Ministry of Agriculture to make
No. 10
"Pesticide registration requirement" been December 6, 2007 Department of Agriculture 15th executive meeting, is hereby promulgated, and January 8, 2008 shall come into force. April 12, 2001 the Ministry of Agriculture "on the release <pesticide registration requirements of" notice "(Agriculture Agricultural Development [2001] No. 8) since January 1, 2009 repealed.
Minister: Sun Zhengcai
December 8, 2007
Pesticide registration requirements
Chapter I General Provisions
1.1 In order to regulate the registration of pesticides, pesticide products to ensure quality, promote agricultural development, protect the environment, according to the "Pesticide Management Regulations" (hereinafter referred to as "the" Regulations "") and "Implementation Measures pesticide regulations" the relevant provisions of the enactment of this pesticide registration provisions (hereinafter referred to as "Regulations").
1.2 applies in China in the production (including the original drug production, processing and packing preparations) and imports from outside the registration of pesticide products.
1.3 The applicant shall comply with the 'Regulations' requirements. Overseas applicants should be registered according to law in our country with the office or agency.
1.4 new pesticides, new agents into the field trial product registration, provisional registration and full registration of three stages.
1.5 pesticide registration application shall be provided in accordance with the provisions of pesticide registration information and samples.
1.5.1 apply for temporary registration of new pesticides or official registration, provide the active ingredients should be pure or standard 2 grams of active ingredient important metabolites, related impurities standard 0.5 g, TC 100 grams (ml), preparation 250 grams (ml ).
1.5.2 for efficacy, residue, toxicity, environmental samples of pesticides should be registered test mature shape of the test product, and quality testing by the provincial statutory agency qualified. Domestic product by the applicant's area of administrative departments at provincial agricultural pesticide certification bodies (hereinafter referred to as the provincial pesticide institute) seal-like, outside of the product by the Ministry of Agriculture seal-like.
1.5.3 the information submitted should be complete, standardized, data should be true and effective. Application, product summary information and product safety data sheets (MSDS) should be provided electronically.
1.5.3.1 pesticide efficacy, residue, toxicology, environmental impact and the original all-components analysis, drug registration trial data should be announced by the Ministry of Agriculture's pesticide registration with the appropriate qualifications test units issued; pesticide product quality inspection report should be above the provincial level statutory quality inspection agency issued.
1.5.3.2 overseas test data should be confirmed by the Ministry of Agriculture issued by the agency, along with Chinese summary data.
1.5.3.3 Pesticide Registration outdoor test range should be registered according to the product distribution, a representative selection of areas.
1.5.3.4 annotated works cited literature should be the name, titles and volume number, issue, page and so on.
1.5.3.5 livestock products, crops, environmental impact, which may cause harm, the applicant shall provide information on hazard control measures.
1.6 The applicant should be registered on the authenticity of the information provided and does not infringe intellectual property rights of others to make a written statement and commitment may constitute infringement of the consequences.
1.7 State of first registration, with the new pesticide compounds provided by the applicant of its own and has not been achieved by the disclosure of test data and other data protection implementation.
Since the six years from the date of registration, the other applicants have been registered without the consent of the applicant, the use of pesticide registration applications for the preceding data, the Ministry of Agriculture shall not be registered; However, other applicants to provide their own data obtained excluded.
Encourage independent owners with complete information has been authorized to use the registration information of other applicants.
1.8 officially registered products for direct application, the applicant shall submit the interim stage of the registration stage and officially registered under the relevant information.
Expand the use of the product range of 1.9 to change the use or change the dose, do not change the validity of the registration of the product.
1.10 in the temporary registration period has been provided testing and inspection data, the official registration of new pesticide application, can provide a copy; apply for other types of formal registration, the written description of the case, can no longer be available.
1.11 does not change the active ingredient in the type of content, dosage form, scope and methods used under the premise of the product optimization, registration certificate holder to the Ministry of Agriculture should submit a written application, provided does not affect product quality, efficacy, toxicology, residues and environmental safety information, and reviewed by the Ministry of Agriculture.
1.12 Classification of pesticide products and additives in pesticide formulations applied in the registration information requested separately.
1.13 pesticide registration application information by the temporary registration of pesticide review committee or the jury panel, the product does not fully meet the evaluation requirements, the applicant should be based on review comments, add relevant information.
1.14 not covered by special provisions, requiring reduction of information, the applicant may submit a written application Ministry of Agriculture together with the relevant information, the Pesticide Registration Evaluation Committee or the temporary registration of pesticides, the jury panel, made by the Ministry of Agriculture decision.
Terminology and scope Chapter II
2.1 is a new pesticide containing the active ingredient has not been approved in China's domestic and international pesticide registration and formulation.
2.2 refers to new formulations containing the active ingredient and has registered over the same, and dosage form, content (ratio) has not yet been registered in our preparations.
2.2.1 refers to new formulations containing the active ingredient and has registered over the same, and dosage forms has not yet been registered in our preparations.
2.2.2 optimized small dose is a registered product formulations optimized for small, more conducive to environmental protection and the type and content of active ingredient (ratio) unchanged. Include the following situations:
- From WP (WP) becomes available dispersible granules (WG);
- By the EC (EC) into a water emulsion (EW) or oil emulsion (OW) or micro-emulsion (ME) (not including a large number of organic solvents);
- By the soluble powder (SP) into soluble granules (SG);
- From the granules (GR) into a fine-grained agent (FG) or particulate agent (MG);
- Other.
2.2.3 New mixed formulations are those containing the active ingredient and dosage form and have registered over the same and the first of more than two mixed formulations or active ingredients of pesticides Although mixtures have the same active ingredients, but the ratio of different product registration preparations.
2.2.4 is the new content formulations and dosage forms containing the active ingredient has been registered with the same, while the content (the ratio of the same mixed formulations) had not been registered in our preparations.
2.2.5 Drug fat is mixed formulations and dosage forms containing the active ingredient has been registered with the same, and the first active ingredient mixed pesticides and fertilizer ingredients preparation or product registration, but has produced mixed ratio of different agents .
2.2.6 New penetrant (or synergist) with the mixed formulations are those containing a pesticide active ingredients and formulations have been registered with the same, and the first mixed pesticide active ingredients and penetrant (or synergist) component Although there are mixed formulations or products registered but penetrant (or synergist) species, the ratio of different formulations.
2.3 pesticide mainly refers to the special health use of pesticides, rodenticides, biochemical pesticides, microbial pesticides, botanical pesticides, genetically modified organisms, biological and other natural enemies.
Special new pesticides containing the active ingredient is not registered in China and abroad approved pesticide and special agents.
2.3.1 Health of pesticides is used to prevent, eliminate or control the living environment of people in the aquaculture and agroforestry animal living environment mosquitoes, flies, cockroaches, ants and other pests pesticides.
2.3.2 rodenticide is used to prevent, eliminate and control rodents, rodents and other harmful pesticides.
2.3.3 Pesticide Biochemistry Biochemistry pesticides must meet the following two conditions:
- Prevention and treatment of objects is not directly toxic, but only regulate growth, interfere with mating or lure, and other special effects;
- Must be a natural compound, if it is synthetic, and natural compounds, their structure must be the same (to allow differences in the proportion of isomers).
Biochemical pesticides include the following four categories:
2.3.3.1 pheromone secreted by plants and animals, can change the same or different kinds of receptor biological behavior of chemical substances, including pheromones, self-serving element, kairomone.
2.3.3.2 hormone is synthesized by the organism can be transmitted to a part from other parts of the control, regulation of biochemical substances.
2.3.3.3 natural plant growth regulators and natural insect growth regulator
Is a natural plant growth regulator produced by plants or microorganisms, on the same or different species of plant growth and development (including germination, growth, flowering, fertilization, fruit, ripe and shedding process) can inhibit, stimulate or regulate such effect plant resistance to stress (cold, hot, dry, wet and wind, etc.) of chemical substances.
Natural insect growth regulators are produced by insects to inhibit the growth process of insects, such as the role of chemical stimuli.
2.3.3.4 enzyme in the reaction as a gene carrier in biochemical reactions in the body act as a catalyst of protein molecules.
2.3.4 Microbial pesticides are bacteria, fungi, viruses and protozoa or micro-organisms such as genetically modified in vivo as an active ingredient, with control diseases, insects, grass, rats and other harmful biological effects of pesticides.
2.3.5 is a botanical pesticide active ingredients derived from plants of the pesticide.
2.3.6 GMO refers to the prevention and treatment "regulations" referred to in Article II of pests, use of exogenous genetic engineering techniques to change the composition of the genome of agricultural biotechnology. Does not include naturally occurring, artificial selection and cross breeding, or by physical methods of chemical mutagenesis, cell engineering techniques to get through the plants and naturally occurring, artificial selection, artificial insemination, superovulation, chimeric embryos, embryo division, nuclear transfer, times of operation to get the animals, and through chemical and physical mutagenesis, transduction, transformation, recombinant DNA and other non-bonding approach to genetic traits modified micro-organisms.
2.3.7 predators is the commercialization of biological control with the "Regulations" referred to in Article II of biological pest living (except for microbial pesticides).
2.4 is the same active ingredient pesticide product types, content, formulations and other products have been registered with the same product.
2.4.1 no significant difference in the quality of the original drug is the same as the original drug application for registration and the registration has been made no significant difference in the quality of the original drug, that is, its active ingredient content of not less than the original drug has been registered, and the impurities (content 0.1 percent and 0.1 percent but the mammals, there are significant environmental harm) the composition and content of the registered drugs are basically the same or less than the original registered the original drug.
2.4.2 no significant difference in the quality of preparation is the same application for registration of registered agents and has made no significant difference in the quality of products, that product types of active ingredients, dosage forms, the same content, the other major controls and indicators are not lower than the registered products, auxiliary components and content consistent with the registered products or equivalent.
2.5 New methods of registration and use of active ingredients and preparation is already enrolled with the same, but the scope and methods of use have not yet registered in China before.
2.5.1 is the use of newly registered active ingredients and formulations have been registered with the same, while the use of registration had not been in our country.
2.5.2 New registration method is to use active ingredients, preparation and use of the scope and registered over the same, but use had not been registered in China.
2.6 expand the scope to change the use and dose changes
2.6.1 expand the scope of registered products is to increase use of applications.
2.6.2 changing the use of registered products is to increase or change the application to use.
2.6.3 change the dosage is to change the use of registered products applied dose.
2.7 is defined in the pesticide active ingredient additives other than any intentionally added to the pesticide product itself does not have pesticide activity, but can increase or improve, or help to increase or improve the product physical and chemical properties of a single group points or more components of the mixture.
2.8-related impurities is compared with the pesticide active ingredients, pesticide products in the production or storage process contained in the human and the environment has obvious toxicity, or for crops to produce injury, or cause contamination of agricultural products, or affect the quality of pesticide products stability, or cause other adverse effects of impurities.
Chapter III provides new information on pesticide registration
3.1 General requirements
3.1.1 on the new pesticide, the applicant shall also apply for their original registration of drugs and formulations. New pesticide registration, the applicant may apply for the original drug and the preparations were registered.
3.1.2 has been registered in our country and in the protection period of the pesticide registration, pesticide registration requirements under the new information.
3.1.3 Special new pesticide registration, applicable provisions of Chapter IV.
3.2 Registration of new pesticide
3.2.1 temporary registration the original drug
3.2.1.1 Temporary Registration Application Form
3.2.1.2 Summary of Data Products
Including the origin (of manufacturing the product addresses, the same below), product chemistry, toxicology, environmental impact, such as registration information outside of the brief.
3.2.1.3 Product chemistry data
3.2.1.3.1 Identification of the active ingredient
Active ingredient common name, the international generic name [implementation of the International Organization for Standardization (ISO) approved name, the same below], chemical name, Chemical Abstracts Service (CAS) Registry Number, International Pesticide Analytical Partnership Committee (CIPAC) digital code, development number, structural formula, empirical formula, molecular weight (used in the calculation indicate the relative atomic mass table of the international release time, the same below).
There are many forms of active ingredients exist, it should be clear that the active ingredient present in the form of the final product, and indicate the exact name, structural formula, empirical formula and molecular weight.
Active ingredients and active isomer exists a significant difference, the proportion should be indicated.
3.2.1.3.2 physical and chemical properties of the active ingredient
Should provide standard samples (generally be higher than 98% purity) and the determination of the following parameters: appearance (color, physical state, odor, etc.), acid / alkalinity or pH range, melting point, boiling point, solubility, density or bulk density, Partition coefficient (octanol / water, the same below), vapor pressure, stability (light, heat, acids, alkalis), hydrolysis, explosive, flash point, ignition, oxidizing, corrosive, alpha (for a optical activity, the same below), etc.
3.2.1.3.3 of the original drug's physical and chemical properties
Shall provide the original drug and the determination of the following parameters: appearance (color, physical state, odor, etc.), melting point, boiling point, explosive, flash point, ignition, oxidation, corrosion, specific rotation and so on.
3.2.1.3.4 Control Project and their indicators
A content of active ingredient
Clearly the minimum active ingredient content (in mass fraction). No grading, at least 5 batches of taking representative samples to measure levels of its active ingredient, take 3 times the standard deviation as the lower levels.
B-related impurities
Specifically related to the highest level of impurities (in mass fraction).
Add the name of the other components of C, content
Based on the actual situation on the added stabilizer, security agents, clear and specific names, content.
D acidity, alkalinity or pH range
Acidity or alkalinity to the mass fraction of sulfuric acid or sodium hydroxide, said, regardless of its actual forms. pH range should provide upper and lower limits.
E solid insoluble
Provides the maximum allowable value, quality fraction.
F Loss of water or heating
Provides the maximum allowable value, quality fraction.
3.2.1.3.5 and product quality control project and its indicators correspond to the detection method and method validation
Feed detection methods typically include methods, principles (such as chemical reaction equation, etc.), equipment, reagents, operating conditions, solution preparation, determination of procedures, results calculation, and the associated spectrum allows the poor and so on.
Confirmation of detection methods including the linear relationship between the precision, accuracy, and so the original spectrum, low-level control of the project and its indicators should also be given the lowest detectable concentration.
Use of the existing national standards, industry standards or CIPAC methods, the need to provide the original chromatogram (including but not limited to standard products, such as samples and internal standard chromatogram), can not provide a linear relationship, precision, and accuracy of data minimum detectable concentration of test data.
3.2.1.3.6 Control of indicators to determine the description of the project and its
Control project and its development of indicators and reasonable basis to make the necessary explanations.
3.2.1.3.7 TC 5 batch analysis of all components
All components including the active ingredient, 0.1% of the content of any impurities and 0.1% of the relevant impurities.
A qualitative analysis
Impurities of the active ingredients and provide related: infrared spectroscopy (IR), ultraviolet spectroscopy (UV), mass spectrometry (MS) and nuclear magnetic resonance spectroscopy (NMR) test methods, analytical procedures, and Structure.
Provided to non-related impurities: infrared spectroscopy, mass spectrometry and nuclear magnetic resonance in at least a qualitative test method, the resolution process, structured and impurities name.
Quantitative Analysis B
Mass fraction of each component provided, determination and method validation process.
3.2.1.3.8 product quality testing and method validation report
Providing national quality inspection agency issued a statutory product quality testing and method validation report.
Quality inspection report should include items all items specified in 3.2.1.3.4. Method validation report should be attached to the original relevant typical chromatograms, and to evaluate the feasibility of the method, stamped with the official seal of inspection.
3.2.1.3.9 Production
A raw materials, chemical name, code, purity;
B reaction equations (including the main product, by-products);
C production flow chart.
3.2.1.3.10 packaging (including material, shape, size, weight, etc., the same below), transport and storage precautions, safety alerts, the acceptance period, etc.
3.2.1.4 Toxicological information
3.2.1.4.1 Acute toxicity test
A acute oral toxicity test;
B acute skin toxicity test;
C acute inhalation toxicity
One of the following conditions of products, should provide the toxicological data (below):
- The gas or liquefied gas;
- May be used for processing of fumigants;
- May be used for processing of smoke, fog or gas production release formulations;
- May need to spray the pesticide application equipment;
- Vapor pressure of> 10-2Pa, and may be used for processing in the warehouse or greenhouse and other agents used in confined spaces;
- May be included in powder formulations, and its diameter with <50μm particles account for a large proportion (by weight> 1%);
- For processing arising from the use of agents in diameter <50μm particles or droplets account for a large proportion (by weight> 1%);
D eye irritation test;
E skin irritation test;
F skin sensitization tests.
3.2.1.4.2 Asia Slow (acute) toxicity test
Requires 90 days feeding study in rats. Based on product characteristics should also be 28 days or 28 days after skin inhalation toxicity test.
3.2.1.4.3 Mutagenicity test
A Salmonella typhimurium / reverse mutation test;
B in vitro mammalian cell gene mutation test;
C in vitro mammalian cell chromosome aberration test;
D in vivo mammalian bone marrow micronucleus test.
AC trials than any of the positive result, the first item D is negative, you should add another in vivo (preferred mammalian cells in vivo UDS test). When the AC entry test results were negative, and the first item D is positive, you should increase the reproductive cells in vivo mammalian chromosome aberration test or the dominant lethal test.
3.2.1.4.4 necessary, should provide 6 months to 2 years of chronic and carcinogenicity studies.
3.2.1.4.5 delayed neurotoxicity test (to organophosphate pesticides, or chemical structure and delayed neurotoxicity positive substances structurally similar pesticides, the same below).
3.2.1.5 Environmental Impact Data
Provides the following test report. According to features or use of different pesticides, some relief may be appropriate tests (see, Annex 4, below).
3.2.1.5.1 environmental behavior test
A volatile test (should clarify three different ways of evaporation characteristics; on the vapor pressure of less than 1 × 10-5Pa of pesticides is not required; below);
B soil assay (for the test should be clarified in the three pesticides in the soil adsorption / desorption, the same below);
C leaching test (the test should be clarified in the three pesticides leaching of the soil, the same below);
D soil degradation test (it should be clarified in the aerobic and anaerobic conditions, the mother of the degradation pathway, the main metabolite of the parent and degradation, the same below);
E hydrolysis test (it should be clarified in the three pesticides tested the pH buffer solution in the hydrolysis and the degradation pathway in the water the mother, the mother and the degradation of the major metabolite; below);
F water photolysis experiments (it should be clarified for the test pesticides in water by photolysis, as well as in water photolysis degradation pathway when the mother, the mother and the degradation of the major metabolite; below);
G soil surface photolysis experiments;
H water - sediment degradation test (it should be clarified in the water - sediment system in the maternal degradation pathway, the main metabolite of the parent and degradation, the same below).
3.2.1.5.2 Environmental Toxicity
A bird acute oral toxicity test (limit test dose of 1000 mg / kg, the same below);
B short-term feeding of birds toxicity test;
C fish acute toxicity test (test should be used one kind of warm water species, such as high toxicity test results shall be re-tested using a cold-water fish species, and provide risk assessment analysis of information; in addition to insoluble compound, the test dose limit of 100mg / L; below);
D Daphnia acute toxicity test (in addition to insoluble compound, the test dose limit of 100mg / L, the same below);
E algal acute toxicity test (in addition to insoluble compound, the test dose limit of 100mg / L, the same below);
F bees acute oral toxicity test;
G bee acute contact toxicity test;
H silkworm acute toxicity test;
I test non-target vegetation (only herbicides and plant growth regulators, the same below).
