Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food: SOR/2024-244

Canada Gazette, Part II, Volume 158, Number 26

Registration
SOR/2024-244 November 29, 2024

FOOD AND DRUGS ACT
EXCISE ACT, 2001
PEST CONTROL PRODUCTS ACT
SAFE FOOD FOR CANADIANS ACT
CANNABIS ACT
FEEDS ACT

P.C. 2024-1270 November 29, 2024

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, with respect to the provisions of the annexed Regulations other than sections 161, 164, 165 and 170, and on the recommendation of the Minister of National Revenue with respect to that section 161 and of the Minister of Agriculture and Agri-Food with respect to those sections 164, 165 and 170, makes 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};
(e) subsection 139(1) of the Cannabis Act ^{footnote g}; and
(f) subsection 5(1)^{footnote h} of the Feeds Act ^{footnote i}.

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 1} 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authorization, parts per million or p.p.m. and unstandardized food in subsection B.01.001(1) of the Regulations are repealed.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substances adultérantes dans les aliments in subsection B.01.001(1) of the French version of the Regulations is repealed.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: La 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, words and expressions that are used but not defined in that document have the same meaning as in those parts.

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) Scotch whisky, Irish whisky, Armagnac brandy, Cognac brandy, Bourbon whisky, Tennessee whisky, Tequila and Mezcal; 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.16.016 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.16.016(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, Scotch whisky, Irish whisky, Armagnac brandy, Cognac brandy, Bourbon whisky, Tennessee whisky, Tequila and Mezcal;
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

(6) Item 1 of the table to subsection B.01.009(2) of the Regulations is repealed.

(7) Item 8 of the table to subsection B.01.009(2) of the Regulations is replaced by the following:
Item	Preparation/Mixture
8	food additive preparations, including food colour preparations and rennet preparations

(8) Item 9 of the table to subsection B.01.009(2) of the Regulations is repealed.

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.16.016(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.16.016(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.16.016(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.16.016(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 a 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), if a substance — other than a supplemental ingredient — is 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.16.016(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

(7) Paragraph B.01.350(13)(d) of the French version of the Regulations is replaced by the following:

d) le produit vendu uniquement dans l’établissement de détail où il est préparé et transformé à partir de ses ingrédients, y compris un prémélange si un ingrédient autre que de l’eau y est ajouté lors de la préparation et de la transformation du produit;

18 Subparagraph B.01.401(2)(b)(v) of the French version of the Regulations is replaced by the following:

(v) un produit vendu uniquement dans l’établissement de détail où il est préparé et transformé à partir de ses ingrédients, y compris un prémélange si un ingrédient autre que de l’eau y est ajouté lors de la préparation et de la transformation du produit,

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

(iv) any statement referred to in subsection B.16.016(1); and

20 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;

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

(b) the food does not contain a sweetener.

22 (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:

23 Section B.02.001 of the Regulations is repealed.

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

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

26 (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.

27 Section B.02.018 of the Regulations is repealed.

28 (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.

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

30 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.

31 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.

32 Section B.02.030 of the Regulations is repealed.

33 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.

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

35 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.

36 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)

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

38 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

39 (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.

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

41 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.

42 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.

43 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.

44 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.

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

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

47 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.

48 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.

49 Sections B.08.003 to B.08.009 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.

50 Sections B.08.010 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.

51 (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.

52 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.

53 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.

54 (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.

55 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).

56 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

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

58 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.

59 Sections B.08.075 to B.08.077 of the Regulations and the heading before them are replaced by the following:

Sour Cream

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

60 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.

61 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.

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

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

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

65 Section B.11.001.1 of the Regulations is repealed.

66 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.

67 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.

68 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.

69 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.

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

71 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.

72 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.

73 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.

74 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.

75 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.

76 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 :

77 (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.

78 (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.

79 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.

80 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.

81 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.

82 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.

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

84 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.

85 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 it 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)

86 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.

87 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 or 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.

88 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.

89 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.

90 Section B.14.020 of the Regulations is repealed.

91 (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.

92 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.

93 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.

94 (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.

95 (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.

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

97 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;

98 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

99 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

100 (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

101 (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

102 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

103 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

104 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;

105 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;

106 (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;

107 (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;

108 (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;

109 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;

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

Contaminants

111 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.

112 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)
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.16.005 and B.16.006, 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 additive set out in column 1 of the Lists of Permitted Food Additives is combined with other ingredients to manufacture a pre-mix — other than a pre-mix set out in column 3 — the pre-mix 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 if

(a) the pre-mix is intended solely for use as an ingredient in the manufacture of another food intended for sale to a consumer at the retail level or as an ingredient in the preparation of another food by a commercial or industrial enterprise or an institution;
(b) the pre-mix is not intended for sale to a consumer at the retail level;
(c) the food additive is obtained from any corresponding source set out in column 2; and
(d) the food additive is intended for any corresponding purpose of use set out in column 4 in relation to a corresponding food set out in column 3.

B.16.005 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.16.006 (1) Subject to subsections (2) to (4), sections B.16.003 and B.16.005 do not apply to an infant food.

(2) Sections B.16.003 and B.16.005 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.16.005 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.16.007 (1) Sections B.16.003, B.16.005 and B.16.006 apply to the foods referred to in those sections if the other requirements of these Regulations that apply with respect to the food additive referred to in those sections are met.

(2) Section B.16.004 applies to the pre-mix referred to in that section if the other requirements of these Regulations that apply with respect to the food additive referred to in that section are met.

Prohibitions

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 and Packaging

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 these 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 A quantitative statement of the amount of each food additive referred to in section B.16.004 and directions for use that, if followed, will produce a corresponding food set out in column 3 of the Lists of Permitted Food Additives that does not contain these 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 a pre-mix referred to in that section.

B.16.015 No person shall sell for household use in or on a food, a food colour preparation containing one or more synthetic colours unless

(a) the words “Food Colour Preparation” appear on the principal display panel;
(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; and
(c) the food colour preparation contains less than 3% dye.

B.16.016 (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.16.017 The label of a food that contains polydextrose must indicate the amount of polydextrose, expressed in grams per serving of stated size.

B.16.018 (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.16.019 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.16.020 (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.

113 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.

114 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.

115 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”.

116 Division 20 of Part B of the Regulations is repealed.

117 Section B.21.001 of the Regulations is repealed.

118 (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.

119 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.

120 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.

121 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.

122 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;

123 Sections B.21.027 to 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.

124 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 a poultry meat by-product unless it is clean, dressed and derived from eviscerated poultry that was healthy at the time of slaughter.

125 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.

126 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.

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

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

129 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;

130 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).

131 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;

132 (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;

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

134 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.

135 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.

136 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

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

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

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

140 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

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

142 (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.

143 (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;

144 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.

145 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 :

146 (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)

147 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)

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

(iv) any statement referred to in subsection B.16.016(1); and

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

(iv) any statement referred to in subsection B.16.016(1),

150 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.

151 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)

152 Section D.01.011.1 of the Regulations is repealed.

153 (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.

154 (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

155 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

156 The French version of the Regulations is amended by replacing “vaseline” with “gelée de pétrole” in the following provisions:

(a) subsection B.01.312(1.1);
(b) subparagraph B.01.401(2)(c)(i);
(c) subsection B.01.503(2.1);
(d) the portion of item 1 of the table following section B.01.603 in column 3;
(e) the portion of subitem 2(2) of the table following section B.01.603 in column 3;
(f) the portion of item 3 of the table following section B.01.603 in column 3;
(g) subsection D.01.004(1.1); and
(h) subsection D.02.002(1.1).

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

157 (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 2} 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.16.016; and
(j) section B.16.019.

(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)

158 (1) Subsection 31(1) of the Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods) ^{footnote 3} 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.

159 (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.

