To standardize the registration and management of RNA‑based pesticides, the Ministry of Agriculture and Rural Affairs has issued a draft of specific data requirements for public comment.

On March 23, 2026, in order to standardize the registration of ribonucleic acid (RNA)‑based pesticides, the Department of Crop Production under the Ministry of Agriculture and Rural Affairs issued a letter soliciting comments on the data requirements for the registration of RNA‑based pesticides.

The original text is as follows:

Letter from the Department of Crop Production Management, Ministry of Agriculture and Rural Affairs, Soliciting Comments on the Data Requirements for the Registration of RNA‑Based Pesticides

No. 20 [2026] of Nongnong (Pesticides)

To the Departments (Bureaus, Commissions) of Agriculture and Rural Affairs (Agriculture and Animal Husbandry) of all provinces, autonomous regions, and municipalities directly under the central government; to the Bureau of Agriculture and Rural Affairs of the Xinjiang Production and Construction Corps; to the China Pesticide Industry Association; and to the China Pesticide Development and Application Association:

　　To standardize the registration of ribonucleic acid (RNA)‑based pesticides, these requirements are hereby established in accordance with the “Requirements for Pesticide Registration Data” (Ministry of Agriculture Announcement No. 2569).

　　I. Definitions and Scope of Application

　　Ribonucleic acid (RNA) pesticides are a class of agrochemicals that harness the RNA interference (RNAi) mechanism. By externally delivering short RNA fragments to target organisms, they specifically disrupt the expression of genes in pest species or crop plants, inhibiting the synthesis of relevant proteins and thereby achieving pest control or modulation of plant growth.

　　This requirement applies to the registration of RNA-based pesticides that are applied exogenously and have not been artificially modified.

　 　II. Documentation Requirements

　　(1) Technical Grade (Active Ingredient)

　　1. General Information

　　1.1 Application Form: Complete the form in accordance with the template issued by the Ministry of Agriculture and Rural Affairs.

　　1.2 Applicant’s Supporting Documents: (1) For pesticide manufacturers, submit photocopies of the production license, business license, and unified social credit code, all stamped with the official seal; (2) A statement from the developer of a new pesticide requesting pesticide registration; (3) For overseas enterprises, provide proof of identity, a description of registration and usage in the relevant countries and regions, an explanation of the establishment of a representative office or agency within China, and the corresponding business license.

　　1.3 Applicant’s Declaration: Statement that the application materials are true and lawful

　　1.4 Product Overview: Includes information on the country of origin, product chemistry, toxicology, a summary of environmental impact data, and overseas registration status, among other details.

　　1.5 Labels and Instructions: Sample labels and instructions prepared in accordance with the Measures for the Administration of Pesticide Labels and Instructions.

　　1.6 Other registration‑related supporting documents: (1) Existing product chemistry, toxicology, and environmental impact data, or comprehensive search reports, from other countries or regions; (2) The rationale for the nomenclature of the active ingredient of the new pesticide.

　　1.7 Product Safety Data Sheet

　　1.8 References, etc.: The sources should be clearly cited.

　　2. Requirements for Product Chemical Information

　　2.1 Identification of the active ingredient and other restricted components, such as safeners, stabilizers, and synergists: the common name of the active ingredient, the sense‑strand sequence and the antisense‑strand sequence with the core region indicated, the molecular formula, the length of the double‑stranded RNA, the relative molecular mass or the molecular mass range (with an explicit note on the publication date of the international relative atomic mass table used for the calculation), and a gene‑sequence determination report issued by an authoritative institution.

　　2.2 Production Process

　　2.2.1 Raw Material Description: Provide the chemical names, CAS numbers, technical specifications, and sources of the compounds involved in the reaction, as well as the principal solvents. If the product is obtained through extraction from a biological source, furnish detailed information on the organism used in the extraction process and on the relevant raw materials.

　　2.2.2 Chemical Reaction Equations or Biological Reaction Descriptions

　　2.2.3 Description of the Production Process: Describe each production operation unit in sequence, as per actual production practices.