3.2.1.6 accompanied by the label or instructions
Shall be in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and sample test results of the design, content can be used after approval.
3.2.1.7 Product Safety Data Sheet (MSDS)
The specific format requirements see Annex 6 (below).
3.2.1.8 Other information
3.2.1.8.1 in other countries or regions have the toxicology and environmental impact testing and registration information or a combination of inquiry reports
3.2.1.8.2 Other
3.2.2 of the original drug official registration
3.2.2.1 official registration application form
3.2.2.2 Summary of Data Products
Including place of origin, product chemistry, toxicology, environmental impact, such as registration information outside of the brief.
3.2.2.3 Product chemistry data
With temporary registration requirements, see 3.2.1.3.
3.2.2.4 Toxicological information
3.2.2.4.1 Acute toxicity test
A acute oral toxicity test;
B acute skin toxicity test;
C acute inhalation toxicity;
D eye irritation test;
E skin irritation test;
F skin sensitization tests.
3.2.2.4.2 Asia Slow (acute) toxicity test
Require 90 days feeding study in rats. Based on product characteristics should also be 28 days or 28 days after skin inhalation toxicity test.
3.2.2.4.3 Mutagenicity test
A Salmonella typhimurium / reverse mutation test;
B in vitro mammalian cell gene mutation test;
C in vitro mammalian cell chromosome aberration test;
D in vivo mammalian bone marrow micronucleus test.
AC trials than any of the positive result, the first item D is negative, you should add another in vivo (preferred mammalian cells in vivo UDS test). When the AC entry test results were negative, and the first item D is positive, you should increase the reproductive cells in vivo mammalian chromosome aberration test or the dominant lethal test.
3.2.2.4.4 Reproductive toxicity
3.2.2.4.5 Teratogenicity Tests
3.2.2.4.6 Chronic toxicity and carcinogenicity testing
3.2.2.4.7 delayed neurotoxicity test
3.2.2.4.8 In vivo metabolism
As needed, to provide the compound in vivo absorption, distribution, excretion, accumulation, transformation, and metabolites and their toxicity data.
3.2.2.4.9 population exposure survey
3.2.2.4.10 toxicity data related impurities
3.2.2.4.11 daily intake (ADI) or provisional tolerable daily intake (TADI) data
3.2.2.4.12 symptoms of poisoning, first aid and treatment information
3.2.2.5 Environmental Impact Data
Provides the following test report. According to features or use of different pesticides, some relief may be appropriate test.
3.2.2.5.1 environmental behavior test
A volatile test;
B soil assay;
C leaching test;
D soil degradation test;
E hydrolysis test;
F water photolysis experiments;
G soil surface photolysis experiments;
H water - sediment degradation test;
I Bioconcentration test (only when pesticides need to log pow ≥ 3 provided below).
3.2.2.5.2 Environmental Toxicity
A bird acute oral toxicity test;
B short-term feeding of birds toxicity test;
C fish acute toxicity test;
D Daphnia acute toxicity test;
E algal acute toxicity test;
F bees acute oral toxicity test;
G bee acute contact toxicity test;
H predators Trichogramma acute toxicity test;
I predators of amphibians acute toxicity test;
J silkworm acute toxicity test;
K earthworm acute toxicity test;
L crustacean toxicity test (for insect growth regulator, the same below);
M soil microorganisms affect the test (using two kinds of test should be representative of fresh soil, the same below);
N non-target vegetation test.
3.2.2.5.3 other environmental impact information
Some aspects of the environmental risks of specific pesticides, should also provide additional information. Include: the impact of groundwater, soil impact on the terrestrial, aquatic toxicity, reproductive toxicity or chronic.
3.2.2.6 accompanied by the label or instructions
3.2.2.6.1 in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and test results of the official registration tag design sample
3.2.2.6.2 approve temporary registration of pesticides, pesticide registration approval seal affixed label proofs, instruction manual (copy below)
3.2.2.6.3 in the market during the temporary registration tag in circulation
3.2.2.7 Product Safety Data Sheet (MSDS)
3.2.2.8 Other information
3.2.2.8.1 in other countries or regions have the toxicology, efficacy, residue, environmental impact testing and registration information or a combination of inquiry reports
3.2.2.8.2 Other
3.3 Registration of new pesticide formulations
3.3.1 Field trials
3.3.1.1 Field Test Application Form
3.3.1.2 Summary of information on chemical products
3.3.1.2.1 active ingredients
Active ingredient common name, the international generic name, chemical name, Chemical Abstracts Service (CAS) Registry Number, International Pesticide Analytical Partnership Committee (CIPAC) digital code, development number, empirical formula, molecular weight, structure, major physical and chemical parameters (such as: appearance, melting point, boiling point, density or bulk density, specific rotation, vapor pressure, solubility, partition coefficient, etc.).
3.3.1.2.2 TC
Active ingredients, mainly the name and content of impurities, the main physical and chemical parameters (such as: appearance, melting point, boiling point, density or bulk density, specific rotation, etc.), the active ingredient analysis methods.
3.3.1.2.3 Preparation
Formulations, active ingredients, other components of the specific names and content, the main physical and chemical parameters, quality control project and its target, category (by use), the active ingredient analysis methods.
3.3.1.3 Summary of toxicological data
3.3.1.3.1 TC
Acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, skin and eye irritation and skin sensitization tests.
3.3.1.3.2 Preparation
Acute oral toxicity, acute dermal toxicity, acute inhalation toxicity and symptoms first aid measures.
3.3.1.4 efficacy data
3.3.1.4.1 mode of action, action spectra, the mechanism or the mechanism of prediction analysis
3.3.1.4.2 indoor activity tests reported
3.3.1.4.3 When the crop for the indoor test crop safety trials report
3.3.1.4.4 the purpose of description and indoor mixed formulation screening report (for mixed formulations)
3.3.1.4.5 test crops, control objects, application methods and precautions
3.3.1.5 Other information
In other countries or regions have the field efficacy, toxicology, residues, environmental impact and registration, etc. or a combination of query reports.
3.3.2 temporary registration
3.3.2.1 Temporary Registration Application Form
3.3.2.2 Summary of Data Products
Including place of origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside the brief.
3.3.2.3 Product chemistry data
3.3.2.3.1 Identification of the active ingredient
Active ingredients generic name, the international generic name, chemical name, Chemical Abstracts Service (CAS) Registry Number, International Pesticide Analytical Partnership Committee (CIPAC) digital code, structure, empirical formula, molecular weight.
There are many existing forms of active ingredients (eg, salt or ester), it should be clear that the active ingredient present in the form of the final product, and indicate the exact name, structural formula, empirical formula and molecular weight.
There are significant differences between active isomers, the ratio should be clearly stated and effective body.
3.3.2.3.2 of the original drug (or parent drug) Basic Information
Active ingredients (real form) levels, related impurities and so on.
3.3.2.3.3 Product composition
Preparation of all components of the specific product name, content and role in the product. For the restrictive components, such as penetrant, synergist, security etc., should also provide its chemical name, structure, basic physical and chemical properties, sources, security, inside and outside use of such information.
3.3.2.3.4 processing methods described
Major equipment and process.
3.3.2.3.5 Identification Test
Active ingredient in products such as the identification of test methods.
3.3.2.3.6 Physical and Chemical Properties
Determination of the following parameters and measurement results: the appearance (color, physical state, odor, etc.), density or bulk density, viscosity, flammable, corrosive, explosive, flash point and mixed with other pesticides and so on.
3.3.2.3.7 Quality Control Project
A concentration of active ingredients (including the proportion of isomers)
have a national standard, industry-standard products, according to the corresponding standard active ingredient content.
b Not yet a national standard, industry-standard products, according to the provisions of the effective ingredients in Table 1. Indicate the content producers on the label is the active ingredient content; permitted fluctuation range of customers or third-party testing organization registered in accordance with the life of the product testing methods for detection, it should be in line with the concentration range.
Table 1, the active ingredient content of the product range of requirements
Indicate the content X (% or g/100mL, 20 ℃ ± 2 ℃)
Allowed fluctuation range
X ≤ 2.5
± 15% X (for EC, SC, may evenly preparation solution etc.)
± 25% X (on the granules, water dispersible granule formulations of non-uniform etc.)
2.5 <X ≤ 10
± 10% X
10 <X ≤ 25
± 6% X
25 <X ≤ 50
± 5% X
X> 50
± 2.5% or 2.5g/100mL
Solid dosage forms the active ingredient content in mass fraction (%) indicated. Liquid formulations of chemical products in the product information should be both clear and effective ingredients in the product g / L and mass fraction (%) that the technical requirements, applicants to take one of them that way on the label.
Special products can refer to Table 1, the scope of the development of effective ingredients required.
B-related impurities
Provisions related to the maximum levels of impurities to the mass fraction of that.
C other restrictive component (penetrant, synergist, security etc.) content
According to the provisions of the actual situation.
Other formulations D projects related to control
Annex 1. Not listed in Annex 1 formulations, can refer to the FAO (FAO), World Health Organization (WHO) to develop specifications. Innovative dosage forms of control programs according to the characteristics of the active ingredient, application methods, safety and other aspects into account to develop.
E storage stability
Including low-temperature stability (for liquid preparations), thermal storage stability (for solid, liquid formulations), freeze-thaw stability (for micro-capsules).
3.3.2.3.8 indicators and quality control of projects and their corresponding test methods and method validation
Requirements see 3.2.1.3.5.
3.3.2.3.9 Quality control indicators to determine the description of the project and its
Quality control of the project and its development of indicators and reasonable basis to make the necessary explanations.
3.3.2.3.10 determination of product quality testing and verification report
Providing national quality inspection agency issued a statutory product quality testing and method validation report.
Quality inspection report should include items all items specified in 3.3.2.3.7. Method validation report should be attached to the original relevant typical chromatograms, and to evaluate the feasibility of the method, stamped with the official seal of inspection.
3.3.2.3.11 packaging, transport and storage precautions, safety alerts, expiration date.
3.3.2.4 Toxicological information
3.3.2.4.1 Acute oral toxicity test;
3.3.2.4.2 Acute percutaneous toxicity test;
3.3.2.4.3 Acute inhalation toxicity
One of the following conditions to provide the toxicological information on the product (below):
A gas or liquefied gas;
B or the fumigation preparations smoke formulations;
Spraying with spray equipment C preparations;
D steam release formulations;
E aerosol;
F with diameter <50um particles account for a large proportion (by weight> 1%) of the preparations;
G aircraft pesticide exposure may have inhaled preparations;
H contains the active ingredient of the vapor pressure> 1 × 10-2Pa and may be used for storage or preparation of greenhouse and other enclosed spaces;
I according to usage, can produce diameter <50μm particles or droplets represent a sizeable proportion (by weight> 1%) of the preparations.
3.3.2.4.4 Eye irritation test;
3.3.2.4.5 Skin irritation test;
3.3.2.4.6 skin sensitization tests.
3.3.2.5 efficacy data
3.3.2.5.1 indoor activity tests report (field trial stage has been provided, and can provide a copy)
3.3.2.5.2 When the crop for the indoor test crop safety trials report (field trial stage has been provided, and can provide copies);
3.3.2.5.3 efficacy reports
Insecticides, fungicides to provide in our country more than four provincial-level administrative regions, more than 2 years of field plot efficacy trials report.
Herbicides, plant growth regulators to provide in our country more than five provincial-level administrative regions, more than 2 years of field plot efficacy trials reported on the long residual effect of herbicides, should also be provided after the main crop safety test report .
Crops in some areas (such as flax, sugar beet, sunflower, ginseng, rubber tree, lychee trees, longan trees, bananas, mango trees, etc.) or limited to local region of the diseases, insects and weeds, can provide three or more provinces level administrative regions, more than 2 years of field plot efficacy trials report.
Relatively stable environmental conditions in place for the use of pesticides, such as Warehouse, antiseptic use, and preservation of pesticides used, can provide in our country more than two provincial-level administrative regions, more than two test cycles efficacy test report.
3.3.2.5.4 pesticide field trial approval certificate (copy)
3.3.2.5.5 Other
A mode of action, action spectra, the mechanism or the mechanism of prediction analysis;
B resistance, including on-target organisms susceptibility testing, resistance monitoring methods and resistance risk assessment;
C on the field the main predators and parasitic natural enemies;
D product characteristics and use precautions.
3.3.2.6 Residual data
3.3.2.6.1 Residual Test quantity requirements
Conducted in China provided more than 2 years of residual test report. For pesticide products applied to different crops, farming systems in different natural conditions or provincial administrative regions the number of residue testing requirements in Annex 2.
3.3.2.6.2 Residual information specific requirements
A residue test report;
B-residue Analysis
Including determination of crop (its exact location should be made clear), soil, water, pesticide and its major metabolites and maternal toxic metabolites analysis. Methods should be detailed, feasible in our country, including methods of origin, principles, instruments, reagents, steps (including extraction, purification and instrument conditions), the results calculated, method recovery, sensitivity, coefficient of variation and so on.
C in other countries and regions of residual test data (if necessary)
Including crop, soil, water, residues and primary agricultural products (fish, meat, eggs, milk, etc.) in the second residue.
D in the stability of agricultural products
Necessary to provide in the registration of pesticide residues in agricultural crops, the storage stability test data.
E in the metabolism of crops
Provide the necessary absorption of compounds in plants, transformation, distribution, metabolites and degradation products eventually and toxicity data.
F FAO (FAO), World Health Organization (WHO) recommended or in other countries the maximum residue limits (MRL), acceptable daily intake (ADI), and indicate the source.
G in our country the applicant proposes to maximum residue limits (MRL) or guidance limits (GL) and the frequency of spraying, application methods and safety interval.
H for the following pesticide residue test is generally not required:
a for non-food crops (except forage crops) and pesticides;
b low-toxic or slightly toxic seed treatment agent include: seed dressing agents, seed coating, seed soaking with the preparation, etc.;
c pesticides used for non-arable land (except livestock pasture);
d other.
I used a variety of crops, pesticides, can be classified according to crop, choose one of them to do more than residual test. Crop classification in Annex 3.
3.3.2.7 Environmental Impact Data
Report provides the following environmental tests. According to pesticide properties, formulation, use of and use, etc., may be appropriate relief for part of the test (the pesticide environmental impact features or use of specific deductions information see Annex 5, below). Processing agents used in the original drug to the daphnia, algae toxicity test results for the low toxicity, non-target plants affect the test results as low-risk, and provides summary information on environmental testing the original drug, and can no longer provide the kinds of organisms test report. Products for the slow release formulations of pesticides, soil degradation and soil adsorption to provide the test report.
3.3.2.7.1 Birds Acute oral toxicity test
3.3.2.7.2 Fish Acute toxicity test
3.3.2.7.3 Daphnia acute toxicity test
3.3.2.7.4 Acute toxicity algae
3.3.2.7.5 Acute oral toxicity test bees
3.3.2.7.6 bee acute contact toxicity test
3.3.2.7.7 Acute toxicity test silkworm
3.3.2.7.8 affect non-target plant test
3.3.2.8 accompanied by the label or instructions
Shall be in accordance with the "Regulations", the Ministry of Agriculture pesticide product labeling requirements related to design and test results of sample, the content can be used after approval.
Toxic level of pesticide products according to product classification of acute toxicity, but by the highly toxic, highly toxic pesticide formulations processed product, when used with the product's toxicity level of the highest toxicity level of the original drug is inconsistent, it should be in brackets used by the original drug's highest toxicity level. Pesticide toxicity classification and product identification in Table 2:
Table 2 Toxicity grading and identification of pesticide products
Toxicity grading
Level symbolic language
Oral half
Lethal dose
(Mg / kg)
Percutaneous half
Lethal dose
(Mg / kg)
Inhaled half
Lethal concentration
(Mg/m3)
Logo
Description on the label
Ⅰ a level
Toxic
≤ 5
≤ 20
≤ 20
Toxic
Class Ⅰ b
Highly toxic
> 5 to 50
> 20 to 200
> 20 to 200
Highly toxic
Grade Ⅱ
Moderate toxicity
> 50 500
> 200 ~ 2000
> 200 ~ 2000
Moderate toxicity
Grade Ⅲ
Low toxicity
> 500 ~ 5000
> 2000 ~ 5000
> 2000 ~ 5000
Grade Ⅳ
Slightly toxic
> 5000
> 5000
> 5000
Slightly toxic
3.3.2.9 Product Safety Data Sheet (MSDS)
3.3.2.10 Other information
3.3.2.10.1 in other countries or regions have the toxicology, efficacy, residue, environmental impact testing and registration information or a combination of inquiry reports
3.3.2.10.2 Other
3.3.3 officially registered
3.3.3.1 official registration application form
3.3.3.2 Summary of Data Products
Including place of origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside the brief.
3.3.3.3 Product chemistry data
In addition to the provisions of the temporary registration of chemical products (see 3.3.2.3), should also provide storage stability at room temperature for more than 3 batches of the report.
3.3.3.4 Toxicological information
3.3.3.4.1 Acute oral toxicity test
3.3.3.4.2 Acute percutaneous toxicity
3.3.3.4.3 Acute inhalation toxicity
3.3.3.4.4 Eye irritation test
3.3.3.4.5 Skin irritation test
3.3.3.4.6 skin sensitization test
3.3.3.5 efficacy data
3.3.3.5.1 two or more regions of different natural conditions, the model test report
3.3.3.5.2 The use of temporary registration of the product during the synthesis report
Include: product area, the main application areas, the use of technology, the use of effects, resistance development, crop safety and for the impact of non-target organisms and other aspects of comprehensive evaluation.
3.3.3.6 Residual data
Conducted in our country provided more than 2 years of residual test report. For pesticide products applied to different crops, farming systems in different natural conditions or provincial administrative regions the number of residue testing requirements in Annex 2.
Residual data with the specific requirements of temporary registration, see 3.3.2.6.
3.3.3.7 Environmental Impact Data
Report provides the following environmental tests. According to pesticide properties, formulation, use of and use, etc., may be appropriate relief for part of the test. Processing agents used in the original drug to the daphnia, algae, predators or earthworms Trichogramma toxicity test results for the low toxicity, non-target plants affect the test results as low-risk, and provides summary information on environmental testing the original drug, and can not then provide the kinds of biological test report. Products for the slow release formulations of pesticides, soil degradation and soil to provide assay data. There are special risks to the environment of pesticides, should also provide additional information on the environmental impact.
