Miljø- og Fødevareudvalget 2015-16
MOF Alm.del Bilag 108
Offentligt
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EFSA explains risk assessment
Glyphosate
Glyphosate is an active substance that is widely used in pesticides. Glyphosate-based
pesticides (i.e. formulations containing glyphosate and other chemicals) are used in
agriculture and horticulture primarily to combat weeds that compete with cultivated
crops. They are typically applied before crops are sown and as a pre-harvest desiccating
treatment, accelerating and evening the ripening process.
What has EFSA done?
EFSA and EU Member States have carried out a risk assessment and peer review that
updates our scientific knowledge of the toxicity of glyphosate. EFSA has published a
Conclusion on glyphosate
as part of this process. The conclusion will be used by the
European Commission in deciding whether or not to keep glyphosate on the EU list of
approved active substances, and to inform the subsequent evaluations by Member
States on the use of glyphosate-based formulations in their territories. (See box: “How is
the safety of glyphosate assessed in the EU?”)
Main findings of the assessment
After considering the huge amount of relevant data, an EFSA peer review expert group
made up of EFSA scientists and representatives nominated by EU Member States
concluded that:
The toxicity of glyphosate needs to be redefined. An acute reference dose (ARfD)
of 0.5 mg/kg of body weight has therefore been proposed, the first time such a
safety measure has been introduced for glyphosate. EFSA will use this ARfD
during its review of the maximum residue levels for glyphosate, which will be
carried out in cooperation with Member States in 2016. The acceptable operator
exposure level (AOEL) has also been set at 0.1 mg/kg body weight per day and
an acceptable daily intake (ADI) for consumers has been set in line with the ARfD
at 0.5 mg/kg body weight per day.
The substance is unlikely to be genotoxic (i.e. damaging to DNA) or to pose a
carcinogenic threat to humans. Glyphosate is not proposed to be classified as
carcinogenic under the EU regulation for classification, labelling and packaging of
chemical substances. In particular, all the Member State experts but one agreed
that neither the epidemiological data (i.e. on humans) nor the evidence from
animal studies demonstrated causality between exposure to glyphosate and the
development of cancer in humans.
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How is the safety of pesticides assessed in the EU?
Under EU legislation, pesticide active substances in plant protection products are
approved in the EU only if it may be expected that their use will not have any harmful
effects on human and animal health or the environment.
The evaluation of both existing and new active substances follows a phased approach:
1. For each substance an initial draft assessment report (DAR) or renewal
assessment report (RAR) is produced by a designated rapporteur Member State
(RMS). Regarding applications for renewal of an approval, the Commission
decides on the designation of a rapporteur Member State in consultation with all
Member States and industry.
2. The RMS’s risk assessment is peer reviewed by EFSA in cooperation with all
Member States.
3. EFSA drafts a report (“Conclusion”) on the active substance. The EFSA Conclusion
informs the European Commission in the approval process, the subsequent
assessments of plant protection products by the Member States, and the revision
of maximum residue levels in food by EFSA.
4. The European Commission decides whether or not to include the substance in the
EU’s list of approved active substances. This determines whether the substance
can be used in a plant protection product in the EU.
5. EU Member States assess or re-assess the safety of pesticides containing the
active substance that are sold in their territory.
Why do some scientists say that glyphosate is carcinogenic?
The International Agency for Research on Cancer (IARC) said earlier this year that
glyphosate was genotoxic and would “probably” cause cancer in humans.
However, the IARC report looked at both glyphosate – an active substance – and
glyphosate-based formulations, grouping all formulations regardless of their composition.
The EU assessment, on the other hand, considered only glyphosate. Member States are
responsible for evaluating each plant protection product that is marketed in their
territories.
This is because the EU and IARC take different approaches to the classification of
chemicals. The EU scheme –assesses each individual chemical, and each marketed
mixture separately. IARC assesses generic agents, including groups of related chemicals,
as well as occupational or environmental exposure, and cultural or behavioural practices.
