Regulation on Pesticide Administration (2022 Revision)

Regulation on Pesticide Administration (2022 Revision)

(Issued by Order No. 216 of the State Council of the People's Republic of China on May 8, 1997; revised for the first time according to the Decision of the State Council on Amending the Regulation on Pesticide Administration on November 29, 2001, and revised and adopted at the 164th executive meeting of the State Council on February 8, 2017; and revised for the second time according to the Decision of the State Council to Amend and Repeal Certain Administrative Regulations on March 29, 2022)

Chapter I General Provisions

Article 1 This Regulation is developed for the purposes of strengthening the administration of pesticides, ensuring the quality of pesticides, guaranteeing the quality safety of agricultural products as well as the safety of people and livestock, and protecting agriculture and forestry production and ecological environment.

Article 2 For the purpose of this Regulation, “pesticides” means any substance or a mixture of substances chemically synthesized or originating from biological and other natural substances and their preparations used for preventing or controlling diseases, pests, weeds, rats and other harmful organisms endangering agriculture and forestry and for purposefully regulating the growth of plants and insects.

“Pesticides” as prescribed in the preceding paragraph shall be used for different purposes and in different places as follows:

(1)Preventing or controlling diseases, pests (including insects, ticks and mites), weeds, rats, mollusks and other harmful organisms endangering agriculture and forestry.

(2) Preventing or controlling diseases, pests, rats and other harmful organisms at storage and processing places.

(3) Regulating the growth of plants and insects.

(4) Preventing the corrosion of or keeping fresh agricultural and forest products.

(5) Preventing or controlling mosquitoes, flies, cockroaches, rats and other harmful organisms.

(6) Preventing or controlling the harmful organisms endangering river dams, railroads, docks, airports, buildings and other places.

Article 3 The competent agricultural department of the State Council shall take charge of the supervision and administration of pesticides nationwide.

The competent agricultural departments of the local people's governments at or above the county level shall take charge of the supervision and administration of pesticides within their respective administrative regions.

Other relevant departments of the people's governments at or above the county level shall take charge of the relevant supervision and administration of pesticides within the scope of their respective functions.

Article 4 The local people's governments at or above the county level shall strengthen the organization and leadership of the supervision and administration of pesticides, and include pesticide supervision and administration expenditures in the budgets of governments at the same level, so as to guarantee the implementation of the supervision and administration of pesticides.

Article 5 Pesticide production enterprises and pesticide operators shall be responsible for the safety and effectiveness of the pesticides they produce and distribute, and consciously accept the government supervision and social supervision.

Pesticide production enterprises and pesticide operators shall strengthen self-regulation, and regulate production and operation.

Article 6 The state shall encourage and support the development, production and use of safe, highly effective and economical pesticides, boost the specialized use of pesticides, and promote the upgrading of the pesticide industry.

The entities and individuals that have made outstanding contributions during the development, promotion, and supervision and administration of pesticides and other work shall be commended or rewarded in accordance with the relevant provisions of the state.

Chapter II Pesticide Registration

Article 7 The state shall implement the pesticide registration system. Pesticide production enterprises and enterprises that export pesticides to China shall apply for pesticide registration in accordance with the provisions of this Regulation, and new pesticide developers may apply for pesticide registration in accordance with the provisions of this Regulation.

The institution in charge of pesticide testing subordinated to the competent agricultural department of the State Council shall take charge of the specific work of pesticide registration. The institutions in charge of pesticide testing subordinated to the competent agricultural departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall give assistance in effectively conducting the specific work of pesticide registration within their respective administrative regions.

Article 8 The competent agricultural department of the State Council shall form the pesticide registration review committee which takes charge of pesticide registration review.

The pesticide registration review committee shall consist of the following:

(1) The experts of pesticide product chemical, efficacy, toxicology, residues, environment, quality standards and testing, among others, recommended by the departments of agriculture, forestry, sanitation, environmental protection, grains, industrial administration, and work safety supervision and administration, and other relevant departments of the State Council, All-China Federation of Supply and Marketing Cooperatives and other entities.