3.3.3.7.1 Birds Acute oral toxicity test
3.3.3.7.2 Fish Acute toxicity test
3.3.3.7.3 Daphnia acute toxicity test
3.3.3.7.4 Acute toxicity algae
3.3.3.7.5 Acute oral toxicity test bees
3.3.3.7.6 bee acute contact toxicity test
3.3.3.7.7 Acute toxicity test predators Trichogramma
3.3.3.7.8 Acute toxicity test silkworm
3.3.3.7.9 earthworm acute toxicity test
3.3.3.7.10 on non-target plants affect the test
3.3.3.8 accompanied by the label or instructions
3.3.3.8.1 in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and test results of the official registration tag design sample
3.3.3.8.2 approve temporary registration of pesticides, pesticide registration approval seal affixed label proofs, instructions
3.3.3.8.3 in the market during the temporary registration tag in circulation
3.3.3.9 Product Safety Data Sheet (MSDS)
3.3.3.10 Other information
3.3.3.10.1 in other countries or regions have the toxicology, efficacy, residue, environmental impact testing and registration information or a combination of inquiry reports
3.3.3.10.2 Other
Chapter IV Special New Pesticide Registration
4.1 Health of pesticides
4.1.1 Field trials
4.1.1.1 Field Test Application Form
4.1.1.2 Summary of information on chemical products
4.1.1.2.1 active ingredients
Active ingredient common name, the international generic name, chemical name, Chemical Abstracts Service (CAS) Registry Number, International Pesticide Analytical Partnership Committee (CIPAC) digital code, development number, empirical formula, molecular weight, structure, major physical and chemical parameters (such as: appearance, melting point, boiling point, density or bulk density, specific rotation, vapor pressure, solubility, partition coefficient, etc.).
4.1.1.2.2 TC
Active ingredients, mainly the name and content of impurities, the main physical and chemical parameters (such as: appearance, melting point, boiling point, density or bulk density, specific rotation), the active ingredient analysis methods.
4.1.1.2.3 Preparation
Formulations, active ingredients, other components of the specific names and content, the main physical and chemical parameters, quality control project and its target, category (by use), the active ingredient analysis methods.
4.1.1.3 Summary of toxicology data
4.1.1.3.1 TC
Acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, skin and eye irritation and skin sensitization.
4.1.1.3.2 Preparation
Acute oral toxicity, acute dermal toxicity, acute inhalation toxicity and poisoning emergency treatment measures.
4.1.1.4 efficacy data
4.1.1.4.1 mode of action, action spectra, the mechanism or the mechanism of prediction analysis
4.1.1.4.2 indoor activity tests reported
4.1.1.4.3 the purpose of description and indoor mixed formulation screening report (for mixed formulations)
4.1.1.4.4 Test venues, control objects, application methods and precautions
4.1.1.5 Other information
In other countries or regions have efficacy, toxicology, environmental impact and registration, etc. or a combination of query reports.
4.1.2 temporary registration
Temporary registration of the original drug 4.1.2.1
4.1.2.1.1 Temporary Registration Application Form
4.1.2.1.2 Product summary information
Including place of origin, product chemistry, toxicology, environmental impact, such as registration information outside of the brief.
4.1.2.1.3 Product chemistry data
With most of the new pesticide, see 3.2.1.3.
4.1.2.1.4 Toxicological information
A acute toxicity test
a Acute oral toxicity test;
b Acute Dermal Toxicity test;
c Acute Inhalation Toxicity Test;
d eye irritation test;
e skin irritation test;
f skin sensitization tests.
B sub-slow (acute) toxicity test
Requires 90 days feeding study in rats. Classes for processing into coils, aerosol and repeated inhalation of moth agent with the original drug agents may also be provided 28 days sub-acute inhalation toxicity; repellent agents for processing into possible long-term exposure to skin preparation of the original drugs, should also provide 28 days subacute percutaneous toxicity.
C mutagenicity test
a Salmonella typhimurium / reverse mutation test;
b in vitro mammalian cell gene mutation test;
c in vitro mammalian cell chromosome aberration test;
d in vivo mammalian bone marrow micronucleus test.
Any of the above ac trials a positive result, the d-term is negative, you should add another in vivo (preferred mammalian cells in vivo UDS test). When the ac trials were negative results, while the d-term is positive, you should increase the reproductive cells in vivo mammalian chromosome aberration test or the dominant lethal test.
D delayed neurotoxicity test.
4.1.2.1.5 Environmental Impact Data
A dedicated to the processing agents within the environment, provide the following test report. According to features or use of different pesticides, some relief may be appropriate test.
a volatile test;
b hydrolysis test;
c water photolysis experiments;
d Silkworm toxicity.
B of the preparation process for the external environment, the following test report. According to features or use of different pesticides, some relief may be appropriate test.
a volatile test;
b soil assay;
c soil degradation test;
d hydrolysis test;
e water photolysis test;
f water - sediment degradation test;
g bird acute oral toxicity test;
h fish acute toxicity test;
i Daphnia acute toxicity test;
j algal acute toxicity test;
k bee acute oral toxicity test;
l bee acute contact toxicity test;
m silkworm acute toxicity test.
4.1.2.1.6 product label
With most of the new pesticide, see 3.2.2.6.
4.1.2.1.7 Product Safety Data Sheet (MSDS)
4.1.2.1.8 Additional information
A in other countries or regions have the toxicology and environmental impact testing and registration information or a combination of inquiry reports;
B Other.
4.1.2.2 Preparation temporary registration
4.1.2.2.1 Temporary Registration Application Form
4.1.2.2.2 Product summary information
Including place of origin, product chemistry, toxicology, efficacy, environmental impact, such as registration information outside the brief.
4.1.2.2.3 Product chemistry data
With most of the new pesticide formulations, see 3.3.2.3. However, the following main differences:
A concentration of active ingredient less than 1% of the variety of pesticides, the active ingredient in the product identification tests (including the identification of isomers) an explanation of the circumstances, it can not provide the corresponding isomers split method.
B on the incense coil products, the active ingredient concentration range, indicating the value should be no higher than 40%, indicating the value of not less than 20%.
C on aerosol products, should provide propellant (CFC substances can not be as propellant) the name and content.
4.1.2.2.4 Toxicological information
According to the different formulations to provide the appropriate toxicological data, specific requirements are as follows:
A mosquito coils, electric mosquito coils: acute inhalation toxicity test;
Aerosol B: acute inhalation toxicity, eye irritation, skin irritation test;
C Mosquito fluid: acute oral toxicity, acute dermal toxicity, acute inhalation toxicity;
D repellents: acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, eye irritation, skin irritation and sensitization of multiple testing.
E Other dosage forms: acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, eye irritation, skin irritation and sensitization test.
Product formulations and active ingredients for the special circumstances can increase or reduction pilot projects.
4.1.2.2.5 efficacy data
A report on the indoor activity tests;
B mixed statement of purpose and indoor formulation screening report (for mixed formulations, field trials have provided, and can provide copies);
C in our country more than two provincial-level administrative regions, more than 1 year of indoor efficacy test test report include: determination of down when (KT50) or death when (LT50), lethal dose (LD50) or lethal concentration (LC50), mortality;
2 D in our country over the provincial administrative region, more than 1 year of simulated field test report (indoor preparations);
E 2 in our country more than the provincial administrative region, more than 1 year on-site test report (termite preparations and preparations outside environment).
F pesticide field trial approval certificate (copy);
G Other
a mode of action, action spectra, the mechanism or the mechanism of prediction analysis;
b resistance, including on-target organisms susceptibility testing, resistance monitoring methods and resistance risk assessment;
c product characteristics and use precautions.
4.1.2.2.6 Environmental Impact Data
A room with space for release formulations, providing silkworm toxicity test report. According to pesticide properties, formulation, use of and use, etc., may be appropriate relief for the pilot.
B outdoor preparations, the following test data. According to pesticide properties, formulation, use of and use, etc., may be appropriate relief for part of the test. Processing agents used in the original drug for algae or Daphnia toxicity test results of low toxicity and environmental testing to provide summary information on the original drug, and can no longer provide the kinds of biological test report. Products for the slow release formulations of pesticides, soil degradation and soil adsorption to provide the test report.
a bird acute oral toxicity test;
b Fish acute toxicity test;
c Daphnia acute toxicity test;
d algal acute toxicity test;
e bee acute oral toxicity test;
f bee acute contact toxicity test;
g silkworm acute toxicity test.
C pyrethroid pesticide products with health Silkworm toxicity test report is not available, but need to be labeled highly toxic to the silkworm and safety instructions.
4.1.2.2.7 label or the instructions are accompanied by
With most of the new pesticide, see 3.3.2.8.
4.1.2.2.8 Product Safety Data Sheet (MSDS)
4.1.2.2.9 Additional information
A in other countries or regions have the toxicology, efficacy, environmental impact testing and registration information or a combination of inquiry reports;
B Other.
4.1.3 officially registered
4.1.3.1 original drug official registration
4.1.3.1.1 official registration application form
4.1.3.1.2 Product summary information
Including place of origin, product chemistry, toxicology, environmental impact, such as registration information outside of the brief.
4.1.3.1.3 Product chemistry data
With temporary registration requirements, see 3.2.1.3.
4.1.3.1.4 Toxicological information
Registration of new pesticides with the general requirements (see 3.2.2.4). But included in the World Health Organization (WHO) recommended for the control of pests and vectors list of pesticides and pyrethroid pesticides in the temporary registration on the basis of additional six-month feeding study in rats reports.
4.1.3.1.5 Environmental Impact Data
A dedicated to the processing agents within the environment, provide the following test report. According to features or use of different pesticides, some relief may be appropriate test.
a volatile test;
b hydrolysis test;
c water photolysis experiments;
d Silkworm toxicity.
B of the preparation process for the external environment, the following test report. According to features or use of different pesticides, some relief may be appropriate test.
a volatile test;
b soil assay;
c soil degradation test;
d hydrolysis test;
e water photolysis test;
f water - sediment degradation test;
g bird acute oral toxicity test;
h fish acute toxicity test;
i Daphnia acute toxicity test;
j algal acute toxicity test;
k bee acute oral toxicity test;
l bee acute contact toxicity test;
m predators of amphibians acute toxicity test;
n silkworm acute toxicity test.
4.1.3.1.6 label or the instructions are accompanied by
A in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and test results of the official registration tag design proofs;
B approve temporary registration of pesticide pesticide registration approval seal affixed label proofs, brochures;
C on the market during the temporary registration tag in circulation.
4.1.3.1.7 Product Safety Data Sheet (MSDS)
4.1.3.1.8 Additional information
A in other countries or regions have the toxicology and environmental impact testing and registration information or a combination of inquiry reports;
B Other.
4.1.3.2 Preparation official registration
4.1.3.2.1 official registration application form
4.1.3.2.2 Product summary information
Including place of origin, product chemistry, toxicology, efficacy, environmental impact, such as registration information outside the brief.
4.1.3.2.3 Product chemistry data
In addition to the provisions of the temporary registration of the product chemistry data (see 4.1.2.2.3), should also provide storage stability at room temperature for more than 3 batches of the report.
4.1.3.2.4 Toxicological information
With temporary registration requirements (see 4.1.2.2.4).
4.1.3.2.5 efficacy data
A two or more regions of different natural conditions, the model test report (the external environment preparations);
B temporary registration during the synthesis report on the use of products, including: product effects, resistance development, security, the impact of non-target organisms and other aspects of comprehensive evaluation.
4.1.3.2.6 Environmental Impact Data
A room with space for release formulations, providing silkworm toxicity test report. According to pesticide properties, formulation, use of and use, etc., may be appropriate relief for the pilot.
B outdoor preparations, the following test report. According to pesticide properties, formulation, use of and use, etc., may be appropriate relief for part of the test. Processing agents used in the original drug for algae or Daphnia toxicity test results of low toxicity and environmental testing to provide summary information on the original drug, and can no longer provide the kinds of biological test report. Products for the slow release formulations of pesticides, soil degradation and soil adsorption to provide the test report.
a bird acute oral toxicity test;
b Fish acute toxicity test;
c Daphnia acute toxicity test;
d algal acute toxicity test;
e bee acute oral toxicity test;
f bee acute contact toxicity test;
g silkworm acute toxicity test.
C pyrethroid pesticide products with health Silkworm toxicity tests do not provide information, but should be on the label of the silkworm highly toxic and safe for use.
4.1.3.2.7 label or the instructions are accompanied by
A in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and test results of the official registration tag design proofs;
B approve temporary registration of pesticide pesticide registration approval seal affixed label proofs, brochures;
C on the market during the temporary registration tag in circulation.
4.1.3.2.8 Product Safety Data Sheet (MSDS)
4.1.3.2.9 Additional information
A in other countries or regions have the toxicology, efficacy, environmental impact testing and registration information or a combination of inquiry reports;
B Other.
4.2 Rodenticides
4.2.1 Field trials
4.2.1.1 Field Test Application Form
4.2.1.2 Summary of information on chemical products
4.2.1.2.1 active ingredients
Active ingredient common name, the international generic name, chemical name, Chemical Abstracts Service (CAS) Registry Number, International Pesticide Analytical Partnership Committee (CIPAC) digital code, development number, empirical formula, molecular weight, structure, major physical and chemical parameters (such as: appearance, melting point, boiling point, density or bulk density, specific rotation, vapor pressure, solubility, partition coefficient, etc.).
4.2.1.2.2 TC
Active ingredients, mainly the name and content of impurities, the main physical and chemical parameters (such as: appearance, melting point, boiling point, density or bulk density, specific rotation), the active ingredient analysis methods.
4.2.1.2.3 Preparation
Formulations, active ingredients, other ingredients and content, the main physical and chemical parameters, quality control project and its target, category (according to mode of action), the active ingredient analysis methods.
4.2.1.3 Summary of toxicology data
4.2.1.3.1 TC
Acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, skin and eye irritation and skin sensitization;
4.2.1.3.2 Preparation
Acute oral toxicity, acute dermal toxicity, acute inhalation toxicity and poisoning emergency treatment measures.
4.2.1.4 efficacy data
4.2.1.4.1 mode of action, action spectra, the mechanism or the mechanism of prediction analysis;
4.2.1.4.2 Test venues, control objects, application methods and precautions.
4.2.1.5 Other information
In other countries or regions have efficacy, environmental impact testing and registration information or a combination of query reports.
4.2.2 temporary registration
Temporary registration of the original drug 4.2.2.1
4.2.2.1.1 Temporary Registration Application Form
4.2.2.1.2 Product summary information
Including place of origin, product chemistry, toxicology, environmental impact, such as registration information outside of the brief.
4.2.2.1.3 Product chemistry data
With the general registration of new pesticides, see 3.2.1.3.
4.2.2.1.4 Toxicological information
A acute toxicity test
a Acute oral toxicity test;
b Acute Dermal Toxicity test;
c Acute Inhalation Toxicity Test;
d eye irritation test;
e skin irritation test;
f sensitization test.
B sub-slow (acute) toxicity
Requires 90 days feeding study in rats. Based on product characteristics should also be 28 days or 28 days after inhalation skin toxicity;
C mutagenicity test
a Salmonella typhimurium / reverse mutation test;
b in vitro mammalian cell gene mutation test;
c in vitro mammalian cell chromosome aberration test;
d in vivo mammalian bone marrow micronucleus test.
Any of the above ac trials a positive result, the d-term is negative, you should add another in vivo (preferred mammalian cells in vivo UDS test). When the ac trials were negative results, while the d-term is positive, you should increase the reproductive cells in vivo mammalian chromosome aberration test or the dominant lethal test.
D delayed neurotoxicity test.
4.2.2.1.5 Environmental Impact Data
Environment provides the following original drug test report. According to the characteristics of pesticides, may be appropriate relief part of the test.
A environmental behavior Shiyan
a volatile test;
b soil assay;
c leaching test;
d soil degradation test;
e hydrolysis test;
f water photolysis experiments;
g soil surface photolysis test;
h water - sediment degradation experiments.
B Environmental Toxicity
a bird acute oral toxicity test;
b short-term feeding of birds toxicity test;
c fish acute toxicity test;
d Daphnia acute toxicity test;
e acute algae toxicity test.
C poultry, livestock toxicity.
4.2.2.1.6 label or the instructions are accompanied by
Product labels provide proofs, content requirements with 3.2.1.6. At the same time, it should be in line with our management of the relevant provisions of the rodenticide label.
4.2.2.1.7 Product Safety Data Sheet (MSDS)
4.2.2.1.8 Additional information
A in other countries or regions have the toxicology and environmental impact testing and registration information or a combination of inquiry reports;
B Other.
4.2.2.2 Preparation temporary registration
4.2.2.2.1 Temporary Registration Application Form
4.2.2.2.2 Product summary information
Including place of origin, product chemistry, toxicology, efficacy, environmental impact, such as registration information outside the brief.
4.2.2.2.3 Product chemistry data
With most of the new pesticide, see 3.3.2.3.
4.2.2.2.4 Toxicological information
A acute oral toxicity test;
B acute skin toxicity test;
C acute inhalation toxicity;
D eye irritation test;
E skin irritation test;
F sensitization test.
4.2.2.2.5 efficacy data
A report on the efficacy
Farmland, forests and grasslands on the use of rodenticides should 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 should provide two or more provincial-level administrative regions, one year efficacy trials reported above.
B pesticide field trial approval certificate (copy);
C Other
a mode of action, action spectra, the mechanism or the mechanism of prediction analysis;
b product characteristics and use precautions.
4.2.2.2.6 Residual data
Applicator of the rodenticide to provide comprehensive in our country more than 2 provincial administrative areas, more than 2 years of residual test report. Residual data with the specific requirements of the new pesticides generally, see 3.3.2.6.
4.2.2.2.7 Environmental Impact Data
Provides the following environmental test report. According to pesticide properties, formulation, use of and use, etc., may be appropriate relief for part of the test. Processing agents used in the original drug to the daphnia, algae or poultry, livestock toxicity test results low toxicity and environmental testing to provide summary information on the original drug, and can no longer provide the kinds of biological test report. Products for the slow release formulations of pesticides, soil degradation and soil adsorption to provide the test report. There are special risks to the environment of pesticides, should also provide additional information on the environmental impact.
A bird acute oral toxicity test;
B Fish acute toxicity test;
C Daphnia acute toxicity test;
D algal acute toxicity test;
E poultry, livestock toxicity.
4.2.2.2.8 label or the instructions are accompanied by
Product labels provide proofs, content requirements with 3.3.2.8. At the same time, it should be in line with our management of the relevant provisions of the rodenticide label.
4.2.2.2.9 Product Safety Data Sheet (MSDS)
4.2.2.2.10 Other information
A in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of inquiry reports;
B Other.
4.2.3 officially registered
4.2.3.1 original drug official registration
4.2.3.1.1 official registration application form
4.2.3.1.2 Product summary information
Including place of origin, product chemistry, toxicology, environmental impact, such as registration information outside the brief.
4.2.3.1.3 Product chemistry data
With temporary registration requirements, see 3.2.1.3.
4.2.3.1.4 Toxicological information
In the temporary registration on the basis of information provided, should be added six months of chronic toxicity test data. If there are no special problems, do not require further tests.
4.2.3.1.5 Environmental Impact Data
Provides the following environmental test report. According to the characteristics of pesticides, may be appropriate relief part of the test.
