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Regulation on Agricultural Chemicals Administration - 1997

(Promulgated by Decree No. 216 of the State Council of the People's Republic of China on May 8, 1997, and effective on the date of promulgation)



Chapter I General Provisions
Article 1
For purposes of strengthening supervision and control over production, distribution and use of agricultural chemicals, assuring the quality of agricultural chemicals, protecting the agricultural and forestry production and ecological environment, and ensuring the safety of human beings and livestock, this Regulation is formulated.

Article 2
The expression "agricultural chemicals" as employed in this Regulation means chemical synthesis or any substances or mixtures of substances originating from organisms or other natural substances, as well as their formulations, which are used to prevent, destroy or control diseases, pests, weeds or other harmful organisms which cause danger to the agriculture and forestry, or for the purpose of regulating the growth of plants and insects.

According to their purposes and suitability, agricultural chemicals prescribed in the preceding paragraph shall include those used to --

1. prevent, destroy or control diseases, pests (including insects, ticks and mites), weeds, rodents, molluscs and other harmful organisms which cause danger to the agriculture and forestry;
2. prevent, destroy or control diseases, pests, rodents and other harmful organisms in warehouses;
3. regulate the growth of plants and insects;
4. preserve agricultural or forest products or keep them from corrosion;
5. prevent, destroy or control mosquitoes, flies, cockroaches, rodents and other harmful organisms; and
6. prevent, destroy or control harmful organisms which cause danger to dikes and dams, railroads, airports, buildings and other places.

Article 3
Production, distribution and use of agricultural chemicals in the territory of the People's Republic of China shall conform to this Regulation.

Article 4
The State encourages and supports to develop, produce and use safe, highly effective and economical agricultural chemicals.

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

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

Other relevant departments of people's governments at and above the county level shall, within their respective spheres of competence, be responsible for related supervision and control work of agricultural chemicals.

Chapter II Registration of Agricultural Chemicals
Article 6
The State has the agricultural chemicals registration system.

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

Article 7
The registration of agricultural chemicals produced or imported for the first time in China shall be accomplished according to the following three stages:

1. the field trial stage
Where an agricultural chemical is to be registered, the developer shall apply for the field trial and only after being approved, may start the trial. No agricultural chemical at the field trial stage may be sold.
2. the interim registration stage
Where an agricultural chemical needs, after the field trial, to go through field demonstrations and trial sale or to be used under special circumstances, the producer shall apply for interim registration and only after obtaining the interim registration certificate therefor issued by the administrative department of agriculture of the State Council, may start the demonstration and sale within the specified ranges.
3. the official registration stage
Where an agricultural chemical may, subject to field demonstration and trial sale, be put into circulation as a formal commodity, the producer shall apply for official registration and only after obtaining the registration certificate therefor issued by the administrative department of agriculture of the State Council, may start the production and sale thereof.

Both the registration certificate and the interim registration certificate of an agricultural chemical shall specify the period of registration validity. If, after the said period expires, it is necessary to continue to produce or sell to China the agricultural chemical product, an application for renewal of registration shall be required before the expiry date.

If, within the period of registration validity, an alteration needs to be made in the form, content, the scope of application or methods of use of an agriculturai chemial registered officially or interimly, an application for alteration registration shall be required.

Article 8
The developer, producer or foreign enterprise selling an agricultural chemical to China shall, at the time when applying for registration of an agricultural chemical according to the provisions of Article 7 of this Regulation, submit the required samples to the administrative department of agriculture of the State Council directly or through the administrative department of agriculture of the people's government of the province, autonomous region or municipality directly under the Central Government, and as required by the administrative department of agriculture of the State Council for agricultural chemicals registration, the information relating to product chemistry and toxicology, effectiveness, residues, environmental impact and label.

The agricultural chemicals inspection bodies of the administrative department of agriculture of the State Council shall be responsible for the concrete work relating to the agricultural chemicals registration throughout the country. The agricultural chemicals inspection bodies of the administrative departments of agriculture of people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall assist to do a good job within their respective administrative areas.

