Data Requirements on Pesticide Registration Translation of China MoA Announcement 2569 Data...

China MoA Announcement 2569

Data Requirements onPesticide Registration

Promulgated by Ministry of Agriculture

of People’s Republic of ChinaImplementation Date:2017/11/01

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

Table of 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 ......................................................................................................................... 9

4.1 BIOCHEMICAL TECHNICAL/TECHNICAL MATERIAL (TC/TK) ................................................................... 9

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 ......................................................................................................................................................................... 25

8.7 AMENDMENT TO TOXICOLOGICAL CLASS .................................................................................................. 25

CHAPTER IX REGISTRATION RENEWAL ......................................................................................................................... 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 ........................................................................................................ 68

3. MICROBIAL FORMULATED PRODUCT .............................................................................................................. 79

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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

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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

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Tel : +86 571 87007555 / Fax : +86 571 87007566 / E-mail : [email protected]

杭州市文一西路 1288 号海创科技中心 3 号楼 14 层/ https://agrochemical.chemlinked.com/

14th Floor, Building No.3, Haichuang Technology Center, 1288 West Wen Yi Road, Hangzhou,

ANNOUNCEMENT 2569 OF THE MINISTRY OF

AGRICULTURE OF PEOPLE’S REPUBLIC OF CHINA The Data Requirements on Pesticide Registration compiled by the Ministry in accordance with the

“Regulation on the Administration of Pesticides” and the “Administrative Measures for the Registration of

Pesticide” is hereby promulgated and shall come into force as of November 1, 2017.

Ministry of Agriculture

September 13, 2017

DATA REQUIREMENTS ON PESTICIDE REGISTRATION

CHAPTER I GENERAL PROVISIONS

1.1 The Data Requirements on Pesticide Registration is formulated according to the “Regulation on the

Administration of Pesticides” and the “Administrative Measures for the Registration of Pesticide

Registration”.

1.2 The dossier for the application of pesticide registration consists of experimental data and assessment

reports, product quality specification and corresponding test methods, templates of pesticide label and

manual, comprehensive report, other supporting documents relevant to pesticide registration, Material

Safety Data Sheet (MSDS), application form, certificates of the applicant and declaration, as well as cited

literatures.

The cited literatures should clearly attributed with the title, name, volume, edition and page number of

the publication. If the literature or data was not yet publically available, an authorization from its

proprietor supporting the use of the literature or data should be provided. If the data was non-Chinese,

the Chinese translation should be provided.

1.3 Experimental data includes test reports and evaluation reports on product chemistry, toxicology,

efficacy, residue and environmental impact. If specific co-formulant was added due to other

considerations such as safety and stability, a test sample added with the co-formulant should be utilized

for the regulatory study.

The experimental data required for the registration for chemical pesticides, biochemical pesticides,

microbial pesticides and hygienic pesticides are specified in Chapter III to IIV.

1.4 The data requirements for the registration under pesticide technical (technical material), formulations,

hygienic pesticides, rodenticides, registration amendment and minor crop use purpose are specified in

Annex I to VI.

The areal arrangement of efficacy trial sites shall comply with the requirements specified in Annex IIV and

crop grouping and minimum number of trial sites required for residue study should comply with the

requirements specified in Annex IIX and IX.

1.5 The applicant should submit one original papery copy of the dossier and classification, constituent,

content and page number should be sorted in accordance with the Annexes. The Chinese content should

be laidout in Song typeface and the font size should be greater 4 and font size for English content should

be greater than 11. All contents should be printed on A4 papers and bind in either single volume or

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

1 CHEMICAL TECHINAL/TECHNICAL MATERIAL (TC/TK)

DATA ITEM DEFINITION AND INSTRUCTION A B C

Type of Registration 1. A: New pesticide technical/technical material, including: a. pesticide previously registered in China but not product is in registration validity, b. pesticide which is under 6-year data protection period and the data access was not yet granted by its initial registrant; 2. B: Me-too TC/TK, including pesticide which is under 6-year data protection period and the data use was granted by its original registrant; 3. C: Non me-too TC/TK Note: “√” means required, “×” refers to not required and “○” means not required for rodenticide

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1. Application Form Fill in the information as per the template provided by the MoA. √

2. Credential documents of the applicant (1) Indigenous pesticide production company shall submit officially sealed photocopies of pesticide production license, Industrial and commercial business license and unified social credit code, etc.; (2) R&D entity of new pesticide shall provide supporting explanation on application of new pesticide; (3) Overseas company shall provide identification documents, description on the registration status and uses in overseas country, the statement and business license of its Chinese branch or authorized agency.

