合成生物食品的风险评估要求与国际监管现状

Risk assessment requirements and international regulatory status for synthetic biological foods

中文关键词:  合成生物学  遗传修饰微生物  三新食品  风险评估  食品安全监管

英文关键词:synthetic biology  genetically modified microorganism  three new foods  risk assessment  food safety supervision

中文摘要:

      合成生物学是一门新兴学科, 已逐渐被引入产业界, 合成生物产业已成为食品领域的创新高地, 是目前最能体现世界各国核心竞争力的产业之一。其生产工艺区别于传统的物理分离和化学合成, 是以各类微生物细胞为底盘在“细胞工厂”中高效生产目的产物。其生产工艺特点对其食用安全性的监管提出了相对较高的要求, 风险控制不容忽视。目前, 世界各国均重点关注合成生物食品的健康风险, 包括国际食品法典委员会(Codex Alimentarius Commission, CAC)在内的关键国际组织以及欧洲、美洲和我国等地的食品监管机构正处于相关法规的制定前沿。本文系统梳理了CAC、美国、欧盟等关键国际组织、国家和地区对于合成生物食品的监管现状和风险评估要求, 比较分析了风险评估要点的异同点, 并对我国该类食品的食用安全性风险评估和监管提出建议。研究结果可为我国合成生物类“三新食品”进一步的安全风险管理提供参考和借鉴。

英文摘要:

      As an emerging discipline, synthetic biology has gradually been introduced into the industrial sector. Moreover, the synthetic biology industry has become an innovation highland in the food industry and is currently one of the industries that best reflects the core competitiveness of countries around the world. The production process of synthetic biology differs from traditional physical separation and chemical synthesis, using various microbial cells as the chassis to efficiently produce target products in a ‘cell factory’. Therefore, the characteristics of its production process pose relatively high requirements for the supervision of its edible safety, and risk control cannot be ignored. At present, global attention is focusing on the health risks of synthetic biological foods. Key international and regional regulatory bodies, including the Codex Alimentarius Commission (CAC), as well as food safety authorities in Europe, the Americas and China, are leading efforts in formulating relevant regulations. This paper systematically reviewed the regulatory status and risk assessment requirements for synthetic biological foods of key international organizations, countries and regions, such as the CAC, the United States and the European Union. It comparatively analysed their similarities and differences in the key points for risk assessment. This review proposed reasonable suggestions for the risk assessment and supervision of the food safety of such foods in China. This study aimed to serve as a further reference for enhancing the safety risk management of biosynthetic three new foods in China.