China Ends the Emergent Market Entry of Disinfectants

China Ends the Emergent Market Entry of DisinfectantsOn August 4, 2020, the General Office of the National Health Commission released the final notice regarding the enhanced regulation of disinfection products during the Covid-19 control, which was consulted early on June 19. Apart from the aims of resuming normal record-filing management of non-new disinfectants and ensure the safety and effectiveness of disinfection products produced in China and intensifying the ex-post surveillance of disinfection products already been placed on the market, the emergently placed disinfectants will have a longer transitional period to complete the normal record-filing procedures until December 31, 2020.

In February this year, NHC announced the interim measures for the emergency use of 4 disinfectants: Alcohols, chlorines, chlorine dioxide, and peroxyacetic acid disinfectants that satisfy simple technical requirements can be placed on the market instead of completing the full record-filing formality with the provincial health authorities, the compulsory requirements for the market entry of all non-new disinfectants in China.

NHC pointed out that the interim measures that time was in response to the partial shortage of disinfectants lead by the serious outbreak, massive factory stoppage and logistic blockage. Given the fact the Covid-19 prevention has transformed from an emergent state to a normalized one and the liberal supply, the provincial health authorities are required to take adjusted measures to local conditions:

  • The placing of disinfectants through the interim procedures shall be immediately suspended as of the date of the promulgation of this notice;
  • The domestic producers or Chinese representative legal entities of the emergently placed disinfectants shall complete the record-filing formality following the “Provisions for the Hygienic and Safety Evaluation of Disinfection Products”, otherwise their production and marketing activities shall be suspended after 31 December 2020.

NHC urged domestic producers to strengthen their production management and quality control. The export-purpose disinfectants shall meet the quality requirements in both China and the export destinations.

Since the beginning of this year, China has released a dozen national standards concerning the efficacy evaluation, toxicity test, compulsory technical requirements and the ingredient lists of disinfectant/disinfectors, some of which will come into effect on October 1, 2020.

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