　　2.2.4 Process Flow Diagram

　　2.2.5 Process Flow Diagram and Description of the Production Unit

　　2.2.6 Description of Quality Control Measures During Production

　　2.3 Physicochemical Properties of the Technical (Parent) Material: (1) Includes appearance (color, physical state, odor), melting point (Tm value), stability (at 54°C for 2 weeks or at 30°C for 18 weeks), and corrosivity toward packaging materials; (2) In accordance with the characteristics of the compound and as stipulated in the “Guidelines for the Determination of Physicochemical Properties of Pesticides,” provide the relevant physicochemical property test reports.

　　2.4 Component Analysis

　　2.4.1 Component Analysis Test Report: Conducted in accordance with the “Guideline for Full-Component Analysis of Technical Grade Pesticides for Registration.”

　　2.4.2 Impurity Formation Analysis Report: Analyze the causes of impurities identified through analytical testing and those presumed to exist, considering chemical theory, raw materials, manufacturing processes, and other relevant factors.

　　2.5 Product Quality Specifications

　　2.5.1 Appearance: The product’s color, physical state, odor, and other characteristics shall be clearly described.

　　2.5.2 Active Ingredient Content: The active ingredient content of the technical material consists of the labeled content and its allowable tolerance range. The labeled content is typically determined as the average of the test results from five representative batches, while the allowable tolerance range shall be in accordance with the relevant provisions for pesticide registration.

　　2.5.3 Content of Related Impurities: Products containing related impurities shall have their maximum allowable content specified, expressed as a mass fraction.

　　2.5.4 Content of Other Restricted Ingredients: For products containing safety agents, stabilizers, synergists, and other restricted ingredients, the declared content shall be accompanied by an allowable range of variation, with the permissible fluctuation range in accordance with the relevant provisions on pesticide registration.

　　2.5.5 Acidity, Alkalinity, or pH Range: Acidity or alkalinity is expressed as the mass fraction of sulfuric acid or sodium hydroxide, irrespective of its actual form.

　　2.5.6 Water-insoluble matter: Specifies the maximum permissible limit, expressed as a mass fraction (%).

　　2.5.7 Moisture or Loss on Heating: Specifies the maximum permissible limit, expressed as a mass fraction (%).

　　2.6 Test Methods and Method Validation Corresponding to Product Quality Control Items

　　2.6.1 Identification methods for the active ingredients in the product: gel electrophoresis combined with q‑PCR, gene sequencing, and other techniques; if liquid chromatography retention time is used for identification, additional accurate and convenient identification methods shall also be provided.

　　2.6.2 Methods for the determination of active ingredients, related impurities, and other restricted components such as safeners, stabilizers, and synergists, along with method validation: (1) Provide a complete analytical method, which typically includes an overview, underlying principles, sample information, reference standard information, instruments, reagents, solution preparation, operating conditions, assay procedures, result calculations, statistical methods, and allowable tolerances; (2) Method validation shall be conducted in accordance with the provisions of the “Guideline for Validation of Analytical Methods for Pesticide Products.”

　　2.6.3 Other methods for testing technical indicators: Conduct in accordance with the provisions of the “Guidance on Validation of Analytical Methods for Pesticide Products.”

　　2.7 Explanation of Product Quality Specification Determination: Provide necessary explanations regarding the basis for establishing the technical specifications and their rationale.

　　2.8 Product Quality Test Report and Test Method Validation Report: (1) The product quality test report shall cover all items specified in the product quality specifications; (2) The analytical methods for determining the content of active ingredients, relevant impurities, and other restricted components such as safety agents, stabilizers, and synergists shall be validated by the registration testing institution that issues the product quality test report, which shall also prepare a test method validation report. For other control parameters, method validation may not be required; (3) The test method validation report shall include: the test conditions provided by the commissioning party; the test conditions adopted by the registration testing institution (e.g., chromatographic conditions, sample preparation, etc.) along with an explanation of any modifications; all results of parallel determinations together with their standard deviations; typical chromatograms (including those of reference standards and samples); and an evaluation of the method’s feasibility.

