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Table of Contents
- General Requirements
- How Food Additives are Regulated
- Manner of Declaring in the List of Ingredients
- Food Additive Preparations
- Caffeine as a Food Additive
- Food Colours
- Related Links
A food additive (definition) is any substance that, when added to a food, becomes part of that food or affects its characteristics.
Food additives do not include:
- any nutritive material that is used, recognized or commonly sold as an article of food or an ingredient of food;
- vitamins, mineral nutrients and amino acids, except those listed in the lists of permitted food additives;
- spices, seasonings, flavouring preparations (definition), essential oils, oleoresins and natural extractives;
- agricultural chemicals, except those listed in the tables to lists of permitted food additives;
- food packaging materials and their components; and
- drugs recommended for administration to animals that may be consumed as food; [B.01.001(1), FDR; 2(1), Processed Products Regulations].
Food additives or classes of food additives can only be used in certain foods. Health Canada's 15 lists of permitted food additives indicate which standardized and unstandardized foods can contain a given food additive.
There are specifications in the Food and Drug Regulations (FDR) for certain food additives. If there are no food additive specifications under the FDR, food additives, including most food colours must comply with specifications set out in the Food Chemical Codex (FCC) or the specifications of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) [B.01.045, FDR].
How Food Additives are Regulated
Health Canada regulates food additive use under the FDR and associated Marketing Authorizations (MA). The CFIA is responsible for the enforcement of these regulations and MAs.
If the lists of permitted food additives do not allow for a particular use of a food additive, a manufacturer may file a food additive submission with Health Canada in order to use that food additive in foods sold in Canada. For additional information, refer to Health Canada's Guide for the Preparation of Submissions on Food Additives.
Manner of Declaring in the List of Ingredients
As indicated in the section on manner of declaring ingredients, food additives must be declared by an acceptable common name in the list of ingredients of a prepackaged product. However, as per B.01.008(4)(d) of the FDR, they may be listed at the end of the list of ingredients in any order.
For all requirements and information related to the list of ingredients, refer to the List of Ingredients and Allergens page.
Use of Optional Class Names
The FDR allows for the use of collective/class names to classify a group of similar food additives in the list of ingredients, without having to list each ingredient individually.
For example: any combination of disodium phosphate, monosodium phosphate, sodium hexametaphosphate, sodium tripolyphosphate, tetrasodium pyrophosphate and sodium acid pyrophosphate can be listed as "sodium phosphate" or "sodium phosphates" as shown under item 8 of the table to B.01.010(3)(b) of the FDR.
Similarly, when potassium bisulphite, potassium metabisulphite, sodium bisulphite, sodium metabisulphite, sodium sulphite, sodium dithionite, sulphur dioxide and/or sulphurous acid are used together as preservatives, they can be listed as "sulphiting agents", "sulfiting agents", "sulphites" or "sulfites" as shown under item 21 of the table to B.01.010(3)(b) of the FDR.
Note: Sulphites have been identified as one of the nine priority allergens in Canada. Please refer to the Food allergens, Gluten and Added Sulphite Declaration section regarding the regulatory requirements for declaration of sulphites in the list of ingredients.
Components of Preparations
When food additives are used in preparations or mixtures and have a function or effect on the food, they are required to be declared in the list of ingredient as if they were ingredients.
For example: brominated vegetable oil and sucrose acetate isobutyrate are additives that are permitted solely in flavours for use in citrus-flavoured and spruce-flavoured beverages, and their maximum level of use is based on their concentration in the beverage as consumed. These additives are density adjusting agents and will have an effect on the final beverage. As these additives keep the flavour preparation in suspension and prevent the formation of an oil ring at the surface of the beverage, they must be declared in the list of ingredients as ingredients are declared (i.e. in the order of their proportion of the product) [B.01.009(3)(f), FDR].
Use of Synonyms
For food additives, the names in Health Canada's lists of permitted food additives are always acceptable common names. In some cases, there are also permitted synonyms. Synonyms acceptable for use as common names for food additives may include names used by the international Codex Alimentarius Commission, names accepted by other regulatory authorities, names in specifications for food additives established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), or names in food additive monographs published in the Food Chemicals Codex (FCC). Acceptable names can also include the name(s) by which the food additive is generally known in Canada.
Some alternate common names to the ones listed in Health Canada's lists of permitted food additives are recognized for use in the lists of ingredients of foods sold in Canada. The CFIA reviews and assesses synonyms for use as common names in the list of ingredients. Acceptable alternate common names are listed in the Permitted Synonyms for Food Additives table.
The Codex Alimentarius International Numbering System (INS) for food additives or the numbering system used by the European Union (e.g., E 102) are not acceptable alone as the common name declaration for the food additive in Canada. They may be declared as supplementary information, when the food additive is already declared in the list of ingredients by its required common name or acceptable synonym.
Use of Abbreviations
In some cases the use of abbreviations for food additives may be acceptable common names in the list of ingredients. For example, TBHQ is an acceptable synonym for tertiary butylhydroquinone. Acceptable abbreviations are also listed in the Permitted Synonyms for Food Additives table.
Food Additive Preparations
Food additive preparations must include the following information on their labels:
- either a quantitative statement of the amount of each additive present, or
- directions for use which, if followed, will produce a food that does not contain additives above the maximum levels prescribed in the lists of permitted food additives.
