Regulatory Affairs: A bit of housekeeping

In November 2023, proposed regulations were published in Canada Gazette I, which would see a significant reconsolidation of federal food compositional standards, modernization of food additive rules and its associated documents incorporated by reference (IbR), and modernization of analytical methods.

It is a bit perplexing to see federal food standards in both the Food and Drug Regulations (FDR), and those IbR by Safe Food for Canadians Regulations (SFCR), particularly when they cover the same food. This is because Canada had several federal food regulations in the past. Since food standards are also tethered to food additive rules, it becomes a more complex process to consolidate standards. The current FDR differentiates the use of food additives based on whether a food is standardized or unstandardized. Chutney is unstandardized under FDR but standardized by SFCR. This means chutney may include food additives that are permitted in unstandardized food, but pickles may only include those permitted in pickles.

New compositional standards

The proposed approach to modernizing food standards involves the creation of Canadian Food Compositional Standards, which would be IbR by FDR, and administered by CFIA in regard to a food’s composition, strength, potency, purity, quality or other property of standardized foods. Health Canada would retain health and safety criteria for foods in FDR. The dream of consolidating federal food standards has been around since CFIA’s creation in 1997. The proposed plan would not result in a single reference document. FDR would retain rules related to analytical criteria and nutrient composition and Canadian Food Compositional Standards would include the trade and commerce criteria.

Food additives

Health Canada is also working towards reconfiguring food additive rules. The current 15 food additive tables (collectively the Lists of Permitted Food Additives) that are IbR by 15 marketing authorizations (MAs) would be consolidated in an IbR document directly under FDR. The 15 MAs would be repealed and vestigial tables that have been codified in FDR since 2012 would be repealed. The food additive tables would be updated in tandem with the changes to food standards.

Division 16 of FDR, which sets out the core framework for food additive rules, would be modified to include other food additive related rules, such as those around sweetness and colour additive. The use of food additives would be defined as an adulteration except if in compliance with Division 16, FDR. The definition of ‘food additive’ would also be amended. Currently, ‘essential oils, oleoresins and natural extractives’ are considered food additives. This will change. Only ‘spices, seasonings and flavouring preparations’ would be exempt. This establishes that only ‘natural extractives’ used for flavouring wouldn’t be considered as food additive.

Food additives are currently required to meet applicable specifications in the Food Chemicals Codex, Combined Compendium of Food Additive Specifications or that defined in B.01.045, FDR, for certain food colours. This is limiting, as several newer food additives, such as modified vinegar, do not have specifications in these references. To overcome this, Health Canada proposes to create an IbR Table of Food Additive Specifications to allow a more efficient and clear approach to amending the food additive rules in the future.

Health Canada has also proposed to modernize Official Methods and how they may be used in ensuring compliance with FDR for certain microbiological, chemical, physical and/or nutritional requirements. Three new microbiological IbRs are proposed—Table of Microbiological Criteria for Food; Table of Microbiological Reference Methods for Food; and Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis. A new IbR Table of Chemical, Physical and Nutritional Characteristics of Food will include a more flexible approach in selecting suitable methods for compliance assurance purposes. Some of the current methods are dated, such as Official Method FO-1 from 1981 that speaks to protein quality determinations. Changes here would impact food standards and even nutrient content claim considerations.

The totality of the proposed amendments to FDR, SFCR and the documents IbR represent decades of pent-up regulatory housekeeping needs. But brace yourself, as more is on the way.

Gary Gnirss is a partner and president of Legal Suites, specializing in regulatory software and services. Contact him at president@legalsuites.com.

This column was originally published in the April/May 2024 issue of Food in Canada.