√

3. Declaration of the applicant Declaration on legitimacy and authenticity of the application materials. √

4. Product overview Summary on the place of origin, product chemistry, toxicology, environmental impact data, outcomes of risk assessment and information on the registration status in overseas countries, etc.

√

5. Template of product label and manual Pesticide label and manual should be prepared in accordance with the "Administrative Measures for Pesticide Labels and Manuals".

√

6. Other relevant supporting documents (1) Available data on product chemistry, toxicology, environmental impact or comprehensive investigative report obtained in overseas countries; (2) Nomenclature justification in case of new pesticide

√

7. Material Safety Data Sheet(MSDS) √

8.Reference data Origins of the sourced data should be attributed. √

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2 BIOCHEMICAL TECHINAL/TECHNICAL MATERIAL (TC/TK)

DATA ITEM DEFINITION AND INSTRUCTION A B C

Type of Registration 1. A: New pesticide technical/technical material, including: a. pesticide previously registered in China but not product is in registration validity, b. pesticide which is under 6-year data protection period and the data access was not yet granted by its initial registrant; 2. B: Me-too TC/TK, including pesticide which is under 6-year data protection period and the data use was granted by its original registrant; 3. C: Non me-too TC/TK Note: “√” means required, “×” refers to not required and “○” means not required for rodenticide

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2. Credential documents of the applicant

(1) Indigenous pesticide production company shall submit officially sealed photocopies of pesticide production license, Industrial and commercial business license and unified social credit code, etc.; (2) R&D entity of new pesticide shall provide supporting explanation on application of new pesticide; (3) Overseas company shall provide identification documents, description on the registration status and uses in overseas country, the statement and business license of its Chinese branch or authorized agency.

√



√

5. Template of product label and manual Pesticide label and manual should be prepared in accordance with the "Administrative Measures for Pesticide Labels and Manuals".

√


√



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3 MICROBIAL TECHNICAL MATERIAL (TK)

DATA ITEM DEFINITION AND INSTRUCTION A C

Type of Registration: 1. A: New pesticide technical/technical material, including: a. pesticide previously registered in China but not product is in registration validity, b. pesticide which is under 6-year data protection period and the data access was not yet granted by its initial registrant; 2. C: Non me-too TK Note: “√” means required, “×” refers to not required and “○” means not required for rodenticide

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√



√

5. Product label and manual Pesticide label and manual should be prepared in accordance with the "Administrative Measures for Pesticide Labels and Manuals".

√


√



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√



√

5. Product label and manual Pesticide label and manual should be prepared in accordance with the "Administrative Measures for Pesticide Labels and Manuals".

√


√



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①

1.Product identity

1.1 Product Name

For botanical pesticide extracted from single plant species, the product can be named either by the name of the active ingredient or the common name of the raw material plant plus the word “extract”. But the characteristic active ingredient should be explicitly defined. If the botanical pesticide was extracted from multiple plant species, it should be named with the characteristic active ingredient.

√

1.2 Identity of active ingredient or characteristic active ingredient, stabilizer, synergist and other limitative component

(1)The common names, generic names approved by ISO and other international organizations, chemical names, CAS numbers, CIPAC codes, develop codes, empirical and structural formulae, isomer ratios, MW molecular weights and ranges(noted with the issuing date of the Relevant Atomic Mass Table used) of active ingredient or characteristic active ingredient, stabilizer, synergist and other limitative components; (2) If the active ingredient exists in certain form of salt compound, identity information on the derivatives should be provided accordingly.

