Canada Gazette, Part I, Volume 157, Number 44: Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food

November 4, 2023

Statutory authorities
Food and Drugs Act
Excise Act, 2001
Pest Control Products Act
Safe Food for Canadians Act
Cannabis Act

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues

Canada’s FDR set out rules to help ensure food products available to Canadians are safe, as well as rules to prevent misleading or deceiving consumers as to the foods they eat. Since their introduction, the FDR have, over the decades, evolved into a highly prescriptive and increasingly complex set of interconnected rules that are challenging to navigate, to understand and to keep up to date.

Today’s dynamic food marketplace includes an ever-evolving array of foods, food ingredients and methods of food production, packaging, testing, etc. Moreover, the increasingly global trade in foods coupled with other factors, such as climate change, increases risks for the introduction and spread of new foodborne hazards, including contaminants, harmful pathogens and diseases. While the SFCR modernized several areas of Canada’s food regulations, certain aspects of the FDR currently lack the agility to take into account advances in science and technology, new product development and emerging food risks. This lack of agility can result in barriers to the introduction of safe and innovative foods and food ingredients. It can also pose challenges to the Government’s ability to help ensure that critical regulatory protections, such as microbiological criteria, reflect the latest science and best practices for health and safety, and to support economic growth and innovation.

1. Outdated regulatory framework for food compositional standards

The food compositional standards set out the compositional requirements (e.g. permitted ingredients, quality parameters, manufacturing methods, prescribed common names) for certain foods imported for sale in Canada or sold interprovincially (between provinces and territories). In some cases, the standards also include health and safety rules that apply to standardized foods sold at all levels of trade, as was originally intended by Health Canada in the regulations on standards. In 2019, the standards of identity from the commodity-specific regulations that were captured under the Canada Agricultural Products Act, as well as the Meat Inspection Regulations, 1990 and the Fish Inspection Regulations, were repealed and subsequently incorporated by reference into the SFCR. The CFIA is now addressing the way in which current food compositional standards are structured under the Food and Drugs Act (FDA) and FDR. Currently, they are not responsive to innovations in food types or food ingredients, to changes in consumer demand, or to changes in international standards or trading partner practices, which can create a barrier to domestic and international trade and prevent or slow industry innovation.

2. Outdated regulatory framework for microbiological criteria

Over the last few decades, there have been significant changes in approaches to food safety management arising from increased knowledge of existing and emerging foodborne pathogens such as Escherichia coli (E. coli), Salmonella, and Cronobacter. Given the challenges with amending the microbiological criteria (i.e. rules concerning the presence and tolerable levels of certain microorganisms in food) currently prescribed in the FDR, Health Canada has had to rely increasingly on administrative policies and guidance to articulate new or updated microbiological criteria. While this adapted approach has enabled the Department to more rapidly introduce new and updated criteria, it has led to certain inconsistencies with the criteria set out in the FDR. Such inconsistencies diminish confidence in the regulatory requirements that are intended to help protect the health and safety of Canadians, while also potentially challenging compliance and enforcement efforts.

3. Outdated regulatory frameworks for methods of analysis

Certain provisions under the FDR reflect the use of specific “official methods” of analysis to measure whether a food meets certain microbiological, chemical, physical and/or nutritional requirements. These official methods were incorporated by reference into the FDR on a static (i.e. fixed) basis in the 1980s. While they reflect the standard analytical methods of that time, the official methods have not been revised since. Technological and scientific advances have led to the development of more reliable, rapid, cost-effective, sensitive and accurate methods. However, despite the availability of more modern alternatives, the FDR have not been amended to recognize those alternative methods.

As the FDR are presently set out, amending them is the only way to enable the use of new methods. Recognizing the limitations of this scheme and the challenges of keeping regulatory references up to date, similar to the situation with the microbiological criteria, Health Canada and the CFIA have been relying on administrative policies, guidance and other non-regulatory measures to effectively enable the use of more modern and rapid methods of analysis, where appropriate. However, as with the microbiological criteria, relying on these administrative measures over the long term complicates compliance and enforcement efforts.

4. Lack of flexibility for measuring the protein quality of foods

With respect to the analysis of the protein quality of certain foods, the FDR only permits the use of the protein efficiency ratio (PER) method (as set out in official method FO-1 in the FDR). This restriction has been identified as a long-standing stakeholder issue due to this method’s high cost; its requirement for lengthy tests; its use of animal studies, which goes against certain companies’ bioethical standards; and its inability to calculate the protein quality of a food that contains more than one source of protein (i.e. a new animal assay is required specific to each new product formulation). Newer methods for measuring protein quality, which address some of these issues, are available and have been widely used by several of Canada’s major trading partners, including the United States, the European Union, Australia and New Zealand, for over 20 years.

In December 2020, Health Canada and the CFIA issued a joint policy statement to recognize the use of an additional method, i.e. the Protein Digestibility Corrected Amino Acid Score (PDCAAS), as an interim solution until the FDR are formally amended. This method is acknowledged globally to measure the protein quality of most foods and has been used by the United States for regulatory purposes since the early 1990s.

5. Continuing the modernization of the food additives framework

In October 2012, the regulatory framework for food additives was modernized through the creation of 15 ministerial regulations (“marketing authorizations” or “MAs”), which incorporated by reference the 15 Lists of Permitted Food Additives on an ambulatory basis. This new scheme essentially replicated the structure of the 15 tables of permitted food additives set out under Division 16 of the FDR. Prior to this modernization, any modification to these tables required a regulatory amendment, which led to significant delays in enabling the use of food additives that Health Canada had assessed as safe and effective.

Since 2012, Health Canada has enabled the use of new food additives and extended the use of existing food additives that it has assessed as safe and effective by adding them to the Lists of Permitted Food Additives through a transparent administrative process managed by the Department. However, the tables of permitted food additives set out under Division 16 have not been amended to reflect decisions made since 2012. It is therefore necessary to repeal these now obsolete tables. In addition, many provisions in Part B of the FDR (such as the food compositional standards) still refer to the obsolete tables to section B.16.100 instead of to the Lists of Permitted Food Additives, or to specific food additives and conditions for their use. The Lists of Permitted Food Additives include many references to these rules set out in the food compositional standards, but the standards would be repealed under the proposed amendments. Therefore, changes are necessary to the Lists of Permitted Food Additives to reflect the proposed repeal of the food compositional standards. These discrepancies have the potential to create confusion among stakeholders as to the applicable food additive rules.

In response to the five issues described above, Health Canada and the CFIA are proposing significant amendments to Part B of the FDR. These amendments, which would help advance commitments made in the Agri-Food and Aquaculture Sector Regulatory Review Roadmap, include modernizing the frameworks for setting and updating regulations related to food compositional standards, microbiological criteria and methods of analysis, and food additives. The modernized food additives framework would remove duplications and inconsistencies from the FDR, consolidate most of the food additives rules in a new Division 16 and directly incorporate by reference the Lists of Permitted Food Additives as well as a new Table of Food Additive Specifications into the FDR on an ambulatory basis.

Background

The FDA and the FDR set out rules regarding the health and safety, composition, labelling, treatment, processing, packaging, sale and advertising of food. Health Canada establishes the policies, regulations, standards and guidelines related to the health, safety and nutritional quality of all food sold in Canada. The CFIA is responsible for enforcing the FDA provisions relating to food and also establishes the policies, regulations, standards and guidelines of FDA provisions that are not related to the health, safety of food (e.g. food compositional standards and labelling).

1. Food compositional standards

There are over 300 food compositional standards prescribed under the FDR. Food compositional standards, also known as standards of identity (identified by the symbol “[S]” in Part B of the FDR), are a set of established requirements, including technical specifications and other properties (such as ingredients, strength, potency, purity and quality), that define a particular food, often with an associated standardized common name (e.g. butter, whisky, cheddar cheese). A food that is likely to be mistaken for a standardized food and that is imported or traded interprovincially, and intended for sale in Canada is required to comply with the prescribed standard.

Food compositional standards were introduced to provide consumers with predictability of composition for specific foods and help protect consumers from products that are labelled falsely or are misleading. By imposing defined compositional requirements for food, the food compositional standards were also introduced to promote honesty and fair dealings in the marketplace by establishing a level playing field as to the composition, strength, purity and quality of foods that are imported into Canada and traded inter-provincially. In some cases, the food compositional standards also contain health and safety rules such as mandatory processing steps to address microbiological safety (e.g. pasteurization of ice cream mix) or mandatory levels of vitamins and mineral nutrients for an established public health purpose (e.g. the mandatory amount of vitamin D in cow’s milk to help address bone diseases).

The components of the food compositional standards, such as required or optional ingredients, which are unrelated to the health and safety of the food under the FDR apply to imported food products and food products traded interprovincially. They do not apply to food products traded intraprovincially (within a province).

2. Microbiological criteria

Microbiological criteria aim to ensure the microbiological safety and/or general cleanliness of food by setting out parameters for the presence of specific microorganisms in certain foods or food categories. These microorganisms include harmful pathogens, such as Salmonella linked to foodborne illnesses as well as indicator organisms, such as coliform bacteria or generic E.coli, which can indicate whether a food has potentially been manufactured or processed under unsanitary conditions.

Health Canada currently uses a mix of regulatory and non-regulatory approaches to administer its microbiological criteria. There are 21 microbiological criteria prescribed throughout Part B of the FDR. These are set out as either standalone prohibitions of sale or embedded within food compositional standards as “shall not contain” provisions. These microbiological criteria include the name of the food, the name of the microorganism or category of microorganism, the tolerance level for the microorganism and an official microbiological method of analysis (MFO) that must be used to assess compliance.

Non-regulatory criteria (known as “microbiological guidelines”) are set out in a variety of publicly available policies and guidelines, such as the Health Products and Food Branch (HPFB) Standards and Guidelines for Microbiological Safety of Food – An Interpretive Summary and the Policy on Listeria monocytogenes in ready-to-eat foods.

Regardless of the mechanism used (i.e. regulatory or non-regulatory), microbiological criteria are established with the same objective in mind: to help protect health and improve the safety and general cleanliness of foods by restricting or limiting the presence of certain problematic microorganisms.

3. Official methods of analysis

The official methods of analysis referenced in the FDR are defined in technical documents that set out the detailed procedures regulated parties and food inspectors must follow to measure whether a food meets a given regulatory provision. Official methods designated in the FDR as “MFOs” serve for assessing whether a food meets certain microbiological requirements, whereas official methods designated as “FOs” serve for measuring whether a food meets certain chemical, physical or nutritional requirements. There are currently 13 MFOs and 30 FOs referenced in approximately 93 provisions of the FDR. These official methods are used for compliance and enforcement purposes and must be used as published in their original form. Responsibility for the maintenance of the official methods is shared between Health Canada and the CFIA.

The official methods prescribed in the FDR are associated to a specific year and this has created issues for the Department and the CFIA in terms of ensuring that the best methods can be used for regulatory purposes. Modern methods that are typically more accurate, faster, cost-effective and sensitive exist, and new methods have emerged to reflect current food safety issues related to pathogens, contaminants and nutritional quality.

With respect to MFOs, Health Canada sets out acceptable alternatives in its online administrative Compendium of Analytical Methods. This Compendium is maintained by the Microbiological Methods Committee, which is composed of scientific staff from both Health Canada and the CFIA. The Committee assesses method submissions produced internally by Health Canada and the CFIA laboratories, as well as proposed new methods submitted on a voluntary basis by third parties. In practice, it is the methods deemed appropriate by the Committee and set out in the Compendium that are used by the food industry and the CFIA for measuring compliance with microbiological criteria. Current microbiological policies and guidelines also consistently direct regulated parties to the Compendium as the authoritative source of acceptable methods of analysis.

Regarding chemical, physical and nutritional methods of analysis, while no formal mechanism such as the Microbiological Methods Committee is in place, the Department and the CFIA again rely on a number of administrative tools to address current limitations.

4. Protein quality of certain foods

Protein quality is the capacity of a protein to provide accessible essential amino acids. There are several methods available to measure the protein quality of foods, including the PER and the PDCAAS methods. The FDR only permits the use of the official method FO-1, which uses PER, to determine the protein quality of certain foods.

The PER method quantifies protein quality by dividing the weight gain of rats fed a diet containing a particular food protein by the grams of protein consumed, using rats fed a casein protein diet as a control group. It was established in 1919 and was widely used globally to assess the protein quality of human foods. When official methods were introduced into the FDR, the PER was the most widely used and accepted method for measuring protein quality and was therefore selected while developing official method FO-1. Since then, newer methods have been developed for measuring protein quality, including the PDCAAS method. The PDCAAS method was recommended for regulatory use by the Food and Agriculture Organization of the United Nations and the World Health Organization in 1991 and is recognized by other regulators, including the United States. This method compares the essential amino acids provided by a food protein to the essential amino acids required by humans, and adjusts the score based on the ability for the protein to be digested.

On December 3, 2020, Health Canada and the CFIA published the interim policy statement Measuring the protein quality of foods to recognize the use of PDCAAS as an additional method to measure protein quality to comply with certain provisions in the FDR. The policy statement also reconfirmed the Department’s commitment to pursuing the necessary amendments to the FDR to permit this method’s use and creating a flexible framework that would continue to consider alternate methods in the future.

5. Food additives

In 2012, the Government of Canada brought forward two targeted changes to the FDA as part of Bill C-38, the Jobs, Growth and Long-term Prosperity Act, which aimed, among other things, to bring greater efficiency and responsiveness to the federal regulation of substances in or on foods (i.e. food additives, agricultural chemicals, veterinary drugs and vitamins, mineral nutrients or amino acids). The first change was to enact a new authority allowing the Minister of Health to issue a marketing authorization (MA) — a ministerial regulation — that enables the Minister to exempt a food from the application of specific prohibitions in the FDA or the FDR based on safety considerations. The new marketing authorization authority also allows the Minister to set specific conditions that must be met for the exemptions to apply. The second change allowed for the broader incorporation by reference of documents, including documents developed by Health Canada, into either a Governor in Council Regulation (e.g. the FDR) or an MA.

Shortly after the adoption of Bill C-38, the Minister of Health made use of these new authorities to modernize the regulatory framework for food additives through the creation of 15 food additive MAs, each of which incorporates by reference a corresponding list of substances permitted for use as food additives in or on foods sold in Canada. These lists, collectively referred to as the Lists of Permitted Food Additives, are administratively maintained by the Department following an established process and are published on the Canada.ca website. The lists are organized according to the technical purposes for which the food additives may be used (e.g. List of Permitted Preservatives; List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents). The MAs legally authorize the food additive uses that are set out in the lists by exempting a food to which a food additive is added from the application of certain prohibitions in the FDA and the FDR. This exemption applies in respect of the use or presence of the food additive only, provided the applicable conditions set out in the lists are met.

6. Regulatory review

In Budget 2018, the Government of Canada announced a regulatory reform agenda focussed on removing barriers to innovation and growth in key sectors, including the agri-food and aquaculture sector. A targeted review of the sector, including public consultations, was completed in 2018, culminating in the publication of the Agri-Food and Aquaculture Sector Regulatory Review Roadmap (the Roadmap) in early June 2019.

As part of the Roadmap, Health Canada and the CFIA committed to pursuing amendments to the FDR to address a number of long-standing irritants and barriers to innovation for the food industry and bring much needed flexibility and agility to Canada’s food regulations.

Health Canada and the CFIA would address commitments made under the theme of “Clear, Agile, Responsive Regulations” through this joint regulatory initiative.

• 1. Health Canada committed to incrementally redesigning the food regulations, including modernizing the regulatory frameworks for setting and updating microbiological criteria and methods of analysis and streamlining food additive provisions. This commitment can be found in the Department’s Forward Regulatory Plan, as part of its initiative to “modernize food regulations to enable innovative and safe foods for Canadians.”
• 2. The CFIA moved forward with its Food Labelling Modernization initiative, which had considered the modernization of food compositional standards (as announced in Budget 2014). Through the SFCR, which came into force in January 2019, the CFIA incorporated by reference the food compositional standards of eight specific food commodity groups. This proposed regulatory package, which repeals the food compositional standards from the FDR and incorporates them by reference, delivers on the commitment made under the CFIA’s “Creating an agile framework for compositional standards” initiative.

Objectives

The objectives of these proposed amendments are to contribute to making the Canadian food regulatory system more agile, transparent and responsive to new and emerging science, technology, market innovation and risks to health. This would be accomplished by

• Enabling administrative updates to food compositional standards to reflect current market practices, to address changes in consumer demand, to harmonize more closely with trading partners, to enable product innovation, and to facilitate the inter-provincial and international trade of foods;
• Enabling administrative updates to microbiological criteria and associated methods of analysis to help ensure that regulatory rules intended to help protect the health and safety of Canadians can be updated to reflect the latest science;
• Enabling industry and regulators to make use of more modern and effective methods of analysis to substantiate various chemical, physical and/or nutritional requirements for food, allowing regulated parties to keep pace with innovations; and
• Helping to reduce the burden on industry by removing duplications of food additive references throughout Part B of the FDR and between the tables to section B.16.100 of the FDR and the current Lists of Permitted Food Additives, as well as consolidating rules pertaining to food additives and simplifying the food additives framework.

The proposed Regulations would support science-based decision-making, which would help protect Canadians from deception and enable improved informed purchasing decisions. They would also support innovation by the food industry and the research community and provide greater clarity on what constitutes a compositional requirement of a standardized food versus a health and safety requirement that applies to a food regardless of the level of trade. For the agri-food industry in particular, the modernization of these components of the FDR would address long-standing irritants and barriers to market by providing a more responsive and adaptable regulatory framework that supports growth and innovation.

Description

Health Canada and the CFIA are proposing a significant number of amendments to bring flexibility and coherence to a number of provisions under Part B of the FDR. The proposed amendments would include modernized regulatory frameworks for setting and updating rules pertaining to food compositional standards, microbiological criteria and methods of analysis. This would include the incorporation by reference of certain aspects of these rules, which in turn would enable Health Canada and the CFIA to help ensure rules better respond to new and emerging science, technology, market innovation and/or risks to health.

In addition, the proposed amendments related to food additives would create a new regulatory framework in Division 16, repeal redundant rules from the FDR and consolidate other rules pertaining to permitted food additives, including those in existing MAs. These amendments would include the proposed incorporation by reference of the Lists of Permitted Food Additives into the FDR on an ambulatory basis.

As a result, the proposed Regulations would significantly amend Divisions 1 through 22 of Part B (Foods) of the FDR while also making additional targeted amendments to provisions found in Divisions 24 and 25 of Part B, Part A (Administration) and Divisions 1, 2 and 3 of Part D (Vitamins, Minerals and Amino Acids). Consequential amendments would also be made to a number of other regulations, as would be revisions to existing documents incorporated by reference, as indicated in the respective sections below.

1. Food compositional standards

The proposed Regulations would amend sections B.01.002 and B.01.042 of the FDR to clarify that food compositional standards not related to health and safety would now be found in a document defined as the Food Compositional Standards Document and incorporated by reference on an ambulatory basis into section B.01.002 of the FDR. A new proposed section B.01.043 would clarify that other substances (e.g. food additives, vitamins and mineral nutrients), except supplemental ingredients, could be required or permitted in a food for which a standard is set out in the Food Compositional Standards Document, if so prescribed in a provision of the FDR. Below are the specific amendments being proposed respecting food compositional standards in the FDR.

Definitions and interpretation

The proposed Regulations would update the existing definition of “common name” to refer to the Food Compositional Standards Document and to make reference to and better align it with the same defined term in the SFCR. The existing definitions of “flavouring preparation” and “sweetening agent” would also be updated to refer to the Food Compositional Standards Document. The existing definition of “unstandardized food” would be replaced with an updated definition for “unstandardized” and would also point to the Food Compositional Standards Document. This document would be defined in Parts B and D of the FDR. Lastly, two new definitions for “solid cut meat” and “solid cut poultry meat” would be introduced in Division 1 of Part B.

The proposed Regulations would introduce a new interpretation provision that clarifies that any words or expressions that are used but not defined in a food-related document that is published by the Government of Canada and incorporated by reference into parts A, B or D of the FDR have the same meaning as in those parts of the FDR.

Incorporation by reference — Food Compositional Standards Document

To allow for changes to support industry innovation or administrative additions, the proposed Regulations would repeal the food compositional standards from the FDR and move them into the Food Compositional Standards Document, which would be incorporated by reference into the FDR on an ambulatory basis.

This new document would capture the food compositional standards of 19 specific food commodities currently prescribed in Divisions 1 to 22 of Part B of the FDR: mixed nuts; alcoholic beverages; baking powder; cocoa and chocolate products; coffee; spices, dressings and seasonings; dairy products; fats and oils; flavouring preparations; fruits, vegetables, their products and substitutes; prepackaged water and ice; grain and bakery products; meat, its preparations and products; salt; sweetening agents; vinegar; tea; marine and fresh water animal products; and poultry, poultry meat, their preparations and products. As a result, Divisions 3, 4, 5 and 20 of Part B of the FDR would be repealed in their entirety.

