Overview of Chinese Regulations for Registration of Biologicals

By Cici Hou
Regulatory Affairs Specialist for Knoell

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.

Data Requirements

• Registration: To obtain registration, manufacturers must provide comprehensive data on the product’s active ingredients and formulation. For technical, it will request: Certificate of component, manufacturing process, physical and chemical report, certificate of analysis, toxicity data, and environmental impact test data.
• Formulation: For formulation, it will request a compiling of summaries of dietary, occupational health, and environmental risk assessment of products, product economic benefit, social benefit, and environmental benefit analysis data summary, physical and chemical report, toxicity data, pharmacodynamic data, residue test, environmental toxicity, etc.
• Laboratory and Field Trials: Biologicals must undergo extensive laboratory and field trials to evaluate their efficacy and safety. These trials are conducted according to standardized protocols and guidelines issued by the relevant authorities. The trials assess parameters such as pest control efficacy, non-target organism toxicity, residue levels, and environmental fate.
• Risk Assessment: The registration process in China includes a thorough risk assessment to evaluate potential risks and hazards associated with the use of biologicals. This assessment aims to ensure that the product does not pose unreasonable risks to human health, agricultural produce, or the environment. If any risks are identified, appropriate risk mitigation measures are implemented.

Timeline for Biological Registration

The registration process for biologicals in China typically involves several stages and can take approximately one to five years to complete, depending on the complexity of the product, the availability of data, and the category of registration. The stages include application submission, data evaluation, laboratory testing, field trials, risk assessment, and final registration approval. Throughout the process, regulators closely examine the product’s safety, efficacy, and environmental impact to guarantee its suitability for use in agriculture.

Challenges

The regulatory landscape for biological pesticide registration in China presents a formidable challenge for companies entering the market. Governed by stringent regulations, including the “Regulations on the Administration of Pesticides” and the “Interim Measures for the Registration and Administration of Biopesticides,” the process demands adherence to complex requirements, standards, and procedures.

With more than 120 biological standards and various evaluation and technical regulations, navigating the intricacies becomes a daunting task. The National Food Safety Standards further add to the challenge by stipulating maximum residue limits for pesticides in food.

Extensive data requirements, encompassing technical and formulation aspects, contribute to the complexity. Foreign companies face language barriers, procedural intricacies, and nuanced regulatory expectations, making engagement with a reliable local partner imperative. Local expertise is crucial for compiling necessary data, facilitating communication with authorities, and ensuring alignment with China’s regulatory standards. The intricate data requirements, mandatory laboratory and field trials, and risk assessments all underscore the formidable challenge of navigating the regulatory landscape for biological registration in China.

Conclusion

China’s regulations for biologicals registration emphasize the importance of safety, efficacy, and environmental sustainability. The strict guidelines, data requirements, and risk assessments ensure that only high-quality biopesticides, which pose minimal risks to humans and the environment, are registered. By implementing these regulations, China aims to promote the sustainable and responsible use of biologicals in agricultural practices, contributing to a greener and healthier future.  •

By Олег Мальшаков – Adobe.stock.com