160 (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

161 (1) The portion of the table to section 3 of the Denatured and Specially Denatured Alcohol Regulations ^{footnote 4} in column 2 opposite the denaturant “Brilliant blue FCF” 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 table to section 3 of the Regulations in column 2 opposite the denaturant “Indigotine” 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

162 The portion of paragraph 4(1)(g) of the Pest Control Products Regulations ^{footnote 5} 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

163 Clause 1(d)(ii)(A) of the Pest Control Products Fees and Charges Regulations ^{footnote 6} 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

164 (1) The definition wine in section 1 of the Safe Food for Canadians Regulations ^{footnote 7} 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)

165 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

166 (1) The definition marketing authorization in subsection 1(2) of the Cannabis Regulations ^{footnote 8} 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)

167 (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.

168 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.

169 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.

Feeds Act

Feeds Regulations, 2024

170 Subparagraphs 69(2)(d)(iii) to (x) of the Feeds Regulations, 2024 ^{footnote 9} are replaced by the following:

(iii) the List of Permitted Anticaking Agents, the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents, the List of Permitted Firming Agents, the List of Permitted Flour Treatment Agents, the List of Permitted Food Additives with Other Purposes of Use, the List of Permitted Food Enzymes, the List of Permitted Preservatives or the List of Permitted Yeast Foods, referred to in the definition Lists of Permitted Food Additives in subsection B.01.001(1) of the Food and Drug Regulations.

Transitional Provisions

171 (1) The following definitions apply 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. (ancien règlement)
prepackaged product: has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (produit préemballé)

(2) Subject to subsection (3) and for the period that begins on the day on which these Regulations come into force and ends on December 31, 2027, section B.16.014 of the Food and Drug Regulations, as enacted by section 112, does not apply to a pre-mix that is referred to in section B.16.004 of those Regulations if it is labelled in accordance with the former Regulations.

(3) For the period that begins on the day on which these Regulations come into force and ends on December 31, 2025, a pre-mix referred to in section B.16.004 of the Food and Drug Regulations, as enacted by section 112, does not need to be labelled in accordance with section B.01.014 of the former Regulations if the pre-mix is a prepackaged product containing aspartame and is labelled in accordance with section B.01.014 of the Food and Drug Regulations as it read on December 13, 2016.

Coming into Force

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

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues: Canada’s Food and Drug Regulations (FDR) set out rules regulating various aspects of food products, including health, safety, composition, labelling, treatment, processing, packaging, sale and advertising. Included among these are over 300 food compositional standards, which set out requirements (e.g. permitted ingredients, quality parameters, manufacturing methods, prescribed common names) for foods that must be followed if the food is to be imported or traded between provinces. Many of these food compositional standards are not responsive to innovations in food manufacturing, to changes in consumer demand or to changes in international standards or trading partner practices. Further, many health and safety rules (e.g. microbiological criteria, food additives) are embedded within the food compositional standards, which leads to unnecessary duplication and can confuse the proper interpretation, application and enforcement of such rules.

In addition to the framework for food compositional standards, frameworks under the FDR that govern health and safety rules, such as microbiological criteria and official methods of analysis are prescribed in a way that, like standards, does not enable them to respond to new science, innovation or emerging risks to health. For example, the FDR only reflect the use of specific official methods of analysis to assess whether a food meets certain microbiological, chemical, physical and/or nutritional requirements. Unless amendments are made to the FDR, the use of modern and often better-performing alternative methods will not be reflected in them. Finally, outdated references to food additives remain throughout Part B of the FDR, as do redundant tables that were not removed when a new framework for these substances was created in 2012 through the creation of 15 marketing authorizations (MAs).

Description: These Regulations significantly amend Part B of the FDR, and include targeted amendments to Parts A and D. In particular, these amendments will introduce modernized frameworks for food compositional standards, microbiological criteria and official methods of analysis, as well as will complete the modernization of the food additives framework that was initiated in 2012. After the publication of the final Regulations in the Canada Gazette, Part II, a separate MA will be issued to repeal the existing 15 food additive MAs.

For food compositional standards, these amendments will move the elements of the standards that do not pertain to health and safety into a new document entitled Canadian Food Compositional Standards. This document is incorporated by reference into the FDR and doing so will allow the Canadian Food Inspection Agency (CFIA) to update food compositional standards. The health and safety provisions that previously formed part of the standards will remain in the FDR, with some modifications as described below. The amendments also repeal redundant rules for distinctive products captured under the Spirit Drinks Trade Act. A number of consequential amendments to the Safe Food for Canadians Regulations (SFCR) and revisions to four existing documents incorporated by reference, i.e. Canadian Standards of Identity (under the SFCR), Common Names for Ingredients and Components (under the FDR), Nutrition Labelling – Table of Reference Amounts of Food (under the FDR) and the Nutrition Labelling – Table of Permitted Nutrient Content Statements and Claims (under the FDR), will be made to align with these amendments to the FDR.

With respect to microbiological criteria and their associated microbiological methods of analysis, these Regulations amend the FDR to introduce a new regulatory framework under a new Division 30 of Part B that will include a new declaration of adulteration and exemption model. The microbiological criteria, previously included within the food compositional standards or separate provisions of the FDR, have been consolidated and will be moved into a new Table of Microbiological Criteria for Food that will be incorporated by reference into the FDR. In place of the current microbiological official methods of analysis, a new provision will require the use of a microbiological reference method or an equivalent method to determine whether a food meets its microbiological criteria. Accordingly, two new documents, entitled Table of Microbiological Reference Methods for Food and Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis, will also be incorporated by reference into the FDR. References to the microbiological official methods of analysis throughout Part B will be repealed.

To allow Health Canada and the CFIA to update requirements and allow the use of other official methods of analysis in response to new science, technology and innovation, current official methods linked to either health and safety requirements or compositional requirements will remain incorporated by reference into the FDR but now on an ambulatory (i.e. as amended from time to time) basis. A new Table of Chemical, Physical and Nutritional Characteristics of Food will consolidate such rules and also reference a new method for measuring the protein quality of foods. Official methods uniquely linked to a compositional requirement for a standardized food will move to the Canadian Food Compositional Standards. A number of consequential revisions to the Nutrition Labelling - Table of Permitted Nutrient Content Statements and Claims (under the FDR) will also be made to align it with these amendments to the FDR related to official methods.

Finally, most food additive provisions will be set out in Division 16 of Part B of the FDR within a declaration of adulteration and exemption model, which will incorporate by reference the Lists of Permitted Food Additives into the FDR and will remove duplications throughout Part B, including those in the food compositional standards. Rules with respect to food additives that are currently set out in the food compositional standards will be reflected in the 15 Lists of Permitted Food Additives as conditions of the exemptions. Consequential amendments will be made to the Cannabis Regulations, Denatured and Specially Denatured Alcohol Regulations, Pest Control Products Fees and Charges Regulations, Pest Control Products Regulations and the Feeds Regulations, 2024. A new document entitled Table of Food Additive Specifications will also be incorporated by reference into the FDR and consequential revisions will be made to the List of Permitted Supplemental Ingredients (under the FDR).

Rationale: These Regulations will support the implementation of science-based decision making, which will help prevent harm to the health of consumers, provide people in Canada with the predictability of composition, quality and purity of foods and protect them from deception, as well as enable improved informed purchasing decisions. They will also support innovation by the food industry and the research community. For the agri-food industry in particular, the modernization of these frameworks of the FDR will address long-standing irritants and barriers to market by providing a more responsive and adaptable regulatory framework that supports growth and innovation. In November 2023, the regulatory proposal was prepublished in the Canada Gazette, Part I. Health Canada and the CFIA received 56 submissions from stakeholders, which have been used to refine the regulations for final publication in the Canada Gazette, Part II. Overall, stakeholders supported the proposal to modernize the regulatory frameworks related to food compositional standards, microbiological criteria, and methods of analysis and to complete the modernization of the food additives framework. These amendments should not result in additional costs for industry. However, there will be a one-time cost to Health Canada (the Department) and the CFIA to create and enhance online webpages to include a number of documents that will be incorporated by reference into the FDR.

