Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐NL‐2015‐126) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87705 × MON 87708 × MON 89788

Following a request from the European Commission, the GMO Panel assessed additional information related to the application for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON × MON 87708 × MON 89788 (EFSA-GMO-NL-2015-126). The applicant conducted a 90-day feeding study on GM soybean MON 87705 and provided a proposal for post-market monitoring considering the altered fatty acid profile of GM soybean MON 87705 × MON 87708 × MON 89788, to fulfil the deficiencies identified by EFSA GMO Panel, addressing elements that remained inconclusive from a previous EFSA scientific opinion issued in 2020. The GMO Panel concludes that the 90-day feeding study on GM soybean MON 87705 is in line with the requirements of Regulation (EU) No 503/2013 and that no treatment-related adverse effects were observed in rats after feeding diets containing soybean MON 87705 meals at 30% or 15% for 90 days. The GMO Panel reiterates the recommendation for a PMM for food in accordance with Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013 and concludes that the proposal provided by the applicant is in line with the recommendations described for the PMM plan of soybean MON 87705 × MON 87708 × MON 89788 in the adopted scientific opinion. Taking into account the previous assessment and the new information, the GMO Panel concludes that soybean MON 87705 × MON 87708 × MON 89788, as assessed in the scientific opinion on application EFSA-GMO-NL-2015-126 and in the supplementary toxicity study, is as safe as its non-GM comparator and the non-GM reference varieties tested and does not represent a nutritional concern in humans and animals, within the scope of this application.

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Publication Details

Journal
EFSA Journal
Published
2024-10-01
DOI
https://doi.org/10.2903/j.efsa.2024.9061
Citations
1
Primary Topic
Genetically Modified Organisms Research
Type
article
Field-Weighted Citation Impact
0.60

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article

Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐NL‐2015‐126) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87705 × MON 87708 × MON 89788

Arianna Ferrari, José Ángel Gómez Ruiz, Jean‐Luc Gallois, Ruud A. de Maagd et al.
1 citations
EFSA Journal
Genetically Modified Organisms Research
0.60
article

Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐NL‐2015‐126) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87705 × MON 87708 × MON 89788

Arianna Ferrari, José Ángel Gómez Ruiz, Jean‐Luc Gallois, Ruud A. de Maagd, Francisco Barro, Alan H. Schulman, Antoine Messéan, Fabien Nogué, Tilemachos Goumperis, Frits Koning, Josep Casacuberta, Eve Veromann, G. Savoini, Christoph C. Tebbe, Albert Braeuning, F. Javier Moreno, M. Epstein, Thomas Frenzel, Antonio Fernández Dumont, Michele Ardizzone, Pilar Cubas
article en
1 citations

Abstract

Following a request from the European Commission, the GMO Panel assessed additional information related to the application for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON × MON 87708 × MON 89788 (EFSA-GMO-NL-2015-126). The applicant conducted a 90-day feeding study on GM soybean MON 87705 and provided a proposal for post-market monitoring considering the altered fatty acid profile of GM soybean MON 87705 × MON 87708 × MON 89788, to fulfil the deficiencies identified by EFSA GMO Panel, addressing elements that remained inconclusive from a previous EFSA scientific opinion issued in 2020. The GMO Panel concludes that the 90-day feeding study on GM soybean MON 87705 is in line with the requirements of Regulation (EU) No 503/2013 and that no treatment-related adverse effects were observed in rats after feeding diets containing soybean MON 87705 meals at 30% or 15% for 90 days. The GMO Panel reiterates the recommendation for a PMM for food in accordance with Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013 and concludes that the proposal provided by the applicant is in line with the recommendations described for the PMM plan of soybean MON 87705 × MON 87708 × MON 89788 in the adopted scientific opinion. Taking into account the previous assessment and the new information, the GMO Panel concludes that soybean MON 87705 × MON 87708 × MON 89788, as assessed in the scientific opinion on application EFSA-GMO-NL-2015-126 and in the supplementary toxicity study, is as safe as its non-GM comparator and the non-GM reference varieties tested and does not represent a nutritional concern in humans and animals, within the scope of this application.

EFSA JournalVol. 22(10)
European Food Safety Authority (IT), University of Helsinki (FI), Consejo Superior de Investigaciones Científicas (ES), Estonian University of Life Sciences (EE), Leiden University Medical Center (NL), Federal Institute for Risk Assessment (DE), Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement (FR), Johann Heinrich von Thünen-Institut (DE), Département agronomie et sciences de l'environnement pour les agroécosystèmes (FR), Institut Jean-Pierre Bourgin (FR), Génétique et amélioration des fruits et légumes (FR), Instituto de Agricultura Sostenible (ES), Center for Research in Agricultural Genomics (ES), Saxon State Ministry for Science and the Arts (DE), Universidad Autónoma de Madrid (ES), University of Milano-Bicocca (IT), Universidad de Sevilla (ES), IT University of Copenhagen (DK), Wageningen University & Research (NL)
European Food Safety Authority
Zero hunger
Openalex Percentile: Top 21%
Genetically Modified Organisms Research
0.60
DOIOpen Access PDFOpenAlex
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