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Agriculture & environment

Regulations on the Safety Administration of Agricultural Genetically Modified Organisms

农业转基因生物安全管理条例

This regulation governs the safety management of agricultural genetically modified organisms (GMOs) in China, covering research, testing, production, processing, operation, import, and export activities.

Issuing authority
State Council of the People's Republic of China中华人民共和国国务院
Published
2017-10-07
Effective
2017-10-07
Status
In force
Open official source ↗Source checked: 2026-07-30Version history: 2001-05-23 · 2011-01-08 · 2017-10-07
Original ChineseTranslation
Original Chinese

(2001年5月23日中华人民共和国国务院令第304号公布 根据2011年1月8日《国务院关于废止和修改部分行政法规的决定》第一次修订 根据2017年10月7日《国务院关于修改部分行政法规的决定》第二次修订)

Translation

(Promulgated by Decree No. 304 of the State Council of the People's Republic of China on May 23, 2001; first revised in accordance with the Decision of the State Council on Repealing and Amending Certain Administrative Regulations on January 8, 2011; second revised in accordance with the Decision of the State Council on Amending Certain Administrative Regulations on October 7, 2017)

Original Chinese第一章

总则

TranslationChapter I

General Provisions

Original Chinese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。

TranslationArticle 1

These Regulations are formulated to strengthen the safety management of agricultural genetically modified organisms, ensure human health and the safety of animals, plants, and microorganisms, protect the ecological environment, and promote research on agricultural genetically modified organism technology.

Original Chinese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。

TranslationArticle 2

Any person engaged in the research, testing, production, processing, operation, import, or export of agricultural genetically modified organisms within the territory of the People's Republic of China must comply with these Regulations.

Original Chinese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:

TranslationArticle 3

For the purposes of these Regulations, 'agricultural genetically modified organisms' refer to animals, plants, microorganisms, and their products whose genomic composition has been altered using genetic engineering technology and which are used in agricultural production or the processing of agricultural products, mainly including:

Original Chinese

(一)转基因动植物(含种子、种畜禽、水产苗种)和微生物;

Translation

(1) Genetically modified animals and plants (including seeds, breeding livestock and poultry, aquatic fry) and microorganisms;

Original Chinese

(二)转基因动植物、微生物产品;

Translation

(2) Products of genetically modified animals, plants, and microorganisms;

Original Chinese

(三)转基因农产品的直接加工品;

Translation

(3) Directly processed products of genetically modified agricultural products;

Original Chinese

(四)含有转基因动植物、微生物或者其产品成份的种子、种畜禽、水产苗种、农药、兽药、肥料和添加剂等产品。

Translation

(4) Products such as seeds, breeding livestock and poultry, aquatic fry, pesticides, veterinary drugs, fertilizers, and additives that contain components of genetically modified animals, plants, microorganisms, or their products.

Original Chinese

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。

Translation

For the purposes of these Regulations, 'safety of agricultural genetically modified organisms' refers to the prevention of dangers or potential risks posed by agricultural genetically modified organisms to humans, animals, plants, microorganisms, and the ecological environment.

Original Chinese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。

TranslationArticle 4

The agricultural administrative department of the State Council shall be responsible for the supervision and management of agricultural genetically modified organisms safety nationwide.

Original Chinese

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。

Translation

The agricultural administrative departments of local people's governments at or above the county level shall be responsible for the supervision and management of agricultural genetically modified organisms safety within their respective administrative regions.

Original Chinese

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。

Translation

The relevant departments of local people's governments at or above the county level shall, in accordance with the relevant provisions of the Food Safety Law of the People's Republic of China, be responsible for the supervision and management of genetically modified food safety.

Original Chinese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。

TranslationArticle 5

The State Council shall establish an inter-ministerial joint meeting system for agricultural genetically modified organisms safety management.

Original Chinese

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。

Translation

The inter-ministerial joint meeting for agricultural genetically modified organisms safety management shall be composed of responsible persons from relevant departments such as agriculture, science and technology, environmental protection, health, foreign trade and economic cooperation, inspection and quarantine, and shall be responsible for studying and coordinating major issues in the safety management of agricultural genetically modified organisms.

Original Chinese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。

TranslationArticle 6

The State implements a graded management and evaluation system for agricultural genetically modified organisms safety.

Original Chinese

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。

Translation

Agricultural genetically modified organisms are classified into four levels, I, II, III, and IV, according to their degree of danger to humans, animals, plants, microorganisms, and the ecological environment. The specific classification standards shall be formulated by the agricultural administrative department of the State Council.

