosate case study 24
a maximum period of 3 years. (…) Three Member States voted against
due to political and societal sensitivity and environmental concerns.
(…) One Member State voted against as its national parliament had
adopted a formal position against any period of renewal or extension
of approval. Three Member States abstained as they considered a 5-
year renewal period too short and because they saw no scientific or
legal reasons justifying such a short period of renewal. One of them
indicated that the resources needed at national level to review the
existing authorisations of glyphosate-containing products were of
concern in particular in the light of the short period of renewal
proposed.’
88
Finally, on 27 November an Appeal Committee voted in favour of a 5 year renewal,
89
after
Germany had changed its position from an abstention to a positive vote.
90
On 12
December 2017 the renewal of the glyphosate approval was adopted by the
European Commission.
91
This approval of glyphosate will expire on 15 December 2022.
On 12 December 2019 a group of companies referring to themselves as the Glyphosate
Renewal Group
92
has submitted an application for renewal of the glyphosate approval. In
deviation from the normal renewal procedure, the application will be assessed by a group
of 4 Member States consisting of France, Hungary, the Netherlands and Sweden, forming
the Assessment Group on Glyphosate (AGG).
93
The precautionary principle in the glyphosate approval
As the previous sections have shown, the precautionary principle is deeply embedded in
the regulatory framework for pesticides in the EU. Submitting glyphosate to an approval
procedure based on the hazard-based approach, which is continuously repeated in each
renewal, is an expression of the precautionary principle in itself. Therefore, it is important
to stress that according to the finding of a study carried out for the European Parliament,
“did not find evidence that, in the case of glyphosate, the national and EU authorities
88
European Commission, Summary Report of the Standing Committee on Plants, Animals, Food and
Feed held in Brussels on 17 July 2017, sante.ddg2.g.5(2017)4119844.
89
See: https://ec.europa.eu/food/plant/pesticides/glyphosate/earlier-assessment_en, last
accessed: 13/4/2020.
90
https://euobserver.com/environment/140042, last accessed 13/4/2020;
https://www.politico.eu/pro/glyphosate-renewal-shakes-germany-france-italy/, last accessed
13/4/2020.
91
Commission Implementing Regulation (EU) 2017/2324 of 12 December 2017 renewing the
approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of
the European Parliament and of the Council concerning the placing of plant protection products on
the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011,
OJ L 333, 15.12.2017, pp. 10–16.
92
https://glyphosate.eu, last accessed: 13/4/2020.
93
Commission Implementing Regulation (EU) 2019/724 of 10 May 2019 amending Implementing
Regulation (EU) No 686/2012 as regards the nomination of rapporteur Member States and co-
rapporteur Member States for the active substances glyphosate, lambda-cyhalothrin, imazamox
and pendimethalin and amending Implementing Regulation (EU) No 844/2012 as regards the
possibility that a group of Member States assumes jointly the role of the rapporteur Member State,
OJ L 124, 13.5.2019, pp. 32–35.

Glyphosate case study 25
involved in the evaluation process did not comply with the relevant procedures under the
approval (renewal of approval) of substances.”
94
In the case of glyphosate, after a scientific risk assessment by EFSA (and hazard
assessment by ECHA), the Commission as risk manager - in accordance with the
comitology committee vote - decided that a ban was not necessary, even in the face of
large public pressure. The decision to grant the renewal shows that the threshold of
damage that would have triggered a ban/non-renewal has not been met. This is due to
the fact that in the risk assessment process neither ECHA nor EFSA classified the substance
as carcinogenic, or meeting any of the other cut-off criteria. To a certain degree this also
explains why carcinogenicity became the focal point of the glyphosate renewal procedure:
Had glyphosate been classified as carcinogenic in the EU, it would have met a cut-off
criterion and would have been banned immediately.
When considering the role of cost effectiveness/ proportionality, as glyphosate has
been renewed, no cost-effectiveness assessment of a ban has taken place. The same also
holds true with regard to the absence of an impact assessment. In this regard it can be
added that for the measures taken under the Regulation, such as the approval or renewal
of an active substance, no impact assessments of the risk management measures are
routinely carried out in the regulatory process (Bozzini 2017).
With regard to reversibility of the glyphosate renewal in 2017, one has to refer to the
possibility to review any approval under Article 21 of the Pesticide Regulation where this is
warranted by new scientific findings and technical knowledge. Also the European
Commission stressed in its answer to the European Citizens Initiative that “the Commission
can, at any time, review the approval of glyphosate if new scientific evidence emerges that
indicates that the substance no longer fulfils the approval criteria laid down in the Plant
Protection Products Regulation.”
95
Moreover, in case of glyphosate, the renewal was only
granted for 5 year, which entails that the new dossier had to be submitted until December
2019. Thus, there is very quick review of the measure. As the Commission explains: “This
renewal period is significantly shorter than the maximum of 15 years foreseen in EU
legislation but the Commission also took into account the views of the European Parliament
and other legitimate factors when setting the appropriate period of renewal. In fact, the
Commission has taken into account possibilities of rapid future developments in science
and technology: while a large amount of inform.”
96
Court of Justice of the European Union
The glyphosate approval has kept the Court of Justice of the European Union quite busy,
which for a technical issue like the approval of an active substance is relatively uncommon.
The glyphosate approval was dealt with by the General Court and the Court of Justice in
the cases:
94
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668, April 2018,
p. 47.
95
European Commission, Communication from the Commission on the European Citizens' Initiative
"Ban glyphosate and protect people and the environment from toxic pesticides", C(2017) 8414
final, p. 9.
96
Ibid.