Definitions that are unique to a specific division and only apply to standardized products within that division would be moved over or copied into the interpretation section of the Food Compositional Standards Document volumes. The symbol “[S]” would no longer appear in the FDR to indicate a food for which a standard is prescribed, as all the standards would now be set out in the Food Compositional Standards Document.

Certain labelling provisions that are currently contained within the standards and form part of, or are closely associated with, a compositional standard of a food would be moved, along with the rest of the non-health and non-safety-related components of the standards, into the Food Compositional Standards Document, as they aim to communicate that the food meets the standard. For example, when a flavouring preparation is added to a cheese, the words “with (naming the flavouring preparation)” must be added to the common name on any label. All other commodity-specific labelling rules that apply to foods sold at all levels of trade would remain in the FDR. For example, the labelling of cheese requires a statement of the percentage of milk fat (“milk fat,” “B.F.” or “M.F.”) and the percentage of moisture in the cheese followed by the word “moisture” or “water” on the principal display panel. The requirement to indicate the percentage of sugar or invert sugar on the label of liquid sugar and liquid invert sugar would also stay in the FDR. This rule would be amended to clarify that the percentage of sugar or invert sugar content of the food must be indicated on the label, as the case may be, when these foods are sold at all levels of trade. These rules would remain in the FDR, as they provide information to help consumers make healthy and informed purchasing choices and to help protect them from deceptive practices.

Provisions that are not contained within the standards, but that are tightly linked to the standards, are compositional in nature and have no components related to health and safety, would also be moved into the Food Compositional Standards Document. These provisions typically provide an exemption to the compositional requirements of a particular standard. For example, the FDR contains a provision allowing specialty breads to contain different types of flour (such as graham flour and whole-wheat flour) in a greater amount than what is permitted for white bread. While captured outside of the standard for bread, this provision would move to the Food Compositional Standards Document.

Substances set out in the Lists of Permitted Food Additives would generally be excluded from standards set out in the Food Compositional Standards Document, with certain exceptions: for example, the compositional standard for “baking powder” currently requires the combination of certain ingredients, one of which is an acid-reacting material (food additive), but also allows for the use of an anticaking agent (also a food additive) as an optional ingredient. The latter rule is already captured in the List of Permitted Anticaking Agents and would be removed, but the reference to “acid-reacting material” would remain within the standard. The compositional standard for “gelatin” would continue to provide for the use of acidic or basic compounds but instead of listing individual food additives, would point to those set out in the new List of Permitted Acidity Regulators and Acid-Reacting Materials. The standard would also continue to provide for specific filtering and clarifying agents, as these substances are not regulated as food additives when used for this purpose in the manufacture of gelatin. The standards for “(naming the flavour) Extract” or “(naming the flavour) Essence,” and “(naming the flavour) Flavour,” set out in sections B.10.003 and B.10.005, respectively, of the FDR provide that flavouring preparations subject to these standards may contain a food colour, a Class II preservative, a Class IV preservative and, in the case of “(naming the flavour) Flavour,” an emulsifying agent. These general provisions for food additives would remain in these standards as an interim measure until Health Canada permits individual food additives in these flavouring preparations by modifying the Lists of Permitted Food Additives. Health Canada intends to take into consideration information industry has submitted on the use of food additives in flavouring preparations, and to propose new list entries for public and stakeholder comments prior to finalizing them.

Similar to those for food additives, applicable food fortification and microbiological safety rules would also be excluded from the Food Compositional Standards Document. Food fortification rules would remain in Parts B and D of the FDR as prohibitions of sale and would be consolidated where possible. Certain microbiological safety rules would also remain in the text of the FDR, as prohibitions of sale and others would be managed through the proposed Table of Microbiological Criteria for Food (described in section 2 below), which would be incorporated by reference into the FDR on an ambulatory basis. Prohibitions of sale apply to all foods sold in Canada, regardless of level of trade.

Further amendments to clarify and streamline remaining rules and to update certain French terms where necessary are also proposed in the Food Compositional Standards Document and the FDR, including any relevant documents incorporated by reference. For example, the French term for “pumping pickle” would be updated to “marinade par injection” in the FDR, and the same change would be made in the Food Compositional Standards Document and in the Lists of Permitted Food Additives. The Food Compositional Standards Document would continue not to prescribe a standardized common name for pumping pickle. Other French terms that are proposed to be updated include “marinades et relishs” for “pickles and relishes,” “marinade par immersion” for “cover pickle,” “mélange de salaison à sec” for “dry cure,” “(nom de…)” for “(naming the…)”, “saumuré(e)” for “cured,” “sauces pour salades” for “dressings for salad,” “assaisonnements” for “seasonings,” “d’œuf entier” for “whole egg,” “viande coupée solide” for “solid cut meat” and “viande de volaille coupée solide” for “solid cut poultry meat,” where necessary.

Lastly, any remaining provisions in the FDR that currently refer to a food compositional standard would be amended to point to the relevant section of the Food Compositional Standards Document. If a provision referred to a food in a certain division of Part B of the FDR (e.g. “fats and oils referred to in Division 9,” “marine and fresh water animal products referred to in Division 21”), that provision would also be amended to consider that the food compositional standards would no longer appear in a provision of the FDR and the general term applies.

Geographical indications and distinctive products

Certain standardized alcoholic beverages in Division 2 of Part B of the FDR serve as distinctive products in that they prohibit the use of the name of certain spirit drinks (i.e. Scotch whisky, Irish whisky, Bourbon whisky, Tennessee whisky, Armagnac brandy, Cognac brandy, Tequila, Mezcal) unless the product is manufactured in accordance with the laws of the country of origin. These provisions, which do not prescribe the composition, strength, potency, purity, quality or other property of the food, are linked to various international trade commitments, and as such are not viewed as true compositional requirements.

Agriculture and Agri-Food Canada administers the Spirit Drinks Trade Act, which implements Canada’s international trade commitments related to the use of spirit drink names from foreign countries. Distinctive products mentioned above that are currently captured in the FDR are virtually identical to the provisions in the Spirit Drinks Trade Act and are considered to be either redundant and/or in conflict with this Act, and as such would be repealed from the FDR and would not be copied over to the Food Compositional Standards Document. Any remaining requirements related to modifying or blending certain alcoholic beverages would be converted to prohibitions of sale in the FDR, if not already prescribed as such. The current French heading before section B.02.050 (“Eau-de-vie”) of Part B would be updated to “Eau-de-vie de vin (brandy),” to better reflect distillates captured in the provisions that would remain in this section of the FDR once the food compositional standards are repealed. The French text in section B.02.043, which currently refers to “genièvre,” would be amended to align it with the English to clarify that the age claim prohibition, which prohibits a declaration of the length of time the gin was aged, applies to all gin rather than only to a specific type of gin, namely “genièvre.” Gins would continue to be permitted to bear a label declaration to indicate that a gin has been aged (e.g. aged, barreled) provided it was stored in a suitable container.

Future changes to the Food Compositional Standards Document

After the coming into force of these proposed Regulations, changes to the Food Compositional Standards Document would follow the process set out in the CFIA Incorporation by Reference Policy, ensuring that the Food Compositional Standards Document is maintained based on guiding principles of accessibility, transparency, consistency, reasonableness and clarity. The Food Compositional Standards Document is to be created and reviewed in an open, transparent, consistent and inclusive way that meaningfully engages the public. Stakeholders would be notified and provided the opportunity to comment on proposed revisions to this document. The CFIA has also published guidelines for stakeholders titled How to request a modification to a document incorporated by reference by CFIA into the Safe Food for Canadians Regulations or the food-related provisions of the Food and Drug Regulations.

Consequential amendments/revisions — SFCR, Canadian Standards of Identity

References to the FDR in the SFCR, as well as in certain documents incorporated by reference into the SFCR, such as CFIA’s Canadian Standards of Identity document, would be amended to refer to the Food Compositional Standards Document rather than the FDR, where necessary. The Canadian Standards of Identity would also be revised to eliminate, to the extent possible, regulatory overlap with health and safety requirements that are proposed to be maintained in the FDR (e.g. fortification rules) and permitted food additives that would be maintained via Health Canada’s Lists of Permitted Food Additives.

A new definition for the Food Compositional Standards Document would be added to the SFCR. The existing definition of “common name” would be amended to align it with the proposed changes to the same term in the FDR, and the existing definition of “wine” would be amended to point to the Food Compositional Standards Document. Similarly, the reference to cheese in paragraph 249(2)(l), Part 11, of the SFCR would be amended to point to the appropriate reference in the Food Compositional Standards Document.

Consequential revisions — Common Names for Ingredients and Components, Table of Permitted Nutrient Content Statements and Claims

A number of revisions would also be made to CFIA’s Common Names for Ingredients and Components document and to Health Canada’s Nutrition Labelling - Table of Permitted Nutrient Content Statements and Claims document, which are incorporated by reference into the FDR, to make reference to the new Food Compositional Standards Document, where necessary.

2. Microbiological criteria and associated microbiological methods of analysis

The proposed Regulations would create a new Division 30 in Part B of the FDR that sets out a regulatory framework for microbiological criteria for foods, including a new declaration of adulteration provision, a new provision setting out exemptions from the application of certain prohibitions in the FDA and a new provision regarding the methods to be used for compliance with the microbiological criteria.

Incorporation by reference — Table of Microbiological Criteria for Food

All of the existing regulatory microbiological criteria prescribed in the FDR would be repealed and consolidated into the Table of Microbiological Criteria for Food. This table would be defined in Division 30 and incorporated by reference into the FDR on an ambulatory basis through section B.30.002.

Adulteration and exemptions

A new provision would be created that would declare a food set out in the Table of Microbiological Criteria for Food to be adulterated if it does not meet the corresponding microbiological criteria in the table. The criteria would specify the type of microorganism, the tolerable limit for the microorganism and the required sampling parameters (e.g. the maximum level of a microorganism in a specified number of sample units). Within the Table of Microbiological Criteria for Food, the column that would reflect the level of microorganism (as prescribed under the FDR) would be expanded to include details on the sampling parameters that are currently set out in the referenced MFOs, bringing all of the sampling parameters together into a single location.

This would be followed by a new provision exempting a food from the application of paragraph 4(1)(a) of the FDA (prohibition on the sale of food that has in or on it a poisonous or harmful substance), in respect of the microorganism, where the amount of the microorganism in the food is within its tolerable limit as set out in the Table of Microbiological Criteria for Food.

For scenarios outside the scope of the incorporated table (i.e. food/microorganism combinations for which a criterion has not been set in the table), Health Canada would continue to rely, where appropriate, on its microbiological guidelines and policies, such as the Policy on Listeria monocytogenes in ready-to-eat foods, to help manage foodborne risks associated with certain microorganisms. Where no such policies are in place, individual situations would continue to be assessed on a case-by-case basis to determine the level of risk to health and appropriate risk management measures. The case-by-case assessment would determine whether the sale of the food contravenes the FDA.

Prohibitions outside of Division 30

Health Canada is proposing to amend the existing prohibition in paragraph B.12.005(2)(a), which pertains to the manufacture of prepackaged ice from water that does not meet its microbiological criteria. The specific reference to the microorganism (i.e. coliform bacteria) and its associated official microbiological method of analysis (i.e. MFO-15) would be replaced with the requirement that the water be potable.

Similar to being free of any coliform bacteria, potable water is also an indicator that the source water used is not contaminated with microorganisms. This proposed amendment would align the rules for prepackaged ice (and the water used to make such ice) with those that apply to mineral water and spring water, which must also be made from potable water and be free of any coliform bacteria. The French term for “water represented as mineral water or spring water” would also be updated to “une eau présentée comme étant une eau minérale ou une eau de source” throughout the FDR and in the Food Compositional Standards Document, where necessary.

Health Canada is also proposing to repeal the prohibition in section B.08.025 from the FDR, which pertains to the purchase of milk for manufacture or the manufacture of milk into other dairy products suspected of not meeting the criteria set out in paragraphs B.08.024(a) and (b). Health Canada has determined that this prohibition is redundant and unnecessary as the microbiological safety and quality of milk for manufacture (and products made from such milk) is assured through the existing criteria for milk for manufacture and the prohibition in subsection B.08.002.2(1).

Compliance with microbiological criteria

The proposed Regulations would replace the outdated MFOs prescribed throughout Part B of the FDR with a new provision requiring that compliance with microbiological criteria be measured by way of either a “microbiological reference method” or an “equivalent method.” These two terms would be defined in Division 30 and would refer to two new documents entitled Table of Microbiological Reference Methods for Food and Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis, respectively. Both documents would be incorporated by reference into the FDR on an ambulatory basis.

Incorporation by reference — Table of Microbiological Reference Methods for Food

The Table of Microbiological Reference Methods for Food would consist of the relevant reference methods currently set out in Volume 2: HPB Methods for the Microbiological Analysis of Foods of the Compendium of Analytical Methods. These reference methods are periodically reviewed by the Department’s Microbiological Methods Committee to reflect the latest science and are the gold standard against which all other microbiological methods set out in the Compendium of Analytical Methods are validated.

Incorporation by reference — Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis

A new document entitled Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis would set out the requirements a regulated party must demonstrate in order for the Government of Canada to consider their method equivalent to a microbiological reference method set out in the Table of Microbiological Reference Methods for Food. The requirements in question would be modelled on those presently set out in Volume 1: Official Methods for the Microbiological Analysis of Foods of the Compendium of Analytical Methods.

Future changes to microbiological documents incorporated by reference

After the coming into force of the proposed Regulations, changes to the Table of Microbiological Criteria for Food, the Table of Microbiological Reference Methods for Food or the Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis documents would follow the process set out in the Health Canada Incorporation by Reference Policy. Health Canada would update these documents as necessary based on the latest science, risk assessments and/or in response to a public health crisis. These documents are created and reviewed in an open, transparent, consistent and inclusive way that meaningfully engages the public. Stakeholders would be notified and provided the opportunity to comment on proposed revisions to these documents through Health Canada’s established notification process.

3. Chemical, physical and nutritional methods of analysis

Incorporation by reference — official methods of analysis

Health Canada and the CFIA are proposing to repeal from the FDR the statically incorporated by reference FOs and their associated values (where applicable) respecting the chemical, physical or nutritional characteristics of certain foods, and move them into documents that would be incorporated by reference into the FDR on an ambulatory basis. Depending on the FO method in question, this would be done in one of two ways:

• Existing FO references uniquely linked to compositional requirements that apply to standardized foods would be repealed from the FDR and included in the CFIA’s Food Compositional Standards Document that would be incorporated by reference into the FDR along with the compositional standard; and
• Existing FO references linked to either health and safety requirements (i.e. FO-1, FO-40, FO-41 and FO-42) or compositional requirements that apply to unstandardized foods would be repealed from the FDR and incorporated by reference into the FDR through a new Table of Chemical, Physical and Nutritional Characteristics of Food. A new definition would be introduced in Part B of the FDR for this table, similar to the Food Compositional Standards Document. These official methods of analysis would remain linked to the FDR in their respective prohibitions, but the details of the methods and their values would be maintained in the proposed Table of Chemical, Physical and Nutritional Characteristics of Food.

Regarding the FO methods in the Food Compositional Standards Document as well as those set out in the Table of Chemical, Physical and Nutritional Characteristics of Food that are linked to compositional requirements, it is the CFIA’s intent, over the coming years, to undertake a comprehensive review of these methods to determine the appropriate course of action, i.e. replace the method, retain the method, or repeal the method.

With respect to the four FOs linked to health and safety, FO-1 would be retained in the Table of Chemical, Physical and Nutritional Characteristics of Food and the internationally recognized PDCAAS method would be added as an option. The remaining three methods are planned to be addressed as part of future modernization work on the regulations for food packaging materials (FO-40 and FO-41) and for food fortification (FO-42).

Protein quality method (FO-1) and protein ratings

As mentioned previously, a second validated method for measuring protein quality, the PDCAAS, would be added to the Table of Chemical, Physical and Nutritional Characteristics of Food along with the respective protein quality requirements for certain foods. The PER method as described in FO-1 would continue to be required to evaluate the protein quality in infant foods.

A separate document titled Methodology for Determining the Protein Rating Using the Protein Digestibility Corrected Amino Acid Score (PDCAAS) would also be incorporated by reference into the FDR (through the Table of Chemical, Physical and Nutritional Characteristics of Food) and would describe the details for determining the protein rating of a food using PDCAAS to assess compliance with protein quality requirements. Health Canada would be proposing to follow a similar methodology for measuring PDCAAS as outlined in the Food and Agriculture Organization of the United Nations and the World Health Organization’s 1991 report Protein Quality Evaluation: Report of the Joint FAO/WHO Expert Consultation. A draft version of the Methodology for Determining the Protein Rating Using the Protein Digestibility Corrected Amino Acid Score (PDCAAS) is available for review as part of this pre-consultation.

Consequential revisions — Table of Permitted Nutrient Content Statements and Claims

Revisions would be made to Health Canada’s Nutrition Labelling - Table of Permitted Nutrient Content Statements and Claims document for items 8 (“source of protein”), 9 (“excellent source of protein”) and 10 (“more protein”). The revisions would make reference to the new Table of Chemical, Physical and Nutritional Characteristics of Food and remove references to the protein quality method (FO-1) and associated protein ratings.

Future changes to official (FO) methods documents

After the coming into force of the proposed Regulations, changes to the Table of Chemical, Physical and Nutritional Characteristics of Food or the Methodology for Determining the Protein Rating Using the Protein Digestibility Corrected Amino Acid Score (PDCAAS) would follow the established, open and transparent processes applicable to all documents that are incorporated by reference. Health Canada and the CFIA would update these documents as necessary based on the latest science and in accordance with their respective incorporation by reference policies and Canadians would be informed of proposed revisions and provided the opportunity to comment in accordance with their respective incorporation by reference policies.

4. Food additives

The proposed Regulations would amend Division 16 in Part B of the FDR to set out a new regulatory framework for food additives. Most provisions specific to food additives throughout Part B of the FDR as well as some of the existing provisions in the 15 food additives MAs would be consolidated and reorganized in this division.

A new declaration of adulteration provision and new provisions setting out exemptions from certain prohibitions in the FDA would be introduced. The 15 Lists of Permitted Food Additives would be incorporated by reference into the FDR on an ambulatory basis. Provisions related to the pre-market submission process for food additives would be repealed from the FDR and set out instead in guidance from Health Canada. In addition, certain provisions within Part B of the FDR specifically related to food additives (e.g. those for infant foods in Division 25, certain labelling rules specific to high-intensity sweeteners in Division 1 as well as definitions and food colour specifications in Division 6) would be repealed and/or set out in Division 16 of the FDR, to consolidate most of the rules pertaining to food additives into a single Division. A new Table of Food Additive Specifications would also be incorporated by reference into the FDR on an ambulatory basis.

Definitions and interpretation

In Division 1 of Part B of the FDR, the proposed Regulations would amend the existing definitions of “agricultural chemical” and “food additive” to replace the reference to the tables to section B.16.100 with the new defined term for the Lists of Permitted Food Additives. Health Canada is proposing to amend the titles of several food additive lists, and the new definition of the “Lists of Permitted Food Additives” would reflect these proposed changes. A public consultation took place on the proposed changes to these titles, including an explanation of each change, in Health Canada’s Proposal to Modernize the Structure and Titles of the Lists of Permitted Food Additives (Ref.  No. NOP/AD-0038). The references to “essential oils,” “oleoresins” and “natural extractives” in paragraph (c) of the definition of “food additive” would also be removed. Manufacturers wishing to request that Health Canada permit essential oils, oleoresins and natural extractives to be used as food additives in the future could do so through Health Canada’s food additive submission pre-market review process. Those substances, when used as a flavouring preparation, would continue to be excluded from the definition of a food additive, as paragraph (c) excludes flavouring preparations from the definition.

The existing definitions of “food colour” and “sweetener” would also be amended in Division 1 of Part B. Both defined terms would include the function of the food additive as defined in the respective MA and the references to the MAs would be removed. A new definition of “food enzyme” would be added to a new section B.16.019 and would also include the function as defined in the respective marketing authorization.

The definition of “gelling agent” in Division 1 of Part B would be repealed from the FDR and the definition of “parts per million” in Division 1 of Part B would be amended to add the acronym “ppm.”

The definitions “infant” and “infant food” would be repealed from Division 25 of Part B and moved to Division 1 of Part B and the definition of “supplemented food” would be amended to refer to the latter term.

Lastly, the existing definitions of “dye,” “diluent,” “mixture,” “preparation” and “synthetic colour” in Division 6 of Part B would be moved to Division 16 and updated where necessary to reflect that these terms apply specifically to food colours.

The proposed Regulations would introduce a new interpretation provision that clarifies that a reference to any list referred to in the definition of “Lists of Permitted Food Additives” is a reference to the list as published by the Government of Canada on its website, as amended from time to time.

Declaration of adulteration

A new provision in Division 16 (section B.16.002) of Part B would declare a food adulterated if a food additive is present in or on, or has been added to, that food.