　　2.9 Packaging (materials, shape, dimensions, net content), storage and transportation (transportation and storage), safety warnings, etc.

　　2.9.1 Packaging, Storage, and Transportation: The applicant shall, in accordance with the product’s hazard classification, select appropriate packaging materials, package dimensions, and transport vehicles. Transportation and storage precautions shall be prepared in compliance with relevant national laws, regulations, and standards pertaining to production safety, storage, and transportation.

　　2.9.2 Safety Warnings: Based on the product’s physicochemical property data and in accordance with the classification criteria for chemical hazards, the product’s hazard level shall be assessed and classified, and this information shall be disclosed through labels, safety data sheets (SDS), and other appropriate formats.

　　3. Toxicological Data Requirements

　　3.1 Basic Toxicology Study Data

　　3.1.1 Acute Oral Toxicity Test Data

　　3.1.2 Acute Dermal Toxicity Test Data

　　3.1.3 Acute Inhalation Toxicity Test Data

　　3.1.4 Eye Irritation Test Data

　　3.1.5 Skin Irritation Test Data

　　3.1.6 Data on Skin Sensitization Testing

　　3.1.7 Subchronic Oral Toxicity Study Data: 90-Day Oral Toxicity Study

　　3.1.8 Data on the in vivo degradation and gastrointestinal absorption of the active ingredient; as appropriate, provide information on tissue distribution and retention.

　　3.2 Supplementary Toxicology Study Data (Based on the product type, route of exposure, results of the basic toxicology studies, and the specific characteristics of the active ingredient, supplementary data shall be provided for subchronic (acute) dermal toxicity, subchronic (acute) inhalation toxicity, immunotoxicity, mutagenicity, neurotoxicity, reproductive toxicity, chronic toxicity, carcinogenicity, or endocrine-disrupting effects of the active ingredient.)

　　3.3 Analysis of off-target effects between RNA pesticides and human genome sequences based on bioinformatics. For cases where potential off-target effects are identified, additional supporting safety data should also be submitted.

　　3.4 Information on Poisoning Symptoms, First Aid, and Treatment Measures

　　3.5 Data on Human Contact Surveys

　　4. Environmental Impact Data Requirements

　　4.1 Acute Oral Toxicity Test Data for Birds

　　4.2 Acute Oral Toxicity Test Data for Honeybees

　　4.3 Acute Toxicity Test Data for Fish

　　4.4 Data from the Acute Activity Inhibition Test with Daphnia magna

　　4.5 Data on Selectivity Toward Target and Non-Target Organisms: Provide toxicity test data for species closely related to the target organism, or submit an analysis report—based on bioinformatics—of the potential off-target effects of the RNA‑based pesticide on non-target organisms. For non-target organisms with potential off-target effects, additional supporting safety data shall also be submitted.

　　4.6 If the test results indicate that the active ingredient (or technical material) has an acute oral LD50 of less than 500 mg a.i./kg in birds, an acute oral LD50 of less than 11 µg a.i./bee in honeybees, an acute LC50 of less than 10 mg a.i./L in fish, or an acute EC50 of less than 10 mg a.i./L in Daphnia magna, then the active ingredient (or technical material) shall be accompanied by test reports or relevant data in accordance with the requirements for chemical pesticide technical materials.

　　(II) Preparations

　　1. General Information

　　1.1 Application Form: Complete the form in accordance with the template issued by the Ministry of Agriculture and Rural Affairs.

　　1.2 Applicant’s Supporting Documents: (1) Pesticide manufacturers shall submit photocopies of their production license, business license, and unified social credit code, all bearing the official seal; (2) A description by the developer of a new pesticide applying for pesticide registration; (3) For overseas enterprises, supporting documents proving their identity, a description of registration and usage in the relevant countries and regions, an explanation of the establishment of a representative office or agency within China, and their business license.

