On 13 Sep. 2017, China MoA detailed new data requirements for pesticide registration. The supporting document was compiled under new pesticide regulation which was promulgated earlier this year. The required data consists of study reports, risk assessment reports, sample of product, impurity and analytical standard, product quality specification, testing methods, label and manual templates, material safety data sheet, summary report, statement on authenticity, cited reference and documentary evidence. Depending on the pesticide origin and application area, the main text divides pesticide into 4 types: chemical pesticide, biochemical pesticide, microbial pesticide, botanical pesticide, hygienic pesticide and the technical details are separately provided in the annexes.

Table of contents:

• Main Text

• ANNEX I - Table of Definition and Item & Description on Data Requirements for the Registration TC/TKs

• ANNEX II - Table of Definition and Item & Description on Data Requirements for the Registration Formulated Product

• ANNEX III - Table of Definition and Item & Description on Data Requirements for the Registration Hygienic Formulated Product

• ANNEX IV - Table of Definition and Item & Description on Data Requirements for the Registration Formulated Rodenticide

• ANNEX V - Table of Definition and Item & Description on Data Requirements for Registration Amendment

• ANNEX VI - Data Requirement for the Registration of Minor Crop Use Purpose

• ANNEX VII - Guideline for the Areal Distribution of Efficacy Trial Site

• ANNEX VIII - Crop Grouping for Residue Study

• ANNEX IX - Minimal Number of Trial Sites Required for Residue Study

• ANNEX X - Criterion for Technical Equivalence Determination of Me-too Pesticide

• ANNEX XI - Principles for the Nomenclature of Pesticide

• ANNEX XII - Principles for Concentration Ranges of Active Ingredient(s)

• ANNEX XIII - Tests of Physical and Chemical Properties and Quality Specification Required for Different Formulation Type

• ANNEX XIV –Criterion for the Toxicological Classification of Pesticide Product

Reference Links

• MoA Announcement 2569 of 2017(in Chinese);

• AgroAnalysis: China's New Pesticide Regulation: Elevated Criteria for “Me-too” Pesticide Registration;

• Data Requirement for Pesticide Registration (PDF in Chinese)