Supplemented Food Regulations Published July 2022: What you Need to Know

 In Uncategorized

By: Joanna Chudyk, Regulatory Affairs Specialist, email

On July 20, 2022, the long-awaited Supplemented Food Regulations were published in the Canada Gazette, Part II. What will this mean for the industry? Temporary Marketing Authorizations (TMA’s) will be a thing of the past for this food category, making it easier to bring supplemented foods into Canada. Health Canada has granted a transition period that will end on December 31, 2025, for products that follow two specific scenarios:

  1. Products holding a valid Temporary Marketing Authorization Letter (TMAL) at the time the regulations came into force. A list of foods with TMAL’s that will qualify for the transition period has been published in Table 1 here. Moreover, products under the transition period should have received a notification from the Food Directorate authorizing the sale of their product.
  2. Products still in queue for a TMAL at the time the regulations were published and received a Health Canada Notification.

The transition period will be revoked for any product issued a TMAL that has had significant modifications made, such as container sizes or formulation changes to the supplemental ingredients. Products falling outside the scope outlined will be required to immediately comply with the new regulations before being marketed in Canada.

It is important to note that these regulations apply to only products that are classified as Supplemented Foods. All other food categories, including meal replacements, nutritional supplements, and formulated liquid diets, must still comply with Division 24 of the Food and Drugs Regulations or apply for a TMA if your formula is non-compliant.

Are you still waiting for a Notification from the Food Directorate authorizing the sale of your Supplemented Food? Do your products not appear on published lists of foods that have received Temporary Marketing Authorization Letters (TMALs)? Dell Tech is here to assist you in navigating these new regulations and to help you become compliant. Contact Joanna Chudyk (joanna@delltech.com), our in-house food regulatory expert, today!

Contact:
Dell Tech
Joanna Chudyk, M. Sc. 
Regulatory Affairs Specialist
joanna@delltech.com


Dell Tech has provided professional, confidential consulting services to the chemical specialty

industry in Canada, the USA, Europe, and Asia for the last 40 years.

Contact us today for more information.

 

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