Original Chinese第七条

国家建立农业转基因生物安全评价制度。

TranslationArticle 7

The State establishes a safety evaluation system for agricultural genetically modified organisms.

Original Chinese

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。

Translation

The standards and technical specifications for safety evaluation of agricultural genetically modified organisms shall be formulated by the agricultural administrative department of the State Council.

Original Chinese第八条

国家对农业转基因生物实行标识制度。

TranslationArticle 8

The State implements a labeling system for agricultural genetically modified organisms.

Original Chinese

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。

Translation

The catalog of agricultural genetically modified organisms subject to labeling administration shall be formulated, adjusted, and published by the agricultural administrative department of the State Council in consultation with the relevant departments of the State Council.

Original Chinese第二章

研究与试验

TranslationChapter II

Research and Testing

Original Chinese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。

TranslationArticle 9

The agricultural administrative department of the State Council shall strengthen the safety evaluation management of agricultural genetically modified organism research and testing, and shall establish an agricultural genetically modified organism safety committee responsible for the safety evaluation of agricultural genetically modified organisms.

Original Chinese

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。

Translation

The agricultural genetically modified organism safety committee shall be composed of experts engaged in agricultural genetically modified organism research, production, processing, inspection and quarantine, as well as health, environmental protection, and other fields.

Original Chinese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。

TranslationArticle 10

The agricultural administrative department of the State Council may, based on the needs of agricultural genetically modified organism safety evaluation work, entrust technical testing institutions with testing conditions and capabilities to conduct testing of agricultural genetically modified organisms.

Original Chinese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。

TranslationArticle 11

Units engaged in agricultural genetically modified organism research and testing shall have safety facilities and measures corresponding to the safety level to ensure the safety of agricultural genetically modified organism research and testing, and shall establish an agricultural genetically modified organism safety group responsible for the safety work of the unit's agricultural genetically modified organism research and testing.

Original Chinese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。

TranslationArticle 12

Those engaged in research on agricultural genetically modified organisms of safety levels III and IV shall report to the agricultural administrative department of the State Council before the start of the research.

Original Chinese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。

TranslationArticle 13

Agricultural genetically modified organism testing shall generally go through three stages: intermediate testing, environmental release, and productive testing.

Original Chinese

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。

Translation

Intermediate testing refers to small-scale testing conducted within a control system or under controlled conditions.

Original Chinese

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。

Translation

Environmental release refers to medium-scale testing conducted under natural conditions with corresponding safety measures.

Original Chinese

生产性试验,是指在生产和应用前进行的较大规模的试验。

Translation

Production trial refers to a large-scale trial conducted before production and application.

Original Chinese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。

TranslationArticle 14

After the completion of laboratory research on agricultural genetically modified organisms, if it is necessary to proceed to intermediate trials, the trial unit shall report to the agricultural administrative department of the State Council.

Original Chinese第十五条

农业转基因生物试验需要从上一试验阶段转入下一试验阶段的,试验单位应当向国务院农业行政主管部门提出申请;经农业转基因生物安全委员会进行安全评价合格的,由国务院农业行政主管部门批准转入下一试验阶段。

TranslationArticle 15

When an agricultural genetically modified organism trial needs to transition from the previous trial stage to the next trial stage, the trial unit shall submit an application to the agricultural administrative department of the State Council; after the safety evaluation by the Agricultural Genetically Modified Organisms Safety Committee is passed, the agricultural administrative department of the State Council shall approve the transition to the next trial stage.

Original Chinese

试验单位提出前款申请,应当提供下列材料:

Translation

When submitting the application mentioned in the preceding paragraph, the trial unit shall provide the following materials:

Original Chinese

(一)农业转基因生物的安全等级和确定安全等级的依据;

Translation

(1) The safety level of the agricultural genetically modified organism and the basis for determining the safety level;

Original Chinese

(二)农业转基因生物技术检测机构出具的检测报告;

Translation

(2) The test report issued by an agricultural genetically modified organism technical testing institution;

Original Chinese

(三)相应的安全管理、防范措施;

Translation

(3) Corresponding safety management and preventive measures;

Original Chinese

(四)上一试验阶段的试验报告。

Translation

(4) The trial report of the previous trial stage.

Original Chinese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。

TranslationArticle 16

After the completion of production trials, the unit engaged in agricultural genetically modified organism trials may apply to the agricultural administrative department of the State Council for an agricultural genetically modified organism safety certificate.

