Health Canada published in the Canada Gazette, Part I vol 156, proposed new regulations under the FDA. Health Canada will regulate disinfectants and sanitizers for use on hard or soft non-living or non-liquid surfaces (biocides) under a single regime. The new framework would transfer disinfectants that are currently regulated under the FDA and surface sanitizers regulated under the Pest Control Products Act (PCPA) that meet the definition of a drug and are for use on non-liquid surfaces, to the proposed Biocides Regulations. The proposed Biocides Regulations would come into force one year following the registration of the Regulations.
Provide your input and comments concerning the proposed Regulations closing on July 16, 2022.
Biocides are currently regulated under separate regulatory frameworks in Canada with surface sanitizers and disinfectants having different associated requirements, despite having similar risks, benefits, uses, and ingredients.
The proposed Regulations would create a new, modern authorization and regulatory framework with safety, efficacy and quality requirements tailored to biocides, including the use of a foreign decision pathway.
Health Canada is proposing to create new regulations under the Food and Drugs Act (FDA) specific to biocides that would see the transfer of disinfectants that are currently regulated under the Food and Drug Regulations (FDR) and surface sanitizers regulated under the Pest Control Products Act (PCPA) that meet the definition of a drug to the proposed Biocides Regulations;
- the creation of a new, modern authorization and regulatory framework with safety, efficacy and quality regulatory requirements better suited to biocides;
- the maintenance of a life cycle approach to the regulation of biocides while supporting requirements and authorities for the continuous post-market monitoring of a biocide’s risks and benefits; and
- the creation of a pathway for authorization based on decisions from foreign regulatory authorities.
For more information or inquiries on the proposed regulations contact Health Canada, Office of Legislative and Regulatory Modernization, Health Products and Food Branch
Email: lrm.consultations-mlr@hc-sc.gc.ca
Also, Health Canada has developed a fee proposal that lays out the fees for biocides that would support activities under the proposed Biocides Regulations. The Fees in Respect of Drugs and Medical Devices Order (Fees Order) would be amended to replace existing fees for disinfectants with the fees laid out in the fee proposal. No amendments would be made to any fees under the PCPA. The proposed consequential amendment to the Fees Order would come into force on the day on which the Biocides Regulations come into force.
Health Canada’s Biocides Fee Proposal is the consultation document that stakeholders and the public are invited to review. This document includes new fees as well as revised fee amounts and performance standards. Visit the Fee Proposal consultation page for details on how to participate in the consultation. The fee proposal consultation open for comments till July 16, 2022.
Any inquiries or comments on the fees order can be directed to Etienne Ouimette, Director General, Resource Management and Operations Directorate, Health Products and Food Branch, Health Canada, Tel 613‑957‑6690, email CRO-BRC@hc-sc.gc.ca.