Temporary registration application documents for approval of pesticides
1 within the applicant shall sign the provincial pesticide institute views
(2) must provide two copies of the following materials and content should be exactly the same. One should be original, a copy can (but with six copies of application forms and product summary data). Copy of the data product chemistry, toxicology, efficacy, residue, environmental impact, packaging and labeling information should be, respectively, and the application form, the product summary data volumes bound. Application, product summary information and product safety data sheet should provide electronic text.
(1) "Application for temporary registration of pesticides."
(2) new pesticides should provide the following information:
① original drug:
A. Product summary data (origin, product chemistry, toxicology, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (the active ingredient, the original drug)
C. Toxicological information
D. Environmental impact information
E. The instructions are accompanied by labels or
F. Product Safety Data Sheet (MSDS)
G. Other information: in other countries or regions have the toxicology and environmental impact testing and registration information or a combination of query reports.
② Preparation:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (the active ingredient, the original drug, preparation)
C. Toxicological information
D. Efficacy data
E. Residual data
F. Environmental impact information
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
(3) Special new pesticide products should provide the following information:
① health use of pesticides (rodenticides, biochemical pesticides, botanical pesticides) TC:
A. Product Summary information (place of origin, product chemistry, toxicology, environmental impact, such as registration information outside the brief)
B. Product chemistry data (the active ingredient, the original drug)
C. Toxicological information
D. Environmental impact information
E. The instructions are accompanied by labels or
F. Product Safety Data Sheet (MSDS)
G. Other information: in other countries or regions have the toxicology and environmental impact testing and registration information or a combination of query reports.
② health with pesticide formulations:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (the active ingredient, the original drug, preparation)
C. Toxicological information
D. Efficacy data: report include indoor activity tests; the purpose of description and indoor mixed formulation screening report (for mixed formulations); two or more provincial-level administrative regions, more than 1 year of indoor efficacy test test reports; two or more provinces level administrative regions, more than 1 year of simulated field test report (indoor preparations); in our country more than two provincial-level administrative regions, more than one year field test report (termite preparations and preparations outside environment) and so on.
E. Environmental impact information
F. The instructions are accompanied by labels or
G. Product Safety Data Sheet (MSDS)
H. Other information: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
③ rodenticide formulations:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (the active ingredient, the original drug, preparation)
C. Toxicological information
D. Efficacy data: farmland, forests and grasslands on the use of rodenticides to provide two or more provincial-level administrative regions, more than 2 years of the efficacy of the test report; other cases the use of rodenticides to provide two or more provincial-level administrative regions, 1 year efficacy test report.
E. Residual data (full applicator of the rodenticide)
F. Environmental impact information
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
Parts, domestic enterprises), etc.
④ biochemical pesticide formulations:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (the active ingredient, the original drug, preparation)
C. Toxicological information
D. Efficacy data
E. Residual data (depending on the features and use of pesticides, provided in accordance with jury comments)
F. Environmental impact data (acute toxicity test report provided by the silkworm. Have a special risk to the environment of pesticides, should also provide additional information on the environmental impact.)
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
⑤ microbial pesticide:
A. Product Summary Information (products of chemical and biological characteristics, toxicology, environmental impact, such as registration information outside the brief)
B. Production of chemical and biological properties of materials (active ingredients, the original drug)
C. Toxicological data (the active ingredient for confirmation or other mammals are not known pathogens that information; basic toxicological information; additional toxicological data)
D. Environmental impact information
E. The instructions are accompanied by labels or
F. Product Safety Data Sheet (MSDS)
G. Other information: in other countries or regions have the toxicology and environmental impact testing and registration information or comprehensive inquiry report; variation in the release to the environment and risk descriptions.
⑥ microbial pesticide formulations:
A. Product summary data (origin, products of chemical and biological properties, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Products of chemical and biological properties of materials (active ingredients, the original drug, preparation)
C. Toxicological data (the active ingredient for confirmation or other mammals are not known pathogens that information; basic toxicological data)
D. Efficacy data
E. Residual data (depending on the features and use of pesticides, provided in accordance with jury comments)
F. Environmental impact data (acute oral toxicity test of birds, fish acute toxicity test, acute oral toxicity test bees, bee acute contact toxicity test, acute toxicity test silkworm)
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or comprehensive inquiry report; variation in the release to the environment and risk descriptions.
⑦ botanical pesticide formulations:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (the active ingredient, the original drug, preparation)
C. Toxicological information
D. Efficacy information include: the active ingredient or the original drug and the standard sample preparation for indoor activity determination report (field trial stage has been provided, and can provide copies); test crop of the interior when the crop safety trials report (field trials have provided , and can provide copies); field experiment report.
E. Residual data
F. Environmental impact information
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
⑧ GMO pesticides:
A. Product summary data (genetic engineering body profiles, toxicology, effects, residues, environmental impact, such as registration information outside of a brief description)
B. Overview of genetic engineering body
C. Toxicology information: genetic engineering body of mammals (rat) Acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, skin sensitization, agricultural security.
D. Efficacy data
E. Residual data (after toxicology tests showed that there are toxicity issues, toxic substances should be measured agricultural residues)
F. Environmental impact data (genetic engineering body debris impact on the environment, genetic engineering body residue decomposition characteristics in the environment, genetically engineered biological body residue effects on the environment)
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information: in other countries or regions have been genetically engineered body profiles, toxicology, environmental testing and registration information or a combination of query reports.