Exemptions — general

Paragraphs 4(1)(a) and (d) of the FDA prohibit the sale of a food that has in or on it any poisonous or harmful substance or that is adulterated. A new provision in Division 16 (section B.16.003) would provide that, if a food additive set out in column 1 of the Lists of Permitted Food Additives is added to a food set out in column 3, that food does not have a poisonous or harmful substance in or on it for the purposes of paragraph 4(1)(a) of the FDA, or is not adulterated for the purposes of paragraph 4(1)(d) of the FDA by reason only that the food additive is in or on it, or has been added to it, and provided that the conditions set out in paragraphs (a) to (e) of that provision are met.

In summary, a food would meet the applicable conditions if the food additive is set out in column 1 of the Lists of Permitted Food Additives; the food additive is obtained from a source set out in column 2 (if specified); the food additive is in or on, or has been added to a food set out in column 3; the food additive is used for a purpose of use set out in column 4 (if specified); the amount of the food additive does not exceed the maximum level of use or maximum level of residue set out in column 5; the amount of the food additive does not exceed the amount required to accomplish the purpose for which it is added, in the case where the words “Good Manufacturing Practice” appear in column 5; and any other condition set out in column 5 is met. The exemptions would be similar to the exemptions set out in section 2 of the 15 food additives MAs for foods and the new Lists of Permitted Food Additives would be amended to reflect the proposed structure in the FDR.

The proposed Regulations would also provide for the carry-over of food additives into foods. Accordingly, under a new section B.16.004, if a food does not contain a poisonous or harmful substance or is not adulterated under section B.16.003, and is used as an ingredient in another food, that other food would also not contain a poisonous or harmful substance, or be adulterated, by reason only that the food additive is present in or on that other food, or has been added to the ingredient.

Exemptions — infant food

Currently, the provisions that allow food additives in some infant foods are found in Divisions 1 and 25 of Part B of the FDR, and in certain food additive MAs. The proposed Regulations would consolidate these rules in Division 16.

A new section B.16.005 would provide that the proposed exemptions in sections B.16.003 and/or B.16.004 would also apply to infant foods in the following circumstances:

• 1. If it is a bakery product that is labelled or advertised for consumption by infants, e.g. “bread”, “unstandardized bakery products”;
• 2. If a food additive in or on a food that is labelled or advertised for consumption by infants is citric acid and it is used in accordance with the applicable conditions set out in columns 1 to 5 of the Lists of Permitted Food Additives;
• 3. If the word “infant” is mentioned in relation to a food in column 3 of the Lists of Permitted Food Additives, e.g. “infant cereal product”, “spray-dried bacterial culture preparations for use in dried infant cereal products”;
• 4. If it is a “human milk fortifier” set out in column 3 of the Lists of Permitted Food Additives;
• 5. If it is an infant formula that contains as an ingredient a food set out in column 3 of the List of Permitted Food Enzymes to which a corresponding food enzyme set out in column 1 was added; and
• 6. If it contains as an ingredient a food set out in column 3 of the Lists of Permitted Food Additives to which a corresponding food additive set out in column 1 has been added, and the use of that ingredient in that infant food is mentioned in column 3.

Exemptions — other requirements

A new provision in Division 16 would indicate that the exemptions in sections B.16.003 to B.16.005 with respect to a food, including an infant food, would only apply if all the other requirements in the FDR relating to the food additive, such as any prescribed specifications, are met.

Prohibitions

Three existing prohibitions of sale specific to food additives would be repealed from Divisions 6 (section B.06.002), 10 (paragraph B.10.026(c)) and 11 (section B.11.001.1) and moved to Division 16 to consolidate these rules in the same Division of the FDR. The existing prohibition in section B.16.100 would also be retained but renumbered and amended to now refer to the Lists of Permitted Food Additives.

Specifications

The general rules with respect to food additive specifications are currently set out in Division 1 of Part B (section B.01.045). In addition, specifications for the synthetic colours Ponceau SX and Citrus Red No. 2 and for the lakes of synthetic colours are currently set out in Division 6 of Part B (sections B.06.043, B.06.053 and B.06.061, respectively).

The general rules as well as the specification for lakes of synthetic colours would be moved to Division 16, and sections B.01.045 and B.06.061 would be repealed.

The general rule would be updated to include a reference to a new Table of Food Additive Specifications, which would be incorporated by reference on an ambulatory basis into the FDR, and would set out specifications for two food additives, namely Ponceau SX and Citrus Red No. 2, currently prescribed in Division 6 (further details are provided below under the subheading “Incorporation by reference — Table of Food Additive Specifications”).

If a food additive is not listed in the proposed new Table of Food Additive Specifications, the general rule would continue to require that food additives meet the specifications, if any, set out in either the Combined Compendium of Food Additive Specifications or the Food Chemicals Codex, both of which are currently incorporated by reference into section B.01.045 of the FDR on an ambulatory basis. Minor revisions are proposed to the reference to the Food Chemicals Codex to clarify that its incorporation by reference into the FDR is ambulatory in nature by removing the edition number, the year currently referenced, and mention of the city and state.

Lastly, the provisions in Division 1 of Part B that set out the limits for arsenic and lead in food colours without prescribed specifications in the FDR or in either the Combined Compendium of Food Additive Specifications or Food Chemicals Codex would be repealed, as these limits are outdated.

Incorporation by reference — Table of Food Additive Specifications

It is proposed to repeal the specifications for Ponceau SX and Citrus Red No. 2 from Division 6, Part B, and move them into a new document entitled Table of Food Additive Specifications. This document would be incorporated by reference into the FDR on an ambulatory basis, which would allow changes to be made in the future without the need for regulatory amendments. As specifications for food additives apply at all levels of trade, the two synthetic food colours would no longer be prescribed as food compositional standards. Division 6 would be repealed in its entirety, as there would be no remaining provisions.

Incorporation by reference — Lists of Permitted Food Additives

At this time, the Lists of Permitted Food Additives are incorporated by reference into the 15 food additive MAs on an ambulatory basis. Under the current framework, Health Canada can enable all new uses of food additives through an administrative process to modify the Lists, with the exception of a new purpose of use for new food additives. In these cases, the Minister of Health must add the new food additive and its new purpose of use to the Schedule to the Marketing Authorization for Food Additives with Other Accepted Uses that incorporates by reference the List of Permitted Food Additives with Other Accepted Uses. This regulatory amendment must be completed in order for the new entry that the Department sets out on the List of Permitted Food Additives with Other Accepted Uses to have the legal effect of permitting the new food additive with the new purpose of use. With the proposed amendments to Division 16 of the FDR and the proposed repeal of the MAs, a regulatory amendment would no longer be required in these circumstances.

To consolidate all food additive regulations, Health Canada is proposing to incorporate by reference the 15 Lists of Permitted Food Additives, which are currently incorporated by reference into the 15 food additive MAs on an ambulatory basis, directly into the FDR on an ambulatory basis instead. As part of these proposed amendments, the Department would modify the 15 Lists to have a consistent structure and would modernize the title of certain Lists to reflect modern terminology and to be consistent with the terminology of other jurisdictions. Further revisions would be made to the terminology across and within the Lists for consistency and clarity. The majority of the references in the Lists of Permitted Food Additives to provisions in the FDR (e.g. “in accordance with” rules) would be replaced with the rules set out in those provisions, and corresponding amendments would be made to repeal such rules from the FDR. For example, column 3 of subitem C.2(8) of the List of Permitted Sequestering Agents currently sets out the maximum level of use and other conditions for the use of calcium disodium EDTA in “[c]anned legumes except canned green beans, canned peas and canned wax beans” as follows: “(8) 365 p[arts] p[er] m[illion] calculated as the anhydrous form in accordance with the requirements of B.11.002”. Proposed new paragraph C.2(f) in column 5 of the List of Permitted Sequestering Agents would reflect the rule currently set out in subparagraph B.11.002(d)(v) [i.e. that the food additive calcium disodium EDTA is not to be used with disodium EDTA].

Changes to the Lists of Permitted Food Additives

Section B.16.002 currently outlines the information that must be submitted in a form and manner established by the Minister of Health to request a change to the tables of permitted food additives to section B.16.100. However, since the regulatory amendments propose the repeal of the tables to section B.16.100, and given that the Lists of Permitted Food Additives are administratively maintained outside the FDR, Health Canada is proposing to remove the existing submission requirements for requesting a change to one or more of the tables from the FDR. These requirements would instead be placed in the existing guidance document on the pre-market submission process for food additives entitled A Guide for the Preparation of Submissions on Food Additives, which would be updated accordingly.

The existing requirement under section B.16.003 for the Minister of Health to notify the person filing the submission in writing about their decision would also be removed since the service standard of 90 days does not reflect the current practice. Further, the Minister of Health would no longer need to make a recommendation to the Governor in Council since the Lists of Permitted Food Additives would be directly incorporated by reference into the FDR on an ambulatory basis and be administratively maintained.

After the coming into force of these proposed Regulations, changes to the Lists of Permitted Food Additives would follow the process set out in the Health Canada Incorporation by Reference Policy. Stakeholders would be notified and provided the opportunity to comment on proposed revisions to these documents through Health Canada’s established notification process.

Consequential amendments — Food additives MAs

Given that the Lists of Permitted Food Additives would be incorporated by reference into the FDR on an ambulatory basis, Health Canada intends to repeal the following 15 MAs for food additives:

• 1. Marketing Authorization for Food Additives That May Be Used as Anticaking Agents;
• 2. Marketing Authorization for Food Additives That May Be Used as Bleaching, Maturing or Dough Conditioning Agents;
• 3. Marketing Authorization for Food Additives That May Be Used as Colouring Agents;
• 4. Marketing Authorization for Food Additives That May Be Used as Emulsifying, Gelling, Stabilizing or Thickening Agents;
• 5. Marketing Authorization for Food Additives That May Be Used as Food Enzymes;
• 6. Marketing Authorization for Food Additives That May Be Used as Firming Agents;
• 7. Marketing Authorization for Food Additives That May Be Used as Glazing or Polishing Agents;
• 8. Marketing Authorization for Food Additives with Other Accepted Uses (including the Schedule);
• 9. Marketing Authorization for Food Additives That May Be Used as Sweeteners;
• 10. Marketing Authorization for Food Additives That May Be Used as pH Adjusting Agents, Acid-Reacting Materials or Water Correcting Agents;
• 11. Marketing Authorization for Food Additives That May Be Used as Preservatives;
• 12. Marketing Authorization for Food Additives That May Be Used as Sequestering Agents;
• 13. Marketing Authorization for Food Additives That May Be Used as Starch-Modifying Agents;
• 14. Marketing Authorization for Food Additives That May Be Used as Yeast Foods; and
• 15. Marketing Authorization for Food Additives That May Be Used as Carrier or Extraction Solvents.

Prior to publication of the final Regulations in the Canada Gazette, Part II, a separate marketing authorization would be issued repealing the 15 food additive MAs. A notice of intent signalling the Minister of Health’s intent to make an MA to this effect would be published shortly after the prepublication of this regulatory proposal.

Consequential amendments — Cannabis Regulations

The Cannabis Regulations currently allow the holder of a licence for processing to use a food additive as an ingredient to produce edible cannabis that is a cannabis product (or contained in a cannabis accessory that is a cannabis product), subject to certain requirements set out in subsection 102(5). A holder of a licence for research that administers or distributes edible cannabis to human participants in the conduct of non-therapeutic research on cannabis is subject to similar conditions. The Cannabis Regulations currently refer to food that is the subject of an MA. Consequential amendments are being proposed to the Cannabis Regulations to align them with the proposed repeal of the 15 MAs and the proposed amendments to Part B of the FDR (including the proposed introduction of the new declaration of adulteration and exemption provisions and the direct incorporation by reference of the Lists of Permitted Food Additives into the FDR on an ambulatory basis).

The proposed amendments to subsection 102(5) of the Cannabis Regulations include removing all references to MAs and incorporating by reference the Lists of Permitted Food Additives and the conditions set out in those lists. The Lists of Permitted Food Additives would be defined under subsection 1(2) of the Cannabis Regulations as having the same meaning as in subsection B.01.001(1) of the FDR. The definition of “marketing authorization” under subsection 1(2) of the Cannabis Regulations would be repealed.

Furthermore, given the proposed introduction of the new declaration of adulteration and exemption provisions for food additives under Division 16 of the FDR, it is proposed that subsection 102.1(2) of the Cannabis Regulations be amended to indicate that edible cannabis would not have a poisonous or harmful substance for the purposes of paragraph 4(1)(a) of the FDA or is not adulterated for the purposes of paragraph 4(1)(d) of the FDA if a food additive was used as an ingredient to produce the edible cannabis.

Finally, the proposed amendments to subparagraphs 28.1(4)(c)(i) to (iv) of the Cannabis Regulations are intended to ensure that they are consistent with the changes made to subsection 102(5). Specifically, a holder of a licence for research that administers or distributes edible cannabis in the conduct of non-therapeutic research on cannabis would be allowed to use a food additive as an ingredient to produce edible cannabis if the revised conditions are met.

These proposed changes would not have an impact on the existing policy regarding the use of a food additive in edible cannabis that is a cannabis product or for use in the conduct of non-therapeutic research on cannabis.

Consequential amendments — Denatured and Specially Denatured Alcohol Regulations, Pest Control Products Fees and Charges Regulations and Pest Control Products Regulations

The proposed consequential amendments to the Denatured and Specially Denatured Alcohol Regulations would amend the characteristics of certain denaturants to refer to the specifications of the related food additives set out in the amended provisions in the FDR.

The proposed consequential amendments to the Pest Control Products Fees and Charges Regulations would amend certain provisions that relate to food additives and MAs to refer to the amended provisions in the FDR and to the Lists of Permitted Food Additives.

The proposed consequential amendments to the Pest Control Products Regulations would amend the reference to a preservative set out in column 1 of Part 2 – Class 2 Preservatives or in column 1 in Part 3 – Class 3 Preservatives of the List of Permitted Preservatives to reflect the proposed new structure of the Lists of Permitted Food Additives. In particular, paragraph 4(1)(g) would refer to a food additive set out in column 1 of the List of Permitted Preservatives.

5. Miscellaneous amendments

The proposed Regulations would amend a number of other provisions in Divisions 7, 9, 15, 25, 27 and 28, Part B, as well as provisions in Parts A and D of the FDR.

Divisions 7, 9 and 15, Part B — Contaminants

Two provisions in Divisions 7 and 9 that prohibit the sale of a dressing or certain fats and oils that contain more than 5% of the contaminant C₂₂ Monoenoic Fatty Acid, and one provision in Division 25 that prohibits the sale or advertisement for sale of an infant formula that contains more than one kilocalorie from C₂₂ Monoenoic Fatty Acid, would be repealed from the FDR, and the maximum levels would be moved to the List of Contaminants and Other Adulterating Substances in Foods, which is incorporated by reference under Division 15 of the FDR on an ambulatory basis. As a result of this change and the changes identified earlier for food compositional standards, Division 7 would be repealed entirely.

The existing definition of the “List of Contaminants and Other Adulterating Substances in Foods” in Division 1 would be slightly amended to align with other proposed defined terms of documents that are incorporated by reference on an ambulatory basis into the FDR and published by Health Canada. The French title of this list would be updated to “Liste des contaminants et autres substances adultérantes dans les aliments” throughout the FDR, where necessary.

Lastly, the current title of Division 15 (“Adulteration of Food”) of Part B would be updated to “Contaminants,” to distinguish the Division from adulteration provisions in other Divisions of Part B. As noted earlier, two new declaration of adulteration provisions are also being introduced for food additives in Division 16 and for microbiological criteria in Division 30.

Divisions 27 and 28, Part B

Targeted amendments would be made to Division 27, including the current title, to align the French term for “hermetically sealed container” (proposed as “récipient hermétiquement scellé”) throughout Part B of the FDR. The existing definition in Division 27 would be repealed and moved to Division 1. The French term for “microorganism” (“microorganisme”) would also be updated throughout Part B, including in Division 28, to remove the existing dash (“micro-organisme”) and align the wording with that in the new proposed Division 30. Similar changes to these French terms would be reflected in the Food Compositional Standards Document.

Part A

The proposed amendments would include minor changes to one provision in Part A of the FDR to update the language in section A.01.002 and align with the wording used in the enabling authority (the FDA).

Part D

A number of amendments to the table to section D.03.002 that permits certain foods to have added vitamins, mineral nutrients or amino acids are proposed to clarify which foods have a food compositional standard. This change would similarly reflect how other requirements for adding vitamins, mineral nutrients and amino acids to foods are currently embedded within a food compositional standard but are proposed to remain as prohibitions of sale in Part B of the FDR.

6. Coming into force and transitional provisions

The proposed Regulations would come into force on the day on which they are published in the Canada Gazette, Part II. While these regulations propose to correct the gin labelling prohibition in French to better reflect the intent of the provision and to align it with the wording of the prohibition in English, no transitional provision would be provided as the current prohibition is already understood to apply to all gins. The CFIA has not identified any products that would require a labelling change and will continue to consult further on this aspect prior to the final publication of these regulations in the Canada Gazette, Part II.

However, to take into account the proposed changes made by these regulations, amendments are proposed to existing transitional provisions in the Regulations Amending the Food and Drug Regulations (Nutrition Symbols, Other Labelling Provisions, Vitamin D and Hydrogenated Fats or Oils) [SOR/2022-168] so that they would continue to operate as intended. In particular, these changes would reflect the new provision numbers in the FDR or in the Food Compositional Standards Document, as the case may be, as a result of the proposed amendments made under this proposal.

Amendments are also proposed to the Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods) [SOR/2022-169] to reflect the new food additives framework, including the revised Lists of Permitted Food Additives. These regulations provided manufacturers a transitional period for products with expired Temporary Marketing Authorizations or for products that have received a written notification that they are authorized to be conditionally sold to come into compliance with the new supplemented foods framework. The proposed amendments would clarify the intent that transitioning products need to continue to meet the latest rules in the FDR, including but not limited to, food additives, microbiological criteria and contaminants, except for certain provisions (sections B.29.031, D.01.011, D.02.009 and D.03.002) until such time the manufacturer makes a labelling change to comply with the new supplemented foods framework in its entirety. In particular, this package would amend the transitional provisions to clarify that transitioning products can remain on the market if they continue to meet certain conditions and that they would not be considered supplemented foods or to be containing supplemental ingredients during such time. This means that these foods would not be required to comply with supplemented food and supplemental ingredient-specific requirements, such as those found in Division 29.

For greater certainty, no changes would be made to the end of the transition periods of either package (i.e. January 1, 2026).

Regulatory development

Consultation

Health Canada and the CFIA have conducted the following preliminary consultation activities to obtain early feedback from consumers and impacted stakeholders on the four policy elements of the proposal. The combined findings were taken into account in the development and refinement of the regulatory proposal in preparation for prepublication in the Canada Gazette, Part I. A cost-benefit analysis survey was not conducted.

On October 20, 2022, Health Canada and the CFIA held virtual French and English information sessions to provide stakeholders with an overview of the proposal described in this document and address any questions or concerns they may have. Approximately 300 representatives from the agri-food industry, academia, public health and patient groups as well as provincial and territorial governments attended these sessions. Overall, participants responded positively, and no concerns were raised that would impact the proposal.

1. Food compositional standards

Feedback on food compositional standards was captured throughout the three phases of the Food Labelling Modernization consultation (spanning from 2013 to 2017); this was originally a component of the Food Labelling Modernization initiative. The overall response from both consumers and industry stakeholders has indicated strong support to incorporate by reference the food compositional standards.

During Phase 1 of the Food Labelling Modernization consultation (2013 to 2014), industry and government identified that several standards are outdated or too prescriptive and pose barriers to trade, stifle innovation and limit consumer offerings. Phase 2 of the Food Labelling Modernization consultation included proposed options to modernize Canada’s food systems, including the compositional standards. Consultation feedback from both external and internal stakeholders showed strong support to modernize the standards and use new tools such as incorporation by reference to enable timely updates.

From 2016 to 2017, Phase 3 of the Food Labelling Modernization consultation sought feedback on key Food Labelling Modernization regulatory proposals developed as a result of feedback obtained during the Phase 2 consultation. This included incorporating by reference the food standards into the FDR and the SFCR and continuing to explore, in collaboration with other organizations, options to maintain and modernize these standards. There was broad stakeholder support to move the food compositional standards into an incorporated by reference document. Stakeholders agreed that current food compositional standards are outdated and expressed overall support to modernize them. Canada also provided notification of the draft Food Labelling Modernization initiative to the World Trade Organization in early 2017 during the third phase of Food Labelling Modernization engagement, which raised trading partners’ awareness of the plan for food compositional standards. The CFIA will be seeking feedback on a strategic approach to updating food compositional standards prior to the final publication of the proposed Regulations.

2. Microbiological criteria

Dating back to the 1990s, there have been a number of targeted consultations conducted with industry, academia and federal, provincial and territorial governments on the microbiological criteria and associated official methods of analysis set out in the FDR. These consultations focused on updating the microbiological criteria for foods set out in the Standards and Guidelines for Microbiological Safety of Food – An Interpretive Summary, but also considered the criteria prescribed in the FDR. Any future changes to the proposed Table of Microbiological Criteria will consider this past feedback, as well as any other input received through Health Canada’s administrative notification process.

