On October 1, 2012, Germany’s Federal Institute for Risk Assessment (BfR) made public its review of a controversial study on the health effects of the genetically engineered corn.
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German Risk Assessor Finds Flaws In Séralini Study
Biotechnology - GE Plants and Animals
Leif Erik Rehder
On October 1, 2012, Germany’s Federal Institute for Risk Assessment (BfR) made public its
review of a controversial study on the health effects of the genetically engineered corn NK603
and the herbicide glyphosate. According to BfR, the study contains flaws and is not grounds
for new safety evaluations.
German Risk Assessor’s Review of the Séralini Study
A study published in the Journal Food and Chemical Toxicology (Séralini et al.) reportedly
found a link between long-term health effects in rats fed the genetically engineered corn
NK603 and the herbicide glyphosate. In response, the Federal Institute for Risk Assessment
(BfR) and the Federal Office of Consumer Protection and Food Safety (BVL) reviewed the
On October 1, BfR published its findings that, in effect, the study contains flaws and is not
grounds for new safety evaluations of NK603 or glyphosate.
The following is an unofficial translation of the BfR press statement:
“The claim that rats, which receive genetically modified corn for their entire lifespan, die earlier
than animals fed with conventional corn, is not sufficiently supported experimentally. This is
the conclusion of an evaluation which the Federal Institute for Risk Evaluation (BfR) performed
after the publication of „Long term toxicity of a Roundup herbicide and a Roundup-tolerant
genetically modified maize” by Gilles-Eric Séralini and others in the Journal „Food and
Chemical Toxicology“. „The study has both weaknesses in its design as well as in statistical
evaluation,[and] as a result the conclusions by the authors cannot be followed”, says Professor
Dr. Reiner Wittkowski, Vice President of the Federal institute. Likewise, the statement that the
long term uptake of Roundup, a plant protection product containing glyphosate, leads to
severe health damage and early death, is not sufficiently supported. Numerous long term
studies are available for glyphosate as a herbicidal active substance. Cancer, higher mortality
or impacts on the hormonal system of lab animals, as reported on by the authors in the study,
have not been observed in these studies.
In mid-September 2012, a research team led by Gilles-Eric Séralini at the University of Caen
in France published the results of a longitudinal study with rats which were fed genetically
modified corn, which is glyphosate tolerant. A portion of the GM maize had been treated with a
glyphosate pesticide (Roundup), another part was untreated. The corn was given in three
doses. In addition, other animals were fed with conventional food and had Roundup in their
drinking water at three dose levels. A control group was fed with genetically modified corn. The
authors report that the animals in some of the test groups have earlier developed tumors and
other organ damage and had died earlier than in the control group. The results could be
caused by hormonal effects of Roundup, as well as ingredients of genetically modified maize.
The BfR has reviewed the study in terms of relevance to the assessment of the health risk
genetically modified corn, which is glyphosate tolerant and also for the assessment of the
health risk of glyphosate as the active ingredient. Based on the publication BfR comes to the
conclusion that the main findings of the publication are not sufficiently documented
experimentally. Moreover, essential conclusions of the authors are incomprehensible due to
the shortcomings of the study design and the type of presentation and interpretation of data.
Particularly criticized in the study is that the number of animals per group is too low, which
does not comply with the recommendations of internationally recognized standards for studies
on carcinogenicity. The rat strain used has a relatively high spontaneous tumor rate in
particular for breast and pituitary tumors, and the number of animals used is not adequate to
assess the differences made by the authors between the test and control groups. The thesis of
the authors, the observed effects could be due to endocrine-related harm is not covered
sufficiently by the collected data. BfR complains further that the investigation was carried with
the glyphosate pesticide Roundup with no determination of the administered dose. In addition,
the collected data are published incompletely.
BfR has asked the authors of the study due to these shortcomings to provide the full study
report, including individual animal data. BfR also asked specific questions in order to allow
further evaluation of the reported effects.”
(Click here for a link to the German language press release on the BfR website. BfR will
reportedly release and English version of its study soon.)
Background on BfR
The Federal Institute for Risk Assessment (BfR) was established in 2002. It is responsible for
preparing expert reports and opinions on food and feed safety as well as on the safety of
substances and products. BfR reports to the Federal Ministry of Food, Agriculture and
Consumer Protection (BMELV).