13 efficacy evaluation methods have been established for commonly used but legally grey-zone antimicrobial products such as hand cleaner, sprays, gels, wet wipe, facial mask, sanitary towel, diaper, towel, underwear, socks, fabric, plastics, floorboards and tiles, etc.
Once NHC made adequate clarification on product definition/scope, necessity of risk/safety assessment and relevant evaluation guidelines, these products are likely to be brought into stringent supervision
On 30 Jan 2019, the National Health Commission published 6 voluntary hygienic standards for biocidal products, which will take effect on 1 Jul 2019. Among them, the “WS/T 650-2019 Evaluating Method for Efficacy of Antibacterial and Bacteriostasis” was firstly issued. The standard specifies 13 testing methods, procedures the application scope and criteria for commonly used items with antimicrobial claim including hand cleaner, sprays, gels, wet wipe, facial mask, sanitary towel, diaper, towel, underwear, socks, fabric, plastics, floorboards and tiles, etc. These antimicrobial products are mostly categorized as the Category II disinfection products but comparatively in a regulatory grey zone because most of them are not yet included into the pre-marketing assessment. Considering the complicacy of product type and feature, WS/T 650-2019 can be an evident progress and these commonly used antimicrobial products are likely to be brought into supervision after NHC made adequate clarification on product definition/scope, necessity of risk/safety assessment and relevant evaluation guidelines.
Hygienic Standards to be Enforced on 1 Jul 2019
Efficacy Evaluation of Antimicrobial Products
Applicable Scope(Test item)
(stops bacteria from reproducing, while not necessarily killing them otherwise)
Quantitative bacteriostasis test using suspension method
Liquid bacteriostatic agents such as sanitary lotion and sprays, etc.
Quantitative bacteriostasis test using carrier immersion method
Pasty or half-solid bacteriostatic agents such as gel and cream, etc.
Carrier bacteriostasis test
Solid bacteriostatic products containing dissoluble bacteriostatic substance, such as non-woven mask, sanitary towel, sanitary pad and diaper, etc.
Inhibition zone test
Platelike solid bacteriostatic products 5 millimeters wide and qualitative determination of dissoluble bacteriostatic substance in antimicrobial products;
bacteriostasis test using infiltration method
Fabric products containing dissoluble bacteriostatic substance, such as bacteriostatic towel, facial mask and underwear, etc.
Persistent bacteriostasis test
washing liquors with persistent bacteriostatic effect;
destroys or inhibits the growth of microorganisms and especially pathogenic microorganisms
Quantitative bactericidal test using suspension method
Liquid antibacterial agents such as sanitary lotion and sprays, etc.
Quantitative bactericidal test using carrier immersion method
sticky or half-solid antibacterial agents such as antimicrobial hand cleanser, shower gel, antimicrobial gel and cream, etc.
Carrier bactericidal test
hygienic wet wipe and other carrier products containing dissoluble bactericidal substance, such as
Bactericidal test using infiltration method
Fabric products containing dissoluble antibacterial substance, such as bacteriostatic towel, soaks, cotton cloth and cotton cloth respirator, etc.
Shake flask method
Antibacterial products containing non-dissoluble antibacterial substance
PE films, PE porous films, antimicrobial PE packing bag, plastic, floorboards and tiles, etc.
Persistent bactericidal test
Antimicrobial products with persistent bacteriostatic effect;
- China NHC Publishes New Mandatory Technical Requirements for Premarketing Assessment on Disinfection Products
- China to Adopt Mandatory Hygienic Standard for Pre-marketing Assessment on Disinfection Products
- China NHC Considers Inventory Management on Antimicrobial Agents
- Regulatory Status of Disinfectant Wet Wipes in China
- Mandatory Premarketing Testing of Disinfectants and Sterilizers/Disinfectors in China
- China to Enact Mandatory Industrial Standard for the Hygienic Safety Assessment on Disinfection Products
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