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农药管理条例 REGULATIONS ON THE CONTROL OF AGRICULTURAL CHEMICALS

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国务院令第216号
(Promulgated by Decree No. 216 of the State Council of the People's Republic of China on May 8, 1997)
颁布日期:19970508  实施日期:19970508  颁布单位:国务院

  Chapter I General Provisions

  Article 1 These Regulations are formulated for the purpose of strengthening the supervision and control of the production, management and application of agricultural chemicals, ensuring the quality of agricultural chemicals, protecting the agricultural and forestry production, ecological environment, and maintaining the safety of human beings and animals.

  Article 2 Agricultural chemicals referred to in these Regulations mean mixtures or preparations of one or more substances by chemical synthesis or originating from organisms or other natural substances with the intent to prevent, eliminate or put under control plant diseases, insect pests, weeds or other living beings harmful to agriculture and forestry and to purposely regulate the growth of plants and insects.

  Agricultural chemicals prescribed in the preceding paragraph include the following categories used for different purposes or sites:

  (1) to prevent, eliminate or put under control plant diseases, insect pests (including insects, ticks and mites), weeds, rats, mollusks and other living beings harmful to agriculture and forestry;

  (2) to prevent, eliminate or put under control diseases, insect pests, rats and other harmful living beings in warehouses;

  (3) to regulate the growth of plants and insects;(4) to be used as antiseptics or preservatives of agricultural products or forest products;

  (5) to prevent, eliminate or put under control mosquitoes, flies, cockroaches, rats and other harmful living beings; and

  (6) to prevent, eliminate or put under control living beings harmful to dykes and dams, railways, airports, buildings and other sites.

  Article 3 The production, management and application of agricultural chemicals within the territory of the People's Republic of China shall observe these Regulations.

  Article 4 The State encourages and supports research, production and application of agricultural chemicals that are safe, highly efficacious and economical.

  Article 5 The agricultural department under the State Council shall be responsible for the registration, supervision and control of agricultural chemicals throughout the country. The agricultural departments of people's governments of provinces, autonomous regions or municipalities directly under the Central Government shall assist the agricultural department under the State Council in the registration of agricultural chemicals, and shall be responsible for the supervision and control of agricultural chemicals within their respective administrative regions. The agricultural departments of people's governments at the county level and in municipalities with subordinate districts or autonomous prefectures shall be responsible for the supervision and control of agricultural chemicals within their respective administrative regions.

  The chemical industry department under the State Council shall be responsible for the overall planning, coordination, guidance, supervision and administration of the production of agricultural chemicals. The chemical industry departments of people's governments of provinces, autonomous regions or municipalities directly under the Central Government shall be responsible for the supervision and administration of the production of agricultural chemicals within their respective administrative regions.

  Other relevant departments of people's governments at or above the county level shall be responsible for the supervision and administration of the production of agricultural chemicals according to their terms of reference.

  Chapter II Registration of Agricultural Chemicals

  Article 6 The State practises a registration system for agricultural chemicals.

  The production (including the production of raw agricultural chemicals as well as the processing and packing of preparations, the same hereinafter) and importation of agricultural chemicals must enter into registration.

  Article 7 Agricultural chemicals produced or imported in the country for the first time shall be registered by the following three phases:

  (1) the Field Trial Phase: Agricultural chemicals the registration of which to be applied for shall be put in field trials subject to approval after their researchers so apply for. Those at the field trial phase shall not be sold.

  (2) the Interim Registration Phase: Producers of agricultural chemicals which require demonstrations of field trials for trial sale and which require to be used under special circumstances after field trials shall apply for interim registration. After the agricultural department under the State Council issues a certificate for interim registration, those agricultural chemicals can be demonstrated for trial sale within a designated scope.

  (3) the Formal Registration Phase: Producers of agricultural chemicals which can be circulated as standard commodities upon demonstrations of field trials for trial sale shall apply for formal registration. After the agricultural department under the State Council issues a registration certificate of agricultural chemicals, those agricultural chemicals can be produced and sold.

  The registration certificate of agricultural chemicals and the certificate for interim registration of agricultural chemicals shall respectively specify the period of validity for registration. If it is necessary to continue to produce or sell to China agricultural chemical products after the expiration of such period of validity, an application for the extension of registration shall be filed before the expiration date of the registration.

  An application for change in registration shall be filed if an agricultural chemical having been granted formal registration or interim registration changes in its pharmaceutical form, ingredients, usage or directions for use within the period of validity for its registration.

