Overview of Chinese Regulations for Registration of Biologicals

Biologicals are gaining increased importance in agricultural practices due to their eco-friendly nature and minimal negative impact on human health. In China, the registration of biologicals follows a strict regulatory framework to ensure their efficacy, safety, and environmental sustainability. This article provides a comprehensive overview of the regulations surrounding biologicals registration in China, including the registration process, key requirements, and the timelines involved.

Registration Regulations

The registration of biopesticides in China is governed by multiple regulations, primarily the “Regulations on the Administration of Pesticides” and the “Interim Measures for the Registration and Administration of Biopesticides.” These regulations outline the requirements, standards, and procedures for biological registration and establish a legal framework to ensure their quality, efficacy, and safety.

So far, China has established more than 120 biological standards, including more than 60 product quality and method standards.

There are nearly 30 evaluation and technical regulations for efficacy, and six microbiological toxicology test guidelines (NY/T 2186.1-6-2012). There are nine new standards released for the environment, namely the Guidelines for Environmental Risk Assessment of Microbials (bird, bee, silkworm, fish, daphnia, algae, NY/T 3152.1-6-2017) and (microbials, soil, water, and plant leaves NY/T 3278.1-3-2018) along with 14 additional standards. In the National Food Safety Standards — Maximum Residue Limits of Pesticides in Food GB 2763-2016, it specifies the daily maximum allowable intake (ADI) and maximum allowable residue limit (MRL) for abamectin, kasugamycin, polyoxin B, spinosad, jingangmycin A, ningnanmycin, pyrethrins, matrine, rotenone, sodium nitrophenolate, etc.

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