Why is it so challenging to register a disinfectant in Canada?
By: Sarah Calder, Regulatory Affairs Specialist, email
The challenges with hard surface disinfectant registration in Canada begins with the differences in regulations compared with countries like the United States, who regulate these products as antimicrobial pesticides with the EPA.
In Canada, hard surface disinfectants are considered drugs and regulated under the Food and Drug Act and Regulations. Specifically, they fall under the Natural and Non-Prescription Health Products Directorate (NNHPD).
Although they are considered drugs under the regulations, hard surface disinfectants have unique exemptions compared to other drugs in Canada. Hard surface disinfectants are exempt from certain requirements such as the Drug Facts Table and Drug Establishment Licensing.
The submission requirements for a disinfectant product is determined by the types of claims specified on the product label and their intended uses, and are not required to use a registered source of active ingredient. Submissions can also be reviewed in a variety of classes, some with reduced timelines (ie. monograph, labelling standard, or Administrative submissions).
If you are having difficulty navigating the registration pathway for your disinfectant, please contact Dell Tech today