Biochemical Pesticide Registration in China

Biochemical pesticides refer to pesticides that meet the following two conditions at the same time:

• They have no direct toxicity to the target, but only have special effects such as regulating growth, interfering with mating or luring; and
• Natural compounds. If they are synthetic, their structure should be the same as that of natural compounds (differences in the proportion of isomers are allowed).

Main Categories of Biochemical Pesticides

• Pheromone substances: These refer to the chemical substances secreted by animals and plants that can change the biological behavior of the same or different receptors.
• Natural plant growth regulator: refers to the chemical substances produced by plants or microorganisms that inhibit and stimulate the growth and development of the same or different plants (including the processes of germination, growth, flowering, fertilization, fruit set, maturity, and abscission) or regulate the resistance of plants to adversity (cold, heat, drought, humidity, wind, disease and insect pests).
• Natural insect growth regulator: It refers to the chemical substances produced by insects that inhibit and stimulate the growth process of insects.
• Natural plant inducer: refers to the natural source material that can induce plants to produce a defense response to pest infection and improve their resistance.
• Other types of chemicals which fit the biochemical pesticide definition.

Registered Biochemical Pesticides

There are more than 38 kinds of active ingredients of biochemical pesticides registered, more than 600 registered, involving more than 200 production enterprises. The largest number of registered products are gibberellic acid and aminooligosaccharides. The top five varieties of biochemical pesticides in yield are gibberellic acid, aminooligosaccharide, brassinolide, Triacontanol and 14-hydroxybrassinosterol, accounting for about 70% of biochemical pesticides.

Data Requirements

TC (TK)

There are varity of biochemical pesticide, different active ingredients have different properties, so the data requirement are vary.

Product Chemistry data, toxicity data and eco-tox data are required for biochemical pesticide.

Formulation

Product chemistry data, toxicity data are similar to conventional pesticide.

Efficacy

Can be done in China within one year.

Eco-tox data

4 species tests are required.

Residue

Requirement is same as conventional pesticide, some active ingredient residue data can be waived.

Evaluation

Evaluation process please refer to the pesticide registration webpage. For biochemical pesticide registered products, the applicant submitted a written application for accelerating registration approval, and the ICAMA of the Ministry of Agriculture and Rural Affairs shall report to the office of the national pesticide registration and evaluation committee for approval if the products meet the "green channel" requirements. For those meeting the requirements of "green channel" products, priority shall be given to technical review, and the evaluation process shall be accelerated on the premise of quality and safety.

Notes

• Agricultural antibiotic pesticides are the same as chemical pesticides in registration management.
• Synthetic biochemical pesticides are treated as chemical pesticides.
• In principle, it is not allowed to register the new pesticide technical concentration, except for the technical material that cannot be applied for due to material characteristics, technology or safety registration, such as fermented or extracted biochemical pesticides, which are allowed to register the technical concentration.

Low toxic (micro toxic) chemical information substances, fermented natural plant growth regulators and polysaccharide pesticides can be exempted from the registration of Technical materials (technical concentrations), but the relevant chemical test data required for the registration of Technical materials (technical concentrations) completed with fermentation broth and extract of processed formulations, as well as the relevant toxicological and environmental test data completed by formulations shall be submitted to meet the needs of safety assessment. Among them, amino ligosaccharide, chitosan, lentinan, oligosaccharide and glucomannan can reduce the corresponding technical material test data.

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