Extensions granted to all 2-year TMALs due to delay in finalization of the guidance document, and updates to the SFCA provided by the CFIA.

Earlier this year Health Canada released an expanded consultation document titled Category Specific Guidance for Temporary Marketing Authorization: Beverages, Beverage Mixes and Concentrated, Powders, Bars, and Confectionaries, for stakeholder review and input on products with food-like format.

The finalization of this document is aimed for early 2015, which is past the expiration date set for a number of the Temporary Marketing Authorizations issued since the introduction of this pilot in 2011/2012. To accommodate this gap in compliance, Health Canada is extending all 2-year Temporary Marketing Authorization Letters until August 31, 2016.

Some points to note for Temporary Marketing Authorization Letter holders from this extension (as quoted in the Temporary Marketing Authorization Letter Extension notification):

• To receive an additional Temporary Marketing Authorization Letter extension beyond August 31st 2016 your product (s) must be compliant with the final version of the guidance document as well as the food additive and novel food provisions of the Food and Drug Act (FDA)
• Any new Temporary Marketing Authorization Letters issued after August 31st 2014 will expire on August 31st 2016, at which time the product must be in compliance with the final version of the guidance document and other relevant food provisions

In addition to the Temporary Marketing Authorization Letter extension, the Canadian Food Inspection Agency (CFIA) is also undergoing some regulatory changes aimed at improving the Safe Food for Canadians Act (SFCA), through stronger safety rules, more effective inspection, commitment to service, and more available information for consumers.

Some of the proposed changes include:

• Licensing for those involved in importing or preparing food for export or inter-provincial trade (with limited exceptions)
• Establish baseline food safety requirements for all license holders that reflect CODEX standards in areas such as sanitation, pest control, hygiene, equipment and conveyances, etc.
• Commodity-specific requirements where necessary
• The preparation and maintenance of a Preventative Control Plan (PCP) to demonstrate compliance with food safety and other requirements of the Safe Food for Canadians Regulations (SFCR) and FDA
• Document the potential risks and hazards applicable to food commodity or process and provide a plan on how the hazards will be controlled and corrected (HACCP)
• Micro businesses (worth less than $30K) will require a license, but may be exempt from requirements for a written preventative control plan
• Improved document tractability for inter-provincial trade, with records maintained for 3 years

The CFIA is planning to have the proposed regulations published in the Canadian Gazette Part I in January 2015, with the final regulations published by June 2015. At this time, the final regulations will come into effect.

The full industry update can be found in the CFIA Press release at:
http://www.inspection.gc.ca/about-the-cfia/transforming-the-cfia/action-plan/food-regulatory-forum/presentations/proposed-sfcr/eng/1401581354273/1401581355226

dicentra can assist with food compliance in accordance to the Canadian and U.S. regulations and guidelines. Our in-depth knowledge of novel foods and labeling requirements allow us to determine the most compliant way to market your product, as well as helping novel products to be sold with a Temporary Marketing Authorization Letters.

dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces. Contact us at info@dicentra.com or at 1-866-647-3279.