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REGULATIONS ON THE CONTROL OF AGRICULTURAL CHEMICALS

Category  AGRICULTURE, FORESTRY AND METEOROLOGY Organ of Promulgation  The State Council Status of Effect  In Force
Date of Promulgation  1997-05-08 Effective Date  1997-05-08  

Regulations on the Control of Agricultural Chemicals



Chapter I  General Provisions
Chapter II  Registration of Agricultural Chemicals
Chapter III  Production of Agricultural Chemicals
Chapter IV  Marketing of Agricultural Chemicals
Chapter V  Application of Agricultural Chemicals
Chapter VI  Other Provisions
Chapter VII  Penalties
Chapter VIII  Supplementary Provisions

(Promulgated by Decree No. 216 of the State Council of the People's

Republic of China on May 8, 1997)
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, molluscs 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.

    Article 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 foodgrains 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 to tally 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.

    Hypertoxic 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, foodgrains
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 effective ingredients 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 undergoing 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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