Naegeli Hanspeter, Birch Andrew Nicholas, Casacuberta Josep, De Schrijver Adinda, Gralak Mikolaj Antoni, Guerche Philippe, Jones Huw, Manachini Barbara, Messéan Antoine, Nielsen Elsa Ebbesen, Nogué Fabien, Robaglia Christophe, Rostoks Nils, Sweet Jeremy, Tebbe Christoph, Visioli Francesco, Wal Jean-Michel, Eigenmann Philippe, Epstein Michelle, Hoffmann-Sommergruber Karin, Koning Frits, Lovik Martinus, Mills Clare, Moreno Francisco Javier, van Loveren Henk, Selb Regina, Fernandez Dumont Antonio
EFSA J. 2017 Jun 22;15(6):e04862. doi: 10.2903/j.efsa.2017.4862. eCollection 2017 Jun.
This document provides supplementary guidance on specific topics for the allergenicity risk assessment of genetically modified plants. In particular, it supplements general recommendations outlined in previous EFSA GMO Panel guidelines and Implementing Regulation (EU) No 503/2013. The topics addressed are non-IgE-mediated adverse immune reactions to foods, protein digestibility tests and endogenous allergenicity. New scientific and regulatory developments regarding these three topics are described in this document. Considerations on the practical implementation of those developments in the risk assessment of genetically modified plants are discussed and recommended, where appropriate.
本文件就转基因植物致敏性风险评估的特定主题提供补充指南。特别是,它补充了欧洲食品安全局转基因生物小组先前指南及欧盟第503/2013号实施条例中概述的一般建议。所涉及的主题包括对食品的非IgE介导的不良免疫反应、蛋白质消化率测试和内源性致敏性。本文件描述了关于这三个主题的新科学和监管进展。酌情讨论并建议了在转基因植物风险评估中实际实施这些进展的考虑因素。