TY - JOUR
T1 - Statement complementing the EFSA Scientific Opinion on application (EFSA-GMO-UK-2006-34) for authorisation of food and feed containing, consisting of and produced from genetically modified maize 3272
AU - EFSA Panel on Genetically Modified Organisms (GMO)
AU - Naegeli, Hanspeter
AU - Bresson, Jean Louis
AU - Dalmay, Tamas
AU - Dewhurst, Ian Crawford
AU - Epstein, Michelle M.
AU - Firbank, Leslie George
AU - Guerche, Philippe
AU - Hejatko, Jan
AU - Moreno, Francisco Javier
AU - Mullins, Ewen
AU - Nogué, Fabien
AU - Rostoks, Nils
AU - Sánchez Serrano, Jose Juan
AU - Savoini, Giovanni
AU - Veromann, Eve
AU - Veronesi, Fabio
AU - Álvarez, Fernando
AU - Ardizzone, Michele
AU - Lanzoni, Anna
AU - Gómez Ruiz, Jose Ángel
AU - De Sanctis, Giacomo
AU - Fernández Dumont, Antonio
AU - Gennaro, Andrea
AU - Neri, Franco Maria
N1 - Publisher Copyright:
© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
PY - 2019/11/1
Y1 - 2019/11/1
N2 - 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 (GM) maize 3272 (EFSA-GMO-UK-2006-34). The applicant conducted new agronomic, phenotypic and compositional analysis studies on maize 3272 and assessed the allergenic potential of AMY797E protein, addressing elements that remained inconclusive from previous EFSA opinion issued in 2013. The GMO Panel is of the opinion that the agronomic and phenotypic characteristics as well as forage and grain composition of maize 3272 do not give rise to food and feed safety, and nutritional concerns when compared to non-GM maize. Considering the scope of this application and the characteristics of the trait introduced in this GM maize, the effect of processing and potential safety implications of specific food or feed products remain to be further investigated. Regarding the allergenic potential of AMY797E protein and considering all possible food and feed uses of maize 3272, the Panel concludes that the information provided does not fully address the concerns previously raised by the Panel in 2013. Owing to the nature and the knowledge available on this protein family, it is still unclear whether under specific circumstances the alpha-amylase AMY797E has the capacity to sensitise certain individuals and to cause adverse effects. To further support the safety of specific products of maize 3272, the applicant provided thorough information relevant for the allergenicity assessment of dried distiller grains with solubles (DDGS), which is the main product of interest for importation into the EU. Having considered the information provided on this product, the Panel is of the opinion that under the specific conditions of use described by the applicant, DDGS produced from maize 3272 does not raise concerns when compared to DDGS from non-GM maize.
AB - 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 (GM) maize 3272 (EFSA-GMO-UK-2006-34). The applicant conducted new agronomic, phenotypic and compositional analysis studies on maize 3272 and assessed the allergenic potential of AMY797E protein, addressing elements that remained inconclusive from previous EFSA opinion issued in 2013. The GMO Panel is of the opinion that the agronomic and phenotypic characteristics as well as forage and grain composition of maize 3272 do not give rise to food and feed safety, and nutritional concerns when compared to non-GM maize. Considering the scope of this application and the characteristics of the trait introduced in this GM maize, the effect of processing and potential safety implications of specific food or feed products remain to be further investigated. Regarding the allergenic potential of AMY797E protein and considering all possible food and feed uses of maize 3272, the Panel concludes that the information provided does not fully address the concerns previously raised by the Panel in 2013. Owing to the nature and the knowledge available on this protein family, it is still unclear whether under specific circumstances the alpha-amylase AMY797E has the capacity to sensitise certain individuals and to cause adverse effects. To further support the safety of specific products of maize 3272, the applicant provided thorough information relevant for the allergenicity assessment of dried distiller grains with solubles (DDGS), which is the main product of interest for importation into the EU. Having considered the information provided on this product, the Panel is of the opinion that under the specific conditions of use described by the applicant, DDGS produced from maize 3272 does not raise concerns when compared to DDGS from non-GM maize.
KW - 3272
KW - GMO
KW - food and feed safety
KW - maize (Zea mays)
KW - thermotolerant alpha-amylase
UR - https://www.scopus.com/pages/publications/85076132620
U2 - 10.2903/j.efsa.2019.5844
DO - 10.2903/j.efsa.2019.5844
M3 - Article
AN - SCOPUS:85076132620
SN - 1831-4732
VL - 17
JO - EFSA Journal
JF - EFSA Journal
IS - 11
M1 - e05844
ER -