What are the requirements for the registration of fungicides in the new pesticide regulations

Everyone knows that the newly revised "Pesticide Management Regulations" has brought a great impact on the pesticide industry.
Many of the drawbacks of the pesticide industry that existed before have been revised.
Then, what are the regulations on the registration of fungicides? According to statistics from the Pesticide Inspection Institute of the Ministry of Agriculture, as of October 2016, there are more than 9,200 registered fungicides, of which 3,173 are mixtures
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In recent years, the registration and development of fungicides has several notable features: first, triazoles, methoxy acrylates, and SDHIs products are still hotspots for registration; second, super-efficient varieties continue to emerge, such as Syngenta’s Fluconazolamide, fluthiazole pyridoxine (EC50=0.
00025mg/L); third, the rapid development of bio-derived fungicides, microorganisms, plant-derived, agricultural antibiotics, etc.
; fourth, domestic independent research and development The variety of fungicides has been increasing, such as toxflufen, phenoxystrobin, chloroxystrobin, cyanostrobin, syringostrobin, oxystrobin, flufenostamide and so on
.
At the same time, the registration of fungicides on small crops has received attention and attention in recent years
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1 The main registration status of fungicides There are currently more than 80 crops (categories) registered, and the number of fungicides registered on different crops is also different
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The top three types of crops with the largest number of fungicide registrations are food crops, vegetables, and fruit trees.
The number of fungicides registered on these three types of crops exceeds 3,000, and the situation is very impressive
.
According to statistics, the number of fungicides registered on major crops accounts for 75% of the total, of which 2,420 are registered on rice, 1,938 are cucumbers, 1,290 are apples, 1,085 are wheat, and 1 are tomatoes.
There are 048 species, 561 bananas, 536 pears, 534 grapes, and 476 citrus, and there are fewer registrations on small crops
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A total of 20 new active ingredients of fungicides have been registered from 2013 to 2016, of which 3 were registered in 2016, namely fluoxastrobin, terpene alcohol and indazol sulfanilamide
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2 Issues that should be paid attention to in the efficacy test 2.
1 Issues that should be noted in the indoor test ①Technical issues that should be paid attention to in the indoor activity determination and formulation screening test In the indoor activity determination, first attention should be paid to the rationality of the test method, and the selection should be related to the characteristics of the agent and the prevention and treatment.
Test methods that are compatible with the biological characteristics of the target; secondly, attention should be paid to the rationality of the concentration gradient setting; finally, attention should be paid to the rationality of the selection of the control agent.
The control agent should be selected as the test agent with similar mechanism and mode of action.
In principle, it is not Choose the same active ingredient as the test agent
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First, the number of ratios should be sufficient, and at least 5 different ratios should be set according to relevant standards; second, the ratio of the ratio should be reasonable, and the ratio for the test of the formula screening test does not include the ratio of the product to be registered or the report recommendation The scope of the ratio does not include the ratio of the products applied for registration; third, the selection of test results should be reasonable.
In principle, the ratio with the largest synergistic effect or significant synergistic effect should be selected.
When applying for multiple control targets, there should be at least one The target is the best ratio, and other targets cannot have an antagonistic effect
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②The technical issues that should be paid attention to in the indoor safety test of crops should refer to the "Indoor Test Methods for the Evaluation of Fungicides and Pesticides on Crop Safety" (NY/T1965.
1?2010) and "Evaluation of the Safety of Seed Treatment Agents on Crops" Indoor Test Method" (NY/T1965.
3?2013)
.
First, the number of crop varieties should be sufficient.
In principle, the safety test should be conducted indoors during the seedling stage of the crop.
The test crops are tall crops such as fruit trees and forest trees.
If the safety test is difficult to complete indoors, it can be conducted in the field; At least 3 varieties of different biotypes, special circumstances such as the test crops are relatively rare and expensive, or when the variety in production is relatively single, the number of test crops can be relatively reduced, but a description of the situation should be provided
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Second, the test dose should meet the requirements.
According to the standard, the dose should not be less than 1 times, 2 times, and 4 times the high dose recommended in the field as the reagent amount for the safety test.
At the same time, the treatment without chemicals should be used as the blank control.

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Third, it is necessary to provide comprehensive survey data.
For example, fungicides should investigate the growth rate inhibition rate, the falling flower (leaf, fruit) rate and the increase rate of the empty grain rate, and the seed treatment agent should also investigate the germination rate and the emergence rate inhibition rate, etc.

