Abstract：
New sources of proteins are essential to meet the demands of the growing world population and evolving food trends. Assessing the allergenicity of proteins in novel food (NF) poses a significant food safety regulatory challenge. The Codex Alimentarius Commission presented an allergenicity assessment protocol for genetically modified (GM) foods, which can also be adapted for NF. Since no single laboratory test can adequately predict the allergenic potential of NF, the protocol follows a weight-of-evidence approach, evaluated by experts, as part of a risk management process. Regulatory bodies worldwide have adopted this safety protocol, which, among other things, promotes global harmonization. This review unravels the reliability and various motivations, terms, concepts, and approaches of allergenicity assessments, aiming to enhance understanding among manufacturers and the public. Health Canada, Food Safety Commission JAPAN, and Food Standards Australia New Zealand were surveyed, focusing on the European Food Safety Authority and the US Food Safety Administration for examples of scientific opinions regarding allergenicity assessments for novel and GM foods, from 2019 to 2023. According to our findings, current regulatory allergenicity assessments for NF approval primarily rely on literature reviews. Only a few of the NF assessments proactively presented additional tests. We recommend conducting bioinformatic analyses on NF when a panel of experts deems that there is insufficient prior scientific research.
摘要：
新的蛋白质来源对于满足不断增长的世界人口和不断发展的食品趋势的需求至关重要。评估新型食品（NF）中蛋白质的致敏性提出了重大的食品安全监管挑战。食品法典委员会提出了转基因（GM）食品的致敏性评估方案，这也可以适用于NF。由于没有单一的实验室测试可以充分预测NF的过敏潜力，协议遵循证据权重的方法，由专家评估，作为风险管理过程的一部分。世界各地的监管机构都采用了这项安全协议，which,除其他外，促进全球协调。这篇评论揭示了可靠性和各种动机，terms,概念,和过敏原性评估的方法，旨在增进制造商和公众之间的了解。加拿大卫生部,日本食品安全委员会,澳大利亚和新西兰食品标准进行了调查，专注于欧洲食品安全局和美国食品安全局，以获取有关新型和转基因食品致敏性评估的科学意见示例，从2019年到2023年。根据我们的发现,目前对NF批准的监管变应原性评估主要依靠文献综述。只有少数NF评估主动提出了额外的测试。当专家小组认为先前的科学研究不足时，我们建议对NF进行生物信息学分析。
