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

Title:English Translation of China MoA Announcement 2569"Data Requirements on Pesticide Registration"
中华人民共和国农业部第2569号公告《农药登记资料要求》
Language:EN
Price: $1499
Format:Electronic Edition (Adobe PDF)
Pages:217
Translated byChemLinked Editorial Team
Release date:2017-09-13
Details

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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Contents

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: