Information on How to Obtain and Use an Expected Claim Related to Emerging Viral Pathogens Including COVID-19 (Coronavirus)

Information on How to Obtain and Use an Expected Claim Related to Emerging Viral Pathogens Including COVID-19 (Coronavirus)

March 13, 2020 By

Companies following the media coverage surrounding Coronavirus may be interested to know that their Broad Spectrum viricides could be eligible to be used as an Expected Claim related to Emerging Viral Pathogens including COVID-19. This article presents information on how to obtain an expected claim related to COVID-19/Coronavirus for disinfectants intended for use on non-porous environmental surfaces and inanimate objects.

What is an Expected Claim Related to Emerging Viral Pathogens?

For emerging viral pathogens in which the taxonomic genus of the virus has been identified, efficacy data against other viruses within that genus may be considered acceptable for use in that it (the product) can be expected to be effective against said emerging pathogen.

According to the guidance document – Safety and Efficacy Requirements for Hard Surface Disinfectant Drugs, disinfectants which have received market authorization for the following efficacy claims are permitted to make Expected Claims Related to Emerging Viral Pathogens:

  • Broad-spectrum viricide, supported by an efficacy claim against any of:
    • Adenovirus type 5
    • Bovine Parvovirus
    • Canine Parvovirus
    • Poliovirus type 1
  • For emerging viral pathogens for which the taxonomic genus of the virus has been identified, efficacy data against other viruses within that genus may be considered acceptable (with respect to COVID-19, a specific claim against a Coronavirus within the Betacoronavirus is considered acceptable).

Health Canada has also recently provided further guidance on the use Expected Claim Related to Emerging Viral Pathogens for disinfectant drugs with respect to COVID-19:

  • Communications to the public by manufactures regarding the expected efficacy of certain Broad Spectrum Viricide disinfectant drugs against COVID-19 is permittable provided their disinfectant is supported by a Broad-Spectrum efficacy claim for the specific organisms outlined above.
  • However, Health Canada permits ONLY indirect and “expected to be effective” and “likely to be effective” types of communications for COVID-19, and that no direct claims against COVID-19 can be made for DIN-authorized disinfectants, as these claims are, at the present time, considered to be unsubstantiated.

If you have any questions, or you’re looking for additional information on expected claims related to Coronavirus, contact dicentra today.