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Regulations on the Administration of Pesticides (Second Amendment pursuant to the Decision of the State Council dated March 29, 2022, on Amending and Repealing Certain Administrative Regulations)


Category:

Industry Information

Author:

Pesticide Registration and Trial Information Exchange

Source:

Pesticide Registration and Trial Information Exchange

Release date:

2022-06-05

 

Note: State Council Order No. 752 promulgates the “Decision of the State Council on Amending and Repealing Certain Administrative Regulations,” which shall take effect as of May 1, 2022. Attachment: 1. Administrative regulations amended by decision of the State Council: VI. Article 9, paragraph 3 of the Regulations on the Administration of Pesticides is deleted (namely: Applications for registration trials of new pesticides shall be submitted to the agricultural administrative department under the State Council. The said department shall, within 40 working days from the date of acceptance of the application, review the safety risks of the trial and the corresponding preventive measures; if the conditions are met, the registration trial shall be approved; if not, the applicant shall be notified in writing with an explanation of the reasons).

 

 

Regulations on the Administration of Pesticides

(Promulgated on May 8, 1997, by Order No. 216 of the State Council of the People’s Republic of China)

First revised in accordance with the Decision of the State Council on Amending the Regulations on the Administration of Pesticides, dated November 29, 2001.

Revised and adopted at the 164th Executive Meeting of the State Council on February 8, 2017.

As amended for the second time pursuant to the Decision of the State Council on Amending and Repealing Certain Administrative Regulations dated March 29, 2022.

 

Chapter I General Provisions

Article 1 This Regulation is enacted to strengthen the administration of pesticides, ensure their quality, safeguard the safety of agricultural products and the health of humans and livestock, and protect agricultural and forestry production as well as the ecological environment.

Article 2: For the purposes of these Regulations, “pesticides” refer to chemical substances or mixtures of such substances, as well as their formulations, that are used to prevent and control diseases, pests, weeds, rodents, and other harmful organisms affecting agriculture and forestry, and to intentionally regulate the growth of plants and insects.

The pesticides specified in the preceding paragraph include the following categories, which are used for different purposes and in various settings:

(1) Prevention and control of diseases, pests (including insects, ticks, and mites), weeds, rodents, mollusks, and other harmful organisms that threaten agriculture and forestry;

(2) Prevent and control diseases, pests, rodents, and other harmful organisms in storage and processing facilities;

(3) Regulates the growth of plants and insects;

(4) Preservation or fresh-keeping of agricultural and forestry products;

(5) Prevention and control of mosquitoes, flies, cockroaches, rodents, and other harmful organisms;

(6) Preventing and controlling harmful organisms that pose threats to river embankments, railways, docks, airports, buildings, and other facilities.

Article 3. The agricultural administrative department under the State Council is responsible for the nationwide supervision and administration of pesticides.

The agricultural administrative departments of local people’s governments at or above the county level are responsible for the supervision and administration of pesticides within their respective administrative areas.

Other relevant departments of people’s governments at or above the county level shall, within the scope of their respective responsibilities, be responsible for the supervision and administration of pesticides.

Article 4: People’s governments at or above the county level shall strengthen organizational leadership over the supervision and administration of pesticides, include funding for such activities in their respective government budgets, and ensure the effective implementation of pesticide supervision and management.

Article 5: Pesticide manufacturers and pesticide operators shall be responsible for the safety and efficacy of the pesticides they produce and market, and shall voluntarily accept government oversight and public scrutiny.

Pesticide manufacturers and pesticide operators shall strengthen industry self-regulation and standardize their production and business practices.

Article 6 The State encourages and supports the research, development, production, and use of safe, efficient, and economical pesticides, promotes the professional application of pesticides, and facilitates the upgrading of the pesticide industry.

Units and individuals that have made outstanding contributions to the research, development, promotion, and supervision and administration of pesticides shall be commended or rewarded in accordance with relevant state regulations.

Chapter 2: Pesticide Registration

Article 7 The State shall implement a pesticide registration system. Pesticide manufacturers and enterprises exporting pesticides to China shall apply for pesticide registration in accordance with the provisions of these Regulations; developers of new pesticides may also apply for pesticide registration pursuant to these Regulations.

The agency under the State Council’s agricultural administrative department responsible for pesticide registration is tasked with the specific implementation of pesticide registration. The agencies under the agricultural administrative departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the central government that are responsible for pesticide registration shall assist in carrying out the specific work of pesticide registration within their respective administrative areas.

Article 8 The agricultural competent department of the State Council shall establish a Pesticide Registration Review Committee, which shall be responsible for the review and evaluation of pesticide registrations.

The Pesticide Registration Review Committee shall be composed of the following members:

(1) Experts in pesticide chemistry, efficacy, toxicology, residue analysis, environmental impact, quality standards, and testing, recommended by the relevant departments of the State Council—namely, those responsible for agriculture, forestry, health, environmental protection, grain, industrial sector management, and work safety supervision—and by organizations such as the All‑China Federation of Supply and Marketing Cooperatives;

(2) Relevant experts from the National Food Safety Risk Assessment Expert Committee;

(3) Representatives from the State Council’s departments responsible for agriculture, forestry, health, environmental protection, grain, industrial sector management, and work safety supervision, as well as from the All-China Federation of Supply and Marketing Cooperatives and other relevant entities.