Original Chinese

试验单位提出前款申请,应当提供下列材料:

Translation

When submitting the application mentioned in the preceding paragraph, the trial unit shall provide the following materials:

Original Chinese

(一)农业转基因生物的安全等级和确定安全等级的依据;

Translation

(1) The safety level of agricultural genetically modified organisms and the basis for determining the safety level;

Original Chinese

(二)生产性试验的总结报告;

Translation

(2) A summary report of the productive trial;

Original Chinese

(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。

Translation

(3) Other materials such as test materials and testing methods as prescribed by the agricultural administrative department of the State Council.

Original Chinese

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。

Translation

Upon receiving the application, the agricultural administrative department of the State Council shall entrust a technical testing institution with the necessary testing conditions and capabilities to conduct testing, and organize the Agricultural Genetically Modified Organisms Safety Committee to carry out a safety assessment; only if the safety assessment is passed may an agricultural genetically modified organism safety certificate be issued.

Original Chinese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份的种子、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。

TranslationArticle 17

Transgenic plant seeds, breeding livestock, poultry, and aquatic fry, as well as seeds, breeding livestock, poultry, aquatic fry, pesticides, veterinary drugs, fertilizers, and additives produced using or containing components of agricultural genetically modified organisms, shall, before undergoing examination, registration, evaluation, or approval in accordance with relevant laws and administrative regulations, obtain an agricultural genetically modified organism safety certificate in accordance with Article 16 of these Regulations.

Original Chinese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。

TranslationArticle 18

Chinese-foreign cooperative, joint venture, or wholly foreign-owned enterprises engaged in research and testing of agricultural genetically modified organisms within the territory of the People's Republic of China shall obtain approval from the agricultural administrative department of the State Council.

Original Chinese第三章

生产与加工

TranslationChapter III

Production and Processing

Original Chinese第十九条

生产转基因植物种子、种畜禽、水产苗种,应当取得国务院农业行政主管部门颁发的种子、种畜禽、水产苗种生产许可证。

TranslationArticle 19

The production of transgenic plant seeds, breeding livestock, poultry, and aquatic fry shall require a production license for seeds, breeding livestock, poultry, and aquatic fry issued by the agricultural administrative department of the State Council.

Original Chinese

生产单位和个人申请转基因植物种子、种畜禽、水产苗种生产许可证,除应当符合有关法律、行政法规规定的条件外,还应当符合下列条件:

Translation

Production units and individuals applying for a production license for transgenic plant seeds, breeding livestock, poultry, and aquatic fry shall, in addition to meeting the conditions prescribed by relevant laws and administrative regulations, also meet the following conditions:

Original Chinese

(一)取得农业转基因生物安全证书并通过品种审定;

Translation

(1) Having obtained an agricultural genetically modified organism safety certificate and passed the variety approval;

Original Chinese

(二)在指定的区域种植或者养殖;

Translation

(2) Planting or breeding in designated areas;

Original Chinese

(三)有相应的安全管理、防范措施;

Translation

(3) Having corresponding safety management and prevention measures;

Original Chinese

(四)国务院农业行政主管部门规定的其他条件。

Translation

(4) Other conditions prescribed by the agricultural administrative department of the State Council.

Original Chinese第二十条

生产转基因植物种子、种畜禽、水产苗种的单位和个人,应当建立生产档案,载明生产地点、基因及其来源、转基因的方法以及种子、种畜禽、水产苗种流向等内容。

TranslationArticle 20

Units and individuals that produce transgenic plant seeds, breeding livestock and poultry, or aquatic fry shall establish production archives, recording the production location, genes and their sources, the transgenic method, and the flow direction of seeds, breeding livestock and poultry, and aquatic fry.

Original Chinese第二十一条

单位和个人从事农业转基因生物生产、加工的,应当由国务院农业行政主管部门或者省、自治区、直辖市人民政府农业行政主管部门批准。具体办法由国务院农业行政主管部门制定。

TranslationArticle 21

Units and individuals engaged in the production or processing of agricultural genetically modified organisms shall obtain approval from the agricultural administrative department of the State Council or the agricultural administrative department of the province, autonomous region, or municipality directly under the Central Government. Specific measures shall be formulated by the agricultural administrative department of the State Council.

Original Chinese第二十二条

从事农业转基因生物生产、加工的单位和个人,应当按照批准的品种、范围、安全管理要求和相应的技术标准组织生产、加工,并定期向所在地县级人民政府农业行政主管部门提供生产、加工、安全管理情况和产品流向的报告。

TranslationArticle 22

Units and individuals engaged in the production or processing of agricultural genetically modified organisms shall organize production and processing in accordance with the approved varieties, scope, safety management requirements, and corresponding technical standards, and shall periodically submit reports to the local county-level agricultural administrative department on production, processing, safety management, and product flow.