This is important because although some studies suggest that certain glyphosate-based
formulations may be genotoxic (i.e. damaging to DNA), others that look solely at the
active substance glyphosate do not show this effect. It is likely, therefore, that the
genotoxic effects observed in some glyphosate-based formulations are related to the
other constituents or “co-formulants”. Similarly, certain glyphosate-based formulations
display higher toxicity than that of the active ingredient, presumably because of the
presence of co-formulants. In its assessment, EFSA proposes that the toxicity of each
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pesticide formulation and in particular its genotoxic potential should be further considered
and addressed by Member State authorities while they re-assess uses of glyphosate-based
formulations in their own territories.
This distinction between active substance and pesticide formulation mainly explains the
differences in how EFSA and IARC weighed the available data. For the EU assessment,
studies conducted with glyphosate were more relevant than studies conducted with
formulated products containing other constituents, particularly when the other
constituents could not be clearly identified.
What data was used in this assessment?
The EFSA-led review considered a large body of evidence, including the IARC report. In
addition to the original studies submitted by the applicants in line with the legal
requirements, all available and published studies were considered.
IARC included a number of epidemiological studies in its monograph that were absent
from the draft EU assessment; these studies were later added to the EU dossier.
In total EFSA assessed more evidence including additional key studies that were not
considered by IARC.
How were the animal studies on carcinogenicity interpreted?
The EU peer review concluded that no significant increase in tumour incidence could be
observed in any of the treated groups of animals in the nine long term rat studies
considered. IARC, on the other hand, interpreted two studies as showing statistically
significant carcinogenic effects. Similarly, with the mice studies, IARC identified positive
carcinogenic trends in two studies that the EU peer reviewers assessed as insignificant.
The main differences between the EFSA and IARC evaluations are explained in detail in a
special background document published by EFSA. As well as reviewing a larger number
of studies, EFSA for example considered that carcinogenic effects observed at high doses
were unreliable as they could be related to general toxicity.
What happens next?
The EFSA conclusion will inform the European Commission in deciding whether or not to
retain the active substance glyphosate on the EU’s list of approved active substances, in
other words to authorise its continued use in pesticides in the EU.
Timeline
2012
May
Germany, as rapporteur member state (RMS), receives dossier in support
of the possible renewal of the authorisation of glyphosate.
2013
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December
2014
January
RMS sends draft renewal assessment report (RAR) to EFSA.
Peer review begins. RAR sent to Member States and applicants for
consultation and comments.
Public consultation launched, lasting 60 days.
RMS evaluates all comments.
Additional information requested from applicants.
March
July
August
2015
Feb–March
EFSA organises expert consultations in the areas of mammalian
toxicology, residues, environmental fate, and ecotoxicology
Member State consultation is launched on conclusions arising from peer
review.
IARC monograph published.
July
August
RMS prepares assessment of the monograph, which is circulated to
Member States for comments.
Following receipt of comments, EFSA organises second expert consultation
on carcinogenicity and mammalian toxicology.
Glyphosate authorisation provisionally extended until June 2016, pending
finalisation of EU peer review
Peer review updated accordingly and final consultation takes place with
Member States.
September
October
October
What do we mean by…
Active substance
An active substance is any chemical, plant extract, pheromone or micro-organism that acts
against “pests” on plants, parts of plants or plant products.
Acute reference dose (ARfD)
An ARfD is an estimate of a chemical substance in food, expressed on a bodyweight basis, that
can be ingested over a short period of time, usually during one meal or one day, without posing a
health risk.
Co-formulant
Pesticides are marketed in different formulations that consist of the active substance and various
co-formulants. Glyphosate can be used in combination with POE-tallowamine, a co-formulant that
promotes the penetration of the active substance into plants.
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Genotoxicity
Genotoxic chemicals damage the genetic information within a cell (DNA), causing mutations that
may lead to cancer.
Maximum residue levels
A maximum residue level (MRL) is the highest concentration of an active substance that is legally
permitted in food or feed when pesticides are applied correctly. EFSA is responsible for proposing
MRLs in the EU.
Metabolite
Metabolites are breakdown products that form when a pesticide mixes with air, water, soil or
living organisms. They are considered in EFSA’s pesticide safety assessments
Weight of evidence
When there are many studies available on a subject, it is good practice to integrate all the
available information and identify consistencies and inconsistencies in the results, then weigh the
results according to their reliability and relevance.
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