《标准物质管理办法》出台 “标尺”更准 监管更强

Core Viewpoint - The State Administration for Market Regulation has introduced the "Standard Substance Management Measures," which will take effect on December 1, 2026, to adapt to new requirements and improve the quality and efficiency of standard substance supply [1][5]. Summary by Relevant Sections Revision Aspects - The new measures clarify the concept of standard substances, defining them as materials with uniformity, stability, reliable metrological traceability, and uncertainty, serving as a unified reference for measurement activities [2][6]. - The classification of standard substances has been changed from a two-tier system (primary and secondary) to a three-tier system, including national benchmark substances, primary standard substances, and secondary standard substances [2][6]. - The management system has been improved, with the national benchmark substances planned by the State Administration for Market Regulation, while primary and secondary standard substances will be subject to licensing management [2][7]. - Responsibilities of relevant entities have been strengthened, establishing a system for the commissioned production of standard substances, allowing certified institutions to produce independently or through commission [2][9]. Administrative Approval and Market Environment - The new measures streamline the administrative approval process for secondary standard substances by delegating authority to provincial market regulation departments, significantly reducing approval times and lowering institutional transaction costs for enterprises [7][8]. - A system for commissioned production of standard substances has been established, ensuring that the commissioning party is responsible for the safety, accuracy, and traceability of the standard substances [8][9]. Classification Conditions - National benchmark substances must use benchmark measurement methods and possess the highest metrological characteristics, with technical indicators such as uniformity and stability at the leading level [11]. - Primary standard substances should use benchmark measurement methods or reliable measurement methods from different principles, ensuring reliable metrological traceability [12]. - Secondary standard substances must use primary standard substances for value determination or comparative measurement methods, meeting practical measurement needs [12]. Conditions for Production Units - Units engaged in the production of standard substances must have legal entity status, a quality management system appropriate to the level and type of standard substances produced, and qualified technical and management personnel [13][15]. Penalties for Violations - Penalties for falsifying or misusing standard substance certificates include fines ranging from 30,000 to 100,000 yuan, depending on the severity of the violation [16][17].