English Translation of China MoA Announcement 2569"Data Requirements on Pesticide Registration"

Summary

The “Data Requirements on Pesticide Registration”was promulgated under the “Regulation on the Administration of Pesticides(Decree 677)” and the “Administrative Measures for the Registration of Pesticide Registration(MoA Order 3 of 2017)”, aimed at standardizing the layout, data, criteria and conditions of dossier required for pesticide registration. For more information on the new data requirements, please see our analysis on An Introduction on China’s New Pesticide Registration Data Requirements-MoA Announcement 2569

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Obligations

DATA REQUIREMENTS ON PESTICIDE REGISTRATION 1

CHAPTER I GENERAL PROVISIONS 1

CHAPTER II TERMINOLOGY AND DEFINITIONS 2

CHAPTER III CHEMICAL PESTICIDES 4

3.1 CHEMICAL TECHNICAL/TECHNICAL MATERIAL (TC/TK) 4
3.2 CHEMICAL FORMULATED PESTICIDES 7

CHAPTER IV BIOCHEMICAL PESTICIDES 8

4.1 BIOCHEMICAL TECHNICAL/TECHNICAL MATERIAL (TC/TK) 8
4.2 BIOCHEMICAL FORMULATED PRODUCT 10

CHAPTER V MICROBIAL PESTICIDES 11

5.1 MICROBIAL TECHNICAL MATERIAL (TK) 11
5.2 MICROBIAL FORMULATION PRODUCT 13

CHAPTER VI BOTANICAL PESTICIDES 14

6.1 BOTANICAL TECHNICAL MATERIAL/TECHNICAL (TK /TC) 14
6.2 BOTANICAL FORMULATED PRODUCT 16

CHAPTER VII HYGIENIC FORMULATED PRODUCTS 17

7.1 HYGIENIC CHEMICAL FORMULATED PRODUCT 17
7.2 HYGIENIC BIOCHEMICAL FORMULATED PRODUCT 19
7.3 HYGIENIC MICROBIAL FORMULATED PRODUCT 20
7.4 HYGIENIC BOTANICAL FORMULATED PESTICIDE 21

CHAPTER VIII REGISTRATION AMENDMENT 23

8.1 USE SCOPE EXPANSION 23
8.2 AMENDMENT TO APPLICATION METHOD 23
8.3 DOSE INCREASE 24
8.4 DOSE DECREASE 24
8.5 AMENDMENT TO QUALITY SPECIFICATION OR COMPOSITION OF TC/TK 24
8.6 AMENDMENT TO QUALITY SPECIFICATION OR PRODUCT COMPOSITION OF FORMULATED PRODUCT 24
8.7 AMENDMENT TO TOXICOLOGICAL CLASS 25

CHAPTER IX REGISTRATION RENEWAL 25

CHAPTER X SUPPLEMENTARY PROVISIONS 25

ANNEXES 26

ANNEX I-TABLES OF DEFINITIONS AND INSTRUCTIONS ON THE DATA REQUIREMENT FOR THE REGISTRATION OF TC/TK(S) 27

1 CHEMICAL TECHINAL/TECHNICAL MATERIAL (TC/TK) 27
2 BIOCHEMICAL TECHINAL/TECHNICAL MATERIAL (TC/TK) 37
3 MICROBIAL TECHNICAL MATERIAL (TK) 44
4 BOTANICAL TECHNICAL MATERIAL/TECHNICAL (TK/TC) 49

ANNEX II TABLES OF DEFINITIONS AND INSTRUCTIONS ON THE DATA REQUIREMENT FOR THE REGISTRATION OF FORMULATED PRODUCTS 56

1 CHEMICAL FORMULATED PRODUCT 56
2 BIOCHEMICAL FORMULATED PRODUCT 67
3 MICROBIAL FORMULATED PRODUCT 78
4 BOTANICAL FORMULATED PESTICIDE 87

