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
EFSA Journal, vol. 22, pp. e9061
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.
Authors 22
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Consejo Superior de Investigaciones Científicas · Instituto de Agricultura Sostenible
Affiliation as printed
IAS CSIC - Instituto de Agricultura Sostenible - Institute for Sustainable Agriculture (Cordoba - Spain)
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Federal Institute for Risk Assessment
Affiliation as printed
BfR - Bundesinstitut für Risikobewertung - Federal Institute for Risk Assessment (Berlin - Germany)
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Consejo Superior de Investigaciones Científicas
Affiliation as printed
CSIC - Consejo Superior de Investigaciones Cientificas [España] = Spanish National Research Council [Spain] (Serrano 117, 28006, Madrid - Spain)
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Wageningen University & Research
Affiliation as printed
WUR - Wageningen University and Research [Wageningen] (Droevendaalsesteeg 4, 6708 PB Wageningen - Netherlands)
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European Food Safety Authority
Affiliation as printed
EFSA - European Food Safety Authority (Autorité européenne de sécurité des aliments Via Carlo Magno 1A 43126 Parma - Italy)
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Affiliation as printed
Saxon State Office for Environment, Agriculture and Geology (Pillnitzer Pl. 3, 01326 Dresden - Germany)
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Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · Génétique et amélioration des fruits et légumes
Affiliation as printed
GAFL - Génétique et Amélioration des Fruits et Légumes (INRAE Domaine Saint-Maurice 67 allée des chênes CS60094 84143 MONTFAVET CEDEX - France)
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Jean‐Luc Gallois Aachen
Leiden University · Leiden University Medical Center
Affiliation as printed
LUMC - Leiden University Medical Center (Leids Universitair Medisch Centrum, Universiteit Leiden - 1233 ZA, Leiden - Netherlands)
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Affiliation as printed
Agronomie (22 place de l'Agronomie CS 20040 91123 Palaiseau cedex - France)
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Affiliation as printed
Universidad de Sevilla = University of Seville (C/ S. Fernando, 4, C.P. 41004-Sevilla - Spain)
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Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · Institut Jean-Pierre Bourgin
Affiliation as printed
IJPB - Institut Jean-Pierre Bourgin - Sciences du végétal (INRAE Centre de Versailles-Grignon, Route de St-Cyr (RD10), 78026 Versailles Cedex - Ancien nom : Institut Jean-Pierre Bourgin - France)
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Affiliation as printed
UNIMIB - Università degli Studi di Milano-Bicocca = University of Milano-Bicocca (Piazza dell'Ateneo Nuovo, 1 - 20126, Milano - Italy)
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Affiliation as printed
Helsingin yliopisto = Helsingfors universitet = University of Helsinki (Yliopistonkatu 4, 00100 Helsinki - Finland)
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Affiliation as printed
Thunen Institute of Forest Ecosystems (Germany)
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Estonian University of Life Sciences
Affiliation as printed
EMU - Estonian University of Life Sciences (Kreutzwaldi 1 Tartu 51006, Estonia - Estonia)
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European Food Safety Authority
Affiliation as printed
EFSA - European Food Safety Authority (Autorité européenne de sécurité des aliments Via Carlo Magno 1A 43126 Parma - Italy)
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European Food Safety Authority
Affiliation as printed
EFSA - European Food Safety Authority (Autorité européenne de sécurité des aliments Via Carlo Magno 1A 43126 Parma - Italy)
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European Food Safety Authority
Affiliation as printed
EFSA - European Food Safety Authority (Autorité européenne de sécurité des aliments Via Carlo Magno 1A 43126 Parma - Italy)
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Affiliation as printed
ITU - IT University of Copenhagen (Rued Langgaards Vej 7, 2300 København, Danemark - Denmark)
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Universidad Autónoma de Madrid
Affiliation as printed
UAM - Universidad Autónoma de Madrid (Ciudad Universitaria de Cantoblanco · 28049 Madrid - Spain)
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European Food Safety Authority
Affiliation as printed
EFSA - European Food Safety Authority (Autorité européenne de sécurité des aliments Via Carlo Magno 1A 43126 Parma - Italy)
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