Director Zhou Puguo: Chemical data for pesticide‑registered products place greater emphasis on safety, environmental friendliness, scientific rigor, and compliance with standards.

On June 4–5, 2020, a training workshop on the chemical data requirements for pesticide registration and the promotion of the CCPIA group standard was held in Yixing, Jiangsu Province. At the event, Zhou Puguo, Director of the Pesticide Inspection Institute of the Ministry of Agriculture and Rural Affairs, delivered an important address and outlined his views on two key issues.

1 Requirements for Chemical Data of Pesticide-Registered Products

In 2017, the revised Regulations on the Administration of Pesticides were promulgated, marking a significant shift in pesticide management philosophy—from an earlier emphasis on efficacy and quality to a greater focus on safety, scientific rigor, and green practices. As an important ancillary regulation to the Regulations, the revision of the Requirements for Pesticide Registration Data likewise reflects this transformation. With regard to the requirements for product‑chemical information, the key changes are evident in the following areas.

First, greater emphasis is placed on prioritizing safety. When it comes to prioritizing safety, a key hallmark of safety management is the formulation and implementation of risk assessments. The newly revised “Requirements for Pesticide Registration Data” introduces, for the first time, explicit requirements for risk assessment. On the one hand, pesticide products are evaluated across multiple dimensions—dietary risk, environmental risk, and occupational health risk—placing greater emphasis on scientific rigor. On the other hand, the assessment extends beyond the active ingredient to include adjuvants; it also evaluates not only the parent compound but also its metabolites and degradation products, thereby enhancing the comprehensiveness of the evaluation. Meanwhile, the new requirements for product chemistry further refine specifications related to manufacturing processes, physicochemical properties, and impurities, sharpening the focus on safety management and ensuring the quality and safety of pesticide products.

Second, greater emphasis will be placed on green development. The green development of agriculture necessarily calls for the green development of pesticides, and the cornerstone of this lies in expanding the supply of environmentally friendly pesticide products. The “Requirements for Pesticide Registration Data” include exemptions and special provisions for biopesticides such as microbial and plant‑derived formulations, clearly signaling a policy orientation that encourages the green transformation of the pesticide sector. With regard to specific chemical‑data requirements, based on actual production conditions, we propose that active ingredients of microbial and plant‑derived pesticides submit component‑analysis test reports; furthermore, we advocate classifying plant‑derived active ingredients for management purposes, lowering the requirements for physicochemical properties and component analysis when the source plants have been widely used over long periods. These measures are designed to foster the development of microbial and plant‑based biopesticides. For conventional chemical pesticides, we encourage the research, development, and registration of green formulations that are highly effective, low‑risk, and leave minimal residues.

Third, greater emphasis is placed on scientific rigor and controllability. Test data form the foundation of pesticide registration and review. The robustness of this foundation—namely, the quality of the test data—directly determines the scientific soundness of the evaluation conclusions. Pesticide registration testing has fully adopted the principles of Good Laboratory Practice, ensuring end-to-end traceability of test data integrity, reliability, and authenticity, thereby effectively safeguarding the scientific rigor and authority of the registration and review process. For pesticide products, chemical information is paramount; qualified testing facilities and scientifically sound, truthful test reports are essential safeguards for accurately characterizing product properties and reliably assessing product quality.

Fourth, greater emphasis is placed on standard-setting leadership. Adhering to standards means applying a single, consistent benchmark throughout. Whether at the pesticide registration‑testing stage or during the registration‑review process, compliance with established standards is a prerequisite for effective work. The “Requirements for Pesticide Registration Data” comprehensively incorporates the concept of standards, specifying in each specialized field the guidelines that must be followed when conducting registration tests and outlining the review procedures in accordance with registration‑review regulations. The Regulations stipulate that, upon approval of a pesticide product’s registration, the corresponding product quality standard number must be publicly announced. For enterprises, it is essential to proceed from practical considerations, carefully develop product quality standards that meet registration requirements to guide production and quality control, and promptly publish the standard texts on their enterprise standard information management platform to facilitate oversight by the competent authorities.