3. Official methods

Health Canada participated in a multi-stakeholder workshop in November 2016 to discuss the issue of the protein quality method used in Canada and those used internationally. A paper from the workshop published in 2018 highlighted the issues identified and recommended that Health Canada permit the use of the internationally recognized PDCAAS method to determine the protein quality of certain foods, and that methods be incorporated by reference into the FDR to permit more timely updates for methods to keep pace with future scientific advances.

Health Canada has also engaged with one industry association on the limitations of the current FO-1 method and its impacts on the plant-based food sector’s ability to make protein-based claims for plant-based foods and for analyzing the protein quality of certain simulated meat and poultry products. A protein industry supercluster has also expressed their desire for Health Canada to adopt the PDCAAS method.

As part of the regulatory review pre-consultation in the Canada Gazette, Part I, led by the Treasury Board Secretariat in 2018, Health Canada again heard from three industry stakeholders on the need to update methods of analysis and to provide for more modern methods of analysis for protein quality. All stakeholders indicated that the incorporation by reference of a methods document would permit for more timely updates to keep pace with scientific advances, and two of the three stakeholders requested that Health Canada accept the PDCAAS method for measuring protein quality. Other than for protein quality, there have been no recent consultations with respect to other methods of analysis.

4. Food additives

Since 2012, Health Canada has made public its intent to repeal the redundant food additive tables in Division 16 of the FDR and to streamline the food additive regulations overall. No recent consultations on this particular topic have been undertaken.

With respect to the structure and titles of the Lists of Permitted Food Additives, on December 15, 2021, Health Canada published a notice entitled Health Canada’s Proposal to Modernize the Structure and Titles of the Lists of Permitted Food Additives (Ref. No. NOP/ADP-0038) to seek feedback from stakeholders on the proposed revisions to the structure of the Lists and the titles of certain Lists. Health Canada received comments from seven stakeholders, all from industry with the exception of a food inspector. Overall, they were supportive of Health Canada’s proposal to modernize the structure and titles of the Lists of Permitted Food Additives. The majority (six) requested that the searchability of the Lists be improved and three asked that the Lists include permitted synonyms for food additives. Health Canada responded that mechanisms to improve the searchability of the Lists are being pursued, and noted that the CFIA is responsible for administering non-health and non-safety related labelling matters and maintains the Permitted synonyms for food additives table. Health Canada indicated that requests to add synonyms for food additives may be addressed to the CFIA using the online form at Ask CFIA. In response to other issues raised by the stakeholders, Health Canada clarified the scope of the proposed List of Permitted Acidity Regulators and Acid-Reacting Materials, replied to questions about the columns in the Lists, and explained how additional feedback could be provided in the future.

Modern treaty obligations and Indigenous engagement and consultation

As required by the Cabinet Directive on the Federal Approach to Modern Treaty Implementation, an assessment of modern treaty implications was conducted on the proposal. The assessment did not identify any modern treaty implications or obligations.

Instrument choice

1. Food compositional standards

Both regulatory and non-regulatory options were considered.

Option 1: Status quo

The proposed regulatory amendments were developed based on consultations and identification of issues with the status quo. If the food compositional standards were to remain as they are in the FDR, the CFIA will continue to experience challenges in keeping the standards up to date, and the standards will increasingly be viewed as outdated and will continue to pose a barrier to addressing consumer demands, modern food innovation and trade. In addition, the status quo would not provide the means needed to update food compositional standards in an agile and efficient manner and would therefore not respond to industry concerns that these standards are outdated.

Option 2: Non-regulatory approach

Non-regulatory options would maintain prescriptive regulations that may hinder innovation and would not allow for timely updates and modifications to keep pace with and effectively respond to changes in technology, consumer demand or global trends.

Option 3: Regulatory approach (recommended option)

The regulatory option, which makes use of incorporation by reference, is recommended because it enables updating food compositional standards more quickly to keep pace with and respond to changes in consumer expectations, industry practices and global trends. This regulatory option has been supported over three phases of public consultation. The proposed amendments primarily offer an agile, responsive and efficient approach to maintaining food compositional standards for the purpose of consumer protection and market fairness.

2. Microbiological criteria and official methods of analysis

Both regulatory and non-regulatory options were considered.

Option 1: Status quo

The proposed regulatory amendments were developed in response to long-standing issues with the limitations and lack of flexibility of the current regulatory frameworks for microbiological criteria and methods of analysis. Maintaining the status quo would not be a viable option and would not address the stated objectives of this proposal.

Option 2: Non-regulatory approach

Managing microbiological criteria and methods of analysis through non-regulatory approaches (i.e. relying on microbiological guidelines and policies in place of prescribed regulations) was considered, as doing so would provide Health Canada with the greatest degree of flexibility possible to make revisions in response to new science or emerging food safety risks. However, despite these administrative efficiencies, requirements set out in non-regulatory guidelines and policies do not have the force of law and cannot place obligations on a regulated party, which presents potential vulnerabilities from a compliance and enforcement perspective. In light of this reality and considering that the requirements in question concern critical food safety and quality measures, pursuing a non-regulatory approach was not deemed appropriate and in the best interest of Canadians.

Option 3: Regulatory approach (recommended option)

Proceeding with the proposed incorporation by reference of the current regulatory microbiological criteria and official methods of analysis is the recommended option, as it will strengthen regulatory responsiveness by enabling Health Canada to administratively revise critical food safety and quality measures, while also ensuring these requirements retain the force of law and are enforceable by the CFIA.

Similar regulatory structures are already in place for food additives, veterinary drug residues, and contaminants and other adulterating substances in foods, and have proven successful in helping to ensure regulations keep pace with evolving science.

3. Food additives

No alternatives to the food additives proposal were explored.

The aim of the proposed amendments is to continue the modernization of the food additives regulatory framework that was initiated in 2012, by removing duplications, discrepancies in the references to the tables to section B.16.100, and redundant entries from Part B of the FDR. Directly incorporating by reference the Lists of Permitted Food Additives into the FDR, consolidating food additive specific rules and creating new declaration of adulteration and exemption provisions in Division 16 would bring greater coherence to the framework, which would facilitate compliance and enforcement.

Regulatory analysis

Benefits and costs

The cost-benefit analysis (CBA) seeks to explain the qualitative and quantitative costs and benefits of the proposed amendments to the FDR. The information used to complete the analysis was collected through stakeholder consultations and internal data provided by Health Canada and the CFIA.

Benefits

Benefit to industry

The proposed amendments to the FDR would help create a more agile, transparent and responsive set of regulations, benefiting industry in particular.

They would enable administrative revisions to microbiological safety criteria and official methods of analysis to ensure these requirements remain up to date with the latest science and innovation.

In addition, by permitting the use of more cost-effective and adaptive methods to demonstrate protein quality, such as the PDCAAS method, costs to industry would be reduced. The use of the PDCAAS method is currently being permitted through policy but would be incorporated by reference into the FDR, which would provide for greater certainty for both industry and the Government of Canada. The existing PER (FO-1) method requires that a new animal bioassay be performed to determine the protein rating for new mixed protein source foods. Protein rating for foods with more than one protein source, such as the many new plant protein products, can simply be calculated using PDCAAS when the digestibility and amino acid profile of the proteins are known.

The proposed amendments would also facilitate the modernization of all food standards (i.e. those incorporated by reference under the SFCR, and those incorporated by reference under the FDR). It would also help enable administrative updates to food compositional standards to harmonize them more closely with those of trading partners, enable product innovation, and facilitate the interprovincial trade and importation for sale of foods.

The proposed revisions to the food additives framework would help reduce a burden on industry by reducing the time and effort required by staff to search for the requirements that apply to their individual circumstance. Eliminating discrepancies between sources of information (e.g. the food additives tables to section B.16.100 and the existing Lists of Permitted Food Additives), consolidating, restructuring and/or simplifying the rules pertaining to these substances would simplify industry’s review of the regulatory requirements.

Benefit to the Government

These proposed amendments to the FDR would enable administrative updates to food compositional standards, microbiological criteria, and methods of analysis in response to new science and technology, emerging risks to health, current market practices and/or address changes in consumer demand. Amending the FDR would also help to harmonize more closely with international trading partners (where appropriate) and facilitate the interprovincial trade and importation for sale of food.

Costs

Costs to industry

There are no new anticipated costs for industry, as these proposed amendments are assumed not to introduce new regulatory requirements. Current regulatory requirements and their specifics (e.g. levels, foods, methods of analysis, compositional standards) would be moved into documents incorporated by reference, where relevant.

Costs to Government

There would be new costs for the Government of Canada, including both Health Canada and the CFIA; however, they are not expected to be significant.

These proposed regulatory amendments are estimated to result in a one-time cost to enhance both Health Canada’s and the CFIA’s web pages to include a number of documents that would be incorporated by reference into the existing FDR, following the final publication of the proposed amendments in the Canada Gazette, Part II.

Since 2012, Health Canada and the CFIA have incorporated by reference into regulations a number of technical documents covering topics including food additives, contaminants and other adulterating substances in foods, and veterinary drug residues. The increasing number of these referenced documents poses a challenge for some stakeholders to find the information they need to keep their food products compliant with regulatory requirements.

To help simplify stakeholder access to this information, Health Canada and the CFIA have established consolidated online inventories of their respective documents that have been incorporated by reference.

Health Canada’s inventory would need to be updated to include the new documents involved in this regulatory proposal, and to make appropriate linkages with the CFIA’s online repository, which would also need to be updated. This would be considered a one-time cost to Health Canada and the CFIA. However, the contents of the documents incorporated by reference would require some level of maintenance and additional resource time on an ongoing basis when updates to such documents are deemed necessary. Health Canada and the CFIA already have established administrative processes in place to conduct such activities and to modify their respective documents.

There would be no increased costs to CFIA for compliance and enforcement, as no new regulatory requirements would be imposed.

Small business lens

The Policy on Limiting Regulatory Burden on Business defines a small business as any business, including its affiliates, that has fewer than 100 employees or less than $5 million in annual gross revenues. No new regulatory requirements are being created by the proposed amendments. Small businesses have the flexibility to use the new proposed method for measuring protein quality, which is less costly, or to continue using the existing method. As mentioned earlier, the interim policy that has been published by Health Canada and the CFIA already recognizes the use of the PDCAAS method by industry. All other existing regulatory requirements remain unchanged.

One-for-one rule

The one-for-one rule does not apply, since the regulatory changes only amend existing regulatory titles and do not impose any incremental change in the administrative burden on business.

Regulatory cooperation and alignment

Codex Alimentarius

Internationally, the CFIA leads the Government of Canada’s implementation of the World Trade Organization’s Agreement on the Application of Sanitary and Phytosanitary Measures, and plays a leadership role in three official international standard-setting bodies to promote science-based international standards, i.e. the International Plant Protection Convention, the World Organisation for Animal Health and the Codex Alimentarius Commission (Codex).

In the case of food, Codex standards provide the foundation for robust domestic regulatory systems and contribute to a predictable trade environment, reducing business risks and facilitating market access. The mandate of Codex is to develop international food standards, guidelines, and codes of practice to help protect the health of consumers and to help ensure fair practices in the food trade. These include commodity standards that describe standards of identity for individual commodities, in line with current scientific knowledge and industry practices. Moving the FDR’s food compositional standards into a document that would be incorporated by reference would allow for more timely alignment of the food compositional standards with international standards as set out by Codex or other jurisdictions.

The existing regulatory process for amending the food compositional standards in the FDR has not kept pace with international standards or global trends. For example, the spices compositional requirements, currently captured in Division 7, Part B, haven’t been updated in decades and refer to outdated quality compositional parameters, common names and plant botanical names. The development of international standards on spices and culinary herbs are underway via the Codex Committee on Spices and Culinary Herbs. With the incorporation by reference of the food compositional standards for spices into the Food Compositional Standards Document, the CFIA would be better able to align Canada’s standards with those adopted by Codex.

Interprovincial trade

The components of the food compositional standards under the FDR that are not related to health or to safety apply to imported food products and food products traded interprovincially. They do not apply to food products traded intraprovincially. While some provinces refer to the federal food compositional standards in provincial legislation, certain provinces have established more modern food compositional standards that are applicable to foods produced and sold intraprovincially. Incorporating by reference the food compositional standards may serve to facilitate the alignment of federal food standards with provincial interests and thereby address interprovincial barriers to trade. For clarity, the health and safety-related components of the food compositional standards that remain under the FDR apply to foods sold at all levels of trade, including food products traded intraprovincially.

Alcohol-related trade agreements, geographical indications and distinctive products

Canada is a signatory to two wine and spirit trade agreements that include provisions on oenological practices:

• Agreement on Mutual Acceptance of Oenological Practices (PDF), signed on December 18, 2001, by parties of the World Wine Trade Group;^{footnote 1} and
• Agreement Between Canada and the European Community on Trade in Wine and Spirit Drinks, signed on September 16, 2003. This agreement was later incorporated into the Comprehensive Economic and Trade Agreement when it was signed on October 30, 2016.

The Agreements contain provisions for mutual recognition of oenological (wine making) practices and product specifications, a requirement for parties to notify of any changes or updates. The Agreements also require the parties to accept/adopt each other’s laws, regulations and requirements, even if those practices, which include permitted food additives in wine, do not necessarily align. New oenological practices of each party in the Comprehensive Economic and Trade Agreement are listed in an annex, and for the World Wine Trade Group Agreement, in an online database.

Health Canada works closely with Global Affairs Canada and other government departments on meeting the obligations under these Agreements. The Department continues to use its existing regulatory framework for food additives, which provides for the evaluation of new food additives upon receipt of a pre-market submission filed with Health Canada in accordance with the FDR. Since this proposal does not change any existing provisions for uses of food additives in wine or spirit beverages, and the Department would retain its existing practice of notifying domestic and international stakeholders of any changes related to food additives, there should be no impacts or concerns with respect to these existing wine and spirits trade agreements.

For distinctive product provisions currently captured in the FDR, the CFIA consulted with Agriculture and Agri-Food Canada and Global Affairs Canada to determine whether these should be repealed, left as is in the FDR or included in the Food Compositional Standards Document. As a result of the consultation, it was determined that distinctive product provisions, which are linked to various international trade agreements, should be repealed from the FDR given that they are not true compositional standards and that the wording of these provisions is almost identical to the prohibitions in the Spirit Drinks Trade Act. The Spirit Drinks Trade Act implements international trade commitments by Canada regarding spirit drinks of foreign countries and prohibits the use of the name of spirit drinks when not used exclusively in relation to their country of origin. As previously mentioned, Agriculture and Agri-Food Canada administers the Spirit Drinks Trade Act and has the authority to implement requirements regarding the use of the names of spirit drinks from foreign countries.

This incorporation-by-reference proposal for the food compositional standards would also create a framework that permits the CFIA to address specific trading partner concerns in the future related to mentions of geographical indications that may have been in the FDR food compositional standards for decades, but that have since been registered as protected geographical indications in Canada (e.g. the FDR reference to “champagne cider”).

Microbiological criteria and associated methods of analysis

International regulatory cooperation plays a key role in the development of microbiological criteria. For example, the Department engages with other jurisdictions and organizations, such as the International Commission on Microbiological Specifications for Foods, on the development of new and revised microbiological criteria. Health Canada adheres to internationally recognized principles, such as those of Codex, when developing its criteria.

Chemical, physical and nutritional methods of analysis

International regulatory cooperation forms a key component of Health Canada’s plans to implement modernized regulatory approaches. For example, the official methods related to food packaging materials are in alignment with those of other international jurisdictions in that they indicate that chemicals must not migrate from the package into the food in detectable quantities, or can only do so in quantities as low as reasonably achievable. Future work will look at internationally developed criteria, such as the Codex Alimentarius’ Recommended Methods of Analysis and Sampling (CXG 234-1999), to determine if they are appropriate for the Canadian context and could therefore be included in the proposed Table of Chemical, Physical and Nutritional Characteristics of Food.

Protein quality

Canada is the only jurisdiction that continues to rely solely on the use of PER for enforcing regulations related to the protein quality of foods. A scan of international protein quality regulations shows that other jurisdictions have moved towards the use of PDCAAS. In the United States, while PER continues to be used to evaluate the protein quality of certain foods, PDCAAS is used to determine a corrected amount of protein for protein declarations in the Nutrition Facts label. In the European Union, Australia and New Zealand, the protein quality for certain foods is measured using PDCAAS or comparing the protein to an amino acid profile; however, protein quality determination is not required for protein declarations or protein claims. PDCAAS has been globally recognized as an acceptable method for several decades, being recommended by the Food and Agriculture Organization of the United Nations and the World Health Organization since 1991, and is used extensively by researchers. Its inclusion within this proposal would align with its use in other jurisdictions. The proposed amendments to incorporate by reference the methods from a static to an ambulatory basis into the FDR would also allow for Health Canada to more easily adopt alternate methods for determining protein quality in the future, such as the Digestible Indispensable Amino Acid Score and in vitro methods for measuring digestibility, if they are validated and more widely applied in routine regulatory use.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required, because these proposed amendments have no environmental impact.

Gender-based analysis plus

No gender-based analysis plus impacts have been identified for these amendments, as they do not have a direct focus on men, women and/or diverse individuals. Therefore, there are no sex, gender and/or diversity implications to these proposed amendments to the FDR.

Implementation, compliance and enforcement, and service standards

Implementation

The proposed Regulations would come into force on the day on which they are published in the Canada Gazette, Part II. Information on the implementation of this regulatory proposal would be posted on the Government of Canada website. To support the updating of food compositional standards through incorporation by reference, the CFIA is developing a strategic approach. This strategic approach will be used to develop principles and processes to manage the anticipated requests for changes to compositional standards, noting that the actual volume of requests is unknown at this time and could be significant. Stakeholders would be able to access information incorporated by reference into the FDR more easily through two single-window online inventories of such documents that would be managed respectively by Health Canada and the CFIA.

Compliance and enforcement, and service standards

The only service standard affected by this proposal is the one currently prescribed in section B.16.003 pertaining to pre-market submissions for food additives. Health Canada would continue to operate under other service standards for these submissions, currently set out in the following departmental guidance documents: The Food Directorate’s Pre-Market Submission Management Process for Food Additives, Infant Formulas and Novel Foods (September 2012) and the Priority Scheduling and Expedited Handling of Submissions that have the Capacity to Enhance Food Safety (January 2011).

In regard to compliance verification, the CFIA uses a range of tools, including preventive control inspections, sample collection, and commodity inspections (such as label reviews). When non-compliance is determined, the CFIA normally takes enforcement actions commensurate with the seriousness of the non-compliance, following a standard regulatory response process and associated guidance.

Contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite P2108
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address Locator: 3000A
Email: lrm.consultations-mlr@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council proposes to make the annexed Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food, under

• (a) subsection 30(1)^{footnote a} of the Food and Drugs Act ^{footnote b};
• (b) paragraph 304(1)(o) of the Excise Act, 2001 ^{footnote c};
• (c) section 67 of the Pest Control Products Act ^{footnote d};
• (d) section 51^{footnote e} of the Safe Food for Canadians Act ^{footnote f}; and
• (e) subsection 139(1) of the Cannabis Act ^{footnote g}.

Interested persons may make representations concerning the proposed Regulations within 90 days after the date of publication of this notice. They are strongly encouraged to use the online commenting feature that is available on the Canada Gazette website but if they use email, mail or any other means, the representations should cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Bruno Rodrigue, Executive Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health, postal locator 3000A, 11 Holland Avenue, Suite P2108, Ottawa, Ontario K1A 0K9 (email: lrm.consultations-mlr@hc-sc.gc.ca).

Ottawa, October 27, 2023

Wendy Nixon
Assistant Clerk of the Privy Council

Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food

Food and Drugs Act

Food and Drug Regulations

1 Section A.01.002 of the Food and Drug Regulations ^{footnote 2} is replaced by the following:

A.01.002 These Regulations, where applicable, prescribe the standards of composition, strength, potency, purity, quality or other property of the article of food or drug to which the standards refer.

2 (1) The definitions gelling agent, marketing authorization, parts per million or p.p.m. and unstandardized food in subsection B.01.001(1) of the Regulations are repealed.

(2) The definition Liste de contaminants et d’autres substances adultérantes dans les aliments in subsection B.01.001(1) of the French version of the Regulations is repealed.