  Article 8 When applying for registration of agricultural chemicals pursuant to the provisions of Article 7 of these Regulations, researchers, producers or foreign enterprises selling agricultural chemicals to China shall provide samples of agricultural chemicals to the agricultural department under the State Council, or to the agricultural department under the State Council via the agricultural departments of provinces, autonomous regions and municipalities directly under the Central Government, and shall, at the same time, provide information on product chemistry and toxicology, effectiveness, residues, environmental impact and label as required by the agricultural department under the State Council for registration of agricultural chemicals.

  The appraisal institution of agricultural chemicals attached to the agricultural department under the State Council shall be responsible for specific affairs relating to the registration of agricultural chemicals throughout the country. The appraisal institutions of agricultural chemicals attached to the agricultural departments of provinces, autonomous regions and municipalities directly under the Central Government shall assist in handling specific affairs relating to the registration of agricultural chemicals within their respective administrative regions. #13Article 9 Managerial specialists and technical specialists of agricultural chemicals recommended by departments under the State Council in charge of agriculture, forestry, chemical industry, public health, environmental protection and food grains as well as the Chinese Federation of Supply and Marketing Cooperatives shall form an evaluation and examination committee for registration of agricultural chemicals.

  After the departments under the State Council in charge of agriculture, chemical industry, public health and environmental protection and the Chinese Federation of Supply and Marketing Cooperatives separately examine information on applications for formal registration of agricultural chemicals and write down their comments, the evaluation and examination committee for registration of agricultural chemicals shall conduct an evaluation on the agricultural chemicals in terms of product chemistry, toxicology, effectiveness, residues and environmental impact. Based on the evaluation of the evaluation and examination committee for registration of agricultural chemicals, the agricultural department under the State Council shall issue registration certificates for agricultural chemicals to those applicants who conform to requirements.

  Article 10 If a producer produces identical agricultural chemicals already under registration by other manufacturers, the producer shall apply for registration for the agricultural chemicals and provide samples and information prescribed in Article 8 of these Regulations. The agricultural department under the State Council shall issue to the producer a registration certificate for agricultural chemicals.

  Chapter III Production of Agricultural Chemicals

  Article 11 Production of agricultural chemicals shall conform to the state industrial policies on the agricultural chemical industry.

  Article 12 Whoever intends to establish an agricultural chemicals producing enterprise (including any jointly operated enterprise, any branch or any workshop established for producing agricultural chemicals in a non-agricultural chemicals producing enterprise) shall fulfil the following conditions, subject himself/herself to the examination and consent of the chemical industry department of the province, autonomous region or municipality directly under the Central Government in the place where the enterprise is to be located, then report to the chemical industry department under the State Council for approval. If laws or administrative regulations have other provisions regarding conditions for the establishment of enterprises, and the examination and approval authority, these provisions shall prevail.

  (1) having technicians and skilled workers required by the kind of agricultural chemicals to be produced;

  (2) having workshops, production facilities and hygienic conditions required by the kind of agricultural chemicals to be produced;

  (3) having facilities up to the national standards for labour safety and health and corresponding rules for labour safety and health management;

  (4) having product quality standards and product quality guarantee system;

  (5) producing agricultural chemicals having been granted registration according to law; and

  (6) having facilities and measures for pollution prevention and treatment as required by the state for environmental protection and discharge of pollutants not exceeding the national and local standards.

  After the establishment of an agricultural chemicals producing enterprise has been approved, it shall apply to the organ of industry and commerce administration for a business licence.

  Article 13 The State practises a licence system for production of agricultural chemicals.

  Production of those agricultural chemicals for which the national or trade standards exist shall acquire a production licence issued by the chemical industry department under the State Council.

  Production of those agricultural chemicals for which a standard within the enterprise exists but the national or trade standards have not yet been set shall be examined by the chemical industry department of the province, autonomous region and municipality directly under the Central Government and, on gaining consent, reported to the chemical industry department under the State Council for approval and issuance of an approval document for production of agricultural chemicals.

  Article 14 Agricultural chemicals producing enterprises shall conduct production according to quality standards and technical rules for agricultural chemical products, and shall keep their production records complete and accurate.

  Article 15 Products of agricultural chemicals shall be attached with a label or a description. Labels shall be tightly stuck on or be printed on packages of agricultural chemicals. Labels or descriptions shall have indications concerning the name of agricultural chemicals, name of the producing enterprise, product batch number and number of the registration certificate or interim registration certificate, number of the production licence or number of the approval document for production of the agricultural chemicals, as well as ingredients, contents, weight, product characteristics, toxicity, usage, techniques and directions for use, date of production, period of effectiveness and precautions for applying the agricultural chemicals. Those agricultural chemicals separately packed for distribution shall also be given the names of the packing units.