The rules for the review and approval of pesticide registration are formulated by the agricultural administrative department under the State Council.

Article 9: Applicants for pesticide registration shall conduct registration trials.

Registration trials for pesticides shall be filed with the agricultural administrative department of the people’s government of the province, autonomous region, or municipality directly under the central government where they are conducted.

Article 10. Registration trials shall be conducted by registration trial units recognized by the agricultural administrative department under the State Council, in accordance with the regulations of that department.

Pesticides that have the same active ingredients, intended uses, and application methods as those already registered in China are exempt from residue and environmental testing. However, if such pesticides are still within the data‑protection period specified in Article 15 of these Regulations, authorization and consent from the holder of the pesticide registration certificate shall be obtained.

The registration testing institution shall be responsible for the authenticity of the registration test report.

Article 11: Upon completion of the registration trials, the applicant shall submit a pesticide registration application to the agricultural administrative department of the people’s government of the province, autonomous region, or municipality directly under the central government where the applicant is located, and shall provide the registration trial report, sample labels, and documentation on the quality standards for the pesticide product and its testing methods. For applications for the registration of new pesticides, the applicant shall also furnish reference standards for the pesticide.

The agricultural authorities of the people’s governments of provinces, autonomous regions, and municipalities directly under the central government shall, within 20 working days from the date of accepting the application, submit their preliminary review opinions and forward them to the agricultural authority of the State Council.

Enterprises seeking to export pesticides to China shall, in accordance with the requirements set forth in paragraph 1 of this Article, submit an application to the agricultural administrative department under the State Council, together with the documents specified therein, a reference standard for the pesticide, and supporting documentation demonstrating registration and use in the relevant countries or regions.

Article 12. Upon receipt of an application or of application materials submitted by the agricultural authorities of the people’s governments of provinces, autonomous regions, and municipalities directly under the central government, the agricultural competent department of the State Council shall organize a review and a registration evaluation, and shall render an approval decision within twenty working days from the date of receipt of the evaluation opinions. If the application meets the requirements, a pesticide registration certificate shall be issued; if it does not meet the requirements, the applicant shall be notified in writing, with reasons stated.

Article 13 The pesticide registration certificate shall specify the pesticide’s name, formulation, active ingredients and their content, toxicity, scope of use, methods of application and dosage, the holder of the registration certificate, the registration certificate number, and the period of validity, among other particulars.

The validity period of a pesticide registration certificate is five years. Upon expiration, if the holder intends to continue manufacturing the pesticide or exporting it to China, they shall submit an application for renewal to the agricultural authority under the State Council no later than 90 days before the certificate’s expiration date.

If any of the particulars stated on the pesticide registration certificate are changed, the holder of the certificate shall apply for an amendment to the certificate in accordance with the regulations of the agricultural authority under the State Council.

The agricultural competent department of the State Council shall promptly publish information on the issuance, renewal, and amendment of pesticide registration certificates, as well as relevant details such as the quality standard numbers for pesticide products, maximum residue limits, testing methods, and approved label contents.

Article 14: Developers of new pesticides may transfer the registration data for their newly registered pesticides; pesticide manufacturers may transfer the registration data for their registered pesticides to other pesticide manufacturers possessing the corresponding production capacity.

Article 15 The State shall afford protection to the test data and other data obtained by the applicant and not yet disclosed, which are submitted in connection with a pesticide containing a new compound that has been granted first registration.

Within six years from the date of registration, if another applicant seeks pesticide registration by using the data specified in the preceding paragraph without the consent of the applicant who has already obtained registration, the registration authority shall refuse to grant registration; provided, however, that this shall not apply where the other applicant submits data independently generated by itself.

Except in the following circumstances, the registration authority shall not disclose the data specified in paragraph 1 of this Article:

(1) Necessary for the public interest;

(2) Measures have been taken to ensure that such information will not be improperly used for commercial purposes.

Chapter 3: Pesticide Production

Article 16: The production of pesticides shall comply with the state’s industrial policies. The state encourages and supports pesticide manufacturers in adopting advanced technologies and management practices to enhance the safety and efficacy of pesticides.

Article 17 The State shall implement a licensing system for the production of pesticides. Pesticide manufacturers shall meet the following conditions and, in accordance with the provisions of the agricultural competent department under the State Council, apply to the agricultural competent department of the people’s government of the province, autonomous region, or directly administered municipality for a pesticide production license:

(1) Possess technical personnel commensurate with the pesticide being applied for production;

(2) Possess production facilities and premises suitable for the pesticide being applied for.

(3) Possession of personnel, instruments, and equipment for quality management and quality inspection of the pesticide being applied for.

(4) Possession of regulations and procedures to ensure the quality of the pesticide being applied for.

