Publication of the New Biocides Regulations Coming Soon
By: Jacqui Jenskey, Senior Regulatory Affairs Specialist, email
In Canada, Biocides (disinfectants and certain sanitizers) are currently regulated separately under two regimes:
- disinfectants are regulated under the Food and Drugs Act (FDA)
- sanitizers are regulated under the Pest Control Products Act (PCPA)
Health Canada intends to bring forward a regulatory proposal to introduce flexibilities for biocides while placing them under a single regulatory framework.
The proposed flexibilities would allow the use of regulatory decisions from the United States Environmental Protection Agency (USEPA), and potentially other countries, for these products. This, in turn, will promote trade and further alignment with other jurisdictions and ensure that Canadians have access to innovative products.
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. In almost all cases, this safety and efficacy data follows the same GLP-certified lab requirements and the same test method requirements. By allowing these flexibilities, this proposed pathway will reduce authorization time and associated fees thereby providing an incentive for manufacturers to bring their products to the Canadian market.
The proposed regulation is expected to be published in Canada Gazette Part I (Proposed regulations) in May-June2022. It will be available for review and comment for 60 days. Dell Tech will stay actively engaged in this proposed regulation and if you have any questions please reach out to our Senior Regulatory Affairs Specialist, Jacqui Jenskey.
Dell Tech Laboratories
Senior Regulatory Affairs Specialist
519-858-5021 x 2028
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