  Article 16 Before leaving the factory, agricultural chemicals shall undergo quality inspections and be attached with a certificate of quality inspection. No substandard agricultural chemicals shall be dispatched from the factory.

  Chapter IV Marketing of Agricultural Chemicals

  Article 17 Any of the following units may market agricultural chemicals:

  (1) units of the supply and marketing cooperatives marketing means of agricultural production;

  (2) plant protection stations;

  (3) soil fertilizer stations;

  (4) agricultural or forestry technology dissemination institutions;

  (5) institutions for prevention of forest diseases and insect pests;

  (6) agricultural chemicals producing enterprises; and

  (7) other marketing units stipulated by the State Council.

  Whoever intends to market agricultural chemicals categorized as dangerous chemicals shall obtain a marketing licence according to the relevant state provisions.

  Article 18 An agricultural chemicals marketing unit shall meet the following requirements and other requirements prescribed in the relevant laws and administrative regulations and shall take out a business licence according to law from the organ of industry and commerce administration before engaging in marketing of agricultural chemicals:

  (1) having technicians qualified for marketing agricultural chemicals;

  (2) having a place of business, equipment, warehousing facilities, safety and protection measures and facilities and measures for pollution prevention and treatment required by marketing of agricultural chemicals;

  (3) having rules and regulations established for marketing of agricultural chemicals; and

  (4) having a commensurate system and means for quality control over agricultural chemicals to be marketed.

  Article 19 When purchasing agricultural chemicals, an agricultural chemicals marketing unit shall check the agricultural chemical products with the product labels or descriptions and certificates of product quality to find them totally and conduct quality inspections.

  Purchase or sale of those agricultural chemicals without a registration certificate or interim registration certificate, without a production licence or approval document for production, without product quality standards and a certificate of product quality, or without passing quality inspection shall be prohibited.

  Article 20 Agricultural chemicals marketing units shall build up reserve of agricultural chemicals according to the relevant state provisions.

  Rules for the storage and safekeeping of agricultural chemicals shall be established and executed to ensure the quality and safety of agricultural chemical products.

  Article 21 Agricultural chemicals marketing units shall guarantee quality of agricultural chemicals they sell and shall check product labels or descriptions and certificates of product quality with the agricultural chemical products to find them to tally.

  Agricultural chemicals marketing units shall explain correctly to the users of agricultural chemicals, whether units or individuals, the usage, directions for use, dosages, emergency measures for poisoning and precautions of agricultural chemicals.

  Article 22 Agricultural chemical products with an expired period of guaranteed quality may continue to be sold within a fixed period if they are still up to the standards subject to the inspection of the appraisal institution of agricultural chemicals attached to the agricultural department of the people's government at or above the provincial level. However, the words “expired agricultural chemicals” must be indicated and directions for use and dosages must be given.

  Chapter V Application of Agricultural Chemicals

  Article 23 Agricultural departments of people's governments at or above the county level shall, under the plant protection policy of “prevention first and integrated prevention and control”, organize the popularization of agricultural chemicals that are safe and highly efficacious, conduct training to improve peasants' level in the application of agricultural chemicals, and give forecasts of plant diseases and insect pests.

  Article 24 Agricultural departments of local people's governments at or above the county level shall give directions for safe and rational use of agricultural chemicals and, in the light of occurrences of local agricultural disasters due to plant diseases, insect pests, weeds or rats, work out programmes for alternate use of agricultural chemicals, by alternately using agricultural chemicals according to the programmes, alleviate the drug-resistance of plant diseases, insect pests, weeds and rats and improve the results of prevention and control.

  Article 25 Use of agricultural chemicals shall comply with anti-poisoning rules. The preparation and application of agricultural chemicals, disposal of wastes and safety and protection shall be properly handled to prevent environmental pollution and poisoning accidents by agricultural chemicals.

  Article 26 Use of agricultural chemicals shall comply with the relevant state provisions regarding safe and rational use of agricultural chemicals. Dosages, frequency, ways and safety intervals for use of agricultural chemicals shall conform to the regulations to prevent pollution to agricultural and sideline products.

  Hyper toxic or high toxic agricultural chemicals shall not be used for the prevention and control of insects harmful to hygienic conditions, and shall not be applied to vegetables, melons, fruits, tea and traditional Chinese medicinal herbs.

