Proposed Regulatory Framework for Biocides in Canada

Health Canada has released a proposal for public comment to create a unified regulatory framework for disinfectants and sanitizers. In Canada, biocidal products are currently governed by distinct regulatory systems. Surface sanitizers are governed by the Pest Control Products Act, while disinfectants are governed by the Food and Drug Regulations (FDR) (PCPA). At present, The Food and Drugs Act is the only law that regulates products that claim to be disinfection and sanitizer (FDA).

According to the agency, the proposed revisions would "enable more international harmonisation, lower the administrative cost, provide stronger post-market control, and provide Canadians with more prompt access to biocides" by combining requirements from several rules. The proposed regulations also include the use of foreign decisions (UFD) pathway, which would allow applicants to use a trusted foreign regulatory authority's judgement when applying for market authorisation of an identical product in Canada. Also, the suggested flexibilities would allow these products to be regulated by the US EPA and other nations.

According to the proposed proposal, you only need to submit one application for marketing authorisation. This may include multiple products with slight deviations. However, the associated data package must be applied to all products listed in the application. The market authorisation holder, importer, or manufacturer would be required to submit recalls under the new guidelines. The public consultation will be open until July 16^th and the biocides laws would go into force a year after they are published in the Canada Gazette. The new biocides regulations would require registrants and holders of authorizations to complete an abridged application and acquire authorization within four years of its implementation.