On December 31, 2020, the Chinese National Health Commission（NHC） issue an announcement regarding the hygiene and safety evaluation of low-temperature use disinfectants, aimed to address the continuous covid-19 contamination detected in cold-chain items and scattered cases reported as temperatures decrease. The low-temperature use disinfectants are now specified with definite efficacy and stability test conditions distinct from normal use disinfectants.
China has a standardized market entry process for non-new disinfectants known as the hygiene and safety evaluation of disinfection products. Domestic producers and legal responsible units (of imported disinfectants) need to file the evaluation report at their provincial health authorities in a prescribed format, consisting of product label, manual, formula, test reports and conclusion, product quality standard (or quality commitment letter for imported disinfectants) and production license for domestic products, as well as necessary credentials in case of imported disinfectants. The latest update on the test requirements was made in the form of a mandatory hygienic standard, “WS 628-2018 Technical Requirements for the Hygiene and Safety Evaluation of Disinfection Products”, which specified the test scope including content assay, corrosivity, stability, pH value, heavy metal content, stability, microbial contaminant, laboratory germicidal effect, simulated field test, field test, acute toxicity, mutagenicity and continuous duty stability depending on different targets such as air, skin, mucosa, hands, drinking water, swimming pool, hard surface, fabrics, tableware, food processing equipment, fruits and vegetables, etc.
To guarantee the disinfection effect at low temperatures, the announcement clarified that low-temperature use disinfectants should be tested as hard surface use disinfectants, but the laboratory germicidal test and field test should be performed in different temperature conditions and an 8-hour low-temperature stability test will be additionally required:
- The carrier quantitative method should be taken in the laboratory test and the sample, carrier and the whole process should be kept at the lowest effective temperature prescribed in the product manual.
- The field trial should also be performed at the lowest effective temperature prescribed on the product manual. Staphylococcus aureus (ATCC 6538 strain) and Escherichia coli (8099 strain) shall act as the indicative microbial and Poliovirus-I is also an available option;
- After overnight storage (at least 8 hours) at the lowest effective temperature, low-temperature use disinfectants shall maintain the original liquid state without any precipitate or crystal substance.
China had temporarily taken an expedited process for disinfectants since early 2020, allowing enterprises to submit waived test data before going on sale and supplement the rest data within the emergency period, which was terminated on August 4, 2020. The production and marketing of disinfectants that have not yet completed the evaluation and filing process shall be suspended after December 31, 2020. NHC reiterated that low-temperature use disinfectants that went on sale through the expedited process shall complete the full evaluation and filing process otherwise they shall be withdrawn from the market starting from June 1, 2021.
- NHC's Annoucement(in Chinese)
- China Ends the Emergent Market Entry of Disinfectants
- China NHC Releases Interim Measures for the Emergency Use of 4 Disinfectants
- China NHC Released Hygienic Standard for Efficacy Tests of Antimicrobial Products
- China NHC Publishes New Mandatory Technical Requirements for Premarketing Assessment on Disinfection Products
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