Original Chinese第二十三条

农业转基因生物在生产、加工过程中发生基因安全事故时,生产、加工单位和个人应当立即采取安全补救措施,并向所在地县级人民政府农业行政主管部门报告。

TranslationArticle 23

When a genetic safety accident occurs during the production or processing of agricultural genetically modified organisms, the producing or processing unit or individual shall immediately take safety remedial measures and report to the local county-level agricultural administrative department.

Original Chinese第二十四条

从事农业转基因生物运输、贮存的单位和个人,应当采取与农业转基因生物安全等级相适应的安全控制措施,确保农业转基因生物运输、贮存的安全。

TranslationArticle 24

Units and individuals engaged in the transportation or storage of agricultural genetically modified organisms shall adopt safety control measures corresponding to the safety level of the agricultural genetically modified organisms to ensure the safety of transportation and storage.

Original Chinese第四章

经营

TranslationChapter IV

Operation

Original Chinese第二十五条

经营转基因植物种子、种畜禽、水产苗种的单位和个人,应当取得国务院农业行政主管部门颁发的种子、种畜禽、水产苗种经营许可证。

TranslationArticle 25

Units and individuals that operate transgenic plant seeds, breeding livestock and poultry, or aquatic fry shall obtain an operation license for seeds, breeding livestock and poultry, or aquatic fry issued by the agricultural administrative department of the State Council.

Original Chinese

经营单位和个人申请转基因植物种子、种畜禽、水产苗种经营许可证,除应当符合有关法律、行政法规规定的条件外,还应当符合下列条件:

Translation

Operating entities and individuals applying for a license to operate genetically modified plant seeds, breeding livestock and poultry, and aquatic fry shall, in addition to meeting the conditions stipulated by relevant laws and administrative regulations, also meet the following conditions:

Original Chinese

(一)有专门的管理人员和经营档案;

Translation

(1) Having dedicated management personnel and operating files;

Original Chinese

(二)有相应的安全管理、防范措施;

Translation

(2) Having corresponding safety management and prevention measures;

Original Chinese

(三)国务院农业行政主管部门规定的其他条件。

Translation

(3) Other conditions stipulated by the agricultural administrative department of the State Council.

Original Chinese第二十六条

经营转基因植物种子、种畜禽、水产苗种的单位和个人,应当建立经营档案,载明种子、种畜禽、水产苗种的来源、贮存、运输和销售去向等内容。

TranslationArticle 26

Entities and individuals operating genetically modified plant seeds, breeding livestock and poultry, and aquatic fry shall establish operating files, recording the source, storage, transportation, and sales destination of the seeds, breeding livestock and poultry, and aquatic fry.

Original Chinese第二十七条

在中华人民共和国境内销售列入农业转基因生物目录的农业转基因生物,应当有明显的标识。

TranslationArticle 27

Agricultural genetically modified organisms listed in the catalog of agricultural genetically modified organisms sold within the territory of the People's Republic of China shall have clear labeling.

Original Chinese

列入农业转基因生物目录的农业转基因生物,由生产、分装单位和个人负责标识;未标识的,不得销售。经营单位和个人在进货时,应当对货物和标识进行核对。经营单位和个人拆开原包装进行销售的,应当重新标识。

Translation

For agricultural genetically modified organisms listed in the catalog, the producing and repackaging entities and individuals shall be responsible for labeling; those without labeling shall not be sold. Operating entities and individuals shall check the goods and labels when purchasing. If operating entities and individuals open the original packaging for sale, they shall re-label.

Original Chinese第二十八条

农业转基因生物标识应当载明产品中含有转基因成份的主要原料名称;有特殊销售范围要求的,还应当载明销售范围,并在指定范围内销售。

TranslationArticle 28

The label of agricultural genetically modified organisms shall indicate the name of the main raw material containing genetically modified ingredients; if there are special sales scope requirements, the sales scope shall also be indicated, and sales shall be conducted within the designated scope.

Original Chinese第二十九条

农业转基因生物的广告,应当经国务院农业行政主管部门审查批准后,方可刊登、播放、设置和张贴。

TranslationArticle 29

Advertisements for agricultural genetically modified organisms shall be published, broadcast, displayed, and posted only after review and approval by the agricultural administrative department of the State Council.

