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Maize MON 88017 × MON 810Scientific opinion on assessment of genetically modified maize MON 88017 × MON 810 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-017).

EFSA opinion:  29 January 2021

EFSA opinion annexes

Deadline: 7 March 2021

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EFSA: 2.1.3 Updated bioinformatic data11

At the time of submission of the renewal dossier, the applicant provided a complete bioinformatic dataset for maize MON 88017 and MON 810 events including an analysis of the insert and flanking sequences, an analysis of the potential similarity to allergens and toxins of the newly expressed proteins and of all possible open reading frames (ORFs) within the insert and spanning the junction sites, an analysis of possible horizontal gene transfer (EFSA, 2017b), and a safety assessment of the newly expressed proteins Cry3Bb1, Cry1Ab and CP4 EPSPS regarding their capacity to trigger celiac disease (EFSA GMO Panel, 2017a). The outcome of the updated bioinformatic analyses is presented in Section 3.3

Histopathological Investigation of the Stomach of Rats Fed a 60% Genetically Modified Corn Diet

Irena M. Zdziarski1*, Judy A. Carman2,3, John W. Edwards3
Discipline of Anatomy and Pathology, School of Medicine, University of Adelaide, Australia 2
The Institute of Health and Environmental Research (IHER), Kensington Park, Australia
Health and Environment, College of Science and Engineering, Flinders University, Bedford Park, Australia

Genetic modification (GM) represents new opportunities for enhanced crop
features such as improved insect resistance and herbicide tolerance. The
technology allows for cross-species alterations, therefore potentially allowing a
vast array of novel traits. Many GM crops have been developed and approved
for human and animal consumption. The present study investigated a
triple-stacked GM corn variety containing modifications for insect resistance
(via cry1Ab and cry3Bb1 genes) and herbicide tolerance (Roundup) (via an EPSPS gene),
which was fed to rats for six months.

The study investigated the mucosa of the stomach. Alterations to tight junction apposition, gland dilatations with epithelial elongation and dysplasia in the GM-fed rats were observed. These results indicate that GM-corn may have an effect on rat stomach mucosa, which
may have health implications.

Genetically Modified Corn, Rat Feeding Study, Long-Term Feeding Study,
Histopathology, Stomach

How to cite this paper: Zdziarski, I.M.,
Carman, J.A. and Edwards, J.W. (2018)
Histopathological Investigation of the Stomach of Rats Fed a 60% Genetically Modified Corn Diet. Food and Nutrition
Sciences, 9, 763-796.
Received: April 28, 2018
Accepted: June 26, 2018
Published: June 29, 2018

Environ Health. 2015; 14: 70.Published online 2015 Aug 25. doi: 10.1186/s12940-015-0056-1PMCID: PMC4549093PMID: 26302742

Transcriptome profile analysis reflects rat liver and kidney damage following chronic ultra-low dose Roundup exposure

Robin MesnageMatthew ArnoManuela CostanzoManuela MalatestaGilles-Eric Séralini, and Michael N. Antoniou


Our results suggest that chronic exposure to a GBH in an established laboratory animal toxicity model system at an ultra-low, environmental dose can result in liver and kidney damage with potential significant health implications for animal and human populations.

Wikileaks: Fragment: MON 810’s transgene structure differs from the original plasmid constructed for the safety assessment for Monsanto[1] and has changed compared to the naturally occurring (non-active) Cry1Ab protein.[7]Gilles-Eric Seralini and colleagues (2007 & 2009) re-analyzed Monsanto data for MON 810 (which was made available following a demand for public availability of the data, and a court case) and found that it had caused liver, kidney, and heart damage in rats.[8][9] However, the European Food Safety Authority (EFSA) reviewed this re-analysis and concluded that the differences observed were within a normal range for control rats and deemed the statistical methods used inappropriate.[10] 

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