Glyphosate case study 26
• T-545/11 Stichting Greenpeace Nederland and Pesticide Action Network Europe
(PAN Europe) v European Commission, ECLI:EU:T:2013:523
§ C-673/13 P Commission v Stichting Greenpeace Nederland and PAN
Europe, ECLI:EU:C:2016:889
§ T-545/11 RENV Stichting Greenpeace Nederland and Pesticide Action
Network Europe (PAN Europe) v European Commission,
ECLI:EU:T:2018:817
• T-12/17 Mellifera eV, Vereinigung für wesensgemäße Bienenhaltung v
European Commission, ECLI:EU:T:2018:616
§ Currently under appeal: C-784/18 P Mellifera v Commission
§ T-383/18 Mellifera v. Commission
• T-178/18 Région de Bruxelles-Capitale v European Commission,
ECLI:EU:T:2019:130 (Order of the General Court)
§ Currently under appeal: C-352/19 P Région de Bruxelles-Capitale v
European Commission
• T-125/18 Associazione Nazionale Granosalus vs. European Commission,
ECLI:EU:T:2019:92
§ Currently under appeal: Case C-313/19 P Associazione GranoSalus v
Commission
• T-716/14 Tweedale v EFSA, ECLI:EU:T:2019:141
• T-329/17 Hautala v EFSA, ECLI:EU:T:2019:142
• C-616/17 Criminal proceedings against Mathieu Blaise and Others,
ECLI:EU:C:2019:800
Most cases related to access to documents, where third parties requested to see certain
studies that were part of the dossiers of the original glyphosate approval procedure in 2002
as well as the renewal procedure. This line of case law has significantly contributed to the
balancing of transparency of the authorisation procedure and the scientific
assessment and commercially confidential information contained in the authorisation
dossier. These developments are not directly related to the precautionary principle.
However, the Court clearly connected the increasing transparency with regard to
documents to constitutional values such as democracy, accountability and
participatory openness (Morvillo 2019; Korkea-aho & Leino 2017). The Court was thus
concerned with making the risk assessment stage visible to the broader public, to enhance
the citizens trust in the process and also to allow for an open debate. Ultimately, this led
to a reform of the transparency rules with regard to studies submitted to EFSA in the
context of the approval of new active substances and in other fields of activity of the
Agency.
97
The adopted Regulation now provides for publication of all studies submitted in
the risk assessment process and also requires all studies commissioned to be registered,
in order to prevent that unfavourable studies can go unnoticed (de Boer 2019).
In the case brought by the government of the region Brussels (T-178/18 Région de
Bruxelles-Capitale v European Commission), it was pleaded that the glyphosate
97
Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the
transparency and sustainability of the EU risk assessment in the food chain and amending
Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC)
No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive
2001/18/EC, OJ L 231, 6.9.2019, pp. 1–28.

Glyphosate case study 27
renewal infringed the precautionary principle claiming that the renewal fails to ensure
a high level of protection of human health and of the environment, as the risk assessment
would fail to fulfil the conditions of the precautionary principle. In an article published by
the webportal Politico, an official of the region bringing the claim was cited to have stated:
“As long as the causal link between glyphosate and harmful effects is not 100% proven, it
cannot be banned. This is diametrically opposed to the precautionary principle.”
98
However,
as the case was declared inadmissible due to strict rules on standing and an absence of
direct concern, the position of the Court concerning this line of argumentation is not
available.
However, in the Blaise case, ruled by the Grand Chamber of the Court of Justice in October
2019, the Court was asked in a preliminary reference to assess if Regulation
1107/2019 is compatible with the precautionary principle. In the case the Court
clarified the requirements of the correct application of the precautionary principle in the
regulation of pesticides, stating that it should entail (i) the identification of potential risks
of active substances and PPPs for health and (ii) a comprehensive risk assessment “based
on the most reliable scientific data available and the most recent results of international
research”.
99
The Court stated the benchmark laid by the precautionary principle for the
validity of the Regulation is the question whether the legislation ensures that the
competent authorities have enough information to adequately assess the risk of the active
substances and PPPs under review.
100
Importantly, however, the Court stressed that a
finding of non-compliance of the Regulation with the precautionary principle could not be
based - solely - on the circumstances of a particular case, here the alleged errors in the
glyphosate approval procedure.
101
Overall, none of the questions raised in the procedure
led to a finding that challenged the validity of the Regulation.
Measures taken by Member States
When looking beyond the active substance glyphosate, the plant protection products –
including their formulation, are assessed on Member State level. With regard to PPPs the
EU operates a specific version of mutual recognition: the territory of the EU is divided in
three zones: north, centre and south, which is based on comparability of agricultural, plant
health and environmental (including climatic conditions). If a product is authorised in a
Member State belonging to one zone, e.g. North, then the authorisation should also be
granted in the other Member States of this zone based on the risk assessment carried out
by the other Member State.
102
However, the criteria on which the authorisation procedure
in the national competent authorities are based are subject to EU harmonisation, to
ensure the same level of safety across the Union and in order to facilitate mutual
recognition.
103
Nonetheless, a recent study conducted for the European Parliament,
concluded that there are still significant differences between the standards and
98
https://www.euractiv.com/section/agriculture-food/news/brussels-government-takes-
commission-to-eu-court-over-glyphosate/, last accessed: 13/4/2020.
99
C-616/17 Criminal proceedings against Mathieu Blaise and Others, ECLI:EU:C:2019:800, para. 48.
100
Ibid., para. 74.
101
Ibid., paras 48-49.
102
Annex 1 Regulation (EC) No 1107/2009. The North Zone includes Denmark, Estonia, Latvia,
Lithuania, Finland, Sweden; the Centre Zone is composed of Belgium, Czech Republic, Germany,
Ireland, Luxembourg, Hungary, Netherlands, Austria, Poland, Romania, Slovenia, Slovakia; and the
South Zone is made up of Bulgaria, Greece, Spain, France, Croatia, Italy, Cyprus, Malta, Portugal.
103
The data requirements for the dossier are set in Implementing Regulation (EU) No 284/2013 and
Regulation (EU) 546/2011 establishes uniform principles for evaluation and authorisation of PPs.

