Forward Regulatory Plan 2021-2023: Regulations amending the Food and Drug Regulations, Part C (Biocides, use of foreign decisions for disinfectants and certain sanitizers)

Title of Regulatory Initiative

Regulations amending the Food and Drug Regulations, Part C (Biocides, use of foreign decisions for disinfectants and certain sanitizers)

Enabling Act

Food and Drugs Act

Description

Biocides (disinfectants and certain sanitizers) are currently regulated separately under two regimes: disinfectants are regulated under the Food and Drugs Act (FDA) and sanitizers are regulated under the Pest Control Products Act (PCPA).

The Department intends to bring forward a regulatory proposal to introduce flexibilities for biocides and place them under a single regulatory framework.

The Department will also be advancing a Ministerial Order Fees Amendment for fees that are commensurate to the regulatory approach.

Regulatory cooperation efforts (domestic and international)

This regulatory initiative is not part of a formal regulatory cooperation plan.

The proposal would allow the use of regulatory decisions from the United States Environmental Protection Agency (USEPA) for these products. Health Canada will conduct international scans to explore extending the Use of Foreign Decisions pathway to other key regulatory partners in the future as appropriate.

The Use of Foreign Decisions pathway is based on the confidence that Health Canada has with other foreign regulators as a result of collaboration, harmonization and other regulatory confidence building activities. It will also promote trade and further alignment with other jurisdictions and ensure that Canadians have access to innovative products.

Potential impacts on Canadians, including businesses

Many Canadian companies that produce biocides have parent companies in other countries, predominantly in the United States (US), and are regulated by the USEPA, which conducts a comprehensive review of these products for their safety and efficacy.

The Use of Foreign Decisions pathway would allow manufacturers of biocides to rely on the decision of a trusted foreign regulator when applying for market authorization in Canada. By doing so, this pathway will reduce authorization time and associated fees thereby providing an incentive for manufacturers to bring their product to the Canadian market.

Consultations

Health Canada will conduct consultations on this regulatory initiative and its components with key stakeholders in 2021.

For the Use of Foreign Decisions pathway, Health Canada engaged in targeted preliminary consultations with stakeholders in 2019.

Stakeholders have recently been engaged in the context of Health Canada’s interim measures and regulatory response to the COVID-19 pandemic.

Consultations were done as Health Canada was putting temporary measures in place to leverage foreign decisions in exceptionally importing disinfectant products for COVID-19, along with other regulatory flexibilities. Learnings and stakeholder feedback will help inform the policy approach for this proposal.

Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part l, public comment period, which is expected to take place in fall 2021.

Further information

Additional information can be requested from the departmental contact.

Departmental contact information

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Telephone: 613-946-6586
Email: hc.lrm-mlr.sc@canada.ca

Date the regulatory initiative was first included in the Forward Regulatory

February 2021

Consult Health Canada's acts and regulations web page for:

• a list of acts and regulations administered by Health Canada
• further information on Health Canada's implementation of government-wide regulatory management initiatives

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

• Federal regulatory management and modernization
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To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

• Consulting with Canadians
• Canada Gazette