(3) The definitions common name, flavouring preparation, food colour, sweetener and sweetening agent in subsection B.01.001(1) of the Regulations are replaced by the following:

common name,

in respect of a food, means

• (a) the name of the food printed in boldface type, but not in italics, in a section of the Food Compositional Standards Document;
• (b) the name of the food printed in boldface type, but not in italics, in a section of the Standards of Identity Document, as defined in section 1 of the Safe Food for Canadians Regulations; or
• (c) in any other case, the name by which it is generally known or a name that is not generic and that describes the food; (nom usuel)

flavouring preparation

includes any food for which a standard is set out in Volume 9 of the Food Compositional Standards Document; (préparation aromatisante)

food colour

means any food additive used to add or restore colour to a food; (colorant alimentaire)

sweetener

means any food additive used to impart a sweet taste to a food; (édulcorant)

sweetening agent

includes any food for which a standard is set out in Volume 15 of the Food Compositional Standards Document, but does not include a sweetener; (agent édulcorant)

(4) The definition List of Contaminants and Other Adulterating Substances in Foods in subsection B.01.001(1) of the English version of the Regulations is replaced by the following:

List of Contaminants and Other Adulterating Substances in Foods

means the List of Contaminants and Other Adulterating Substances in Foods, published by the Government of Canada on its website, as amended from time to time; (Liste des contaminants et autres substances adultérantes dans les aliments)

(5) Paragraph (a) of the definition agricultural chemical in subsection B.01.001(1) of the Regulations is replaced by the following:

• (a) food additive that is set out in, and used in accordance with, the Lists of Permitted Food Additives,

(6) Paragraph (b) of the definition food additive in subsection B.01.001(1) of the Regulations is replaced by the following:

• (b) vitamins, mineral nutrients and amino acids, other than those substances set out in the Lists of Permitted Food Additives;

(7) Paragraphs (c) and (d) of the definition food additive in subsection B.01.001(1) of the Regulations are replaced by the following:

• (c) spices, seasonings and flavouring preparations;
• (d) agricultural chemicals, other than those substances set out in the Lists of Permitted Food Additives;

(8) Paragraph (b) of the definition main dish in subsection B.01.001(1) of the Regulations is replaced by the following:

• (b) meat products, poultry products, marine and fresh water animal products, and their alternatives such as eggs, tofu, legumes, nuts, seeds, nut or seed butters and spreads made from legumes;

(9) The definition supplemented food in subsection B.01.001(1) of the Regulations is amended by adding the following after paragraph (a):

• (a.1) infant food;

(10) Subparagraph (b)(i) of the definition supplemented food in subsection B.01.001(1) of the Regulations is repealed.

(11) Paragraph (c) of the definition plat principal in subsection B.01.001(1) of the French version of the Regulations is replaced by the following:

• c) les fruits et les légumes, autres que les marinades, les relishs, les olives et les garnitures;

(12) Subsection B.01.001(1) of the Regulations is amended by adding the following in alphabetical order:

Food Compositional Standards Document

means the document entitled Canadian Food Compositional Standards, prepared by the Canadian Food Inspection Agency and published on its website, as amended from time to time; (Document sur les normes de composition des aliments)

hermetically sealed container

means a container designed and intended to be secure against the entry of microorganisms, including spores; (récipient hermétiquement scellé)

infant

means an individual who is under the age of one year; (bébé)

infant food

means a food that is labelled or advertised for consumption by infants; (aliment pour bébés)

Lists of Permitted Food Additives

means one or more of the following lists that are published by the Government of Canada on its website, as they are amended from time to time:

• (a) the List of Permitted Acidity Regulators and Acid-Reacting Materials;
• (b) the List of Permitted Anticaking Agents;
• (c) the List of Permitted Food Colours;
• (d) the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents;
• (e) the List of Permitted Firming Agents;
• (f) the List of Permitted Flour Treatment Agents;
• (g) the List of Permitted Food Additives with Other Purposes of Use;
• (h) the List of Permitted Food Enzymes;
• (i) the List of Permitted Glazing Agents;
• (j) the List of Permitted Preservatives;
• (k) the List of Permitted Sequestering Agents;
• (l) the List of Permitted Solvents;
• (m) the List of Permitted Starch-Modifying Agents;
• (n) the List of Permitted Sweeteners;
• (o) the List of Permitted Yeast Foods; (Listes des additifs alimentaires autorisés)

parts per million, p.p.m. or ppm

means parts per million by weight unless otherwise stated; (parties par million, p.p.m. ou ppm)

solid cut meat

means

• (a) a whole cut of meat; or
• (b) a product consisting of pieces of meat of which at least 80 per cent of the pieces weigh at least 25 g each; (viande coupée solide)

solid cut poultry meat

means

• (a) a whole cut of poultry meat; or
• (b) a product consisting of pieces of poultry meat of which at least 80 per cent of the pieces weigh at least 25 g each; (viande de volaille coupée solide)

Table of Chemical, Physical and Nutritional Characteristics of Food

means the Table of Chemical, Physical and Nutritional Characteristics of Food, published by the Government of Canada on its website, as amended from time to time; (Tableau des caractéristiques chimiques, physiques et nutritionnelles des aliments)

unstandardized

in relation to a food, means that a standard is not set out in the Food Compositional Standards Document for that food; (non normalisé)

(13) Subsection B.01.001(1) of the French version of the Regulations is amended by adding the following in alphabetical order:

Liste des contaminants et autres substances adultérantes dans les aliments

Liste des contaminants et autres substances adultérantes dans les aliments, publiée par le gouvernement du Canada sur son site Web, avec ses modifications successives; (List of Contaminants and Other Adulterating Substances in Foods)

(14) Section B.01.001 of the Regulations is amended by adding the following after subsection (1):

(1.1) A reference in these Regulations to any of the lists referred to in the definition Lists of Permitted Food Additives is a reference to the list as published by the Government of Canada on its website, as amended from time to time.

(15) Section B.01.001 of the Regulations is amended by adding the following after subsection (4):

(5) For the purposes of the definition solid cut meat in subsection (1), meat has the same meaning as in section B.14.001.

(6) For the purposes of the definition solid cut poultry meat in subsection (1), poultry meat has the same meaning as in section B.22.001.

3 The Regulations are amended by adding the following after section B.01.001.1:

B.01.001.2 For the purposes of interpreting any food-related document published by the Government of Canada on its website and incorporated by reference into parts A, B or D of these Regulations, words and expressions that are used but not defined in that document have the same meaning as in those parts of these Regulations.

B.01.001.3 For the purposes of interpreting the Lists of Permitted Food Additives, a reference in those lists to a food that is subject to a standard set out in the Food Compositional Standards Document means that food for which the standard is set out in that document.

4 Section B.01.002 of the Regulations is replaced by the following:

B.01.002 The Food Compositional Standards Document sets out the standards of composition, strength, potency, purity, quality or other property of the foods that are referred to in that document.

5 Paragraphs B.01.008(2)(f) and (g) of the Regulations are replaced by the following:

• (f) prepackaged products that comply with the standards set out in sections 2.1.1 to 2.1.4, 2.2.1, 2.3.1, 2.3.2, 2.4.1 to 2.4.7, 2.5.1, 2.6.1, 2.7.1 to 2.7.8, 2.8.1, 2.8.2 and 2.9.1 of Volume 2 of the Food Compositional Standards Document;
• (f.1) Bourbon whisky, Scotch whisky, Irish whisky, Armagnac brandy and Cognac brandy; or
• (g) prepackaged products that comply with the standards set out in sections 16.1.1 to 16.1.5 of Volume 16 of the Food Compositional Standards Document.

6 The portion of subsection B.01.008.1(1) of the Regulations before paragraph (a) is replaced by the following:

B.01.008.1 (1) Information appearing on the label of a prepackaged product according to sections B.01.008.2 to B.01.010.4, B.16.015 and B.29.020 must be shown

7 Subparagraph B.01.008.2(2)(b)(iii) of the Regulations is replaced by the following:

• (iii) any statement referred to in subsection B.16.015(1),

8 (1) Item 10 of the table to subsection B.01.009(1) of the Regulations is replaced by the following:

Item	Ingredient
10	breads that comply with the standards set out in sections 12.2.1 to 12.2.6 of Volume 12 of the Food Compositional Standards Document

(2) Item 16 of the table to subsection B.01.009(1) of the Regulations is replaced by the following:

Item	Ingredient
16	milks that comply with the standards set out in sections 7.1.1 to 7.1.20 of Volume 7 of the Food Compositional Standards Document

(3) Item 18 of the table to subsection B.01.009(1) of the Regulations is replaced by the following:

Item	Ingredient
18	sweetening agents that comply with the standards set out in sections 15.1.1 to 15.1.14 of Volume 15 of the Food Compositional Standards Document

(4) Items 21 to 24 of the table to subsection B.01.009(1) of the Regulations are replaced by the following:

Item	Ingredient
21	vinegars that comply with the standards set out in sections 16.1.1 to 16.1.5 of Volume 16 of the Food Compositional Standards Document
22	alcoholic beverages that comply with the standards set out in sections 2.1.1 to 2.1.4, 2.2.1, 2.3.1, 2.3.2, 2.4.1 to 2.4.7, 2.5.1, 2.6.1, 2.7.1 to 2.7.8, 2.8.1, 2.8.2 and 2.9.1 of Volume 2 of the Food Compositional Standards Document, Bourbon whisky, Scotch whisky, Irish whisky, Armagnac brandy and Cognac brandy
23	cheeses that comply with the standards set out in Division 7.4 of Volume 7 of the Food Compositional Standards Document, if the total amount of those cheeses is less than 10 per cent of the prepackaged product
24	jams, marmalades and jellies that comply with the standards set out in sections 10.4.1 to 10.4.10 of Volume 10 of the Food Compositional Standards Document, if the total amount of those ingredients is less than 5 per cent of the prepackaged product

(5) Item 26 of the table to subsection B.01.009(1) of the Regulations is replaced by the following:

Item	Ingredient
26	vegetable or animal fats or oils that comply with the standards set out in sections 8.1.1 to 8.1.9, 8.2.1 to 8.2.4 and 8.3.1 to 8.3.3 of Volume 8 of the Food Compositional Standards Document, and modified, interesterified or fully hydrogenated vegetable or animal fats or oils, if the total amount of those fats and oils is less than 15 per cent of the prepackaged product

9 (1) Subparagraph B.01.010.3(1)(a)(iv) of the Regulations is replaced by the following:

• (iv) if the statement is preceded by a statement referred to in subsection B.16.015(1) and begins on the line on which that statement ends, is shown in a type that is of a height that is at least 0.2 mm greater than the height of the type used in that statement;

(2) Paragraph B.01.010.3(1)(a.1) of the Regulations is replaced by the following:

• (a.1) appear, in respect of each linguistic version, immediately after any statement referred to in subsection B.16.015(1) appearing in the same language or, if there is no such statement, immediately after the list of ingredients appearing in the same language and, in either case, without any intervening printed, written or graphic material;

10 (1) Subparagraph B.01.010.4(1)(a)(ii) of the Regulations is replaced by the following:

• (ii) any statement referred to in subsection B.16.015(1), if no food allergen source, gluten source and added sulphites statement appears on the label, or

(2) Paragraph B.01.010.4(1)(g) of the Regulations is replaced by the following:

• (g) if the declaration is preceded by a statement referred to in subsection B.16.015(1) and begins on the line on which the statement ends, the title of the declaration — or the declaration itself, if no title appears — must be shown in a type that is of a height that is at least 0.2 mm greater than the height of the type used in the statement.

11 Subsection B.01.013(2) of the Regulations is replaced by the following:

(2) Despite subsection (1), the label of, or an advertisement for, a food may include a statement that the food “complies with the standard for (naming the common name of the food in respect of which the claim is made) in the Food and Drug Regulations” if the food complies with the standard prescribed by these Regulations for that food and the manufacturer of the food has substantiated, by means of the results of tests carried out before the statement is made or by other evidence that exists before the statement is made, that the food complies with the standard.

12 Sections B.01.014 to B.01.023 of the Regulations are repealed.

13 Sections B.01.042 to B.01.045 of the Regulations are replaced by the following:

B.01.042 If a standard for a food is set out in the Food Compositional Standards Document:

• (a) the food must contain only the ingredients set out in the standard for the food;
• (b) the food must contain each ingredient in a quantity within any limits set out in the standard for that ingredient;
• (c) the food must be labelled and advertised in accordance with any requirements set out in the standard; and
• (d) the food must comply with any other requirements set out in the standard in relation to the composition, strength, potency, purity, quality or other property of the food.

B.01.043 Despite paragraph B.01.042(a), in the case of a substance — other than a supplemental ingredient — required or permitted by a provision of these Regulations in a food for which a standard is set out in the Food Compositional Standards Document, that food must contain the required substance and may contain the permitted substance.

14 Section B.01.070 of the Regulations is repealed.

15 Section B.01.091 of the French version of the Regulations is replaced by the following:

B.01.091 L’étiquette de toute viande coupée solide ou de toute viande de volaille coupée solide à laquelle ont été ajoutés des sels de phosphate ou de l’eau, qui est non saumurée et qui est préemballée chez le détaillant, indique les ingrédients de cet aliment conformément aux paragraphes B.01.008.2(1) à (5) et (7).

16 Paragraph B.01.305(3)(g) of the Regulations is replaced by the following:

• (g) any statement referred to in subsection B.16.015(1);

17 (1) Paragraph B.01.350(5)(i) of the Regulations is replaced by the following:

• (i) fats and oils, including fish and other marine fats and oils, butter, ghee and margarine and other similar substitutes for butter; or

(2) Paragraph B.01.350(6)(c) of the French version of the Regulations is replaced by the following:

• c) les œufs entiers, notamment les œufs liquides, congelés ou desséchés ou le mélange d’œufs entiers;

(3) Paragraph B.01.350(6)(f) of the Regulations is replaced by the following:

• (f) marine and fresh water animal products in which less than 30% of the total fat content consists of saturated fat; or

(4) Paragraph B.01.350(7)(c) of the French version of the Regulations is replaced by the following:

• c) les œufs entiers, notamment les œufs liquides, congelés ou desséchés ou le mélange d’œufs entiers;

(5) Paragraph B.01.350(7)(f) of the Regulations is replaced by the following:

• (f) marine and fresh water animal products in which less than 30% of the total fat content consists of saturated fat.

(6) Subparagraph B.01.350(9)(a)(v) of the Regulations is replaced by the following:

• (v) marine and fresh water animal products in which less than 30% of the total fat content consists of saturated fat; and

18 Subparagraph B.01.467(2.1)(b)(iv) of the Regulations is replaced by the following:

• (iv) any statement referred to in subsection B.16.015(1); and

19 Paragraph B.01.502(2)(c) of the Regulations is replaced by the following:

• (c) a representation provided for by column 1 of Table 2 to Volume 7 of the Standards of Identity Document, as defined in section 1 of the Safe Food for Canadians Regulations;

20 Paragraph B.01.509(1)(b) of the Regulations is replaced by the following:

• (b) the food does not contain a sweetener.

21 (1) The portion of paragraph 4(a) of the table following section B.01.603 of the Regulations before subparagraph (i) in column 2 is replaced by the following:

Item	Column 2 Conditions — Food
4	(a) is one of the following foods and does not contain ingredients other than food additives that are set out in column 1 of the Lists of Permitted Food Additives, sweetening agents, salt, herbs, spices, seasonings and water:

(2) The portion of paragraph 4.1(a) of the table following section B.01.603 of the Regulations before subparagraph (i) in column 2 is replaced by the following:

Item	Column 2 Conditions — Food
4.1	(a) is one of the following foods and does not contain ingredients other than food additives that are set out in column 1 of the Lists of Permitted Food Additives, salt, herbs, spices, seasonings and water:

22 Section B.02.001 of the Regulations is repealed.

23 The definitions absolute alcohol, grain spirit, malt spirit, molasses spirit and sweetening agent in section B.02.002 of the Regulations are repealed.

24 Sections B.02.010 to B.02.016 of the Regulations are repealed.

25 (1) The portion of section B.02.017 of the Regulations before paragraph (a) is replaced by the following:

B.02.017 No person shall blend or modify Scotch whisky that is imported in bulk for the purpose of bottling and sale in Canada as Scotch whisky except by

(2) Paragraphs B.02.017(a) to (c) of the French version of the Regulations are replaced by the following:

• a) par mélange avec d’autres whiskys écossais;
• b) par addition d’eau distillée ou autrement purifiée en vue de porter le whisky au degré alcoolique requis;
• c) par addition de caramel.

26 Section B.02.018 of the Regulations is repealed.

27 (1) The portion of section B.02.019 of the Regulations before paragraph (a) is replaced by the following:

B.02.019 No person shall blend or modify Irish whisky that is imported in bulk for the purpose of bottling and sale in Canada as Irish whisky except by

(2) Paragraphs B.02.019(a) to (c) of the French version of the Regulations are replaced by the following:

• a) par mélange avec d’autres whiskys irlandais;
• b) par addition d’eau distillée ou autrement purifiée en vue de porter le whisky au degré alcoolique requis;
• c) par addition de caramel.

28 Subsection B.02.020(1) of the Regulations is repealed.

29 Sections B.02.021 to B.02.022.1 of the Regulations are replaced by the following:

B.02.022 No person shall modify Bourbon whisky that is imported for the purpose of bottling and sale in Canada as Bourbon whisky except by the addition of distilled or otherwise purified water to adjust the Bourbon whisky to a required strength.

B.02.022.1 No person shall modify Tennessee whisky that is imported for the purpose of bottling and sale in Canada as Tennessee whisky except by the addition of distilled or otherwise purified water to adjust the Tennessee whisky to a required strength.

30 Subsection B.02.023(1) of the Regulations is replaced by the following:

B.02.023 (1) No person shall sell whisky for consumption in Canada, other than Bourbon whisky or Tennessee whisky, unless it has been aged for at least three years in small wood.

31 Section B.02.030 of the Regulations is repealed.

32 Subsection B.02.031(1) of the English version of the Regulations is replaced by the following:

B.02.031 (1) No person shall sell rum for consumption in Canada unless it has been aged for at least one year in small wood.

33 Sections B.02.040 and B.02.041 of the Regulations are repealed.

34 Section B.02.043 of the French version of the Regulations is replaced by the following:

B.02.043 Est interdite toute déclaration sur l’âge du gin, mais dans le cas du gin qui a été conservé dans des récipients appropriés, l’étiquette peut porter une déclaration en ce sens.

35 The heading before section B.02.050 of the French version of the Regulations is replaced by the following:

Eau-de-vie de vin (brandy)

36 Sections B.02.050 to B.02.058 of the Regulations are repealed.

37 The portion of section B.02.059 of the Regulations before paragraph (a) is replaced by the following:

B.02.059 No person shall blend or modify brandy that is imported in bulk for the purpose of bottling and sale in Canada as imported brandy, except by

38 (1) Subsection B.02.061(1) of the English version of the Regulations is replaced by the following:

B.02.061 (1) No person shall sell brandy unless it has been aged for at least one year in wooden containers or at least six months in small wood.

(2) Subsection B.02.061(3) of the Regulations is replaced by the following:

(3) Subsections (1) and (2) do not apply in respect of Armagnac brandy, Cognac brandy or any other brandy that complies with the standards set out in sections 2.4.2 to 2.4.7 of Volume 2 of the Food Compositional Standards Document.

39 The heading before section B.02.070 and sections B.02.070 and B.02.080 of the Regulations are repealed.

40 Section B.02.090 of the Regulations is replaced by the following:

B.02.090 No person shall modify Tequila that is imported for the purpose of bottling and sale in Canada as Tequila except by the addition of distilled or otherwise purified water to adjust the Tequila to a required strength.

41 Section B.02.091 of the Regulations is replaced by the following:

B.02.091 No person shall modify Mezcal that is imported for the purpose of bottling and sale in Canada as Mezcal except by the addition of distilled or otherwise purified water to adjust the Mezcal to a required strength.

42 Sections B.02.100 to B.02.107 of the Regulations are replaced by the following:

B.02.101 No person shall sell wine unless it has an amount of volatile acidity, expressed as acetic acid, that is equal to or less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4.

43 Sections B.02.120 to B.02.123 of the Regulations are replaced by the following:

B.02.123 No person shall sell cider unless it has an amount of volatile acidity, expressed as acetic acid, that is equal to or less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4.

44 The heading before section B.02.130 and sections B.02.130 to B.07.043 of the Regulations are repealed.

45 Sections B.08.001 and B.08.001.1 of the Regulations are repealed.

46 Section B.08.002.1 of the Regulations is replaced by the following:

B.08.002.1 Paragraphs B.08.002.3(a) to (i) and sections B.08.003 to B.08.028 do not apply to a lacteal secretion obtained from the mammary gland of any animal other than a cow, genus Bos, or a product or derivative of such secretion.

47 The Regulations are amended by adding the following after section B.08.002.2:

B.08.002.3 The percentage of milk fat contained in the following dairy products must be shown on the principal display panel followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”:

• (a) partly skimmed milk;
• (b) partly skimmed milk with added milk solids;
• (c) evaporated partly skimmed milk;
• (d) (naming the flavour) milk;
• (e) (naming the flavour) partly skimmed milk;
• (f) (naming the flavour) partly skimmed milk with added milk solids;
• (g) cream;
• (h) canned cream;
• (i) sour cream;
• (j) yogurt;
• (k) cottage cheese; and
• (l) creamed cottage cheese.

48 Sections B.08.003 to B.08.007 of the Regulations are replaced by the following:

B.08.003 Despite sections D.01.009 to D.01.011, no person shall sell any of the following dairy products for which a standard is set out in Volume 7 of the Food Compositional Standards Document unless the food contains 2 μg of vitamin D per 100 mL:

• (a) milk;
• (b) sterilized milk; and
• (c) (naming the flavour) milk.