Issues

Canada’s FDR set out rules to help prevent harm to the health of consumers and ensure food products available to people in Canada are safe, rules to prevent misleading or deceiving consumers as to the foods they eat as well as rules to prevent deception in the manufacture and sale of goods consumed by the public. 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 in respect of foods that are imported, exported or traded interprovincially, 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. 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 standards prescribed under the SFCA apply to foods that are imported, exported and traded interprovincially. The CFIA and Health Canada have carefully considered the food compositional standards framework under the Food and Drugs Act (FDA) and FDR and determined that it is 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 pathogenic 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 people in Canada, while also potentially challenging compliance and enforcement efforts.

3. Outdated regulatory frameworks for methods of analysis

Certain provisions under the FDR refer to 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 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 and permit their use.

Currently, amendments to the FDR are needed 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 diminishes confidence in the regulatory requirements and also 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 referenced 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. 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, where applicable, 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, where applicable, effective by adding them to the Lists of Permitted Food Additives through an open and transparent process managed by the Department. However, the tables of permitted food additives set out under Division 16 were not repealed in October 2012 and have not, since the creation of the MAs, been amended regularly to reflect decisions made since 2012. These discrepancies have the potential to create confusion among stakeholders as to the applicable food additive rules. 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 such provisions, including some that are set out in the food compositional standards. Since the standards will be moved to an incorporated by reference document under these amendments, it is necessary to revise the Lists of Permitted Food Additives accordingly.

In response to the five issues described above, Health Canada and the CFIA will make significant amendments to Part B of the FDR. These amendments, which will also help advance commitments made in the Agri-Food and Aquaculture Sector Regulatory Review Roadmap (the Roadmap), focus on food compositional standards, microbiological criteria, methods of analysis and food additives. The modernized food additives framework will remove duplications and inconsistencies from the FDR, consolidate most of the food additives rules in a revised Division 16 and incorporate by reference the Lists of Permitted Food Additives as well as a new Table of Food Additive Specifications into the FDR.

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 in relation to food and also establishes the policies, regulations, standards and guidelines under the FDA that are not related to public health, safety of food or nutrition.

1. Food compositional standards

There are over 300 food compositional standards prescribed under the FDA. 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). These health and safety rules of the food compositional standards apply at all levels of trade.

The elements 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 imbedded 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 verify 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 (2023).

Regardless of the mechanism used (i.e. regulatory or non-regulatory), microbiological criteria are established by Health Canada 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 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 verifying 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 references to official methods in the FDR are to specific versions (i.e.1981). This has created issues for the Department and the CFIA in terms of ensuring that the most suitable methods can be used for regulatory purposes. Modern methods exist that are typically faster and more accurate, cost-effective and sensitive, and new methods have emerged to better respond to food safety issues related to pathogens, contaminants and nutritional quality.

With respect to MFOs, Health Canada sets out acceptable options in its online administrative Compendium of Analytical Methods. This Compendium is managed 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, the methods deemed appropriate by the Committee and set out in the Compendium of Analytical Methods are used by the food industry and the CFIA for verifying compliance with microbiological criteria. Current microbiological policies and guidelines also consistently direct regulated parties to the Compendium of Analytical Methods as the authoritative source of acceptable microbiological methods of analysis.

Regarding chemical, physical and nutritional methods of analysis, there is no formal mechanism in place, such as the Microbiological Methods Committee, to review and establish acceptable alternatives methods. The Department and the CFIA 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 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 commitments to pursuing the necessary amendments to the FDR to permit this method’s use and to create a flexible framework that would facilitate consideration of 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 broadened 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 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 managed by the Department following an open and transparent process. 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 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 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 will be addressing commitments made under the theme of “Clear, Agile, Responsive Regulations” through this joint regulatory initiative.

Health Canada committed to incrementally redesigning the food regulations, including modernizing the regulatory frameworks for microbiological criteria, methods of analysis and food additives. 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.”
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 regulatory package, which moves the elements of the food compositional standards that do not pertain to health and safety from the FDR to an incorporated by reference document, delivers on the commitment made under the CFIA’s “Creating an agile framework for compositional standards” initiative.

Objectives

These amendments contribute to making Canada’s FDR more agile, transparent and responsive to new and emerging science, technology, market innovation and risks to health. This will be accomplished by:

Enabling modifications to the FDR’s food compositional standards through an open and transparent process. This will help ensure the standards reflect current market practices, changes in consumer demand, are more closely harmonized with trading partners, enable product innovation, and facilitate the inter-provincial and international trade of foods;
Enabling modifications to the FDR’s microbiological criteria and associated microbiological methods of analysis through an open and transparent process. This will help ensure that regulatory rules intended to help protect the health and safety of people in Canada can be more easily updated to reflect the latest science;
Enabling modifications to the FDR’s methods of analysis through an open and transparent process. This will help ensure industry and regulators make use of more modern and effective methods of analysis in the FDR 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 duplicative 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.

These Regulations will support the implementation of science-based decision-making, which will help prevent harm to the health of consumers, provide people in Canada with the predictability of composition, quality and purity of foods and to protect them from deception, as well as enable improved informed purchasing decisions. They will 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 will 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 will make a significant number of amendments to bring flexibility and coherence to several provisions under Part B of the FDR. These amendments will include modernized regulatory frameworks for food compositional standards, microbiological criteria and methods of analysis. This will include the incorporation by reference of certain aspects of these rules, which in turn will enable Health Canada and the CFIA to better ensure rules respond to new and emerging science, technology, market innovation and/or risks to health.

In addition, the amendments related to food additives will create a modernized 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 will include the incorporation by reference of the Lists of Permitted Food Additives and the new Table of Food Additive Specifications into the FDR.

As a result, these Regulations will 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 will also be made to a number of other regulations, as will be revisions to existing documents incorporated by reference, as indicated in the respective sections below.

1. Food compositional standards

These Regulations will amend sections B.01.002 and B.01.042 of the FDR to clarify that food compositional standards, other than the health and safety rules formerly included in such standards, will now be found in a document defined as the Canadian Food Compositional Standards and incorporated by reference into section B.01.002 of the FDR. A new section B.01.043 will clarify that other substances (e.g. food additives, vitamins and mineral nutrients), except supplemental ingredients (as defined in the FDR), could be required or permitted in a food for which a standard is set out in the Canadian Food Compositional Standards, if so prescribed in a provision of the FDR. Below are the specific amendments respecting food compositional standards in the FDR.

Definitions and interpretation

These Regulations will update the existing definition of “common name” in the FDR to refer to the Canadian Food Compositional Standards 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” will also be updated to refer to the Canadian Food Compositional Standards. The existing definition of “unstandardized food” will be replaced with an updated definition for “unstandardized” and will also point to the Canadian Food Compositional Standards. This document will be defined in Parts B and D of the FDR. Lastly, two new definitions for “solid cut meat” and “solid cut poultry meat” will be introduced in Division 1 of Part B. These changes reflect that the foods are mentioned in other divisions and their definitions apply to these references throughout Part B.

These Regulations will introduce a new interpretation provision that clarifies that any words and 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 — Canadian Food Compositional Standards

To allow for changes to support industry innovation or administrative adjustments, these Regulations will move the elements of the food compositional standards that do not relate to health and safety from the FDR to a document entitled Canadian Food Compositional Standards, which will be incorporated by reference into the FDR.

This new document will set out the food compositional standards of 19 specific food commodities currently prescribed in Divisions 1 to 22 of Part B of the FDR: mixed nuts (revised to nut products in the Canadian Food Compositional Standards); alcoholic beverages; baking powder; cocoa and chocolate products; coffee; spices, dressings and seasonings (revised to spices, seasonings and dressings for salads in the Canadian Food Compositional Standards); dairy products; fats and oils; flavouring preparations; fruits, vegetables, their products and substitutes; prepackaged water and ice (revised to prepackaged water in the Canadian Food Compositional Standards); 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 will be repealed in their entirety.