A environmental behavior Shiyan
a volatile test;
b soil assay;
c leaching test;
d soil degradation test;
f hydrolysis test;
g water photolysis test;
h soil surface photolysis experiments;
i water - sediment degradation test;
j bioaccumulation test.
B Environmental Toxicity
a bird acute oral toxicity test;
b short-term feeding of birds toxicity test;
c birds chronic toxicity test;
d fish acute toxicity test;
e Daphnia acute toxicity test;
f algal acute toxicity test;
g predators of amphibians acute toxicity test;
h earthworm acute toxicity test;
i test the impact of soil microbes;
j poultry, livestock toxicity.
C provides information on secondary poisoning carnivorous animals (the original drug toxicity, and can not provide).
4.2.3.1.6 label or the instructions are accompanied by
A in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements;
B approve temporary registration of pesticide pesticide registration approval seal affixed label proofs, brochures;
C on the market during the temporary registration tag in circulation.
4.2.3.1.7 Product Safety Data Sheet (MSDS)
4.2.3.1.8 Additional information
A in other countries or regions have the toxicology and environmental impact testing and registration information or a combination of inquiry reports;
B Other.
4.2.3.2 Preparation official registration
4.2.3.2.1 official registration application form
4.2.3.2.2 Product summary information
Including place of origin, product chemistry, toxicology, efficacy, residue, environmental impact, foreign registration, etc. briefly.
4.2.3.2.3 Product chemistry data
In addition to the provisions of the temporary registration of the product chemistry data (see 4.2.2.2.3), should also provide storage stability at room temperature for more than 3 batches of the report.
4.2.3.2.4 Toxicological information
A acute oral toxicity test;
B acute skin toxicity test;
C acute inhalation toxicity;
D eye irritation test;
E skin irritation test;
F skin sensitization tests.
4.2.3.2.5 efficacy data
A two or more regions of different natural conditions, the model test report (on farmland, forests and grasslands on the use of rodenticides);
B temporary registration during the synthesis report on the use of products, including: product area, the main application areas, the use of technology, the use of results, development of resistance to non-target organisms and the impact of other aspects of the comprehensive evaluation.
4.2.3.2.6 Residual data
Full applicator of rodenticides in our country should be provided two or more provincial-level administrative regions, more than 2 years of residual test report.
Residual data with the specific requirements of the general new pesticides (see 3.3.2.6).
4.2.3.2.7 Environmental Impact Data
Provides the following environmental test report. According to pesticide properties, formulation, use of and use, etc., may be appropriate relief for part of the test. Processing agents used in the original drug to the daphnia, algae, earthworms or poultry, livestock toxicity test results low toxicity and environmental testing to provide summary information on the original drug, and can no longer provide the kinds of biological test report. Products for the slow release formulations of pesticides, soil degradation and soil should be provided assay report. There are special risks to the environment of pesticides, should also provide additional information on the environmental impact.
A bird acute oral toxicity test;
B Fish acute toxicity test;
C Daphnia acute toxicity test;
D algal acute toxicity test;
E earthworm acute toxicity test;
F poultry, livestock toxicity.
4.2.3.2.8 label or the instructions are accompanied by
A in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements, labeling requirements and rodenticide test results of the official registration tag design proofs;
B approve temporary registration of pesticide pesticide registration approval seal affixed label proofs, brochures;
C on the market during the temporary registration tag in circulation.
4.2.3.2.9 Product Safety Data Sheet (MSDS)
4.2.3.2.10 Other information
A in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of inquiry reports;
B Other.
4.3 Pesticide Biochemistry
4.3.1 Field trials
4.3.1.1 Field Test Application Form
4.3.1.2 Summary of information on chemical products
4.3.1.2.1 active ingredients
Active ingredient common name, the international generic name, chemical name, Chemical Abstracts Service (CAS) Registry Number, International Pesticide Analytical Partnership Committee (CIPAC) digital code, development number, empirical formula, molecular weight, structure, major physical and chemical parameters (such as: appearance, melting point, boiling point, density or bulk density, specific rotation, vapor pressure, solubility, partition coefficient, etc.).
4.3.1.2.2 TC
Active ingredients, mainly the name and content of impurities, the main physical and chemical parameters (such as: appearance, melting point, boiling point, density or bulk density, specific rotation), the active ingredient analysis methods.
4.3.1.2.3 Preparation
Formulations, active ingredients, other components of the specific names and content, the main physical and chemical parameters, quality control project and its target, category (by use), the active ingredient analysis methods.
4.3.1.3 Summary of toxicology data
4.3.1.3.1 TC
Acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, skin and eye irritation and skin sensitization tests.
4.3.1.3.2 Preparation
Acute oral toxicity, acute dermal toxicity, acute inhalation toxicity testing and treatment of poisoning, first aid measures.
4.3.1.4 efficacy data
4.3.1.4.1 mode of action, action spectra, the mechanism or the mechanism of prediction analysis
4.3.1.4.2 indoor activity tests reported
4.3.1.4.3 the purpose of description and indoor mixed formulation screening report (for mixed formulations)
4.3.1.4.4 Shiyan crops, control objects, application methods and precautions
4.3.1.5 Other information
In other countries or regions have the field toxicology, efficacy, residue, environmental impact testing and registration information or a combination of query reports.
4.3.2 temporary registration
Temporary registration of the original drug 4.3.2.1
4.3.2.1.1 Temporary Registration Application Form
4.3.2.1.2 Product summary information
Including place of origin, product chemistry, toxicology, environmental impact, such as registration information outside the brief.
4.3.2.1.3 Product chemistry data
With the general registration of new pesticides, see 3.2.1.3.
4.3.2.1.4 Toxicological information
A basic toxicology data
a Acute oral toxicity test;
b Acute Dermal Toxicity test;
c Acute Inhalation Toxicity Test;
d eye irritation test;
e skin irritation test;
f skin sensitization tests.
Additional toxicology data B
Such as basic toxicology tests found highly toxic or highly toxic to mammals, it should be added 90 days depending on the situation in rats fed the test report. For special needs, should also provide 28 days of percutaneous toxicity, immune toxicity, mutagenicity, teratogenicity, carcinogenicity studies, etc..
4.3.2.1.5 Environmental Impact Data
Provides the following environmental test report. According to the characteristics or use of pesticides in different, appropriate relief can be part of the test.
A fish acute toxicity test;
B Daphnia acute toxicity test;
C algal acute toxicity test;
D bee acute oral toxicity test;
E bee acute contact toxicity test;
F silkworm acute toxicity test.
These tests showed that the original drug to non-target organisms is highly toxic, and should be provided with the non-target organisms for environmental behavior of the original drug test report.
4.3.2.1.6 label or the instructions are accompanied by
Product labels provide proofs, content requirements with 3.2.1.6.
4.3.2.1.7 Product Safety Data Sheet (MSDS)
4.3.2.1.8 Additional information
A in other countries or regions have the toxicology and environmental impact testing and registration information or a combination of inquiry reports;
B Other.
4.3.2.2 Preparation temporary registration
4.3.2.2.1 Temporary Registration Application Form
4.3.2.2.2 Product summary information
Including place of origin, product chemistry, toxicology, efficacy, environmental impact, foreign registration, etc. briefly.
4.3.2.2.3 Product chemistry data
With the general registration of new pesticides, see 3.3.2.3.
4.3.2.2.4 Toxicological information
A acute oral toxicity test;
B acute skin toxicity test;
C acute inhalation toxicity;
D eye irritation test;
E skin irritation test;
F skin sensitization tests.
4.3.2.2.5 efficacy data
A report on the indoor activity tests (field trial stage has been provided, and can provide copies);
B mixed statement of purpose and indoor formulation screening report (for mixed formulations, field trials have provided, and can provide copies);
C efficacy reports
Provide in our country more than four provincial-level administrative regions (of the plant growth regulator is more than five provincial-level administrative regions), more than 2 years of field plot efficacy trials report.
Crops in some areas (such as flax, sugar beet, sunflower, ginseng, rubber tree, lychee trees, longan trees, bananas, mango trees, etc.) or limited to local region of the diseases, insects and weeds, can provide three or more provinces level administrative regions, more than 2 years of field plot efficacy trials report.
Relatively stable environmental conditions in place for the use of pesticides, such as Warehouse, antiseptic use, and preservation of pesticides used, can provide in our country more than two provincial-level administrative regions, more than two test cycles efficacy test report.
D pesticide field trial approval certificate (copy);
E Other
a mode of action, action spectra, the mechanism or the mechanism of prediction analysis;
b product characteristics and use precautions.
4.3.2.2.6 Residual data
According to the features and use of pesticides, according to the Vetting Committee to provide advice in our country's more than 2 years of residual test report. For pesticide products applied to different crops, farming systems in different natural conditions or provincial administrative regions the number of residue testing and information requirements, see 3.3.2.6.
4.3.2.2.7 Environmental Impact Data
Acute toxicity test report provided by the silkworm. According to pesticide properties, formulation, use of and use, etc., can waive this test.
There are special risks to the environment of pesticides, should also provide additional information on the environmental impact.
4.3.2.2.8 label or the instructions are accompanied by
Product labels provide proofs, content requirements with 3.3.2.8.
4.3.2.2.9 Product Safety Data Sheet (MSDS)
4.3.2.2.10 Other information
A in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of inquiry reports;
B Other.
4.3.3 officially registered
4.3.3.1 original drug official registration
4.3.3.1.1 official registration application form
4.3.3.1.2 Product summary information
Including place of origin, product chemistry, toxicology, environmental impact, such as registration information outside the brief.
4.3.3.1.3 Product chemistry data
With temporary registration requirements, see 3.2.1.3.
4.3.3.1.4 Toxicological information
A basic toxicology data
a Acute oral toxicity test;
b Acute Dermal Toxicity test;
c Acute Inhalation Toxicity Test;
d eye irritation test;
e skin irritation test;
f skin sensitization tests.
Additional toxicology data B
Such as basic toxicology tests found highly toxic or highly toxic to mammals, it should be added 90 days depending on the situation in rats fed the test report. For special needs, should also provide 28 days of percutaneous toxicity, immune toxicity, mutagenicity, teratogenicity, carcinogenicity studies, etc..
4.3.3.1.5 Environmental Impact Data
Provides the following environmental test report. According to the characteristics and pesticide use will be different, appropriate relief part of the test. Tests showed that the original drug to non-target organisms is highly toxic, and should be provided with the non-target organisms for environmental behavior of the original drug test report.
A fish acute toxicity test;
B Daphnia acute toxicity test;
C algal acute toxicity test;
D bee acute oral toxicity test;
E bee acute contact toxicity test;
F silkworm acute toxicity test.
4.3.3.1.6 label or the instructions are accompanied by
A in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and test results of the official registration tag design proofs;
B approve temporary registration of pesticide pesticide registration approval seal affixed label proofs, brochures;
C on the market during the temporary registration tag in circulation.
4.3.3.1.7 Product Safety Data Sheet (MSDS)
4.3.3.1.8 Additional information
A country or region other than toxicology, environmental impact testing and registration information or a combination of inquiry reports;
B Other.
4.3.3.2 Preparation official registration
4.3.3.2.1 official registration application form
4.3.3.2.2 Product summary information
Including place of origin, product chemistry, toxicology, efficacy, residue, environmental impact, foreign registration, etc. briefly.
4.3.3.2.3 Product chemistry data
In addition to the provisions of the temporary registration of chemical products (see 3.3.2.3), should also provide storage stability at room temperature for more than 3 batches of the report.
4.3.3.2.4 Toxicological information
A acute oral toxicity test;
B acute skin toxicity test;
C acute inhalation toxicity;
D eye irritation test;
E skin irritation test;
F skin sensitization tests.
4.3.3.2.5 efficacy data
A two or more regions of different natural conditions, the model test report;
B temporary registration during the synthesis report on the use of products, including: product area, the main application areas, the use of technology, the use of effects, resistance development, crop safety and for the impact of non-target organisms and other aspects of comprehensive evaluation.
4.3.3.2.6 Residual data
According to the features and use of pesticides, according to the Vetting Committee to provide advice in our country's more than 2 years of residual test report. For pesticide products applied to different crops, farming systems in different natural conditions or provincial administrative regions the number of residue testing and information requirements, see 3.3.2.6.
4.3.3.2.7 environmental toxicity data
Acute toxicity test report provided by the silkworm. According to pesticide properties, formulation, use of and use, etc., can waive this test.
There are special risks to the environment of pesticides, should also provide additional information on the environmental impact.
4.3.3.2.8 label or the instructions are accompanied by
A in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and test results of the official registration tag design proofs;
B approve temporary registration of pesticide pesticide registration approval seal affixed label proofs, brochures;
C on the market during the temporary registration tag in circulation.
4.3.3.2.9 Product Safety Data Sheet (MSDS)
4.3.3.2.10 Other information
A in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of inquiry reports;
B Other.
4.4 Microbial Pesticides
4.4.1 Field trials
4.4.1.1 Field Test Application Form
4.4.1.2 Summary of product characteristics of chemical and biological data
4.4.1.2.1 biological characteristics of the active ingredient
Active ingredient common name, the international generic name, taxonomic status and strains, the presence of microbial forms in nature.
4.4.1.2.2 TC
Qualification test procedures for the active ingredient (such as morphology, biochemistry, serology, molecular genetics) and content, other ingredients (such as bacteria) and content, the main physico-chemical and biochemical parameters, and other technological requirements.
4.4.1.2.3 Preparation
Formulations, active ingredients, other components of the specific names and content, the main physico-chemical and biochemical parameters, quality control project and its target, category (by use), the active ingredient analysis methods.
4.4.1.3 Summary of toxicological data
4.4.1.3.1 TC
Acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, eye irritation, allergenicity, pathogenicity tests.
4.4.1.3.2 Preparation
Acute oral toxicity, acute dermal toxicity, acute inhalation toxicity and poisoning, first aid measures.
4.4.1.4 efficacy data
4.4.1.4.1 mode of action, action spectra, the mechanism or the mechanism of prediction analysis;
4.4.1.4.2 indoor activity tests report;
4.4.1.4.3 the purpose of description and indoor mixed formulation screening report (for mixed formulations);
4.4.1.4.4 test crops, control objects, application methods and precautions.
4.4.1.5 Other information
In other countries or regions have the field efficacy, residue, environmental impact testing and registration information or a combination of query reports.
4.4.2 temporary registration
4.4.2.1 original drug temporary registration
4.4.2.1.1 Temporary Registration Application Form
4.4.2.1.2 Product summary information
Including product chemistry and biology, toxicology, environmental impact, such as registration information outside of the brief.
4.4.2.1.3 chemical and biological characteristics of the product information
A recognition of active ingredients: active ingredient common name, the international generic name, position and classification of strains of microorganisms naturally present in the form, etc.;
B of the original drug's physical and chemical properties;
C product quality control project and its targets
and a content of active ingredient;
b other ingredients (such as bacteria) and content;
c products and other indicators of control programs.
D and quality control programs corresponding to the test methods and method validation
Feed detection methods typically include methods, principles, instruments, reagents, operating conditions, solution preparation, determination of procedures, results analysis, tolerance and related maps and so on.
Test method validation, including method precision, the original map, etc., and gives the minimum detectable concentration of detection methods.
Use of the existing national standards, industry standards, can not provide precision data and the minimum detectable concentration of test data.
E control targets to determine the description of the project and its
Control project and its development of indicators and reasonable basis to make the necessary explanations.
F 5 batch analysis of all items (including the active ingredient of the appraisal report, such as morphology, biochemistry, or serology);
G product quality testing and method validation report
Issued by statutory bodies to provide quality testing and product quality testing method validation reporting.
Quality inspection report should include 4.4.2.1.3C items all items specified. Method validation report should be attached to the typical pattern associated original, and to evaluate the feasibility of the method, stamped with the official seal of inspection.
H production process
Including raw materials, names, codes, production flow chart (including the main product, by-products), etc.
I packaging, transport and storage precautions, safety alerts, and acceptance periods of time.
4.4.2.1.4 Toxicological information
A person confirming the active ingredient or other mammals are not known pathogens that information;
B basic toxicology data
a Acute oral toxicity test;
b Acute Dermal Toxicity test;
c Acute Inhalation Toxicity Test;
d eye irritation / infection test;
e sensitization test, the contact with staff sensitization of cases inside and outside the survey data and case reports related to allergenicity;
f pathogenicity
- Oral pathogenic;
- Inhalation pathogenicity;
- Injection of pathogenic (bacteria and viruses intravenous test; fungi or protozoa intraperitoneal injection test);
C supplementation toxicology data
If you find micro-organisms produce toxins pesticides, obvious signs of infection or the persistence of such signs, as the case may complement experimental data, such as sub-chronic toxicity, mutagenicity, reproductive toxicity, chronic toxicity, carcinogenicity, immune deficiency, primates animal pathogenicity.
4.4.2.1.5 Environmental Impact Data
Provides the following environmental test report. According to the characteristics or use of pesticides in different, appropriate relief can be part of the test report. Tests showed that the original drug on the biological environment as highly toxic or pathogenic, the need for the kinds of microorganisms in the environment to test the ability of reproduction.
A bird acute oral toxicity test;
B Fish acute toxicity test;
C Daphnia acute toxicity test;
D algal acute toxicity test;
E bee acute oral toxicity test;
F bee acute contact toxicity test;
G silkworm acute toxicity test.
4.4.2.1.6 label or the instructions are accompanied by
The product label provides proofs, content requirements with 3.2.1.6.
4.4.2.1.7 Product Safety Data Sheet (MSDS)
4.4.2.1.8 Additional information
A in other countries or regions have the toxicology and environmental impact testing and registration information or a combination of inquiry reports;
B variations in the environment and the risk of the release notes;
C Other.
4.4.2.2 Preparation temporary registration
4.4.2.2.1 Temporary Registration Application Form
4.4.2.2.2 Product summary information
Including the origin, the product of chemical and biological characteristics, toxicology, efficacy, environmental impact, such as registration information outside of the brief.
4.4.2.2.3 chemical and biological characteristics of the product information
A biological characteristics of the active ingredients, including: common name of active ingredients, the international generic name, taxonomic status and strains, the presence of microbial forms in nature.
B TC basic information: active ingredients and content, other ingredients (such as bacteria) and content.
C products: processing of finished products in all components of the specific name, content and its role in the product. For the restrictive components, such as penetrant, synergist, security etc., should also provide its chemical name, structure, basic physical and chemical properties, sources, security, inside and outside use of such information.
D processing methods description: The main production equipment and processing.
E Identification Test
Active ingredient in products such as the identification of test methods.
F Physical and Chemical Properties
Provide finished products for the following parameters determination and measurement results: the appearance (including color, physical state, odor, etc.), density or bulk density, viscosity, flammable, corrosive, explosive, flash point and mixed with other pesticides of and so on.
G quality control project and its targets
a content of active ingredient
Existing national standards, industry-standard products, according to the corresponding standard active ingredient content.