Article 9
An evaluation board for agricultural chemicals registration shall be organized, which shall be composed of agricultural chemicals control and technical experts recommended by the departments of the State Council in charge of agriculture, forestry, chemical industry, public health, environmental protection and grains as well as such departments as the All China Federation of Supply and Marketing Cooperatives.

After an application for official registration for an agricultural chemical is filed, all application documents shall be examined and signed with their written comments separately by the departments of the State Council in charge of agriculture, chemical industry, public health and environmental protection and All China Federation of Supply and Marketing Cooperatives, and the evaluation board for agricultural chemicals registration shall evaluate the agricultural chemical in terms of product chemistry, toxicology, effectiveness, residues and environmental impact. The administrative department of agriculture of the State Council shall, in accordance with the evaluation of the board, issue the registration certificate for the qualified agricultural chemical.

Article 10
A producer intending to produce an agricultural chemical already registered by another producer shall apply for the agricultural chemical registration and submit samples thereof and information prescribed by Article 8 of this Regulation. The administrative department of agriculture of the State Council shall issue to the said producer a registration certificate thereof.

Chapter III Production of Agricultural Chemicals
Article 11
Agricultural chemicals production shall conform to the State's industrial policies on the agricultural chemicals industry.

Article 12
The establishment of an agricultural chemicals production enterprise (including any jointly operated enterprise, any branch or any workshop established for producing agricultural chemicals in a non-agricultural chemicals production enterprise) shall satisfy the following conditions, be examined and permitted by the administrative department of chemical industry of the province, autonomous region or municipality directly under the Central Government in the place where the enterprise is to be located, and be submitted to the administrative department of chemical industry of the State Council for approval. Where, however, laws or administrative regulations have other provisions regarding the conditions and examination or approval authority for the establishment of the enterprise, these provisions shall prevail:

1. having technicians and skilled workers required by the agricultural chemicals to be produced;
2. having workshops, production facilities and hygienic conditions required by the agricultural chemicals to be produced;
3. having facilities up to the national standards for labour safety and health and corresponding rules therefor;
4. having product quality standards and product quality assurance system;
5. producing agricultural chemicals which have the registration certificate 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.

The agricultural chemicals production enterprise may, according to law, apply to the administrative authority of industry and commerce for a business licence only after being approved.

Article 13
The State has the licence system for agricultural chemicals production.

Producers of agricultural chemicals for which the national or trade standards are available shall aplly for the agricultural chemical production licence to the administrative department of chemical industry of the State Council.

The poduction of an agricultural chemical for which the national or trade standards have not yet been available but the enterprise standards are available shall be examined and permitted by the administrative department of chemical industry of the province, autonomous region or municipality directly under the Central Government, and reported to the administrative department of chemical industry of the State Council for approval. If being approved, an approval document for the agricultural chemical production shall be issued thereto.

Article 14
Agricultural chemicals production enterprises shall conduct their production in accordance with the quality standards and technical rules for agricultural chemical products, and shall keep their production records complete and accurate.

Article 15
Packages of agricultural chemical products must be labelled or bear descriptions. Labels shall be tightly stuck or printed on packages of agricultural chemicals. Labels or descriptions shall clearly indicate the name of the agricultural chemical, name of the production enterprise, product batch number, number of the registration certificate or interim registration certificate, number of the production licence or the approval document for the agricultural chemical production, as well as its active ingredients, content, weight, product features, toxicity, usage, techniques and directions for use, production date, period of effectiveness and precautions. In the case of repacked agricultural chemicals, the name of the repacking unit shall also be indicated.

Article 16
All agricultural chemical products shall, before leaving the factory, be subject to quality inspections and attached with a quality inspection certificate. No unconforming agricultural chemicals may be permitted to leave the factory.