Original Chinese第五章

进口与出口

TranslationChapter 5

Import and Export

Original Chinese第三十条

从中华人民共和国境外引进农业转基因生物用于研究、试验的,引进单位应当向国务院农业行政主管部门提出申请;符合下列条件的,国务院农业行政主管部门方可批准:

TranslationArticle 30

To introduce agricultural GMOs from outside the People's Republic of China for research or testing, the introducing entity shall submit an application to the competent agricultural department of the State Council; the competent agricultural department of the State Council may approve only if the following conditions are met:

Original Chinese

(一)具有国务院农业行政主管部门规定的申请资格;

Translation

(1) Possessing the application qualifications prescribed by the competent agricultural department of the State Council;

Original Chinese

(二)引进的农业转基因生物在国(境)外已经进行了相应的研究、试验;

Translation

(2) The introduced agricultural GMOs have already undergone corresponding research and testing abroad (outside the country);

Original Chinese

(三)有相应的安全管理、防范措施。

Translation

(3) Having corresponding safety management and prevention measures.

Original Chinese第三十一条

境外公司向中华人民共和国出口转基因植物种子、种畜禽、水产苗种和利用农业转基因生物生产的或者含有农业转基因生物成份的植物种子、种畜禽、水产苗种、农药、兽药、肥料和添加剂的,应当向国务院农业行政主管部门提出申请;符合下列条件的,国务院农业行政主管部门方可批准试验材料入境并依照本条例的规定进行中间试验、环境释放和生产性试验:

TranslationArticle 31

If an overseas company exports to the People's Republic of China transgenic plant seeds, breeding livestock and poultry, aquatic fry, and plant seeds, breeding livestock and poultry, aquatic fry, pesticides, veterinary drugs, fertilizers, and additives produced using or containing agricultural GMOs, it shall submit an application to the competent agricultural department of the State Council; the competent agricultural department of the State Council may approve the entry of test materials and conduct intermediate tests, environmental release, and productive tests in accordance with these Regulations only if the following conditions are met:

Original Chinese

(一)输出国家或者地区已经允许作为相应用途并投放市场;

Translation

(1) The exporting country or region has already allowed the corresponding use and placed them on the market;

Original Chinese

(二)输出国家或者地区经过科学试验证明对人类、动植物、微生物和生态环境无害;

Translation

(2) The exporting country or region has proven through scientific tests that they are harmless to humans, animals, plants, microorganisms, and the ecological environment;

Original Chinese

(三)有相应的安全管理、防范措施。

Translation

(3) Having corresponding safety management and prevention measures.

Original Chinese

生产性试验结束后,经安全评价合格,并取得农业转基因生物安全证书后,方可依照有关法律、行政法规的规定办理审定、登记或者评价、审批手续。

Translation

After the productive test is completed, upon passing the safety assessment and obtaining the agricultural GMO safety certificate, the procedures for examination, registration, or evaluation and approval may be handled in accordance with relevant laws and administrative regulations.

Original Chinese第三十二条

境外公司向中华人民共和国出口农业转基因生物用作加工原料的,应当向国务院农业行政主管部门提出申请,提交国务院农业行政主管部门要求的试验材料、检测方法等材料;符合下列条件,经国务院农业行政主管部门委托的、具备检测条件和能力的技术检测机构检测确认对人类、动植物、微生物和生态环境不存在危险,并经安全评价合格的,由国务院农业行政主管部门颁发农业转基因生物安全证书:

TranslationArticle 32

If an overseas company exports agricultural GMOs to the People's Republic of China for use as processing raw materials, it shall submit an application to the competent agricultural department of the State Council, providing test materials, testing methods, and other materials required by the competent agricultural department of the State Council; if the following conditions are met, and after a technical testing institution commissioned by the competent agricultural department of the State Council and possessing testing conditions and capabilities confirms through testing that there is no danger to humans, animals, plants, microorganisms, and the ecological environment, and after passing the safety assessment, the competent agricultural department of the State Council shall issue an agricultural GMO safety certificate:

Original Chinese

(一)输出国家或者地区已经允许作为相应用途并投放市场;

Translation

(1) The exporting country or region has already allowed the use for the corresponding purpose and placed it on the market;

Original Chinese

(二)输出国家或者地区经过科学试验证明对人类、动植物、微生物和生态环境无害;

Translation

(2) The exporting country or region has proven through scientific experiments that it is harmless to humans, animals, plants, microorganisms, and the ecological environment;

Original Chinese

(三)有相应的安全管理、防范措施。

Translation

(3) There are corresponding safety management and preventive measures.

Original Chinese第三十三条

从中华人民共和国境外引进农业转基因生物的,或者向中华人民共和国出口农业转基因生物的,引进单位或者境外公司应当凭国务院农业行政主管部门颁发的农业转基因生物安全证书和相关批准文件,向口岸出入境检验检疫机构报检;经检疫合格后,方可向海关申请办理有关手续。

TranslationArticle 33

When introducing agricultural genetically modified organisms from outside the People's Republic of China, or exporting agricultural genetically modified organisms to the People's Republic of China, the introducing unit or the overseas company shall, based on the agricultural genetically modified organism safety certificate issued by the agricultural administrative department of the State Council and relevant approval documents, apply to the port entry-exit inspection and quarantine agency for inspection; after passing the inspection, they may apply to the customs for relevant procedures.