B.08.004 Despite sections D.01.009 to D.01.011, no person shall sell milk powder for which a standard is set out in Volume 7 of the Food Compositional Standards Document unless it contains 2 μg of vitamin D per 100 mL when reconstituted according to directions for use.

B.08.005 (1) No person shall sell a food referred to in subsection (2) unless it contains

• (a) despite sections D.01.009 and D.01.010, vitamin A in such an amount that a reasonable daily intake of the food contains at least 1,200 I.U. and not more than 2,500 I.U. of vitamin A; and
• (b) despite sections D.01.009 to D.01.011, 2 μg of vitamin D per 100 mL.

(2) The foods to which subsection (1) applies are the following dairy products for which a standard is set out in Volume 7 of the Food Compositional Standards Document:

• (a) skim milk;
• (b) partly skimmed milk;
• (c) (naming the flavour) skim milk;
• (d) (naming the flavour) partly skimmed milk;
• (e) skim milk with added milk solids;
• (f) partly skimmed milk with added milk solids;
• (g) (naming the flavour) skim milk with added milk solids; and
• (h) (naming the flavour) partly skimmed milk with added milk solids.

B.08.006 No person shall sell skim milk powder for which a standard is set out in Volume 7 of the Food Compositional Standards Document unless it contains

• (a) despite sections D.01.009 and D.01.010, vitamin A in such an amount that a reasonable daily intake of the dairy product contains at least 1,200 I.U. and not more than 2,500 I.U. of vitamin A; and
• (b) despite sections D.01.009 to D.01.011, 2 μg of vitamin D per 100 mL when reconstituted according to directions for use.

49 Sections B.08.008 to B.08.014A of the Regulations are replaced by the following:

B.08.010 No person shall sell evaporated milk for which a standard is set out in Volume 7 of the Food Compositional Standards Document unless it contains

• (a) despite sections D.01.009 to D.01.011, vitamin C in such an amount that a reasonable daily intake of the dairy product contains at least 60 mg and not more than 75 mg of vitamin C; and
• (b) despite sections D.01.009 to D.01.011, 2 μg of vitamin D per 100 mL when reconstituted to its original volume.

B.08.011 No person shall sell evaporated skim milk or evaporated partly skimmed milk for which a standard is set out in Volume 7 of the Food Compositional Standards Document unless it contains

• (a) despite sections D.01.009 and D.01.010, vitamin A in such an amount that a reasonable daily intake of the dairy product contains at least 1,200 I.U. and not more than 2,500 I.U. of vitamin A;
• (b) despite sections D.01.009 to D.01.011, vitamin C in such an amount that a reasonable daily intake of the dairy product contains at least 60 mg and not more than 75 mg of vitamin C; and
• (c) despite sections D.01.009 to D.01.011, 2 μg of vitamin D per 100 mL when reconstituted to its original volume.

50 (1) The portion of section B.08.015 of the Regulations before paragraph (a) is replaced by the following:

B.08.015 (1) No person shall sell a food referred to in subsection (2) in which the content of vitamin D has been increased by either addition or irradiation unless

(2) Paragraph B.08.015(1)(b) of the Regulations is replaced by the following:

• (b) in cases where the vitamin D content is increased by irradiation, the principal display panel carries the statement “Vitamin D Increased” immediately preceding or following the name of the food, without intervening written, printed or graphic matter.

(3) Section B.08.015 of the Regulations is amended by adding the following after subsection (1):

(2) The foods to which subsection (1) applies are the following dairy products for which a standard is set out in Volume 7 of the Food Compositional Standards Document:

• (a) milk;
• (b) skim milk;
• (c) partly skimmed milk;
• (d) skim milk with added milk solids;
• (e) partly skimmed milk with added milk solids;
• (f) (naming the flavour) milk;
• (g) (naming the flavour) skim milk;
• (h) (naming the flavour) partly skimmed milk;
• (i) (naming the flavour) skim milk with added milk solids;
• (j) (naming the flavour) partly skimmed milk with added milk solids;
• (k) condensed milk;
• (l) evaporated milk;
• (m) evaporated skim milk;
• (n) evaporated partly skimmed milk;
• (o) milk powder; and
• (p) skim milk powder.

51 Sections B.08.016 to B.08.024 of the Regulations are replaced by the following:

B.08.024 No person shall sell milk for manufacture into dairy products unless the milk contains an amount of sediment equal to or less than that set out in column 3 of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4.

52 Sections B.08.025 to B.08.028 of the Regulations are replaced by the following:

B.08.027 Despite anything contained in these Regulations, the following dairy products for which a standard is set out in Volume 7 of the Food Compositional Standards Document are not required to contain added vitamins if they are used in or sold for the manufacture of other foods:

• (a) milk;
• (b) skim milk;
• (c) partly skimmed milk;
• (d) sterilized milk;
• (e) evaporated milk;
• (f) evaporated skim milk;
• (g) evaporated partly skimmed milk;
• (h) milk powder;
• (i) skim milk powder;
• (j) skim milk with added milk solids; and
• (k) partly skimmed milk with added milk solids.

53 (1) The definition pickles and relishes in subsection B.08.030(1) of the Regulations is repealed.

(2) Subsection B.08.030(2) of the Regulations is repealed.

54 Sections B.08.031 to B.08.041.8 of the Regulations are replaced by the following:

B.08.031 A cheese made from milk that is the normal lacteal secretion of the mammary gland of animals other than the cow, genus Bos, must be labelled to show the source of the milk on the principal display panel.

B.08.032 (1) Cheeses, other than cottage cheese and creamed cottage cheese, must be labelled to show on the principal display panel a statement of the percentage of milk fat in the food followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”, and the percentage of moisture in the food followed by the word “moisture” or “water”.

(2) Subject to subsection B.01.301(1), no person shall make any direct or indirect reference on the label of a food referred to in subsection (1) to the milk fat content or moisture content of the food except as required by subsection (1).

55 The portion of section B.08.043 of the Regulations before paragraph (a) is replaced by the following:

B.08.043 No manufacturer shall sell cheese that is not made from a pasteurized source if it has been cut into smaller portions unless

56 Sections B.08.048 to B.08.052 of the Regulations are repealed.

57 Sections B.08.054 to B.08.074 of the Regulations are replaced by the following:

Ice Cream Mix and Ice Milk Mix

B.08.071 No person shall sell ice cream mix or ice milk mix unless it has been pasteurized or unless the dairy products that are contained in the mix have been pasteurized.

58 Sections B.08.075 to B.08.077 of the Regulations are replaced by the following:

B.08.077 No person shall sell sour cream unless it has been prepared with pasteurized cream.

59 Sections B.09.001 to B.09.009A of the Regulations are replaced by the following:

B.09.002 No person shall sell animal fats and oils obtained from slaughtered animals unless they are derived from animals that were healthy at the time of slaughter.

60 Sections B.09.011 to B.09.022 of the Regulations are replaced by the following:

B.09.016 (1) No person shall sell margarine or calorie-reduced margarine for which a standard is set out in Volume 8 of the Food Compositional Standards Document unless

• (a) the margarine or calorie-reduced margarine contains at least 3,300 I.U. of vitamin A per 100 g; and
• (b) despite sections D.01.009 to D.01.011, the margarine or calorie-reduced margarine contains 26 μg of vitamin D per 100 g.

(2) No person shall sell margarine or calorie-reduced margarine for which a standard is set out in Volume 8 of the Food Compositional Standards Document and to which vitamin E has been added unless the finished product contains at least 0.6 I.U. of alpha-tocopherol per gram of linoleic acid.

61 Sections B.10.003 to B.10.007 of the Regulations are repealed.

62 Sections B.10.009 to B.10.027 of the Regulations are repealed.

63 The definition acid ingredient in section B.11.001 of the Regulations is repealed.

64 Section B.11.001.1 of the Regulations is repealed.

65 Sections B.11.002 to B.11.004 of the Regulations are replaced by the following:

B.11.002 No person shall sell canned vegetables unless they

• (a) have been obtained by heat processing fresh vegetables; and
• (b) are packaged in hermetically sealed containers.

B.11.003 No person shall sell canned mushrooms unless they

• (a) have been obtained by heat processing cultivated mushrooms; and
• (b) are packaged in hermetically sealed containers.

66 Sections B.11.005 and B.11.007 of the Regulations are replaced by the following:

B.11.005 No person shall sell canned tomatoes unless they have been obtained by heat processing fresh tomatoes.

B.11.007 No person shall sell tomato juice unless it has been pasteurized.

67 Sections B.11.009 to B.11.017 of the Regulations are replaced by the following:

B.11.011 No person shall sell tomato pulp or tomato puree unless it has been obtained by heat processing tomatoes.

B.11.012 No person shall sell tomato catsup unless it has been obtained by heat processing the liquid extracted from tomatoes.

68 Section B.11.025 of the French version of the Regulations is replaced by the following:

B.11.025 Est interdite la vente de pommes de terre, de patates douces ou d’ignames qui ont été colorées artificiellement.

69 Sections B.11.040 to B.11.051 of the Regulations are repealed.

70 Sections B.11.101 to B.11.134 of the Regulations are replaced by the following:

B.11.101 No person shall sell canned fruit unless it

• (a) has been obtained by heat processing fresh fruit; and
• (b) is packaged in hermetically sealed containers.

71 Sections B.11.201 to B.11.203 of the Regulations are replaced by the following:

B.11.201 No person shall sell fruit jam or jam containing rhubarb unless the jam has been obtained by boiling the fruit or rhubarb, as the case may be, with water and a sweetening ingredient.

72 Sections B.11.220 to B.11.224 of the Regulations are replaced by the following:

B.11.220 No person shall sell a citrus fruit marmalade unless it has been obtained by boiling the zest or peel, pulp and juice of the citrus fruit with water and a sweetening ingredient.

B.11.221 No person shall sell a pineapple marmalade or fig marmalade unless it has been obtained by boiling the pulp and juice of the pineapple or fig, as the case may be, with water and a sweetening ingredient.

73 Sections B.11.240 to B.11.260 of the Regulations are replaced by the following:

B.11.240 No person shall sell fruit jelly unless it has been obtained by boiling the fruit, the juice of the fruit or a concentrate of the juice of the fruit with water and a sweetening ingredient.

74 Section B.12.001 of the Regulations is replaced by the following:

B.12.001 (1) No person shall sell water represented as mineral water or spring water unless it is potable water obtained from an underground source and not from a public community water supply.

(2) No person shall sell water represented as mineral water or spring water for which a standard is set out in Volume 11 of the Food Compositional Standards Document, to which fluoride has been added unless the total fluoride ion content is equal to or less than one part per million.

75 The portion of section B.12.002 of the French version of the Regulations before paragraph (a) is replaced by the following:

B.12.002 L’étiquette d’un récipient contenant une eau présentée comme étant une eau minérale ou une eau de source doit indiquer :

76 (1) The portion of section B.12.004 of the French version of the Regulations before paragraph (a) is replaced by the following:

B.12.004 Il est interdit de vendre de l’eau en contenants scellés, à l’exclusion de l’eau présentée comme étant une eau minérale ou une eau de source, qui contient

(2) Paragraphs B.12.004(a) and (b) of the Regulations are repealed.

(3) Paragraph B.12.004(d) of the Regulations is replaced by the following:

• (d) added fluoride in such an amount that the total amount of fluoride ion exceeds one part per million.

77 (1) Paragraph B.12.005(1)(a) of the Regulations is repealed.

(2) Paragraph B.12.005(1)(c) of the Regulations is replaced by the following:

• (c) added fluoride in such an amount that the total amount of fluoride ion exceeds one part per million.

(3) Subsection B.12.005(2) of the Regulations is replaced by the following:

(2) No person shall manufacture prepackaged ice for sale if the water from which it is made

• (a) is not potable;
• (b) contains naturally occurring fluoride ion in an amount that exceeds its naturally occurring amount; or
• (c) contains added fluoride in such an amount that the total amount of fluoride ion exceeds one part per million.

78 Section B.12.007 of the Regulations is replaced by the following:

B.12.007 Despite section B.01.008, chlorine or any compounds of chlorine need not be shown as ingredients on any part of the label on a sealed container of water, other than water represented as mineral water or spring water, when chlorine or any compounds of chlorine have been used in the treatment of the water and subsequently removed from the water together with any chlorine and compounds of chlorine produced in the water.

79 Section B.12.008 of the French version of the Regulations is replaced by the following:

B.12.008 La teneur totale en ion fluorure doit être indiquée, en parties par million, dans l’espace principal de l’eau vendue en contenants scellés, à l’exclusion de l’eau présentée comme étant une eau minérale ou une eau de source, ainsi que sur l’étiquette de la glace préemballée.

80 Sections B.13.001 to B.13.010 of the Regulations are replaced by the following:

B.13.001 (1) No person shall sell white flour for which a standard is set out in Volume 12 of the Food Compositional Standards Document unless the white flour contains, per 100 g,

• (a) 0.64 mg of thiamine;
• (b) 0.40 mg of riboflavin;
• (c) 5.30 mg of niacin or niacinamide;
• (d) 0.15 mg of folic acid; and
• (e) 4.4 mg of iron.

(2) No person shall sell white flour for which a standard is set out in Volume 12 of the Food Compositional Standards Document and to which any of the following vitamins or mineral nutrients have been added unless each 100 g of the white flour contains, in total, the following amount of the added vitamin or mineral nutrient:

• (a) 0.31 mg of vitamin B₆;
• (b) 1.3 mg of d-pantothenic acid;
• (c) 190 mg of magnesium; and
• (d) 140 mg of calcium from one or any combination of the following sources:
  • (i) calcium carbonate,
  • (ii) edible bone meal,
  • (iii) chalk (B.P.),
  • (iv) ground limestone,
  • (v) calcium sulphate.

B.13.002 Despite subsection B.13.001(1), white flour used in or sold for the manufacture of gluten or starch is not required to contain added thiamine, riboflavin, niacin, folic acid or iron.

81 Subsection B.13.010.1(1) of the Regulations is replaced by the following:

B.13.010.1 (1) In this section, pre-cooked rice means rice, for which a standard is set out in Volume 12 of the Food Compositional Standards Document, that has been polished and cooked in water or steam and dried in a way that allows the rice grains to remain porous and open-structured.

82 Sections B.13.011 to B.13.020 of the Regulations are repealed.

83 Sections B.13.021 to B.13.029 of the Regulations are replaced by the following:

B.13.022 (1) No person shall sell enriched white bread for which a standard is set out in Volume 12 of the Food Compositional Standards Document unless the enriched white bread contains, per 100 g,

• (a) 0.40 mg of thiamine;
• (b) 0.24 mg of riboflavin;
• (c) 3.3 mg of niacin or niacinamide;
• (d) 0.10 mg of folic acid; and
• (e) 2.76 mg of iron.

(2) No person shall sell enriched white bread for which a standard is set out in Volume 12 of the Food Compositional Standards Document and that is made from white flour to which any of the following vitamins or mineral nutrients have been added unless each 100 g of the enriched white bread contains, in total, the following amount of the added vitamin or mineral nutrient:

• (a) 0.14 mg of vitamin B₆;
• (b) 0.6 mg of d-pantothenic acid;
• (c) 90 mg of magnesium; and
• (d) 66 mg of calcium.

84 Section B.14.001 of the Regulations is amended by adding the following in alphabetical order:

meat means the edible part of

• (a) the skeletal muscle of an animal; or
• (b) the muscle that is found in the tongue, diaphragm, heart or oesophagus of an animal.

This definition also applies to the muscle tissue when it is overlaid with or includes fat, portions of bone, skin, sinew, nerve or blood vessels that are normally attached to the muscle tissue and are not separated from it in the process of dressing. This definition does not include muscle found in the lips, snout, scalp or ears; (viande)

meat by-product means any edible part of an animal, other than meat. (sous-produit de viande)

85 Sections B.14.002 and B.14.003 of the Regulations are replaced by the following:

B.14.002 No person shall sell meat, a meat by-product or edible bone meal unless it is derived from animals that were healthy at the time of slaughter.

86 Sections B.14.004 and B.14.005 of the Regulations are replaced by the following:

B.14.004 Meat, meat by-products, preparations of meat and preparations of meat by-products are adulterated if any organ or portion of an animal that is not commonly sold as food — including mucous membranes, organs or portions of the genital system, black gut, spleens, udders and lungs — is present in or has been added to the food.

87 Sections B.14.007 to B.14.009 of the Regulations are replaced by the following:

B.14.008 No person shall sell a meat binder, filler or preparations for pumping pickle, cover pickle or dry cure represented for use in meat products unless its label sets out directions for use that, when followed, produces a food

• (a) that complies with the requirements of section B.14.030 in relation to the filler; and
• (b) that does not contain food additives, if any, in excess of the maximum level of use or maximum level of residue for that food set out in the Lists of Permitted Food Additives.

88 Sections B.14.015 to B.14.015C of the Regulations are replaced by the following:

B.14.015C No person shall sell ground beef unless it contains an amount of beef fat equal to or less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4.

89 Section B.14.020 of the Regulations is repealed.

90 (1) The portion of subsection B.14.021(1) of the Regulations before paragraph (a) is replaced by the following:

B.14.021 (1) No person shall sell solid cut meat to which food additives or water have been added unless

(2) Paragraph B.14.021(1)(b) of the Regulations is repealed.

91 Sections B.14.030A to B.14.032 of the Regulations are replaced by the following:

B.14.030A For the purposes of sections B.14.030 and B.14.074 to B.14.077 and Division 13.3 of Volume 13 of the Food Compositional Standards Document, if any non-meat ingredients are present in a prepared meat or a prepared meat by-product in pieces that are distinguishable from the other ingredients, those non-meat ingredients must be excluded when calculating the total fat or protein content of the prepared meat or prepared meat by-product.

92 Sections B.14.032A to B.14.038 of the Regulations are replaced by the following:

B.14.033 No person shall sell any of the following foods unless they are cooked or unless the meat and meat by-products, as the case may be, contained in them are cooked:

• (a) potted meat;
• (b) meat loaf;
• (c) meat roll;
• (d) luncheon meat;
• (e) potted meat by-product;
• (f) meat by-product loaf;
• (g) meat and meat by-product loaf;
• (h) headcheese; and
• (i) brawn.

93 (1) The portion of section B.14.040 of the Regulations before paragraph (a) is replaced by the following:

B.14.040 Subject to Division 13.3 of Volume 13 of the Food Compositional Standards Document, no person shall sell a food that consists of a mixture of ground meat and filler, of ground meat by-product and filler or of ground meat, ground meat by-product and filler unless that food

(2) Paragraphs B.14.040(b) and (c) of the Regulations are replaced by the following:

• (b) has a fat content of not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4, in the case of a mixture containing pork meat or pork meat by-product or both; and
• (c) has a fat content of not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4, in the case of any other meat mixture.

94 (1) The portion of section B.14.041 of the Regulations before paragraph (a) is replaced by the following:

B.14.041 Subject to Division 13.3 of Volume 13 of the Food Compositional Standards Document, no person shall sell a food that consists of a mixture of ground meat and spices and seasonings, of ground meat by-product and spices and seasonings, of ground meat, ground meat by-product and spices and seasonings or of ground meat and ground meat by-product unless that food

(2) Paragraphs B.14.041(b) and (c) of the Regulations are replaced by the following:

• (b) has a fat content of not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4, in the case of a mixture containing pork meat or pork meat by-product or both; and
• (c) has a fat content of not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4, in the case of any other meat mixture.