Chapter IV Distribution of Agricultural Chemicals
Article 17
The following units may distribute agricultural chemicals:

1. agricultural production means distribution units under the supply and marketing cooperatives;
2. plant protection stations;
3. soil fertilizer stations;
4. agricultural or forestry technology promotion services;
5. forest diseases and pests control organizations;
6. agricultural chemicals production enterprises; and
7. other distribution units prescribed by the State Council.

A distribution unit of agricultural chemical classified as a dangerous chemical shall apply for a distribution licence in accordance with the relevant regulations of the State.

Article 18
An agricultural chemicals distribution unit shall satisfy the following conditions and other conditions laid down by the relevant laws and administrative regulations and may engage in the distribution of agricultural chemicals only after a business licence is applied for and obtained according to law from the administrative authority of industry and commerce:

1. having qualified technicians for agricultural chemicals to be distributed;
2. having a place of business, equipment, warehousing facilities, safety and protection measures and facilities and measures for pollution prevention and treatment required by agricultural chemicals to be distributed;
3. having rules and regulations established for agricultural chemicals to be distributed; and
4. having a quality control system and administrative means for agricultural chemicals to be distributed.

Article 19
An agricultural chemicals distribution unit shall, after purchasing an agricultural chemical, check the agricultural chemical products against the product labels or descriptions and the product quality certificate, and conduct the quality inspection.

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

Article 20
Agricultural chemicals distribution units shall ensure proper storage and reserves of agricultural chemicals in accordance with the relevant regulations of the State.

In storing agricultural chemicals, the system for the storage and safekeeping shall be established and implemented, and the quality and safety of agricultural chemical products being stored shall be ensured.

Article 21
Agricultural chemicals distribution units shall guarantee the quality of agricultural chemicals they sell and shall check them exactly against product labels or descriptions and product quality certificates.

Agricultural chemicals distribution units shall give correct instructions to the units and individuals using agricultural chemicals about the usage, methods for use, dosages, first-aid measures and precautions relating to agricultural chemicals.

Article 22
An agricultural chemical product with an expired period of guaranteed quality may, if still conforming to standards as inspected by the agricultural chemicals inspection bodies of the administrative department of agriculture of the people's government at or above the provincial level, be sold within a specified period of time. However, the words "expired agricultural chemicals" must be clearly indicated together with instructions about methods and dosages.

Chapter V Use of Agricultural Chemicals
Article 23
Administrative departments of agriculture of people's governments at and above the county level shall, in accordance with the plant protection principle of "prevention first and comprehensive control", arrange for wide use of safe and highly effective agricultural chemicals, provide training, improve the use techniques of farmers, and do a good job in the forecast of diseases and pests.

Article 24
Administrative departments of agriculture of local people's governments at and above the county level shall enhance guidance for safe and rational use of agricultural chemicals and, in the light of local occurrences of agricultural disasters, pests, weeds and rodents, formulate the plans for alternate use of agricultural chemicals, use agricultural chemicals alternately in a planned way, reduce the pesticide-resistance of diseases, pests, weeds and rodents, and improve the prevention and control.

Article 25
In using agricultural chemicals, anti-poisoning rules shall be complied with, agricultural chemicals shall be mixed and applied in a proper way, disposal of wastes and work of safety and protection shall be well done, environmental pollution and poisoning accidents by agricultural chemicals shall be prevented.

Article 26
Agricultural chemicals shall be used in accordance with the relevant regulations of the State regarding safe and rational use of agricultural chemicals and the specified dosages, frequency, methods and safety intervals for use, and any pollution to agricultural and sideline products shall be avoided.

Extremely and highly toxic agricultural chemicals may not be used for control of insects harmful to hygienic conditions, and may not be applied to vegetables, melons, fruits, tea and traditional Chinese medicinal herbs.

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

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

Article 28
Administrative departments of forestry, grains and public health shall strengthen guidance on safe and rational use of agricultural chemicals in forestry, grain reserve and public health.

