China Microbial Pesticide Registration

Introduction to Microbial Pesticides

Microbial pesticides refer to pesticides that use living organisms such as bacteria, fungi, viruses, protozoa, or genetically modified microorganisms as active ingredients. These pesticides are safe for humans, animals, crops, and the natural environment, do not harm natural enemies, and are not easily resistant, making them a highly advocated category of pesticide in today's agricultural industry. Microbial pesticide registration differs significantly in multiple aspects from ordinary chemical pesticides. The top three products registered are Bacillus thuringiensis, Bacillus subtilis, and Bacillus cereus, accounting for about 73% of the total.

Since the release and implementation of the revised Pesticide Administration Regulations and Pesticide Registration Data Requirements in 2017, China has implemented several preferential measures for microbial pesticide registration. Since September 18, 2020, the registration and approval of microbial pesticides have been included in the green channel to speed up the technical review process under the premise of ensuring quality and safety.

About Us

As a leading regulatory consulting firm in China, we provide comprehensive services for microbial pesticide registration in China.

Our team of experts has extensive experience in the registration of microbial pesticides in China and can provide tailored solutions to meet the unique needs of our clients. Our services include pre-registration consultation, data gap analysis, formula and label review, dossier preparation and submission, and post-registration support. We work closely with our clients to ensure that their products are registered as quickly and efficiently as possible while maintaining the highest standards of regulatory compliance.

Our Microbial Pesticide Registration Services

Our compliance specialists help our clients prepare and submit the required registration documents to the Ministry of Agriculture. Our services include, but are not limited to:

• Microbial pesticide identification (species, subspecies, serotypes, pathogenic mutants, etc.)
• Nomenclature of active ingredients in microbial pesticides
• Formula review
• Data evaluation and gap analysis
• Registration data preparation
• Product chemistry data
• Toxicity data
• Efficacy data
• Microbial proliferation test data (including 3 parts: soil, water, and plant leaves. The specific test items are determined according to the environmental test results of specific products.)

Note: The microbial proliferation test can be waived if no death or irreversible symptoms occur at the maximum hazard dose of the ecotoxicity test for birds, bees, silkworms, fish, Daphnia magna, etc.

• Proof materials that the active ingredients of microbial pesticides are not known pathogens of humans or other mammals

Note: A clear conclusion must be provided by the unit engaged in medical microbiology research and teaching on the safety of the biological ingredients applied for registration.

• Eco-tox data (5 species tests are required)
• Other required data

Note: For genetically modified microorganisms, we also assist in preparing dossiers including the genetic engineering techniques used, the gene fragments inserted or knocked out, the new characteristics exhibited compared to the parent strain, the genetic stability in the natural environment, the GMO safety certificate, etc.

• Import and export customs release certificate
• Registration change and renewal
• Registration and production license consulting and training
• Local representation

Our microbial pesticide registration services cover a wide range of product types, including:

If you need help or have a question, please feel free to contact us for more details.