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根据(欧盟)第1829/2003号法规(申请编号EFSA-GMO-NL-2019-162)对转基因大豆豆血红蛋白进行的评估。

Assessment of soy leghemoglobin produced from genetically modified , under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2019-162).

作者信息

Casacuberta Josep, Barro Francisco, Braeuning Albert, Cubas Pilar, de Maagd Ruud, Epstein Michelle M, Frenzel Thomas, Gallois Jean-Luc, Koning Frits, Messéan Antoine, Moreno F Javier, Nogué Fabien, Savoini Giovanni, Schulman Alan H, Tebbe Christoph, Veromann Eve, Gennaro Andrea, Gil Gonzalez Aina Belen, Gómez Ruiz José Ángel, Goumperis Tilemachos, Kagkli Dafni Maria, Lenzi Paolo, Lewandowska Aleksandra, Piffanelli Pietro, Schoonjans Reinhilde

出版信息

EFSA J. 2024 Nov 15;22(11):e9060. doi: 10.2903/j.efsa.2024.9060. eCollection 2024 Nov.

Abstract

Genetically modified strain MXY0541 was developed to produce soy leghemoglobin by introducing the coding sequence encoding leghemoglobin from soybean (). The molecular characterisation data and bioinformatic analyses do not raise any safety concerns. The safety of soy leghemoglobin as a food additive has already been assessed by the EFSA FAF Panel (EFSA-Q-2022-00031). The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of soy leghemoglobin protein as expressed in , and finds no evidence that the genetic modification would change its overall allergenicity. The GMO Panel concludes that the LegH Prep derived from genetically modified strain MXY0541 is safe for human consumption with regard to the effects of the genetic modification. No environmental impact from the use of this product is expected regarding the recombinant DNA sequences possibly remaining in the product. The GMO Panel concludes that LegH Prep from genetically modified strain MXY0541 is safe with respect to potential effects on human health and the environment at the proposed use and use level as far as the impact of the genetic modification is concerned. The overall conclusion is that the genetic modification does not lead to safety issues.

摘要

通过引入来自大豆的编码豆血红蛋白的编码序列,开发了转基因菌株MXY0541以生产大豆豆血红蛋白。分子表征数据和生物信息学分析未引发任何安全问题。欧洲食品安全局食品添加剂和营养源司专家小组(EFSA-Q-2022-00031)已经对大豆豆血红蛋白作为食品添加剂的安全性进行了评估。转基因生物小组未发现有关在[具体情况未明确]中表达的大豆豆血红蛋白蛋白的毒性和致敏性的安全问题,并且没有发现证据表明基因改造会改变其总体致敏性。转基因生物小组得出结论,就基因改造的影响而言,源自转基因菌株MXY0541的LegH Prep对人类消费是安全的。关于该产品中可能残留的重组DNA序列,预计使用该产品不会对环境产生影响。转基因生物小组得出结论,就基因改造的影响而言,就拟议的用途和使用水平而言,来自转基因菌株MXY0541的LegH Prep对人类健康和环境的潜在影响是安全的。总体结论是基因改造不会导致安全问题。

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