Hello. Thank you for the opportunity to appear before you today.
My name is Celia Lourenco. I am the associate assistant deputy minister of the health products and food branch at Health Canada. I am joined by David Lee, chief regulatory officer of the health products and food branch, as well as colleagues from Health Canada's Pest Management Regulatory Agency and Global Affairs Canada.
In Canada, biocides are products that sanitize or disinfect non-living and non-liquid surfaces to prevent disease in humans or animals. Examples of biocides include wipes or sprays applied to sanitize or disinfect surfaces such as countertops, floors or objects.
Depending on their use or purpose, biocides are currently regulated under two separate legal frameworks: either the Food and Drugs Act or the Pest Control Products Act. As the federal regulating authority, Health Canada oversees the market authorization and safety of these products to help ensure that Canadians have access to a wide range of biocides that meet safety, efficacy and quality standards.
As members of this committee are aware, Health Canada is proposing to create new regulations for biocides under the Food and Drugs Act that would consolidate the regulation of these products under a single framework. The current system of multiple frameworks results in inconsistent oversight, confusion for some stakeholders and delays to market access. Stakeholders have been asking for change for a number of years.
In addition, the COVID-19 pandemic increased the demand for biocides, leading to shortages. Also, the department experienced an influx of biocide applications that led to delays, underscoring the challenges with the current system. Interim measures were put in place during the pandemic to expedite access and reinforced the need for a more agile way of regulating these products.
The new regulations aim to build on the lessons learned from the pandemic and to create a more modern approach, with risk-based requirements that will reduce market disruption. They will provide more clarity and predictability for industry and Health Canada and bring innovative biocides to the market sooner, while also continuing to protect the health and safety of Canadians.
One of the innovative approaches in the proposed regulations is that Health Canada would allow applicants to leverage the authorization of a trusted foreign regulatory authority to expedite the review and authorization of the same product in Canada. This review pathway recognizes that scientific and regulatory standards used in the development and regulation of these products are aligned internationally and would create efficiencies in the regulatory approval process in Canada without compromising our standards.
While Health Canada's regulatory review would be streamlined, the same level of scientific evidence as for any other biocide would still be required prior to approving a product. Additionally, once these biocides are on the Canadian market, a greater level of safety oversight would be applied to these products, as compared to other biocides.
As is standard for all regulatory proposals, this proposal has undergone extensive consultation to date. We have gone through the rigorous Canada Gazette process that included a 70‑day public consultation period beginning on May 7th, 2022. In addition, Health Canada has met regularly with stakeholders, starting in July 2019, to inform the development of the proposed regulations.
We have heard from many stakeholders who welcome these measures to simplify the regulations and encourage market access of innovative biocides. However, some stakeholders representing Canadian companies have expressed concerns about competition from foreign products entering the market. As mentioned, regardless of the review pathway, all biocides must meet the Canadian scientific and regulatory requirements before they can be approved.
In closing, Madame Chair, the proposed Biocides Regulations are an innovative set of measures that will simplify the regulatory process and bring about a more agile framework without compromising safety, efficacy, and quality.
We are committed to continuing to work with stakeholders and evaluating their feedback as we move to final publication.
Thank you once again for inviting us and I look forward to answering any questions that the committee may have.