To ensure safe use of genetically modified organisms (GMOs), since 1993, China has made great efforts to establish and improve the safety regulatory system for GMOs. Here, we summarize and analyze the regulatory framework of agricultural GMOs, and the progress in regulatory approval of GM crops in China. In general, the development of GMO safety regulations underwent four stages: exploration (1993-2000), development (2001-2010), improvement (2011-2020) and current (2021-present) stage. The first formal regulation was promulgated in 1993, which provided a basis for further development of the regulations, during the exploration stage, when insect-resistant GM cotton, expressing genes from Bacillus thuringiensis (Bt), was approved for cultivation. During the development stage, the Chinese government issued a series of administrative measures, which covered almost all the fields relative to GMO safety when the basic regulatory system was established. Along with the controversy over GMO safety, the regulations have been further, and greatly improved, during improvement stage. From 2021, a few additional revisions have been made, and meanwhile, the new regulation on gene-edited crops was introduced with the development of biotechnology, forming a relative complete regulation and law system for China. The well-developed GMO regulations establishes a firm basis for safe use of GM crops in China. Currently, GM cotton and GM papaya have been widely grown on a large scale in China that have brought great economic and ecological benefits. In addition, 12 corn events, 3 soybean events, and 2 rice events have also obtained biosafety certification, but presently, these lines have yet to enter commercial production. However, several GM soybean and corn events have entered pilot industrialization, and can soon be expected to be commercially grown in China. In addition to planting, six GM crops, including soybean, corn, cotton, canola, papaya and sugar beet, with a total of 64 events, have been approved for import as processing material in China.
Keywords: Biosafety certificate; Gene editing; Genetically modified organisms; Pilot phase; Regulatory approval.
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