⑨ predators bio-pesticides:
A. Product summary data (biological characteristics, effects, environmental impacts, outside the brief registration, etc.)
B. Biological characteristics and product quality control requirements and test methods
C. Efficacy data (two or more provincial-level administrative regions, more than 2 years of field trials report; biological activity and safety data; application of risk prediction and control measures; Features and Precautions)
D. Impact on crops
E. Impact on the environment (state protected species, beneficial organisms, the impact of non-target organisms, and native species or hybrids of the small possibility and impact, etc.)
F. The instructions are accompanied by labels or
G. Product Safety Data Sheet (MSDS)
H. Other information: in other countries or regions have the biological characteristics and product quality control, efficacy, environmental impact testing and registration information or a combination of query reports.
(4) new agents should also provide the following information:
① new dosage form:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (the active ingredient, the original drug, preparation)
C. Toxicological information
D. Efficacy data
E. Residual data
F. Environmental impact information
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
② pesticide formulations minor optimization:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (the active ingredient, the original drug, preparation)
C. Toxicological information
D. Efficacy data
E. Residual data (such as one of the following conditions, our residue test results in the provision of summary information or written statement related to the case, can not provide residual test report: a formulation of the small business and the corresponding optimization formulations have been registered with residual test data and apply a small dosage of active ingredients to optimize the use of the product formulations of active ingredients of the original amount of 1.5 times using the following; b residual data of the applicants already have in our country have the same active ingredients, dosage form, scope and methods of using the official registration of 6 years, and the application to optimize product formulations of active ingredients with small amount of active ingredient is the use of 1.5 times; c independent with the same active ingredients, formulations, and methods of use of the registered product residue data were authorized, and apply a small dosage optimize the use of the product active ingredient is the use of its active ingredient 1.5 times.)
F. Environmental impact information
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
③ new mixed formulations, new drug formulations mixed fertilizer:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (the active ingredient, the original drug, preparation)
C. Toxicological information
D. Efficacy data
E. Residual data (such as product containing the active ingredients in the following conditions, our residue test results in the provision of summary information or written statement related to the case, you can remove the corresponding residue information requirements: a residual data of the applicants have been In our country have the same active ingredients, formulations, and methods of use of officially registered more than 6 years, and the product registration application for mixed formulations of the active ingredient is the use of use of its active ingredient is 1.5 times; b have the same effective independent ingredients, formulations, and methods of use of the information registered by license, registration and application for mixed formulations of the active ingredient in the product use is the amount of active ingredient used 1.5 times.)
F. Environmental impact information
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
④ new content:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (the active ingredient, the original drug, preparation)
C. Toxicological information
D. Efficacy data (relative to the enterprise applicants registered for the new content of the product, the product can change the content of active ingredients for more than 1 year of field plot efficacy trials)
E. Residual data (such as one of the following conditions, our residue test results in the provision of summary information or written statement related to the case, you can remove the corresponding residue information requirements: a residual data of the applicants have been in China to achieve the same effective ingredients, formulations, and methods of use of officially registered more than 6 years, and the application for registration of products use the active ingredient is the active ingredient use 1.5 times; b independent with the same active ingredients, formulations, and methods of use of information registered by the authority, and the application for registration of products use the active ingredient is the active ingredient use 1.5 times.)
F. Environmental impact information
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
⑤ new penetrant (or synergist) mixed with pesticide formulations
A. The penetrant, synergist common name, chemical name, structure, basic physical and chemical properties, concentration and detection methods, sources, security and other domestic and foreign use
B. The penetrant, synergist indoor formulation screening report
C. Applicants relative to the company's products have been registered active ingredient types and formulations of the same content, but increased the penetrant or synergist product registration, the registration can provide information on new content, other cases should be mixed according to the new formulations or new Mixture registration information.
(4) the same pesticide product shall submit the following information:
① contain the active ingredient has been made in our country is only temporary registration and the registration of pesticides during the period of data protection, according to a new pesticide registration should be required to provide information.
① ② In addition to the first item only to obtain temporary registration outside of the same pesticide product, single-agent formulations according to the provisional registration of the new content required to provide information; mixed formulations according to the provisions of the new mixed formulations temporary registration information.
(5) expand the scope to change the use of pesticide products and should submit the following information:
① to expand use of:
A. Product summary data (efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Efficacy data
C. Residual data (with the respective pesticide product registration application for registration temporary registration remains types of information required)
D. Environmental impact data (increased use of registration or registration to use the original pesticide product registration information provided does not meet environmental safety assessment requirements, should be added that the environmental impacts associated test data)
E. The instructions are accompanied by labels or
F. Other information
② change to use:
A. Product summary (including efficacy, residue, environmental impact, such as registration information outside of the brief and explain the purpose of changing the use and meaning)
B. Efficacy data
C. Residual data (with the respective pesticide product registration application for registration temporary registration remains types of information required)
D. Environmental impact data (due to changes in use, resulting in the original pesticide product registration information provided does not meet the requirements of environmental safety assessment, it should add the relevant environmental impact data)
E. The instructions are accompanied by labels or
F. Other information