The health committees of all provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps, and the Chinese Center for Disease Control and Prevention:

　　Recently, many places in my country have successively reported that the new coronavirus nucleic acid test positive for the outer packaging of cold chain items, and new coronavirus pneumonia outbreaks caused by cold chain items have occurred from time to time. In order to meet the urgent needs of national epidemic prevention and control and ensure the effect of low temperature disinfection, the relevant matters are hereby notified as follows:

　　For low-temperature disinfectants used for surface disinfection of low-temperature frozen items, when the product is on the market, the product responsible unit shall conduct a sanitary safety evaluation and record it in accordance with the "Regulations on Sanitation and Safety Evaluation of Disinfected Products". Low-temperature disinfectants that have passed the health and safety evaluation can be marketed. Hygienic safety evaluation of low-temperature disinfectants includes product labels, instructions, product formulas, inspection reports (see the requirements in the appendix for inspection items, and the inspection report contains conclusions), corporate standards or quality standards, sanitary license qualifications for domestic product manufacturers, and import product production countries ( Region) Proving documents and customs declaration forms that allow production and sales.

　　Domestic manufacturers of low-temperature disinfectants that are urgently listed on the market should obtain a sanitation license for disinfection product manufacturers. When low-temperature disinfectants are urgently marketed, the product responsible unit shall promptly provide the following qualified filing materials to the territorial disinfection product filing department: product labels, instructions, product formulas, corporate standards or quality standards, and product quality and safety commitments (including active ingredient content, Qualified report of pH value, microbial killing experiment, field test, low temperature test); for similar imported low-temperature disinfectants, in addition to providing the above materials, the responsible unit in China should also submit the imported product production country (region) to the territorial disinfection product filing department ) Documents and customs declarations that allow production and sales. The exported low-temperature disinfectants should also meet the relevant requirements of the importing country (region).

　　When emergency-market low-temperature disinfectants are used on the market, the product responsible unit shall conduct inspections in accordance with the inspection items required by the low-temperature disinfectant hygienic safety evaluation technical requirements and complete the filing in accordance with the requirements of the "Sanitary Safety Evaluation Regulations for Disinfectants". As of June 1, 2021, if the product responsible unit has not completed the inspection and filing, it shall immediately stop the production and sale of the emergency low-temperature disinfectant. Those who are willing to continue production and sales should go through the relevant procedures in accordance with the original normal procedures, otherwise they will be investigated and dealt with seriously in accordance with the "Infectious Disease Control Law", "Disinfection Management Measures" and other relevant regulations.

　　Attachment: Technical Requirements for Hygienic Safety Evaluation of Low Temperature Disinfectants

General Office of the National Health Commission

December 31, 2020

Technical requirements for hygienic safety evaluation of low-temperature disinfectants

　　The low-temperature disinfectant inspection items are tested in accordance with the "Technical Requirements for Sanitary Safety Evaluation of Disinfection Products" (WS 628-2018) for the surface disinfectants of hard objects, and the low temperature test is added. Testing methods and evaluation indicators can refer to "Disinfection Technical Specifications" (2002 Edition), "Disinfectant Laboratory Sterilization Effect Test Method" (GB/T 38502-2020) and "Disinfectant Safety Toxicology Evaluation Procedures and Methods" (GB /T 38496-2020) and other relevant standards, the microbial killing test should be performed under the corresponding low temperature conditions marked in the product manual. Because low-temperature disinfectants are suitable for low-temperature conditions, their inspection items and evaluation methods are different from conventional surface disinfectants for hard objects. The specific technical requirements are as follows:

　　1. Laboratory microorganism killing test

　　The laboratory test should use the carrier method.

　　Before the test, put the low-temperature disinfectant (application solution) under the corresponding low temperature conditions marked in the product manual, and measure the temperature of the low-temperature disinfectant with a thermometer. The test operation can be performed after reaching the corresponding low temperature.

　　After the infected carrier is dried, place it at the corresponding low temperature indicated in the product manual for at least 30 minutes.

　　During the experimental operation, it should be ensured that the operating temperature of the low-temperature disinfectant and the bacterial tablet is kept at the corresponding low temperature condition.

　　2. Field test

　　According to the application scenarios marked in the product standard manual, select the corresponding site, use it with the disinfection equipment, and conduct a simulated field test with a carrier stained with indicator microorganisms. Generally, cloth sheets are selected as the carrier. When disinfection methods such as aerosol or ultra-low-volume spray are used, cloth sheets and filter paper sheets should not be used as carriers with adsorption capacity. Metal sheets or glass sheets can be selected.

　　Staphylococcus aureus (ATCC 6538) and Escherichia coli (8099), which have higher resistance than the new coronavirus, were selected as indicator microorganisms. If you have special requirements, you can also choose the poliovirus-I (PV-I) vaccine strain as the indicator microorganism.

　　Put the carrier contaminated with indicator microorganisms into the on-site low temperature environment for at least 30 minutes to ensure that the indicator microorganisms reach the corresponding low temperature before performing on-site experiments. During the test, the carrier contaminated with indicator microorganisms should be placed in the most difficult to disinfect position.

　　3. Low temperature test

　　Test whether the low-temperature disinfectant can maintain a liquid state at the lowest applicable temperature specified in the manual of the low-temperature disinfectant. Take 5mL of low-temperature disinfectant (application solution) and place it at the corresponding low temperature overnight (>8h), observe and record its properties. If the low-temperature disinfectant remains in a liquid state without precipitation or crystallization, it is judged as qualified.

Information source: China Detergent Industry Information Network