Mullins Ewen, Bresson Jean-Louis, Dalmay Tamas, Dewhurst Ian Crawford, Epstein Michelle M, Firbank Leslie George, Guerche Philippe, Hejatko Jan, Moreno Francisco Javier, Naegeli Hanspeter, Nogué Fabien, Rostoks Nils, Sánchez Serrano Jose Juan, Savoini Giovanni, Veromann Eve, Veronesi Fabio, Dumont Antonio Fernandez, Ardizzone Michele
EFSA J. 2023 Jan 19;21(1):e07732. doi: 10.2903/j.efsa.2023.7732. eCollection 2023 Jan.
EFSA carries out the risk assessment of genetically modified plants for food and feed uses under Regulation (EU) No 503/2013. Exposure assessment - anticipated intake/extend of use shall be an essential element of the risk assessment of genetically modified feeds, as required by Regulation (EU) No 503/2013. Estimates of animal dietary exposure to newly expressed proteins should be determined to cover average consumption across all the different species, age, physiological and productive phases of farmed and companion animals, and identify and consider particular consumer groups with expected higher exposure. This statement is aimed at facilitating the reporting of the information that applicants need to provide on expected animal dietary exposure to newly expressed proteins and to increase harmonisation of the application dossiers to be assessed by the EFSA GMO Panel. Advice is provided on the selection of proper feed consumption and feed concentration data, and on the reporting of exposure's estimates. An overview of the different uncertainties that may be linked to the estimations is provided. This statement also explains how to access an Excel calculator which should be used in future applications as basis to provide a more consistent presentation of estimates of expected animal dietary exposure.
欧洲食品安全局(EFSA)根据欧盟第503/2013号法规对用于食品和饲料的转基因植物进行风险评估。按照欧盟第503/2013号法规的要求,暴露评估——预期摄入量/使用范围应成为转基因饲料风险评估的一个基本要素。应确定动物对新表达蛋白质的膳食暴露估计值,以涵盖养殖动物和伴侣动物所有不同物种、年龄、生理和生产阶段的平均消费量,并识别和考虑预期暴露量较高的特定消费群体。本声明旨在促进申请人报告其需要提供的关于动物对新表达蛋白质预期膳食暴露的信息,并提高欧洲食品安全局转基因生物小组评估的申请档案的协调性。提供了关于选择合适的饲料消费量和饲料浓度数据以及报告暴露估计值的建议。概述了可能与估计值相关的不同不确定性。本声明还解释了如何获取一个Excel计算器,该计算器应在未来的申请中用作基础,以便更一致地呈现动物预期膳食暴露估计值。