Take part in Health Canada's Consultation on Regulatory Modernization

Written by: Christopher Marinangeli, PhD, RD, Director of the Centre for Regulatory Research and Innovation

On Nov. 4, 2023, the Government of Canada launched a public consultation with the intent to modernize aspects of Canada’s Food and Drug Regulations (FDR) that affect the rules regulating aspects of various food products. The proposed amendments outlined in Gazette 1 alter various frameworks that are broadly considered to be outdated, not representing today’s food and innovation landscape, and/or continue to create inefficiencies in regulatory oversight. Many of the amendments are repealing specific regulations and tables from the FDR, which, moving forward, will be Incorporated by Reference (IBR) in a separate document that is administratively managed by the Canadian Food Inspection Agency or Health Canada. Thus, as part of the consultation, draft IBR documents have also been provided to which stakeholders can also provide comments. Using IBR as a tool for regulatory modernization can create efficiencies when new tools, methods, compositional standards, etc. are available that reflect advances in science, technology, and innovation.

The summary below provides a high-level overview of the proposed changes outlined by the Government of Canada. Compared to regulatory change, increased use of IBR for standards, methods and food additives can be an effective tool for facilitating more frequent and efficient policy updates as global food landscapes and trade evolve. There are additional changes suggested under each category not captured and it is recommended that stakeholders look at the broader proposed changes and submit any comments that would assist the Government in their modernization efforts.

The Government of Canada has given the public until Feb. 2, 2024, to submit via the consultation page. If stakeholders have any questions regarding the proposed regulatory amendments, please feel free to contact Protein Industries Canada’s Centre for Regulatory Research and Innovation (christopher@proteinsupercluster.ca).

1. Outdated Compositional Standards
   Many foods within the FDR have compositional standards of identity and are identified as “standardized foods” with the symbol “[S].” The implementation of the Safe Food for Canadians Regulations in 2019 consolidated various regulatory frameworks for commodities, which also adopted 8 volumes of “Canadian Standards of Identity” IBR documents for commodities regulated by the SFCR, which, in some cases, references standards of identity in the FDR. The proposed amendment looks to remove compositional standards from the FDR, and incorporates standards using a newly drafted IBR document “Food Compositional Standard Document” that will be referenced in the FDR. Compositional aspects related to health for certain foods, i.e. fortification, would remain in the FDR.
   
   
2. Microbiological Criteria
   Currently, the Government of Canada uses a mixed approach comprised of regulatory and non-regulatory to administer parameters around the presence of pathogens in food. Within the FDR, regulated methods of analysis for levels of microbes are identified as “MFOs”. At the same time, non-regulated criteria for food pathogens are informed by various policies and guidelines. The proposed regulatory amendment aims to create an IBR document “Table of Microbiological Criteria for Food.” All existing criteria for microbial analysis of food in the FDR would be repealed and replaced with reference to the IBR document.
   
   
3. Outdated Methods of Analysis
   In addition to microbial analyses, the various parts of the FDR refer to official methods that are to be used to determine the chemical, physical or nutritional characteristics of food. Within the FDR, these are identified as “FO” methods. Within the proposed amendment, FO methods will be repealed and replaced with reference to a newly formed IBR document “Table of Chemical, Physical, and Nutritional Characteristics” of food.
   
   In addition, the Protein Digestible Corrected Amino Acid Score (PDCAAS) will be officially adopted as a valid method for determining the protein rating for food and the ability to market those foods as a “source of protein.” Currently, the protein efficiency ratio, a rat growth bioassay, is the only official method referenced in the FDR. While the Health Canada and CFIA adopted a policy in 2020 that would permit the use of PDCAAS to generate a protein rating, the present amendment officially adopts PDCAAS as an acceptable method for validating protein nutrient content claims. As part of this regulatory amendment, the IBR document “Methodology for Determining the Protein rating using the Protein Digestibility Corrected Amino acid Score (PDCAAS)” has been proposed that will be referenced in the abovementioned “Table for Chemical, Physical, and Nutritional Characteristics of Food” document.
   
   
4. Food Additives
   In 2012, 15 Lists of Permitted Food Additives were incorporated by reference using a Market Authorization framework to reduce the regulatory burden around the approval of new food additives. However, Tables of Lists of Food Additives remain in the FDR, which are not aligned with the current IBR documents. Furthermore, Division 16 make references to standards and other regulatory requirements that are or would be obsolete if other proposed regulatory changes proposed within this consultation are adopted. The proposed amendment would change the framework for food additives. The IBR Lists of Approved Food Additives would be incorporated by reference on an ambulatory basis, where, as with other IBR documents, can be administratively changed over time. Provisions in the FDR for the approval of new food additives would be repealed and, instead, incorporated into a guidance document.