  Article 27 In use of agricultural chemicals, attention shall be paid to environmental protection, protection of beneficial organisms and precious and rare species.

  It is strictly prohibited to poison fishes, shrimps, birds, beasts, etc. with agricultural chemicals.

  Article 28 Administrative departments in charge of forestry, food grains and public health shall step up guidance for safe, rational use of agricultural chemicals in forestry, grain reserve and public health.

  Chapter VI Other Provisions

  Article 29 No unit or individual shall produce agricultural chemicals without a production licence for agricultural chemicals or an approval document for the production of agricultural chemicals.

  No unit or individual shall produce, market, import or use agricultural chemicals without a registration certificate or an interim registration certificate for agricultural chemicals.

  Import of agricultural chemicals shall comply with the relevant state provisions. An importer or his/her agent shall produce to the Customs his/her registration certificate or interim registration certificate acquired for agricultural chemicals in China.

  Article 30 Production, marketing or use of fake agricultural chemicals shall be prohibited.

  Any of the following agricultural chemicals are fake agricultural chemicals:

  (1) those not being agricultural chemicals but passed off as genuine ones, or those being a kind of agricultural chemicals but passed off as another kind; or

  (2) those with the kinds and names of effective ingredients not in conformity with the kinds and names of effectiveingredients indicated in the product labels or descriptions.

  Article 31 Production, marketing or use of inferior agricultural chemicals shall be prohibited.

  Any of the following agricultural chemicals are inferior agricultural chemicals:

  (1) those not conforming to the quality standards of agricultural chemical products;

  (2) those having lost effectiveness; or

  (3) those mixed with ingredients that can cause harmful chemical effects or mixed with other harmful ingredients.

  Article 32 Marketing of agricultural chemicals without labels or with incomplete or unclear labels on product packages shall be prohibited.

  Article 33 Printing, broadcasting, setting up or putting up of advertisements for agricultural chemicals without under going registration shall be prohibited.

  Advertisements for agricultural chemicals shall have contents consistent with those in registration of agricultural chemicals and shall be subject to examination according to the provisions of the advertisement law and the relevant state provisions governing advertisements for agricultural chemicals.

  Article 34 If those agricultural chemicals having undergone registration are found within the period of validity for registration severely harmful to agriculture, forestry, safety of humans and animals and ecological environment, the agricultural department under the State Council shall, based on the deliberation of the evaluation and examination committee for registration of agricultural chemicals, announce restrictions upon the use or nullify the registration thereof.

  Article 35 No unit or individual shall produce, market or use agricultural chemicals the production of which has been prohibited expressly by the state or the registration of which has been nullified by the state.

  Article 36 Competent departments of people's governments at or above the county level shall check and monitor the amount of residues of agricultural chemicals accumulating in agricultural and sideline products.

  Article 37 It is prohibited to sell agricultural and sideline products containing residues of agricultural chemicals in excess of the standards.

  Article 38 Disposal of fake, inferior, expired or prohibited agricultural chemicals, or discarded packages of agricultural chemicals, or other wastes containing agricultural chemicals must strictly conform to the relevant provisions of laws and regulations on environmental protection in order to prevent environmental pollution.

  Chapter VII Penalties

  Article 39 Whoever commits any of the following acts shall be penalized by the agricultural departments according to the following provisions:

  (1) Anyone who, without a registration certificate or an interim registration certificate for agricultural chemicals, produces or markets agricultural chemicals, or produces or markets agricultural chemicals the registration of which has been nullified, shall be ordered to stop the production or marketing, and, in addition to confiscation of the illegal gains, concurrently fined more than 100% and less than ten times of the amount of the illegal gains. If there is no illegal gain, the offender shall be concurrently fined not more than RMB 100,000 Yuan.

  (2) Anyone who continues to produce agricultural chemicals without renewing the expired registration certificate or the expired interim registration certificate for agricultural chemicals, shall be ordered to go through the renewing formalities within a time limit retrospectively, with the illegal gains confiscated, and may be concurrently fined not more than five times of the amount of the illegal gains. If there is no illegal gain, the offender shall be concurrently fined not more than RMB 50,000 Yuan. If the offender fails to go through the renewing formalities within the time limit retrospectively, the department that issued the certificate shall order him/her to stop production and marketing and revoke the registration certificate or the interim registration certificate for agricultural chemicals.

