WHAT DOES THIS MEAN?
As such, disinfectant and biocide registrants in Canada are eligible to communicate qualifying language relating to the expected efficacy of a disinfectant/biocide against the Bundibugyo virus, consistent with the disinfectant/biocide Emerging Viral Pathogens (EVP) policies.
Health Canada’s EVP policy:
You may make indirect efficacy claims against emerging enveloped or large non-enveloped viral pathogens if the disinfectant/biocide you received a market authorization for is:
- a “broad-spectrum virucide,” supported by an efficacy claim against any small non-enveloped virus from the following families:
- Picornaviridae (for example, rhinovirus)
- Parvoviridae (for example, canine parvovirus)
- Caliciviridae (for example, feline calicivirus)
- Astroviridae (for example, human astrovirus)
- Polyomaviridae (for example, human polyomavirus)
- effective against other viruses in the identified genus of the emerging viral pathogen
- for example, any influenza A virus for a claim against influenza A H1N1
As indicated in table 2 of the guidance on efficacy requirements, NNHPD no longer recommends the use of poliovirus or adenovirus type 5 as qualifying surrogate viruses in support of a broad-spectrum virucide or emerging viral pathogen claim for surface disinfectants. Health Canada will continue to allow existing historical Poliovirus data to support broad spectrum viral and emerging pathogen claims; however, they will no longer allow existing historical data against human adenovirus type 5 to be used to support new broad spectrum virucide and emerging pathogen claims.
HOW DO YOU COMMUNICATE THIS TO YOUR CUSTOMERS?
- As per the disinfectant and biocides EVP guidance, once one of the EVP triggers have been met, market authorization holders can immediately use qualifying language relating to the expected efficacy of a biocide against an EVP within their non-label communications (such as websites, toll-free consumer information services and similar media).
- On-label EVP communication for registered disinfectants under the Food and Drug Regulations (FDR) (so not yet transitioned over to the new Biocide Regulations) is permitted and should be filed via a post-division change (PDC) (no fee). Provided that no other changes are introduced through the PDC notification, there should be minimal risk in a registrant proceeding with making the EVP-related change to their printed disinfectant label prior to receipt of the NOL.
- On-label EVP communication for authorized biocides under the Biocides Regulations is permitted and should be filed as a minor change (NNHPD cost recovered activity of $1387 per DIN).
Examples of some acceptable claims:
“DIN-approved disinfectants which have received market authorization for a “broad spectrum virucide” claim (i.e., have proven efficacy against a hard-to-kill non-enveloped virus) or a specific claim against a non-enveloped virus are expected to inactivate less resistant enveloped viruses, such as Bundibugyo virus [which causes Ebola disease]. Therefore, in choosing a hard surface disinfectant to be used against Bundibugyo virus [which causes Ebola disease], any disinfectant with a “broad spectrum virucide” claim or a specific claim against a non-enveloped virus would be appropriate, as it would be expected to also inactivate the Bundibugyo virus and other viruses [in the Orthoebolavirus genus] that cause Ebola disease.”
“This product (insert Product Name) is a broad-spectrum virucidal hard surface disinfectant that is expected to inactivate the Bundibugyo virus [which causes Ebola disease]”.
“Kills (insert surrogate virus name) and is likely to kill the Bundibugyo virus [which causes Ebola disease]”.
“Effective against (insert surrogate virus name) and likely to kill the Bundibugyo virus [which causes Ebola disease].”
“This product has demonstrated effectiveness against (insert surrogate virus name) and is expected to inactivate the Bundibugyo virus [which causes Ebola disease].”
Let Dell Tech know if we can assist you if you decide to pursue this indirect efficacy claim.
Blog Author
Jackie Menzies Yarnton
Jackie Menzies Yarnton is a Principal Regulatory Consultant with over 15 years of experience in natural health products, cosmetics, and food regulations in Canada. She is actively involved in advancing regulatory standards through her work with industry organizations.
