Mullins Ewen, Bresson Jean-Louis, Dalmay Tamas, Dewhurst Ian Crawford, Epstein Michelle M, George Firbank Leslie, Guerche Philippe, Hejatko Jan, Naegeli Hanspeter, Nogué Fabien, Rostoks Nils, Sánchez Serrano Jose Juan, Savoini Giovanni, Veromann Eve, Veronesi Fabio, Fernandez Dumont Antonio, Moreno Francisco Javier
EFSA J. 2022 Jan 25;20(1):e07044. doi: 10.2903/j.efsa.2022.7044. eCollection 2022 Jan.
This Scientific Opinion addresses the formulation of specific development needs, including research requirements for allergenicity assessment and protein safety, in general, which is urgently needed in a world that demands more sustainable food systems. Current allergenicity risk assessment strategies are based on the principles and guidelines of the Codex Alimentarius for the safety assessment of foods derived from 'modern' biotechnology initially published in 2003. The core approach for the safety assessment is based on a 'weight-of-evidence' approach because no single piece of information or experimental method provides sufficient evidence to predict allergenicity. Although the Codex Alimentarius and EFSA guidance documents successfully addressed allergenicity assessments of single/stacked event GM applications, experience gained and new developments in the field call for a modernisation of some key elements of the risk assessment. These should include the consideration of clinical relevance, route of exposure and potential threshold values of food allergens, the update of tools used with more targeted databases and better integration and standardisation of test materials and / protocols. Furthermore, more complex future products will likely challenge the overall practical implementation of current guidelines, which were mainly targeted to assess a few newly expressed proteins. Therefore, it is timely to review and clarify the main purpose of the allergenicity risk assessment and the vital role it plays in protecting consumers' health. A roadmap to (re)define the allergenicity safety objectives and risk assessment needs will be required to inform a series of key questions for risk assessors and risk managers such as 'what is the purpose of the allergenicity risk assessment?' or 'what level of confidence is necessary for the predictions?'.
本科学意见阐述了特定的发展需求，包括一般情况下过敏原性评估和蛋白质安全性的研究要求，在一个需要更可持续食品系统的世界中，这是迫切需要的。当前的过敏原性风险评估策略基于食品法典委员会2003年首次发布的关于“现代”生物技术衍生食品安全性评估的原则和指南。安全性评估的核心方法基于“证据权重”方法，因为没有单一的信息或实验方法能提供足够的证据来预测过敏原性。尽管食品法典委员会和欧洲食品安全局的指导文件成功地解决了单一/叠加事件转基因应用的过敏原性评估问题，但该领域获得的经验和新进展要求对风险评估的一些关键要素进行现代化改进。这些改进应包括考虑食品过敏原的临床相关性、暴露途径和潜在阈值，更新使用更具针对性数据库的工具，以及更好地整合和标准化测试材料及/方案。此外，未来更复杂的产品可能会挑战当前指南的整体实际实施情况，当前指南主要旨在评估少数新表达的蛋白质。因此，及时审查和阐明过敏原性风险评估的主要目的及其在保护消费者健康方面所起的关键作用是很有必要的。需要一个（重新）定义过敏原性安全目标和风险评估需求的路线图，以便为风险评估人员和风险管理人员提供一系列关键问题的信息，例如“过敏原性风险评估的目的是什么？”或“预测需要何种置信水平？”
