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Major News: The Plant Extract Industry’s First Full-Process National Standard Takes Effect on May 1—How Should Companies Respond?
Time：
Apr 01,2026
Major Industry Announcement! On May 1, 2026, China’s first full-process national standard in the plant-extract industry—GB/T 46671-2025 “Technical Specifications for Plant-Extract Production Processes”—will officially come into effect, marking the industry’s definitive departure from the era of unregulated, extensive production and its entry into a new phase of standardized development. Relevant enterprises must therefore make proactive preparations to mitigate compliance risks and seize emerging opportunities.
As a global core supplier of plant extracts, China accounts for more than 60% of world production, with its products widely used across multiple sectors and the industry continuing to expand in scale. However, for a long time the sector has been plagued by chaotic production processes and the coexistence of small, artisanal workshops and large-scale enterprises competing on the same playing field, resulting in significant variability in active ingredient content, inconsistent product quality, and even safety concerns.
The rampant practice of “same product, different labeling” not only complicates raw-material quality control for downstream enterprises but also undermines the international recognition of Chinese products, thereby becoming a bottleneck for industrial upgrading. The implementation of this national standard is precisely aimed at addressing this critical issue and laying a solid foundation for high-quality industrial development.
Key Takeaways! Core Requirements of the National Standard—Every Single One Is Closely Related to Businesses
This national standard was jointly issued by the State Administration for Market Regulation and the National Standardization Administration Committee, with the Ministry of Agriculture and Rural Affairs serving as the competent authority. It covers the entire production chain, establishing a comprehensive standards framework with four core components that enterprises are required to implement item by item:
1. Raw Materials and Processing Aids: Quality Control at the Source The national standard stipulates that plant-based raw materials must be clearly identified in terms of species and used plant parts, and must be free from spoilage or deterioration. Production water must comply with GB 5749, and residues of organic solvents and other processing aids must be strictly controlled to prevent contamination and cross-contamination of ingredients at the source.
2. End-to-end process: Each step is governed by clear, standardized procedures. The national standard covers five core stages—raw material pre-processing, extraction, purification, and others—and specifies precise technical parameters. For example, heat-sensitive components are recommended to be extracted using supercritical fluid extraction, with the final product moisture content not exceeding 8% after drying, thereby completely eliminating “production based on experience.”
3. Facilities and Hygiene: Strict Prevention of Cross-Contamination National standards require that plant design comply with GBZ 1, with clearly defined functional zones. Closed systems should be prioritized for processes such as extraction and purification, while hygiene requirements for buildings, equipment, and personnel must be standardized to prevent all types of contamination.
4. Traceability and Record-Keeping: Full-Process Auditability and Evidence-Based Documentation The national standard requires enterprises to establish a comprehensive production record-keeping system, with relevant records retained for at least three years. Key quality indicators must be accurately measured and documented, ensuring full traceability throughout the production process—aligning with the requirements of the new regulations on the supervision of traditional Chinese medicines.
What does the implementation of the national standard mean for the industry?
This national standard strikes a balance between uniformity and flexibility, allowing enterprises to select processes based on product characteristics and specifying differentiated requirements for different application areas, thereby exerting influence across the entire industrial chain:
For businesses: survival of the fittest—compliance wins. Small and medium-sized enterprises with outdated processes and lax management will be phased out, while larger, quality-focused firms will gain greater market recognition. Meanwhile, the adoption of unified standards will reduce production and communication costs and enhance efficiency.
For the industry: quality improvement and upgrading, standardized development Promote a shift in the industry from “scale expansion” to “quality and efficiency,” guide enterprises in upgrading their processes and pursuing intensive development, reduce industry-wide communication costs, and expand the scope of product applications.
For the international market: break down barriers and enhance competitiveness. China’s national standards, which draw on internationally advanced concepts and are tailored to domestic conditions, will serve as a “pass” for product exports, reduce technical barriers, and enhance the international recognition of China’s plant extracts.
A Must-Read for Businesses: How to Quickly Comply with National Standards and Avoid Common Pitfalls?
With only one month remaining until the national standard takes effect, companies must promptly conduct inspections and make necessary rectifications, focusing on three key tasks to ensure smooth compliance:
In accordance with the national standards, conduct a comprehensive self-inspection by establishing a dedicated task force to review the entire production process, with particular emphasis on key stages such as raw material identification, parameter control, solvent residue levels, and record-keeping, and clearly define the direction for corrective actions.
Optimize processes and address weaknesses: refine workflows and develop standard operating procedures (SOPs) to address self-inspection findings; upgrade production and testing equipment as necessary; and adopt advanced technologies to enhance product compliance.
Strengthen training and ensure thorough implementation: Organize training on national standards for personnel in relevant positions to ensure that all staff fully understand the requirements, integrate these standards into every stage of production, and mitigate compliance risks.
Conclusion: Empowering through Standards, Ushering in a New Future for the Industry
The implementation of the GB/T 46671-2025 national standard is not a restrictive constraint on the industry; rather, it serves as a guiding compass for high-quality development, filling the gap in end-to-end standards and laying the foundation for the industry to benchmark against international best practices and expand globally.
The plant extracts industry is undergoing a transformation and upgrade, shifting from “extensive production” to “standard-driven quality enhancement.” Only by proactively aligning with national standards, steadfastly upholding quality, and deeply investing in innovation can companies consolidate their position amid industry consolidation and seize new opportunities for growth.
The countdown has begun—enterprises must promptly benchmark against the national standards to identify and address gaps, proactively ensure compliance, and jointly usher in a new future of standardized industry development!
Shandong Zhonghuan Zhongjie Biotechnology Co., Ltd. is a high-tech enterprise specializing in the research, development, production, and application of cyclodextrin derivatives, cyclodextrin inclusion complexes, and novel cyclodextrin materials. The company is lean and agile, with cutting-edge technology, and utilizes domestically leading production equipment and well-established, advanced manufacturing processes to operate two state-of-the-art pharmaceutical excipient production lines that comply with GMP standards. It has an annual production capacity of over 1,000 metric tons of various cyclodextrin derivatives and inclusion complex products.
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