95 The heading before section B.14.061 and sections B.14.061 to B.14.071 of the Regulations are repealed.

96 Subparagraph B.14.073(a)(ii) of the Regulations is replaced by the following:

• (ii) a protein quality of not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4;

97 Paragraph B.14.074(b) of the Regulations is replaced by the following:

• (b) has a fat content of not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4; and

98 Paragraph B.14.075(b) of the Regulations is replaced by the following:

• (b) has a fat content of not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4; and

99 (1) The portion of section B.14.076 of the Regulations before paragraph (a) is replaced by the following:

B.14.076 No person shall sell a food that consists of a mixture of meat product and meat product extender and that resembles cooked sausage, meat loaf, meat by-product loaf, meat roll, or luncheon meat, unless that food

(2) Paragraph B.14.076(b) of the Regulations is replaced by the following:

• (b) has a fat content of not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4; and

100 (1) The portion of section B.14.077 of the Regulations before paragraph (a) is replaced by the following:

B.14.077 No person shall sell a food that consists of a mixture of meat product and meat product extender and that resembles potted meat, or potted meat by-product, unless that food

(2) Paragraph B.14.077(b) of the Regulations is replaced by the following:

• (b) has a fat content of not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4; and

101 Subparagraphs B.14.078(b)(i) to (iii) of the Regulations are replaced by the following:

• (i) not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4, if the product is represented as being regular,
• (ii) not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4, if the product is represented as being medium, or
• (iii) not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4, if the product is represented as being lean; and

102 Paragraph B.14.079(b) of the Regulations is replaced by the following:

• (b) has a fat content of not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4; and

103 Subparagraphs B.14.085(a)(ii) and (iii) of the Regulations are replaced by the following:

• (ii) a protein quality of not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4, and
• (iii) a fat content of not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4;

104 Paragraphs B.14.086(b) and (c) of the Regulations are replaced by the following:

• (b) has a protein quality of not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4;
• (c) has a fat content of not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4;

105 (1) The portion of section B.14.087 of the Regulations before paragraph (a) is replaced by the following:

B.14.087 No person shall sell a simulated meat product that resembles cooked sausage, meat loaf, meat by-product loaf, meat roll, or luncheon meat, unless that product

(2) Paragraphs B.14.087(b) and (c) of the Regulations are replaced by the following:

• (b) has a protein quality of not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4;
• (c) has a fat content of not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4;

106 (1) The portion of section B.14.088 of the Regulations before paragraph (a) is replaced by the following:

B.14.088 No person shall sell a simulated meat product that resembles potted meat, or potted meat by-product, unless that product

(2) Paragraphs B.14.088(b) and (c) of the Regulations are replaced by the following:

• (b) has a protein quality of not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4;
• (c) has a fat content of not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4;

107 (1) Paragraph B.14.089(b) of the Regulations is replaced by the following:

• (b) has a protein quality of not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4;

(2) Subparagraphs B.14.089(c)(i) to (iii) of the Regulations are replaced by the following:

• (i) not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4, if the product is represented as being regular,
• (ii) not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4, if the product is represented as being medium, or
• (iii) not more than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4, if the product is represented as being lean;

108 Paragraph B.14.090(b) of the Regulations is replaced by the following:

• (b) has a protein quality of not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4;

109 The heading “Adulteration of Food” before section B.15.001 of the Regulations is replaced by the following:

Contaminants

110 Subsections B.15.001(1) to (3) of the French version of the Regulations are replaced by the following:

B.15.001 (1) Un aliment visé à la colonne 2 de la partie 1 de la Liste des contaminants et autres substances adultérantes dans les aliments est falsifié si est présente dans l’aliment ou sur sa surface une substance dont le nom ou la catégorie figure à la colonne 1.

(2) Un aliment visé à la colonne 2 de la partie 2 de la Liste des contaminants et autres substances adultérantes dans les aliments est falsifié si est présente dans l’aliment ou sur sa surface une substance dont le nom ou la catégorie figure à la colonne 1 en une quantité dépassant la limite maximale prévue à la colonne 3.

(3) Un aliment visé à la colonne 2 de la partie 2 de la Liste des contaminants et autres substances adultérantes dans les aliments est soustrait à l’application de l’alinéa 4(1)a) de la Loi, en ce qui concerne une substance dont le nom ou la catégorie figure à la colonne 1, si la substance est présente dans l’aliment ou sur sa surface en une quantité ne dépassant pas la limite maximale prévue à la colonne 3.

111 Sections B.16.001 to B.16.100 of the Regulations are replaced by the following:

Interpretation

B.16.001 The following definitions apply in this Division.

dye,

in relation to a synthetic colour, means the principal dye and associated subsidiary and isomeric dyes contained in the synthetic colour. (pigment)

food colour preparation

means a preparation, of one or more synthetic colours, that contains less than 3% dye and is sold for household use in or on a food. (préparation pour colorant alimentaire)

synthetic colour

means any organic food colour, other than caramel, that is produced by chemical synthesis and that has no counterpart in nature. (colorant synthétique)

Adulteration

B.16.002 A food is adulterated if a food additive is present in or on, or has been added to, the food.

Exemptions

B.16.003 Subject to sections B.16.004 and B.16.005, if a food additive set out in column 1 of the Lists of Permitted Food Additives is added to a corresponding food set out in column 3, that food does not have a poisonous or harmful substance in or on it for the purposes of paragraph 4(1)(a) of the Act — or is not adulterated for the purposes of paragraph 4(1)(d) of the Act — by reason only that the food additive is in or on it, or has been added to it, if

• (a) the food additive is obtained from any corresponding source set out in column 2;
• (b) the food additive is used for any corresponding purpose of use set out in column 4;
• (c) the amount of the food additive does not exceed
  • (i) any corresponding maximum level of use and any corresponding maximum level of residue set out in column 5, and
  • (ii) the amount that is required to accomplish the purpose for which it is added, in the case where the words “Good Manufacturing Practice” appear in column 5 for that food additive in the food; and
• (d) any other corresponding condition set out in column 5 is met.

B.16.004 If a food that, under section B.16.003, does not contain a poisonous or harmful substance in or on it for the purposes of paragraph 4(1)(a) of the Act — or is not adulterated for the purposes of paragraph 4(1)(d) of the Act — is used as an ingredient in another food, that other food also does not contain a poisonous or harmful substance in or on it for the purposes of paragraph 4(1)(a) of the Act and is not adulterated for the purposes of paragraph 4(1)(d) of the Act, by reason only that the food additive referred to in section B.16.003 is present in or on that other food, or has been added to the ingredient.

B.16.005 (1) Subject to subsections (2) to (4), sections B.16.003 and B.16.004 do not apply to an infant food.

(2) Sections B.16.003 and B.16.004 apply to an infant food if

• (a) it is a bakery product; or
• (b) the food additive in or on the food is citric acid.

(3) Section B.16.003 applies to an infant food if

• (a) the word “infant” is mentioned in column 3 of the Lists of Permitted Food Additives in relation to a food set out in that column; or
• (b) it is a human milk fortifier set out in column 3 of the Lists of Permitted Food Additives.

(4) Section B.16.004 applies to an infant food if

• (a) it contains, as an ingredient, a food set out in column 3 of the Lists of Permitted Food Additives to which a corresponding food additive set out in column 1 has been added, and the use of that ingredient in that infant food is mentioned in column 3; or
• (b) it is an infant formula that contains, as an ingredient, a food set out in column 3 of the List of Permitted Food Enzymes that contains a corresponding food additive set out in column 1.

B.16.006 Sections B.16.003 to B.16.005 apply to the food if all of the other requirements of these Regulations that apply with respect to the food additive are met.

Prohibitions

B.16.007 (1) The following definitions apply in this section.

diluent

means any substance, other than a synthetic colour, that is present in a food colour mixture or food colour preparation. (diluant)

food colour mixture

means a mixture of two or more synthetic colours or a mixture of one or more synthetic colours with one or more diluents. (mélange pour colorant alimentaire)

(2) No person shall sell a food – other than a synthetic colour, food colour mixture, food colour preparation or flavouring preparation – that contains, when prepared for consumption according to label directions, more than

• (a) 300 ppm of Allura Red, Amaranth, Erythrosine, Indigotine, Sunset Yellow FCF or Tartrazine or any combination of those synthetic colours, unless otherwise provided in column 5 of the List of Permitted Food Colours;
• (b) 100 ppm of Brilliant Blue FCF or Fast Green FCF or any combination of those synthetic colours, unless otherwise provided in column 5 of the List of Permitted Food Colours;
• (c) subject to paragraphs (a) and (b), 300 ppm of any combination of the synthetic colours referred to in those paragraphs; or
• (d) 150 ppm of Ponceau SX, unless otherwise provided in column 5 of the List of Permitted Food Colours.

B.16.008 No person shall sell any fresh fruit or vegetable, except grapes, to which sulphurous acid or any of its salts has been added and that is intended to be consumed raw.

B.16.009 No person shall sell a substance as a food additive unless the substance is set out in column 1 of the Lists of Permitted Food Additives.

B.16.010 No person shall sell vanilla extract or vanilla flavour for which a standard is set out in Volume 9 of the Food Compositional Standards Document to which a food colour has been added.

Specifications

B.16.011 (1) A food additive set out in column 1 of the Table of Food Additive Specifications must meet the specifications set out in column 2 for that food additive.

(2) If a food additive is not listed in the Table of Food Additive Specifications, but specifications are set out for the food additive in one of the following publications, the food additive must meet the specifications set out for it in that publication:

• (a) the Food Chemicals Codex, published by the United States Pharmacopeial Convention, including its supplements, as amended from time to time; or
• (b) the Combined Compendium of Food Additive Specifications, prepared by the Joint FAO/WHO Expert Committee on Food Additives and published by the Food and Agriculture Organization of the United Nations, on its website, as amended from time to time.

(3) For greater certainty, the specifications referred to in subsection (1) may incorporate portions of the publications referred to in paragraphs (2)(a) and (b).

(4) In this section, Table of Food Additive Specifications means the Table of Food Additive Specifications, published by the Government of Canada on its website, as amended from time to time.

B.16.012 If a food additive is a water soluble synthetic colour, its lake must be the calcium or aluminum salt of the synthetic colour adsorbed or precipitated on alumina.

Labelling, Packaging and Advertising

B.16.013 A quantitative statement of the amount of each food additive present or directions for use that, if followed, will produce a food that does not contain such food additives in excess of the maximum levels of use or maximum levels of residue prescribed by these Regulations must be shown, grouped together with the list of ingredients, in respect of any substance or mixture of substances for use as a food additive.

B.16.014 No person shall sell a food colour preparation unless

• (a) the words “Food Colour Preparation” appear on the principal display panel; and
• (b) in the case of a liquid food colour preparation, the container has a capacity of 60 mL or less and permits dropwise discharge only.

B.16.015 (1) The label of a food that contains aspartame must carry a statement warning individuals with phenylketonuria that the food contains phenylalanine or a statement to the effect that aspartame contains phenylalanine.

(2) The statement must

• (a) be shown in bold type;
• (b) appear, in respect of each linguistic version, immediately after the list of ingredients appearing in the same language, either on the same line as the last ingredient in the list or on the following line, without any intervening printed, written or graphic material; and
• (c) appear on the same continuous surface as the list of ingredients and be shown in the same manner as that list is shown in accordance with subsection B.01.008.2(2).

B.16.016 The label of a food that contains polydextrose must indicate the amount of polydextrose, expressed in grams per serving of stated size.

B.16.017 (1) The label of a food that contains erythritol must carry a statement indicating the amount of erythritol, expressed in grams per serving of stated size, unless the label carries a nutrition facts table or supplemented food facts table.

(2) The statement of the amount of erythritol must be grouped together with the statement of the amount of any other sugar alcohols and the amount of polydextrose.

B.16.018 The label of a table-top sweetener that contains aspartame, sucralose, acesulfame-potassium or neotame must carry a statement of the sweetness per serving, expressed in terms of the amount of sugar required to produce an equivalent degree of sweetness.

B.16.019 (1) The label of cured beef, the cuts of which have been cured with pumping pickle that contains any proteolytic food enzyme, must carry, on the principal display panel, immediately preceding or following the common name, the statement “Tenderized with (naming the proteolytic food enzyme)”.

(2) In this section, food enzyme means any enzyme that is a food additive used to catalyze a chemical reaction in a food.

112 Sections B.17.001 and B.17.003 of the Regulations are replaced by the following:

B.17.003 (1) No person shall sell, for table or general household use, salt for which a standard is set out in Volume 14 of the Food Compositional Standards Document unless the salt contains 0.01% potassium iodide.

(2) The presence of iodide must be shown on the principal display panel.

B.17.004 Salt for table or general household use referred to in section B.17.003 may contain dextrose to stabilize potassium iodide.

113 Sections B.18.001 to B.18.027 of the Regulations are replaced by the following:

B.18.005 No person shall sell liquid sugar or liquid invert sugar unless the label carries a statement of the percentage of its sugar or invert sugar content, as the case may be.

114 Sections B.19.002 to B.19.007 of the Regulations are replaced by the following:

B.19.002 The percentage of acetic acid by volume contained in vinegar must be shown on the principal display panel followed by the words “acetic acid”.

115 Division 20 of the Regulations is repealed.

116 Section B.21.001 of the Regulations is repealed.

117 (1) The definition remplissage in section B.21.002 of the French version of the Regulations is repealed.

(2) Paragraphs (b) and (c) of the English version of the definition filler in section B.21.002 of the Regulations are replaced by the following:

• (b) processed wheat flour containing an amount of reducing sugars, expressed as dextrose equivalent, of not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4,
• (c) bakery products, except those containing a legume,

(3) Section B.21.002 of the Regulations is amended by adding the following in alphabetical order:

meat

means the clean and dressed flesh of crustaceans, molluscs, other marine invertebrates and marine mammals. (chair)

(4) Section B.21.002 of the French version of the Regulations is amended by adding the following in alphabetical order:

agent de remplissage

• a) Farine ou semoule de céréales ou de pommes de terre, mais non de légumineuses;
• b) farine de blé conditionnée qui contient une quantité de sucres réducteurs, exprimée en équivalent dextrose, au moins égale à celle figurant à la colonne 3 du Tableau des caractéristiques chimiques, physiques et nutritionnelles des aliments pour cet article, et déterminée selon la méthode correspondante figurant à la colonne 4;
• c) produits de boulangerie qui ne contiennent pas des légumineuses;
• d) poudre de lait, lait écrémé en poudre, babeurre en poudre et petit-lait en poudre;
• e) amidon; (filler)

(5) Section B.21.002 of the Regulations is renumbered as subsection B.21.002(1) and is amended by adding the following:

(2) For the purposes of sections B.21.005, B.21.008 and B.21.020, except the terms fish protein and fish binder, fish means clean and dressed fish.

118 Sections B.21.003 to B.21.007 of the Regulations are replaced by the following:

B.21.005 Fish or fish preparations, except fish protein, and meat products or meat product preparations are adulterated if any mucous membranes, any organ or portion of the genital system or any other organ or portion of a marine or fresh water animal that is not commonly sold as food is present in or has been added to them.

119 Section B.21.008 of the Regulations is replaced by the following:

B.21.008 No person shall sell filler or a fish binder represented for use in fish products either by label or in any advertisement unless the label carries adequate directions for use in accordance with the requirements of sections B.21.020 and B.21.021, as the case may be.

120 Sections B.21.020 to B.21.024 of the Regulations are replaced by the following:

B.21.020 No person shall sell prepared fish that contains

• (a) more than that amount of filler, fish binder and other ingredients that is represented by an amount of reducing sugars, expressed as dextrose equivalent, that is set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4; or
• (b) more than 70% moisture, in the case of prepared fish that contains filler.

B.21.021 No person shall sell prepared meat that contains more than that amount of filler, fish binder and other ingredients that is represented by an amount of reducing sugars, expressed as dextrose equivalent, that is set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4.

B.21.024 Despite section B.21.021, lobster paste must not contain more than 2% filler or fish binder.

121 Paragraph B.21.025(b) of the Regulations is replaced by the following:

• (b) the contents of the container contain an amount of salt not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4;

122 Sections B.21.027 and B.21.031 of the Regulations are replaced by the following:

B.21.027 No person shall sell fish protein unless

• (a) it has a total protein content of at least 75%; and
• (b) the quality of the protein is not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4.

123 Sections B.22.001 to B.22.004 of the Regulations are replaced by the following:

B.22.001 The following definitions apply in this Division.

poultry

means any bird that is commonly used as food. (volaille)

poultry meat

means poultry flesh, including the heart and gizzard. (viande de volaille)

poultry meat by-product

means any part of poultry, other than poultry meat, commonly used as food, including the liver and skin but excluding the oesophagus, feet and head. (sous-produit de viande de volaille)

B.22.002 No person shall sell poultry meat or poultry meat by-product unless it is clean, dressed and derived from eviscerated poultry that was healthy at the time of slaughter.

124 Sections B.22.005 to B.22.008 of the Regulations are replaced by the following:

B.22.005 Poultry meat, poultry meat by-products, preparations of poultry meat or preparations of poultry meat by-products are adulterated if any organ or portion of poultry that is not commonly sold as food is present in or has been added to them.

125 Sections B.22.011 to B.22.013 of the Regulations are replaced by the following:

B.22.012 (1) No person shall sell solid cut poultry meat to which food additives or water have been added unless

• (a) in the case where the meat is cooked, it has a meat protein content of at least 12 per cent; and
• (b) in the case where the meat is uncooked, it has a meat protein content of at least 10 per cent.

(2) A bone or visible fat layer is excluded in calculating the meat protein content.

B.22.013 No person shall sell the whole or any part of a dressed poultry carcass that has been placed in a chilling tank containing fluids to which phosphate salts or lactate salts have been added.

126 The heading before section B.22.016 and sections B.22.016 to B.22.019 of the Regulations are repealed.

127 Sections B.22.021 to B.22.025 of the Regulations are repealed.

128 Subparagraph B.22.027(a)(ii) of the Regulations is replaced by the following:

• (ii) a protein quality of not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4;

129 Section B.22.028 of the Regulations is replaced by the following:

B.22.028 No person shall sell a food that consists of a mixture of poultry product and poultry product extender, unless

• (a) the food has a total protein content of at least 16%;
• (b) the food has a protein quality of not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4; and
• (c) the poultry product extender meets the requirements of paragraphs B.22.027(a) to (c).

130 Paragraph B.22.029(b) of the Regulations is replaced by the following:

• (b) has a protein quality of not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4;

131 (1) The portion before paragraph (a) in section B.22.032 of the French version of the Regulations is replaced by the following:

B.22.032 Est interdite la vente d’un produit imitant l’œuf entier, sauf si ce produit

(2) Paragraph B.22.032(b) of the Regulations is replaced by the following:

• (b) has a protein quality of not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4;

132 Sections B.22.033 to B.22.037 of the Regulations are repealed.

133 Subsections B.22.038(1) and (2) of the Regulations are replaced by the following:

B.22.038 (1) No person shall use a common name for a food identified in subsection (2.1) that has been subjected to a process, other than a process referred to in Division 19.4 of Volume 19 of the Food Compositional Standards Document, if that process results in a decrease in the amount of a vitamin or mineral nutrient that was present in the food before processing in an amount equal to at least 10% of the weighted recommended nutrient intake per 100 g, unless the amount of the vitamin or mineral nutrient is restored to the amount that was present before processing.

(2) Despite sections D.01.009, D.01.011 and D.02.009, a person may sell the foods identified in subsection (2.1) to which a vitamin or mineral nutrient referred to in column II of item 27 of the table to section D.03.002 has been added to restore the vitamin or mineral nutrient to the amount that was present in the food before processing.

(2.1) Subsection (2) applies to the following foods for which a standard is set out in Volume 19 of the Food Compositional Standards Document:

• (a) liquid whole egg;
• (b) dried whole egg;
• (c) frozen whole egg;
• (d) liquid yolk;
• (e) dried yolk;
• (f) frozen yolk;
• (g) liquid egg-white;
• (h) dried egg-white;
• (i) frozen egg-white;
• (j) liquid whole egg mix;
• (k) dried whole egg mix;
• (l) frozen whole egg mix;
• (m) liquid yolk mix;
• (n) dried yolk mix; and
• (o) frozen yolk mix.

134 Sections B.23.007 and B.23.008 of the Regulations are replaced by the following:

B.23.007 No person shall sell a food in a package that may transfer to the food any amount of vinyl chloride or acrylonitrile, as determined by the corresponding method set out in column 4 of the Table of Chemical, Physical and Nutritional Characteristics of Food.

135 Subparagraph B.24.102(1)(a)(i) of the Regulations is replaced by the following:

• (i) at least 20 g of protein, the quality of which is not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4, or

136 The definitions infant food and infant in section B.25.001 of the Regulations are repealed.

137 Subparagraph B.25.054(1)(a)(iii) of the Regulations is repealed.

138 Section B.25.062 of the Regulations before Table I is repealed.

139 The heading “Aliments peu acides emballés dans des récipients hermétiquement fermés” before section B.27.001 of the French version of the Regulations is replaced by the following:

Aliments peu acides emballés dans des récipients hermétiquement scellés

140 The definition hermetically sealed container in section B.27.001 of the Regulations is repealed.

141 (1) Subsection B.27.002(1) of the French version of the Regulations is replaced by the following:

B.27.002 (1) Il est interdit de vendre un aliment peu acide emballé dans un récipient hermétiquement scellé à moins que cet aliment ne soit dans un état de stérilité commerciale.

(2) The portion of subsection B.27.002(2) of the French version of the Regulations before paragraph (a) is replaced by the following:

(2) Le paragraphe (1) ne s’applique pas aux aliments peu acides emballés dans des récipients hermétiquement scellés lorsque, selon le cas :

(3) Subsection B.27.002(3) of the French version of the Regulations is replaced by the following:

(3) Le paragraphe (1) ne s’applique pas aux tomates et aux produits de tomates dont le pH est égal ou inférieur à 4,7 après le traitement thermique, qui sont emballés dans des récipients hermétiquement scellés.

142 (1) The portion of section B.27.003 of the French version of the Regulations before paragraph (a) is replaced by the following:

B.27.003 Il est interdit de vendre un aliment peu acide emballé dans un récipient hermétiquement scellé qui, selon le cas :

(2) Paragraph B.27.003(b) of the French version of the Regulations is replaced by the following:

• b) n’est pas bien scellé;

143 Subsection B.27.004(1) of the French version of the Regulations is replaced by the following:

B.27.004 (1) Lorsque le ministre juge que la vente d’un aliment peu acide emballé dans un récipient hermétiquement scellé risque d’être en contravention avec les articles B.27.002 ou B.27.003, il peut, par avis écrit, demander au fabricant ou à l’importateur de l’aliment de lui présenter, au plus tard à la date précisée dans l’avis, la preuve que les procédés de fabrication, de transformation et d’emballage de l’aliment permettent d’atteindre et de maintenir la stérilité commerciale.