　　1.3 Applicant’s Declaration: Statement that the application materials are true and lawful

　　1.4 Product Overview: A brief summary of information including the country of origin, product chemistry, efficacy, residues, toxicology, environmental impact, and overseas registration status.

　　1.5 Summary of Benefit Analysis: Summary of Analyses on Product Economic Benefits, Social Benefits, and Environmental Benefits

　　1.6 Labels and Instructions: Sample labels and instructions prepared in accordance with the Measures for the Administration of Pesticide Labels and Instructions.

　　1.7 Other registration‑related supporting documents: (1) Existing data on product chemistry, efficacy, residues, toxicology, and environmental impact, or comprehensive search reports, obtained in other countries or regions; (2) Justification for the nomenclature of the active ingredient of a new pesticide; (3) For new formulation types not specified in national standards, the applicant shall submit the rationale for the formulation name and an identification report; (4) A description of the origin of the technical material.

　　1.8 Product Safety Data Sheet

　　1.9 References, etc.: Sources should be clearly cited.

　　2. Requirements for Product Chemical Information

　　2.1 Identification of the active ingredient and other restricted components such as safeners, stabilizers, and synergists: the common name of the active ingredient, the sense‑strand sequence and the antisense‑strand sequence with the core region indicated, the molecular formula, the length of the double‑stranded RNA, and the relative molecular mass or molecular mass range (with an explicit note on the publication date of the international relative atomic mass table used for the calculation); a gene‑sequence determination report issued by an authoritative institution.

　　2.2 Basic Information on the Active Ingredient (Technical Grade): Provide basic information on the manufacturer, registration status, quality control parameters, and their respective specifications for the technical-grade active ingredient used.

　　2.3 Product Composition: (1) For the components used in formulation processing, provide their chemical names, CAS numbers, molecular formulas, structural formulas, concentrations, and functions. For mixed solvents and mixed adjuvants designated by codes, also furnish information on their composition, sources, and safety data, such as material safety data sheets (MSDS); (2) For individually packaged adjuvants (designated adjuvants) added during on-site preparation of the working solution, separately submit their composition and the aforementioned information.

　　2.4 Description of Processing Method

　　2.4.1 Process Flow Diagram

　　2.4.2 Amounts and Order of Addition of Each Component

　　2.4.3 Major Equipment and Operating Conditions

　　2.4.4 Description of Quality Control Measures During Production

　　2.5 Physicochemical Properties: (1) Include appearance (color, physical state, odor), density, viscosity, oxidizing/reducing properties, corrosivity to packaging materials, miscibility with nonpolar organic solvents (applicable to formulations intended for dilution with organic solvents), explosiveness, flammability, and other relevant characteristics; (2) Provide test reports on physicochemical properties in accordance with the “Guidelines for the Determination of Physicochemical Properties of Pesticides.” If certain parameters are not applicable to a specific product, an explanatory note shall be provided.

　　2.6 Product Quality Specifications: During the warranty period, the product shall meet the following quality specifications.

　　2.6.1 Appearance: The product’s color, physical state, odor, and other characteristics shall be clearly described.

　　2.6.2 Active Ingredient Content: (1) The active ingredient content consists of the labeled content and an allowable range of variation; requirements shall be established in accordance with those for chemical pesticide formulations, specifying a range for the active ingredient content. (2) Active ingredient content is generally expressed as a mass fraction (%). For liquid formulations, the active ingredient content may be expressed either as a mass concentration (g/L) or as a mass fraction (%); when expressed as a mass concentration, the corresponding mass fraction must also be clearly indicated.

　　2.6.3 Content of Other Restricted Ingredients: For products containing safety agents, stabilizers, synergists, and other restricted ingredients, the declared content shall be accompanied by an allowable tolerance range, with the latter conforming to the requirements applicable to chemical pesticide formulations.