Caffeine as a Food Additive
Health Canada's Marketing Authorizations allow for the use of caffeine and caffeine citrate as food additives in cola type beverages and "non-alcoholic carbonated water-based flavoured sweetened beverages" (this includes carbonated soft drinks). Additionally, Health Canada has provided preliminary guidance for industry on the labelling of caffeine content in prepackaged foods. While Health Canada's guidance reflects a best practice, it is currently a voluntary approach.
Caffeinated energy drinks are considered a food and require a Temporary Marketing Authorization Letter (TMAL) to allow for the use of caffeine. A TMAL may also include specifications regarding product composition and labelling. Refer to CFIA's guidance on the Transition of Caffeinated Energy Drinks from NHPs to Food using Temporary Marketing Authorization Letters (TMAL) for more information.
Colours that are acceptable for use as food additives are listed in the list of permitted colouring agents.
Most food colours must meet the specifications set out in the Food Chemical Codex (FCC) or the specifications of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The two food colours Ponceau SX and Citrus Red No. 2 must meet the specifications set out in Division 6 of the Food and Drug Regulations (FDR). In the case where no FDR, FCC or JECFA specifications exist for a specific food colour, it must contain no more than 3 parts per million of arsenic, and 10 parts per million of lead [B.01.045, FDR].
Colours are permitted to be declared in the list of ingredients of a prepackaged product by using the names in Health Canada's list of permitted colouring agents as common names, or by using the collective class name "colour" [B.01.010(1)(b), item 3, FDR].
Rules surrounding the use of colours include:
- The term "colour" cannot be used to describe annatto, allura red or sunset yellow FCF when used in certain meat preparations;
- Annatto must be declared as "annatto" when used in the preparation of tocino [B.14.031(i), FDR];
- Annatto, allura red, and/or sunset yellow FCF must be declared as annatto, allura red, and/or sunset yellow FCF when used in the preparation of longaniza sausage [B.14.032(d)(xvi), FDR];
- The US colour common name is only acceptable when it is presented in brackets following the Canadian colour common name (e.g., "Brilliant Blue FCF (FD & C Blue No. 1)") or if it is followed by the collective class name "colour" (e.g., "FD & C Blue No. 1 colour");
- A preparation of colours for use in or upon food must carry the words "Food Colour Preparation" on its principal display panel (definition) B.06.007(a), FDR].
In Canada, there is no regulatory definition for processing aids. However, the Food Directorate of Health Canada has defined a processing aid as a substance that:
- is used for a technical effect in food processing or manufacture;
- when used, does not affect the intrinsic characteristics of the food; and
- when used, results in no or negligible residues of the substance or its by-products in or on the finished food.
Food additives are not processing aids. Unlike food additives, processing aids are not considered to be ingredients, and are therefore not required to be declared on prepackaged food labels under FDR. Although there are no regulatory requirements for the preclearance of processing aids as there are for food additives, using processing aids is controlled by subsection 4(1) of the Food and Drugs Act.
Health Canada has developed a policy for differentiating between food additives and food processing aids. This policy provides guidance to determine whether or not a substance is a food additive or a processing aid.
The following table is a list of substances that are added to food during processing for a "processing aid" function, and are not required to be declared in the list of ingredients (because they are not considered food ingredients).
|1.||Hydrogen for hydrogenation purposes, currently exempt under B.01.008|
|2.||Cleansers and sanitizers|
|3.||Head space flushing gases and packaging gases Table Note 1|
|4.||Contact freezing and cooling agents|
|5.||Washing and peeling agents|
|6.||Clarifying or filtering agents used in the processing of fruit juice, oil, vinegar, beer, wine and cider (The latter three categories of standardized alcoholic beverages are currently exempt from ingredient listing.)|
|7.||Catalysts that are essential to the manufacturing process and without which, the final food product would not exist, e.g., nickel, copper, etc.|
|8.||Ion exchange resins, membranes and molecular sieves that are involved in physical separation and that are not incorporated into the food|
|9.||Desiccating agents or oxygen scavengers that are not incorporated into the food|
|10.||Water treatment chemicals for steam production|
- Table Note 1
Includes gases such as nitrogen and carbon dioxide
- Permitted Synonyms for Food Additives table
- Specific Food Colours Permitted in Canada and their Corresponding European Numbers and/or United States Names
- Health Canada's Transition Guide: Understanding and Using the Lists of Permitted Food Additives
- Health Canada's guide for the preparation of submissions on food additives
- Health Canada's Food additive submission checklist
A food additive is any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of or affecting the characteristics of a food [B.01.001, FDR].
Food Additive Categories
There are fifteen lists of permitted food additives, which are housed on the Health Canada website, and organized by major functional categories:
- Anti-caking agents
- Bleaching, maturing and dough conditioning agents
- Colouring agents
- Emulsifying, gelling, stabilizing or thickening agents
- Food enzymes
- Firming agents
- Glazing and polishing agents
- Food additives with other generally accepted uses
- pH adjusting agents, acid reacting materials or water correcting agents
- Preservatives (Classes I-IV)
- Part 1 - Class 1 - curing preservatives;
- Part 2 - Class 2 - antibacterial;
- Part 3 - Class 3 - antifungal and antimycotic;
- Part 4 - Class 4 - antioxidants
- Sequestering agents
- Starch modifying agents
- Yeast foods
- Carrier or extraction solvents
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