| Regulation on Administration of Safety of Agricultural Genetically Modified Organisms | | 农业转基因生物安全管理条例 |
(Issued by the Order No. 304 of the State Council of the People's Republic of China on May 23, 2001, revised in accordance with the Decision of the State Council on Abolishing and Amending Some Administrative Regulations by the Order No. 588 of the State Council on January 8, 2011; and amended in accordance with the Decision of the State Council to Amend Certain Administrative Regulations by the Order No. 687 of the State Council on October 7, 2017) | | （2001年5月23日中华人民共和国国务院令第304号发布 根据2011年1月8日国务院令第588号《国务院关于废止和修改部分行政法规的决定》修订 根据2017年10月7日国务院令第687号《国务院关于修改部分行政法规的决定》修正） |
| Chapter I General Provisions | | 第一章 总则 |
| Article 1 These Regulations are formulated for the purposes of strengthening the administration of agricultural genetically modified organisms safety, safeguarding the health of human bodies and the safety of animals, plants and microorganisms, protecting the ecological environment, and promoting the research into technologies of agricultural genetically modified organisms. | | 第一条 为了加强农业转基因生物安全管理，保障人体健康和动植物、微生物安全，保护生态环境，促进农业转基因生物技术研究，制定本条例。 |
| Article 2 The activities of research, experiment, production, processing, marketing, import and export with respect to agricultural genetically modified organisms within the territory of the People's Republic of China must conform to these Regulations. | | 第二条 在中华人民共和国境内从事农业转基因生物的研究、试验、生产、加工、经营和进口、出口活动，必须遵守本条例。 |
| Article 3 Agricultural genetically modified organism, as referred to in these Regulations, means animals, plants, microorganisms and their products whose genomic structures have been modified by genetic engineering technologies for the use in agricultural production or processing, which mainly include: | | 第三条 本条例所称农业转基因生物，是指利用基因工程技术改变基因组构成，用于农业生产或者农产品加工的动植物、微生物及其产品，主要包括： |
| (1) genetically modified animals, plants (including plant seeds, breeding livestock and poultry, aquatic fry and seeds) and microorganisms; | | （一）转基因动植物（含种子、种畜禽、水产苗种）和微生物； |
| (2) products of genetically modified animals, plants and microorganisms; | | （二）转基因动植物、微生物产品； |
| (3) products directly processed from genetically modified agricultural products; | | （三）转基因农产品的直接加工品； |
| (4) seeds, breeding livestock and poultry, aquatic fry and seeds, pesticides, veterinary drugs, fertilizers, additives and other products containing ingredients of genetically modified animals, plants and microorganisms or their products. | | （四）含有转基因动植物、微生物或者其产品成分的种子、种畜禽、水产苗种、农药、兽药、肥料和添加剂等产品。 |
| Agricultural genetically modified organisms safety, as referred to in these Regulations, means the protection of human being, animals, plants and microorganisms and the ecological environment against the danger or potential risk arising from agricultural genetically modified organisms. | | 本条例所称农业转基因生物安全，是指防范农业转基因生物对人类、动植物、微生物和生态环境构成的危险或者潜在风险。 |
| Article 4 The competent agricultural administrative department of the State Council is responsible for the nationwide supervision and administration of agricultural genetically modified organisms safety. | | 第四条 国务院农业行政主管部门负责全国农业转基因生物安全的监督管理工作。 |
| The competent agricultural administrative departments of local people's governments at or above the county level are responsible for the supervision and administration of agricultural genetically modified organisms safety within their respective administrative areas. | | 县级以上地方各级人民政府农业行政主管部门负责本行政区域内的农业转基因生物安全的监督管理工作。 |
The relevant departments of the people's governments at and above the county level shall be responsible for the supervision and administration of safety of genetically modified food according to the relevant provisions of the Food Safety Law of the People's Republic of China | | 县级以上各级人民政府有关部门依照《中华人民共和国食品安全法》的有关规定，负责转基因食品安全的监督管理工作。 |
| Article 5 The State Council establishes a system of inter-ministerial joint conference for administration of agricultural genetically modified organisms safety. | | 第五条 国务院建立农业转基因生物安全管理部际联席会议制度。 |
| The inter-ministerial joint conference for administration of agricultural genetically modified organisms safety shall be composed of responsible persons from the departments of agriculture, science and technology, environmental protection, public health, foreign trade and economic cooperation, inspection and quarantine, and from other relevant departments as well, and shall be responsible for the discussion and coordination of major issues involved in the administration of agricultural genetically modified organisms safety. | | 农业转基因生物安全管理部际联席会议由农业、科技、环境保护、卫生、外经贸、检验检疫等有关部门的负责人组成，负责研究、协调农业转基因生物安全管理工作中的重大问题。 |