The agricultural authorities of the people’s governments of provinces, autonomous regions, and municipalities directly under the central government shall, within 20 working days from the date of receipt of the application, render an approval decision; where necessary, on-site inspections shall be conducted. If the applicant meets the requirements, a pesticide production license shall be issued; if not, the applicant shall be notified in writing, with reasons provided.

Where laws and administrative regulations on work safety, environmental protection, and other matters impose additional requirements on enterprises’ production conditions, pesticide manufacturers shall also comply with such provisions.

Article 18. A pesticide production license shall specify the name of the pesticide manufacturing enterprise, its domicile, the legal representative (person in charge), the scope of production, the production address, and the validity period, among other particulars.

The pesticide production license is valid for a period of five years. Upon expiration, if the pesticide manufacturer intends to continue production, it shall submit an application for renewal to the agricultural administrative department of the people’s government of the province, autonomous region, or municipality directly under the central government no later than 90 days before the license expires.

If any of the particulars stated on a pesticide production license change, the pesticide manufacturer shall apply for an amendment to the license in accordance with the regulations of the agricultural authority under the State Council.

Article 19 Where pesticides are entrusted for processing or repackaging, the entrusting party shall obtain the corresponding pesticide registration certificate, and the entrusted party shall obtain a pesticide production license.

The consignor shall be responsible for the quality of the pesticides entrusted for processing or repackaging.

Article 20: Pesticide manufacturers shall, when procuring raw materials, verify the certificates of product quality inspection and relevant licensing documents, and shall not procure or use any raw materials that, in accordance with law, are not accompanied by a certificate of product quality inspection or have not obtained the requisite licensing documents.

Pesticide manufacturers shall establish a system for recording raw material purchases, accurately documenting the name of each raw material, the relevant license or certification document numbers, specifications, quantities, the supplier’s name and contact information, as well as the date of purchase. Such records shall be retained for a period of no less than two years.

Article 21: Pesticide manufacturers shall strictly adhere to product quality standards in the course of production, ensuring that their pesticide products are consistent with the registered formulations. Before being released for sale, pesticides must pass quality inspection and be accompanied by a certificate of compliance.

Pesticide manufacturers shall establish a system for maintaining records of pesticide sales upon leaving the factory, accurately documenting the pesticide’s name, specifications, quantity, date and batch number of manufacture, product quality inspection information, the purchaser’s name and contact details, and the date of sale. Such records shall be retained for a period of no less than two years.

Article 22: Pesticide packaging shall comply with relevant national regulations and shall be printed with or affixed with labels. The State encourages pesticide manufacturers to use recyclable pesticide packaging materials.

Pesticide labels shall, in accordance with the regulations of the agricultural authority under the State Council, bear in Chinese the pesticide’s name, formulation, active ingredients and their concentrations, toxicity and corresponding hazard symbols, scope of use, methods and dosage of application, technical requirements and precautions for use, date of manufacture, and traceability electronic information code, among other required information.

Labels for restricted-use pesticides, including highly toxic and acutely toxic pesticides as well as other pesticides subject to stringent application requirements, must also bear the words “Restricted Use” and specify any special restrictions and particular requirements for their use. Labels for pesticides used on food crops must additionally indicate the pre-harvest interval.

Article 23: Pesticide manufacturers shall not, without authorization, alter the content of pesticide labels that have been approved, nor shall they include on such labels any false or misleading information that could mislead users.

If the packaging of a pesticide is too small to accommodate all required label information, an accompanying leaflet shall be provided, and the content of such leaflet shall be consistent with the approved label.

Chapter 4: Pesticide Business Operations

Article 24 The State shall implement a licensing system for the operation of pesticides, except for those used for public health purposes. Pesticide operators shall meet the following conditions and, in accordance with the regulations of the agricultural competent department under the State Council, apply to the agricultural competent department of the local people’s government at or above the county level for a pesticide business license:

(1) Employ personnel who possess specialized knowledge of pesticides and pest and disease control, are familiar with pesticide management regulations, and are capable of providing guidance on the safe and rational use of pesticides;

(2) Possess business and storage premises that are effectively segregated from other commodities, drinking water sources, residential areas, and other such facilities, and be equipped with protective measures appropriate to the pesticides for which operation is being applied;

(3) Possess systems for quality management, record-keeping, safety protection, emergency response, and storage management that are commensurate with the pesticides being applied for.

Operators engaging in the sale of restricted-use pesticides shall also employ qualified personnel to provide guidance on pesticide application and pest‑and‑disease control, and shall conduct their business at designated locations in accordance with the regulations issued by the agricultural authorities of the people’s governments of the relevant provinces, autonomous regions, or municipalities directly under the central government.

The agricultural administrative department of the people’s government at or above the county level shall, within 20 working days from the date of receipt of the application, make an approval decision. If the applicant meets the requirements, a pesticide business license shall be issued; if not, the applicant shall be notified in writing with an explanation of the reasons.

Article 25: A pesticide business license shall specify the name of the pesticide operator, its domicile, the person in charge, the scope of business, and the validity period, among other particulars.

The pesticide business license is valid for a period of five years. Upon expiration, if the operator intends to continue engaging in the pesticide business, they shall submit an application for renewal to the issuing authority no later than 90 days before the license expires.

