In response to the tight supply of disinfectants caused by 2019 Novel Coronavirus(2019-nCoV), on February 3, 2020, the National Health Committee released "The Emergency Product Launching Notification of Disinfectants during Prevention And Control Period of Pneumonia Outbreak Caused by 2019-nCoV". Under this emergency measure, China has opened a "Green Channel," entailing expedited and exceptional market access for four types of disinfectants, including alcohol disinfectant, chlorine-containing disinfectant, chlorine dioxide disinfectant, and peracetic acid disinfectant placing on China market (see below).
According to the Notification:
- Disinfectants that use alcohol as the active substance can be placed on the Chinese market after completing content tests either by the manufacturers (for the domestic disinfectants) or by Chinese legal entity (for the imported disinfectants) or 3rd party laboratories. For hand-application alcohol disinfectants, the alcohol concentration in the disinfectants should be higher than 60% (V/V). The raw materials used in ethanol disinfectants shall conform to the requirements regulated in the national standard “GB26373-2010 Hygienic Standard for Alcohol Disinfectants," and ethanol concentration should be 70% - 80% (V/V);
- Chlorine-containing disinfectants, chlorine dioxide disinfectants, and peroxyacetic acid disinfectants can be placed on the Chinese market after completing the content test and pH test and compliant with related standards. The period of validity for “84” liquid disinfectants containing sodium hypochlorite should be limited to 3 months, with the exception that products can be distributed and used until expiration date supported by the qualified stability test data.
- The producers of disinfectants already on the market that has completed record filing are encouraged to expand their production by adding new production lines, new plants, and production sites. The disinfectants produced can be placed on the market after conducting and complying with content testing and pH testing requirements.
Producers of the aforementioned products should obtain the production license of disinfection products and submit product labels and quality safety commitment (attached with test reports) to the provincial or municipal health administrative departments.
For imported disinfectants, the notification points out that “imported disinfectants similar to previously approved disinfectants can be placed in the market after the Chinese representative legal entity submits product quality and safety commitments. The commitment must be attached with test reports and credential documents certifying that the product has legally marketed overseas).
In this way, China has opened the gate for imported disinfectants to enter the Chinese market quickly. It is worth noting that imported disinfectants can enjoy the green channel only when they meet the following three requirements:
- First of all, the imported disinfectants to be placed in China should be categorized as alcohol disinfectants, chlorine-containing disinfectants, chlorine dioxide disinfectants, or peroxyacetic acid disinfectants.
- Secondly, the overseas disinfectant manufacturer has already completed the record-filing for similar disinfectants in China before.
- Thirdly, submit the product quality and safety commitment and other credential documents that certify that the product has been legally marketed overseas. Test reports must also be submitted to the Health and Family Planning Commission, where the China representative legal entity is located.
Responsible entities should carry out testing in accordance with the regulation of WS628-2018 "Technical requirements for hygienic safety evaluation of disinfection products," and file a record in accordance with the provisions and regulations. After the emergency response for epidemic prevention and control is ended, if the product responsible entities fail to complete the tests and file records, they should stop selling the disinfectants immediately. Companies wishing to continue selling the disinfectants should follow all relevant procedures per the original disinfectant regulatory compliance procedures or face related punitive measures.
To this end, REACH24H has summed up the documents required for the premarket evaluation and record-filing of imported disinfectants, providing a reference for overseas enterprises.
1.Data submitted for emergency use
1). Letter of product quality safety commitment;
2). Test reports either issued by domestic or overseas lab owned by the Chinese representative legal entity or outsourcing testing organizations:
- Disinfectants with alcohol as active substances can be placed on the Chinese market after completing content tests either by the manufacturers (for the domestic disinfectants) or by Chinese legal entity (for the imported disinfectants) or by 3rd party labs. For hand-use alcohol disinfectants , the alcohol concentration in the disinfectants should be higher than 60% (V/V). The raw materials used in ethanol disinfectants shall conform to the requirements regulated in the national standard "GB26373-2010 Hygienic Standard for Alcohol Disinfectants" and ethanol concentration should be 70% - 80% (V/V)
- Chlorine-containing disinfectants, chlorine dioxide disinfectants, and peroxyacetic acid disinfectants can be placed on the Chinese market after completing the content test and pH test and comply with national requirements. In the meantime, the period of validity for "84" liquid disinfectants containing sodium hypochlorite should be limited to 3 months, with the exception that products can be distributed and used until the expiration date if supported by qualified stability test data
3) Credential documents that certifying that the product has been legally marketed overseas
2.Data required for record-filing after the emergency case:
1)Product label(nameplate) and product manual;
2)Test report (including conclusion);
3）Letter of product quality commitment;
4）Credential documents that certifying that the product has been legally marketed overseas;
5）Declaration for importation;
7）Certificate of authorization signed by the overseas producer and Chinese representative legal entity;
8）Business license of the Chinese representative legal entity;
To fight against the 2019 Novel Coronavirus, REACH24H is ready, and we are confident to give full support by offering specific and practical compliance solutions and advice for Chinese and overseas disinfectant enterprises. If you have any questions regarding Chinese disinfectant regulation, feel free to contact us via email@example.com.