| Article 6 The State institutes a class-based administration and evaluation system for agricultural genetically modified organisms safety. | | 第六条 国家对农业转基因生物安全实行分级管理评价制度。 |
| Agricultural genetically modified organisms are classified into Classes I, II, III and IV according to the extent of their risks to human beings, animals, plants, microorganisms and the ecological environment. The specific standards for the classification are to be formulated by the competent agricultural administrative department of the State Council. | | 农业转基因生物按照其对人类、动植物、微生物和生态环境的危险程度，分为Ⅰ、Ⅱ、Ⅲ、 Ⅳ四个等级。具体划分标准由国务院农业行政主管部门制定。 |
| Article 7 The State establishes a safety evaluation system for agricultural genetically modified organisms. | | 第七条 国家建立农业转基因生物安全评价制度。 |
| The standards and technical norms for safety evaluation of agricultural genetically modified organisms are to be formulated by the competent agricultural administrative department of the State Council. | | 农业转基因生物安全评价的标准和技术规范，由国务院农业行政主管部门制定。 |
| Article 8 The State institutes a labeling system for agricultural genetically modified organisms. | | 第八条 国家对农业转基因生物实行标识制度。 |
| The catalogue of agricultural genetically modified organisms subject to labeling administration shall be determined, adjusted and published by the competent agricultural administrative department of the State Council in consultation with the other relevant departments of the State Council. | | 实施标识管理的农业转基因生物目录，由国务院农业行政主管部门商国务院有关部门制定、调整并公布。 |
| Chapter II Research and Testing | | 第二章 研究与试验 |
| Article 9 The competent agricultural administrative department of the State Council shall strengthen the safety evaluation administration of research into and testing of agricultural genetically modified organisms, and set up a bio-safety committee on agricultural genetically modified organisms responsible for safety evaluation of agricultural genetically modified organisms. | | 第九条 国务院农业行政主管部门应当加强农业转基因生物研究与试验的安全评价管理工作，并设立农业转基因生物安全委员会，负责农业转基因生物的安全评价工作。 |
| The bio-safety committee on agricultural genetically modified organisms shall be composed of the experts who are engaged in biological research, production, processing, inspection and quarantine with respect to agricultural genetically modified organisms, as well as those in the fields of public health and environmental protection, etc. | | 农业转基因生物安全委员会由从事农业转基因生物研究、生产、加工、检验检疫以及卫生、环境保护等方面的专家组成。 |
| Article 10 Based on the needs of the safety evaluation of agricultural genetically modified organisms, the competent agricultural administrative department of the State Council may entrust the inspection of agricultural genetically modified organisms to technical inspection bodies with necessary inspecting facilities and capability. | | 第十条 国务院农业行政主管部门根据农业转基因生物安全评价工作的需要，可以委托具备检测条件和能力的技术检测机构对农业转基因生物进行检测。 |
| Article 11 Units engaged in research into and testing of agricultural genetically modified organisms shall have facilities and measures commensurate with the safety class so as to ensure the safety of research into and testing of agricultural genetically modified organisms, and shall establish bio-safety groups of agricultural genetically modified organisms which shall be responsible for the safety of the research into and testing of agricultural genetically modified organisms in the units concerned. | | 第十一条 从事农业转基因生物研究与试验的单位，应当具备与安全等级相适应的安全设施和措施，确保农业转基因生物研究与试验的安全，并成立农业转基因生物安全小组，负责本单位农业转基因生物研究与试验的安全工作。 |
| Article 12 A unit conducting research into agricultural genetically modified organisms classified as Classes III and IV shall make a report to the competent agricultural administrative department of the State Council prior to the commencement of the research. | | 第十二条 从事Ⅲ、 Ⅳ级农业转基因生物研究的，应当在研究开始前向国务院农业行政主管部门报告。 |
| Article 13 The testing of agricultural genetically modified organisms shall normally go through three stages, i.e. restricted field testing, enlarged field testing and productive testing. Restricted field testing means a small-scale test conducted within a controlled system or under controlled conditions. Enlarged field testing means a medium-scale test conducted under natural conditions with appropriate safety measures. Productive testing means a large-scale test prior to production and application. | | 第十三条 农业转基因生物试验，一般应当经过中间试验、环境释放和生产性试验三个阶段。中间试验，是指在控制系统内或者控制条件下进行的小规模试验。环境释放，是指在自然条件下采取相应安全措施所进行的中规模的试验。生产性试验，是指在生产和应用前进行的较大规模的试验。 |