Chapter VI Other Provisions
Article 29
No unit or person may produce any agricultural chemicals without a production licence or an approval document for the agricultural chemicals production.

No unit or person may produce, distribute, import or use any agricultural chemicals without a registration certificate or an interim registration certificate.

Import of agricultural chemicals shall comply with the relevant regulations of the State. The importer or his agent shall produce to the Customs the registration certificate or interim registration certificate he obtained in China.

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

The followings shall be 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 types and names of active ingredients not in conformity with that indicated in the product labels or descriptions.

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

The followings shall be inferior agricultural chemicals:

1. those failing to conform to the quality standards of agricultural chemical products;
2. those having lost efficacy; and
3. those containing harmful ingredients that can cause hazards.

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

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

The contents of agricultural chemicals advertisements must be in keeping with those of registration and shall be subject to examination in accordance with the provisions of the Advertisement Law and the relevant regulations of the State governing agricultural chemicals advertisements.

Article 34
Where an agricultural chemical already registered is, within its period of registration validity, found severely harmful to agriculture, forestry, safety of human beings or livestock or ecological environment, the administrative department of agriculture of the State Council shall, after being examined by the evaluation board for agricultural chemicals registration, announce its restricted use or revoke its registration.

Article 35
No unit or person may produce, distribute or use any agricultural chemicals which are officially prohibited or revoked the registration by the State.

Article 36
Relevant departments of people's governments at and above the county level shall check and monitor the amount of residues of agricultural chemicals 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
In disposing fake, inferior, expired or prohibited agricultural chemicals, or discarded packages of agricultural chemicals or other wastes containing agricultural chemicals, the relevant provisions of laws and regulations on environmental protection must be strictly complied with and environmental pollution must be prevented.

Chapter VII Penalty Provisions
Article 39
In one of the following circumstances, the administrative department of agriculture shall impose penalties in accordance with the following provisions:

1. In the case of unapproved production or distribution of an agricultural chemical without obtaining the registration certificate or interim registration certificate, or in the case of production or distribution of an agricultural chemical with its registration being revoked, production or distribution shall be ordered to stop, the illegal gains therefrom shall be confiscated, and concurrently a fine exceeding one times and not exceeding ten times of the illegal gains shall be imposed thereon or, if there is no illegal gains therefrom, a fine not exceeding 100,000 yuan shall be imposed thereon concurrently.
2. In the case of continuing to produce an agricultural chemical without renewing the expired registration certificate or the expired interim registration certificate, renewal procedures shall be ordered to complete within a time limit, the illegal gains therefrom shall be confiscated and concurrently a fine not exceeding five times of the illegal gains may be imposed thereon or, if there is no illegal gains therefrom, a fine not exceeding 50,000 yuan may be imposed thereon concurrently. If the producer fails to renew the registration certificate within the time limit, the original issuing authority shall order him to stop the production or distribution, and revoke his registration certificate or interim registration certificate.
3. In the case of production or distribution of an agricultural chemical product which fails to have labels on the packages or has incomplete or unclear labels or has illegally altered contents in the labels, a warning shall be given thereto, the illegal gains therefrom shall be confiscated and concurrenty a fine not exceeding three times of the illegal gains may be imposed thereon or, if there is no illegal gains therefrom, a fine not exceeding 30,000 yuan may be imposed thereon concurrently.
4. In the case of a failure to use an agricultural chemical in accordance with the relevant regulations of the State regarding safe use of agricultural chemicals, a warning shall be given thereto and a fine not exceeding 30,000 yuan shall be imposed thereon concurrently in the light of the damage thus caused.

If a crime is constituted under sub-paragraph 4 of the preceeding paragraph, criminal responsibility shall be demanded for according to law.

