Currently, due to the serious pneumonia epidemic caused by novel coronavirus, a very tight supply of disinfectants was reported in China. To ensure the effective supply of disinfectants, on February 4, 2020, the National Health Commission hereby issued the Notice on Emergency Listing of Some Disinfectants during the Prevention and Control of the Novel Coronavirus-Related Pneumonia, which specified four types of disinfectants (alcohol-based disinfectants, chlorine-containing disinfectants, chlorine dioxide-based disinfectants and peroxyacetic acid-based disinfectants) that met relevant requirements could be urgently released on the market without registration.
Obviously, during this special stage, it is good news for the manufacturers and importers who are involved in this industry. As it is known that, according to the regulations, disinfectants shall first be registered before being marketed in China, and the process will need at least 2 to 3 months, which seems to be a little long, while the emergency listing may need only about 2 to 3 weeks, which no doubt shortened a lot of time. To help companies who are interested in this better understand this Notice, CIRS summarized the following six key points:
1. Currently, the disinfectants permitted for emergency listing are limited to the following four types only: Alcohol-based disinfectants, chlorine-containing disinfectants, chlorine dioxide-based disinfectants and peroxyacetic acid-based disinfectants. Disinfectants with other active ingredients as well as disinfection devices and antibacterial & bacteriostatic agents, such as antibacterial hand sanitizers, are not included;
Note: Chlorine-containing disinfectants refer to disinfectants with available chlorine as the main bactericidal ingredient. Common products include Sodium hypochlorite(NaClO), Calcium hypochlorite(Ca(CIO)2), Sodium dichloroisocyanurate, Trichloro-isocyanuric acid etc.
2. For marketing of imported disinfectants via emergency listing, the Responsible Entity in China must have registered the similar category of disinfectants in China, which refer to disinfectants with the same active ingredients and manufactured by the same company, regardless of the formulation type and concentration. The Responsible Entity in China which has not registered similar category of disinfectants or even has not registered any disinfectants in China is not allowed to market the above-mentioned four types of imported disinfectants via emergency listing;
3. The Responsible Entity must provide the testing report of active ingredient concentration and pH value prior to the marketing of the four types of disinfectants via emergency listing. The testing report shall be issued by Chinese laboratory with a CMA qualification. The active ingredient concentration and pH value in the testing report shall comply with relevant requirements.
4. In addition to the testing report, the manufacturer of domestic disinfectants must obtain the Hygiene License for the Disinfectants, and the Responsible Entity should also submit the Disinfectant Label & Instruction and the Product Quality & Safety Commitment to local health commission. For imported disinfectants, the China Responsible Entity should also submit the Product Quality & Safety Commitment and attach the product marketing ducuments (certificate of free sale, if any) and a complete set of testing reports issued in foreign laboratories.
5. Where the Responsible Entity adds the production lines, workshops or sites for the sake of expanding the production scale of domestic disinfectants that have been registered before, emergency listing may be granted if the testing report of active ingredient concentration and pH value conforming to relevant hygiene standards are provided by the Responsible Entity. This item doesn't apply to imported disinfectants;
6. Regarding to the disinfectants that are marketed via emergency listing during the current epidemic, while engaging to the sales, the Responsible Entity should also test relevant items and conduct the hygiene and safety evaluation and registration in accordance with the Technical Requirements for the Hygiene and Safety Evaluation of Disinfection Products (WS 628-2018) and other regulations. The Responsible Entity should immediately stop the production and sales of the four types of disinfectants marketed via emergency listing after the end of emergency response to the prevention and control of epidemic, if the test and product registration have not been completed by then; to continue the sales, the Responsible Entity should handle relevant procedures according to the original process, otherwise would be strictly investigated and punished in accordance with the Law on the Prevention and Control of Infectious Diseases, Measures for the Administration of Disinfection and other laws and provisions.
CIRS also sorted out all requirements for marketing of the four types of disinfectants via emergency listing for corporate reference, as shown in Table 1.
Table 1 Relevant Requirements for Marketing of Disinfectants via Emergency Listing
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