In response to the 2019 Novel Coronavirus epidemic, China will facilitate market access for disinfectants containing alcohol, chlorine, chlorine dioxide, and peroxyacetic acid. Data requirements for these disinfectants are waived.
In response to disinfectant demand-side pressures precipitated by the 2019 Novel Coronavirus, the National Health Commission announced on Feb. 3 that disinfectants containing alcohols, chlorines, chlorine dioxide, and peroxyacetic acid could be temporarily exempted from full record-filing requirements.
The Commission specifies:
- Disinfectants using alcohol ingredients can be placed on the market after completing content tests either by the producers (homemade products)/ Chinese representative legal entity (imported products) themselves or 3rd party labs. The alcohol concentration of hand disinfectants should be greater than 60%. The raw material used in ethanol disinfectant shall conform to the national standard “GB26373-2010 Hygienic Standard for Alcohol Disinfectants” and ethanol content should be greater than 70% and less than 80%;
- Disinfectants using chlorines, chlorine dioxide, and peroxyacetic acid ingredients can be placed on the market after completing the content test, and PH test and the validity of sodium hypochlorite liquid(know as the “84” disinfecting solution) is limited to 3 months, with the exception that products can be distributed and used until expiration date supported by the qualified stability test data;
- For disinfectants that have already completed record-filing, the producers are encouraged to expand their production by adding new production lines, new plants, and production sites, and the disinfectants produced in these new plants can be directly placed on the market after completing the content test and/or PH test.
The domestic producers of these products should obtain the production license of disinfection products and submit product labels and quality safety commitment (attached with test reports) to the provincial health department. For imported disinfectants which have already completed the record-filing procedure, the overseas producers are allowed to export similar disinfectants(containing the same active substance) by submitting product label and quality safety commitment (attached test report and credential documents that certifying that the product has been legally marketed overseas) through their Chinese representative legal entity entrusted.
During the market circulation and uses of these products, the domestic producer or Chinese representative legal entity should complete all the tests in accordance with the “WS 628-2018 Technical Requirements for the hygiene and safety evaluation of disinfection products” and the record-filing formality. Products that have not yet completed the tests and record-filing may not continue to be sold after the end of the epidemic. NHC pointed out that disinfectants produced overseas need to comply with Chinese regulation before entering China. To help readers better understand the interim measures, we offer a comparison table of the data requirements.
(only applicable to alcohols, chlorines, chlorine dioxide, and peroxyacetic acid disinfectants)
(applicable to all types of disinfectants)
- NHC's News Release
- 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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