By: Jacqui Jenskey, DIRECTOR OF REGULATORY AFFAIRS, email
After much anticipation, Canada will see disinfectants and sanitizers (including food contact surface sanitizer) come under a single regulatory framework this year. Many companies will be looking for regulatory support to navigate the new biocides regulation. Dell Tech’s multidisciplinary team has been supporting the specialty chemical industry for over 40 years, and we’re excited to use our extensive experience to support companies in understanding the regulatory requirements for biocidal products.
Let’s walk through what you need to know before the new biocidal products regulation is here.
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Background: Disinfectants and Sanitizers
To date, biocidal active substances, otherwise known as biocidal products (disinfectants and most sanitizers) have been regulated under two different acts:
· disinfectants are regulated under the Food and Drugs Act (FDA)
· sanitizers are regulated under the Pest Control Products Act (PCPA)
· food contact surface sanitizers – unregulated, but Letters Of No Objection through the Foods Directorate are being provided upon request
One of the major regulatory challenges of this split pathway has always been determining the best option for a product.
Benefits of the New Regulation
We hope to see Canada involved in more international trade of biocidal products as the new regulations propose to allow the use of regulatory decisions from other countries including the United States Environmental Protection Agency (USEPA) and perhaps the European Union.
With mutual recognition in place for precedent regulatory decisions, especially with the United States, we hope to see reduced authorization time and associated fees getting the biocidal product family into Canada. As a result, Canadians will have access to a greater range of products.
How Dell Tech Can Help
Our team of registration specialists will continue to provide best-in-class regulatory support to companies bringing both disinfectants and sanitizers to market in Canada under biocidal product regulation. Our Regulatory Affairs services include:
· formula assessment
· label review
· data requirements guidance
· dossier preparation
· Health Canada submission
· ongoing support and liaison while submissions are under review
We will continue to provide assistance with Food Processing Aid applications (required LONO’s) for those sanitizers that come into direct contact with foods during processing that are not part of the new Biocides regulation.
Dell Tech has provided professional, confidential consulting services to the specialty chemical
industry in Canada, the USA, Europe, and Asia for the last 40 years.
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