If any of the particulars stated on a pesticide business license change, the pesticide operator shall apply for an amendment to the license in accordance with the regulations of the agricultural authority under the State Council.

Where a pesticide business operator holding a pesticide business license establishes a branch, it shall, in accordance with the law, apply for an amendment to its pesticide business license and file such amendment with the agricultural administrative department of the local people’s government at or above the county level where the branch is located; the branch shall be exempt from obtaining a separate pesticide business license. The pesticide business operator shall be responsible for the business activities of its branch.

Article 26: When purchasing pesticides, pesticide operators shall verify the product packaging, labels, certificates of product quality inspection, and relevant licensing documents. They shall not purchase pesticides from pesticide manufacturers that have not obtained a pesticide production license or from other pesticide operators that have not obtained a pesticide business license.

Pesticide operators shall maintain a procurement ledger, accurately recording the pesticide’s name, the relevant license‑certificate numbers, specifications, quantities, the manufacturer’s name and address, the supplier’s name and contact information, as well as the date of purchase. The procurement ledger shall be retained for no less than two years.

Article 27: Pesticide operators shall maintain sales records, accurately documenting the name, specification, quantity, manufacturer, purchaser, and date of sale of each pesticide. Such records shall be retained for a period of no less than two years.

Pesticide operators shall inquire with purchasers about the occurrence of pests and diseases and provide scientifically sound recommendations on pesticide use. When necessary, they shall conduct on-site inspections to assess the pest and disease situation and accurately explain the pesticide’s scope of application, methods of use, dosage, technical requirements, and precautions, and shall not mislead purchasers.

The provisions of paragraphs 1 and 2 of this Article shall not apply to those engaged in the business of sanitary pesticides.

Article 28: Pesticide operators shall not engage in the processing or repackaging of pesticides, nor shall they add any substances to pesticides. They shall not purchase or sell pesticides whose packaging and labeling do not comply with the relevant regulations, that are not accompanied by a certificate of product quality inspection, or for which the requisite permits and supporting documentation have not been obtained.

Operators of sanitary pesticides shall display such products in separate cabinets from other goods; operators of other types of pesticides shall not sell food, edible agricultural products, feed, or similar items within their pesticide retail premises.

Article 29: Foreign enterprises shall not directly sell pesticides in China. Where a foreign enterprise seeks to sell pesticides in China, it shall, in accordance with the law, establish a sales entity in China or entrust a qualified Chinese agency to handle such sales.

Pesticides exported to China shall be accompanied by Chinese-language labels and instructions, comply with product quality standards, and have been duly inspected and certified as compliant by the entry‑exit inspection and quarantine authorities in accordance with the law. The import of pesticides that have not obtained a pesticide registration certificate is prohibited.

When handling customs declaration procedures for the import and export of pesticides, the relevant supporting documents shall be presented in accordance with the regulations of the General Administration of Customs.

Chapter 5: Pesticide Use

Article 30: The agricultural administrative departments of people’s governments at or above the county level shall strengthen guidance and services related to the use of pesticides, establish and improve systems for the safe and rational use of pesticides, and, in accordance with the principles of prevention first and integrated pest management, organize the promotion of scientific pesticide‑use technologies and standardize pesticide‑application practices. The forestry, grain, and health authorities shall enhance technical guidance on the safe and rational use of pesticides in forestry, grain storage, and public health applications, while the environmental protection authorities shall strengthen technical guidance on environmental protection and pollution prevention during pesticide use.

Article 31: The agricultural administrative department of the county-level people’s government shall organize institutions engaged in plant protection and agricultural technology extension to provide pesticide users with free technical training, thereby enhancing the safe and rational use of pesticides.

The State encourages agricultural research institutions, relevant schools, farmer specialized cooperatives, supply and marketing cooperatives, agricultural social service organizations, and professional personnel to provide technical services to pesticide users.

Article 32: The State shall, through the promotion of biological control, physical control, and advanced pesticide application equipment, progressively reduce the use of pesticides.

The people’s government at the county level shall formulate and implement a pesticide‑reduction plan for its administrative area; it shall provide encouragement and support to pesticide users who implement such a plan or voluntarily reduce their pesticide usage.

The agricultural administrative department of the county-level people’s government shall encourage and support the establishment of specialized pest and disease control service organizations, and provide guidance, standardization, and management for the preparation and application of restricted‑use pesticides in professional pest and disease control, thereby enhancing the overall level of pest and disease management.

The agricultural administrative department of the county-level people’s government shall guide pesticide users to implement planned rotational use of pesticides, thereby mitigating the development of resistance in pests, diseases, weeds, rodents, and other harmful organisms that threaten agriculture and forestry.

The people’s governments of townships and towns shall assist in providing guidance and services related to the use of pesticides.

Article 33 Pesticide users shall comply with the State’s regulations on the safe and rational use of pesticides, properly store pesticides, and take necessary protective measures during the preparation and application of pesticides to prevent pesticide‑related accidents.

Operators restricted from using pesticides shall provide users with guidance on pesticide application and progressively offer standardized application services.

