Cargando…

Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103)

Maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 (six‐event stack maize) was produced by conventional crossing to combine six single events: Bt11, MIR162, MIR604, 1507, 5307 and GA21. The GMO Panel previously assessed the six single events and 22 of their combinations and did not identify safety co...

Descripción completa

Detalles Bibliográficos
Autores principales: Naegeli, Hanspeter, Bresson, Jean‐Louis, Dalmay, Tamas, Dewhurst, Ian Crawford, Epstein, Michelle M, Firbank, Leslie George, Guerche, Philippe, Hejatko, Jan, Moreno, Francisco Javier, Mullins, Ewen, Nogué, Fabien, Rostoks, Nils, Sánchez Serrano, Jose Juan, Savoini, Giovanni, Veromann, Eve, Veronesi, Fabio, Ardizzone, Michele, Álvarez, Fernando, Fernandez Dumont, Antonio, Gennaro, Andrea, Lanzoni, Anna, Neri, Franco Maria, Papadopoulou, Nikoletta, Paraskevopoulos, Konstantinos, De Sanctis, Giacomo, Raffaello, Tommaso, Federici, Silvia, Koukoulanaki, Marina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009178/
https://www.ncbi.nlm.nih.gov/pubmed/32626276
http://dx.doi.org/10.2903/j.efsa.2019.5635
_version_ 1783495610473644032
author Naegeli, Hanspeter
Bresson, Jean‐Louis
Dalmay, Tamas
Dewhurst, Ian Crawford
Epstein, Michelle M
Firbank, Leslie George
Guerche, Philippe
Hejatko, Jan
Moreno, Francisco Javier
Mullins, Ewen
Nogué, Fabien
Rostoks, Nils
Sánchez Serrano, Jose Juan
Savoini, Giovanni
Veromann, Eve
Veronesi, Fabio
Ardizzone, Michele
Álvarez, Fernando
Fernandez Dumont, Antonio
Gennaro, Andrea
Lanzoni, Anna
Neri, Franco Maria
Papadopoulou, Nikoletta
Paraskevopoulos, Konstantinos
De Sanctis, Giacomo
Raffaello, Tommaso
Federici, Silvia
Koukoulanaki, Marina
author_facet Naegeli, Hanspeter
Bresson, Jean‐Louis
Dalmay, Tamas
Dewhurst, Ian Crawford
Epstein, Michelle M
Firbank, Leslie George
Guerche, Philippe
Hejatko, Jan
Moreno, Francisco Javier
Mullins, Ewen
Nogué, Fabien
Rostoks, Nils
Sánchez Serrano, Jose Juan
Savoini, Giovanni
Veromann, Eve
Veronesi, Fabio
Ardizzone, Michele
Álvarez, Fernando
Fernandez Dumont, Antonio
Gennaro, Andrea
Lanzoni, Anna
Neri, Franco Maria
Papadopoulou, Nikoletta
Paraskevopoulos, Konstantinos
De Sanctis, Giacomo
Raffaello, Tommaso
Federici, Silvia
Koukoulanaki, Marina
collection PubMed
description Maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 (six‐event stack maize) was produced by conventional crossing to combine six single events: Bt11, MIR162, MIR604, 1507, 5307 and GA21. The GMO Panel previously assessed the six single events and 22 of their combinations and did not identify safety concerns. No new data on the maize single events or their 22 combinations that could lead to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the six–event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the six‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable grains of the six‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the 34 maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the six‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the six‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the six‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.
format Online
Article
Text
id pubmed-7009178
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher John Wiley and Sons Inc.
record_format MEDLINE/PubMed
spelling pubmed-70091782020-07-02 Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103) Naegeli, Hanspeter Bresson, Jean‐Louis Dalmay, Tamas Dewhurst, Ian Crawford Epstein, Michelle M Firbank, Leslie George Guerche, Philippe Hejatko, Jan Moreno, Francisco Javier Mullins, Ewen Nogué, Fabien Rostoks, Nils Sánchez Serrano, Jose Juan Savoini, Giovanni Veromann, Eve Veronesi, Fabio Ardizzone, Michele Álvarez, Fernando Fernandez Dumont, Antonio Gennaro, Andrea Lanzoni, Anna Neri, Franco Maria Papadopoulou, Nikoletta Paraskevopoulos, Konstantinos De Sanctis, Giacomo Raffaello, Tommaso Federici, Silvia Koukoulanaki, Marina EFSA J Scientific Opinion Maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 (six‐event stack maize) was produced by conventional crossing to combine six single events: Bt11, MIR162, MIR604, 1507, 5307 and GA21. The GMO Panel previously assessed the six single events and 22 of their combinations and did not identify safety concerns. No new data on the maize single events or their 22 combinations that could lead to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the six–event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the six‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable grains of the six‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the 34 maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the six‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the six‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the six‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment. John Wiley and Sons Inc. 2019-04-05 /pmc/articles/PMC7009178/ /pubmed/32626276 http://dx.doi.org/10.2903/j.efsa.2019.5635 Text en © 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
spellingShingle Scientific Opinion
Naegeli, Hanspeter
Bresson, Jean‐Louis
Dalmay, Tamas
Dewhurst, Ian Crawford
Epstein, Michelle M
Firbank, Leslie George
Guerche, Philippe
Hejatko, Jan
Moreno, Francisco Javier
Mullins, Ewen
Nogué, Fabien
Rostoks, Nils
Sánchez Serrano, Jose Juan
Savoini, Giovanni
Veromann, Eve
Veronesi, Fabio
Ardizzone, Michele
Álvarez, Fernando
Fernandez Dumont, Antonio
Gennaro, Andrea
Lanzoni, Anna
Neri, Franco Maria
Papadopoulou, Nikoletta
Paraskevopoulos, Konstantinos
De Sanctis, Giacomo
Raffaello, Tommaso
Federici, Silvia
Koukoulanaki, Marina
Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103)
title Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103)
title_full Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103)
title_fullStr Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103)
title_full_unstemmed Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103)
title_short Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103)
title_sort assessment of genetically modified maize bt11 × mir162 × mir604 × 1507 × 5307 × ga21 and subcombinations, for food and feed uses, under regulation (ec) no 1829/2003 (application efsa‐gmo‐de‐2011‐103)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009178/
https://www.ncbi.nlm.nih.gov/pubmed/32626276
http://dx.doi.org/10.2903/j.efsa.2019.5635
work_keys_str_mv AT assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT naegelihanspeter assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT bressonjeanlouis assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT dalmaytamas assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT dewhurstiancrawford assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT epsteinmichellem assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT firbanklesliegeorge assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT guerchephilippe assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT hejatkojan assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT morenofranciscojavier assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT mullinsewen assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT noguefabien assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT rostoksnils assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT sanchezserranojosejuan assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT savoinigiovanni assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT veromanneve assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT veronesifabio assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT ardizzonemichele assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT alvarezfernando assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT fernandezdumontantonio assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT gennaroandrea assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT lanzonianna assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT nerifrancomaria assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT papadopoulounikoletta assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT paraskevopouloskonstantinos assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT desanctisgiacomo assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT raffaellotommaso assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT federicisilvia assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103
AT koukoulanakimarina assessmentofgeneticallymodifiedmaizebt11mir162mir60415075307ga21andsubcombinationsforfoodandfeedusesunderregulationecno18292003applicationefsagmode2011103