144 The portion of section B.27.005 of the French version of the Regulations before paragraph (a) is replaced by the following:

B.27.005 Il est interdit de vendre un aliment peu acide qui est dans un état de stérilité commerciale et qui est emballé dans un récipient hermétiquement scellé, à moins que les conditions suivantes ne soient réunies :

145 (1) Paragraph (a) of the definition aliment nouveau in section B.28.001 of the French version of the Regulations is replaced by the following:

• a) substance, y compris un microorganisme, qui ne présente pas d’antécédents d’innocuité comme aliment;

(2) The portion of paragraph (c) of the definition aliment nouveau in section B.28.001 of the French version of the Regulations before subparagraph (i) is replaced by the following:

• c) aliment dérivé d’un végétal, d’un animal ou d’un microorganisme qui, ayant été modifié génétiquement, selon le cas :

(3) Subparagraph (c)(iii) of the definition aliment nouveau in section B.28.001 of the French version of the Regulations is replaced by the following:

• (iii) présente un ou plusieurs caractères qui ne se trouvent plus dans les limites prévues pour ce végétal, cet animal ou ce microorganisme. (novel food)

146 The definition modifier génétiquement in section B.28.001 of the French version of the Regulations is replaced by the following:

modifier génétiquement

Manipuler intentionnellement les caractères héréditaires d’un végétal, d’un animal ou d’un microorganisme. (genetically modify)

147 Subparagraph B.29.018(3)(c)(iv) of the Regulations is replaced by the following:

• (iv) any statement referred to in subsection B.16.015(1); and

148 Subparagraph B.29.020(2)(b)(iv) of the Regulations is replaced by the following:

• (iv) any statement referred to in subsection B.16.015(1),

149 The Regulations are amended by adding the following after section B.29.032:

DIVISION 30

Microbiological Criteria

Interpretation

B.30.001 The following definitions apply in this Division.

equivalent method

means a method of analysis that is equivalent to a microbiological reference method as determined in accordance with the document entitled Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis, published by the Government of Canada on its website, as amended from time to time. (méthode équivalente)

microbiological reference method

means a method of analysis set out in column 2 of the document entitled Table of Microbiological Reference Methods for Food, published by the Government of Canada on its website, as amended from time to time, in respect of a corresponding microorganism set out in column 1. (méthode de référence microbiologique)

Table of Microbiological Criteria

means the document entitled Table of Microbiological Criteria for Food, published by the Government of Canada on its website, as amended from time to time. (Tableau des critères microbiologiques)

Adulteration

B.30.002 A food set out in column 1 of the Table of Microbiological Criteria is adulterated if a corresponding microorganism set out in column 2 is present in or on the food and at least one of the following conditions is met:

• (a) the number of sample units of the food with a level of the microorganism greater than that set out in column 5 is greater than the number set out in column 4; or
• (b) the level of the microorganism in any of the sample units of the food is greater than the level, if any, set out in column 6.

Exemption

B.30.003 A food set out in column 1 of the Table of Microbiological Criteria is, in respect of the presence of a corresponding microorganism set out in column 2, exempt from the application of paragraph 4(1)(a) of the Act, if neither condition described in paragraphs B.30.002(a) or (b) is met in relation to the microorganism.

Assessment

B.30.004 For the purpose of sections B.30.002 and B.30.003,

• (a) the number of sample units taken for a food set out in column 1 of the Table of Microbiological Criteria for the purpose of determining the level of a microorganism set out in column 2 must be the number of sample units set out in column 3 in relation to that microorganism; and
• (b) the level of a microorganism present in or on a food is to be determined in accordance with an applicable microbiological reference method or an equivalent method.

150 Subsection D.01.001(1) of the Regulations is amended by adding the following in alphabetical order:

Food Compositional Standards Document

has the same meaning as in subsection B.01.001(1); (Document sur les normes de composition des aliments)

151 Section D.01.011.1 of the Regulations is repealed.

152 (1) Paragraph D.02.011(a) of the Regulations is replaced by the following:

• (a) the bioavailability of the iron in the food is not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as defined in subsection B.01.001(1), as determined by the corresponding method set out in column 4; and

(2) Paragraph D.02.011(b) of the English version of the Regulations is replaced by the following:

• (b) that person retains documentary evidence showing that the bioavailability of the iron in the food has been determined by the method referred to in paragraph (a) and, on request by the Minister, submits such evidence to the Minister.

153 (1) The portion of item 4 of the table to section D.03.002 of the Regulations in column I is replaced by the following:

Column I Food
4	Margarine and calorie-reduced margarine for which a standard is set out in Volume 8 of the Food Compositional Standards Document, and other similar substitutes for butter

(2) The portion of items 10 to 15 of the table to section D.03.002 of the Regulations in column I is replaced by the following:

Column I Food
10	Condensed milk, milk, milk powder, sterilized milk and (naming the flavour) milk for which a standard is set out in Volume 7 of the Food Compositional Standards Document
11	Skim milk with added milk solids, partly skimmed milk with added milk solids, (naming the flavour) skim milk, (naming the flavour) partly skimmed milk, (naming the flavour) skim milk with added milk solids, (naming the flavour) partly skimmed milk with added milk solids, skim milk, partly skimmed milk and skim milk powder for which a standard is set out in Volume 7 of the Food Compositional Standards Document
12	Evaporated milk for which a standard is set out in Volume 7 of the Food Compositional Standards Document
13	Evaporated skim milk and evaporated partly skimmed milk, for which a standard is set out in Volume 7 of the Food Compositional Standards Document
14	Apple juice, reconstituted apple juice, grape juice, reconstituted grape juice, pineapple juice, reconstituted pineapple juice, apple and (naming the fruit) juice and concentrated (naming the fruit) juice except frozen concentrated orange juice for which a standard is set out in Volume 10 of the Food Compositional Standards Document
15	White flour for which a standard is set out in Volume 12 of the Food Compositional Standards Document

(3) The portion of item 17 of the table to section D.03.002 of the Regulations in column I is replaced by the following:

Column I Food
17	Salt, for table use, for which a standard is set out in Volume 14 of the Food Compositional Standards Document, and table salt substitutes

(4) The portion of item 25 of the table to section D.03.002 of the Regulations in column I is replaced by the following:

Column I Food
25	Pre-cooked rice, as defined in section B.13.010.1

(5) Item 26 of the table to section D.03.002 of the Regulations is replaced by the following:

Column I Food		Column II Vitamin, Mineral Nutrient or Amino Acid
26	Water represented as mineral water or spring water for which a standard is set out in Volume 11 of the Food Compositional Standards Document, water in sealed containers and prepackaged ice	Fluoride

(6) The portion of item 27 of the table to section D.03.002 of the Regulations in column I is replaced by the following:

Column I Food
27	Liquid whole egg, dried whole egg, frozen whole egg, liquid yolk, dried yolk, frozen yolk, liquid egg-white, dried egg-white, frozen egg-white, liquid whole egg mix, dried whole egg mix, frozen whole egg mix, liquid yolk mix, dried yolk mix and frozen yolk mix for which a standard is set out in Volume 19 of the Food Compositional Standards Document

154 Paragraph D.03.003(b) of the Regulations is replaced by the following:

• (b) no standard is set out in the Food Compositional Standards Document for the food; and

Regulations Amending the Food and Drug Regulations (Nutrition Symbols, Other Labelling Provisions, Vitamin D and Hydrogenated Fats or Oils)

155 (1) Subsection 53(1) of the Regulations Amending the Food and Drug Regulations (Nutrition Symbols, Other Labelling Provisions, Vitamin D and Hydrogenated Fats or Oils) ^{footnote 3} is replaced by the following:

53 (1) In this section, former Regulations means the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force.

(2) Section 53 of the Regulations is amended by adding the following after subsection (1):

(1.1) Unless the context requires otherwise, words and expressions used in this section have the same meaning as in the Food and Drugs Act and the Food and Drug Regulations.

(3) Paragraphs 53(3)(e) and (f) of the Regulations are repealed.

(4) Subsection 53(3) of the Regulations is amended by removing “and” at the end of paragraph (g) and by adding the following after paragraph (h):

• (i) section B.16.015; and
• (j) section B.16.018.

(5) The portion of subsection 53(4) of the Regulations before paragraph (a) is replaced by the following:

(4) A prepackaged product is not required to be labelled in accordance with the following provisions of the Food and Drug Regulations if it is labelled in accordance with the former Regulations and no change has been made to the label of the product to bring the product into compliance with any of the following provisions or any of the provisions referred to in paragraphs (4.1)(a) to (d):

(6) Subsection 53(4) of the Regulations is amended by adding “and” at the end of paragraph (i) and by repealing paragraphs (j) and (k).

(7) Subsection 53(5) of the Regulations is replaced by the following:

(4.1) A prepackaged product is not required to be labelled in accordance with the following provisions of the Food Compositional Standards Document, if it is labelled in accordance with the former Regulations and no change has been made to the label of the product to bring the product into compliance with any of the following provisions of that document or any of the provisions referred to in paragraphs (4)(a) to (l):

• (a) paragraph 7.4.2(2)(a);
• (b) paragraph 7.4.2(3)(a);
• (c) paragraph 7.4.3(2)(a); and
• (d) paragraph 7.4.3(3)(a).

(5) A food to which any of the following provisions of the Food and Drug Regulations applies is not required to contain an amount of vitamin D that complies with the requirement set out in that provision if the food contains an amount of vitamin D that complies with the requirement set out in the corresponding provision of the former Regulations:

• (a) paragraph B.08.003(a), the corresponding provision being paragraph B.08.003(b) of the former Regulations;
• (b) paragraphs B.08.005(1)(b) and B.08.005(2)(a), the corresponding provision being paragraph B.08.004(c) of the former Regulations;
• (c) paragraphs B.08.005(1)(b) and B.08.005(2)(b), the corresponding provision being paragraph B.08.005(c) of the former Regulations;
• (d) paragraph B.08.003(b), the corresponding provision being paragraph B.08.007(d) of the former Regulations;
• (e) paragraph B.08.010(b), the corresponding provision being paragraph B.08.010(d) of the former Regulations;
• (f) paragraph B.08.011(c), the corresponding provisions being paragraphs B.08.011(e) or B.08.012(f), as the case may be, of the former Regulations;
• (g) section B.08.004, the corresponding provision being paragraph B.08.013(c) of the former Regulations;
• (h) paragraph B.08.006(b), the corresponding provision being paragraph B.08.014(d) of the former Regulations;
• (i) paragraph B.08.003(c), the corresponding provision being paragraph B.08.016(c) of the former Regulations;
• (j) paragraphs B.08.005(1)(b) and B.08.005(2)(c), the corresponding provision being paragraph B.08.017(d) of the former Regulations;
• (k) paragraphs B.08.005(1)(b) and B.08.005(2)(d), the corresponding provision being paragraph B.08.018(d) of the former Regulations;
• (l) paragraphs B.08.005(1)(b) and B.08.005(2)(e), the corresponding provision being paragraph B.08.019(e) of the former Regulations;
• (m) paragraphs B.08.005(1)(b) and B.08.005(2)(f), the corresponding provision being paragraph B.08.020(d) of the former Regulations;
• (n) paragraphs B.08.005(1)(b) and B.08.005(2)(g), the corresponding provision being paragraph B.08.023(e) of the former Regulations;
• (o) paragraphs B.08.005(1)(b) and B.08.005(2)(h), the corresponding provision being paragraph B.08.026(e) of the former Regulations; and
• (p) paragraph B.09.016(1)(b), the corresponding provision being subparagraph B.09.016(b)(iii) of the former Regulations.

Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods)

156 (1) Subsection 31(1) of the Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods) ^{footnote 4} is amended by adding the following in alphabetical order:

permitted food additive

means a food additive that is set out in, and used in accordance with, the Lists of Permitted Food Additives. (additif alimentaire autorisé)

(2) Section 31 of the Regulations is amended by adding the following after subsection (2):

(3) A food referred to in section 32 or 33 is deemed not to be a supplemented food and a substance referred to in clause 32(1)(b)(ii)(B) or in subparagraph 33(1)(c)(i) is deemed not to be a supplemental ingredient unless a change to the label of the food has been made to bring the food into compliance with any provision of the Food and Drug Regulations respecting the supplemented food facts table, list of cautionary statements or supplemented food caution identifier.

157 (1) The portion of subsection 32(1) of the Regulations before paragraph (a) is replaced by the following:

32 (1) Subject to section 35, the manufacturer of a food for which a Temporary Marketing Authorization Letter was issued under subsection B.01.054(1) of the Food and Drug Regulations and for which a Temporary Marketing Authorization number is set out in the TMAL Lists is exempt from the application of sections B.29.031, D.01.009, D.01.011, D.02.009 and D.03.002 of those Regulations in respect of the food if the following conditions are met:

(2) Subparagraph 32(1)(b)(i) of the Regulations is repealed.

(3) Clause 32(1)(b)(iii)(B) of the Regulations is replaced by the following:

(B) that is a permitted food additive.

158 (1) The portion of subsection 33(1) of the Regulations before paragraph (a) is replaced by the following:

33 (1) Subject to section 35, if a manufacturer of a food has submitted a request for a Temporary Marketing Authorization Letter for the food before the day on which these Regulations come into force and a Temporary Marketing Authorization Letter has not been issued under subsection B.01.054(1) of the Food and Drug Regulations before that day, the manufacturer is exempt from the application of sections B.29.031, D.01.009, D.01.011, D.02.009 and D.03.002 of those Regulations in respect of the food if the following conditions are met:

(2) Paragraph 33(1)(b) of the Regulations is repealed.

(3) Subparagraph 33(1)(c)(ii) of the Regulations is replaced by the following:

• (ii) that is a permitted food additive;

(4) Paragraph 33(1)(d) of the Regulations is replaced by the following:

• (d) with respect to a food, other than a food referred to in paragraph (f) or (g), if a substance set out in column 1 of the table to Part I of the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food — other than as a permitted food additive — and the total amount of that substance contained in the food is above one or more of the thresholds set out in columns 2 to 6 for that substance, the label of the food carries the applicable cautionary statements set out in the headings to columns 2 to 6 or statements with equivalent meaning;

(5) Subparagraph 33(1)(f)(i) of the Regulations is replaced by the following:

• (i) if a substance set out in column 1 of the table to Part I of the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food — other than as a permitted food additive — and the total amount of that substance contained in the food is above the threshold level set out in column 8 for that substance, the applicable cautionary statement set out in the heading to column 8 or a statement with equivalent meaning, and

(6) Subparagraphs 33(1)(g)(i) and (ii) of the Regulations are replaced by the following:

• (i) if a substance set out in column 1 of the table to Part I of the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food — other than as a permitted food additive — and the total amount of that substance contained in the food is above one or more of the thresholds set out in columns 2 to 6 for that substance, the applicable cautionary statements set out in the headings to columns 2 to 6 or statements with equivalent meaning, and
• (ii) if the total amount of caffeine contained in the food is above one or more of the thresholds set out in columns 2 to 4 of the table to Part II of the Threshold Levels for Cautionary Statements and Other Conditions of Use for the food category set out in column 1 to which the food belongs, the applicable cautionary statements set out in the headings to columns 2 to 4 or statements with equivalent meaning;

(7) Subsection 33(3) of the Regulations is repealed.

Excise Act, 2001

Denatured and Specially Denatured Alcohol Regulations

159 (1) The portion of the denaturant “Brillant blue FCF” of the table to section 3 of the Denatured and Specially Denatured Alcohol Regulations ^{footnote 5} in column 2 is replaced by the following:

Column 1 Denaturant	Column 2 Characteristics
Brilliant blue FCF	A blue synthetic colour that meets the specifications set out in either of the publications referred to in subsection B.16.011(2) of the Food and Drug Regulations.

(2) The portion of the denaturant “Indigotine” of the table to section 3 of the Regulations in column 2 is replaced by the following:

Column 1 Denaturant	Column 2 Characteristics
Indigotine	A blue synthetic colour that meets the specifications set out in either of the publications referred to in subsection B.16.011(2) of the Food and Drug Regulations.

Pest Control Products Act

Pest Control Products Regulations

160 The portion of paragraph 4(1)(g) of the Pest Control Products Regulations ^{footnote 6} before subparagraph (i) is replaced by the following:

• (g) a pest control product that is also a food additive set out in column 1 of the List of Permitted Preservatives, published by the Government of Canada on its website, as amended from time to time, if

Pest Control Products Fees and Charges Regulations

161 Clause 1(d)(ii)(A) of the Pest Control Products Fees and Charges Regulations ^{footnote 7} is replaced by the following:

(A) a food additive that is set out in column 1 of the Lists of Permitted Food Additives, as defined in subsection B.01.001(1) of those regulations,

Safe Food for Canadians Act

Safe Food for Canadians Regulations

162 (1) The definition wine in section 1 of the Safe Food for Canadians Regulations ^{footnote 8} is replaced by the following:

wine

means an alcoholic beverage that complies with the standard set out in section 2.7.1 of Volume 2 of the Food Compositional Standards Document. (vin)

(2) Paragraphs (a) to (c) of the definition common name in section 1 of the Regulations are replaced by the following:

• (a) the name of the food printed in boldface type, but not in italics, in a section of the Standards of Identity Document;
• (b) the name of the food printed in boldface type, but not in italics, in a section of the Food Compositional Standards Document; or
• (c) in any other case, the name by which it is generally known or a name that is not generic and that describes the food. (nom usuel)

(3) The portion of the definition nom usuel in section 1 of the French version of the Regulations before paragraph (a) is replaced by the following:

nom usuel

S’agissant d’un aliment :

(4) Section 1 of the Regulations is amended by adding the following in alphabetical order:

Food Compositional Standards Document

has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (Document sur les normes de composition des aliments)

163 Paragraph 249(2)(l) of the Regulations is replaced by the following:

• (l) any cheese that is listed in Part I or II of the table to section 7.4.1 of Volume 7 of the Food Compositional Standards Document.

Cannabis Act

Cannabis Regulations

164 (1) The definition marketing authorization in subsection 1(2) of the Cannabis Regulations ^{footnote 9} is repealed.

(2) Subsection 1(2) of the Regulations is amended by adding the following in alphabetical order:

Lists of Permitted Food Additives

has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (Listes des additifs alimentaires autorisés)

165 (1) Subparagraphs 28.1(4)(c)(i) to (iv) of the Regulations are replaced by the following:

• (i) the edible cannabis would be a food that is set out in column 3 of the Lists of Permitted Food Additives if the edible cannabis did not contain or have on it anything referred to in item 1 or 3 of Schedule 1 to the Act,
• (ii) the food additive is set out in column 1 and is not caffeine or caffeine citrate,
• (iii) the food additive is obtained from any corresponding source set out in column 2,
• (iv) the food additive is used for any corresponding purpose of use set out in column 4,
• (v) the amount of the food additive does not exceed

(A) any corresponding maximum level of use and any corresponding maximum level of residue set out in column 5, and

(B) the amount that is required to accomplish the purpose for which it is added, in the case where the words “Good Manufacturing Practice” appear in column 5 for that food additive in the food, and

• (vi) any other corresponding condition set out in column 5 is met; and

(2) Subsection 28.1(5) of the Regulations is replaced by the following:

Vitamins and mineral nutrients

(5) If the conditions set out in subparagraphs (4)(c)(i) to (vi) are met, the holder of a licence for research whose licence authorizes the production of cannabis may use a vitamin or mineral nutrient as an ingredient to produce edible cannabis that is administered or distributed to a human participant in the conduct of non-therapeutic research on cannabis and that is not a cannabis product or is contained in a cannabis accessory that is not a cannabis product.

166 Paragraphs 102(5)(a) to (d) of the Regulations are replaced by the following:

• (a) the edible cannabis would be a food that is set out in column 3 of the Lists of Permitted Food Additives, if the edible cannabis did not contain or have on it anything referred to in item 1 or 3 of Schedule 1 to the Act;
• (b) the food additive is set out in column 1 and is not caffeine or caffeine citrate;
• (c) the food additive is obtained from any corresponding source set out in column 2;
• (d) the food additive is used for any corresponding purpose of use set out in column 4;
• (e) the amount of the food additive does not exceed
  • (i) any corresponding maximum level of use and any corresponding maximum level of residue set out in column 5, and
  • (ii) the amount that is required to accomplish the purpose for which it is added, in the case where the words “Good Manufacturing Practice” appear in column 5 for that food additive in the food; and
• (f) any other corresponding condition set out in column 5 is met.

167 Subsection 102.1(2) of the Regulations is amended by striking out “or” at the end of paragraph (b), by adding “or” at the end of paragraph (c) and by adding the following after paragraph (c):

• (d) a food additive, if the conditions set out in subparagraphs 28.1(4)(c)(i) to (vi) or the requirements set out in paragraphs 102(5)(a) to (f), as the case may be, are met in respect of the use of the food additive as an ingredient to produce the edible cannabis.

Coming into Force

168 These Regulations come into force on the day on which they are published in the Canada Gazette, Part II.

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