√

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12.Experimental data on toxicity to predatory natural enemy

Toxicity study on at least one predatory natural enemy ○ ○

13.Other higher-tiered experimental data required for environmental risk assessment

If preliminary risk assessment suggest unacceptable risk to certain target, additional studies supporting higher-tiered risk assessment will be required.

√ √

Note: ① The data required for botanical TK is generally the same as required for chemical TC and the differences in data required for manufacturing process information are as follows: --The applicant should provide the name (Chinese common name, English common name and Latin name) of raw material plant, the part of the plant (seed, fruit, leaf, root, bark, stem or truck, etc.), place of origin and growth condition of the plant(cultivated or wild), harvest time and condition, time and condition of storage, etc. The Latin name of the raw material plant shall comply with the International Code of Botanical Nomenclature (ICBN); --The chemical name, CAS number, technical specification, sourcing origin and other information on the major solvents involved in extraction process; --The description shall include the processing of the raw material plant, extraction method and purification process, etc.; ② Characteristic active ingredient refers to the substance stably presented on the “chemical fingerprinting” chromatograms or the potential bioactivity source identified through laboratorial analysis or literately reported. The characteristic active ingredient can be single component compound or multiple component compound and served as a quality control indicator for botanical pesticide. ③ “chemical fingerprinting” spectra refers a series of chromatographs or spectra whose responses are qualitative and quantitatively corresponding to the chromatographs or spectra of reference item or standard substance and utilized for determining the consistence between sample and reference item. ④ The test shall be conducted in China in accordance with the Article 16 of the " Administrative Measures for the Registration of Pesticide Registration". ⑤ If the pesticide has been approved by other Chinese authorities for uses as food additive, health food and pharmaceutical ingredient, data on reproductive toxicity, teratogenicity, chronic toxicity and carcinogenicity, metabolism and toxicokinetics can be exempted under the premise that the applicant can provide certificate of the approval and the document literature of the experimentation, which should be reviewed and satisfy the safety requirement for pesticide product. ⑥ 6-month chronic test will be required for rodenticide.

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

PRODUCTS

1 CHEMICAL FORMULATED PRODUCT

DATA ITEM DEFINITION AND INSTRUCTION D E F G H I J K L M

Type of Registration: 1. D: new pesticide formulated pesticide, including non-new pesticide which is under 6-years data protection and the data access was not yet granted by its initial registrant;

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2. E: Formulated product with new formulation type 3. F: Formulated Product with new content 4. G: Formulated Product with new combination 5. H: Formulated product with new use scope 6. I: Formulated product with new application method 7. J: Me-too Formulated Product with same use scope and application method 8. K: Me-too Formulated Product with different use scope and application method 9. L: Similar formulated product with same use scope and application method

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1. Application Form Fill in the information as per the template provided by MoA. √


(1) Indigenous pesticide production company shall submit officially sealed photocopies of pesticide production license, Industrial and commercial business license and unified social credit code, etc.; (2) R&D entity of new pesticide shall provide supporting explanation on application of new pesticide ; (3) Overseas company shall provide identification documents, description on the registration status and uses in overseas country, the statement and business license of its Chinese branch or authorized agency.

√


4. Comprehensive report

4.1 Product overview Summary on the place of origin, product chemistry, toxicology, environmental impact data, and registration status in overseas countries, etc.

√

4.2 Summary on pesticide risk assessment Summary on the risk assessment of dietary, occupational health and environmental Impact, etc.

√

4.3 Summary on the benefit analysis Summary on the benefit analysis through economic, social and environmental aspects.

√

5. Template of product label and manual Pesticide label and manual should be prepared in accordance with the "Administrative Measures for Pesticide Labels and Manuals"