Glyphosate case study 28
procedures in national risk assessments, which creates obstacles to the mutual recognition
of authorizations.
104
With regard to the authorisation of glyphosate-based herbicides in the Member States, it
should be noted that several states have communicated their plans to ban
glyphosate-based herbicides. The French competent authority in December 2019
announced that after a review of the renewal applications for PPP authorisation, 36 out of
the 39 glyphosate containing products available in France will be prohibited from the end
of 2020 onwards, “due to a lack or absence of scientific data ruling out any genotoxic
risk.”
105
Next to France,
106
there has been debate about glyphosate-bans (more precisely:
bans on glyphosate containing pesticides) in several EU Member States. In Austria, the
Parliament in July 2019 voted positively on a glyphosate ban from 1 January 2020 onwards.
However, the ban until the time of writing has not been signed into law.
107
In Germany,
the government in the so-called ‘Agrarpaket’ decided to ban glyphosate containing
pesticides until the end of 2023 in order to protect insects,
108
but also here no binding law
has been adopted yet. Only Luxemburg has adopted legislation to ban
glyphosate/glyphosate-based herbicides, withdrawing the marketing authorization from 1
February 2020 onwards.
109
Glyphosate risk governance around the world
In the literature it is argued that the European regulatory framework for pesticides is one
of the strictest in global comparison and the regulatory measures taken in the EU, including
both the authorizations and conditions of use of pesticides, are stricter and more
precautionary than comparable decisions in the US (Bozzini 2017).
When it comes to glyphosate, it should be mentioned that its carcinogenicity was
reviewed also by other regulatory bodies outside the EU. As stated by the
Commission in its answer to the citizens’ initiative the conclusion of EFSA and ECHA “is
shared by other national and international bodies (from Canada, Japan, Australia and New
Zealand, and also the Joint UN Food and Agriculture Organisation/World Health
Organisation Meeting on Pesticide Residues.”
110
104
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668, April 2018.
105
https://www.anses.fr/en/content/anses-announces-withdrawal-36-products-containing-
glyphosate, last accessed: 13/4/2020.
106
https://www.euractiv.com/section/agriculture-food/news/french-mayors-ban-glyphosate-
weedkiller-defying-government/, last accessed: 13/4/2020.
107
https://www.parlament.gv.at/PAKT/VHG/XXVII/E/E_00004/fname_775803.pdf, last accessed:
13/4/2020;
https://www.parlament.gv.at/PAKT/PR/JAHR_2019/PK0808/index.shtml, last accessed: 13/4/2020;
https://kontrast.at/glyphosat-verbot-oesterreich/, last accessed: 13/4/2020.
108
https://www.zeit.de/wissen/umwelt/2019-09/tierwohl-label-nutztiere-insekten-glyphosat-julia-
kloeckner, last accessed: 13/4/2020.
109
https://gouvernement.lu/en/actualites/toutes_actualites/communiques/2020/01-janvier/16-
interdiction-glyphosate.html, last accessed: 13/4/2020.
110
European Commission, Communication from the Commission on the European Citizens' Initiative
"Ban glyphosate and protect people and the environment from toxic pesticides", C(2017) 8414
final, p. 7.

Glyphosate case study 29
However, it should also be mentioned that in the US, and specifically in California,
Monsanto/Bayer and other producers of glyphosate-based herbicides have faced
litigation, mostly by professional users of these herbicides who developed cancer later on
(Arcuri & Hendlin 2019). For example in the case Hardeman v. Monsanto (Case No 16-cv-
00525-VC) from the United States District Court Northern District of California, found in
favour of the applicant that Monsanto had negligently failed to place sufficient cancer
warnings on Roundup bottles. Also in the cases brought by Dewayne Johnson (Dewayne
Johnson v Monsanto (case No CGC-16- 550128)) and Alva and Alberta Pilliod v. Monsanto
(Case No. RG17862702, JCCP No. 495), were won by the applicants as the court agreed
that the exposure to glyphosate has caused them to develop cancer. However, the task of
the courts in such cases significantly differs from the risk assessment of a regulatory
authority, which means that the judgment regarding the scientific evidence by the courts
is not easily transferred to a risk assessment (Benbrook 2020).
4.2 Other governance dynamics
Generally the risk perception of pesticides has changed over time: Whereas initially
the early 1900’s the use of chemicals in farming was embraced as it helped to alleviate
hunger, this changed in the 1960s when the risk for human health and the environment
associated with pesticides became clearer (Bozzini 2017). When it comes to plant
protection products, Regulation (EC) 1107/2009 aims to protect human and animal health
as well as the environment, while improving agricultural production.
111
These aims and
whether the Regulation succeeds in achieving them is contested, as shown in a study for
the European Parliament: while some stakeholders including NGOs, but also national
regulators, said that the aim of improving production and trade “are no longer relevant”
112
,
a pesticide manufacturers association expressed their concern that the Regulation is
unnecessarily burdensome in terms of health and environmental protection measures and
negatively impacts on the Unions agricultural industry on the global market.
113
It should be made clear that the debate surrounding glyphosate is deeply entangled
with a bigger societal, political, ecological and economical question on the future
of agriculture.
114
As Alexandra Brand (Syngenta) told Politico: “A lot of what we talk
about pesticides is a symbol for an agriculture we are not happy with.”
115
The discussion
surrounding glyphosate was certainly politicised due to its connection to the very contested
issue of GMOs. For example the Parliament Resolution from April 2016 in paragraphs AC
and AD mentioned the connection between glyphosate and GMOs, and that the Parliament
had objected to four different draft GMO authorisations.
116
Arguably, at the time Monsanto
as one of the most prominent glyphosate-based herbicide producers, attracted normative
critique being “the symbol of industrialized agriculture” (INGSA 2017, p.6).
111
Regulation (EC) No 1107/2009, Art. 1(3).
112
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668, April 2018,
p. 34.
113
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668, April 2018,
p. 34.
114
See: Section 4.2. of this report.
115
https://www.politico.eu/article/battle-over-glyphosate-shifts-to-the-environmental-front-
pesticides-herbicides/, last accessed: 13/4/2020.
116
EP Resolution P8_TA(2016)0119.

Glyphosate case study 30
Glyphosate itself is a catalyst of the shift to large industrial-style farming, which has been
criticized for creating ‘green deserts’ of monocultures, which in turn are detrimental to
biodiversity (Paskalev 2019). This concern with broader questions of agricultural policy is
also very visible in the European Citizens Initiative which called on the Commission to “set
EU-wide mandatory reduction targets for pesticide use, with a view to achieving a
pesticide-free future”.
117
In its answer the Commission made clear that the EU is not in
pursuit of a zero-pesticide policies, but that it is aiming at sustainable use of pesticides.
118
As expressed by the NGO Corporate Europe Observatory:
“In our opinion, one of the most important – but less discussed –
stakes in this process has been the possibility to put an end to the
use of one the most used and efficient plant-killer on Earth while we're
experiencing the fastest biodiversity collapse ever measured. The
glyphosate saga could have been an opportunity to at last discuss and
regulate the use of wide-spectrum herbicides in agriculture, but this
is yet to happen."
119
5 The precautionary principle and its future
5.1 Reflection on the PP in the literature
The use of the precautionary principle in the approval procedure of glyphosate and the
pesticides framework in general have been extensively reflected on and criticised. Many
criticisms were already mentioned in the previous analysis, however, in this section some
of the central reflections on the use of the precautionary principle in the glyphosate renewal
procedure will be discussed.
Although the Pesticides Regulation presents the hazard-based cut-off criteria, like
carcinogenicity, as binary ‘fulfilled or not fulfilled’ criteria, the reality is different: although
some of the criteria are subject to such a black-or-white assessment with clear scientific
indicators, most of these criteria are more openly defined and require an expert judgement,
often using a weight of evidence approach (SAM 2018). Already in the section 3.3.3
discussing ambiguity of scientific findings, it was discussed that the IARC and the EU
agencies assigned different importance to scientific data, and especially studies published
by academics which lack GLP certification. The weight of evidence that EFSA and ECHA
gave to certain studies and the fact that it dismissed others is not undisputed. A group of
scientists led by Prof. Portier (who has also acted as invited specialist during the IARC
meeting) send a letter to the European Commission in November 2015 criticising the BfR
assessment for errors in their assessment and for incorrectly dismissing certain
evidence.
120
Concerned scientists including Prof. Portier and Dr. Clausing (affiliated with
117
European Commission, Communication from the Commission on the European Citizens' Initiative
"Ban glyphosate and protect people and the environment from toxic pesticides", C(2017) 8414
final, p. 12.
118
Ibid.
119
https://corporateeurope.org/en/food-and-agriculture/2016/06/glyphosate-one-pesticide-many-
problems, last accessed 13/4/2020.
120
https://www.baumhedlundlaw.com/pdf/monsanto-documents/johnson-trial/DX-2735-Portier-
Letter-EFSA-BfR-Glyphosate.pdf; last accessed: 13/4/2020. Portier followed up with another letter
in 2017 after the Monsanto papers:

Glyphosate case study 31
the Pesticide Action Network) also voiced criticisms in scientific articles regarding the
application weight of evidence standards and the risk assessment in the case of glyphosate
(Clausing et al 2018; Robinson et al 2020). Moreover, in other articles comparing the IARC
and EFSA assessment, they identified flaws in the risk assessment carried out by EFSA
(Portier et al 2016; Portier et al 2017).
With regard to the glyphosate risk assessment, another core criticism relates to the
reliability of the studies provided for by the industry in the renewal of approval
procedure. Generally, concerns have been raised whether the shift of the burden of proof
that requires the applicant to submit the safety evidence, guarantees correct data and an
independent and transparent risk assessment.
121
The information asymmetry between the
applying companies and the risk assessing public authorities raised concerns.
122
The
Monsanto papers scandal, where Monsanto was forced to release documents including
emails, peer review reports, drafts of manuscripts as well as power point presentations, in
the context of tort litigation against the company in California,
123
has contributed to the
questions concerning the reliability of industry financed studies (McHenry 2018). The
publication of these documents showed that Monsanto actively interfered in the supposedly
objective scientific debate by ghost-writing scientific articles and intruding in peer review
process (McHenry 2018). McHenry (2018, p.202) in this regard concludes that Monsanto
has “poisoned the [scientific] well by flooding the scientific journals with ghost-written
articles and interfering in the scientific process at multiple levels.”
Moreover, the lack of transparency of the approval process and the confidentiality of
the submitted studies was criticized.
124
To address some concerns raised by shifting the
burden of proof on the industry the Commission promised to enhance the auditing of the
studies and their compliance with the GLP, to increase the transparency concerning the
studies taken into account and to create the possibility to exceptionally commission studies
in case of serious doubts.
125
These measures were taken through adoption of Regulation
2019/1381 on the transparency and sustainability of the EU risk assessment in the food
chain.
126
Not only the risk assessment process was criticized for a lack of transparency, but also the
risk management process was deemed to lack transparency. These transparency
https://corporateeurope.org/sites/default/files/attachments/letterjuncker28may2017.pdf, last
accessed: 13/4/2020.
121
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668, April 2018,
p. 40f.
122
Ibid., p. 41.
123
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668, April 2018,
Annex II p. 58.
124
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668, April 2018,
Annex II p.73 and Annex IV p. 57; Korkea-aho & Leino, 2017.
125
European Commission, Communication from the Commission on the European Citizens' Initiative
"Ban glyphosate and protect people and the environment from toxic pesticides", C(2017) 8414
final, p. 12.
126
Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the
transparency and sustainability of the EU risk assessment in the food chain and amending
Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC)
No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive
2001/18/EC, OJ L 231, 6.9.2019, pp. 1–28.