Pesticide registration encompasses areas such as product chemistry, efficacy, residue levels, toxicology, environmental impact, and comprehensive regulatory requirements, making it highly specialized and policy‑driven. On the one hand, we must strengthen outreach and support; on the other, all stakeholders need to engage in diligent study to accurately grasp policy requirements and avoid unnecessary detours.

2. On the Work of Pesticide Standards

Standards serve as the technical foundation for economic activity and social development, form the bedrock of the national governance system, and function as the “universal language” of international trade and cooperation. China is a major producer, exporter, and user of pesticides. Over the years, pesticide standards have played a crucial role in ensuring product quality, fostering technological advancement and growth within the pesticide industry, and enhancing the regulation of industry practices—including management, production, registration, distribution, and use. The Ministry and its affiliated institutions have consistently attached great importance to this work and actively promoted the standardization of pesticides. In summary, current pesticide standards are characterized by the following key features.

First, the number of standards is substantial. Pesticide standards broadly cover all stages of the pesticide industry. Overall, as of the end of 2019, 7,107 maximum residue limits had been established for 483 pesticides across 356 food categories, encompassing both the pesticides approved for use in China and the major food commodities consumed by the population. Both the number of pesticide active ingredients and the total number of residue limits have, for the first time, surpassed those set by the Codex Alimentarius Commission. In other areas—such as foundational and management standards, product standards, production and emissions standards, usage guidelines, and registration requirements—the total number of related pesticide standards also exceeds 1,500.

Second, the scope of application is broad. Pesticides are a category of products that pose potential toxicological risks; to mitigate these risks and expand their range of uses, the competent authorities have developed a series of standards from multiple technical perspectives. In terms of issuing agencies, the standards cover 13 specific sectors, including chemical engineering, agriculture, grain production, forestry, environmental protection, entry‑exit quarantine, and public health. From a procedural standpoint, the standards encompass both foundational, general‑purpose guidelines and industry‑wide, end‑to‑end technical specifications covering registration, manufacturing, distribution, application, and regulatory oversight. As for content, they address such technical aspects as product quality requirements, methods for inspection and testing, procedures for risk assessment, risk‑assessment protocols, and maximum residue limits for pesticides.

Third, the pace of development has been rapid. In terms of maximum residue limits for pesticides, the number has grown from 870 at the time of the 2010 review and consolidation to 7,107. Regarding pesticide quality standards, 65 national standards related to pesticide registration have been established, broadly covering the regulatory requirements and technical methods for chemical data; additionally, 226 national standards for active ingredients have been formulated, accounting for approximately one-third of the registered pesticide varieties. On the front of group standards for pesticide products, around 60 such standards have been developed by national-level industry associations. Moreover, the annual growth rate of these standards has consistently exceeded 10%. In recent years, the level of standards developed by our ministry has continued to improve; for instance, the “Series of National Standards on Test Guidelines for Environmental Safety Assessment of Chemical Pesticides,” which our ministry led in drafting in 2018, was awarded the First Prize of the China Standard Innovation Contribution Award.

Although China’s pesticide standardization efforts have made significant progress in recent years, it is important to recognize that, compared with the new circumstances and requirements, many areas still urgently need improvement. From the perspective of management systems and mechanisms, further streamlining is required. Following the promulgation of the newly revised Regulations on Pesticide Administration in 2017, pesticide management was consolidated under the purview of the agriculture and rural affairs authorities. Consequently, the responsible administrative body, the target users, and the priorities of pesticide standard‑setting have all undergone substantial changes. The previous decentralized approach to developing and revising pesticide standards can no longer meet the new demands of strengthening pesticide regulation and supporting agricultural development in the current era. Looking at the existing pesticide standards system, further refinement is needed. This is particularly evident in the following aspects: enforcement and oversight standards have not kept pace, leaving gaps in product quality supervision; registration‑related standards are insufficiently aligned, undermining the scientific rigor and impartiality of registration reviews; and the absence of a coordination mechanism has resulted in overlaps and redundancies among standards.