√

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--h. pesticide containing active ingredient with vapor pressure greater than 1×10-2Pa and the pesticide can be used in enclosure space such as warehouse or green garden, etc. --i. pesticide utilized under the application method which can cause a significant proportion(over 1%) of particles with diameter less than 50 µm ⑥ For pesticide not involved in new use scope or new application method, 1-year efficacy trial report will suffice. ⑦1-year efficacy trial report will suffice. ⑧For pesticide proposed for new pest, resistance study data will be required, including sensitivity determination of the targeted pest, method of resistance determination and risk evaluation result of pest resistance. ⑨Residue tests report will not be required for pesticide used on non-food and non-feed crops and seed-use pesticide(seed treatment, seed coating and presoaking etc.) using low or slightly toxic TC. For pesticides containing active ingredient(s) within data protection period, the applicant should submit the complete residue data or accessed data granted by the initial registrant/data owner. ⑩ If the new pesticide registration has collected the complete in-plant metabolism data or part of the collect metabolism data has included the type of crop proposed for registration, in-plant metabolism study will not be required. ⑪If the proposed crops are not for feed purpose, in-animal metabolic study will not be required. ⑫If the data was included and submitted in the environmental impact part, repeated submission in residue part will not be required. ⑬Referenced data with proper attribution will be acceptable. ⑭ If the product was a new content product compared with other pesticide previously registered by the applicant (including multiple compounded pesticides with same proportion of active ingredients) and both product possess the same target crop and dose, time, number and method of application and safety interval, etc., the residue data can be exempted. If the crop and application method are identical but alteration in dose, time and number of application and safety intervals might increase the residue risk, the applicant should provide the residue test report in halved trial sites, but at least 2 sites will be required. ⑮if alteration on dosage, number of application and safety interval that does not increase residue risk, residue test can be exempted. If the alteration increase the risk, the applicant should provide the residue test report in halved trial sites, but at least 2 sites will be required. ⑯If it was fully indicated by supporting data that the exposure possibility of certain environmental organism to the pesticide was very low, the applicant may apply for exemption from testing on the environmental organism. For pesticides used through trunk injection and painting or for in-door use only (sprouting inhibitor for post-harvest treatment of potato), data on environmental impact will not be required. ⑰Will not be required for pesticide only used in protected area. ⑱Data will be required for seed treatment, granular formulation applied through broadcasting and bait formulation. ⑲If susceptible environmental species was identified through toxicity test of TC on fish, Daphnia magna and Algea (up to 100 times more susceptible than other two species), the study of formulated product on the susceptible species will be required. Seed treatment for upland crop use, or granular formulation applied through furrow or cavity application will not be required for environmental impact data. ⑳Will not be required for non-spray formulations such as seed treatment, granules, soil treatment. ㉑Will not be required for pesticide only used in water bodies such as pond, river and lakes(e.g. lotus root), etc. ㉒Will not be required for only out-door use at residential area. ㉓ For registration conditions outside types D, H and I, the applicant should compare the application method and eco-toxicity profiles between the proposed product and other product which was previously registered by him, if the dose and number of application were not greater than the registered pesticide and the safety interval was equal to or longer than the registered product and the eco-toxicity was not greater than the registered pesticide, the environmental risk report will not be required.

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2. BIOCHEMICAL FORMULATED PRODUCT


Type of Registration: 1. D: new pesticide formulated pesticide, including non-new pesticide which is under 6-years data protection and the data access was not yet granted by its initial registrant; 2. E: Formulated product with new formulation type 3. F: Formulated Product with new content 4. G: Formulated Product with new combination 5. H: Formulated product with new use scope 6. I: Formulated product with new application method 7. J: Me-too Formulated Product with same use scope and application method 8. K: Me-too Formulated Product with different use scope and application method 9. L: Similar formulated product with same use scope and application method 10. M: Similar formulated product with different usage scope and application method Note: “√” means required, “×” refers to not required

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1. Application form Fill in the information as per the template provided by MoA. √



√



4.1 Product overview Summary on the place of origin, product chemistry, toxicology, environmental impact data, and registration status in overseas countries, etc.

√

4.2 Summary on pesticide risk assessment Summary on the risk assessment of dietary, occupational health and environmental Impact, etc.

√

4.3 Summary on the benefit analysis Summary on the benefit analysis through economic, social and environmental aspects.

√

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⑱ Will not be required for non-spray formulations such as seed treatment, granular, soil treatment. Will not be required for pesticide only used in water bodies such as pond, river and lakes (e.g. lotus root), etc. ⑲ Will not be required for seed treatment for upland crop and granules applied through furrow and cavity application.