No national standard, industry-standard products, active ingredients allowed by the marked fluctuation range of content and composition. Indicate the content producers on the label is the active ingredient content. Fluctuation is allowed customers or third-party testing organization registered in accordance with the life of the product testing methods for detection, it should be in line with the concentration range. Specific reference to 3.3.2.3.7A implementation.
b-related impurities: provisions related bacteria, the highest level of impurities.
c other restrictive component content: According to the provisions of the actual situation (such as ultraviolet protective agent, insurance agent, etc.).
d other formulations related controls: See Annex 1. Not listed in Annex 1 formulations, can refer to the FAO (FAO), World Health Organization (WHO) to develop specifications. Control of the project and its innovative formulation of indicators according to the characteristics of the active ingredient, application methods, safety and other aspects into account to develop.
e storage stability and temperature, storage conditions on the biological activity of the product: According to product characteristics, temperature stability (for liquid preparations), thermal storage stability (for solid, liquid formulations), freeze-thaw stability (for micro-capsules) and other conditions on the quality of the product test.
H and control of projects and their corresponding indicators and methods to confirm the detection method
Feed detection methods typically include methods, principles, instruments, reagents, operating conditions, solution preparation, determination of procedures, results analysis, tolerance and related maps and so on.
Test method validation, including method precision, the original map, etc., and gives the minimum detectable concentration of detection methods.
Use of the existing national standards, industry standards, can not provide precision data and the minimum detectable concentration of test data.
I control the project and its description of indicators to determine
Control project and its development of indicators and reasonable basis to make the necessary explanations.
J determination of product quality testing and verification report
Issued by statutory bodies to provide quality testing and product quality testing method validation reporting.
Quality inspection report should include 4.4.2.2.3G items all items specified. Method validation report should be attached to the typical pattern associated original, and to evaluate the feasibility of the method, stamped with the official seal of inspection.
K packaging, transport and storage precautions, safety alerts, period.
4.4.2.2.4 Toxicological information
A person confirming the active ingredients are not known pathogens or other mammalian supporting information.
B basic toxicology data
a Acute oral toxicity test;
b Acute Dermal Toxicity test;
c Acute Inhalation Toxicity Test;
d eye irritation test;
e skin irritation test;
f skin sensitization tests.
4.4.2.2.5 efficacy data
A report on the indoor activity tests (field trial stage has been provided, and can provide copies);
B mixed statement of purpose and indoor formulation screening report (for mixed formulations, field trials have provided, and can provide copies);
C efficacy reports
Insecticides, fungicides to provide in our country more than four provincial-level administrative regions, more than 2 years of field plot efficacy trials report.
Herbicides, plant growth regulators to provide in our country more than five provincial-level administrative regions, more than 2 years of field plot efficacy trials report.
Crops in some areas (such as flax, sugar beet, sunflower, ginseng, rubber tree, lychee trees, longan trees, bananas, mango trees, etc.) or limited to local region of the diseases, insects and weeds, can provide three or more provinces level administrative regions, more than 2 years of field plot efficacy trials report.
Relatively stable environmental conditions in place for the use of pesticides, such as Warehouse, antiseptic use, and preservation of pesticides used, can provide in our country more than two provincial-level administrative regions, more than two test cycles efficacy test report.
D pesticide field trial approval certificate (copy);
E Other
a mode of action, action spectra, the mechanism or the mechanism of prediction analysis;
b resistance, including on-target organisms susceptibility testing, resistance monitoring methods and resistance risk assessment;
c main prey of the field and the impact of parasitoids;
d products characteristics and use precautions.
4.4.2.2.6 Residual data
According to the features and use of pesticides, according to the Vetting Committee to provide advice in our country's more than 2 years of residual test report. For pesticide products applied to different crops, farming systems in different natural conditions or provincial administrative regions the number of residue testing and information requirements, see 3.3.2.6.
4.4.2.2.7 Environmental Impact Data
Provides the following environmental test report. According to pesticide properties, formulation, use of and use, etc., may be appropriate relief for part of the test report.
A bird acute oral toxicity test;
B Fish acute toxicity test;
C bee acute oral toxicity test;
D bee acute contact toxicity test;
E silkworm acute toxicity test.
4.4.2.2.8 label or the instructions are accompanied by
Product labels provide proofs, content requirements with 3.3.2.8.
4.4.2.2.9 Product Safety Data Sheet (MSDS)
4.4.2.2.10 Other information
A in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of inquiry reports;
B Other.
4.4.3 officially registered
4.4.3.1 original drug official registration
4.4.3.1.1 official registration application form
4.4.3.1.2 Product summary information
Including the origin, the product of chemical and biological characteristics, toxicology, environmental impact, such as registration information outside the brief.
4.4.3.1.3 chemical and biological characteristics of the product information
With temporary registration requirements, see 4.4.2.1.3.
4.4.3.1.4 Toxicological information
A person confirming the active ingredients are not known pathogens or other mammalian supporting information.
B basic toxicology data
a Acute oral toxicity test;
b Acute percutaneous toxicity
c Acute Inhalation Toxicity Test;
d eye irritation / infection test;
e sensitization test, the contact with staff sensitization of cases inside and outside the survey data and case reports related to allergenicity;
f pathogenicity
- Oral pathogenic;
- Inhalation pathogenicity;
- Injection of pathogenic (bacteria and viruses intravenous test; fungi or protozoa intraperitoneal injection test).
g cell culture (virus-like virus, certain bacteria and protozoa requires the pilot).
C supplementation toxicology data
If you find micro-organisms produce toxins pesticides, obvious signs of infection or the persistence of such signs, test data should be added, such as sub-chronic toxicity, mutagenicity, reproductive toxicity, chronic toxicity, carcinogenicity, immune deficiency, caused by primates disease and so on.
D survey population exposure
4.4.3.1.5 Environmental Impact Data
Provides the following environmental test report. According to the characteristics or use of different pesticides, some relief may be appropriate test. Tests showed that the original drug on the biological environment as highly toxic or pathogenic, the need for the kinds of microorganisms in the environment to test the ability of reproduction.
A bird acute oral toxicity test;
B Fish acute toxicity test;
C Daphnia acute toxicity test;
D algal acute toxicity test;
E bee acute oral toxicity test;
F bee acute contact toxicity test;
G silkworm acute toxicity test.
4.4.3.1.6 label or the instructions are accompanied by
A in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and test results of the official registration tag design proofs;
B approve temporary registration of pesticide pesticide registration approval seal affixed label proofs, brochures;
C on the market during the temporary registration tag in circulation.
4.4.3.1.7 Product Safety Data Sheet (MSDS)
4.4.3.1.8 Additional information
A in other countries or regions have the toxicology and environmental impact testing and registration information or a combination of inquiry reports;
B variations in the environment and the risk of the release notes;
C Other.
4.4.3.2 Preparation official registration
4.4.3.2.1 official registration application form
4.4.3.2.2 Product summary information
Including place of origin, product characteristics, toxicology, efficacy, residue, environmental impact, foreign registration, etc. briefly.
4.4.3.2.3 products chemical and biological characteristics of the product information
In addition to the provisions of the temporary registration of the product chemistry data (see 4.4.2.2.3), should also provide storage stability at room temperature for more than 3 batches of the report.
4.4.3.2.4 Toxicological information
A person confirming the active ingredients are not known pathogens or other mammalian supporting information.
B confirm the microbial pesticide formulations contain contaminants or mutants as the existence of pathogens.
C basic toxicology data
a Acute oral toxicity test;
b Acute Dermal Toxicity test;
c Acute Inhalation Toxicity Test;
d eye irritation test;
e skin irritation test;
f skin sensitization tests.
D in the temporary registration on the basis of information provided, if there are special problems, according to the specific situation requires additional necessary information.
4.4.3.2.5 efficacy data
A two or more regions of different natural conditions, the model test report;
B temporary registration during the comprehensive use of the product report. Include: product area, the main application areas, the use of technology, the use of effects, resistance development, crop safety and for the impact of non-target organisms and other aspects of comprehensive evaluation.
4.4.3.2.6 Residual data
According to the features and use of pesticides, according to the Vetting Committee to provide advice in our country's more than 2 years of residual test report. For pesticide products applied to different crops, farming systems in different natural conditions or provincial administrative regions the number of residue testing and information requirements, see 3.3.2.6.
4.4.3.2.7 Environmental Impact Data
Report provides the following environmental tests. According to pesticide properties, formulation, use of and use, etc., may be appropriate relief for part of the test. There are special risks to the environment of pesticides, should also provide additional information on the environmental impact.
A bird acute oral toxicity test;
B Fish acute toxicity test;
C bee acute oral toxicity test;
D bee acute contact toxicity test;
E silkworm acute toxicity test.
4.4.3.2.8 label or the instructions are accompanied by
A in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and test results of the official registration tag design proofs;
B approve temporary registration of pesticide pesticide registration approval seal affixed label proofs, brochures;
C on the market during the temporary registration tag in circulation.
4.4.3.2.9 Product Safety Data Sheet (MSDS)
4.4.3.2.10 Other information
A in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of inquiry reports;
B variations in the environment and the risk of the release notes;
C Other.
4.5 Plant Pesticide
Botanical pesticide registration application should detail the source of raw materials (artificial or specially cultivated wild plants) and plant parts used (seeds, fruit, leaves, roots, bark, stems and tree trunks, etc.) and the ecological environment. Botanical pesticide active ingredients should be selected for the corresponding control object has a high biological activity.
4.5.1 Field trials
With most of the new pesticide, see 3.3.1, but should also provide high purity standard sample or the original drug, preparation of indoor activity determination report.
4.5.2 temporary registration
Temporary registration of the original drug 4.5.2.1
4.5.2.1.1 Temporary Registration Application Form
4.5.2.1.2 Product summary information
Including place of origin, product chemistry, toxicology, environmental impact, such as registration information outside the brief.
4.5.2.1.3 Product chemistry data
With the general registration of new pesticides, see 3.2.1.3. But special circumstances can not be detected when the full analysis, commissioned by the Ministry of Agriculture should be provided by the all-components analysis of pesticide test certificate issued by unit, and the main active ingredient in more than one identification.
4.5.2.1.4 Toxicological information
With the general registration of new pesticides, see 3.2.1.4.
4.5.2.1.5 Environmental Impact Data
Provides the following test report. According to the characteristics of pesticides, may be appropriate relief part of the test.
A environmental behavior Shiyan
a soil degradation test;
b hydrolysis test;
c water photolysis experiments.
B Environmental Toxicology data
a bird acute oral toxicity test;
b Fish acute toxicity test;
c Daphnia acute toxicity test;
d algal acute toxicity test;
e bee acute oral toxicity test;
f bee acute contact toxicity test;
g silkworm acute toxicity test.
4.5.2.1.6 label or the instructions are accompanied by
Product labels provide proofs, content requirements with 3.2.1.6.
4.5.2.1.7 Product Safety Data Sheet (MSDS)
4.5.2.1.8 Additional information
A in other countries or regions have the toxicology, environmental testing, and registration information or a combination of inquiry reports;
B Other.
4.5.2.2 Preparation temporary registration
With the general registration of new pesticides, see 3.3.2, but has the following main differences:
A should provide 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 a copy).
B to provide the following information on the environmental impact test report. According to the characteristics of pesticides, formulations, use of and mode of action, etc., may be appropriate relief for part of the test.
a bird acute oral toxicity test;
b Fish acute toxicity test;
c Daphnia acute toxicity test;
d algal acute toxicity test;
e bee acute oral toxicity test;
f bee acute contact toxicity test;
g silkworm acute toxicity test.
Processing agents used in the original drug's toxicity to daphnia or algae toxicity test results and provide summary information on the original drug test environment, and can no longer provide the kinds of biological test data.
Products for the slow release formulations of pesticides, soil degradation and soil should provide assay data.
4.5.3 officially registered
4.5.3.1 original drug official registration
4.5.3.1.1 official registration application form
4.5.3.1.2 Product summary information
Including place of origin, product chemistry, toxicology, environmental impact, such as registration information outside the brief.
4.5.3.1.3 Product chemistry data
With temporary registration requirements, see 4.5.2.1.3.
4.5.3.1.4 Toxicological information
With the general registration of new pesticides, see 3.2.2.4. However, national authorities have already been approved as a food additive, health food, medicine and other register, the approval of relevant departments in the provision of evidence and trial literature and accredited to meet the safety requirements under the premise of pesticides, can not provide reproductive toxicity, caused by abnormal, chronic and carcinogenicity study and other information.
4.5.3.1.5 Environmental Impact Data
Provides the following test report. According to the characteristics and uses of different pesticides, some relief may be appropriate test.
A environmental behavior Shiyan
a soil degradation test;
b hydrolysis test;
c water photolysis experiments.
B Environmental Toxicity
a bird acute oral toxicity test;
b Fish acute toxicity test;
c Daphnia acute toxicity test;
d algal acute toxicity test;
e bee acute oral toxicity test;
f bee acute contact toxicity test;
g silkworm acute toxicity test.
4.5.3.1.6 label or the instructions are accompanied by
A in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and test results of the official registration tag design proofs;
B approve temporary registration of pesticide pesticide registration approval seal affixed label proofs, brochures;
C on the market during the temporary registration tag in circulation.
4.5.3.1.7 Product Safety Data Sheet (MSDS)
4.5.3.1.8 Additional information
A in other countries or regions have the toxicology and environmental impact testing and registration information or a combination of inquiry reports;
B Other.
4.5.3.2 Preparation official registration
With the general registration of new pesticides, see 3.3.3. However, the following main differences:
In terms of environmental impact data should provide the following test report. According to the characteristics of pesticides, formulations, use of and mode of action, etc., may be appropriate relief for part of the test. Processing agents used in the original drug's toxicity to daphnia or algae toxicity test results and provide summary information on the original drug test environment, and can no longer provide the kinds of biological test report. Products for the slow release of pesticide formulations, should also provide soil degradation and soil assay data.
A bird acute oral toxicity test;
B Fish acute toxicity test;
C Daphnia acute toxicity test;
D algal acute toxicity test;
E bee acute oral toxicity test;
F bee acute contact toxicity test;
G silkworm acute toxicity test.
4.6 Genetically Modified Organisms
4.6.1 Field trials
4.6.1.1 Field Test Application Form
4.6.1.2 Summary of Data
A physical profile of genetic engineering
a body type genetic engineering: plants, animals and their categories;
b Toxicology: Genetic engineering body of mammalian (rat) Acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, skin sensitization, safety of agricultural products, etc.;
c receptor biology: Chinese name, Latin or English name, taxonomic status, level of security;
d gene: the name of the donor organisms, biological function;
e Carrier: name, source, marker genes, reporter gene;
f transgenic methods: genetic type of operation;
g body level of security and genetic engineering approval of conclusions.
B efficacy
a mode of action, action spectra, the mechanism or the mechanism of prediction analysis;
b test purpose, test locations, test area (the size of the release), test time, test units, test methods.
C outside the research, registration
4.6.2 temporary registration
4.6.2.1 Temporary Registration Application Form
4.6.2.2 Summary of Data Products
Overview of the body, including genetic engineering, toxicology, effects, residues, environmental impact, such as registration information outside of the brief.
4.6.2.3 Overview of genetic engineering body
With field trials, see 4.6.1.2 A.
4.6.2.4 Toxicology
Body of genetic engineering of mammalian (rat) Acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, skin sensitization, agricultural security.
4.6.2.5 efficacy data
4.6.2.5.1 Field Efficacy Report
Provide in our country more than four provincial-level administrative regions (with a herbicide, should be more than five provincial-level administrative regions), more than 2 years of field trials report;
Crops in some areas (such as flax, sugar beet, sunflower, ginseng, rubber tree, lychee trees, longan trees, bananas, mango trees, etc.) or limited to local region of the diseases, insects and weeds, can provide three or more provinces level administrative regions, more than 2 years of field plot efficacy trials report.
4.6.2.5.2 pesticide field trial approval certificate (copy);
4.6.2.5.3 Other
A mode of action, action spectra, the mechanism or the mechanism of prediction analysis;
B Resistance and set up the sanctuary;
C on the harvest quality of goods;
D product characteristics and use precautions.
4.6.2.6 Residual data
The toxicology tests showed that there are toxicity issues, toxic substances should be measured agricultural residues.
4.6.2.7 Environmental Impact Data
4.6.2.7.1 Genetic engineering body of debris impact on the environment
Including genetic drift effects on ecosystems, genetic composition, genetic stability.
4.6.2.7.2 Genetic engineering body residue decomposition characteristics in the environment
4.6.2.7.3 genetically engineered biological body residue effects on the environment
A soil microbes;
B birds;
C bees;
D aquatic organisms.
4.6.2.8 accompanied by the label or instructions
Product labels provide proofs, content requirements with 3.3.2.8.
4.6.2.9 Product Safety Data Sheet (MSDS)
4.6.2.10 Other information
4.6.2.10.1 in other countries or regions have been genetically engineered body profiles, toxicology, environmental testing and registration information or a combination of inquiry reports;
4.6.2.10.2 other.
4.6.3 officially registered
The formal registration of genetically modified organisms shall be separately provided.
4.7 predators biological
4.7.1 Field trials
4.7.1.1 Field Test Application Form
4.7.1.2 Summary of Data
4.7.1.2.1 Biology
Including common name, the international generic name, classification status (families, genera, species, strain), identification characteristics, distribution and status.
4.7.1.2.2 Control objects, control methods
4.7.1.2.3 biological activity and safety data
4.7.1.2.4 overseas research, registration
4.7.2 temporary registration
4.7.2.1 Temporary Registration Application Form
4.7.2.2 Summary of Data Products
Including biological characteristics, effects, environmental impacts, the registration of such information outside the brief.
4.7.2.3 Biological characteristics and product quality control requirements and test methods
4.7.2.3.1 Biology
Including common name, the international generic name, classification status (families, genera, species, strain), identification characteristics, distribution and status.
4.7.2.3.2 Quality Control project and its targets
4.7.2.3.3 and control of projects and their corresponding indicators and methods to confirm the detection method
4.7.2.3.4 Control of indicators to determine the description of the project and its
Control project and its development of indicators and reasonable basis to make the necessary explanations.
4.7.2.3.5 Determination of product quality inspection and verification report
4.7.2.3.6 packaging, transport and storage precautions, safety alerts, valid
4.7.2.4 efficacy data
4.7.2.4.1 efficacy reports
In our country more than 2 provincial administrative areas, more than 2 years of field trials report. Including control object, scope, control effect, economic benefits, problems, improvement measures.
4.7.2.4.2 pesticide field trials certificate of approval
4.7.2.4.3 Other
A biological activity and safety data;
B application of risk prediction and control measures;
C product characteristics and use precautions.
4.7.2.5 The impact on crop
4.7.2.6 impact on the environment
4.7.2.6.1 impact on the national protected species
4.7.2.6.2 impact on beneficial organisms
4.7.2.6.3 of the impact of non-target organisms
4.7.2.7 with native species or small species of possibility and impact of hybridization
4.7.2.8 accompanied by the label or instructions
Product labels provide proofs, content requirements with 3.3.2.8.
