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Risk assessment requirements and international regulatory status for synthetic biological foods
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Jin-Yi HE, Yi SU, Ting WANG, Zhu LI*
Journal of Food Safety & Quality | 2026, 17(8) : 172 - 180
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Journal of Food Safety & Quality | 2026, 17(8): 172-180
• Special Topic: Food Safety Risk Monitoring and Assessment •
Risk assessment requirements and international regulatory status for synthetic biological foods
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Jin-Yi HE, Yi SU, Ting WANG, Zhu LI*
Affiliations
  • Shanghai Municipal Center for Disease Control and Prevention (Shanghai Academy of Preventive Medicine), Specialty Laboratory of Food Safety Risk Assessment and Standard Development of the National Health Commission, Shanghai 201107, China
doi: 10.19812/j.cnki.jfsq11-5956/ts.20251028001
Outline
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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.

synthetic biology  /  genetically modified microorganism  /  three new foods  /  risk assessment  /  food safety supervision
何锦怡, 苏怡, 王婷, 李竹. 合成生物食品的风险评估要求与国际监管现状. 食品安全质量检测学报, 2026 , 17 (8) : 172 -180 . DOI: 10.19812/j.cnki.jfsq11-5956/ts.20251028001
Jin-Yi HE, Yi SU, Ting WANG, Zhu LI. Risk assessment requirements and international regulatory status for synthetic biological foods[J]. Journal of Food Safety & Quality, 2026 , 17 (8) : 172 -180 . DOI: 10.19812/j.cnki.jfsq11-5956/ts.20251028001
Year 2026 volume 17 Issue 8
8
2
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doi: 10.19812/j.cnki.jfsq11-5956/ts.20251028001
  • Receive Date:2025-10-28
  • Online Date:2026-11-05
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  • Received:2025-10-28
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    Shanghai Municipal Center for Disease Control and Prevention (Shanghai Academy of Preventive Medicine), Specialty Laboratory of Food Safety Risk Assessment and Standard Development of the National Health Commission, Shanghai 201107, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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