　　2.6.4 Other control items and specifications related to dosage forms: (1) Different dosage forms shall be assigned technical specifications that are consistent with their respective characteristics; (2) For other dosage forms not covered by these requirements, reference may be made to the specification standards established by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). Control items for innovative dosage forms may be developed through comprehensive consideration of factors such as the properties of the active ingredient, the method of application, and safety, and supporting documentation from dosage-form identification studies shall be submitted concurrently.

　　2.7 Test Methods and Method Validation Corresponding to Product Quality Control Items

　　2.7.1 Identification methods for the active ingredients in the product: gel electrophoresis combined with q‑PCR or sequencing, etc.; if liquid chromatography retention time is used for identification, additional accurate and convenient identification methods shall also be provided.

　　2.7.2 Methods for the determination of active ingredients, relevant impurities, and other restricted components such as safeners, stabilizers, and synergists, along with method validation: (1) Test methods: A complete test method shall be provided, typically comprising an overview, underlying principles, sample information, reference standard information, instruments, reagents, solution preparation, operating conditions, analytical procedures, result calculations, statistical methods, and allowable tolerances; (2) Method validation: Conducted in accordance with the “Guidance on Validation of Analytical Methods for Pesticide Products.”

　　2.7.3 Other methods for testing technical indicators: Conduct in accordance with the provisions of the “Guidance on Validation of Analytical Methods for Pesticide Product Quality.”

　　2.8 Explanation of Product Quality Specification Determination: Provide necessary explanations regarding the basis and rationale for establishing the technical specifications.

　　2.9 Data on Room-Temperature Storage Stability Studies: (1) At least one batch of samples shall be provided with room‑temperature storage stability study data; (2) The same product packaged in different materials shall undergo separate room‑temperature storage stability studies; (3) In general, room‑temperature storage stability studies require that the samples be stored under the selected conditions for a period of 2 years.

　　2.10 Product Quality Test Report and Test Method Validation Report: (1) The product quality test report shall cover all items specified in the product quality specifications; (2) For the determination of active ingredients, relevant impurities, and other restricted components such as safety agents, stabilizers, and synergists, the corresponding analytical methods shall be validated by the registration testing institution that issues the product quality test report, which shall also prepare a test method validation report. Validation is not required for the analytical methods of other control parameters; (3) The test method validation report shall include: the test conditions provided by the commissioning party; the test conditions adopted by the registration testing institution (e.g., chromatographic conditions, sample preparation, etc.), together with an explanation of any modifications; all results of parallel determinations along with their standard deviations; typical chromatograms (including those of reference standards and samples); and an evaluation of the method’s feasibility.

　　2.11 Packaging (materials, shape, dimensions, net content), storage and transportation (transportation and storage), safety warnings, shelf life, etc.

　　2.11.1 Packaging and Storage/Transportation: The applicant shall, in accordance with the product’s hazard classification, select appropriate packaging materials, package dimensions, and transport vehicles. Transportation and storage precautions shall be prepared in compliance with relevant national laws, regulations, and standards pertaining to production safety, storage, and transportation.

　　2.11.2 Safety Warnings: Based on the product’s physicochemical property data and in accordance with the classification criteria for chemical hazards, the product’s hazard level shall be assessed and classified, and this information shall be disclosed through labels, safety data sheets (SDS), and other appropriate formats.

　　2.11.3 Quality Assurance Period: The product’s quality assurance period shall be determined in accordance with the stability test data obtained under ambient temperature storage conditions.

　　3. Toxicological Data Requirements

　　3.1 Acute Oral Toxicity Test Data

　　3.2 Acute Dermal Toxicity Test Data

　　3.3 Acute Inhalation Toxicity Test Data

　　3.4 Eye Irritation Test Data

　　3.5 Skin Irritation Test Data

　　3.6 Data on Skin Sensitization Studies

　　4. Requirements for Efficacy Data

　　4.1 Benefit Analysis: (1) Overview of the crops and target organisms for which registration is sought; (2) Substitution analysis and benefit analysis report.