(2) Relevant experts of the National Expert Committee for Food Safety Risk Assessment.

(3) Representatives of the departments of agriculture, forestry, sanitation, environmental protection, grains, industrial administration, and work safety supervision and administration and other relevant departments of the State Council, All-China Federation of Supply and Marketing Cooperatives and other entities.

The review rules on pesticide registration shall be developed by the competent agricultural department of the State Council.

Article 9 An applicant for pesticide registration shall conduct registration testing.

The registration testing of pesticides shall be reported to the competent agricultural department of the people's government of the province, autonomous region or municipality directly under the Central Government at the place where the applicant is located for recordation.

Article 10 Registration testing shall be conducted by the registration testing entity determined by the competent agricultural department of the State Council in accordance with the provisions of the competent agricultural department of the State Council.

The pesticides identical with those that have obtained the China pesticide registration certificates in terms of the composition, use scope and use methods shall be exempt from being subject to residue and environmental testing; but if the pesticides that have obtained the China pesticide registration certificates are during the registration material protection period as prescribed in Article 15 of this Regulation, the authorization and consent of the pesticide registration certificate holders shall be obtained.

Registration testing entities shall be responsible for the authenticity of the registration test reports.

Article 11 After the conclusion of registration testing, an applicant shall file an application for pesticide registration with the competent agricultural department of the people's governments of the province, autonomous region or municipality directly under the Central Government at the place where it is located and submit the registration testing report, label sample and pesticide product quality standard and its inspection methods and other application materials. Where an application for the registration of a new pesticide is made, the standard sample of the pesticide shall be provided.

The competent agricultural department of the people's governments of the province, autonomous region or municipality directly under the Central Government shall, within 20 working days as of the acceptance of the application, put forward the preliminary examination opinions and submit them to the competent agricultural department of the State Council.

Where an enterprise that exports pesticides to China applies for pesticide registration, it shall, upon the strength of the materials and the standard sample of the pesticide as prescribed in paragraph 1 of this Article, and the certification materials registered and used in the relevant country (region), file an application with the competent agricultural department of the State Council.

Article 12 The competent agricultural department of the State Council shall, after accepting an application or receiving the application materials submitted by the competent agricultural department of the people's government of the province, autonomous region or municipality directly under the Central Government, organize examination and registration review, and make an approval or disapproval decision within 20 working days as of receipt of the review opinions. Where the application meets the conditions, the pesticide registration certificate shall be issued; or where the applicant fails to meet the conditions, the applicant shall be notified in writing and the reasons therefor shall be given.

Article 13 A pesticide registration certificate shall specify the pesticide name, dosage form, active ingredients and their contents, toxicity, use scope, use method and dosage, registration certificate holder, registration certificate number and period of validity and other matters.

A pesticide registration certificate shall be valid for five years. Where, after the expiration of the period of validity, it is necessary to continue the production of pesticides or export pesticides to China, the pesticide registration certificate holder shall, 90 days before the expiration of the period of validity,apply to the competent agricultural department of the State Council for the renewal thereof.

Where any matter specified on a pesticide registration certificate changes, the pesticide registration certificate holder shall apply for modifying the pesticide registration certificate in accordance with the provisions of the competent agricultural department of the State Council.

The competent agricultural department of the State Council shall announce in a timely manner the information on the issuance, renewal and modification of the pesticide registration certificate and the quality standard number of the relevant pesticide product, residue limit provisions, inspection methods, approved label and other information.

Article 14 A new pesticide developer may transfer the registration materials on the new pesticides for which it has obtained the registration certificate; and the pesticide production enterprise may transfer to another pesticide production enterprise with the corresponding production capacity the registration materials on the pesticides for which it has obtained the registration certificate.

Article 15 The state shall protect the testing data and other data submitted by an applicant for the pesticide for which the registration certificate has been obtained for the first time or which contains new compounds, which is obtained by the applicant itself and has not been disclosed.

Where, within six years from the date of registration, another applicant applies for pesticide registration with the data as prescribed in the preceding paragraph without the consent of the applicant that has obtained the registration certificate, the registration authority shall not grant registration, except that such another applicant submits the data obtained by itself.