| Article 14 Where a testing of agricultural genetically modified organisms needs to move on to the stage of restricted field testing after completion of research in the laboratory, the testing unit shall make a report to the competent agricultural administrative department of the State Council. | | 第十四条 农业转基因生物在实验室研究结束后，需要转入中间试验的，试验单位应当向国务院农业行政主管部门报告。 |
| Article 15 Where a testing of agricultural genetically modified organisms needs to move on from one testing stage to the next one, the testing unit shall make an application to the competent agricultural administrative department of the State Council; if the testing passes the safety evaluation conducted by the bio-safety committee on agricultural genetically modified organisms, the moving on the next testing stage shall be approved by the competent agricultural administrative department of the State Council. | | |
| When making the application referred to in the preceding paragraph, the testing unit shall provide the following materials: | | 试验单位提出前款申请，应当提供下列材料： |
| (1) the safety class of agricultural genetically modified organisms and the justifications therefor; | | （一）农业转基因生物的安全等级和确定安全等级的依据； |
| (2) the inspection report issued by a technical inspection body of agricultural genetically modified organisms; | | （二）农业转基因生物技术检测机构出具的检测报告； |
| (3) appropriate safety administration and precautionary measures; | | （三）相应的安全管理、防范措施； |
| (4)the summary report of the previous testing stage. | | （四）上一试验阶段的试验报告。 |
| Article 16 After the completion of productive testing, the unit engaged in testing of agricultural genetically modified organisms may make an application to the competent agricultural administrative department of the State Council for a safety certificate of agricultural genetically modified organisms. | | 第十六条 从事农业转基因生物试验的单位在生产性试验结束后，可以向国务院农业行政主管部门申请领取农业转基因生物安全证书。 |
| When making the application referred to in the preceding paragraph, the testing unit shall provide the following materials: | | 试验单位提出前款申请，应当提供下列材料： |
| (1)the safety class of agricultural genetically modified organisms and the justifications therefor; | | （一）农业转基因生物的安全等级和确定安全等级的依据； |
| (2) a summary report of the productive testing; | | （二）生产性试验的总结报告； |
| (3)the experimental materials, testing methods, and other materials prescribed by the agriculture administrative department of the State Council. | | （三）国务院农业行政主管部门规定的试验材料、检测方法等其他材料 |
| After receiving an application, the agriculture administrative department of the State Council shall authorize a technical inspection institution meeting the testing conditions and with testing capability to conduct testing, and arrange for the Commission for the Safety of Agricultural Genetically Modified Organisms to conduct safety evaluation; only after the safety evaluation is passed may an agricultural GMO safety certificate be issued. | | 国务院农业行政主管部门收到申请后，应当委托具备检测条件和能力的技术检测机构进行检测，并组织农业转基因生物安全委员会进行安全评价；安全评价合格的，方可颁发农业转基因生物安全证书。 |
| Article 17 Before the examination, registration, evaluation or approval is conducted as provided for in relevant laws and administrative regulations, the safety certificate of agricultural genetically modified organisms shall, as provided for in Article 16 of these Regulations, be obtained for genetically modified plant seeds, breeding livestock and poultry, as well as aquatic fry and seeds, and for the seeds, breeding livestock and poultry, aquatic fry and seeds, pesticides, veterinary drugs, fertilizers, additives and others, which are either produced by using agricultural genetically modified organisms or contain ingredients of agricultural genetically modified organisms. | | 第十七条 转基因植物种子、种畜禽、水产苗种，利用农业转基因生物生产的或者含有农业转基因生物成分的种子、种畜禽、水产苗种、农药、兽药、肥料和添加剂等，在依照有关法律、行政法规的规定进行审定、登记或者评价、审批前，应当依照本条例第十六条的规定取得农业转基因生物安全证书。 |
| Article 18 Research into and testing of agricultural genetically modified organisms within the territory of the People's Republic of China conducted by means of Chinese-foreign contractual cooperation, joint capital or sole foreign capital shall be approved by the competent agricultural administrative department of the State Council. | | 第十八条 中外合作、合资或者外方独资在中华人民共和国境内从事农业转基因生物研究与试验的，应当经国务院农业行政主管部门批准。 |
| Chapter III Production and Processing | | 第三章 生产与加工
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