3. MICROBIAL FORMULATED PRODUCT

DATA ITEM DEFINITION AND INSTRUCTION D E F G H I L M

Type of Registration: 1. D: new pesticide formulated pesticide, including non-new pesticide which is under 6-years data protection and the data access was not yet granted by its initial registrant; 2. E: Formulated product with new formulation type 3. F: Formulated Product with new content 4. G: Formulated Product with new combination 5. H: Formulated product with new use scope 6. I: Formulated product with new application method 7. L: Similar formulated product with same use scope and application method 8. M: Similar formulated product with different usage scope and application method Note: “√” means required, ““×” means not required.

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1. Application Form Fill in the information as per the template provided by MoA. √

2.Credential documents of the applicant


√

3. Declaration of the applicant Declaration on legitimacy and authenticity of the application materials.

√


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DATA ITEM DEFINITION AND INSTRUCTION D E F G H I L M

1.1 General information on target crop and pest Crop acreage, economic value and areal distribution status of the target crop in China and distribution, occurrence, way of damage, economic loss of target pest, etc.

√

1.2 Report on substitutability and benefit analysis

The proposed use, application method and the applicability to current agricultural practice; The use-cost of the proposed product, estimated redeemable loss and the influence on the incomes of growers; Comparative analysis between the proposed product and currently registered or commonly used product; Effect on pest resistance management of currently registered products; Possibility of substitution for highly risk product, etc.

√

2. Efficacy trial data

2.1 Report of laboratorial bioactivity test

Mode of action, spectrum, mechanism or deductive mechanism (only applicable for formulated product using new active ingredient); Report of laboratorial bioactivity test (applicable to single compounded formulation proposed for new target pest); Explanation on the purpose for combination of different active ingredients and formula screening report (required for multiple compounded formulation)

√ √ √ √ √ × × √

2.2 Experimental data on laboratorial bio-safety to target crop

Required when needed. √

2.3 Field trial report at plot scale②

(1) For insecticides and fungicides, a minimum of 2-year plot efficacy trial report in at least 4 provincial administrative areas or 1-year plot efficacy trial report in at least 8 provincial administrative areas will be required. For herbicide and plant growth regulator, a minimum of 2-years of trial report in at least 5 provincial administrative areas or 1-year plot efficacy trial report in at least 10 provincial administrative area will be required; For long-residue herbicides, Experimental data on bio-safety to succession crop will be additionally required. (2) For pesticide only targeting regional crops or pests, a 2-year plot trial report in 3 provincial administrative areas or 1-year plot trial report in 6 provincial administrative areas will suffice. (3) For forestry pesticides, a 2-year plot trial report in 3 provincial administrative areas or 1-year plot trial report in 6 provincial administrative areas will suffice. (4) For pesticide used under stable environmental condition (e.g.,

√ √④

√④

√ √

√④

√⑤

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ANNEX VI – DATA REQUIREMENT FOR PESTICIDE REGISTRATION FOR MINOR CROP

USE PURPOSE

1 APPLICABLE SCOPE

The practice of registration for minor crop use is only applicable for use scope expansion of a previously

registered product and joint experimentation by multiple applicants will be encouraged.

2. REQUIREMENT FOR EXPERIMENTATION

2.1 NUMBER OF TRIAL SITE

2.1.1 Efficacy trial should be conducted at least 3 sites.

2.1.2 Residue trial should be conducted at least 4 sites.

2.1.3 For crops grown in more than one provinces (districts, cities), the experimentation should be

conducted in multiple province with different agro-ecological types; if the crop was grown in local areas

in only one or two provinces (districts, cities), the study can be conducted at different areas in the same

province(district, city).

