Biologicals: Challenges and Opportunities in a Growing Sector for China

Piyatida (Tung) Pukclai By Piyatida (Tung) Pukclai|1 February 2025

Biological products, including biopesticides, biofertilizers, and biostimulants, are gaining attention as essential tools for sustainable agriculture. However, their regulatory landscape in China remains underdeveloped, presenting unique challenges for stakeholders.

The most pressing issue is the lack of clear and unified classification for biostimulants. Unlike traditional pesticides or fertilizers, biostimulants encompass a wide range of substances, including microbial agents, humic acids, amino acids, and algal extracts. This diversity complicates their categorization and registration. As a result, many biostimulants are registered under existing frameworks for fertilizers or pesticides, which may not fully reflect their intended functions or benefits.

The absence of comprehensive regulations and standards exacerbates this challenge. Businesses often face inconsistencies and delays in the registration process due to undefined evaluation criteria and outdated testing methods. For instance, existing analytical techniques may struggle to identify the active ingredients in complex biostimulant mixtures, making it difficult to demonstrate efficacy and quality.

Additionally, the limited understanding of biostimulants’ mechanisms of action poses a hurdle. Without robust scientific data, companies may struggle to meet regulatory requirements, particularly for innovative products. The lack of standardized protocols for safety and efficacy evaluation further complicates the registration process, creating barriers for market entry.

Despite these challenges, the future of biologicals in China is promising. The government is expected to introduce unified definitions, classifications, and regulatory frameworks for biostimulants as awareness of their potential grows. Aligning domestic regulations with international standards—such as those established in the European Union—could boost the global competitiveness of Chinese biological products and open new markets.

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For businesses, the key to success lies in investment in R&D. Companies that prioritize research into biostimulants’ mechanisms, develop advanced testing methods, and establish robust safety and efficacy data will be better positioned to navigate regulatory requirements and capture market share.

Dr. Piyatida (Tung) Pukclai is an editorial adviser and Asia-Pacific Director for Knoell, an independent service provider for Regulatory Affairs and Product Registrations. She has worked in several technical and managerial positions within the Business Development and Regulatory Policy. As Asia-Pacific Director for Crop Protection and Industrial Chemicals, she is responsible for registrations, monitors and reviews scientific data, new regulatory policies, and guidance developments in the Asian region. As speaker, she is active in various international conferences and workshops. Piyatida specializes in plant pathology and biological controls that reduce the use of chemical agriculture and improve the efficiency of plants or microorganisms. See all author stories here.