The New Biocides Regulation
By: Jacqui Jenskey, Principal Regulatory Affairs Consultant, email
On May 7, 2022, Health Canada published and proposed a new regulation under the Food and Drugs Act (FDA) called the Biocides Regulation. This new regulation will regulate disinfectants and sanitizers for use on hard surfaces, soft surfaces, non-living surfaces, or non-liquid surfaces (biocides) under a single regime. The new framework will transfer disinfectants currently regulated under the FDA and surface sanitizers regulated under the Pest Control Products Act (PCPA) that meet the definition of a drug and are for use on non-liquid surfaces, to the proposed Biocides Regulations. The proposed Biocides Regulations would come into force one year following the registration of the Regulation with a proposed 4-year implementation timeline.
Biocides are currently regulated under separate regulatory frameworks in Canada with surface sanitizers and disinfectants having different associated requirements. This is the case, despite having similar risks, benefits, uses, and ingredients. It is important to note that Food-contact sanitizers (currently unregulated) will also be included within the scope of the proposed Biocides Regulations. This will mean that companies selling Food-contact sanitizers that do not require registration today, will require it in the future. Any claims related to these products will require efficacy data from a Good Laboratory Practice (GLP)-certified laboratory using test methods acceptable to Health Canada.
The proposed Regulations will create a new, modern authorization and regulatory framework with safety, efficacy, and quality requirements tailored to biocides. This would include the use of a foreign decision pathway that could help international players launch products in Canada if they are registered in other countries.
Health Canada has also developed a fee proposal that lays out the fees for biocides. The fees would support activities under the proposed Biocides Regulations. The Fees in Respect of Drugs and Medical Devices Order (Fees Order) would be amended to replace existing fees for disinfectants with the fees laid out in the fee proposal. No amendments would be made to any fees under the PCPA. The proposed consequential amendment to the Fees Order would come into force on the day on which the Biocides Regulations come into force.
You can provide your input and comments concerning the proposed Regulation and the proposed fees by July 16, 2022.
Dell Tech can help you navigate these changes when they are finalized and if you have any questions please reach out to us.
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