4.7.2.9 Product Safety Data Sheet (MSDS)
4.7.2.10 Other information
4.7.2.10.1 in other countries or regions have the biological characteristics and product quality control, efficacy, environmental impact testing and registration information or a combination of inquiry reports
4.7.2.10.2 Other
4.7.3 officially registered
The official registration of biological predators provisions separately.
Chapter V Registration of new agents
5.1 New formulations
5.1.1 Field trials
5.1.1.1 Field Test Application Form
5.1.1.2 Summary of information on chemical products
5.1.1.2.1 active ingredients
Active ingredient common name, the international generic name, chemical name, Chemical Abstracts Service (CAS) Registry Number, International Pesticide Analytical Partnership Committee (CIPAC) digital code, development number, empirical formula, molecular weight, structure, major physical and chemical parameters (such as: appearance, melting point, boiling point, density or bulk density, specific rotation, vapor pressure, solubility, partition coefficient, etc.).
5.1.1.2.2 Preparation
Formulations, active ingredients, other components of the specific names and content, the main physical and chemical parameters, controls and indicators, category (by use), the active ingredient analysis methods.
5.1.1.3 Summary of toxicological data
Acute oral toxicity, acute dermal toxicity, acute inhalation toxicity and poisoning, first aid measures.
5.1.1.4 efficacy data
5.1.1.4.1 indoor activity tests report (only the new control object related to the product)
5.1.1.4.2 When the crop for the indoor test crop safety trials report (only for use of products involving new)
5.1.2.4.3 the purpose of description and indoor mixed formulation screening report (for mixed formulations)
5.1.1.4.4 test crops, control objects, application methods and precautions
5.1.1.5 Other information
5.1.1.5.1 the purpose of changing the dosage form, meaning
5.1.1.5.2 Other
5.1.2 temporary registration
5.1.2.1 Temporary Registration Application Form
5.1.2.2 Summary of Data Products
Including place of origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside the brief.
5.1.2.3 Product chemistry data
With 3.3.2.3. However, the following differences:
Shall provide the provincial quality inspection agency issued a statutory product quality testing and method validation report. Quality inspection report should include items all items specified in 3.3.2.3.7. Method validation report should be attached to the original relevant typical chromatograms, and to evaluate the feasibility of the method, stamped with the official seal of inspection.
5.1.2.4 Toxicological information
5.1.2.4.1 Acute oral toxicity test
5.1.2.4.2 Acute percutaneous toxicity
5.1.2.4.3 Acute inhalation toxicity
5.1.2.4.4 Eye irritation test
5.1.2.4.5 Skin irritation test
5.1.2.4.6 skin sensitization test
5.1.2.5 efficacy data
5.1.2.5.1 indoor activity tests report (only the new control object related to the products, field trials have provided, and can provide a copy)
5.1.2.5.2 When the crop for the indoor test crop safety trials report (used only for the new range of products involved, field trials have provided, and can provide a copy)
5.1.2.5.3 the purpose of description and indoor mixed formulation screening report (for mixed formulations, field trials have provided, and can provide a copy)
5.1.2.5.4 efficacy reports
Insecticides, fungicides to provide in our country more than four provincial-level administrative regions, more than 2 years of field plot efficacy trials report.
Herbicides, plant growth regulators to provide in our country more than five provincial-level administrative regions, more than 2 years of field plot efficacy trials reported on the long residual effect of herbicides, should also be provided after the main crop safety test report .
Crops in some areas (such as flax, sugar beet, sunflower, ginseng, rubber tree, lychee trees, longan trees, bananas, mango trees, etc.) or limited to local region of the diseases, insects and weeds, can provide three or more provinces level administrative regions, more than 2 years of field plot efficacy trials report.
For some special agents, such as Herbicide, etc., can provide more than three provincial-level administrative regions, more than 2 years of field plot efficacy trials report.
Relatively stable environmental conditions in place for the use of pesticides, such as Warehouse, antiseptic use, and preservation of pesticides used, can provide in our country more than two provincial-level administrative regions, more than two test cycles efficacy test report.
5.1.2.5.5 pesticide field trial approval certificate (copy)
5.1.2.5.6 Other
A resistance, including on-target organisms susceptibility testing, resistance monitoring methods and resistance risk assessment (involving new control object only product);
B on the field the main predators and parasitic natural enemies (only involving the use of new products);
C product characteristics and use precautions.
5.1.2.6 Residual data
Increase the active ingredients are not registered to use the crops or products, should provide more than 2 years in our country's residual test report; active ingredients registered for use in crops and products, should provide more than 1 year in our country's residual test report.
For pesticide products applied to different crops, farming systems in different natural conditions or provincial administrative regions the number of residue testing and information requirements, see 3.3.2.6.
5.1.2.7 Environmental Impact Data
Report provides the following environmental tests. According to pesticide properties, formulation, use of and use, etc., may be appropriate relief for part of the test report. If the applicant can provide information indicating that the active ingredients of the product than the original drug on a biological toxicity test results for the low toxicity, effects on non-target plant test results for the low-risk, they do not provide the appropriate test report. Products for the slow release of pesticide formulations, should also provide soil degradation and soil assay report.
5.1.2.7.1 Birds Acute oral toxicity test
5.1.2.7.2 Fish Acute toxicity test
5.1.2.7.3 Daphnia acute toxicity test
5.1.2.7.4 Acute toxicity algae
5.1.2.7.5 Acute oral toxicity test bees
5.1.2.7.6 bee acute contact toxicity test
5.1.2.7.7 Acute toxicity test silkworm
5.1.2.7.8 impact on non-target plant test
5.1.2.8 accompanied by the label or instructions
Product labels provide proofs, content requirements with 3.3.2.8.
5.1.2.9 Product Safety Data Sheet (MSDS)
5.1.2.10 Other information
5.1.2.10.1 in other countries or regions have the toxicology, efficacy, residue, environmental impact testing and registration information or a combination of inquiry reports
5.1.2.10.2 change the dosage of the purpose and significance of
5.1.2.10.3 Other
5.1.3 officially registered
5.1.3.1 official registration application form
5.1.3.2 Summary of Data Products
Including place of origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside the brief.
5.1.3.3 Product chemistry data
In addition to the provisions of the temporary registration of chemical products (see 5.1.2.3), should also provide storage stability at room temperature for more than 3 batches of the report.
5.1.3.4 Toxicological information
5.1.3.4.1 Acute oral toxicity test
5.1.3.4.2 Acute percutaneous toxicity
5.1.3.4.3 Acute inhalation toxicity
5.1.3.4.4 Eye irritation test
5.1.3.4.5 Skin irritation test
5.1.3.4.6 skin sensitization test
5.1.3.5 efficacy data
During the temporary use of the product registration comprehensive report, including: product area, the main application areas, the use of technology, the use of effects, resistance development, crop safety and for the impact of non-target organisms and other aspects of the comprehensive evaluation.
5.1.3.6 Residual data
Specific requirements with 3.3.3.6.
5.1.3.7 Environmental toxicity information
Report provides the following environmental tests. According to pesticide properties, formulation, use of and use, etc., may be appropriate relief for part of the test report. If the applicant can provide the information that the product of the original active ingredient drug in a biological toxicity test results of low toxicity, effects on non-target plant test results for the low-risk, they do not provide the appropriate test report. Products for the slow release of pesticide formulations, should also provide soil degradation and soil assay report.
5.1.3.7.1 Birds Acute oral toxicity test
5.1.3.7.2 Fish Acute toxicity test
5.1.3.7.3 Daphnia acute toxicity test
5.1.3.7.4 Acute toxicity algae
5.1.3.7.5 Acute oral toxicity test bees
5.1.3.7.6 bee acute contact toxicity test
5.1.3.7.7 Acute toxicity test predators Trichogramma
5.1.3.7.8 Acute toxicity test silkworm
5.1.3.7.9 earthworm acute toxicity test
5.1.3.7.10 impact on non-target plant test
5.1.3.8 accompanied by the label or instructions
5.1.3.8.1 in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and test results of the official registration tag design sample
5.1.3.8.2 approve temporary registration of pesticides, pesticide registration approval seal affixed label proofs, instructions
5.1.3.8.3 in the market during the temporary registration tag in circulation
5.1.3.9 Product Safety Data Sheet (MSDS)
5.1.3.10 Other information
5.1.3.10.1 in other countries or regions have the toxicology, efficacy, residue, environmental impact testing and registration information or a combination of inquiry reports
5.1.3.10.2 Other
5.2 pesticide formulations small optimization
Applicants registered for the enterprise to optimize product formulations to meet small-optimized pesticide formulations, according to the following requirements can apply for registration, but the application relative to other applicants registered products optimized for the small pesticide formulations, dosage forms according to the new registration shall be required to provide information.
5.2.1 Field trials
5.2.1.1 Field Test Application Form
5.2.1.2 Summary of information on chemical products
5.2.1.2.1 active ingredients
Including the active ingredient common name, the international generic name, chemical name, Chemical Abstracts Service (CAS) Registry Number, International Pesticide Analytical Partnership Committee (CIPAC) digital code, development number, empirical formula, molecular weight, structure, major physical and chemical parameters (such as : appearance, melting point, boiling point, density or bulk density, specific rotation, vapor pressure, solubility, partition coefficient, etc.).
5.2.1.2.2 Preparation
Including formulations, active ingredients, other components of the specific names and content, the main physical and chemical parameters, quality control project and its target, category (by use), the active ingredient analysis methods.
5.2.1.3 Summary of toxicological data
Including acute oral toxicity, acute dermal toxicity, acute inhalation toxicity and poisoning, first aid measures.
5.2.1.4 efficacy data
5.2.1.4.1 indoor activity tests report (only the new control object related to the product)
5.2.1.4.2 When the crop for the indoor test crop safety trials report (only for use of products involving new)
5.2.1.4.3 test crops, control objects, application methods and precautions
5.2.1.5 change the dosage of the purpose and significance of
5.2.1.6 Other
5.2.2 temporary registration
5.2.2.1 Temporary Registration Application Form
5.2.2.2 Summary of Data Products
Including place of origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description, and explain the purpose of changing the dosage form and meaning.
5.2.2.3 Product chemistry data
With 3.3.2.3. However, the following differences:
Shall provide the provincial quality inspection agency issued a statutory product quality testing and method validation report. Quality inspection report should include items all items specified in 3.3.2.3.7. Method validation report should be attached to the original relevant typical chromatograms, and to evaluate the feasibility of the method, stamped with the official seal of inspection.
5.2.2.4 Toxicological information
5.2.2.4.1 Acute oral toxicity test
5.2.2.4.2 Acute percutaneous toxicity
5.2.2.4.3 Acute inhalation toxicity
5.2.2.4.4 Eye irritation test
5.2.2.4.5 Skin irritation test
5.2.2.4.6 skin sensitization test
5.2.2.5 efficacy data
With use of the new registration or new registration method used, the efficacy data requirements with the new pesticide formulations (see 5.1.2.5) the registration requirements. Other provisions of the following information:
5.2.2.5.1 efficacy reports
Insecticides, fungicides to provide in our country more than four provincial-level administrative regions, more than 1 year of field plot efficacy trials report.
Herbicides, plant growth regulators to provide in our country more than five provincial-level administrative regions, more than 1 year of field plot efficacy trials reported on the long residual effect of herbicides, should also be provided after the main crop safety test report .
For some special agents, such as Herbicide, etc., can provide more than three provincial-level administrative regions, more than 1 year of field plot efficacy trials report.
Crops in some areas (such as flax, sugar beet, sunflower, ginseng, rubber tree, lychee trees, longan trees, bananas, mango trees, etc.) or limited to local region of the diseases, insects and weeds, can provide three or more provinces level administrative regions, more than 1 year of field plot efficacy trials report.
Relatively stable environmental conditions in place for the use of pesticides, such as Warehouse, antiseptic use, and preservation of pesticides used, can provide in our country more than two provincial-level administrative regions, a trial period over the efficacy test report.
5.2.2.5.2 pesticide field trial approval certificate (copy)
5.2.2.5.3 Features and use precautions
5.2.2.6 Residual data
Increase the active ingredients are not registered to use the crops or products, should provide more than 2 years in our country's residual test report; active ingredients registered for use in crops and products, should provide more than 1 year in our country's residual test report. For pesticide products applied to different crops, farming systems in different natural conditions or provincial administrative regions the number of residue testing and information requirements, see 3.3.2.6.
But for small-optimized product formulations, such as one of the following conditions, our residue test results in the provision of summary information or written statement related to the case of temporary registration can not provide residual test report:
5.2.2.6.1 The formulations of small businesses 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.
5.2.2.6.2 have the information the applicant has left in our country have the same active ingredients, formulations, and methods of use of officially registered more than 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.
5.2.2.6.3 independent with the same active ingredients, formulations, and methods of use of the registered product residue data were authorized, and the application to optimize product formulations of active ingredients with small amount of active ingredient is the use of 1.5 times.
5.2.2.7 Environmental Impact Data
With 5.1.2.7. However, the small business and optimize product formulations corresponding to the registered formulations have required environmental information, to provide summary information. Slight increase in pesticide formulations of active ingredients to optimize the product or use unregistered crops, provided the original formulation of the environmental impact of the registration information does not meet the requirements of environmental safety assessment, should provide information on the environmental impact.
5.2.2.8 accompanied by the label or instructions
Product labels provide proofs, content requirements with 3.3.2.8.
5.2.2.9 Product Safety Data Sheet (MSDS)
5.2.2.10 Other information
5.2.2.10.1 in other countries or regions have the toxicology, efficacy, residue, environmental impact testing and registration information or a combination of inquiry reports
5.2.2.10.2 Other
5.2.3 officially registered
Minor pesticide formulations to optimize product formulations in the business of the original product to obtain a full registration, the following information required to apply for official registration of the product, or by new pesticide formulation should be (see 5.1) or mixed formulations (5.3) to provide information.
5.2.3.1 official registration application form
5.2.3.2 Summary of Data Products
Including place of origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside the brief;
5.2.3.3 Product chemistry data
In addition to the provisions of the temporary registration of chemical products (see 5.2.2.3), should also provide storage stability at room temperature for more than 3 batches of the report.
5.2.3.4 Toxicological information
5.2.3.4.1 Acute oral toxicity test
5.2.3.4.2 Acute percutaneous toxicity
5.2.3.4.3 Acute inhalation toxicity
5.2.3.4.4 Eye irritation test
5.2.3.4.5 Skin irritation test
5.2.3.4.6 skin sensitization test
5.2.3.5 efficacy data
During the temporary use of the product registration comprehensive report, including: product area, the main application area, the dose, the use of technology, the use of effects, resistance development, crop safety and for the impact of non-target organisms and other aspects of the comprehensive evaluation.
5.2.3.6 Residual data
Increase the active ingredients are not registered to use the crops or products, should provide more than 2 years in our country's residual test report; active ingredients registered for use in crops and products, should provide more than 1 year in our country's residual test report. For pesticide products applied to different crops, farming systems in different natural conditions or provincial administrative regions the number of residue testing and information requirements, see 3.3.2.6.
Minor optimization of product formulations, 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 residue data requirements:
5.2.3.6.1 have been left to other applicants in our data have the same active ingredients, formulations, and methods of use of officially registered more than 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.
5.2.3.6.2 independent with the same active ingredients, formulations, and methods of use of the registered product residue data were authorized, and the application to optimize product formulations of active ingredients with small amount of active ingredient is the use of 1.5 times.
5.2.3.7 Environmental Impact Data
With 5.1.3.7. The small business and optimize product formulations corresponding to the registered formulations have required environmental information, to provide summary information. Slight increase in pesticide formulations of active ingredients to optimize the product or use unregistered crops, provided the original formulation of the environmental impact of the registration information does not meet the requirements of environmental safety assessment, should provide relevant information on environmental impacts.
5.2.3.8 accompanied by the label or instructions
5.2.3.8.1 in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and test results of the official registration tag design sample
5.2.3.8.2 approve temporary registration of pesticides, pesticide registration approval seal affixed label proofs, instructions
5.2.3.8.3 in the market during the temporary registration tag in circulation
5.2.3.9 Product Safety Data Sheet (MSDS)
5.2.3.10 Other information
5.2.3.10.1 in other countries or regions have the toxicology, efficacy, residue, environmental impact testing and registration information or a combination of inquiry reports
5.2.3.10.2 Other
5.3 New mixed formulations
5.3.1 Field trials
5.3.1.1 Field Test Application Form
5.3.1.2 Summary of information on chemical products
5.3.1.2.1 active ingredients
Including the active ingredient common name, the international generic name, chemical name, Chemical Abstracts Service (CAS) Registry Number, International Pesticide Analytical Partnership Committee (CIPAC) digital code, development number, empirical formula, molecular weight, structure, major physical and chemical parameters (such as : appearance, melting point, boiling point, density or bulk density, specific rotation, vapor pressure, solubility, partition coefficient, etc.).
5.3.1.2.2 Preparation
Including formulations, active ingredients, other components of the specific names and content, the main physical and chemical parameters, quality control project and its target, category (by use), the active ingredient analysis methods.
5.3.1.3 Summary of toxicology data
Acute oral toxicity, acute dermal toxicity, acute inhalation toxicity and poisoning, first aid measures.
5.3.1.4 efficacy data
5.3.1.4.1 mixed statement of purpose
5.3.1.4.2 Indoor formulation screening report
5.3.1.4.3 When the crop for the indoor test crop safety trials report (only for use of products involving new)
5.3.1.4.4 Features and use precautions
5.3.1.4.5 test crops, control objects, application methods and precautions
5.3.1.5 Other
5.3.1.5.1 and registered the same types of active ingredients, formulations, and methods of use of different products, but the ratio of comparative analysis of advantages and disadvantages
5.3.1.5.2 Other
5.3.2 temporary registration
5.3.2.1 Temporary Registration Application Form
5.3.2.2 Summary of Data Products
Including place of origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside the brief.
5.3.2.3 Product chemistry data
With 3.3.2.3. However, the following differences:
Shall provide the provincial quality inspection agency issued a statutory product quality testing and method validation report. Quality inspection report should include items all items specified in 3.3.2.3.7. Method validation report should be attached to the original relevant typical chromatograms, and to evaluate the feasibility of the method, stamped with the official seal of inspection.
5.3.2.4 Toxicological information
5.3.2.4.1 Acute oral toxicity test
5.3.2.4.2 Acute percutaneous toxicity
5.3.2.4.3 Acute inhalation toxicity
5.3.2.4.4 Eye irritation test
5.3.2.4.5 Skin irritation test
5.3.2.4.6 skin sensitization test
5.3.2.5 efficacy data
With use of the new registration or new registration method used, the efficacy data requirements with the new pesticide formulations (see 5.1.2.5) the registration requirements. Other provisions of the following information:
5.3.2.5.1 mixed statement of purpose (field trial stage has been provided, and can provide a copy)
5.3.2.5.2 Indoor formulation screening report (field trial stage has been provided, and can provide a copy)
5.3.2.5.3 efficacy reports
Insecticides, fungicides to provide in our country more than four provincial-level administrative regions, more than 2 years of field plot efficacy trials report.