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

Certain labelling provisions that currently form part of, or are closely associated with, a compositional standard of a food will be moved, along with the rest of the non-health and non-safety-related elements of the standards, into the Canadian Food Compositional Standards. 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. Commodity-specific labelling rules that apply to foods sold at all levels of trade will 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 will also stay in the FDR. This rule will 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 will 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, while not contained within the standards, are tightly linked to the standards, are compositional in nature and have no elements related to health and safety, will also be moved into the Canadian Food Compositional Standards. 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 will move to the Canadian Food Compositional Standards.

With certain exceptions, the food compositional standards set out in the Canadian Food Compositional Standards will not refer to food additives. For example, the compositional standard for “baking powder” currently requires the combination of certain ingredients, one of which is an acid-reacting material (a type of food additive), but also allows for the use of an anticaking agent (also a type of food additive) as an optional ingredient. The latter rule for the optional ingredient is already captured in the List of Permitted Anticaking Agents and will be removed from the compositional standard, but the reference to “acid-reacting material” will remain within the standard as this is a required ingredient. The compositional standard for “gelatin” will continue to provide for the use of acidic or basic compounds but instead of listing individual food additives, will point to those set out in the new List of Permitted Acidity Regulators and Acid-Reacting Materials (formerly the List of Permitted pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agents). The standard will 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 food compositional 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 food compositional 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 will be removed from these standards as Health Canada will permit individual food colours, Class II and Class IV preservatives, and emulsifying agents in these flavouring preparations by modifying the Lists of Permitted Food Additives. Health Canada took into consideration information provided from the flavouring industry on the use of food additives in flavouring preparations in response to the April 2020 Call for data on food additives in certain food flavouring preparations. In fall 2024, Health Canada published a notice entitled Modification to the Lists of permitted food additives to extend the use of certain emulsifying agents, food colours and preservatives to two types of standardized flavouring preparations.

Similar to those for food additives, applicable food fortification and microbiological rules will also be excluded from the Canadian Food Compositional Standards as these are health and safety rules applicable at all levels of trade. Food fortification rules will remain in Parts B and D of the FDR as prohibitions of sale and will be consolidated where possible. Certain microbiological safety rules will also remain in the text of the FDR, as prohibitions of sale and/or will be managed through the Table of Microbiological Criteria for Food (described in section 2 below), which will be incorporated by reference into the FDR. Prohibitions of sale apply to all foods sold in Canada, regardless of level of trade.

Other minor amendments that were considered necessary include updating certain French terms in the Canadian Food Compositional Standards and the FDR, including any relevant documents incorporated by reference. For example, the French term for “pumping pickle” will be updated to “marinade par injection” in the FDR, and the same change will be made in the Canadian Food Compositional Standards and in the Lists of Permitted Food Additives. The Canadian Food Compositional Standards will continue not to prescribe a standardized common name for pumping pickle. Other French terms that will be updated include “assaisonnements” for “seasonings,” “d’œuf entier” for “whole egg,” “gelée de pétrole” for “petrolatum,” “marinades et relishs” for “pickles and relishes,” “marinade par immersion” for “cover pickle,” “(nom de…)” for “(naming the…),” “saumuré(e)” for “cured,” “sauces pour salades” for “dressings for salads,” “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 will be amended to point to the relevant section of the Canadian Food Compositional Standards. If a provision referred to a category of standardized foods 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 will also be amended to reflect the fact that the food compositional standards will no longer appear in a provision of the FDR and the general meaning of the term will apply. This means that the provision will apply to the food or food category that is referred to in it regardless if there is a food compositional standard for that food or food category. For further clarity, reference to “marine and fresh water animal products” without the reference to Division 21 in a provision will mean that the provision applies to any marine and fresh water animal product including those that are unstandardized and are not currently mentioned in Division 21 or that will be in the Canadian Food Compositional Standards.

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 either redundant and/or in conflict with this Act, and as such will be repealed from the FDR and will not be copied over to the Canadian Food Compositional Standards. Two exemptions for ingredient and component labelling of certain alcoholic beverages are amended to include all of the above-mentioned distinctive products. Any remaining requirements related to modifying or blending Scotch whisky, Irish whisky, Bourbon whisky, Tennessee whisky, brandy, Tequila and Mezcal will 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 will be updated to “Eau-de-vie de vin (brandy),” to better reflect distillates captured in the provisions that will remain in this section of the FDR following the moving of the food compositional standards into the Canadian Food Compositional Standards. The French text in section B.02.043, which currently refers to “genièvre,” will be amended to align it with the English text 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 will 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 Canadian Food Compositional Standards

After the coming into force of these Regulations, the process set out in the CFIA Incorporation by Reference Policy will apply in respect of any changes to the Canadian Food Compositional Standards, ensuring that the Canadian Food Compositional Standards is managed based on guiding principles of accessibility, transparency, consistency, reasonableness and clarity. The Canadian Food Compositional Standards is to be created and reviewed in an open, transparent, consistent and inclusive way that meaningfully engages the public. Stakeholders will 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 the CFIA’s Canadian Standards of Identity document, will be amended to refer to the Canadian Food Compositional Standards rather than the FDR, where necessary. The Canadian Standards of Identity will also be revised to eliminate, to the extent possible, regulatory overlap with health and safety requirements that are maintained in the FDR (e.g. fortification and food additives rules).

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

Consequential revisions — Common Names for Ingredients and Components, Nutrition Labelling - Table of Permitted Nutrient Content Statements and Claims, Nutrition Labelling – Table of Reference Amounts for Food

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

2. Microbiological criteria and associated microbiological methods of analysis

These Regulations will 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 set out in the FDR will be moved and consolidated into the Table of Microbiological Criteria for Food. This table will be defined in Division 30 and incorporated by reference into the FDR through section B.30.002.

Adulteration and exemptions

A new provision will be created that will 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 will 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 will reflect the level of microorganism (as prescribed under the FDR) will 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 will 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 will continue to rely, where appropriate, on its microbiological guidelines and policies, such as the Policy on Listeria monocytogenes in ready-to-eat foods (2023), to help manage the risk of foodborne illness associated with certain microorganisms. Where no such policies are in place, individual situations will 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 will determine whether the sale of the food contravenes the FDA.

Prohibitions outside of Division 30

These Regulations will 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) will 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 safe to drink. These Regulations will 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” will also be updated to “une eau présentée comme étant une eau minérale ou une eau de source” throughout the FDR and in the Canadian Food Compositional Standards, where necessary.

Health Canada will also 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 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

These Regulations will 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 will be defined in Division 30 and will 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 will be incorporated by reference into the FDR.

Incorporation by reference — Table of Microbiological Reference Methods for Food

The Table of Microbiological Reference Methods for Food will 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 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 will set out the requirements that an alternative method to a microbiological reference method set out in the Table of Microbiological Reference Methods for Food must fulfill to be considered equivalent. The regulated party must demonstrate through validation that the alternative method meets the requirements before it can be used to verify the compliance with the microbiological criteria of food. The requirements in question will be modelled on those presently set out in Volume 1: Official Methods for the Microbiological Analysis of Foods of the Compendium of Analytical Methods.

Volumes 2 and 3 of the Compendium of Analytical Methods include methods and laboratory procedures that are considered equivalent to the microbiological reference methods set out in the Table of Microbiological Reference Methods for Food. However, the Compendium of Analytical Methods does not provide a complete list of all equivalent methods. Regulated parties may choose to use alternative methods and are responsible for ensuring that any such methods meet the necessary equivalency requirements.

Future changes to microbiological documents incorporated by reference

After the coming into force of these Regulations, any revisions 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 will follow an open and transparent process consistent with the Health Canada Incorporation by Reference Policy. Health Canada will update these documents as appropriate based on the latest science, risk assessments and/or in response to an emerging public health risk.

