- Language:EN
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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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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:
China MoA Order 3 of 2017-Administrative Measures for the Registration of Pesticide
China MoA Order 4 of 20417-Administrative Measures for the Production License of Pesticide
China MoA Order 5 of 2017-Administrative Measures for the Marketing License of Pesticide
China MoA Order 6 of 2017-Adminstrative Measures for Pesticide Registration Labs
China MoA Order 7 of 2017-Administrative Measures for Pesticide Labels and Manuals
China MoA Announcement 2567-Catalogue of Restricted Pesticides (Version 2017)
China MoA Announcement 2568-Rules for the Inspection on Pesticide Production License