Article 34: Pesticide users shall strictly adhere to the scope of use, application methods and dosages, technical requirements, and precautions indicated on the pesticide label, and shall not expand the scope of use, increase the dosage, or alter the application method.

Pesticide users shall not use prohibited pesticides.

Pesticides labeled with a pre-harvest interval shall not be used after the specified interval has elapsed prior to harvesting the agricultural product.

Highly toxic and acutely toxic pesticides shall not be used for the control of public health pests, nor shall they be applied in the production of vegetables, melons, fruits, tea, mushrooms, or traditional Chinese medicinal materials, nor shall they be used for the management of plant diseases and pests in aquatic plants.

Article 35 Pesticide users shall protect the environment and safeguard beneficial organisms and endangered species, and shall not discard pesticides, pesticide packaging, or rinse pesticide application equipment within drinking water source protection zones or in river channels.

The use of pesticides within drinking water source protection zones is strictly prohibited, as is the use of pesticides to poison fish, shrimp, birds, and other wildlife.

Article 36: Agricultural product production enterprises, food and edible agricultural product storage enterprises, specialized pest and disease control service organizations, and farmer professional cooperatives engaged in agricultural production shall maintain records of pesticide use, accurately documenting the time, location, target crops or pests, as well as the pesticide’s name, dosage, and manufacturer. Such records shall be retained for a period of no less than two years.

The state encourages other pesticide users to maintain records of pesticide use.

Article 37 The State encourages users of pesticides to properly collect pesticide packaging and other waste; pesticide manufacturers and operators shall recover such waste to prevent environmental pollution and incidents of pesticide poisoning. Specific measures shall be formulated by the environmental protection authority under the State Council, in conjunction with the agricultural authorities and the financial authorities under the State Council, among other relevant departments.

Article 38: In the event of a pesticide-use accident, the pesticide user, the pesticide manufacturer, the pesticide retailer, and other relevant parties shall promptly report to the local agricultural administrative department.

Upon receiving a report, the competent agricultural authority shall immediately take measures to prevent the incident from escalating and shall notify the relevant departments to implement appropriate responses. In cases of pesticide poisoning, the agricultural authority and the public security organs shall, in accordance with their respective duties and powers, organize investigations and handle the matter; the health authority shall, in compliance with applicable national regulations, promptly arrange medical treatment for those who have sustained injuries. For incidents resulting in environmental pollution, the environmental protection authorities and other competent departments shall, in accordance with the law, conduct investigations and take appropriate measures. As for accidents involving the use of grain‑storage agents or phytotoxicity incidents affecting crops, technical appraisals and investigations shall be organized by the departments responsible for grain administration and agriculture, respectively.

Article 39. In cases of urgent need, such as the prevention and control of sudden and major plant pests and diseases, the agricultural competent department under the State Council may decide to permit the temporary production and use of specified quantities of pesticides that have not been registered or are prohibited or subject to restricted use. Where necessary, it shall, in conjunction with the foreign trade competent department under the State Council, decide to impose temporary restrictions on the export or import of specified quantities and varieties of pesticides.

Pesticides specified in the preceding paragraph shall be used under the supervision and guidance of the agricultural administrative department of the people’s government at the county level in the place of use.

Chapter VI Supervision and Administration

Article 40: The agricultural administrative departments of people’s governments at or above the county level shall, on a regular basis, conduct surveys and compile statistics on the production, sale, and use of pesticides, and promptly notify the relevant departments of their respective people’s governments.

The agricultural administrative departments of local people’s governments at or above the county level shall establish and publicly disclose integrity records for pesticide production and business operations; if they discover acts of illegal pesticide production or operation that are suspected of constituting a crime, they shall, in accordance with law, refer such cases to public security organs for investigation and handling.

Article 41. The agricultural administrative departments of people’s governments at or above the county level, in performing their duties of pesticide supervision and administration, may, in accordance with law, adopt the following measures:

(1) Conduct on-site inspections at premises engaged in the production, distribution, or use of pesticides;

(2) Conduct random inspections and tests on pesticides used in production, business operations, and application;

(3) Conduct inquiries with relevant personnel to ascertain the pertinent facts;

(4) Inspect and duplicate contracts, negotiable instruments, accounting books, and other relevant documents;

(5) Seize and impound pesticides that are illegally produced, marketed, or used, as well as tools, equipment, raw materials, and other items used in the illegal production, marketing, or use of such pesticides;

(6) Seize premises engaged in the illegal production, operation, or use of pesticides.

Article 42 The State shall establish a pesticide recall system. If a pesticide manufacturer discovers that its products pose a serious hazard or significant risk to agriculture, forestry, human and animal health, the quality and safety of agricultural products, or the ecological environment, it shall immediately cease production, notify relevant operators and users, report to the competent agricultural authority in its locality, proactively recall the products, and keep records of such notifications and recalls.

If a pesticide operator discovers that the pesticides it handles fall under any of the circumstances specified in the preceding paragraph, it shall immediately cease sales, notify the relevant manufacturer, supplier, and purchaser, report to the local agricultural administrative authority, and keep records of the cessation of sales and the notification.

If a pesticide user discovers that the pesticide they are using falls under the circumstances specified in paragraph 1 of this Article, they shall immediately cease its use, notify the seller, and report the matter to the local agricultural administrative authority.

Article 43 The agricultural administrative department of the State Council and the agricultural administrative departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the central government shall organize the institutions responsible for pesticide registration and plant protection to monitor the safety and efficacy of registered pesticides.

If it is found that a registered pesticide poses serious harm or significant risks to agriculture, forestry, human and animal health, the quality and safety of agricultural products, or the ecological environment, the agricultural authority under the State Council shall convene the Pesticide Registration Review Committee to conduct a review. Based on the review results, the relevant pesticide registration certificates shall be revoked or amended, and, where necessary, a decision shall be made to prohibit or restrict its use, with public notice thereof.

Article 44: Any of the following circumstances shall be deemed to constitute counterfeit pesticides:

(1) Falsely representing non‑pesticides as pesticides;

(2) Impersonating one type of pesticide as another;

(3) The types of active ingredients contained in the pesticide do not match those listed on the pesticide’s label and in its instructions.

Pesticides that are prohibited, pesticides manufactured or imported without a legally obtained pesticide registration certificate, and pesticides not accompanied by labels shall be treated as counterfeit pesticides.

Article 45: Pesticides shall be deemed substandard if any of the following circumstances apply:

(1) Does not comply with the quality standards for pesticide products;

(2) Contaminated with harmful substances that may cause phytotoxicity or other adverse effects.

Pesticides that have exceeded their quality‑guarantee period shall be treated as substandard pesticides.

Article 46: Fake pesticides, substandard pesticides, and recovered pesticide waste shall be handed over to entities holding qualifications for the management of hazardous waste for centralized disposal; the disposal costs shall be borne by the relevant pesticide manufacturers and pesticide operators. If the pesticide manufacturer or operator cannot be identified, the disposal costs shall be covered by the fiscal budget of the county-level people’s government where the matter occurs.

Article 47: It is prohibited to forge, alter, transfer, lease, or lend license documents such as pesticide registration certificates, pesticide production licenses, and pesticide business licenses.

Article 48: The agricultural administrative departments of people’s governments at or above the county level, together with their staff, as well as the institutions and their staff responsible for pesticide registration and testing, shall not engage in any pesticide production or business activities.

Chapter VII Legal Liability

Article 49: If the agricultural administrative departments of people’s governments at or above the county level and their staff members engage in any of the following acts, they shall be ordered by the people’s government at the same level to make corrections; responsible leading personnel and directly responsible personnel shall be subject to disciplinary sanctions in accordance with the law; if such responsible leading personnel or directly responsible personnel commit a crime, they shall be investigated for criminal liability in accordance with the law.

(1) Failure to perform supervisory and administrative duties, resulting in significant losses or severe adverse social repercussions due to illegal pesticide production and business activities within the jurisdiction;

(2) Granting a license to an applicant who does not meet the requirements, or refusing to grant a license to an applicant who does meet the requirements;

(3) Engaging in the production or business operations of pesticides;

(4) Engaging in other acts of favoritism, fraud, abuse of power, or dereliction of duty.

Article 50: If any member of the Pesticide Registration Review Committee seeks improper benefits in the course of pesticide registration review, the agricultural administrative department under the State Council shall remove such member from the committee; if the individual is a state functionary, disciplinary action shall be imposed in accordance with law; and if the conduct constitutes a crime, criminal liability shall be pursued in accordance with law.

Article 51: If a registration testing institution issues a false registration testing report, the agricultural administrative department of the people’s government of the province, autonomous region, or municipality directly under the central government shall confiscate the illegal gains and impose a fine of no less than RMB 50,000 but no more than RMB 100,000; the agricultural administrative department of the State Council shall remove the institution from the register of registration testing institutions and shall not accept any application for recognition as a registration testing institution submitted by it for a period of five years; if the act constitutes a crime, criminal liability shall be pursued in accordance with the law.

Article 52: Any entity that produces pesticides without a pesticide production license or produces counterfeit pesticides shall, upon order of the agricultural administrative department of the people’s government at or above the county level, cease production; its illegal gains, illegally produced products, and the tools, equipment, raw materials, and other items used in such illegal production shall be confiscated. If the value of the illegally produced products is less than RMB 10,000, a fine of not less than RMB 50,000 but not more than RMB 100,000 shall be imposed; if the value exceeds RMB 10,000, a fine of not less than ten times but not more than twenty times the value of the products shall be imposed. The licensing authority shall revoke the pesticide production license and the corresponding pesticide registration certificate. Where the conduct constitutes a crime, criminal liability shall be pursued in accordance with the law.

If a pesticide manufacturer holding a pesticide production license fails to meet the prescribed conditions and continues to produce pesticides, the agricultural administrative department of the local people’s government at or above the county level shall order it to make rectifications within a specified time limit; if it refuses to comply after the deadline or remains non‑compliant even after rectification, the licensing authority shall revoke its pesticide production license.

Where a pesticide manufacturer produces substandard pesticides, the agricultural administrative department of the local people’s government at or above the county level shall order it to cease production, confiscate the illegal gains, the illegally produced products, and the tools, equipment, raw materials, and other items used in the illegal production. If the value of the illegally produced products is less than RMB 10,000, a fine of not less than RMB 10,000 but not more than RMB 50,000 shall be imposed; if the value exceeds RMB 10,000, a fine of not less than five times but not more than ten times the value of the products shall be imposed. In cases of serious circumstances, the licensing authority shall revoke the pesticide production license and the corresponding pesticide registration certificate; if the conduct constitutes a crime, criminal liability shall be pursued in accordance with the law.

Anyone who entrusts a processor without a pesticide production license to manufacture or repackage pesticides, or who entrusts the manufacture or repackaging of counterfeit or substandard pesticides, shall have both the principal and the processor penalized in accordance with the provisions of Paragraph 1 and Paragraph 3 of this Article.

Article 53: If a pesticide manufacturing enterprise engages in any of the following acts, the agricultural administrative department of the local people’s government at or above the county level shall order it to make corrections, confiscate the illegal gains, the illegally produced products, and the raw materials used in the illegal production; where the value of the illegally produced products is less than RMB 10,000, a fine of not less than RMB 10,000 but not more than RMB 20,000 shall be imposed; where the value exceeds RMB 10,000, a fine of not less than twice but not more than five times the value of the products shall be imposed. If the enterprise refuses to make corrections or the circumstances are serious, the licensing authority shall revoke its pesticide production license and the corresponding pesticide registration certificate.

(1) Procuring or using raw materials that, in accordance with the law, are not accompanied by a certificate of product quality inspection or have not obtained the relevant permits and certificates.

(2) Selling pesticides at the factory that have not passed quality inspection and do not bear a certificate of product quality compliance;

(3) The packaging, labels, and instructions for the pesticides produced do not comply with the relevant regulations;

(4) Failure to recall pesticides that are required by law to be recalled.

Article 54: If a pesticide manufacturer fails to implement the systems for recording the procurement of raw materials and the sale of pesticides upon leaving the factory, or fails to fulfill its obligation to collect and recycle pesticide waste, the agricultural administrative department of the local people’s government at or above the county level shall order it to make corrections and impose a fine of no less than RMB 10,000 but no more than RMB 50,000. If the manufacturer refuses to make corrections or if the circumstances are serious, the licensing authority shall revoke its pesticide production license and the corresponding pesticide registration certificate.

Article 55: Where a pesticide operator engages in any of the following acts, the agricultural administrative department of the people’s government at or above the county level shall order it to cease operations, confiscate the illegal gains, the pesticides illegally traded, and the tools and equipment used in such illegal activities. If the value of the illegally traded pesticides is less than RMB 10,000, a fine of not less than RMB 5,000 but not more than RMB 50,000 shall be imposed; if the value exceeds RMB 10,000, a fine of not less than five times but not more than ten times the value of the goods shall be imposed. Where the conduct constitutes a crime, criminal liability shall be pursued in accordance with the law.

(1) Operating a pesticide business without obtaining a pesticide business license in violation of the provisions of these Regulations;

(2) Operating counterfeit pesticides;

(3) Adding substances to pesticides.

Where the acts specified in subparagraphs (2) and (3) of the preceding paragraph are of a serious nature, the licensing authority shall also revoke the pesticide business license.

If a pesticide operator holding a pesticide business license no longer meets the prescribed conditions but continues to engage in pesticide business, the agricultural administrative department of the local people’s government at or above the county level shall order it to make rectifications within a specified time limit; if it refuses to rectify upon expiration of the deadline or remains non‑compliant after rectification, the licensing authority shall revoke its pesticide business license.

Article 56: Where a pesticide operator engages in the sale of substandard pesticides, the agricultural administrative department of the people’s government at or above the county level shall order it to cease operations, confiscate the illegal gains, the illegally sold pesticides, and the tools and equipment used in such illegal activities. If the value of the illegally sold pesticides is less than RMB 10,000, a fine of not less than RMB 2,000 but not more than RMB 20,000 shall be imposed; if the value exceeds RMB 10,000, a fine of not less than twice but not more than five times the value of the illegally sold pesticides shall be imposed. In cases of serious circumstances, the licensing authority shall revoke the pesticide business license; if the conduct constitutes a crime, criminal liability shall be pursued in accordance with the law.

Article 57: Where a pesticide operator engages in any of the following acts, the agricultural administrative department of the local people’s government at or above the county level shall order it to make corrections, confiscate the illegal gains and the pesticides illegally traded, and impose a fine of no less than RMB 5,000 but no more than RMB 50,000; if the operator refuses to make corrections or the circumstances are serious, the licensing authority shall revoke its pesticide business license.

(1) Establishing a branch without legally amending the pesticide business license, or failing to file with the agricultural administrative department of the local people’s government at or above the county level where the branch is located;

(2) Purchasing pesticides from pesticide manufacturers that have not obtained a pesticide production license or from other pesticide operators that have not obtained a pesticide business license;

(3) Purchasing or selling pesticides that are not accompanied by a certificate of product quality inspection, or whose packaging and labeling do not comply with the relevant regulations;

(4) Failure to cease the sale of pesticides that are legally required to be recalled.

