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Interpreting the Laboratorial and Field Efficacy Evaluation of Disinfectants in China: GBT 38502 and GBT 38504
  • China’s biocide sector is becoming increasingly standardized with comprehensive, organized, and intelligible quality specifications and testing guidelines.

  • Biocidal efficacy is guaranteed using staged tests before being placed on the market. The results of these tests affect market positioning.

The latest overhaul of China’s disinfection product regulation goes back as far as 2002, when all related technical matters were simultaneously compiled into the "Technical Standard for Disinfection (version 2002)". The 200-page document offered great value to authorities and testing institutes in assessing product quality, safety, and efficacy, the precondition for entering China's market. After years of regulatory reform, the premarketing surveillance of non-new disinfection products has been delegated to the health department at the provincial level, and regulatory studies can be conducted either by enterprises or third-party testing institutes (CMA-accredited). To improve compliance, help enterprises and testing facility comply and align with international practices, some of the product specifications, testing methods, and technical practice were revised, supplemented, and released in the form of national/industrial standards. Early this year, the Chinese Standardization Administration (SAC) announced seven disinfectant-related standards to be implemented on October 1. Two of these standards related to efficacy evaluation in the most common scenarios. This article explains the enforceability, product scope, and other elements affecting product qualification, etc. to keep overseas enterprises up-to-date with best practices.

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