Glyphosate case study 32
concerns are important with regard to the application of the precautionary principle as it is
in the risk management stage that the principle is applied, in accordance with Article 13 of
the Pesticide Regulation. A report for the European Parliament for example points out:
“Evidence shows that there is a need for a more transparent and comprehensive risk
management stage since most of the time the reasoning behind risk management
decisions, the regulatory criteria adopted and how the discussions among decisions-makers
unfolded is not made explicitly public.”
127
This concern is also voiced by stakeholders.
128
However, the transparency of the application of the principle is in practice challenged by
two factors: first of all, the criteria for decision-making in the risk management task
are not clearly laid down. While this allows for flexibility and a wide margin of
appreciation in the decision-making, which may be necessary in the face of complex risks,
it also hinders legal certainty and the meaningful accountability for the decision made
(Bozzini 2017; Morvillo 2020). Second of all, the actual reasons for concrete decisions
made in the approval of an active substance, like glyphosate, are not openly
communicated.
129
The Scientific Advice Mechanism therefore recommended that the goals
protected by a measure and factors that were taken into account should be clearly
communicated (SAM 2018). Also the European Parliament called for transparency of the
comitology procedure.
130
In the aftermath of the glyphosate renewal the European Parliament decided to investigate
the functioning of the pesticides approval and authorization procedures through a
committee devoted to this topic, the Special Committee on Pesticides (PEST).
131
Based
on this report, the European Parliament on 16 January 2019 adopted a resolution, which
amongst many other issues also addresses the role of the precautionary principle in the
pesticides procedures. The Parliament asked the Commission and the Member States to
“in their role as risk managers to duly apply the precautionary principle when, following an
assessment of the available information, the possibility of harmful effects on health is
identified but scientific uncertainty persists, by adopting provisional risk management
measures necessary to ensure a high level of protection of human health.”
132
Finally, in an article in King’s Law Journal, Arcuri and Hendlin (2019), argue that the
regulatory approach taken in the case of glyphosate fails to sufficiently protect
vulnerable populations and non-human organisms. They argue (Arcuri and Hendlin
2019, p. 236) that in the risk determination of environmental toxicology “legal frameworks
(…) frequently minimise risks and overestimate the certainty and accuracy of assessments,
leading to downplaying the exposures of those populations most threatened by toxic
chemicals.” The risk assessment of glyphosate, and pesticides in general, according to their
view is flawed as it suffers from compartmentalisation and anthropocentrism (Arcuri and
Hendlin 2019). They criticise that, with the regulation being anthropocentric, vulnerable
127
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668, April 2018,
p. 50.
128
Ibid.
129
Ibid.
130
European Parliament resolution of 16 January 2019 on the Union’s authorisation procedure for
pesticides, P8_TA(2019)0023, Point 79.
131
European Parliament, European Parliament decision of 6 February 2018 on setting up a special
committee on the Union’s authorisation procedure for pesticides, its responsibilities, numerical
strength and term of office, P8_TA(2018)0022.
132
European Parliament resolution of 16 January 2019 on the Union’s authorisation procedure for
pesticides, P8_TA(2019)0023, Point 6.

Glyphosate case study 33
groups in the human population as well as animals are not adequately protected in the
current exposure and harm thresholds.
5.2 Effect of the PP on innovation pathways
As far as pesticides are concerned, next to weeds becoming resistant to certain pesticides,
the increasingly demanding regulatory framework and the banning of substances
has led to innovation (Bozzini 2017). While the sector remains very profitable, it is
argued that research and development costs have dramatically increased (Bozzini 2017).
As explained in an article by the legal scholars Garnett, van Calster and Reins (2018, p.6):
although no piece of EU legislation directly and exclusively addresses innovation, general
rules such as the precautionary principle and sector specific legislation, like the Pesticides
Regulation, has an effect on how innovation is approached is certain sectors and
companies. The balance that is struck in the legislation between protection human health
and the environment and promoting trade industrial interests, and therefore innovation, is
a core struggle in the innovation pathway for pesticides.
Whether the debate surrounding the risks of glyphosate will lead to innovation in changing
the product or leading to its replacement is currently not foreseeable. Concerns have been
voiced that in case of a ban, glyphosate might not be easily substituted. Euractive
published an article citing Bayer official Dr. Bob Reiter as referring to glyphosate as a ‘once
in a lifetime product’ and that it has properties that even after intensive research so far
have not been discovered in another substance.
133
According to this interview, Bayer is
aiming to prevent a complete replacement of glyphosate and instead is trying to advocate
to complement it with other substances.
134
However, as was already discussed in section 4.2., the glyphosate debate is very much
influenced by border concerns of agricultural policy and the questioning of the future use
of pesticides. Stakeholders call for new objectives in the pesticide regulation, including:
“developing new technologies, investing in the use of naturally occurring substances and
the protection of farm ecosystems, stimulating use of substances with low risk, or
promoting non-animal methods for assessment of risks of substances and mixtures”.
135
Also the European Green New Deal promoted by the von der Leyen Commission in this
regard states:
“The strategic plans will need to reflect an increased level of ambition
to reduce significantly the use and risk of chemical pesticides, as well
as the use of fertilisers and antibiotics. The Commission will identify
the measures, including legislative, needed to bring about these
reductions based on a stakeholder dialogue. The area under organic
farming will also need to increase in Europe. The EU needs to develop
innovative ways to protect harvests from pests and diseases and to
consider the potential role of new innovative techniques to improve
133
https://www.euractiv.com/section/agriculture-food/news/no-magical-alternative-to-glyphosate-
in-the-next-5-years-bayer-official-says, last accessed: 13/4/2020.
134
https://www.euractiv.com/section/agriculture-food/news/no-magical-alternative-to-glyphosate-
in-the-next-5-years-bayer-official-says, last accessed: 13/4/2020.
135
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668, April 2018,
p. 34-35.

Glyphosate case study 34
the sustainability of the food system, while ensuring that they are
safe.”
136
Thus, some form of innovation will have to occur in the pesticides industry, given the public
and political pressure. In this regard, the application of the precautionary principle -
through the strict regulatory framework for pesticides- can be seen as fostering
innovation. The Bureau Européen des Unions de Consommateurs (BEUC) more generally
expressed it in the following way: “The precautionary principle pushes industry to research
and innovate in safer or greener alternatives, which benefits both consumers and the
economy.”
137
5.3 Innovation principle
This study has not found evidence that the innovation principle has been invoked
formally in the context of the debate surrounding glyphosate. However, when in 2013 12
CEOs wrote a letter to the Presidents of the Commission, European Council and European
Parliament to introduce and promote the innovation principle the CEOs of several
companies producing glyphosate-based pesticides were amongst the signatories Bayer,
BASF, Dow AgroScience, and Syngeta.
138
Many companies participating in the European
Risk Forum (ERF), which is central in proposing and lobbying for the innovation principle
are producers of pesticides and biotechnology.
139
Although not specifically referring to
pesticides a joint position of the ERF, Businesseurope and the European Roundtable of
Industrialists states:
“Regulation which solely concentrates on risk avoidance and removal
of scientific uncertainty and fails to consider both risks and benefits,
stifles technological innovation. This type of regulation tends to result
in companies directing limited budgets towards ‘defensive R&D’, for
compliance, at the expense of more innovative and discovery oriented
research.”
140
Thus, the argument is advanced that strict regulatory frameworks, like the approval and
authorization scheme for pesticides with heavy scientific data requirements hinders
innovation, as money is spent on proving safety for the regulatory procedures rather than
innovating.
As argued by Garnett, van Calster and Reins (2018, p.11), large biotech companies would
use the innovation principle to side-line the precautionary principle, where they “have been
finding it increasingly hard to see their products approved for use in the EU and in some
136
European Commission, Communication from the Commission – The European Green Deal,
COM(2019) 640 final, 11.12.2019, p. 12.
137
https://www.beuc.eu/publications/beuc-x-2018-
112_precautionary_principle_under_attack_please_delete_so-called_innovation_principle.pdf, last
accessed: 13/4/2020.
138
https://corporateeurope.org/sites/default/files/corporation_letter_on_innovation_principle.pdf,
last accessed: 13/4/2020.
139
http://www.riskforum.eu/uploads/2/5/7/1/25710097/businesseurope-erf-
ert_innovation_principle_joint_statement.pdf, last accessed: 13/4/2020.
140
http://www.riskforum.eu/uploads/2/5/7/1/25710097/businesseurope-erf-
ert_innovation_principle_joint_statement.pdf, last accessed: 13/4/2020.

Glyphosate case study 35
cases are fighting long legal battles to see their product licenses renewed (such as with
glyphosate, bisphenol A or endocrine disrupters).” They point out that the industry, like in
the case of glyphosate, has to go through lengthy and demanding risk assessment
procedures which still might not disperse doubts with regard to the safety of the products,
which explains why those companies might be inclined to shift the focus of the debate to
innovation and job creation (Garnett, van Calster and Reins 2018).
Also Corporate European Observatory (CEO) warns that: “(…) these industries are trying
to use this principle to undermine EU laws on chemicals, novel foods, pesticides, nano-
products and pharmaceuticals, amongst others, as well as legal principles of environmental
and human health protection which are enshrined in the EU Treaty.”
141
CEO refers to an
event organized by the ERF and cites a representative of the pesticides industry as arguing
that there is an incompatibility between regulations promoting innovation and those
regulations that prohibit innovative or indispensable substances.
142
The ‘indispensable
substances’ is interpreted by CEO to refer to glyphosate.
143
6 Synthesis
The glyphosate case study illustrates very well that a relatively old technology, widely
used around the world since the 1970s, can with new scientific findings become the center
of an extensive controversy. In the last decade, concerns have been raised with regard to
glyphosate and risk for human health, such as carcinogenicity and endocrine disruption,
as well as risks to the environment, regarding specific species as well as whole ecosystems.
However, these risks are subject to scientific uncertainty even decades after its
invention. This is caused by uncertainty through absence of systematic monitoring of
glyphosate use and exposure. Moreover, the case clearly illustrates that scientific
uncertainty also can exist and persist, in case of an intensely studied chemical substance,
with over 1,000 studies performed and continuous scientific interest leading to an ever-
increasing number of studies. In the glyphosate case, the scientific uncertainty is mostly
fueled by normative and interpretative ambiguity: the reliability of industry studies is
questioned, and, regulatory authorities apply a weight of evidence approach that leads
to academic studies being of limited significance to the risk assessment performed, leading
to opposing findings concerning the highly contested carcinogenicity of glyphosate.
What is remarkable about the risk governance on EU level is that the existence of
scientific uncertainty is not recognized. As the hazard and risk assessment performed
by EFSA and ECHA concluded that glyphosate is not a carcinogen, from the perspective of
these Agencies and the Commission, there is no scientific uncertainty on this question. This
leads to the conclusion that in the EU assessment of the glyphosate debate, the legislation
and the regulatory framework, with the weight of evidence approach as operated in the
scientific assessment, has significantly influenced and shaped the risk assessment process
(Paskalev 2020; Morvillo 2020). As explained by Paskalev (2019, p.3) who compared the
IARC and EFSA/ECHA findings: “the decision of each agency is affected by its own
governing documents, terms of reference, set functions and mission statement and this is
why even if they all appeared to be considering the same issue – carcinogenicity of a
certain substance – they were bound to reach different conclusions.” Thus, the
uncertainty with regard to the glyphosate risk is presented less as a clash of
scientific findings but rather a problem of conflicting regulatory scientific choices
in the hazard identification/risk assessment stage. This has brought to the forefront
141
https://corporateeurope.org/en/environment/2018/12/innovation-principle-trap, last accessed:
13/4/2020.
142
Ibid.
143
Ibid.

Glyphosate case study 36
that in framing the risk analysis process through regulation, political choices are made and
that “[g]lyphosate (…) has become a catalyst for testing existing dichotomies” and that
“glyphosate has the potential of re-politicizing the field of science based-law” (Arcuri,
p.243).
As was shown in this case study, although not all of main components of the
precautionary principle as defined in the WP1 Report: Taking stock as a basis for
the effect of the precautionary principle since 2000,
144
including scientific uncertainty
and risk, scientific evaluation, threshold of damage, cost-effective
measures/proportionality and burden of proof, were directly applicable in the case of
glyphosate as the substance was not banned. However, in principle the regulatory
framework applicable to glyphosate does incorporate these characteristics.
Nonetheless, it also became clear that the application of the precautionary principle
in the risk management stage is not clearly regulated. Although the legislation
specifically mentions taking into account the PP in the decision on approval and renewal of
active substances, how this should happen is not clearly defined and also not well
communicated.
In the case of glyphosate, after a hazard and risk assessment by EFSA and ECHA, it was
decided that a ban was not necessary, even in the face of large public pressure. While this
is criticized by some stakeholders, it is also a sign that innovation and innovative
industries do not need to be specifically protected against ‘laws of fear’
145
. The build-
in mechanisms in the process leading to the application of the principle, like the thorough
risk assessment, in itself protected against a disproportionate precautionary measure.
The glyphosate case also shows how a very technical and scientific debate – surrounding
the carcinogenicity assessment and the underlying scientific methods, can be easily
politicized. With regard to the glyphosate, this is caused, first of all, by the fact that
exposure is in essence unavoidable for everyone, given the residues of glyphosate in food
and water. On the other hand, the debate surrounding glyphosate is deeply
entangled with bigger questions on the future of agriculture and GMOs.
This also has an impact on how the application of the precautionary principle interacts with
innovation. While glyphosate has not been banned on EU level, a ban of the substance or
the further limitation of its use will pose challenges to the chemical industry and farmers.
It is debated if glyphosate would be (easily) replaceable and how innovation with regard
to the substance or a possible substitute will look. What is clear is that the glyphosate
controversy, together with the debate surrounding other pesticides such as neonics,
146
has
reinvigorated the public and political pressure to rethink the use of pesticides in European
agriculture. In this regard, the precautionary principle has been a catalyst for
innovation.
7 Conclusion
The safety of glyphosate, and especially its effects on human health and the environment,
have been called into question in the recent decade by scientific studies. However, these
144
E. Vos & K. de Smedt, ‘Taking stock as a basis for the effect of the precautionary principle since
2000‘, RECIPES WP 1 Report,
,available via: https://recipes-project.eu/sites/default/files/2020-
03/Report%20Taking%20stock%20as%20a%20basis%20for%20the%20effect%20of%20the%20p
recautionary%20principle%20since%202000.pdf, last accessed: 13/04/20.
145
The term was coined by Sunstein (2005).
146
Please see the RECIPES case study on neonicotinoids.

Glyphosate case study 37
studies are debated in terms of their methodology and in how far they should be taken
into account in the risk assessment by regulatory bodies. In the EU, the assessment of
glyphosate in the context of the renewal of approval procedure ended with a re-approval
of the substance for 5 years in 2017. This decision was based on the risk assessment
carried out by EU agencies, which came to the conclusion that glyphosate is not
carcinogenic and also does not pose other risk that would justify banning the substance.
However, this finding is contested by individual scientists and also opposes the finding of
the IARC. This creates scientific uncertainty through ambiguity.
The precautionary principles shapes the approval procedure and regulation of pesticides
as such, however, as in the risk assessment of glyphosate on EU level no risk was
determined, no precautionary measure in the form of a ban was taken. This is contested
by various stakeholders. The politicisation of the glyphosate renewal procedure has to be
seen in the context of the larger debate surrounding the future of EU agriculture and the
use of pesticides. In this regard, the application of the precautionary principle has led to
increased political pressure, which is highly likely to result in some form of innovation in
this area in the long run. As for glyphosate itself, whether innovation will be necessary will
be determined in the currently ongoing renewal procedure.

Glyphosate case study 38
8 References
EU legislation and non-legislative acts
Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February
2011 laying down the rules and general principles concerning mechanisms for control by
Member States of the Commission’s exercise of implementing powers, OJ L 55, 28.2.2011,
pp. 13–18.
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October
2009 concerning the placing of plant protection products on the market and repealing
Council Directives 79/117/EEC and 91/414/EEC, OJ L 309, 24.11.2009, pp. 1–50.
Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019
on the transparency and sustainability of the EU risk assessment in the food chain and
amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC)
No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU)
2015/2283 and Directive 2001/18/EC, OJ L 231, 6.9.2019, pp. 1–28.
Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection
products on the market, OJ L 230, 19.8.1991, pp. 1–32.
Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009
establishing a framework for Community action to achieve the sustainable use of pesticide
OJ L 309, 24.11.2009, pp.71-86.
Commission Directive 2001/99/EC of 20 November 2001 amending Annex I to Council
Directive 91/414/EEC concerning the placing of plant protection products on the market to
include glyphosate and thifensulfuron-methyl as active substances OJ L 304, 21.11.2001,
pp. 14–16.
Commission Directive 2010/77/EU of 10 November 2010 amending Council Directive
91/414/EEC as regards the expiry dates for inclusion in Annex I of certain active substances
Text with EEA relevance OJ L 293, 11.11.2010, pp. 48–57.
Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the
procedure for the renewal of the inclusion of a second group of active substances in Annex
I to Council Directive 91/414/EEC and establishing the list of those substances, OJ L 322,
8.12.2010, pp. 10-19.
Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting
out the provisions necessary for the implementation of the renewal procedure for active
substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament
and of the Council concerning the placing of plant protection products on the market OJ L
252, 19.9.2012, pp. 26–32.
Commission Implementing Regulation (EU) 2016/1313 of 1 August 2016 amending
Implementation Regulation (EU) No 540/2011 as regards the conditions of approval of the
active substance glyphosate, OJ L 208, 2.8.2016, pp. 1–3.
Commission Implementing Regulation (EU) 2017/2324 of 12 December 2017 renewing the
approval of the active substance glyphosate in accordance with Regulation (EC) No
1107/2009 of the European Parliament and of the Council concerning the placing of plant
protection products on the market, and amending the Annex to Commission Implementing
Regulation (EU) No 540/2011, OJ L 333, 15.12.2017, pp. 10–16.
Commission Implementing Regulation (EU) 2019/724 of 10 May 2019 amending
Implementing Regulation (EU) No 686/2012 as regards the nomination of rapporteur