Except under the following circumstances, a registration authority shall not disclose the data as prescribed in paragraph 1 of this Article:

(1) The data is needed for the public interests.

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

Chapter III Pesticide Production

Article 16 Pesticide production shall comply with national industrial policies. The state shall encourage and support the adoption of advanced technologies andadvanced administration normsby pesticide production enterprises, and improve the safety and effectiveness of pesticides.

Article 17 The state shall implement a licensing system for pesticide production. A pesticide production enterprise shall meet the following conditions, and, in accordance with the provisions of the competent agricultural department of the State Council, apply for the pesticide production license to the competent agricultural department of the people's governments of the province, autonomous region or municipality directly under the Central Government in accordance with the provisions of the competent agricultural department of the State Council:

(1) Having the technical personnel suitable for the pesticides it applies for production.

(2) Having the factory buildings and facilities appropriate for the pesticides it applies for production.

(3) Having the personnel, instruments and equipment for the quality administration and quality inspection of the pesticides it applies for production.

(4) Having the rules and regulations that can guarantee the quality of the pesticides it applies for production.

The competent agricultural department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within 20 working days as of the acceptance of an application, makes an approval or disapproval decision; and shall, if necessary, conduct field verification. Where the application meets the conditions, the pesticide production license shall be issued; or if the application fails to meet the conditions, the applicant shall be notified in writing and the reasons therefor shall be given.

Where any law or administrative regulation on work safety and environmental protection, among others, otherwise provides for enterprises' production conditions, a pesticide production enterprise shall comply with such provisions.

Article 18 A pesticide production license shall specify the name, domicile, legal representative (principal), production scope, production address and period of validity of a pesticide production enterprise and other relevant matters.

A pesticide production license shall be valid for five years. Where it is necessary to continue the production of pesticides after the expiration of the period of validity, the pesticide production enterprise shall, 90 days before the expiration of the period of validity,apply to the competent agricultural department of the people's government of the province, autonomous region or municipality directly under the Central Government for the renewal thereof.

Where any matter specified on a pesticide registration certificate changes, the pesticide production enterprise shall apply for modifying the pesticide production license in accordance with the provisions of the competent agricultural department of the State Council.

Article 19 In case of the consigned processing or sub-packaging of pesticides, the consignor shall obtain the corresponding pesticide registration certificate, and the consignee shall obtain the pesticide production license.

The consignor shall be responsible for the quality of the pesticides under consigned processingor sub-packaging.

Article 20 A pesticide production enterprise shall, when purchasing raw materials, examine the product quality conformity certificate and the relevant licensing and certification documents, and may not purchase or use the raw materials to which no product quality conformity certificate is attached in accordance with the law or for which no relevant licensing or certification document has been obtained in accordance with the law.

A pesticide production enterprise shall establish a raw material purchase recording system to truthfully record the name of raw materials, licensing or certification document number, specifications, quantity, name and contact information of the supplier, date of purchase of the raw materials and other contents. The raw material purchase records shall be retained for a period of two years or more.

Article 21 A pesticide production enterprise shall conduct production in strict accordance with product quality standards, so as to ensure the consistency between pesticide products and the registered pesticides. Pesticides may not leave the factory for sale until they pass the quality inspection and are accompanied with product quality conformity certificates.

A pesticide production enterprise shall establish a recording system for pesticides leaving the factory for sale, truthfully record the name, specifications, quantity, production date and batch number of pesticides, product quality testing information, the name and contract information of the purchaser, sales date and other contents. The ex-factorysale records of pesticides shall be retained for a period of two years or more.

Article 22 Pesticide packages shall comply with the relevant provisions of the state, and labels shall be printed on or attached to such packages. The state shall encourage pesticide production enterprises to use the recyclable pesticide packaging materials.

A pesticide label shall, in accordance with the provisions of the competent agricultural department of the State Council, be indicated in Chinese with the pesticide name, dosage forms, active ingredients and their content, toxicity and the......