2.2 DURATION

The efficacy study on minor crop use pesticides can be conducted within one year

3 DATA REQUIREMENT

3.1 SUMMARY

3.2 PHOTOCOPY OF REGISTRATION CERTIFICATION

3.3 LABEL AND MANUAL APPROVED DURING INITIAL REGISTRATION

3.4 EFFICACY DATA

3.4.1 Benefit analysis;

3.4.1.1 General information on target crop and pest;

3.4.1.2 Socioeconomic benefit analysis;

3.4.1.3 Possibility analysis of substitution for other registered products;

3.4.2 Efficacy trial data;

3.4.2.1 Report of laboratorial bioactivity test (only required for expansion on new target pest);

3.4.2.2 Experimental data on laboratorial bio-safety to target crop (only required for expansion on new

target crop;

3.4.2.3 Field trial report at plot scale;

3.4.3 Other information;

The efficacy trial can be conducted at either the crop/pest proposed for registration, or the representative

crop or pest of the group which was separately specified under the crop/pest grouping for minor crop

use pesticide registration.

3.4.4 Comprehensive assessment report

3.5 RESIDUE

3.5.1 Experimental data on storage stability of pesticide residue

3.5.2 Analytical method of pesticide residue in crop

3.5.3Experimenta data on residue in crop

The applicant may either submit the trial report in accordance with the “Minimal Number of Residue Trial

Sites Required for Pesticide Registration” or the report of trial on the representative crop or pest of the

group which was separately specified under the crop/pest grouping for minor crop use pesticide

registration.

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

PESTICIDE REGISTRATION

The guideline was compiled under the actual areal distribution of major crops and occurrence of

diseases, insects sand weeds in China. For other crops, diseases, insects, weeds and particular pesticides

which was not yet specified in this guideline, the efficacy trial can be conducted in the representative

region in accordance with the crop areal distribution.

If it was unable to perform the study in accordance with this guideline due to pest occurrence or natural

disasters, the applicant may adjust the trial sites and justify these modifications.

1. GRAIN CROPS

1.1 RICE

Disease,

insect and

weed

Middle

Yangtze River

paddy region

Lower

Yangtze River

paddy region

Southern

China paddy

region

Southwest

China paddy

region

Huang-Huai

paddy region

Northern

China paddy

region

Hunan, Jiangxi,

Hubei, Henan

Jiangsu,

Zhejiang,

Anhui,

Shanghai

Guangdong,

Guangxi,

Fujian, Hainan

Sichuan,

Yunnan,

Guizhou,

Chongqing,

Shaanxi

Hebei, Tianjin,

Shandong,

Ningxia

Heilongjiang,

Liaoning, Jilin,

Inner

Mongolia

sheath blight 1 1 1 1

false smut 1 1 1 1

rice blast 1 1 1 1

bakanae

disease 1 1 1 1

planthopper;

leaf roller;

leafhopper

thrips

1 1 1 1

chilo

suppressalis 1 1 1 1

tryporyza

incertulas 1 1 1 1

Weeds in

transplanted

rice; weeds in

nursery rice

1 1 1 1 1

Weeds in

direct seeded

rice

1 1 1 2（in different regions）

Weeds in

seedling

throwing rice

5(at least 1 site at each region)

Note: the number in each cell refers to the number of trial site which should be arranged the region.

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ANNEX VIII-CROP GROUPING FOR RESIDUE TRIAL FOR PESTICIDE REGISTRATION

1 CEREALS

1.1 RICE: paddy, upland rice, etc.

Representative crop: rice.

1.2 WHEATS: wheat, barley, oat, rye, triticale, etc.

Representative crop: wheat.

1.3 UPLAND CROPS: corn, sorghum, millet, glutinous millet and adlay, etc.

Representative crop: corn.

