Written By Julia Schatz and Venetia Whiting
Prompted in part by supply chain challenges emerging during the COVID-19 pandemic, Health Canada is proposing a new regulatory framework under the Food and Drugs Act (FDA) specific to biocides. Biocides are products that sanitize or disinfect hard or soft non-living and non-liquid surfaces to prevent disease in humans or animals. After several rounds of consultation, on May 7, 2022, Health Canada published the proposed Biocides Regulations in the Canada Gazette, which attempt to create a regulatory framework that harmonizes the regulation of biocides under one comprehensive framework.
Biocides are currently regulated under separate regulatory frameworks in Canada: disinfectants are regulated under the FDA, surface sanitizers are regulated under the Pest Control Products Act (PCPA), and products with both disinfectant and sanitizer claims are regulated solely under the FDA.1 As such, despite having similar ingredients and risks and benefits, these products and their safety, efficacy and quality are subject to a myriad of requirements, fees and timelines that confuse (and sometimes deter) applicants, burdening the supply chain.
Under the proposed Biocides Regulations, however, disinfectants currently regulated under the Food and Drug Regulations (FDR) and certain surface sanitizers regulated under the PCPA would instead be regulated together under the new regulations. Health Canada's hope is that by reducing the application costs and increasing the predictability of the regulatory process for applicants, the Biocides Regulations will attract more industry to the Canadian market and help secure the Canadian supply chain of biocides for future emergency response preparedness.
The Biocides Regulations would only apply to disinfectants currently regulated under the FDR and surface sanitizers that meet the FDA definition of a drug,2 which includes disinfectants and sanitizers for use on hard or soft non-living and non-liquid surfaces. The Biocides Regulations would not apply to the following products:
- Sanitizers that do not meet the definition of a "drug" under the FDA, including algaecides, slimicides, material preservatives and products for odour control, which would continue to be regulated under the PCPA.
- Sanitizers and disinfectants that meet the definition of a drug, but that are for use in air or water, including pool and spa disinfectants, water sanitizers and air sanitizers. These are considered to be "higher risk" and will continue to be regulated under the PCPA.
- High-level disinfectant and sterilant solutions, including contact lens disinfectants and disinfectants intended for use on medical devices classified by Health Canada as invasive medical devices, which will continue to be regulated under the Medical Devices Regulations.
- Disinfectants and surface sanitizers exclusively used directly on the surface of a food such as fruits, vegetables, and meat products, which will continue to be regulated under the FDR by Food Directorate of Health Canada as processing aids.
- Drugs with antimicrobial activity for use on humans and animals (e.g., hand sanitizers), which will continue to be regulated under the FDR or the Natural Health Products Regulations.
- Cleaners, which will continue to be regulated under the Canada Consumer Product Safety Act and the Hazardous Products Act.
Alternative Pathways to Authorization
The COVID-19 pandemic amplified the shortage of biocides available to Canadians. In response, the proposed Biocides Regulations introduce two different pathways that would allow for more timely authorization of these products.
The first pathway is for applications based on comparison to a biocide already authorized in Canada. The applicant would need to demonstrate that:
- the biocide has the same active ingredients in the same quantities as the authorized biocide;
- the formulants in the biocide are among those permitted to be included in the authorized biocide;
- the uses or purposes, intended users, settings and directions for use fall within the parameters of those approved for the authorized biocide;
- the risk information and directions for storage and disposal are the same as those approved for the authorized biocide;
- the biocide has the same decontamination procedure as the authorized biocide, if applicable; and
- the biocide would be manufactured in accordance with the same master formula as the authorized biocide.
The second pathway, the use of foreign decisions (UFD) pathway, would allow biocide applicants to leverage the authorization from a trusted foreign regulatory authority when applying for a market authorization for an identical product in Canada. Rather than undergoing multiple (and often repetitive) review processes for the same product, applicants would be able to rely on the foreign regulator's decision, ultimately reducing authorization costs and the length of time needed to bring the product to the Canadian market.
Currently, the list of trusted foreign regulatory authorities is limited to the U.S. Environmental Protection Agency, and does not include Pharmaceutical Inspection Co-operation Scheme countries and countries involved in mutual recognition agreements with Canada. Health Canada will consider adding additional foreign regulatory authorities after consulting with Canadians through a notice of proposal published on the Health Canada website.
The proposed Biocides Regulations do not offer data protection for biocides. Currently, registrants of some surface sanitizers have data protection under the Pest Control Products Regulations. For these registrants, Health Canada proposes to allow them to maintain their registration under the PCPA for a period up to four years following the coming into force of the proposed Biocides Regulations. After that time, those registrants would be required to file an abbreviated application and obtain a market authorization under the Biocides Regulations, or risk compliance and enforcement action.
The Biocides Regulations will also include provisions relating to packaging and labeling, reporting of notable and serious incidents, mandatory reporting by hospitals, recalls, quality control and record keeping requirements. In addition, Health Canada would extend its current Compliance and enforcement policy for health products (POL-0001).
Though limited in scope, the proposed Biocides Regulations represent a risk-based approach to increasing harmonization with international regulatory regimes and reducing administrative burdens for prospective players in the Canadian market.
The Biocides Regulations will remain open for public comment until July 16, 2022, and would come into force one year following the registration of the Regulations. At that time, applicants that submit an application for a new market authorization will be required to meet all regulatory requirements in the Biocides Regulations following the coming-into-force date.
The Bennett Jones Product Regulation, Biotech, Pharma and Lifesciences and Agribusiness, Food and Beverage groups have extensive experience in product regulation and would be happy to discuss your legal needs with you.
1 Prior to April 2020, products with both disinfectant and sanitizer claims were regulated by the PCPA.
2 "Drug" includes any substance or mixture of substances manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, (b) restoring, correcting or modifying organic functions in human beings or animals, or (c) disinfection in premises in which food is manufactured, prepared or kept.