At present, the requirements for law-based administration in China are becoming increasingly stringent, and the need to advance the modernization of the national governance system and governance capacity is growing ever more urgent. In the face of the formidable tasks of comprehensive oversight and full‑life‑cycle monitoring of pesticides, pesticide standards—serving as both a policy foundation and a technical underpinning—will assume an even more prominent role. Moving forward, the Ministry and relevant institutes plan, with the concerted efforts of all stakeholders, to carry out work in the following key areas.

First, we will make every effort to advance the adjustment and streamlining of the institutional mechanisms governing pesticide standards. This work has received recognition from the Ministry’s leadership and the attention and support of relevant departments and bureaus, which have urged its prompt implementation. In accordance with the instructions of the Ministry’s leadership, we will collaborate with pertinent agencies, focusing on the systematic and comprehensive nature of pesticide‑standardization efforts, as well as on the scientific rigor and authoritative standing of these standards. Guided by the principles of “serving agriculture, balancing priorities, leveraging complementary strengths, and advancing in stages,” we will further refine the management system, clarify the division of responsibilities, optimize working mechanisms, and ensure alignment with the new landscape and requirements of unified pesticide regulation.

Second, we are actively advancing the preparation of the 14th Five-Year Plan for the formulation and revision of pesticide standards. Under the guidance of relevant departments and bureaus, and in alignment with the Ministry’s core priorities, we are committed to strengthening pesticide management and supporting the high-quality, green development of the pesticide industry and agriculture. To this end, we are vigorously promoting the drafting of the 14th Five-Year Plan for pesticide standard development, clearly defining the guiding principles, objectives, tasks, and implementation steps for standard-setting over the next five years. We are also refining and improving the framework and structure of the pesticide standards system, with a view to establishing a robust, “scientific, advanced, practical, and coordinated” pesticide standards regime.

Third, we will prioritize the development and revision of pesticide standards. First, we will undertake a comprehensive review of existing pesticide standards to gain a clear understanding of the current regulatory landscape. Through measures such as standard consolidation, repeal, and revision, we will gradually address issues like outdated standards, duplication, overlap, and inconsistencies. Second, we will accelerate the formulation and revision of maximum residue limits (MRLs) for pesticides. We will expedite the establishment of MRLs for the remaining approximately 3,000 pesticide‑residue items, ensuring that by 2020 China’s total number of pesticide‑residue MRLs reaches 10,000—a critical target. With the goal of aligning with international standards by establishing both “uniform national limits” and “import‑specific limits,” we will move forward with the preparation of the “14th Five-Year Plan for Enhancing the Quality of China’s Pesticide Residue Standards.” Third, we will diligently advance the development of a unified analytical methodology framework for pesticide potency and quality. I would like to emphasize here that this initiative was launched in 2019 and is scheduled for completion over four years. Thanks to the concerted efforts of the participating institutions, progress has been smooth. Moving forward, we will intensify our efforts to finalize, by the end of 2020, the validation of universal liquid chromatography methods for 295 pesticide active ingredients and gas chromatography methods for 160, thereby covering more than 90% of all registered pesticides and addressing the challenges faced in the oversight and enforcement of most pesticide products. Once these industry‑standard universal analytical methods for liquid and gas chromatography are promulgated and implemented, they will effectively cover the vast majority of pesticide varieties, significantly easing regulatory compliance and enforcement.

As the reform of standardization continues to deepen and the new Standardization Law is revised and promulgated, the hierarchical structure of the standards system has gradually shifted from a government‑led, single‑tier model to a dual‑tier framework that balances government oversight with market forces. Thanks to their rapid initiation and precise alignment with market needs, group standards effectively address the demands of rapidly evolving markets and the innovation requirements of various industries, serving as a valuable complement to national and industry standards and becoming an indispensable component of the overall standards system.

Source: Pesticide Industry Watch