China to Enact Mandatory National Standard for labeling Disinfection Products

China to Enact Mandatory National Standard for labeling Disinfection ProductsOn July 24, 2020, China’s State Administration for Market Regulation (SAMR) notify the TBT/WHO an upcoming national standard, “General Requirement for Label and Instruction of Disinfection Products”, which will enter into force 12 months after the final approval formality with the WTO.
The standard will apply to all health-related products listed in the “Catalog of Disinfection Products Subject to Health License” that produced, circulated and used in China:

  • Disinfectants;
  • Disinfecting apparatus;
  • Indicators (of disinfection effect) and sterilized-packed medical instruments;
  • Sanitary products including skin antibacterial agents/bacteriostats, contact lens solutions, wet wipes and hygiene wet wipes, as well as disposable items with anti-microbial claims, such as sanitary pads, diapers, cotton pads, cotton swabs, paper tableware, tissue papers excluding toilet paper.

The first labeling requirements of disinfection products were promulgated as an MoH's ministerial regulation in 2006 and the Ministry compiled a draft of national standard in 2012. The final consultation was invited by SAMR in May 2020, modifying its enforceability from a recommended standard into a mandatory one.
The notified draft categorizes the compulsory and prohibited label contents of minimum sales packaging, transport packaging, use instruction and nameplate for each category of products and dedicates a significant portion describing the levels of detail needed, layout of information, as well as providing the correct and wrong examples in Annex A.
Comparing with the predecessor and previous draft, the notified draft offers imperceptible adjustments keeping pace with the regulatory reform in recent years:

  • Delegating the approval of non-new disinfection products;
  • Standardized pre-marketing hygienic and safety evaluation of Class I and Class II disinfection products;
  • The country-of-origin label for imported products and the target microbial claims are highlighted.

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