  (3) Anyone who produces or markets agricultural chemical products not having labels attached to the packages, or those having incomplete or unclear labels on product packages, or those having contents in the labels altered, shall be given a warning, with the illegal gains confiscated, and may be concurrently fined not more than three times the amount of the illegal gains. If there is no illegal gain, the offender shall be concurrently fined not more than RMB 30,000 Yuan.

  (4) Anyone who, in using agricultural chemicals, fails to conform to the relevant state provisions regarding safe use of agricultural chemicals, shall be given a warning and may be concurrently fined not more than RMB 30,000 Yuan.

  Whoever commits the act described in Item (4) of the preceding paragraph shall, if a crime has been constituted, be investigated for criminal responsibility according to law.

  Article 40 Whoever commits any of the following acts shall be penalized by the chemical industry department of the people's government at or above the provincial level according to the following provisions:

  (1) Anyone who establishes an agricultural chemicals producing enterprise without approval, or produces agricultural chemicals without a production licence or an approval document for production of agricultural chemicals, shall be ordered to stop production and, with the illegal gains confiscated, concurrently fined more than 100% and less than ten times of the amount of the illegal gains. If there is no illegal gain, the offender shall be fined not more than RMB 100,000 Yuan.

  (2) Anyone who, in producing agricultural chemicals, fails to conform to the provisions in the production licence or the approval document for production of agricultural chemicals, shall be ordered to stop production and, with the illegal gains confiscated, concurrently fined more than 100% and less than five times of the amount of the illegal gains. If there is no illegal gain, the offender shall be concurrently fined not more than RMB 50,000 Yuan. If the circumstances are serious, the organ that issued the licence or the approval document shall revoke the production licence or the approval document for production of agricultural chemicals.

  Article 41 If anyone falsely uses, forges or transfers the registration certificate of agricultural chemicals or the interim registration certificate of agricultural chemicals, or the number of either of the certificates, or the production licence of agricultural chemicals or the approval document for production of agricultural chemicals, or the number of either of the licence or the document, the agricultural department shall withdraw or revoke the registration certificate or the interim registration certificate, the chemical industry department shall withdraw or revoke the production licence or the approval document for production, the agricultural department or the chemical industry department shall confiscate the illegal gains, and may concurrently impose a fine less than ten times the amount of the illegal gains. If there is no illegal gain, the offender may be concurrently fined not more than RMB 100,000 Yuan. If a crime has been constituted, the offender shall be investigated for criminal responsibility according to law.

  Article 42 If anyone produces or markets fake or inferior agricultural chemicals, the agricultural department or other competent departments prescribed in laws or administrative regulations shall confiscate the fake or inferior agricultural chemicals and the illegal gains, and shall concurrently impose a fine more than 100% and less than ten times of the amount of the illegal gains. If there is no illegal gain, the offender shall be concurrently fined not more than RMB 100,000 Yuan. If the circumstances are serious, the agricultural department shall revoke the registration certificate or interim registration certificate of agricultural chemicals, and the chemical industry department shall revoke the production licence or the approval document for production of agricultural chemicals. If a crime has been constituted, the offender shall be investigated for criminal responsibility according to law.

  Article 43 Any producer or seller of agricultural chemicals who violates laws and regulations regarding industry and commerce administration, or any violator of laws governing advertisements for agricultural chemicals shall be penalized by the organ of industry and commerce administration according to the relevant provisions of laws and regulations.

  Article 44 Any violator of these Regulations who causes a poisoning accident by agricultural chemicals, environmental pollution, a chemical disaster or other economic losses shall compensate for losses according to law.

  Article 45 If anyone, in violation of these Regulations, causes a major accident in the course of production, storage, transportation or use of agricultural chemicals, resulting in serious consequences enough to constitute a crime, the person directly in charge or other persons directly responsible shall be investigated for criminal responsibility according to law. If a crime has not been constituted, administrative sanctions shall be imposed according to law.

  Article 46 Functionaries in charge of agricultural chemicals who abuse power, neglect duties, engage in malpractices for selfish gains, or extort or take bribes shall, if a crime has been constituted, be investigated for criminal responsibility according to law. If a crime has not been constituted, the offender shall be imposed administrative sanctions according to law.

  Chapter VIII Supplementary Provisions

  Article 47 If provisions related to agricultural chemicals in an international treaty concluded or acceded to by the People's Republic of China are different from the provisions of these Regulations, the provisions in the international treaty shall prevail with the exception of those articles and paragraphs on which China has stated her reservations.

  Article 48 These Regulations shall come into effect as of May 8, 1997.

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