3. Chemical, physical and nutritional methods of analysis

Incorporation by reference — official methods of analysis

These Regulations will move the statically (i.e. fixed) incorporated by reference FOs and their associated values (where applicable) respecting the chemical, physical or nutritional characteristics of certain foods, from the FDR into documents that will be incorporated by reference into the FDR on an ambulatory basis (i.e. as amended from time to time). Depending on the FO method in question, this will be done in one of two ways:

Existing FO references uniquely linked to compositional requirements that apply to standardized foods will be moved from the FDR into the CFIA’s Canadian Food Compositional Standards that will be incorporated by reference into the FDR along with the compositional food standards; 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 will be moved from the FDR into the Table of Chemical, Physical and Nutritional Characteristics of Food that is incorporated by reference in the FDR. A new definition will be introduced in Part B of the FDR for this table, similar to the Canadian Food Compositional Standards. These official methods of analysis will remain linked to the FDR in their respective prohibitions, but the details of the methods and their values will be maintained in the Table of Chemical, Physical and Nutritional Characteristics of Food.

Regarding the FO methods in the Canadian Food Compositional Standards 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 will be retained in the Table of Chemical, Physical and Nutritional Characteristics of Food and the internationally recognized PDCAAS method will be added as an option. The remaining methods for food packaging materials (FO-40 and FO-41) and for food fortification (FO-42) will be addressed as part of future modernization work.

Protein quality method (FO-1) and protein ratings

As mentioned previously, a second validated method for measuring protein quality, the PDCAAS, will 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 will continue to be required to evaluate the protein quality in infant foods.

A separate document titled Determination of the Protein Rating Using the Protein Digestibility Corrected Amino Acid Score (PDCAAS) will also be incorporated by reference into the FDR (through the Table of Chemical, Physical and Nutritional Characteristics of Food) and will describe the details for determining the protein rating of a food using PDCAAS to assess compliance with protein quality requirements. Health Canada will be following 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. The Determination of the Protein Rating Using the Protein Digestibility Corrected Amino Acid Score (PDCAAS) is available online.

Consequential revisions — Table of Permitted Nutrient Content Statements and Claims

Revisions will 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 will 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, which are now set out in the aforementioned table.

Future changes to official (FO) methods documents

After these Regulations come into force, changes to the Table of Chemical, Physical and Nutritional Characteristics of Food or the Determination of the Protein Rating Using the Protein Digestibility Corrected Amino Acid Score (PDCAAS) will follow the established, open and transparent processes applicable to all documents that are incorporated by reference. Health Canada and the CFIA will update these documents, when appropriate, based on scientific advances and innovation, and in accordance with their respective incorporation by reference policies. Stakeholders will be informed of proposed revisions and provided the opportunity to comment in accordance with their respective incorporation by reference policies.

4. Food additives

These Regulations will amend Division 16 in Part B of the FDR to set out a modernized 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 additive MAs will 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 will be introduced and the 15 Lists of Permitted Food Additives will be incorporated by reference into the FDR. Provisions related to the pre-market submission process for food additives will 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 sweeteners and polydextrose in Division 1 as well as definitions and food colour specifications in Division 6) will be repealed and/or moved to 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 will also be incorporated by reference into the FDR.

Definitions and interpretation

In Division 1 of Part B of the FDR, these Regulations will 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 will be amending the titles of several food additive lists, and the new definition of the “Lists of Permitted Food Additives” will reflect these changes. On December 14, 2021, Health Canada published a proposal entitled Health Canada’s Proposal to Modernize the Structure and Titles of the Lists of Permitted Food Additives (Ref. No. NOP/AD-0038) detailing the revisions to the titles and an explanation of each proposed change. The references to “essential oils,” “oleoresins” and “natural extractives” in paragraph (c) of the definition of “food additive” will also be removed. Those substances, when used to impart flavour to food, will continue to be excluded from the definition of a food additive, as paragraph (c) excludes flavouring preparations from the definition. As has always been the case, manufacturers wishing to request that Health Canada permit essential oils, oleoresins and natural extractives to be used as food additives instead of to impart flavour can do so through Health Canada’s food additive submission pre-market authorization process.

The existing definitions of “food colour” and “sweetener” will also be amended in Division 1 of Part B. Both defined terms will include the function of the food additive as defined in the respective MA and references to the MAs will be removed. A new definition of “food enzyme” will be added to a new section B.16.020 and will include the function as defined in the respective MA.

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

The definitions “infant” and “infant food” will be repealed from Division 25 of Part B and moved to Division 1 of Part B and the definition of “supplemented food” will be amended to refer to “infant food.” Moving the definitions to Division 1 reflects that the foods are mentioned in other divisions and these definitions apply throughout Part B.

Lastly, the existing definitions of “dye” and “synthetic colour” in Division 6 of Part B will be moved to Division 16 and updated where necessary to reflect that these terms apply specifically to food colours. The definition of “preparation” in Division 6 will be repealed and integrated into the labelling provision for food colour preparations that is also moved into Division 16. The definitions of “diluent” and “mixture” will be repealed from Division 6.

These Regulations will 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 will 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) will 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, provided that the conditions set out in paragraphs (a) to (d) of that provision are met.

In summary, a food will meet the applicable conditions of exemption in section B.16.003 if the food additive is set out in column 1 of the Lists of Permitted Food Additives; the food additive is obtained from a corresponding source set out in column 2 (if specified); the food additive is in or on, or has been added to a corresponding food set out in column 3; the food additive is used for a corresponding purpose of use set out in column 4 (if specified); the amount of the food additive does not exceed the corresponding 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 corresponding condition set out in column 5 is met. The exemptions will be similar to the exemptions set out in section 2 of the 15 food additives MAs and the new Lists of Permitted Food Additives will be amended to reflect the new structure in the FDR.

These Regulations will expressly provide for the carry-over of food additives into foods. Accordingly, under a new section B.16.005, if under section B.16.003 a food does not contain a poisonous or harmful substance or is not adulterated, and it is used as an ingredient in another food, that other food will also not contain a poisonous or harmful substance, or will not be adulterated, by reason only that the food additive is present in or on that other food, or has been added to the ingredient. That is, if a food additive is permitted in a food, the food can, in turn, be used as an ingredient in another food. The other food will not be considered to contain a poisonous or harmful substance and will not be considered adulterated solely by virtue of the food additive being present.

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. These Regulations will consolidate these rules in Division 16.

A new section B.16.006 will provide that the exemptions in sections B.16.003 or B.16.005, as applicable, will also apply to infant foods in the following circumstances:

If it is a bakery product that is labelled or advertised for consumption by infants, e.g. a bakery product for infants that is not subject to a food compositional standard and so falls under the “unstandardized bakery products” category in the Lists of Permitted Food Additives;
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;
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”;
If it is a “human milk fortifier” set out in column 3 of the Lists of Permitted Food Additives;
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, e.g. “spray-dried bacterial culture preparations for use in dried infant cereal products”; and
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.

Exemptions – mixes of food additives and other non-additive ingredients intended solely for use in the manufacture or preparation of other foods (“Pre-mixes”)

Currently, the Lists of Permitted Food Additives include entries permitting the use of food additives in a variety of foods that are sold as mixtures, blends and concentrates, such as “beverage mixes and concentrates,” “dessert mixes,” “soup mixes,” “cake mixes,” “sauce mixes,” etc. These mixes, like other foods, are set out in column 3 of the Lists of Permitted Food Additives and must meet all applicable conditions to be sold in Canada. However, with very few exceptions, the Lists of Permitted Food Additives do not at present account for other types of mixes, specifically pre-mixes of food additives and other non-additive ingredients that are intended solely for use in the manufacture or preparation of another food and if the food additives that are combined with the non-additive ingredients are intended to function in the other food. These pre-mixes are not sold directly to consumers; the food additives in them are permitted for use in and intended to have a technical effect on the foods that are manufactured or prepared from pre-mixes, and the pre-mixes are accompanied by information that allow the end users of these pre-mixes to produce foods that will comply with the permitted maximum level of use or maximum level of residue for the food additive(s) in the food as set out in the applicable List(s) of Permitted Food Additives.

To accommodate the sale of such pre-mixes (other than pumping pickle, cover pickle and dry cure employed in the curing of preserved meat and preserved meat by-products, which already are set out in the List of Permitted Food Additives for their sale), a new provision (section B.16.004) will be added that considers these pre-mixes not to be adulterated for the purposes of paragraph 4(1)(d) of the FDA, provided certain conditions are met. Specifically, the pre-mix must be intended solely for use as an ingredient in the manufacture of another food intended for sale to a consumer at the retail level or intended solely as an ingredient in the preparation of another food by a commercial or industrial enterprise or an institution; the pre-mix is not intended for sale to a consumer at the retail level; the food additive in the pre-mix must be obtained from any corresponding source set out in column 2 of the Lists of Permitted Food Additives; and the food additive must be intended for a corresponding purpose of use set out in column 4 in relation to a corresponding food set out in column 3.

In addition, a new provision (section B.16.014) will require that a pre-mix include information on the quantities of the food additives in it as well as directions for use that, if followed, will produce a corresponding food set out in column 3 of the List(s) of Permitted Food Additives that will not contain food additives in excess of the maximum levels of use or maximum levels of residues set out in the applicable List(s) of Permitted Food Additives. This information can be shown on the label of the pre-mix including in a document that accompanies the pre-mix and must be grouped together with a list of ingredients. The quantitative declaration and directions for use set out in section B.16.014 apply specifically to the food additives in the pre-mix that are intended to function in the other food manufactured or prepared with the pre-mix.

Exemptions — other requirements

A new provision in Division 16 (section B.16.007) will indicate that the exemptions in sections B.16.003 to B.16.006 respecting the foods referred to in those sections will only apply if all the other requirements in the FDR relating to the food additive, such as any prescribed specifications, are met.

Prohibitions

Two existing prohibitions of sale specific to food additives will be moved from Divisions 10 (paragraph B.10.026(c)) and 11 (section B.11.001.1) to Division 16 to consolidate these rules with other food additive rules in the same Division of the FDR. The existing prohibition in section B.16.100 will also be retained but renumbered and amended to now refer to the Lists of Permitted Food Additives. The existing prohibition of sale in section B.06.002 related to synthetic colours will also be repealed and the limits that are prescribed by that provision will be set out in the List of Permitted Food Colours.

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 will be moved to Division 16, and sections B.01.045 and B.06.061 will be repealed.

The general rule will be updated to include a reference to a new Table of Food Additive Specifications, which will be incorporated by reference into the FDR, and will set out the existing 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 new Table of Food Additive Specifications, the general rule will continue to require that the food additive 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. Minor revisions will be made 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 will be repealed, as these limits are outdated.

Incorporation by reference — Table of Food Additive Specifications

These Regulations will move the specifications for Ponceau SX and Citrus Red No. 2 from Division 6, Part B into a new document entitled Table of Food Additive Specifications. This document will be incorporated by reference into the FDR, which will 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 will no longer be prescribed as food compositional standards. Division 6 will be repealed in its entirety, as there will be no remaining provisions.

After the coming into force of these Regulations, changes to the Table of Food Additive Specifications will follow an open and transparent process. Stakeholders will be notified and provided the opportunity to comment on proposed revisions to these documents through Health Canada’s established notification process.

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. Under the current framework, Health Canada can authorize new uses of food additives through revisions to the Lists, with the exception of authorizing a new food additive for a new purpose of use in the List of Permitted Food Additives with Other Accepted Uses. In this case, the Minister of Health must first 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 through a regulatory amendment. This is necessary in order to give legal effect to the new entry in the List of Permitted Food Additives with Other Accepted Uses. With these amendments to Division 16 of the FDR and the repeal of the MAs, a regulatory amendment will no longer be required to authorize the use of a new food additive for a new purpose of use, i.e. as with other food additive decisions, Health Canada will be able to implement the decision via a revision to the new List of Permitted Food Additives with Other Purposes of Use (formerly the List of Permitted Food Additives with Other Accepted Uses).

To consolidate all food additive regulations, Health Canada will be incorporating by reference the 15 Lists of Permitted Food Additives, which are currently incorporated by reference into the 15 food additive MAs, directly into the FDR instead. At the same time, the Department will modify the 15 Lists to have a consistent structure and will revise the title of certain Lists to be consistent with terminology used internationally or to be consistent between the English and French titles as internationally recognized. Further revisions will 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) will be replaced with the rules set out in those provisions, and corresponding amendments will be made to remove such rules from the FDR. For example, column 3 of subitem C.2(8) of the List of Permitted Sequestering Agents previously set 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.” The new paragraph C.2(f) in column 5 of the List of Permitted Sequestering Agents will 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

Currently, section B.16.002 prescribes the information that must be submitted in a form and manner satisfactory to the Minister of Health to request a food additive be added to or a change be made to the tables of permitted food additives to section B.16.100. However, since these regulatory amendments repeal the tables to section B.16.100, and given that the Lists of Permitted Food Additives are managed outside the FDR, the existing submission requirements will be repealed. Information requirements for food additive submissions will 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.

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 within 90 days of filing will also be removed since the service standard of 90 days does not reflect current practice. Further, the Minister of Health will no longer need to make a recommendation to the Governor in Council since the Lists of Permitted Food Additives will be directly incorporated by reference into the FDR and will be managed by Health Canada.

After the coming into force of these Regulations, changes to the Lists of Permitted Food Additives will continue to follow an open and transparent process. Stakeholders will 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 will be incorporated by reference into the FDR, Health Canada will consequently repeal the following 15 MAs for food additives:

Marketing Authorization for Food Additives That May Be Used as Anticaking Agents;
Marketing Authorization for Food Additives That May Be Used as Bleaching, Maturing or Dough Conditioning Agents;
Marketing Authorization for Food Additives That May Be Used as Colouring Agents;
Marketing Authorization for Food Additives That May Be Used as Emulsifying, Gelling, Stabilizing or Thickening Agents;
Marketing Authorization for Food Additives That May Be Used as Food Enzymes;
Marketing Authorization for Food Additives That May Be Used as Firming Agents;
Marketing Authorization for Food Additives That May Be Used as Glazing or Polishing Agents;
Marketing Authorization for Food Additives with Other Accepted Uses (including the Schedule);
Marketing Authorization for Food Additives That May Be Used as Sweeteners;
Marketing Authorization for Food Additives That May Be Used as pH Adjusting Agents, Acid-Reacting Materials or Water Correcting Agents;
Marketing Authorization for Food Additives That May Be Used as Preservatives;
Marketing Authorization for Food Additives That May Be Used as Sequestering Agents;
Marketing Authorization for Food Additives That May Be Used as Starch-Modifying Agents;
Marketing Authorization for Food Additives That May Be Used as Yeast Foods; and
Marketing Authorization for Food Additives That May Be Used as Carrier or Extraction Solvents.

A separate marketing authorization will 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 was published on January 29, 2024, for a 75-day consultation period.

Consequential amendments — Cannabis Regulations

The Cannabis Regulations 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 will be made to the Cannabis Regulations to align them with the proposed repeal of the 15 MAs and the amendments to Part B of the FDR (including the 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).

The 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 will 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 will be repealed.

The 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 will be allowed to use a food additive as an ingredient to produce edible cannabis if the revised conditions are met.

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

Additionally, a new provision will be added to the FDR for mixtures of food additives and other non-additive ingredients that are intended solely for use in the manufacture or preparation of other foods (i.e. “pre-mixes”). If a pre-mix referred to in section B.16.004 meets the conditions in the FDR and is exempt from the adulteration provision in paragraph 4(1)(d) of the FDA, the “pre-mix” would not be prohibited as an ingredient in edible cannabis if the requirements in the Cannabis Regulations are also met.