Original Chinese第三十四条

农业转基因生物在中华人民共和国过境转移的,应当遵守中华人民共和国有关法律、行政法规的规定。

TranslationArticle 34

The transit of agricultural genetically modified organisms through the People's Republic of China shall comply with the provisions of relevant laws and administrative regulations of the People's Republic of China.

Original Chinese第三十五条

国务院农业行政主管部门应当自收到申请人申请之日起270日内作出批准或者不批准的决定,并通知申请人。

TranslationArticle 35

The agricultural administrative department of the State Council shall make a decision to approve or disapprove within 270 days from the date of receiving the applicant's application, and notify the applicant.

Original Chinese第三十六条

向中华人民共和国境外出口农产品,外方要求提供非转基因农产品证明的,由口岸出入境检验检疫机构根据国务院农业行政主管部门发布的转基因农产品信息,进行检测并出具非转基因农产品证明。

TranslationArticle 36

When exporting agricultural products to outside the People's Republic of China, if the foreign party requires a certificate of non-genetically modified agricultural products, the port entry-exit inspection and quarantine agency shall, based on the information on genetically modified agricultural products published by the agricultural administrative department of the State Council, conduct testing and issue a certificate of non-genetically modified agricultural products.

Original Chinese第三十七条

进口农业转基因生物,没有国务院农业行政主管部门颁发的农业转基因生物安全证书和相关批准文件的,或者与证书、批准文件不符的,作退货或者销毁处理。进口农业转基因生物不按照规定标识的,重新标识后方可入境。

TranslationArticle 37

If imported agricultural genetically modified organisms do not have the agricultural genetically modified organism safety certificate issued by the agricultural administrative department of the State Council and relevant approval documents, or do not conform to the certificate or approval documents, they shall be returned or destroyed. If imported agricultural genetically modified organisms are not labeled in accordance with regulations, they may only enter the country after being re-labeled.

Original Chinese第六章

监督检查

TranslationChapter VI

Supervision and Inspection

Original Chinese第三十八条

农业行政主管部门履行监督检查职责时,有权采取下列措施:

TranslationArticle 38

When performing supervision and inspection duties, the agricultural administrative department has the authority to take the following measures:

Original Chinese

(一)询问被检查的研究、试验、生产、加工、经营或者进口、出口的单位和个人、利害关系人、证明人,并要求其提供与农业转基因生物安全有关的证明材料或者其他资料;

Translation

(1) Inquire about the units and individuals under inspection for research, testing, production, processing, operation, import, or export, as well as interested parties and witnesses, and require them to providesupporting documents or other materials related to the safety of agricultural genetically modified organisms;

Original Chinese

(二)查阅或者复制农业转基因生物研究、试验、生产、加工、经营或者进口、出口的有关档案、账册和资料等;

Translation

(2) Review or copy relevant archives, account books, and materials concerning the research, testing, production, processing, operation, import, or export of agricultural genetically modified organisms;

Original Chinese

(三)要求有关单位和个人就有关农业转基因生物安全的问题作出说明;

Translation

(3) Require relevant units and individuals to provide explanations on issues related to the safety of agricultural genetically modified organisms;

Original Chinese

(四)责令违反农业转基因生物安全管理的单位和个人停止违法行为;

Translation

(4) Order units and individuals that violate the safety management of agricultural genetically modified organisms to cease their illegal activities;

Original Chinese

(五)在紧急情况下,对非法研究、试验、生产、加工、经营或者进口、出口的农业转基因生物实施封存或者扣押。

Translation

(5) In emergency situations, seal up or seize agricultural genetically modified organisms that are illegally researched, tested, produced, processed, operated, imported, or exported.

Original Chinese第三十九条

农业行政主管部门工作人员在监督检查时,应当出示执法证件。

TranslationArticle 39

When conducting supervision and inspection, staff members of the agricultural administrative department shall present their law enforcement credentials.

Original Chinese第四十条

有关单位和个人对农业行政主管部门的监督检查,应当予以支持、配合,不得拒绝、阻碍监督检查人员依法执行职务。

TranslationArticle 40

Relevant units and individuals shall support and cooperate with the supervision and inspection conducted by the agricultural administrative department, and shall not refuse or obstruct law enforcement personnel from performing their duties.