Article 58: If a pesticide operator engages in any of the following acts, the agricultural administrative department of the local people’s government at or above the county level shall order it to make corrections; if it refuses to correct such acts or the circumstances are serious, it shall be imposed a fine of no less than RMB 2,000 and no more than RMB 20,000, and the licensing authority shall revoke its pesticide business license:

(1) Failure to implement the pesticide procurement ledger and sales ledger systems;

(2) Operating food, edible agricultural products, feed, and other such items within pesticide business premises that are not designated for sanitary-use pesticides;

(3) Hygienic pesticides were not sold in separate cabinets from other products;

(4) Failure to fulfill the obligation to collect and recycle pesticide waste.

Article 59: Where an overseas enterprise directly sells pesticides in China, the agricultural administrative department of the local people’s government at or above the county level shall order it to cease sales, confiscate the illegal gains, the illegally traded pesticides, and the tools and equipment used in such illegal activities. If the value of the illegally traded pesticides is less than RMB 50,000, a fine of not less than RMB 50,000 but not more than RMB 500,000 shall be imposed; if the value exceeds RMB 50,000, a fine of not less than ten times but not more than twenty times the value of the goods shall be imposed, and the pesticide registration certificate shall be revoked by the issuing authority.

If a foreign enterprise that has obtained a pesticide registration certificate exports substandard pesticides under serious circumstances or exports counterfeit pesticides, the agricultural authority under the State Council shall revoke the corresponding pesticide registration certificate.

Article 60: Where a pesticide user engages in any of the following acts, the agricultural administrative department of the people’s government at the county level shall order rectification. If the pesticide user is an agricultural product production enterprise, a food and edible agricultural product storage enterprise, a specialized pest and disease control service organization, or a farmer professional cooperative engaged in agricultural production, a fine of no less than RMB 50,000 but no more than RMB 100,000 shall be imposed; if the pesticide user is an individual, a fine of no more than RMB 10,000 shall be imposed. Where the conduct constitutes a crime, criminal liability shall be pursued in accordance with the law.

(1) Using pesticides in a manner that does not comply with the label‑specified scope of use, application methods and dosages, technical requirements, precautions, or pre‑harvest intervals;

(2) Use of prohibited pesticides;

(3) Using highly toxic or acutely toxic pesticides for the control of public health pests, for the production of vegetables, melons, fruits, tea, fungi, or Chinese medicinal herbs, or for the control of diseases and pests in aquatic plants;

(4) The use of pesticides within drinking water source protection zones;

(5) Using pesticides to poison fish, shrimp, birds, animals, and other organisms;

(6) Disposing of pesticides, pesticide packaging, or washing application equipment within drinking water source protection zones or in river channels.

Where the conduct specified in paragraph 2 of the preceding clause is found, the agricultural administrative department of the people’s government at the county level shall also confiscate the prohibited pesticides.

Article 61: Agricultural product producers, food and edible agricultural product storage enterprises, specialized pest and disease control service organizations, and farmer professional cooperatives engaged in agricultural production that fail to implement the pesticide use record‑keeping system shall be ordered by the agricultural administrative department of the people’s government at the county level to make corrections; if they refuse to correct or the circumstances are serious, they shall be subject to a fine of no less than RMB 2,000 and no more than RMB 20,000.

Article 62: Anyone who forges, alters, transfers, leases, or lends permits such as pesticide registration certificates, pesticide production licenses, or pesticide business licenses shall have the relevant permits confiscated or revoked by the issuing authority, have their illegal gains confiscated, and be subject to a fine of no less than RMB 10,000 but no more than RMB 50,000. If the act constitutes a crime, criminal liability shall be pursued in accordance with the law.

Article 63: Any entity that produces pesticides without a pesticide production license, engages in the sale of pesticides without a pesticide business license, or has its pesticide registration certificate, pesticide production license, or pesticide business license revoked shall prohibit its directly responsible principal personnel from engaging in pesticide production or business activities for a period of ten years.

If a pesticide manufacturer or pesticide operator employs any of the personnel specified in the preceding paragraph to engage in pesticide production or business activities, the licensing authority shall revoke its pesticide production license and pesticide business license.

Where a pesticide registration certificate has been revoked, the agricultural authority under the State Council shall not accept any further pesticide registration applications from the same applicant for a period of five years.

Article 64: If pesticides produced or marketed cause personal injury or property damage to users, the users may seek compensation from either the pesticide manufacturer or the pesticide retailer. Where the liability lies with the pesticide manufacturer, the retailer, after making compensation, shall have the right to seek recourse from the manufacturer; where the liability lies with the retailer, the manufacturer, after making compensation, shall have the right to seek recourse from the retailer.

Chapter VIII Supplementary Provisions

Article 65: Applicants seeking pesticide registration shall, in accordance with the principle of voluntary and paid services, negotiate with the registration testing institution to determine the fees for registration testing.

Article 66 This Regulation shall come into force on June 1, 2017.