The amendments to the Cannabis Regulations will not have an impact on the existing policy regarding the use of permitted food additives used as ingredients in edible cannabis that is a cannabis product or for use in the conduct of non-therapeutic research on cannabis. Guidance to licence holders will be updated to reflect the requirements related to the use of pre-mixes in the production of edible cannabis.

Finally, the Cannabis Regulations do not allow the use of sugars, sweeteners or sweetening agents as ingredients in cannabis extract products. The Cannabis Regulations define sweetener and sweetening agents as those terms are defined in subsection B.01.001(1) of the FDR. The existing definition of “sweetening agent” in the FDR will be updated to refer to the Canadian Food Compositional Standards. With the repeal of the MAs, the existing definition of “sweetener” in the FDR will be amended to include the function of the food additive as a sweetener as it was defined in the respective MA. Prohibiting the use of sugars, sweeteners and sweetening agents in cannabis extract products was intended to reduce the appeal of cannabis extracts to youth and protect youth from an inducement to use cannabis products. Continuing to incorporate these amended terms as defined in the FDR is consistent with this original intent.

Consequential amendments — Denatured and Specially Denatured Alcohol Regulations; Feeds Regulations, 2024; Pest Control Products Fees and Charges Regulations and Pest Control Products Regulations

The consequential amendments to the Denatured and Specially Denatured Alcohol Regulations will 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 consequential amendments to the Feeds Regulations, 2024 will amend the respective references to the Lists of Permitted Food Additives in subparagraphs 69(2)(d)(iii) to (x). The intention of these references is to allow the manufacture of feeds for export with food additives that contain novel traits, novel viable organisms or novel products of biotechnology – even if the food additives do not meet the conditions of the FDR, such as permitted sources or maximum levels of use – as long as the feeds meet the regulatory conditions in the importing state.

The consequential amendments to the Pest Control Products Fees and Charges Regulations will 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 consequential amendments to the Pest Control Products Regulations will 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 new structure of the Lists of Permitted Food Additives. In particular, paragraph 4(1)(g) will refer to a food additive set out in column 1 of the List of Permitted Preservatives.

5. Miscellaneous amendments

These Regulations will 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, will be repealed from the FDR, and the maximum levels will be moved to the List of Contaminants and Other Adulterating Substances in Foods, which is incorporated by reference under Division 15 of the FDR. As a result of this change and the changes identified earlier for food compositional standards, Division 7 will be repealed entirely.

The existing definition of the “List of Contaminants and Other Adulterating Substances in Foods” in Division 1 will be slightly amended to align with other defined terms of documents that are incorporated by reference into the FDR and published by Health Canada. The French title of this list will 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 will 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 will also be introduced for food additives in Division 16 and for microbiological criteria in Division 30.

Divisions 27 and 28, Part B

Targeted amendments will be made to Division 27, including the current title, to align the French term for “hermetically sealed container” (amended to “récipient hermétiquement scellé”) throughout Part B of the FDR. The existing definition in Division 27 will be repealed and moved to Division 1. The French term for “microorganism” (“microorganisme”) will 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 Division 30. Similar changes to these French terms will be reflected in the Canadian Food Compositional Standards.

Part A

These amendments will 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 will be made to clarify which foods have a food compositional standard. This change will similarly reflect how other requirements for adding vitamins, mineral nutrients and amino acids to foods are currently embedded within a food compositional standard but will remain as prohibitions of sale in Part B of the FDR.

6. Coming into force and transitional provisions

These Regulations will come into force on the day on which they are published in the Canada Gazette, Part II. While these Regulations will 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 will be provided as the current prohibition is already understood to apply to all gins. The CFIA has not identified any products that will require a labelling change and has not received any comments from stakeholders in the alcohol and spirits sector during the Canada Gazette, Part I, consultation indicating otherwise. A transition period is also not provided to the ingredient labelling exemption provisions for Tennessee whisky, Tequila and Mezcal products as this change will not impose a new requirement.

A transition period is, however, provided for the new provision in section B.16.014 related to the information that must be provided with pre-mixes containing a food additive that are intended solely for use in the manufacture or preparation of another food. This new rule will apply starting on January 1, 2028, in order to coincide with the first compliance date under Health Canada and the CFIA’s food labelling coordination policy. This policy provides predictability with respect to compliance with labelling changes that are required by new regulations by setting out required compliance dates on a two-year cycle.

To take into account the changes made by these Regulations, amendments 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] are made so that they will continue to operate as intended. In particular, these changes will reflect the new provision numbers in the FDR or in the Canadian Food Compositional Standards, as the case may be, as a result of these amendments.

These Regulations also amend 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. The Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods) 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 regulations for supplemented foods. These amendments will clarify the intent that transitioning products need to continue to meet the latest rules in the FDR, including but not limited to, rules for food additives, microbiological criteria and rules for 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 fully comply with the new regulations for supplemented foods. In particular, these Regulations will amend the transitional provisions to clarify that transition products can remain on the market if they continue to meet certain conditions and that they will not be considered supplemented foods or to be containing supplemental ingredients during such time. This means that these foods will not be required to comply with supplemented food and supplemental ingredient-specific requirements, such as those found in Division 29 of Part B.

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

Regulatory development

Consultation

Health Canada and the CFIA have conducted the following consultation activities to obtain early feedback from consumers and impacted stakeholders on the four policy elements described above. The findings were taken into account in the development and refinement of the final regulations. A cost-benefit analysis survey was not conducted.

Pre-consultations

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 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 to Health Canada and the CFIA’s proposed direction, supporting the separation of health and safety references from food compositional standards as well as the use of incorporation by reference to modernize the regulation of food compositional standards, microbiological criteria, methods of analysis and food additives. No concerns were raised that would considerably impact the proposal.

Questions raised focussed primarily on the proposed use of incorporation by reference. Specifically, participants sought clarification on the scope of the proposed incorporation by reference (e.g. whether the proposal would simply incorporate by reference existing rules or whether revisions to rules would be made as part of the proposal); planned future revisions to rules once incorporated by reference; the functionality and searchability of documents incorporated by reference (in particular the Lists of Permitted Food Additives); and the process by which interested parties would be notified of and engaged in proposed revisions to documents incorporated by reference as well as transition considerations once revisions are made. In addition, a number of consultation-related questions on the proposed deadline for prepublication in the Canada Gazette, Part I; the proposed duration of the consultation as well as accessing draft copies of documents proposed for incorporation by reference, were also addressed.

1. Food compositional standards

Feedback on food compositional standards was captured throughout the three phases of the Food Labelling Modernization consultations (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 consultations 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.

In 2023, the CFIA carried out a consultation on an approach that would guide the CFIA’s future modernization of food compositional standards. The consultation proposed principles that the CFIA would use to guide its triage and prioritization of requests for changes to the food compositional standards and sought specific feedback from industry stakeholders that would allow the CFIA to quantify the demand for future changes. As indicated in the What we heard report published on August 15, 2024, stakeholders supported the CFIA’s proposed approach and feedback from this process will be incorporated into a food compositional standards modernization strategy that the CFIA will finalize by fall 2024. This will provide clarity to industry stakeholders regarding how the CFIA will prioritize requests and proceed with modernization in respect of CFIA resources.

In January 2024, the CFIA met with four national stakeholder associations upon request, to provide them with an overview of the regulatory proposal as it relates to food compositional standards and the CFIA’s strategic approach to updating food compositional standards. Stakeholders were encouraged to read through the regulatory proposal, to review draft documents incorporated by reference and to submit feedback through the Canada Gazette, Part I, process.

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 focussed on updating the microbiological criteria for foods set out in the Health Products and Food Branch (HPFB) 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 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.

Following the 2016 workshop, one industry association communicated to Health Canada 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.