Original Chinese第四十一条

发现农业转基因生物对人类、动植物和生态环境存在危险时,国务院农业行政主管部门有权宣布禁止生产、加工、经营和进口,收回农业转基因生物安全证书,销毁有关存在危险的农业转基因生物。

TranslationArticle 41

When it is discovered that agricultural genetically modified organisms pose a danger to humans, animals, plants, or the ecological environment, the agricultural administrative department of the State Council has the authority to prohibit production, processing, operation, and import, revoke the safety certificate for agricultural genetically modified organisms, and destroy the dangerous agricultural genetically modified organisms.

Original Chinese第七章

罚则

TranslationChapter VII

Penalties

Original Chinese第四十二条

违反本条例规定,从事Ⅲ、Ⅳ级农业转基因生物研究或者进行中间试验,未向国务院农业行政主管部门报告的,由国务院农业行政主管部门责令暂停研究或者中间试验,限期改正。

TranslationArticle 42

Whoever, in violation of these Regulations, engages in research on Class III or IV agricultural genetically modified organisms or conducts intermediate testing without reporting to the agricultural administrative department of the State Council, shall be ordered by the agricultural administrative department of the State Council to suspend the research or intermediate testing and rectify within a specified time limit.

Original Chinese第四十三条

违反本条例规定,未经批准擅自从事环境释放、生产性试验的,已获批准但未按照规定采取安全管理、防范措施的,或者超过批准范围进行试验的,由国务院农业行政主管部门或者省、自治区、直辖市人民政府农业行政主管部门依据职权,责令停止试验,并处1万元以上5万元以下的罚款。

TranslationArticle 43

In violation of these Regulations, engaging in environmental release or productive testing without approval, failing to take safety management and preventive measures as required after approval, or conducting testing beyond the approved scope, the agricultural administrative department of the State Council or the agricultural administrative department of the province, autonomous region, or municipality directly under the Central Government shall, within its authority, order cessation of the testing and impose a fine of not less than 10,000 yuan but not more than 50,000 yuan.

Original Chinese第四十四条

违反本条例规定,在生产性试验结束后,未取得农业转基因生物安全证书,擅自将农业转基因生物投入生产和应用的,由国务院农业行政主管部门责令停止生产和应用,并处2万元以上10万元以下的罚款。

TranslationArticle 44

In violation of these Regulations, after the completion of productive testing, without obtaining the agricultural genetically modified organism safety certificate, arbitrarily putting agricultural genetically modified organisms into production and application, the agricultural administrative department of the State Council shall order cessation of production and application and impose a fine of not less than 20,000 yuan but not more than 100,000 yuan.

Original Chinese第四十五条

违反本条例第十八条规定,未经国务院农业行政主管部门批准,从事农业转基因生物研究与试验的,由国务院农业行政主管部门责令立即停止研究与试验,限期补办审批手续。

TranslationArticle 45

In violation of Article 18 of these Regulations, engaging in research and testing of agricultural genetically modified organisms without approval from the agricultural administrative department of the State Council, the agricultural administrative department of the State Council shall order immediate cessation of research and testing and require completion of approval procedures within a specified period.

Original Chinese第四十六条

违反本条例规定,未经批准生产、加工农业转基因生物或者未按照批准的品种、范围、安全管理要求和技术标准生产、加工的,由国务院农业行政主管部门或者省、自治区、直辖市人民政府农业行政主管部门依据职权,责令停止生产或者加工,没收违法生产或者加工的产品及违法所得;违法所得10万元以上的,并处违法所得1倍以上5倍以下的罚款;没有违法所得或者违法所得不足10万元的,并处10万元以上20万元以下的罚款。

TranslationArticle 46

In violation of these Regulations, producing or processing agricultural genetically modified organisms without approval, or producing or processing not in accordance with the approved variety, scope, safety management requirements, and technical standards, the agricultural administrative department of the State Council or the agricultural administrative department of the province, autonomous region, or municipality directly under the Central Government shall, within its authority, order cessation of production or processing, confiscate the illegally produced or processed products and illegal gains; if the illegal gains are 100,000 yuan or more, a fine of not less than one time but not more than five times the illegal gains shall also be imposed; if there are no illegal gains or the illegal gains are less than 100,000 yuan, a fine of not less than 100,000 yuan but not more than 200,000 yuan shall also be imposed.

