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Biochemical Pesticide Registration in China: Advantages and Compliance Challenges Analysis

Biochemical pesticides are an increasingly popular alternative to traditional chemical pesticides in China. However, registering and complying with regulations for biochemical pesticides in China requires a detailed understanding of the relevant laws and policies.

This article provides an overview of biochemical pesticides in China, including their definition, registration data requirements, compliance costs, cycle time, and challenges.

What is Biochemical Pesticides in China?

According to Announcement No.2569 of China’s Ministry of Agriculture and Rural Affairs (MoARA), biochemical pesticides refer to pesticides that are naturally produced or have the same structure as natural compounds, allowing for differences in the proportion of isomers. These pesticides have no direct toxicity to the control objects but only have special effects such as regulating growth, interfering with mating, or attracting.

Biochemical pesticides in China include chemical information substances, natural plant growth regulators, natural insect growth regulators, natural plant elicitors, and other substances that meet the definition of biochemical pesticides.

  • Chemical information substance refers to the chemical substance secreted by animals and plants, which can change the biological behavior of the same or different receptors. For example, Chilo suppressalis sex pheromone (cis-9-hexadecenal, etc.), Spodoptera litura sex pheromone, Isotropin, etc.

  • Natural plant growth regulators are chemical substances produced by plants or microorganisms, which can inhibit or stimulate the growth and development of the same or different plants (including germination, growth, flowering, fertilization, fruit setting, maturity, and abscission) or regulate plant resistance to adversity (cold, heat, drought, humidity, wind, pests and diseases). For example, gibberellin, indoleacetic acid, furfuryl aminopurine, chameleon, and the like.

  • Natural insect growth regulators are chemical substances produced by insects that inhibit and stimulate the growth of insects. Uch as lecithin, S-methoprene, and the like. Among them, although S-methoprene is chemically synthesized, its structure is highly similar to that of natural insect juvenile hormone and its function is completely consistent, so it is finally recognized as a biochemical pesticide.

  • Natural plant elicitor is a natural substance that can induce plants to produce a defense response to pest infection and improve their resistance. For example, chitosan, oligosaccharin, lentinan, hypersensitive protein, beta-lupin conglutin polypeptide, and the like.

  • Other biochemical pesticides refer to substances other than those mentioned above that meet the definition of biochemical pesticides—for example, cholecalciferol.

According to China’s MoARA Bulletin No.2569, chemical pesticides refer to synthetic pesticides using chemical substances.

Registration Data Requirements for Biochemical Pesticide in China

According to a series of pesticide management policies such as Pesticide Registration Data Requirements in China, compared with chemical pesticides, biochemical pesticides can be exempted from toxicological tests such as teratogenicity, chronic toxicity, and carcinogenicity, in the toxicological data section.

In the part of environmental data, biochemical pesticides can be exempted from short-term feeding of birds, growth inhibition of green algae, acute toxicity of silkworms, and other chronic ecological toxicity and environmental metabolism experiments.

Biochemical pesticide formulations may be exempt from environmental risk assessment reporting.

In terms of efficacy, biochemical pesticides can carry out field experiments in more than one year, while exempting resistance risk assessment data.

In terms of residues, biochemical pesticides are the same as chemical pesticides, and those in the list of exempted substances may not submit residue experimental data. See the following table (Table 1) for details:

Table 1 Requirements for Biochemical Pesticide Data in China

Serial numberData categoryRequest
1Product chemistry dataSame as chemical pesticides.
2Toxicological dataData on 7 items of acute toxicity, subchronic oral toxicity and mutagenicity (15 items of chemical pesticides), and test data on teratogenicity, chronic toxicity and carcinogenicity are not required.
3Environmental informationü    Four items (32 items of chemical pesticides) such as acute oral exposure of birds and acute oral exposure of bees are required for the technical products, and the experimental data of chronic ecotoxicity and environmental metabolism are not required.

ü    The preparation needs to carry out 4 items (10 items of chemical pesticides) such as acute oral exposure of birds and acute oral exposure of bees, and no environmental risk assessment report is required.

4Pharmacodynamic dataField experiments can be carried out for more than one year; Exempt resistance risk assessment information.
5Residual dataAs for chemical pesticides, if they are included in the list of exempted substances, the experimental data of residues may not be submitted.

Biochemical Pesticide Compliance Costs and Cycle Time in China

Compliance with regulations for biochemical pesticides in China is less expensive and has a shorter cycle time than other types of pesticide products due to their relatively low data requirements and higher safety.

Taking the new pesticide registration as an example (see Table 2):

For biochemical pesticides, according to the specific product characteristics, the registration cost ranges from hundreds of thousands to millions of RMB, and the registration cycle is usually about 3-4 years.

In contrast, the registration costs for chemical pesticides can be in the tens of millions of RMB, and the registration cycle can take up to 4-5 years.

Table 2 New Pesticide Compliance Costs and Cycle Time in China

Classification/dataNew Pesticide Registration Fee (RMB)New Pesticide Registration Cycle
Chemical pesticidesTen millionAbout 4-5 years
Biochemical pesticidesHundreds of thousands-millionsAbout 3-4 years

Compliance Challenges for Biochemical Pesticides in China

The definition of biochemical pesticides and the determination of whether a product falls under this category can be challenging. Additionally, different biochemical pesticide products have different characteristics, so a comprehensive analysis of product data and declaration data is necessary.

For example, the specificity of insect sex pheromones and their safety to the environment can reduce the mutagenicity and subchronic oral toxicity of the original drug. However, it is essential to provide environmental impact test data, environmental impact, and residue test data for the reduced preparation, and a risk assessment report.

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