Under the new policy, which pesticide registration studies can be “exempted” or “reduced”?

　　“Reduction or exemption” generally refers to in Pesticide Exemption from testing or from submitting certain documentation at the time of registration. In the new… Pesticide Under the registration policy, the scope of “exemptions and reductions” is limited; the relevant details are as follows.
　　Types of chemical testing for products that may be exempted or reduced
　　Chemistry Pesticide Technical grade material (parent compound) and biochemistry Pesticide Active ingredient (technical grade): (1) For technical-grade active ingredients manufactured by this enterprise from its own registered technical-grade material, the chemical data requirements are the same as those for formulated products; however, the data for room‑temperature storage stability studies may be waived, and the rationale for producing the technical‑grade material, together with the suitable formulation types for processing it, shall be provided. (2) For sanitary‑use technical‑grade active ingredients with a content of less than 1% that involve isomer separation, if an identification test for the active ingredient in the product—including isomer identification—is adequately documented, the corresponding isomer‑separation method and its validation report may be omitted.
　　Biochemistry Pesticide Formulations and plant-derived substances Pesticide Formulation: (1) If a registration exemption is applied, this… Pesticide For the processing of technical-grade active ingredients (parent compounds) into formulated products, the applicant shall submit a full‑component analytical report for the technical‑grade active ingredient (parent compound), together with a complete description of the manufacturing process, quality‑control procedures, and their respective specifications; (2) If the … used… Pesticide If the active ingredient (parent drug) has already been approved and registered with the relevant authorities for pharmaceuticals, food, health products, or other such categories, the aforementioned documentation may be waived; however, a copy of the registration certificate and materials such as product quality standards shall still be submitted.
　　Microorganisms for sanitary use Pesticide Formulation: (1) If a microbial technical grade product subject to registration fee exemption is used to manufacture a formulated product, the applicant shall submit the strain identification report for that technical grade, the strain designation, strain description, the complete manufacturing process, component analysis test reports, and stability study data (including sensitivity to temperature changes, light, and pH), as well as quality control items and their respective specifications; (2) If the microbial agent used… Pesticide If the active pharmaceutical ingredient has already been approved and registered with the relevant authorities for pharmaceuticals, food, health products, or other categories, the aforementioned documentation may be waived; however, a copy of the registration certificate and materials such as product quality standards shall still be submitted.
　　Types of toxicological tests that may be exempted or reduced
　　Plant-derived Pesticide Active ingredient (technical grade): For substances that have been approved by the competent national authorities for registration as food additives, health foods, or pharmaceutical ingredients, upon submission of relevant approval certificates and supporting experimental documentation, and following review, they shall be deemed to comply with… Pesticide Subject to safety requirements, data from studies on reproductive toxicity, teratogenicity, chronic and carcinogenic effects, metabolism and toxicokinetics, and endocrine disruption may be omitted.
　　Types of field efficacy trials that may be exempted or reduced
　　Chemistry Pesticide Formulation, Biochemistry Pesticide Formulations and plant-derived substances Pesticide Formulation: For products that do not involve new intended uses or new application methods, field efficacy trials may be conducted over 1 year in 3 locations (for forestry pesticides, crops grown in specific regions, or pests, diseases, and weeds occurring in particular areas), 1 year in 4 locations (for insecticides and fungicides), or 1 year in 5 locations (for herbicides and plant growth regulators).
　　For sanitary use Pesticide Formulations: (1) Products that cannot undergo indoor efficacy testing, such as ultra‑low‑volume sprays and thermal fogging formulations, are exempt from submitting indoor efficacy test data; (2) Products intended for application by brushing, broadcasting, repellency, pest‑proofing, or indoor residual spraying after dilution, as well as other products for which simulated field trials cannot be conducted, are exempt from submitting simulated field trial data.