ANNEX III TABLES OF DEFINITIONS AND INSTRUCTIONS ON THE DATA REQUIREMENT FOR THE REGISTRATION OF HYGENIC FORMULATED PRODUCT 96

1 HYGENIC CHEMICAL FORMULATED PRODUCT 96
2 HYGIENIC BIOCHEMICAL FORMULATED PRODUCT 106
3 HYGIENIC MICROBIAL FORMULATED PRODUCT 116
4 HYGIENIC BOTANICAL FORMULATED PRODUCT 124

ANNEX IV TABLES OF DEFINITIONS AND INSTRUCTIONS ON THE DATA REQUIREMENT FOR THE REGISTRATION OF FORMULATED RODENTICIDES 132

1 CHEMICAL FORMULATED RODENTICIDES 132
2 BIOCHEMICAL FORMULATED RODENTICIDES 140
3 MICROBIAL FORMULATED RODENTICIDES 147
4 BOTANICAL FORMULATED RODENTICIDES 155

ANNEX V TABLES OF DEFINITIONS AND INSTRUCTIONS ON THE DATA REQUIREMENT FOR REGISTRAITON AMENDMENT 163

1 USE SCOPE EXPANSION 163
2 AMENDMENT TO APPLICATION METHOD 165
3 DOSE INCREASE 167
4 DOSE DECREASE 168
5 AMENDMENT TO QUALITY SPECIFICATION OR COMPOSITION OF TC/TK 169
6 AMENDMENT TO QUALITY SPECIFICATION OR COMPOSITION OF FORMULATED PRODUCT 170
7 AMENDMENT TO TOXICOLOGICAL CLASS 171

ANNEX VI – DATA REQUIREMENT FOR PESTICIDE REGISTRATION FOR MINOR CROP USE PURPOSE 173

ANNEX VII- GUIDELINE FOR THE AREAL DISTRIBUTION OF EFFICACY TRIAL SITE FOR PESTICIDE REGISTRATION 175

1. GRAIN CROPS 175
2 ECONOMIC CROPS 177
3 OIL CROPS 179
4 VEGETABLES 180
5 FRUITS 181

ANNEX VIII-CROP GROUPING FOR RESIDUE TRIAL FOR PESTICIDE REGISTRATION 183

1 CEREALS 183
2 VEGETABLES 183
3 FRUITS 184
4 NUTS 185
5 SUGAR CROPS 185
6 OIL CROPS 185
7 BEVERAGES 185
8 EDIBLE FUNGI 185
9 CONDIMENTS 185
10 FEED CROPS 185
11 MEDICINAL PLANTS 185
12 OTHERS 186

ANNEX IX-MINIMAL NUMBER OF RESIDUE TRIAL SITES REQUIRED FOR PESTICIDE REGISTRATION 187

ANNEX X –CRITERIA FOR THE TECHNICAL EQUIVALENCE DETERMINATION OF ME-TOO PESTICIDES 188

1 GENERAL PROVISION 188
2 TECHNICAL EQUIVALENCE DETERMINATION OF TC 188
3 TECHNICAL EQUIVALENCE DETERMINATION OF FORMULATED PRODUCT 189

ANNEX XI - PRINCIPLES FOR THE NOMENCLATURE OF PESTICIDE PRODUCTS 191

ANNEX XII –PRINCIPLES FOR CONTENT RANGES OF ACTIVE INGREDIENT(S) IN PESTICIDE PRODUCTS 192

ANNEX XIII-QUALITY SPECIFICATION AND PHYSICAL AND CHEMICAL PROPERTIES REQUIRED FOR DIFFERENT FORMULATION TYPE 193

1 SOLID FORMULATIONS 193
2 LIQUID FORMULATIONS 199
3 SEED TREATMENT FORMULATIONS 206
4 OTHER FORMULATIONS 209

ANNEX XIV-CRITERIA FOR THE TOXICOLOGICAL RATING OF PESTICIDE PRODUCTS 214

English Translation Series of China’s New Pesticide Regulations: