Products that sanitize or disinfect hard or soft non-living and non-liquid surfaces to prevent disease in humans or animals are collectively referred to as biocides. The need for health products, including biocides, has exponentially increased as a result of the COVID-19 pandemic. To maintain a safe and effective supply of biocides for Canadians, and to alleviate certain pressures on the health care system and industry, interim orders and operational efficiencies were introduced to mitigate shortages of certain biocides in Canada. However, these are temporary measures that have been put in place to manage the response to the COVID-19 pandemic.
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. Having different requirements for these similar biocides has not provided a consistent approach to the regulation of these products, resulting in product classification challenges, differences in the administrative burden for the biocide supply chain, and potential hurdles for greater international alignment.
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 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.
The development of new regulations for the authorization and regulation of biocides, including a use of foreign decisions (UFD) pathway, would benefit Canadians and industry. Having harmonized regulations for both surface sanitizers and disinfectants as biocides that are modern and easy to understand would encourage industry to bring biocides to the Canadian market and would contribute to maintaining Canadians’ access to safe, effective, and high-quality products. This is critical to prepare for future emergency responses.
Interested persons may make representations concerning the proposed Regulations within 70 days after the date of publication of this notice. (until July 16, 2022).
All such representations must be submitted online on the Canada Gazette, Part I, or, if submitted by email, post or other format, must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Bruno Rodrigue, Executive Director, Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Department of Health, Address Locator: 3000A, 11 Holland Avenue, Suite P2108, Ottawa, Ontario K1A 0K9 (email: lrm.consultations-mlr@hc-sc.gc.ca).
Full Details can be found in the Canada Gazette, Part I, Volume 156, Number 19: Biocides Regulations