　　Types of residue tests that may be exempted
　　Chemistry Pesticide Pharmaceuticals and Biochemistry Pesticide Formulation: (1) Products intended for non‑food crops or non‑feed crops are not required to submit residue study data; the active ingredient is classified as low‑toxicity or slightly toxic. seed Treatment agents (including seed‑treatment formulations, seed coatings, and soaking solutions) are not required to submit residue‑testing data; (2) New Pesticide If complete plant metabolism data have already been submitted, or if the submitted metabolism data already cover the crop type for which registration is sought, plant metabolism data need not be resubmitted. (3) If the registered crop is not intended for use as animal feed, animal metabolism data may be omitted. (4) If this information has already been provided in the environmental dossier, there is no need to resubmit environmental metabolism study data. (5) For new‑formulation products relative to the company’s previously registered products— including mixtures that vary the active‑ingredient content proportionally—residue study data may be waived when the registered crop, application rate, timing of application, number of applications, method of application, and pre‑harvest interval are all identical. However, if the registered crop and application method are the same but the application rate, timing, number of applications, or pre‑harvest interval differ in a way that could increase residue risk, residue study data shall be submitted at half the usual number of test points, with a minimum of two points. (6) For identical formulations and similar formulations (with the same intended uses and application methods): if changes in application rate, number of applications, or pre‑harvest interval do not increase residue risk, residue study data may be waived; if such changes could increase residue risk, residue study data shall be submitted at half the usual number of test points, with a minimum of two points.
　　Microorganism Pesticide Formulations and plant-derived substances Pesticide Formulation: If toxicological testing indicates the presence of toxicologically significant effects, it shall be handled in accordance with… Pesticide The Registration Review Committee requires the submission of residue data for this class of substances in agricultural products; no additional residue data are required beyond this.
　　Rodenticides: No residue data are required, except for chemically formulated rodenticides applied over the entire area.
　　Types of environmental impact tests that may be exempted or reduced
　　Chemistry Pesticide Technical grade material (parent compound), biochemistry Pesticide Active ingredient (technical grade) and microorganisms Pesticide Parent drug: (1) There is sufficient evidence indicating that this… Pesticide When the likelihood of biological exposure to a particular environmental factor is extremely low (e.g., the… Pesticide (1) Applications for exemption from this test may be submitted if the product is intended solely for use in ponds, rivers, lakes, and other water bodies; solely for protected areas; or solely for dryland crops, grasslands, forests, etc.; (2) For sanitary products that are only processed… Pesticide The formulation is specifically intended for hygienic use in indoor environments. Pesticide The active ingredient does not need to be provided (except for birds); (3) For indoor use only. Pesticide (If used for sprout inhibition after potato harvesting) Pesticide ) Environmental data are not required (except for analytical methods and their validation in water, as well as those in soil); (4) If no mortality or irreversible adverse effects are observed at the highest hazard concentrations in ecotoxicity tests, the microbial growth test may be waived.
　　Chemistry Pesticide Formulation, Biochemistry Pesticide Formulations and plant-derived substances Pesticide Formulation: (1) There is sufficient evidence indicating that this… Pesticide When the likelihood of biological contact with a particular environmental compartment is extremely low, an exemption from this test may be requested; (2) trunk injection or application. Pesticide • Formulations intended for indoor use only (such as those used to inhibit sprouting after potato harvest) are not required to submit environmental data; (3) Formulations used exclusively in protected cultivation facilities are not required to submit such data (except for earthworms); (4) seed Formulations that are not applied by spraying, such as treatment agents, granules, and soil treatments, are not required to provide data on honeybees (oral and contact exposure), silkworms, predatory natural enemies, or parasitic natural enemies. (5) If the active‑ingredient test results indicate that one of the three test organisms—fish, daphnia, or algae—is a sensitive species (more than 100 times more sensitive than the other two), then only the sensitive species need to be tested for the formulated product. (6) For use in upland fields… seed Formulations applied as treatment agents, or granular products applied in furrows or planting holes, are not required to provide data on fish, bees, or algae; (7) formulations intended solely for use in aquatic environments such as ponds, rivers, and lakes (e.g., those used on lotus roots) are exempt from submitting data on honeybees (via oral exposure or contact), silkworms, predatory natural enemies, parasitic natural enemies, and earthworms; (8) formulations used exclusively in outdoor residential settings are exempt from providing data on predatory natural enemies, parasitic natural enemies, and earthworms; (9) indoor-use sanitary insecticides and mosquito-repellent products applied directly to the human body may be exempted from submitting environmental data; (10) except for new… Pesticide For registration types other than formulations, new intended uses, or new application methods, applicants shall compare the application methods and ecotoxicological profiles of their company’s already‑registered products. If the application rate and number of applications do not exceed those of the company’s registered products, the interval between applications is no shorter than that of the registered products, and the ecotoxicity is no greater than that of the registered products, an environmental risk assessment report is not required.
　　Rodenticides: For rodenticides used to control house mice, data from acute fish toxicity tests are not required.

Source: Beijing Kefa Weiye