　　4.2 Efficacy Study Data

　　4.2.1 Laboratory Bioassay Data: Mode of action, spectrum of activity, and mechanisms of mortality or inhibition in target organisms; analysis of target genes and sequence specificity; laboratory efficacy test reports.

　　4.2.2 Crop Safety Test Data

　　4.2.3 Field plot efficacy trial data: (1) For insecticides and fungicides, submit field plot efficacy trial reports conducted in four provincial-level administrative regions within China over a period of two years, or in eight provincial-level administrative regions over one year; for herbicides and plant growth regulators, submit field plot efficacy trial reports conducted in five provincial-level administrative regions within China over a period of two years, or in ten provincial-level administrative regions over one year. (2) For crops grown in specific local areas or for diseases, pests, or weeds that occur only in limited regions, field plot efficacy trial reports may be submitted based on three provincial-level administrative regions over two years, or six provincial-level administrative regions over one year. (3) For products used on crops listed in the “Catalogue of Specialty Minor Crops with Drug Shortages,” efficacy trial reports may be submitted as if the crop were grown in a localized area, requiring field plot efficacy trials in three provincial-level administrative regions.

　　4.2.4 Regional Efficacy Test Data: (1) Submit regional efficacy test reports conducted in two provincial-level administrative regions within China over a one-year period; (2) For pesticides used in environments with relatively stable conditions—such as those for storage, preservation, or freshness maintenance—submission of such data may be waived.

　　4.3 Other Information: Provide, as required, a description of the field plot selection for trials (including any additional explanations not covered in the “Guideline on Field Efficacy Test Areas for Pesticide Registration”); the impact on major predatory and parasitic natural enemies in the field; the impact on neighboring crops; overseas registration and use information for this crop or target pest (for products seeking new uses); product characteristics and precautions for use; and any other relevant documentation pertaining to the pesticide formulation and its intended application scope.

　　4.4 Comprehensive Assessment Report: A Summary of All Pharmacodynamic Data

　　5. Requirements for Retained Documentation

　　Toxicological testing has demonstrated that, where a daily acceptable intake (ADI) or an acute reference dose (ARfD) is required, residue study data for such substances in agricultural products shall be submitted.

　　6. Requirements for Environmental Impact Documentation

　　6.1 Acute Oral Toxicity Test Data for Birds

　　6.2 Acute Oral Toxicity Test Data for Honeybees

　　6.3 Acute Toxicity Test Data for Fish

　　6.4 Data from the Acute Activity Inhibition Test with Daphnia magna

　　6.5 If the active (parent) substance has an acute oral LD50 in birds of less than 500 mg a.i./kg, an acute oral LD50 in honeybees of less than 11 µg a.i./bee, an acute LC50 in fish of less than 10 mg a.i./L, or an acute EC50 in Daphnia of less than 10 mg a.i./L, then the pesticide formulation shall submit test reports or supporting data in accordance with the requirements for chemical pesticide formulations.

　　 III. Other

　　1. In principle, the registration of mixed formulations containing RNA-based pesticides and other categories of pesticides is not approved.

　　2. Any other provisions related to the registration of RNA‑based pesticides that are not addressed in this requirement shall be governed by the applicable current pesticide management regulations.

　　Public comments are hereby solicited on the aforementioned registration information. Please submit your feedback, in writing or by email, to the Department of Crop Production Management of the Ministry of Agriculture and Rural Affairs no later than April 8, 2026.

　　Email: pmd@agri.gov.cn

　　Fax: 010-59191875

　　Mailing Address: Division of Crop Production Management, Ministry of Agriculture and Rural Affairs, No. 11, Nongguan Zhan Nanli, Chaoyang District, Beijing (Postal Code: 100125)

Department of Crop Production, Ministry of Agriculture and Rural Affairs

March 23, 2026

Source: Department of Crop Production, Ministry of Agriculture and Rural Affairs