Original Chinese第四十七条

违反本条例规定,转基因植物种子、种畜禽、水产苗种的生产、经营单位和个人,未按照规定制作、保存生产、经营档案的,由县级以上人民政府农业行政主管部门依据职权,责令改正,处1000元以上1万元以下的罚款。

TranslationArticle 47

In violation of these Regulations, units and individuals producing or operating transgenic plant seeds, breeding livestock and poultry, or aquatic fry and fingerlings, failing to produce and keep production and operation records as required, the agricultural administrative department of the people's government at or above the county level shall, within its authority, order correction and impose a fine of not less than 1,000 yuan but not more than 10,000 yuan.

Original Chinese第四十八条

违反本条例规定,未经国务院农业行政主管部门批准,擅自进口农业转基因生物的,由国务院农业行政主管部门责令停止进口,没收已进口的产品和违法所得;违法所得10万元以上的,并处违法所得1倍以上5倍以下的罚款;没有违法所得或者违法所得不足10万元的,并处10万元以上20万元以下的罚款。

TranslationArticle 48

In violation of these Regulations, importing agricultural genetically modified organisms without approval from the agricultural administrative department of the State Council, the agricultural administrative department of the State Council shall order cessation of import, confiscate the imported products and illegal gains; if the illegal gains are 100,000 yuan or more, a fine of not less than one time but not more than five times the illegal gains shall also be imposed; if there are no illegal gains or the illegal gains are less than 100,000 yuan, a fine of not less than 100,000 yuan but not more than 200,000 yuan shall also be imposed.

Original Chinese第四十九条

违反本条例规定,进口、携带、邮寄农业转基因生物未向口岸出入境检验检疫机构报检的,由口岸出入境检验检疫机构比照进出境动植物检疫法的有关规定处罚。

TranslationArticle 49

In violation of these Regulations, importing, carrying, or mailing agricultural genetically modified organisms without declaring to the port entry-exit inspection and quarantine authority, the port entry-exit inspection and quarantine authority shall impose penalties by reference to the relevant provisions of the Law on the Entry and Exit Animal and Plant Quarantine.

Original Chinese第五十条

违反本条例关于农业转基因生物标识管理规定的,由县级以上人民政府农业行政主管部门依据职权,责令限期改正,可以没收非法销售的产品和违法所得,并可以处1万元以上5万元以下的罚款。

TranslationArticle 50

In violation of the provisions of these Regulations on the administration of agricultural genetically modified organism labeling, the agricultural administrative department of the people's government at or above the county level shall, within its authority, order correction within a specified period, may confiscate the illegally sold products and illegal gains, and may impose a fine of not less than 10,000 yuan but not more than 50,000 yuan.

Original Chinese第五十一条

假冒、伪造、转让或者买卖农业转基因生物有关证明文书的,由县级以上人民政府农业行政主管部门依据职权,收缴相应的证明文书,并处2万元以上10万元以下的罚款;构成犯罪的,依法追究刑事责任。

TranslationArticle 51

Counterfeiting, forging, transferring, or buying or selling relevant certification documents for agricultural genetically modified organisms, the agricultural administrative department of the people's government at or above the county level shall, within its authority, confiscate the corresponding certification documents and impose a fine of not less than 20,000 yuan but not more than 100,000 yuan; if a crime is constituted, criminal liability shall be pursued according to law.

Original Chinese第五十二条

违反本条例规定,在研究、试验、生产、加工、贮存、运输、销售或者进口、出口农业转基因生物过程中发生基因安全事故,造成损害的,依法承担赔偿责任。

TranslationArticle 52

In violation of these Regulations, during the research, testing, production, processing, storage, transportation, sale, import, or export of agricultural genetically modified organisms, if a genetic safety accident occurs causing damage, liability for compensation shall be borne according to law.

Original Chinese第五十三条

国务院农业行政主管部门或者省、自治区、直辖市人民政府农业行政主管部门违反本条例规定核发许可证、农业转基因生物安全证书以及其他批准文件的,或者核发许可证、农业转基因生物安全证书以及其他批准文件后不履行监督管理职责的,对直接负责的主管人员和其他直接责任人员依法给予行政处分;构成犯罪的,依法追究刑事责任。

TranslationArticle 53

If the competent agricultural administrative department of the State Council or the competent agricultural administrative department of the people's government of a province, autonomous region, or municipality directly under the Central Government, in violation of these Regulations, issues licenses, agricultural genetically modified organism safety certificates, or other approval documents, or fails to perform supervision and management duties after issuing such licenses, certificates, or documents, the directly responsible supervisors and other directly responsible personnel shall be given administrative sanctions according to law; if a crime is constituted, criminal liability shall be pursued according to law.

Original Chinese第八章

附则

TranslationChapter VIII

Supplementary Provisions

Original Chinese第五十四条

本条例自公布之日起施行。

TranslationArticle 54

These Regulations shall come into force as of the date of promulgation.