Article 40
In one of the following circumstances, the administrative department of chemical industry of the people's government at or above the provincial level shall impose penalties in accordance with the following provisions:

1. In the case of an unapproved establishment of an agricultural chemicals production enterprise, or in the case of production of an agricultural chemical without obtaining a production licence or an approval document for agricultural chemicals production, production shall be ordered to stop, the illegal gains therefrom shall be confiscated and concurrently a fine exceeding one times and not exceeding ten times of the illegal gains shall be imposed thereon or, if there is no illegal gains therefrom, a fine not exceeding 100,000 yuan shall be imposed thereon concurrently.
2. In the case of a failure to produce an agricultural chemicals according to the provisions of the production licence or the approval document for agricultural chemicals production, production shall be ordered to stop, the illegal gains therefrom shall be confiscated and concurrently a fine exceeding one times and not exceeding five times of the illegal gains shall be imposed thereon or, if there is no illegal gains therefrom, a fine not exceeding 50,000 yuan shall be imposed thereon concurrently. If the circumstances are serious, the original issuing authority shall revoke the production licence or the approval document for agricultural chemicals production.

Article 41
In the case of false use or forgery or transfer of the registration certificate or interim registration certificate, or the number of the above-mentioned certificate, or the agricultural chemicals production licence or approval document for agricultural chemicals production, or the number of the above-mentioned licence or document, the administrative department of agriculture shall withdraw or revoke the registration certificate or interim registration certificate, the administrative department of chemical industry shall withdraw or revoke the production licence or approval document for production, the administrative department of agriculture or the administrative department of chemical industry shall confiscate the illegal gains therefrom and may concurrently impose thereon a fine not exceeding ten times of the illegal gains or, if there is no illegal gains therefrom, may concurrently impose thereon a fine not exceeding 100,000 yuan. If a crime is constituted, criminal responsibility shall be demanded for according to law.

Article 42
In the case of production or distribution of fake or inferior agricultural chemicals, the adminstrative department of agriculture or any other appropriate department prescribed by laws or administrative regulations shall confiscate the fake or inferior agricultural chemicals and the illegal gains therefrom, and shall concurrently impose thereon a fine exceeding one times and not exceeding ten times of the illegal gains or, if there is no illegal gains therefrom, shall concurrently impose thereon a fine not exceeding 100,000 yuan. If the circumstances are serious, the administrative department of agriculture shall revoke the registration certificate or interim registration certificate and the administrative department of chemical industry shall revoke the production licence or approval document for production. If a crime is constituted, criminal responsibility shall be demanded for according to law.

Article 43
In the case of a failure to produce or distribute an agricultural chemical in accordance with the laws and regulations regarding industry and commerce administration, or in the case of a violation of the provisions governing agricultural chemicals advertisements, the administrative authority for industry and commerce shall impose penalties in accordance with the relevant provisions of laws and regulations.

Article 44
In the case of a violation of the provisions of this Regulation to cause an agricultural chemicals poisoning, environmental pollution, a chemical disaster or other economic losses, compensation shall be made according to law.

Article 45
In the case of a violation of the proviosions of this Regulation to cause a major accident in the course of production, storage, transportation or use of agricultural chemicals, the person directly in charge and other persons directly responsible shall be demanded for criminal responsibility according to law if the results are serious enough to constitute a crime or, if a crime is not constituted, shall be subject to administrative sanctions according to law.

Article 46
Where a person engaiging in agricultural chemicals administration abuses his power, neglects his duty of office, practices favouritism or other irregularities, or solicits or accepts bribes, his criminal responsibility shall be demanded for according to law if a crime is constituted or, if a crime is not constituted, administrative sanctions shall be imposed thereon according to law.

Chapter VIII Supplementary Provisions
Article 47
In the case of a conflict between the provisions of this Regulation and those of any international treaty relating to agricultural chemicals concluded or acceded to by the People's Republic of China, the latter shall prevail, with the exception of reservations declared by the People's Republic of China.

Article 48
This Regulation shall enter into force on May 8, 1997.

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