The process of pesticide registration

The process of pesticide registration

Efficacy of pesticide registration information for some of the description of the problem

An application for field trials

Field experiment is the first stage of pesticide registration. In accordance with the requirements of the Ministry of Agriculture Bulletin No. 517, the application should be prepared to field test data are: field trial application form and additional information.

Field trials completed application form

"Field Test application of pesticides" in the "Pesticide Information Network of China" on the download site at: http://www.chinapesticide.gov.cn. Download: Log "China Pesticide Information Network", in the home page find the "data center" section, click on "Download", select "Application for Registration Guide Download: pesticide field trial application form" button.

Application form must be read carefully before filling the form in front of the "Guidance Note."

1.1.1 complete cover topics such as "product name" and "applicant." Product name should include three elements: the name of the active ingredient, active ingredient content, product formulation, active ingredient content expressed in two ways: quality score, with "%" means; volume weight, with "g / l" means. Such as: 40% pyrimethanil EC, 25 g / l cyhalothrin EC, and so on. Can not use "EC Pyrimethanil 40% (weight / weight)," "25 g / l cyhalothrin EC (weight / volume)," said.

"Applicant" means the application of the business name, full name to fill business (consistent with the official seal).

1.1.2 Home

Applicants must first fill in the name of earth address, telephone, zip code and other information, and recommended in the "outside the offices of the applicant or agency of a person filling out the appropriate contact handling, in particular, telephone (including mobile) in order to facilitate timely contact.

Pesticide type: in the corresponding category in brackets after the hit "√"

Fill out product registration categories: specific requirements see the "Guidance Note", 2 points to be emphasized: First, note 4, "according to the categories and fill in the registration of pesticide registration information corresponding to request such information," After this training, not with the corresponding data or incomplete data will not be accepted. The second is that the applicant for a Category 4 to determine the losses arising from errors, by themselves, that is, not the Department of Provincial and husband of the enterprise determine the type of product registration responsibilities and obligations.

Preparation of the active ingredients: There are several filled several. Test crop, control target: to fill a variety of crops, a variety of control objects and use, but must be completed branches.

1.1.3 Product Chemistry Part

It should be noted: in addition to product composition and content of active ingredients to specifically include full name, the other components should also write the name and content specific; the main physical and chemical parameters or control of the project: the standard should be consistent with the product, once the application for approval, this section is not change, or only re-apply.

Toxicology section 1.1.4

Original drug, preparations were completed to be, essential items. If Mixture should fill in the single dose of the original were drug-related values.

1.1.5 Pharmacodynamics

"Laboratory test results": According to different product categories to determine whether the registration indoor activity test, fill in mixed formulations or synergistic co-toxicity coefficient filter coefficient, the results of the indoor formula; "efficacy trials to be in China, time, place, crop, Control target, spraying method "should be separately stated, the time to write the year, if two or more control objects and need to be tested in different locations, you can fill out or add pages, respectively; prevention and control of the object following section," pesticide application period and methods "and can not simply write such spray or Guangen, pay attention to the period stated spraying;" Notes "to specify the use of pesticides in the technical, security or other matters requiring special state;" in other registration of crop and other national or regional circumstances ": this column is to illustrate the application for registration of products classified according to the products according to their application for registration of the categories, targeted to be described. For example, a company 80% Mancozeb WP proposed registration, the application test crops are tomatoes, early blight control object is, the registration category of "the same scope of use or method", then it should be listed in this column first in the be registered on tomato early blight Mancozeb 80% WP registration number, registration crops (tomatoes), control target (early blight), but can not just list a registration number, the registration of crop is cucumber cream mold, which control the object you are applying for does not matter, does not describe the problem.

1.2 The two issues need to explain

1.2.1 Toxicity measurement test or screening test recipes born of test subjects need to apply for provincial, fill out the "Indoor Health test an application form," and the cover seal units, measured by the Health Department for approval and then to the specified test units. Conducted laboratory experiments to provide the original drug. Single-agent trials need to have a common drug control, and must have five or more different concentrations of measured data; mixed formulations need to have single-agent and the ratio of 5 or more different groups of measured data.