Herbicides, plant growth regulators to provide in our country more than five provincial-level administrative regions, more than 2 years of field plot efficacy trials report on products with long residual effect of herbicide active ingredients, such as the active ingredient than the dose registered the same active ingredients, formulations, and methods of use of the product dosage, the use or registration of new methods or new use, shall provide for the safety of the main crop after the test report.
Crops in some areas (such as flax, sugar beet, sunflower, ginseng, rubber tree, lychee trees, longan trees, bananas, mango trees, etc.) or limited to local region of the diseases, insects and weeds, can provide three or more provinces level administrative regions, more than 2 years of field plot efficacy trials report.
Relatively stable environmental conditions in place for the use of pesticides, such as Warehouse, antiseptic use, and preservation of pesticides used, can provide in our country more than two provincial-level administrative regions, more than two test cycles efficacy test report.
5.3.2.5.4 pesticide field trial approval certificate (copy)
5.3.2.5.5 Other
Including product characteristics and use precautions.
5.3.2.6 Residual test data
Increase the active ingredients are not registered to use the crops or products, should provide more than 2 years in our country's residual test report; active ingredients registered for use in crops and products, should provide more than 1 year in our country's residual test report.
For pesticide products applied to different crops, farming systems in different natural conditions or provincial administrative regions the number of residue testing and information requirements, see 3.3.2.6.
If the product contains the active ingredients in the following conditions, to provide our residue test results in the summary information or written statement related to the case, you can remove the corresponding residue data requirements:
5.3.2.6.1 have the information the applicant has left 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 active ingredient usage use of 1.5 times.
5.3.2.6.2 independent with the same active 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.
5.3.2.7 Environmental Impact Data
Report provides the following environmental toxicity. According to pesticide properties, formulation, use of and use, etc., may be appropriate relief for part of the test. If the applicant can provide information indicating that the active ingredients of the product in the original drug's toxicity to daphnia or algae toxicity test results, impact on non-target plant testing as low-risk, and can no longer provide the kinds of biological test report.
5.3.2.7.1 Birds Acute oral toxicity test
5.3.2.7.2 Fish Acute toxicity test
5.3.2.7.3 Daphnia acute toxicity test
5.3.2.7.4 Acute toxicity algae
5.3.2.7.5 Acute oral toxicity test bees
5.3.2.7.6 bee acute contact toxicity test
5.3.2.7.7 Acute toxicity test silkworm
5.3.2.7.8 impact on non-target plant test
5.3.2.8 accompanied by the label or instructions
Product labels provide proofs, content requirements with 3.3.2.8.
5.3.2.9 Product Safety Data Sheet (MSDS)
5.3.2.10 Other information
5.3.2.10.1 in other countries or regions have the toxicology, efficacy, residue, environmental impact testing and registration information or a combination of inquiry reports
5.3.2.10.2 registered with the same types of active ingredients, formulations, and methods of use of the product, but the ratio of different strengths and weaknesses of comparative analysis
5.3.2.10.3 Other
5.3.3 officially registered
5.3.3.1 official registration application form
5.3.3.2 Summary of Data Products
Including place of origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside the brief.
5.3.3.3 Product chemistry data
In addition to the provisions of the temporary registration of chemical products (see 5.3.2.3), should also provide storage stability at room temperature for more than 3 batches of the report.
5.3.3.4 Toxicological information
5.3.3.4.1 Acute oral toxicity test
5.3.3.4.2 Acute percutaneous toxicity
5.3.3.4.3 Acute inhalation toxicity
5.3.3.4.4 Eye irritation test
5.3.3.4.5 Skin irritation test
5.3.3.4.6 skin sensitization test
5.3.3.5 efficacy data
Providing temporary use of the product during the registration of the comprehensive report, including: product area, the main application areas, the use of technology, the use of effects, resistance development, crop safety and for the impact of non-target organisms and other aspects of the comprehensive evaluation.
5.3.3.6 Residual test data
Shall provide the natural conditions in our country or provincial administrative regions in different farming systems more than 2 years of residual test report.
For pesticide products applied to different crops, farming systems in different natural conditions or provincial administrative regions the number of residue testing and information requirements, see 3.3.2.6.
If the product contains the active ingredients in the following conditions, to provide our residue test results in the summary information or written statement related to the case, you can remove the corresponding residue data requirements:
5.3.3.6.1 have the information the applicant has left 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 active ingredient usage use of 1.5 times.
5.3.3.6.2 independent with the same active 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.
5.3.3.7 Environmental Impact Data
Report provides the following environmental tests. According to pesticide properties, formulation, use of and use, etc., may be appropriate relief for part of the test. If the applicant can provide the information that the product of the original active ingredient drug in Daphnia, algae, earthworms and other natural enemies of some Trichogramma environment or biological toxicity test results of low toxicity, effects on non-target plant test results for low risk, can no longer provide the kinds of biological test report. There are special risks to the environment of pesticides, should also provide additional information on the environmental impact.
5.3.3.7.1 Birds Acute oral toxicity test
5.3.3.7.2 Fish Acute toxicity test
5.3.3.7.3 Daphnia acute toxicity test
5.3.3.7.4 Acute toxicity algae
5.3.3.7.5 Acute oral toxicity test bees
5.3.3.7.6 bee acute contact toxicity test
5.3.3.7.7 Acute toxicity test predators Trichogramma
5.3.3.7.8 Acute toxicity test silkworm
5.3.3.7.9 earthworm acute toxicity test
5.3.3.7.10 impact on non-target plant test
5.3.3.8 accompanied by the label or instructions
5.3.3.8.1 in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and test results of the official registration tag design sample
5.3.3.8.2 approve temporary registration of pesticides, pesticide registration approval seal affixed label proofs, instructions
5.3.3.8.3 in the market during the temporary registration tag in circulation
5.3.3.9 Product Safety Data Sheet (MSDS)
5.3.3.10 Other information
5.3.3.10.1 in other countries or regions have the toxicology, efficacy, residue, environmental impact testing and registration information or a combination of inquiry reports
5.3.3.10.2 Other
5.4 Preparation of new content
5.4.1 General requirements
5.4.1.1 change the content should be consistent will help improve product quality, protect the environment, reduce the use of cost principles.
5.4.1.2 applicants relative to the company's products have been registered for the new content, change the active ingredients of the product (mixed formulations of active ingredients such as change in ratio) 5.4.2 ~ 5.4.4 can be required to apply for registration information.
5.4.1.3 apply the product relative to other applicants registered for the new content, it should be according to the new dosage form (see 5.1) or a new mixed formulations (see 5.3) provides registration information to provide information. But 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 residue data.
5.4.1.3.1 have the information the applicant has left in our country have the same active ingredients, formulations, and methods of use of officially registered more than 6 years, and the preparation of applications for registration of new content products, the use of the active ingredient is the active ingredient use 1.5 times less.
5.4.1.3.2 independent with the same active ingredients, formulations, and methods of use of the product residue data registered by authorized content and applications for new formulations of the active ingredient of registered products is the use of 1.5 times the amount of active ingredient using the following .
5.4.1.4 Registration on the content of information requirements under the new temporary registration of the product obtained in the same active ingredients of other types of business, product formulations without obtaining official registration should be preceded by a new dosage form (see 5.1) or a new mixed formulations (see 5.3) registration requirements apply for official registration.
5.4.2 Field trials
5.4.2.1 Field Test Application Form
5.4.2.2 Summary of information on chemical products
5.4.2.2.1 active ingredients
Including the active ingredient common name, the international generic name, chemical name, Chemical Abstracts Service (CAS) Registry Number, International Pesticide Analytical Partnership Committee (CIPAC) digital code, development number, empirical formula, molecular weight, structure, major physical and chemical parameters (such as : appearance, melting point, boiling point, density or bulk density, specific rotation, vapor pressure, solubility, partition coefficient, etc.).
5.4.2.2.2 Preparation
Formulations, active ingredients, other components of the specific names and content, the main physical and chemical parameters, controls and indicators, category (by use), the active ingredient analysis methods.
5.4.2.3 Summary of toxicology data
Including acute oral, dermal, inhalation toxicity testing.
5.4.2.4 efficacy data
5.4.2.4.1 indoor activity tests report (only the new control object related to the product)
5.4.2.4.2 When the crop for the indoor test crop safety trials report (only for use of products involving new)
5.4.2.4.3 test crops, control objects, application methods and precautions
5.4.2.5 Other
5.4.2.5.1 change the purpose and significance of information content
5.4.2.5.2 Other
5.4.3 temporary registration
5.4.3.1 Temporary Registration Application Form
5.4.3.2 Summary of Data Products
Including place of origin, product chemistry, toxicology, efficacy, residue, environmental impact and other information brief, and written description of the purpose of changing the content of meaning.
5.4.3.3 Product chemistry data
With 3.3.2.3. However, the following differences:
Shall provide the provincial quality inspection agency issued a statutory product quality testing and method validation report. Quality inspection report should include items all items specified in 3.3.2.3.7. Method validation report should be attached to the original relevant typical chromatograms, and to evaluate the feasibility of the method, stamped with the official seal of inspection.
5.4.3.4 Toxicological information
Should provide the following toxicology reports, but low levels of application for registration with the formulation of finished products, pesticides, additives in the categories does not change the circumstances, the applicant has to provide the original registration of the same active ingredients and formulations product toxicology summary information, can not test for toxicity.
5.4.3.4.1 Acute oral toxicity test
5.4.3.4.2 Acute percutaneous toxicity
5.4.3.4.3 Acute inhalation toxicity
5.4.3.4.4 Eye irritation test
5.4.3.4.5 Skin irritation test
5.4.3.4.6 skin sensitization test
5.4.3.5 efficacy data
With use of the new registration or new registration method used, the efficacy data requirements with the new pesticide formulations (see 5.1.2.5) the registration requirements. Other provisions of the following information:
5.4.3.5.1 efficacy reports
Insecticides, fungicides to provide in our country more than four provincial-level administrative regions, more than 1 year of field plot efficacy trials report.
Herbicides, plant growth regulators to provide in our country more than five provincial-level administrative regions, more than 1 year of field plot efficacy trials reported on the long residual effect of herbicides, should also be provided after the main crop safety test report .
For some special agents, such as Herbicide, etc., can provide more than three provincial-level administrative regions, more than 1 year of field plot efficacy trials report.
Crops in some areas (such as flax, sugar beet, sunflower, ginseng, rubber tree, lychee trees, longan trees, bananas, mango trees, etc.) or limited to local region of the diseases, insects and weeds, can provide three or more provinces level administrative regions, more than 1 year of field plot efficacy trials report.
Relatively stable environmental conditions in place for the use of pesticides, such as Warehouse, antiseptic use, and preservation of pesticides used, can provide in our country more than one provincial administrative region, more than two test cycles efficacy test report.
5.4.3.5.2 pesticide field trial approval certificate (copy)
5.4.3.5.3 Other
Including product characteristics and use precautions.
5.4.3.6 Residual data
Increase the active ingredients are not registered to use the crops or products in our country should provide more than 2 years of residual test report; active ingredients registered for use in crops and products, should provide more than 1 year in our country's residual test report.
For pesticide products applied to different crops, farming systems in different natural conditions or provincial administrative regions the number of residue testing and information requirements, see 3.3.2.6.
Content of the application for registration of new products, 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 residue data requirements:
5.4.3.6.1 have the information the applicant has left in our country have the same active 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 use of its active ingredient 1.5 times.
5.4.3.6.2 independent with the same active ingredients, formulations, and methods of use of the information registered by the authority, and the application for registration of products use the active ingredient is the active ingredient use 1.5 times.
5.4.3.7 Environmental Impact Data
With 5.1.2.7 (for single-agent) or 5.3.2.7 (for mixed formulations). Applicant the same active ingredients, dosage form products have appropriate environmental data, provide summary data. New pesticide active ingredient content of products to increase use of non-registered crops or the original content of pesticide product registration information provided does not meet the requirements of environmental safety assessment, it should add the relevant environmental impact information.
5.4.3.8 accompanied by the label or instructions
Product labels provide proofs, content requirements with 3.3.2.8.
5.4.3.9 Product Safety Data Sheet (MSDS)
5.4.3.10 Other information
5.4.3.10.1 in other countries or regions have the toxicology, efficacy, residue, environmental impact testing and registration information or a combination of inquiry reports;
5.4.3.10.2 Other
5.4.4 officially registered
5.4.4.1 official registration application form
5.4.4.2 Summary of Data Products
Product chemistry, toxicology, efficacy, residue, environmental impact data brief.
5.4.4.3 Product chemistry data
In addition to the provisions of the temporary registration of chemical products (see 5.4.3.3), should also provide storage stability at room temperature for more than 3 batches of the report.
5.4.4.4 Toxicological information
Should provide the following details of the test report, but the low content of applications for product registration with the dosage formulation, additives in the type of pesticide does not change the circumstances, the applicant has to provide the original registration of the same active ingredients and formulations product toxicology data summary , you can not test for toxicity.
5.4.4.4.1 Acute oral toxicity test
5.4.4.4.2 Acute percutaneous toxicity
5.4.4.4.3 Acute inhalation toxicity
5.4.4.4.4 Eye irritation test
5.4.4.4.5 Skin irritation test
5.4.4.4.6 skin sensitization test
5.4.4.5 efficacy data
Providing temporary use of the product during the registration of the comprehensive report, including: product area, the main application areas, the use of technology, the use of effects, resistance development, crop safety and for the impact of non-target organisms and other aspects of the comprehensive evaluation.
5.4.4.6 Residual data
Increase the active ingredients are not registered to use the crops or products, should provide more than 2 years in our country's residual test report; active ingredients registered for use in crops and products, should provide more than 1 year in our country's residual test report.
For pesticide products applied to different crops, farming systems in different natural conditions or provincial administrative regions the number of residue testing and information requirements, see 3.3.2.6.
Application for registration of new content products, 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 residue data requirements:
5.4.4.6.1 have the information the applicant has left in our country have the same active 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 use of its active ingredient 1.5 times.
5.4.4.6.2 independent with the same active ingredients, formulations, and methods of use of the information registered by the authority, and the application for registration of products use the active ingredient is the active ingredient use 1.5 times.
5.4.4.7 Environmental Impact Data
With 5.1.3.7 (for single-agent) or 5.3.3.7 (for mixed formulations). However, the same applicant active ingredients, dosage form products have appropriate environmental data, provide summary data. New pesticide active ingredient content of products to increase use of non-registered crops or the original content of pesticide product registration information provided does not meet the requirements of environmental safety assessment, it should add the relevant environmental impact information.
5.4.4.8 accompanied by the label or instructions
5.4.4.8.1 in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and test results of the official registration tag design sample
5.4.4.8.2 approve temporary registration of pesticides, pesticide registration approval seal affixed label proofs, instructions
5.4.4.8.3 in the market during the temporary registration tag in circulation
5.4.4.9 Product Safety Data Sheet (MSDS)
5.4.4.10 Other information
5.4.4.10.1 in other countries or regions have the toxicology, efficacy, residue, environmental impact testing and registration information or a combination of inquiry reports
5.4.4.10.2 Other
5.5 Drug fat mixed formulations
Reference to the new requirements for mixed formulations (see 5.3), but the following differences:
- Product information should include chemical fertilizer project and its component indicators and determination of control methods, pesticide and fertilizer mix stability, etc.;
- Efficacy data should provide information on the efficacy of pesticides and fertilizers fertilizer test results, the results of crop yield, etc.;
- Environmental impact of information requirements with the new formulation (see 5.1);
- The label should be marked "medicine fat mixture."
5.6 New penetrant (or synergist) mixed with pesticide formulations
5.6.1 provide 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.
5.6.2 provide the penetrant, synergist indoor formulation screening report.
5.6.3 applicants for the enterprise relative to the active ingredients registered product types and formulations of the same content, but increased the penetrant or synergist product registration, new content can be registered (see 5.4) to provide information on other cases should be according to the new dosage form (see 5.1) or a new mixed formulations (see 5.3) provides registration information to provide information. But one of the following conditions, may be exempt from residue test data:
5.6.3.1 Residual data of the applicants already have in our country have the same active 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 .
5.6.3.2 provide independent with the same active ingredients, dosage form, scope and methods of using the information registered by the authority, and the application for registration of products use the active ingredient is the active ingredient use 1.5 times.
5.7 special registration of new pesticides, new formulations
Special new formulation of pesticides, formulations tiny optimization, mixed formulations, new content such as product registration, the registration of new pesticides under the special information requirements with reference to the new pesticides and new formulations, dosage forms tiny optimization, mixed formulations, the principle of the new content of the corresponding registration to provide information.
Use of pesticides on health, only for the enterprise application to change the content of the registered product registration, a description of the reasons; active ingredient content increased (to increase the proportion of mixed formulations of the same), the original registered in the provision of the same active ingredients, dosage form products Summary of efficacy data, efficacy trials can not provide information; active ingredient was reduced (to reduce the proportion of mixed formulations of the same), it does not change in the types of additives that had been registered and provide the same active ingredients, dosage form products Summary of toxicology data, toxicology testing can not provide information.
Chapter VI provides the same pesticide product registration information
6.1 General requirements
6.1.1 has been officially registered with the same pesticide product, the field test by other applicants should apply directly for the official register.
6.1.2 contains the active ingredient has been made in our country and in the registration of pesticide registration data protection period, according to a new pesticide registration should be required to provide information.
6.1.3 meet the following conditions of the same pesticide product, can be 6.2 or 6.3 requirements, reduction of information:
6.1.3.1 The applicant provide the same pesticide product designated corresponding business name, product name, registration number and contrast to determine the conclusion by pesticide registration authorities no significant difference found to meet the same quality of the original drug (or no significant difference in the quality of the same preparation) requirements. No significant difference in the quality of the original drug or the same no significant difference in the quality of preparation of the same basic principles found in Annex 7-8.
6.1.3.2 the applicant corresponding to the same pesticide products specified in our formal registration made more than 6 years, or six years in the formal registration, but the product registration certificate holder has complete information and agree to an independent license.
6.1.4 the same pesticide products registered for use to increase the scope of the new use or new registration shall also comply with the efficacy of new formulations of products, residues and environmental impact of the corresponding registration requirements.
In addition to the provisions of 6.1.5 6.1.2,6.1.3 and 6.1.4 outside the context of the same pesticide product, it should be required to provide the following information:
6.1.5.1 corresponds to the original drug by general or special new pesticide registration of new pesticide regulations to provide information. Passed new pesticide protection of the original drug product, the applicant can provide physical and chemical properties of active ingredients and environmental information related to behavioral characteristics of a comprehensive inquiry report parameters instead of the experimental data.
6.1.5.2 single-agent formulations according to the new content registration requirements (see 5.4) to provide information.
6.1.5.3 mixed formulations according to the new mixed formulations registration requirements (see 5.3) to provide information.
6.2 no significant difference in the quality of the official registration of the same original drug
6.2.1 Application for official registration
6.2.2 Summary of information products
Including place of origin, product chemistry, toxicology, environmental impact and other information outlined.
