EFSA Panel on Genetically Modified Organisms (GMO); Draft Scientific Opinion on the assessment of allergenicity of GM plants and microorganisms and derived food and feed
EFSA Panel on Genetically Modified Organisms (GMO); Draft Scientific Opinion on the assessment of allergenicity of GM plants and microorganisms and derived food and feed
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2010
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Efsa Publication
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Efsa Publication
证据权重法被认为是评估转基因食品和饲料过敏性的最合适的方法。本科学意见讨论了提高这一方法的强度和准确性的各个方面，包括与过敏反应的临床方面、转基因食品和饲料的结构方面以及硅胶方法有关的最新发展，以及IgE结合研究和基于细胞的方法、图谱技术和动物模型。在此背景下，提供了结论和建议，以更新和补充新表达蛋白(S)和整个转基因食品和饲料的过敏性评估的现有风险评估战略。综上所述，对于序列同源性和结构相似性的搜索，与已知变应原的局部比对方法被认为是最低要求，该变应原的阈值在至少80个氨基酸的窗口上具有35%的序列一致性。当认为有必要进行IgE结合试验时，例如，当与已知过敏原有序列同源性和/或结构相似性时，建议使用过敏个体的单独血清，而不是混合血清。除了胃酶抗性测试外，还建议使用其他模拟人类生理条件的体外消化测试来评估新表达蛋白的消化抗性。最后，当导入基因的接受者是过敏性的时，为了将整个转基因植物的过敏性与其适当的参照物(S)的过敏性进行比较，建议在转基因植物及其适当的参照物(S)的比较成分分析中包括相关的具有特征的内源性过敏原。2010年6月30日通过的关于使用可改进证据权重方法的额外测试的提案和1应欧洲食品安全局的要求，问题编号EFSA-Q-2005-125。2名小组成员：汉斯·克里斯特·安德森、塞尔瓦托·阿尔帕亚、德特尔夫·巴奇、Josep Casacuberta、Howard Davies、Patrick Du Jardin、Gerhard Flachowsky、Lieve Herman、Huw Jones、Sirpa Kärenlampi、Jozsef Kiss、Gijs Kleter、Harry Kuiper、Antoine Messéan、Kaare Magne Nielsen、Joe Perry、Annette Pöting、Jeremy Sweet、Christoph Tebbe、Atte Johannes von Wright和Jean-Michel Wal。小组所有成员的意见都是一致的。函件：gmo@efsa.Europa.eu 3确认：小组感谢“转基因食品过敏性评估”工作组成员编写本科学意见草案：罗布·阿尔伯斯、汉斯·克里斯特·安德森、菲利普·艾根曼、拉尔夫·埃斯帕尼耶、卡琳·霍夫曼-索默格鲁伯、吉斯·克莱特、伊洛娜·克里斯平-索伦森、马蒂努斯·L、克莱尔·米尔斯、让-玛丽·圣雷米、威廉·塞宁、丹尼尔·范德迈尔、让-米歇尔·瓦尔(主席)和约翰·华纳(至2008年9月)；以下专家感谢他们在专门问题上的贡献：Dominique Kaiserlian(2007年1月)、Jean-Paul LallèS(2008年7月)、Gabriel Peltre(2007年7月)、AndréPenninks(2007年1月)，以及EFSA的工作人员Ellen Van Haver和Antonio Fernandez Dumont为EFSA的这项科学成果提供的支持。转基因植物和微生物以及衍生食品和饲料的过敏性评估2 EFSA期刊2 2010年；8(7)：1700条关于进一步评估仍处于早期开发阶段的有希望的新方法的建议。
The weight-of-evidence, case-by-case approach is considered the most appropriate way of assessing the allergenicity of genetically modified (GM) food and feed. This scientific opinion discusses various aspects to increase the strength and accuracy of this approach, including the latest developments pertaining to clinical aspects of allergic reactions, structural aspects of GM food and feed and in silico approaches, as well as IgE binding studies and cell-based methods, profiling techniques and animal models. In this context, conclusions and recommendations are provided to update and complement current risk assessment strategies for the allergenicity assessment of newly expressed protein(s) and whole GM food and feed. In summary, it is recommended that with regard to the search for sequence homology and structural similarities, the local alignment method with a known allergen with a threshold of 35% sequence identity over a window of at least 80 amino acids is considered a minimal requirement. When IgE binding tests are considered necessary, e.g. when there is sequence homology and/or structure similarity with known allergens, the use of individual sera from allergic individuals rather than pooled sera is recommended. In addition to the pepsin resistance test, it is recommended that the resistance to digestion of the newly expressed proteins is evaluated using other in vitro digestibility tests mimicking physiological conditions of humans. Finally, when the recipient of the introduced gene is allergenic, in order to compare the allergenicty of the whole GM plant with that of its appropriate comparator(s), it is recommended that relevant characterised endogenous allergens are included in the comparative compositional analysis of the GM plant and its appropriate comparator(s). Proposals for the use of additional testing that may improve the weight-of-evidence approach and 1 On request of EFSA, Question No EFSA-Q-2005-125, adopted on 30 June 2010. 2 Panel members: Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel Wal. Opinion is shared by all members of the Panel. Correspondence: gmo@efsa.europa.eu 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on “The assessment of allergenicity of genetically modified foods” for the preparation of this Draft Scientific Opinion: Rob Aalberse, Hans Christer Andersson, Philippe Eigenmann, Ralf Einspanier, Karin Hoffmann-Sommergruber, Gijs Kleter, Ilona Kryspin-Sorensen, Martinus Lövik, Clare Mills, Jean-Marie Saint-Remy, Willem Seinen, Daniel Soeria-Atmadja (until September 2009), Ingrid Van der Meer, Jean-Michel Wal (Chair) and John Warner (until September 2008); the following experts for their contribution on specialised issues: Dominique Kaiserlian (January 2007), Jean-Paul Lallès (July 2008), Gabriel Peltre (July 2007), André Penninks (January 2007); and EFSA’s staff members Ellen Van Haver and Antonio Fernandez Dumont for the support provided to this EFSA scientific output. Assessment of allergenicity of GM plants and microorganisms and derived food and feed 2 EFSA Journal 2010; 8(7):1700 suggestions for further evaluation of new promising methods that are as yet in an early phase of development are also addressed.