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, Álvarez Fernando, Ardizzone Michele, Lanzoni Anna, Gómez Ruiz Jose Ángel, De Sanctis Giacomo, Fernández Dumont Antonio, Gennaro Andrea, Neri Franco Maria
EFSA J. 2019 Nov 4;17(11):e05844. doi: 10.2903/j.efsa.2019.5844. eCollection 2019 Nov.
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.
应欧盟委员会的要求,转基因生物小组评估了与转基因玉米3272(EFSA-GMO-UK-2006-34)所含、由其组成或由其生产的食品和饲料授权申请相关的补充信息。申请人对玉米3272进行了新的农艺学、表型和成分分析研究,并评估了AMY797E蛋白的致敏潜力,解决了2013年EFSA先前意见中仍未定论的问题。转基因生物小组认为,与非转基因玉米相比,玉米3272的农艺学和表型特征以及草料和谷物成分不会引发食品和饲料安全及营养问题。考虑到本申请的范围以及这种转基因玉米所引入性状的特点,特定食品或饲料产品的加工效果和潜在安全影响仍有待进一步研究。关于AMY797E蛋白的致敏潜力,并考虑到玉米3272所有可能的食品和饲料用途,小组得出结论,所提供的信息并未充分解决小组在2013年先前提出的问题。由于该蛋白家族的性质和现有知识,目前仍不清楚在特定情况下α-淀粉酶AMY797E是否有能力使某些个体致敏并引起不良反应。为进一步支持玉米3272特定产品的安全性,申请人提供了与酒糟及其可溶物(DDGS)致敏性评估相关的全面信息,DDGS是欧盟进口的主要相关产品。在考虑了关于该产品提供的信息后,小组认为,在申请人描述的特定使用条件下,与非转基因玉米生产的DDGS相比,玉米3272生产的DDGS不存在问题。