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Chemicals Safety
In 2013, a routine re-assessment of glyphosate was car-
ried out within the framework of the EU evaluation of
active substances. In this European process, each ap-
proved active substance is re-assessed together with a
sample formulation to determine its risks to health and
the environment as well as its efficacy. The report on the
health assessment was prepared by the BfR – as had
been the case when the active substance was tested in
2003. For this purpose, the BfR described and evaluated
more than 150 new original toxicological studies in addi-
tion to the documents that had already been evaluated in
2003. In addition, over 900 studies published in scientific
journals were also taken into consideration.
Analysis of these numerous new documents did not pro-
vide any indication that glyphosate is either carcinogenic
or toxic for reproduction. Furthermore, there were no
signs of developmental toxicity of glyphosate; nor were
there indications that any major changes to the health-
based limit values needed to be made. In addition, the
BfR still considers the maximum residue concentrations
for glyphosate in food and feed to be safe. When the Euro-
pean Commission defined the maximum residue concen-
trations, it took account of the use of glyphosate as both a
weed killer and a desiccation agent. It is known from past
studies that humans and animals can ingest small quanti-
ties of glyphosate via food and feed that contain residues
at admissible levels. The re-assessment of the BfR scien-
tifically demonstrated that the intake of residues via plant-
based foods amounts to a maximum of 1.5 percent of the
acceptable daily lifelong intake without having any harm
to health. The migration of glyphosate into animal food
products is low and also poses no health risk.
Glyphosate is used in plant protection products as an
aqueous formulation or in combination with various co-
formulants. The herbicidal effect of glyphosate is sys-
tematically reinforced by the addition of so-called sur-
factants, which are designed to promote the penetration
of glyphosate into the plants. Certain surfactants like
POE tallow amines have higher toxicity than the active
substance glyphosate. The higher toxicity of some prep-
arations compared to the toxicity of the active substance
has also been proven in several animal experiments.
Therefore, the BfR supplemented this process by con-
ducting an in-depth toxicological assessment of the POE
tallow amines and integrated the results in the report on
the re-assessment of glyphosate.
In November 2013, the BfR submitted the partial report
of the overall assessment to the lead-managing institu-
tion, the Federal Office of Consumer Protection and Food
Safety (BVL), who then forwarded the overall report to
the European Food Safety Authority. After the public com-
ments of the EU member states and all other interested
parties have been documented, a more extensive expert
meeting will, if necessary, take place on EU level in order
to discuss this active substance. The procedure for the
renewed approval of glyphosate is expected to be com-
pleted at the end of 2014.
From the point of view of BfR, the findings on the toxicity
of the POE tallow amines prove the need for research
regarding the interactions of active substances with co-
formulants. The need for research in this area extends
far beyond glyphosate. Innovative approaches are called
for in order to achieve long-term improvement of risk
assessment methods. In particular, the assessment of
residues of multiple substances in plant protection prod-
ucts and possible interactions with other components of
these products (cumulative risk assessment) are under
consideration. For this reason, BfR is to initiate a research
project to investigate the interactions of different active
substances and co-formulants in plant protection prod-
ucts. Research projects of this kind will help to improve
the methods used for cumulative risk assessment in the
long-term.
Within the framework of the re-assessment of the health
risks of glyphosate in the EU evaluation of active sub-
stances, the BfR staged a scientific symposium in
January 2014.
