Ministry of Agriculture

[Publication number]

[Release Date] 2017-12-22

[Effective Date] 2017-12-22

[Effectiveness]

[Remarks] Decree No. 304 of the State Council of the People's Republic of China issued on 23 May 2001

Amendment in accordance with the Decision of the State Council Decree on Abolishing and Amending Part of Administrative Regulations of 8 January 2011

Amendment in accordance with the Decision of the State Council on the Amendment of Some Administrative Regulations of October 7, 2017

(Promulgated by Decree No. 304 of the State Council of the People's Republic of China on 23 May 2001

Amendment in accordance with the Decision of the State Council Decree on Abolishing and Amending Part of Administrative Regulations of 8 January 2011

According to the "Decision of the State Council on the Amendment of Some Administrative Regulations" of October 7, 2017.

general provisions

Article 1 These Regulations are formulated in order to strengthen the safety management of agricultural genetically modified organisms, ensure human health, animal, plant and microbial safety, protect the ecological environment and promote the research of agricultural genetically modified organisms technology.

Article 2 These Regulations must be abided by when engaging in research, testing, production, processing, operation, import and export of agricultural genetically modified organisms within the territory of the People's Republic of China.

Article 3 Agricultural genetically modified organisms referred to in these Regulations refer to animals, plants, microorganisms and their products that use genetic engineering technology to alter genome composition for agricultural production or processing of agricultural products, mainly including:

(1) Transgenic animals and plants (including seeds, breeding livestock and poultry, aquatic seedlings) and microorganisms;

(2) Genetically modified animals, plants and microbial products;

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

(4) Products including seeds, breeding livestock and poultry, aquatic seedlings, pesticides, veterinary drugs, fertilizers and additives containing genetically modified animals and plants, microorganisms or components of their products.

The term "safety of agricultural genetically modified organisms" as mentioned in these Regulations refers to the prevention of risks or potential risks posed by agricultural genetically modified organisms to human beings, animals and plants, microorganisms and the ecological environment.

Article 4 The administrative department of agriculture under the State Council shall be responsible for the supervision and administration of the safety of genetically modified organisms in agriculture throughout the country.

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

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

Article 5 The State Council shall establish a joint inter-ministerial meeting system for the safety management of agricultural genetically modified organisms.

The Joint Inter-ministerial Meeting on Safety Management of Agricultural GMOs is composed of the heads of relevant departments such as agriculture, science and technology, environmental protection, health, foreign trade, inspection and quarantine. It is responsible for researching and coordinating major issues in safety management of agricultural GMOs.

Article 6 The State implements a hierarchical management and evaluation system for the safety of agricultural genetically modified organisms.

Agricultural genetically modified organisms can be divided into four grades according to their dangerous degree to human beings, animals and plants, microorganisms and ecological environment: I, II, III and IV. Specific criteria for division shall be formulated by the administrative department of agriculture under the State Council.

Article 7 The State shall establish an evaluation system for the safety of agricultural genetically modified organisms.

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

Article 8 The State implements a labeling system for agricultural genetically modified organisms.

The catalogue of agro-genetically modified organisms under the labeling administration shall be formulated, adjusted and published by the competent agricultural administrative department under the State Council in consultation with the relevant departments under the State Council.

Chapter II Research and Experiments

Article 9 The competent agricultural administrative department under the State Council shall strengthen the management of the safety evaluation of agricultural genetically modified organisms research and test, and establish a committee on the safety of agricultural genetically modified organisms, which shall be responsible for the safety evaluation of agricultural genetically modified organisms.

Agricultural GMO biosafety committee is composed of experts engaged in research, production, processing, inspection and Quarantine of agricultural GMOs, as well as health and environmental protection.

Article 10 The competent agricultural administrative department under the State Council may, in accordance with the needs of the evaluation of the safety of agricultural genetically modified organisms, entrust technical testing institutions with the testing conditions and capabilities to carry out the testing of agricultural genetically modified organisms.

Article 11 Units engaged in agricultural genetically modified organisms research and test shall have safety facilities and measures appropriate to the safety level to ensure the safety of agricultural genetically modified organisms research and test, and establish agricultural genetically modified organisms safety teams to be responsible for the safety of agricultural genetically modified organisms research and test in their units.

Article 12 Anyone engaged in research on agricultural genetically modified organisms at grades III and IV shall report to the competent agricultural administrative department under the State Council before the start of the research.

Article 13 Agricultural genetically modified organisms shall generally undergo three stages: intermediate test, environmental release and productive test. Intermediate test refers to the small-scale test conducted in the control system or under the control conditions. Environmental release is a medium-scale test conducted under natural conditions to take appropriate safety measures. Productive test refers to the large-scale test before production and application.

Article 14 When agro-genetically modified organisms need to be transferred into intermediate experiments after laboratory research, the testing unit shall report to the agricultural administrative department under the State Council.

Article 15 Agricultural genetically modified organism experiments need to be transferred from the previous experimental stage to the next.