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The current test lacks survey data, only records the types of phytotoxicity that can be observed visually, and lacks the necessary records and statistics of the degree of phytotoxicity
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2.
2 Issues that should be paid attention to in field trials ① In principle, the validity and consistency of the test report.
For the field efficacy test report for more than 5 years, a 1-year field efficacy verification test report should be provided, or the development of drug resistance should be provided.
Relevant data or information, explaining the changes in product usage measurement and technology
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The multi-site test should be consistent in the application method, application period, application dosage, control agent and investigation method
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② Application method The application method should match the dosage form, mode of action and the occurrence of the target of the test agent, and the description of the application method in multiple places should be consistent
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For example, the application method of thiophanate-methyl to control cucumber fusarium wilt is spraying.
The pathogen of the disease is the deuteromycete Fusarium oxysporum which is a cucumber-specific type.
In order to damage the vascular bundle, the spray application method is difficult to transmit to the vascular bundle, and the prevention and treatment effect is not ideal
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③The application period should indicate the target biological occurrence degree during the application period, and the growth period of the crop should also be noted for the test with a fixed application period
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④The application dosage should be based on the needs of prevention and treatment when it has been used for many years in production, and the test dosage range should be set reasonably to avoid the disconnection between the test dosage and the actual production
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At the same time, the effective dosage of each component in the mixed product should not be higher than the registered maximum dosage of a single agent
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2.
3 Other issues to pay attention to the legality of the active ingredient, with particular reference to Notice No.
194, No.
199, No.
274, No.
322, No.
1586, No.
1744, No.
2032, No.
2289 and so on
.
At the same time, the mixed product should also comply with the principle of mixing: no more than 2 active ingredients in the mixed preparation, no more than 3 active ingredients such as seed treatment agents, pheromones and herbicides; the mixing is in line with synergies, expanding the bactericidal spectrum, and delaying For the purpose of resistance, the experimental data should support the purpose of mixing; it is not recommended to mix the active ingredients with the same mechanism of action.
If you apply for registration, you need to submit test materials without cross-resistance
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3 Changes in the requirements for registration of fungicides under the new policy The new "Pesticide Management Regulations" implemented this year have made major adjustments to the pesticide management system, canceling temporary registrations, streamlining test approvals, and only approving new registration tests
.
The new pesticide management system implements classified management, which is divided into general pesticides, sanitary pesticides and rodenticides.
At the same time, the registration and management of genetically modified organisms and natural enemy organisms are cancelled
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This policy adjustment requires separate requirements for characteristic small crops.
First of all, the scope of characteristic small crops is stipulated by the Ministry of Agriculture
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Secondly, the registration of group expansion of the scope of use: no less than 3 field efficacy test points; the efficacy test of special small crop pesticide registration can be completed in one year; the test can choose "Special small crop pesticide registration efficacy test group Test reports on representative crops and control objects in the same group in the Directory
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Third, special case filing management: Special minor crops or new pests that have not yet registered pesticides, the provincial agricultural department will take temporary measures under the premise that the risk is controllable, and file with the Ministry of Agriculture
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The specific registration information changes are as follows
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3.
1 New drug efficacy data The new drug efficacy data should include benefit analysis, regional test reports and comprehensive reports.
Special attention should be paid to the analysis and report mentioned above for all types of registration
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①Benefit analysis The crops applied for registration should include the planting area, economic value, and distribution of the applied for creation; the profile of target organisms should include the distribution of the target organisms, the law of occurrence, the way of harm, and the economic losses caused
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The analysis should include the purpose, method of use, and actual adaptability to current agricultural production of the product applied for registration; the cost of using the product applied for registration, expected recoverable economic losses, and the impact on the income of growers; and the impact of existing registered products or production Comparative analysis of commonly used pesticides in China; the effect of resistance management on existing registered products and whether it can replace higher-risk pesticides, etc.

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②Regional efficacy test report for general field pesticides: if it is a chemical pesticide, it needs to include the test results of two or more provincial administrative regions in China; if it is a biochemical pesticide, microbial pesticide, and plant-derived pesticide, it needs to be included in the report.
more results than agro-ecological zones
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Crops grown in local areas: For biochemical pesticides, microbial pesticides, and botanical pesticides, the test results of more than 2 agro-ecological areas must be included
.
For pesticides used in places with relatively stable environmental conditions, such as pesticides for storage, preservation, and preservation, no regional efficacy test report may be provided
.
It should be noted that the regional test report can replace the demonstration test report.
Only the new pesticide registration requires a regional efficacy test report for more than one year
.
At the same time, it should be noted that due to the large amount of experimental data and materials, in order to facilitate the applicant and the registration department to sort out, compare and evaluate the efficacy data, all registration types should submit a comprehensive evaluation report when applying for registration, that is, to check all the efficacy data.
Summary summary
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