1.2.2 confirmation on the product category, to recommend a technique (Disclaimer: only personal experience, whether scientific and rational, yet to be verified, but raised with the common communication). Electronic manual to determine the use of pesticides registration categories: for example, to check whether the same use of a product or method, can do: point out the electronic manual on pesticides in the home page click on "crops, control target => Pesticides", then click on "Registration Name" sort , then registration of pesticide they want to find out, if you can not find they have to apply the pesticides, the use of the product or method is not the same; if you want to find a pesticide, then the product you are applying for the same crop registration. Click on the corresponding registration number of pesticides, which can identify all of the registration of the product range and use.

Attention! Found in the same scope of use or method, to determine whether protection has expired, you must also use the Ministry of Agriculture announced the registration of an annual or monthly issue of the Department of Agriculture Pesticide Registration Notice briefing to determine the first registration of a control object time.

1.2.3 Pesticide approval term field experiment: a period of one month by the Ministry of the trial, after accepting the Ministry of Agriculture, Institute for Drug Control Department of the technical review period of three months, the Ministry of Agriculture administrative examination and approval period is 10 working days. This review period is the total four and a half. Pesticides are used for crops, has obvious seasonal. In other words, the application and the data is now complete, was accepted by the Ministry, and then it is possible to February 2007 to receive the review conclusion (! Test this conclusion may be approved, it may not be approved test), if it is approved, an enterprise can be commissioned in February 2007 began a pilot test units. But this season depends on the application of the control object and use, application period is, if it is winter wheat seed coating experiment, we can only wait until October 2007 to conduct tests, that is up to the 2008 June until the end of testing may be about to get a July 2008 report of the first year of testing. Therefore, enterprises in the application before the field trial must take into account this factor, pre-arranged the next two years, the production and reporting scheme, so as not to delay the trial.

2 on the pilot program

Pilot program should include the following:

First, the trial license number

Second, the requester

Third, the experimental design

Test agent and the amount (concentration) - the three dosage gradient, the amount can be determined with reference to the announcement of registration of pesticides or pesticide electronic manual.

Pharmacy and the amount of control: Note should be registered in the trial of pharmaceutical crops, mixed formulations, except in the single-dose control. Application and write the specific amount of regular usage.

Community arrangements: general randomized block arrangement, the plot area of the actual situation according to test guidelines and make appropriate adjustments.

Application methods: including the use of time, frequency, use precautions.

Fourth, the survey recorded: survey methodology, time and frequency, the survey content

V. Other criteria according to trial (which should indicate the number of specific standards, criteria has been out to three.)

Also to note: test is more pesticide registration testing, pilot programs to ensure more consistency, if the amount is a multiple of that must be specified for field crops per acre of water. Because when the Ministry of Agriculture to approve the amount of active ingredient is g / ha said, the only times that amount without that water, often resulting in large differences over water registration approval in the evaluation of the phenomenon can not be affecting the progress of approval . Conversion formula training in 2003 when we have already talked about. Now repeat:

Active ingredient (g / ha) = amount of preparation (g / mu) * * 15 active ingredient preparations

Multiple = per acre water / acre with the amount of preparation

Active ingredient (mg / kg) = 106 agents active ingredient content * / multiples

3 on the test sample

According to the Ministry of Agriculture Pesticide Registration Administration of the test sample, the province on January 1, 2004 implementation of the sample letters from the kind of system where the samples need to be registered test, the test to the provincial 农药检定所 before the closure sample, seal-like scores : number of copies required to remove trial, a province of the retained for future reference, the provincial seal of the annual 10% sample by spot checks, the failure of the samples found, the test report as an invalid address, and according to the Ministry of Agriculture test samples for pesticide registration regulations for punishment. Please check the relevant provisions of the Ministry of Agriculture Pesticide Registration Administration of the test sample. Test samples for pesticide registration are talking about here, including not only the field test sample, and includes registration for the use of toxicology and other test samples.