6.2.3 no significant difference in the quality of the same drug found that the original (including applications for products with no significant difference in the quality of the original drug of the same product name, company name, registration number of pesticides and compared to determine the conclusions), the applicant for corroboration related materials.
6.2.4 Product chemistry data
With 3.2.1.3. However, the following differences:
- The applicant can provide physical and chemical properties of active ingredients literature review of relevant parameters instead of the active ingredient, the original drug's physical and chemical properties Determination of parameters and results;
- Provide statutory provincial quality inspection agency issued the product quality testing and method validation report. Quality inspection report should include items all items specified in 3.2.1.3.4. Method validation report should be attached to the original relevant typical chromatograms, and to evaluate the feasibility of the method, stamped with the official seal of inspection.
6.2.5 Toxicology Data
As identified by the same pesticide products with complete toxicology data, provide summary information in the literature review or case, shall provide the following information. As identified by the same pesticide products are not complete toxicology data, according to a new pesticide registration information should be required to provide the appropriate information (see 3.2.2.4), or according to the following provisions on the basis of information provided to supplement the pesticide products identified by the same The lack of appropriate data.
6.2.5.1 Acute oral toxicity test
6.2.5.2 Acute percutaneous toxicity
6.2.5.3 Acute inhalation toxicity
6.2.6 Environmental Impact Data
As identified by the same pesticide products have a complete environmental impact information, you can provide information or a summary of literature review information. Such as the pesticide products identified by the same environmental impact information is not complete, it should be according to the new pesticide registration requirements (see 3.2.2.5) to provide environmental impact information, or to add the pesticide products identified the same lack of appropriate data.
6.2.7 label or the instructions are accompanied by
Product labels provide proofs, content requirements with 3.3.2.8.
6.2.7 Product Safety Data Sheet (MSDS)
6.2.8 Other
6.3 no significant difference in the quality of registration of the same preparation
6.3.1 Field trials
6.3.1.1 Field Test Application Form
6.3.1.2 Summary of information on chemical products
6.3.1.2.1 active ingredients
Including the active ingredient common name, the international generic name, chemical name, Chemical Abstracts Service (CAS) Registry Number, International Pesticide Analytical Partnership Committee (CIPAC) digital code, development number, empirical formula, molecular weight, structure, major physical and chemical parameters (such as : appearance, melting point, boiling point, density or bulk density, specific rotation, vapor pressure, solubility, partition coefficient, etc.).
6.3.1.2.2 Preparation
Including formulations, active ingredients, other components of the specific names and content, the main physical and chemical parameters, quality control project and its target, category (by use), the active ingredient analysis methods.
6.3.1.3 Summary of product toxicity data
Including acute oral, dermal, inhalation toxicity testing.
6.3.1.4 test crops, control objects, application methods and precautions
6.3.1.5 no significant difference in the quality of identification to prove the same preparation
Including product quality and application of the same preparation no significant difference in the product name, company name, registration number of pesticides and compared to determine the conclusion, the applicant for evidence related materials.
6.3.1.6 Other
6.3.2 officially registered
6.3.2.1 official registration application form
6.3.2.2 Summary of Data Products
Including place of origin, product chemistry, toxicology, efficacy, residue, environmental impact data brief.
6.3.2.3 no significant difference in the quality of identification to prove the same preparation
Including product quality and application of the same preparation no significant difference in the product name, company name, registration number of pesticides and compared to determine the conclusion, the applicant for evidence related materials.
6.3.2.4 Product chemistry data
With 3.3.2.3. However, the following differences:
- Provide statutory provincial quality inspection agency issued the product quality testing and method validation report. Quality inspection report should include items all items specified in 3.3.2.3.7. Method validation report should be attached to the original relevant typical chromatograms, and to evaluate the feasibility of the method, stamped with the official seal of inspection.
- Increase product storage at 30 ℃ for 18 weeks stability test report.
6.3.2.5 Toxicological information
6.3.2.5.1 Acute oral toxicity test
6.3.2.5.2 Acute percutaneous toxicity
6.3.2.5.3 Acute inhalation toxicity
6.3.2.6 efficacy data
6.3.2.6.1 efficacy reports
Insecticides, fungicides to provide in our country more than four provincial-level administrative regions, more than 1 year of field plot efficacy trials report.
Herbicides, plant growth regulators to provide in our country more than five provincial-level administrative regions, more than 1 year of field plot efficacy trials report.
For some special agents, such as Herbicide, etc., can provide more than three provincial-level administrative regions, more than 1 year of field plot efficacy trials report.
Crops in some areas (such as flax, sugar beet, sunflower, ginseng, rubber tree, lychee trees, longan trees, bananas, mango trees, etc.) or limited to local region of the diseases, insects and weeds, can provide three or more provinces level administrative regions, more than 1 year of field plot efficacy trials report.
Relatively stable environmental conditions in place for the use of pesticides, such as Warehouse, antiseptic use, and preservation of pesticides used, can provide in our country more than two provincial-level administrative regions, a trial period over the efficacy test report.
6.3.2.6.2 pesticide field trial approval certificate (copy)
6.3.2.6.3 Other
Including product characteristics and use precautions.
6.3.2.7 Residual data
In the same scope and methods of use, distinguish between different situations according to the following:
6.3.2.7.1 have been identified as the same pesticide products registered in China has completed the application for registration of the product residue testing and the use of dose is 1.5 times the original dose, our residue test results in the provision of summary information or written statement related to circumstances, it can not provide residual test data.
6.3.2.7.2 have been identified as the same pesticide products registered in China has completed the remaining tests, but the use of the product registration application for the original dose is 1.5 times higher than the dose used, and provide our country's more than one year remaining test report.
6.3.2.7.3 have been identified as the same pesticide products registered in our residue test has not been completed, providing more than 2 years in our country's residual test report.
For pesticide products applied to different crops, farming systems in different natural conditions or provincial administrative regions the number of residue testing and information requirements, see 3.3.2.6.
6.3.2.8 Environmental Impact Data
As identified by the same pesticide products have provided the corresponding environmental impact information, to provide environmental testing in the summary data or literature review of the case, the same pesticide product registration application can not provide environmental impact information. As identified by the same pesticide product does not provide information on the environmental impact, the provisions of 5.1.3.7 shall be provided according to the environmental impact information, or to add the same pesticide products identified by the lack of appropriate data.
6.3.2.9 accompanied by the label or instructions
Product labels provide proofs, content requirements with 3.3.2.8.
6.3.2.10 Product Safety Data Sheet (MSDS)
6.3.2.11 Other information
6.4 special pesticide registration of the same pesticide product
Special pesticide registration of the same pesticide product, according to a special new pesticide registration requirements, refer to the new pesticides and new pesticide products registered with the same preparation of corresponding principles, to provide information.
Expand the use of Chapter VII, to change the use of
Registration information and change the dose requirement
Expand the use of 7.1
Expand the use of cover crops and expand the use of control objects. Has made a formal application for expanded use of registered products range, according to official registration requirements should apply to expand use of registration.
7.1.1 Field trials
7.1.1.1 Field Test Application Form
7.1.1.2 indoor activity tests report (only the new control object related to the active ingredient products)
7.1.1.3 Test of the crop when the crop of the interior safety test report (only involving the use of new products)
7.1.1.4 Foreign objects in the registration of crop and control the use of
7.1.1.5 other varieties and the use of pesticide-related information, including human, animal, environmental impact situation.
7.1.2 temporary registration
7.1.2.1 Temporary Registration Application Form
7.1.2.2 Summary of Data Products
Provide efficacy, residue, environmental impact, such as registration information outside the brief.
7.1.2.3 efficacy data
With 5.1.2.5.
7.1.2.4 Residual data
Application for registration of the product belongs to the same type of temporary registration of pesticide residues in the registration requests for information.
7.1.2.5 Environmental Impact Data
Increase the use of registration or registration to use the original pesticide product registration information provided can not meet the requirements of environmental safety assessment, it should be added the environmental impact of test-related information.
7.1.2.6 accompanied by the label or instructions
Product labels provide proofs, content requirements with 3.3.2.8.
7.1.2.7 Other information
7.1.3 officially registered
7.1.3.1 official registration application form
7.1.3.2 Summary of Data Products
Including efficacy, residue, environmental impact, such as registration information outside of the brief.
7.1.3.3 efficacy data
Providing temporary use of the product during the registration of the comprehensive report, including: product area, the main application areas, the use of technology, the use of effects, resistance development, crop safety and for the impact of non-target organisms and other aspects of the comprehensive evaluation.
Without expanding the use of temporary registration phase of the range of products, according to the requirements of the new product formulations to provide information (see 5.1.2.5); the same use of the same pesticide product, made in the first six years after the official registration, according to the requirements of 6.3.2.6 provide information.
7.1.3.4 Residual data
Application for registration of products with the respective types of official registration of pesticide residues in the registration requests for information.
7.1.3.5 Environmental Impact Data
Increase the use of registration or registration to use the original pesticide product registration information provided can not meet the requirements of environmental safety assessment, it should add the relevant environmental test data.
7.1.3.6 accompanied by the label or instructions
7.1.3.6.1 in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and test results of the official registration tag design sample
7.1.3.6.2 approve temporary registration of pesticides, pesticide registration approval seal affixed label proofs, instructions
7.1.3.6.3 in the market during the temporary registration tag in circulation
7.1.3.7 Other information
7.2 Use change
Has made a formal application to change registration of products to use, should apply for registration according to the official expansion to change the use of registration.
7.2.1 Field trials
7.2.1.1 Field Test Application Form
7.2.1.2 Other information
Change the use purpose, meaning and use of new people, animals, environment, security implications and so on.
7.2.2 temporary registration
7.2.2.1 Temporary Registration Application Form
7.2.2.2 Summary of Data Products
Including efficacy, residue, environmental impact, such as registration information outside of the brief and explain the purpose of changing the use and meaning.
7.2.2.3 efficacy data
With 5.1.2.5.
7.2.2.4 Residual data
Application for registration of products with the respective types of temporary registration of pesticide residues in the registration requests for information.
7.2.2.5 Environmental Impact Data
Due to changes in use, resulting in the original pesticide product registration information provided does not meet requirements of environmental safety assessment, it should add the relevant environmental impact information.
7.2.2.6 accompanied by the label or instructions
Product labels provide proofs, content requirements with 3.3.2.8.
7.2.2.7 Other information
7.2.3 officially registered
7.2.3.1 official registration application form
7.2.3.2 Summary of Data Products
Including efficacy, residue, environmental impact, such as registration information outside of the brief.
7.2.3.3 efficacy data
Providing temporary use of the product during the registration of the comprehensive report, including: product area, the main application areas, the use of technology, the use of effects, resistance development, crop safety and for the impact of non-target organisms and other aspects of the comprehensive evaluation.
Temporary registration period without change in use of the product, according to new product formulations to requests for information (see 5.1.2.5); the same use of pesticide products and the same method, to obtain official registration in the first six years, according to 6.3.2.6 of Requests for information.
7.2.3.4 Residual data
Application for registration of products with the respective types of official registration of pesticide residues in the registration requests for information.
7.2.3.5 Environmental Impact Data
Changes in the use of methods, resulting in the original pesticide product registration information provided does not meet the environmental safety assessment requirements, relevant environmental test data should be added.
7.2.3.6 accompanied by the label or instructions
7.2.3.6.1 in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and test results of the official registration tag design sample
7.2.3.6.2 approve temporary registration of pesticides, pesticide registration approval seal affixed label proofs, instructions
7.2.3.6.3 in the market during the temporary registration tag in circulation
7.2.3.7 Other information
7.3 change the dose
Have been officially registered products made in the registration period To change the dose, you can apply for registration according to the following requirements:
7.3.1 Field trials
7.3.1.1 Field Test Application Form
7.3.1.2 change the dose causes and research reports
7.3.1.3 Other
7.3.2 officially registered
7.3.2.1 official registration application form
7.3.2.2 Summary of Data Products
Including product efficacy, residue and other information outlined.
7.3.2.3 efficacy data
7.3.2.3.1 efficacy reports
Insecticides, fungicides to provide in our country more than four provincial-level administrative regions, more than 1 year of field plot efficacy trials report.
Herbicides, plant growth regulators to provide in our country more than five provincial-level administrative regions, more than 1 year of field plot efficacy trials report; the product contains a long residual effect of herbicides, such as the use of doses greater than the original registered dosage, should also provide for the safety of the main crop after the test report.
For some special agents, such as Herbicide, etc., can provide more than three provincial-level administrative regions, more than 1 year of field plot efficacy trials report.
Crops in some areas (such as flax, sugar beet, sunflower, ginseng, rubber tree, lychee trees, longan trees, bananas, mango trees, etc.) or limited to local region of the diseases, insects and weeds, can provide three or more provinces level administrative regions, more than 1 year of field plot efficacy trials report.
Relatively stable environmental conditions in place for the use of pesticides, such as Warehouse, antiseptic use, and preservation of pesticides used, can provide in our country more than two provincial-level administrative regions, a trial period over the efficacy test report.
7.3.2.3.2 pesticide field trial approval certificate (copy)
7.3.2.4 Residual data
Dose is 1.5 times higher than the original dose, it should provide more than 1 year in our country's residual test report.
For pesticide products applied to different crops, farming systems in different natural conditions or provincial administrative regions the number of residue testing and information requirements, see 3.3.2.6.
7.3.2.5 accompanied by the label or instructions
7.3.2.5.1 in accordance with the "Regulations", the Ministry of Agriculture on pesticide product labeling requirements and test results of the official registration tag design sample
7.3.2.5.2 approve temporary registration of pesticides, pesticide registration approval seal affixed label proofs, instructions
7.3.2.5.3 Registration circulation in the market during the label
7.3.3.6 Other
7.4 Special expand use of pesticides, changing methods and changing the dose
Expand the use of specific pesticides, changing methods and change the dose, according to the special provisions of the new pesticide registration information, refer to the new pesticides, new agents, the same pesticide product registration and its expanding use of, use and change of use to change the dose of registration requirements corresponding principles, to provide information.
Chapter VIII of the registration provisions of packing
8.1-packing registration application form
8.2 The validity of the original packing power of attorney or agreement
8.3-packing-packing business entrusted to product quality assurance and bear corresponding legal responsibilities of undertaking
8.4 installation commissioned by the company's products toxicology, efficacy, residue and a summary of the environmental impact of chemical information and complete product information
8.5-packing the product MSDS information entrusted to businesses
8.6-packing company commissioned pesticide registration or temporary registration certificate
8.7 of the original packaging in the market circulation of the label and packing the product label proofs
About 8.8 installed and have a packing qualified business license (copy)
8.9-packing company where the jurisdiction of the provincial institutes of the preliminary views of pesticides
Chapter IX provides registration renewal
Application for renewal of registration of the product should provide the following information:
9.1 Application for renewal of registration
9.2 The applicant affixed the official seal of registration of pesticides or pesticide temporary registration certificate (copy)
9.3 the latest product standards for record
9.4 pairs of officially registered products, the applicant shall present the "pesticide registration requirement" in the original information submitted on the basis of pilot projects to supplement the information or the lack of comprehensive reports.
9.5 pairs of packing the product registration, the applicant should provide the original packing agreement or power of attorney, statutory provincial quality inspection agency issued the product quality inspection report.
9.6 label proofs (photocopy)
9.7 in circulation on the market or are accompanied by the label's instructions
Chapter parent drug registration
10.1 due to material properties, technical and security reasons can not apply for registration of the original drug, the mother can apply for drug registration, the information required with the original drug.
10.2 of the original drug has been registered, due to technical and safety reasons and other special needs parent drug application for registration, registration requirements and registration information corresponding provisions of the same preparations, but not required to provide efficacy, residue and environmental data.
Chapter other matters related to pesticide registration data requirements
11.1 Change Company Name
11.1.1 of the original company changed its name to apply
Such as the cancellation of the original enterprise, to be renamed the new company can apply, but should also provide proof of the original company was canceled, the original relationship between business and new business-related evidence.
11.1.2 renamed detailed description of the reasons
11.1.3 new enterprise business license (copy)
11.1.4 where the provincial pesticide original business certificate issued by certification bodies (outside the applicant can not provide)
11.1.5 of the original business registration certificate of all pesticides or pesticide temporary registration certificate (original)
11.1.6 Other
11.2 up card
Pesticide Registration Certificate or Temporary Pesticide Registration Certificate is lost, its holder of the registration period should apply in writing within the Ministry of Agriculture, explain the reasons for loss, provide evidence, through its local administrative departments at provincial agricultural pesticides institute that (outside the applicant can not provide) before applying for up formalities.
11.3 the number of registration requirements
2 copies of the registration information should be provided, and the content should be exactly the same. One should be original; a copy for (but has 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.
11.4 Binding registration requirements
11.4.1 recommend to use italics 4 Chinese characters, English words with 11. Chinese text with foreign materials should be bound with the book.
11.4.2 Registration information (including supplementary information) should be arranged catalog and page number, such as the use of code should be simple, easy to find, data are organized as follows:
11.4.2.1 Cover
11.4.2.2 Contents
11.4.2.3 data authenticity and non-infringement of intellectual property rights (see annex 9)
11.4.2.4 provincial pesticide certification agency preliminary views (outside of the applicant can not provide)
11.4.2.5 Application (Ministry of Agriculture designed by the corresponding application form)
11.4.2.6 Product summary information
11.4.2.7 product chemistry data
11.4.2.8 toxicology data
11.4.2.9 efficacy data
11.4.2.10 residue data
11.4.2.11 environmental impact data
11.4.2.11 pesticide products demonstrate the same material (for the same pesticide product)
11.4.2.13 technical identification information and relevant supporting materials (if necessary)
11.4.2.14 label or the instructions are accompanied by
11.4.2.15 drug formulations used in the original source and the registration certificate (for the preparation of the product, provided the original drug unit by the issue, the format in Annex 10)
11.4.2.16 Other
Includes company profile, business license, product patents, trademarks descriptions.
11.4.3 all information registered to use 70 grams of white A4 paper, in addition to the signature, all content should be printed.
11.4.4 Registration information should be firmly bound by the order, such as too much information can be bound volumes.
Chapter XII Supplementary Provisions
12.1 with effect from January 8, 2008 shall come into force. April 12, 2001 the Ministry of Agriculture "on the release <pesticide registration requirements of" notice "(Agriculture Agricultural Development [2001] No. 8) since January 1, 2009 repealed.
12.2 provides the implementation of field trials prior to approval or provisional registration of the product, in January 1, 2009 before a formal application for provisional registration or registered, applicants can be "on the release <pesticide registration requirements of" notice "(agriculture agriculture [2001] No. 8) shall apply, but get the same pesticide in the first officially registered, can only apply for official registration.
12.3 at January 1, 2009 renewal application for official registration, the applicant can be "on the release <pesticide registration requirements of" notice "(Agricultural Agricultural Development [2001] No. 8) shall apply. From January 1, 2009, all formal registration renewal shall be in accordance with the regulations.