1.4 COARSE CEREALS: mung bean, lentil, chickpea, adzuki bean, etc.

Representative crop: mung bean

2 VEGETABLES

2.1 BULBS

2.1.1 Bulb onions: garlic, onion, allium sinensis g don, etc.

Representative crop: garlic

2.1.2 Leaf onions: Chinese chieve, scallion, garlic sprouts, young garlic shoot, leek, etc.

Representative crop: chinese chieve

2.1.3 Lilies

2.2 BRASSICAS

2.2.1 Head brassicas: head cabbage, kohlrabi, brussels sprout, etc.

Representative crop: cabbage

2.2.2 Capitate brassicas: cauliflower broccoli, brassica oleracea, etc.

Representative crop: cauliflower broccoli

2.2.3 Stem brassicas: cabbage mustard, flower Chinese cabbage, stem mustard, leaf mustard, etc.

Representative crop: cabbage mustard

2.2.4 Chinese cabbage

2.3 LEAFY VEGETABLES

2.3.1 Green leafy vegetables: spinach, ordinary cabbage (pachoi, edible rape), leaf lettuce, water spinach,

edible amaranth, radish leaf, sugar beet leaf, garland chrysanthemum, leaf mustard, valerianella locusta,

endive, leaf lettuce, etc.

Representative crop: spinach, ordinary cabbage (pachoi, edible rape).

2.3.2 Leaf stalk vegetables: celery, cumin.

Representative crop: celery.

2.4 SOLANACEOUS VEGETABLES: tomato, chili, eggplant, okra, winter cherry, etc.

Representative crop: tomato, chili.

2.5 GOURD VEGETABLES

2.5.1 Cucumber

2.5.2 Small melons: squash, bitter gourd, loofah, line melon, bottle gourd, etc.

Representative crop: squash.

2.5.3 Large melon: wax gourd, pumpkin, winter squash. etc.

Representative crop: squash

2.6 LEGUMES

2.6.1 edible-podded legumes: cowpea, marrow bean, edible podded pea, winged bean, hyacinth bean,

sword bean, etc.

Representative crop: cowpea.

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ANNEX XI - PRINCIPLES FOR THE NOMENCLATURE OF PESTICIDE PRODUCTS

Below provisions are made under the “Regulation on the Administration of Pesticides” and the

“Administrative Measures for the Registration of Pesticides”, aimed at standardizing the nomenclature of

pesticide and protecting the benefit of pesticide producers and users:

1. The name of TC/TK product should be expressed by the Chinese common name or the abbreviated

common name of its active ingredient.

2. The name of single-compounded formulated product should be expressed by the Chinese common

name of its active ingredient.

3. The name of multiple-compounded formulated product should be expressed by the Chinese common

names or the abbreviated common names of its active ingredients. If the common name contains more

than 3 Chinese characters, abbreviated common names can be used for the nomenclature of multiple-

compounded formulated product. In principle, the name of a multiple-compounded formulated product

shall not be longer than 9 Chinese characters. When the name length of multiple-compounded

formulated product has exceeded 9 Chinese characters, the abbreviated common names should be

utilized. When the name length of multiple-compounded formulated product has not yet exceeded 9

Chinese characters, the abbreviated common names shall not be utilized. The common name or

abbreviated common name of each active ingredient should be separated by a space character (notated

as “•”, Chinese solid dot and half angle) and arranged by the Alphabetical order of their Chinese common

names).

4. The abbreviated common name can be formed by selecting no more than 3 Chinese characters form

the common name of its active ingredient with the principles of brevity, understandability, memorability

and unambiguity. An active ingredient can have only one abbreviated common name. If the active

ingredient exists in various salt compounds or different isomers, it can be expressed in the same

abbreviated common name and the difference on the chemical nature will be remarked on the

registration certificate and composition information of active ingredient(s) which included on product

label.

5. The abbreviated common name shall not be confused with the names of pharmaceuticals, veterinary

drugs, detergents, food, food additives, beverages and health care products ,etc. and shall not confused

with the common name, popular name of other active ingredient and formulation type.

6. The product name of direct-use hygienic pesticide the product can be expressed by a functional

descriptive word with the addition of its formulation type. If the hygienic pesticide was diluted prior to its

final usage, the nomenclature should comply with the provisions as set forth in items 2 and 3.

7. The name of a botanical pesticide can be expressed by the plant name of the botanical origin with the

addition of “Extract”.

8. The abbreviated common name will be determined by the Technical Committee on Pesticide

registration and can be utilized after the approval by the MoA.

9. The names of pesticides registered prior to the issuance of these principles can remain unchanged.

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