China Microbial Pesticide Registration

Microbial pesticides refer to pesticides using bacteria, fungi, viruses, protozoans or genetically modified microorganisms or other living organisms as active ingredients.

Registered microbial pesticide in China

There are more than 53 kinds of active ingredients of microbial pesticides registered, more than 550 registered products and more than 200 production enterprises. Top three products registered are Bacillus thuringiensis, Bacillus subtilis and Bacillus cereus, accounting for about 73% of the total. The top five varieties of microbial pesticide in yield are Bacillus thuringiensis, Bacillus subtilis, Helicoverpa armigera nuclear polyhedrosis virus, Metarhizium anisopliae CQMa421 and Bacillus polymyxa KN-03, accounting for about 75% of the microbial pesticide production. Bacillus thuringiensis G033a under plant protection of the Chinese Academy of Agricultural Sciences obtained the safety certificate of genetically modified organisms issued by the Ministry of Agriculture and Rural Affairs in 2006, and obtained the first pesticide registration of genetically modified Bacillus thuringiensis G033a engineering strain in China in 2017.

Data Requirements

TC (TK)

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

Formulation

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

Efficacy

Can be done in China within one year.

Eco-tox data

Have separate eco toxicity test guideline for microbial pesticide. 5 species tests are required.

Residue

Can be waived.

Evaluation

Evaluation process please refer to the pesticide registration webpage. For microbial pesticides, 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 met the "green channel" requirements. For those meet the requirements of "green channel" products, priority shall be given to technical review, and the technical review process shall be accelerated.

Notes:

• If microbial pesticide strains are different from registered pesticides, they shall be submitted for registration according to the new pesticide registration requirements. However, fungi and bacteria with the same strain and different strains do not need to apply to the national pesticide Standards Committee for the name of new pesticide active ingredients and exemption of naming documents.
• Microbial pesticide technical concentration cannot apply for the me-too product registration, so when the applicant has the 6-year protection period for the registration of new microbial pesticide and it is not allowed to authorize data to other manufacturers.

If the microbial pesticide technical concentration has low toxicity or micro toxicity, the technical concentration registration can be waived. The main raw materials and production process shall be described, as well as the relevant product chemical test data required for the technical concentration registration completed by the fermentation broth and extract of the processed formulation, as well as the relevant toxicological and environmental test data completed by the formulation.

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