欧盟新型食品审批动态与过敏原风险评估分析

摘要：

【目的】新型食品是全球保障食品安全、实现食品体系可持续发展的重要途径，研究欧盟新型食品监管制度的趋势与特征，可以助力企业应对欧盟高准入门槛。【方法】围绕2018—2025年欧盟新型食品审批及过敏原风险评估展开系统分析，结合欧盟委员会、欧洲食品安全局的公开数据，梳理审批规律、评估特征与现存问题。【结果】此期间欧盟共批准156项新型食品申请，新授权占52.6%，修订类占39.1%，第三国传统食品仅占8.3%；新授权类别以修饰分子结构类、微生物/真菌/藻类为主，可食用昆虫、细胞培养食品等新兴类别占比提升；所有提交申请中新授权及修订类占92.3%，第三国传统食品申请仅占7.7%。新批准产品中91.46%过敏原性评估含蛋白质定量数据，生物信息学、免疫学测试应用率低，分别为21.95%、9.76%。新批准产品中39.02%存在潜在过敏风险，60.98%风险低或无风险。【结论】欧盟新型食品审批鼓励创新且风险控制趋严，批准量波动上升，对第三国传统食品始终保持严格准入要求。过敏原评估仍依赖蛋白质定量、文献综述等传统方法，生物信息学和免疫学测试应用受限。

Abstract:

[Objective] Novel foods are an important direction globally for ensuring food safety and achieving the sustainable development of the food system. The paper aims to study the trends and characteristics of the European Union (EU) novel food regulatory system, so as to help enterprises cope with the high access thresholds. [Methods] A systematic analysis was conducted on the EU novel food approval and allergen risk assessment from 2018 to 2025. Combined with public data from the European Commission and the European Food Safety Authority, the approval rules, assessment characteristics, and existing problems were sorted out. [Results] During this period, the EU approved a total of 156 novel food applications, with new authorizations accounting for 52.6%, revisions accounting for 39.1%, and thirdcountry traditional foods accounting for only 8.3%. The new authorization categories are mainly those with modified molecular structures, microorganisms/fungi/algae, and the proportion of emerging categories such as edible insects and cell-cultured foods has increased. Among all submitted applications, new authorizations and revisions account for 92.3%, while applications for third-country traditional foods account for only 7.7%. 91.46% of the newly approved products have protein quantitative data in their allergenicity assessment, while the application rates of bioinformatics and immunological tests are low, at 21.95% and 9.76% respectively. 39.02% of the newly approved products have potential allergic risks, and 60.98% have low or no risks. [Conclusion] The EU novel food approval encourages innovation, and has increasingly strict risk control, with the approval quantity fl uctuating and rising, and it has always maintained strict access requirements for third-country traditional foods. Allergen assessment still relies on traditional methods such as protein quantifi cation and literature review, and the application of bioinformatics and immunological tests is limited.

引用格式：刘敏. 欧盟新型食品审批动态与过敏原风险评估分析[J]. 标准化学报，2026 (7)：101-107.

基金项目：本文受海关总署科研项目“新型食品、微塑料等新兴技术性贸易措施及检测技术研究”(课题编号：2025HK238)资助。

作者简介：刘敏，硕士，高级工程师，研究方向为食品领域技术性贸易措施。