Glyphosate case study 39
Member States and co-rapporteur Member States for the active substances glyphosate,
lambda-cyhalothrin, imazamox and pendimethalin and amending Implementing Regulation
(EU) No 844/2012 as regards the possibility that a group of Member States assumes jointly
the role of the rapporteur Member State, OJ L 124, 13.5.2019, pp. 32–35.
Other EU documents
ECHA, Committee for Risk Assessment (RAC) Opinion proposing harmonised classification
and labelling at EU level of glyphosate (ISO); N-(phosphonomethyl)glycine, CLH-O-
0000001412-86-149/F, 15 March 2017.
ECHA, How ECHA is assessing glyphosate, ECHA Newsletter 3/2016.
European Commission, Proposal for a Council Directive concerning the placing of EEC-
accepted plant protection products on the market, COM (1976) 427 final, OJ C 212,
9.9.1976, p. 3–20.
European Commission, Communication from the Commission on the precautionary
principle, COM(2000)0001 final.
European Commission, Communication from the Commission on the European Citizens'
Initiative "Ban glyphosate and protect people and the environment from toxic pesticides",
C(2017) 8414 final.
European Commission, Summary Report of the Standing Committee on Plants, Animals,
Food and Feed held in Brussels on 17 July 2017, sante.ddg2.g.5(2017)4119844.
European Commission, Communication from the Commission – The European Green Deal,
COM(2019) 640 final, 11.12.2019.
European Court of Auditors, Sustainable use of plant protection products: limited progress
in measuring and reducing risks, Special Report 05/2020.
EFSA, Conclusion on the peer review of the pesticide risk assessment of the active
substance glyphosate, 13(11) 4302 EFSA Journal (2015), pp. 1-107.
EFSA, Statement of EFSA on the request for the evaluation of the toxicological assessment
of the co-formulant POE-tallowamine, 13(11) 4303 EFSA Journal (2015), pp. 1-13.
EFSA, Guidance on the use of the weight of evidence approach in scientific assessments,
15(8) 4971 EFSA Journal (2017), pp. 1-69.
EFSA, Conclusion on the peer review of the pesticide risk assessment of the potential
endocrine disrupting properties of glyphosate’, 15(9) 4979 EFSA Journal (2017), pp.1-20.
European Parliament resolution of 24 October 2017 on the draft Commission implementing
regulation renewing the approval of the active substance glyphosate in accordance with
Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning
the placing of plant protection products on the market, and amending the Annex to
Implementing Regulation (EU) No 540/2011, P8_TA(2017)0395.
European Parliament, European Parliament decision of 6 February 2018 on setting up a
special committee on the Union’s authorisation procedure for pesticides, its responsibilities,
numerical strength and term of office, P8_TA(2018)0022.
European Parliament resolution of 16 January 2019 on the Union’s authorisation procedure
for pesticides, P8_TA(2019)0023.

Glyphosate case study 40
European Parliament Research Service, Regulation (EC) 1107/2009 on the Placing of Plant
Protection Products on the Market – European Implementation Assessment, PE 615.668,
April 2018.
Scientific Advice Mechanisms, Group of Chief Scientific Advisors, EU authorisation
processes of Plant Protection Products, Scientific Opinion 5/2018, June 2018.
Judgements Court of Justice of the European Union
T-545/11 Stichting Greenpeace Nederland and Pesticide Action Network Europe (PAN
Europe) v European Commission, ECLI:EU:T:2013:523.
§ C-673/13 P Commission v Stichting Greenpeace Nederland and PAN
Europe, ECLI:EU:C:2016:889.
§ T-545/11 RENV Stichting Greenpeace Nederland and Pesticide Action
Network Europe (PAN Europe) v European Commission,
ECLI:EU:T:2018:817.
T-12/17 Mellifera eV, Vereinigung für wesensgemäße Bienenhaltung v European
Commission, ECLI:EU:T:2018:616.
§ Currently under appeal: C-784/18 P Mellifera v Commission.
§ T-383/18 Mellifera v. Commission.
T-178/18 Région de Bruxelles-Capitale v European Commission, ECLI:EU:T:2019:130
(Order of the General Court).
§ Currently under appeal: C-352/19 P Région de Bruxelles-Capitale v
European Commission.
T-125/18 Associazione Nazionale Granosalus vs. European Commission,
ECLI:EU:T:2019:92.
§ Currently under appeal: Case C-313/19 P Associazione GranoSalus v
Commission.
T-716/14 Tweedale v EFSA, ECLI:EU:T:2019:141.
T-329/17 Hautala v EFSA, ECLI:EU:T:2019:142.
C-616/17 Criminal proceedings against Mathieu Blaise and Others, ECLI:EU:C:2019:800
§ Opinion of Advocate General Sharpston in case C-616/17 Criminal
proceedings against Mathieu Blaise and Others, ECLI:EU:C:2019:190.
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9 Appendix
n/a