On October 4 and 12, 2023, Health Canada held virtual English and French information sessions with targeted stakeholders on the proposed adoption of the PDCAAS method into regulation. Fifty-six stakeholders attended these sessions from various sectors including academia/research, public-private food research groups, food manufacturers, industry associations, health and professional associations and other government organizations. There was overall support for the proposed changes. Two clarification questions were asked, and four questions were asked on protein claim criteria that were outside of the scope of the modernization proposal.

4. Food additives

In 2012, Health Canada 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 as guidance. Health Canada indicated that requests to add synonyms for food additives to guidance may be addressed by 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 (formerly the List of Permitted pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agents), replied to questions about the columns in the Lists, and explained how additional feedback could be provided in the future.

Prepublication in the Canada Gazette, Part I

Comments received on the proposal through the Canada Gazette, Part I, consultation process and through the World Trade Organization Technical Barriers to Trade notification process are summarized below. A range of stakeholders provided feedback, including: 12 consumers, three consultants, one government stakeholder, 10 industry stakeholders, 26 industry associations and two non-governmental organizations.

The majority of comments focussed on the technical details set out in the various documents incorporated by reference. A number of comments were outside the scope of the proposal and will be considered by Health Canada and/or the CFIA, as relevant, in future projects. Examples of such comments included: requested revisions to specific food compositional standards (e.g. shortening, flavours, spices); the fortification of specific foods (e.g. flour); clinical trials for certain foods; labelling (e.g. gluten free, common or class names of ingredients and components, genetically modified foods, nutrient content claims); and changes to section 4 of the FDA. A limited number of adjustments to these Regulations have been made in response to comments and concerns raised by stakeholders as described below.

General comments

Comments on the use of incorporation by reference: The majority of stakeholders supported the proposed use of incorporation by reference for food compositional standards, microbiological criteria, methods of analysis and food additives, noting how this would strengthen the regulatory responsiveness and functionality of the FDR. Eight industry associations, one non-government organization, one consultant and one government stakeholder noted the need to have in place open, accessible, transparent and consultative processes for future revisions to documents incorporated by reference. They also noted the need for ready access to current and previous versions of such documents.

Health Canada and the CFIA’s response: Both Health Canada (Health Canada Incorporation by Reference Policy) and the CFIA (CFIA Incorporation by Reference Policy) have established policies regarding the use of incorporation by reference, including the management of documents incorporated by reference, that are based on the guiding principles of accessibility, transparency, consistency, reasonableness and clarity. Future changes to all documents that are incorporated by reference as part of these Regulations will be done in an open, transparent and inclusive way that meaningfully engages the public. Domestic and international stakeholders will be notified and provided the opportunity to comment on proposed revisions to documents in accordance with the respective incorporation by reference policies as well as any international obligations. Note that revisions to documents that are incorporated by reference that impact mandatory food labelling are subject to Health Canada and the CFIA’s food labelling coordination policy. When revisions to a document that is incorporated by reference are finalized, a final notice will be published confirming the changes made and the formal adoption of the document. In addition, the final notice will summarize the comments received, any revisions resulting from those comments, and detail any associated transition period, if applicable.

Online repositories of all food-related documents incorporated by reference are available in Health Canada’s Incorporation by Reference Inventory and the CFIA’s Inventory of documents incorporated by reference. All notices related to documents incorporated by reference are available online on Health Canada’s Notices of proposal and notices of modification webpage and the CFIA’s website. Previous versions of documents that are incorporated by reference are archived, kept on record and can either be accessed online, typically through a hyperlink provided in the latest version of the document, or by contacting Health Canada’s Food and Nutrition Directorate or the CFIA to obtain copies.

Outcome: Health Canada and the CFIA will maintain the prepublication proposal with respect to the modernization of the frameworks for food compositional standards, microbiological criteria, methods of analysis and food additives and the use of incorporation by reference.

Comments on the lack of updates to rules found in documents incorporated by reference: Some respondents representing the food industry as well as one representative of a non-governmental organization expressed disappointment that the regulatory proposal was limited to only incorporating by reference existing rules in the FDR and that the opportunity was not also taken to propose substantive revisions to these existing rules, in particular food compositional standards and microbiological criteria.

Health Canada and the CFIA’s response: The regulatory proposal was limited to modernizing the regulatory frameworks in the FDR for food compositional standards and microbiological criteria through the incorporation by reference of the Canadian Food Compositional Standards and the Table of Microbiological Criteria for Food into the FDR. Once the modernized frameworks are in place, it is Health Canada and the CFIA’s intention to proceed with revisions to the food compositional standards and microbiological criteria set out in these documents. As noted throughout this Regulatory Impact Analysis Statement, proposed revisions to these documents, or any document incorporated by reference, will follow an open and transparent process consistent with Health Canada and the CFIA’s respective incorporation by reference policies.

Outcome: Health Canada and the CFIA will maintain the prepublication proposal with respect to the contents of these documents.

Comments on methods of analysis that require testing on animals: Three consumers expressed concerns that the proposed Regulations would permit the use of methods of analysis involving animals, highlighting specifically the existing PER method (FO-1) and the method for determining the bioavailability of iron (FO-42), as well as the adoption into regulation of the PDCAAS method. Concerns were also raised regarding the testing of food additives and other chemicals, including pesticides, on animals.

Respondents representing the protein and plant-based foods sectors also acknowledged a general shift away from the use of in vivo protein digestibility methods towards non-animal methods. It was noted that such methods should be considered for inclusion in the Table of Chemical, Physical and Nutritional Characteristics of Food as they become scientifically validated.

Health Canada’s response: Health Canada requires that evidence be submitted by industry stakeholders to demonstrate that certain ingredients (e.g. food additives) will not make food unsafe if they are allowed to be added to food. This safety requirement is intended to protect people in Canada from being exposed to harmful substances in their food. While this often includes the results of tests done in laboratory animals, Health Canada supports the reduction of unnecessary animal testing where scientifically justified.

Laboratory animal testing typically uses rats or mice specifically bred for this purpose. These tests follow strict guidelines on animal care. This type of testing is considered predictive of effects on human health, such as short term and long-term toxicity and carcinogenicity as well as effects on reproduction and development. There are many similarities between humans and other mammals such as rats or mice, which make them good models for predicting potential human health effects.

Health Canada recognizes the global effort to reduce reliance on the use of animal testing when assessing the risks from substances. For food additives, the hope is that new models that are as predictive as laboratory animal testing will become available in the future. In the meantime, all safety rationales submitted by food industry stakeholders will continue to be reviewed, including those based on non-animal models, to determine when the evidence for safety is strong enough to allow these substances in food.

Regarding methods for measuring the protein digestibility of foods, Health Canada is aware that some in vitro methods have been developed for this purpose. However, these methods have not yet been validated and there is currently insufficient evidence to support their routine use for regulatory purposes. Health Canada is staying informed on the ongoing validation studies and international bodies efforts to standardize these in vitro methods.

The PDCAAS is based on human requirements for amino acids and includes a measure of protein digestibility, performed in animal models. Compared to method FO-1, the need for animal testing is reduced for PDCAAS since protein digestibility can often be obtained from published databases or other reliable sources for many foods and used to calculate the PDCAAS for mixed protein source foods.

Health Canada continues to monitor emerging research on the generation and validation of in vitro digestibility methods, and other non-animal models, for routine regulatory use to help replace, reduce or refine the use of animal testing.

Health Canada also requires information on the potential toxic effects of pesticides to determine the potential hazards and risk to human health and the environment from pesticide exposure. Toxicity information typically includes, in part, animal testing data generated by pesticide manufacturers. These studies are conducted according to international testing protocols, which include requirements to ensure protection of the welfare of laboratory animals. While animal toxicity testing currently plays a critical role in assessing human health and environmental risks from exposure to chemical substances, including pesticides, Health Canada supports the reduction of unnecessary animal testing where scientifically justified.

In addition, the Pest Control Products Act currently provides sufficient flexibility for Health Canada to take into consideration alternatives to animal testing in the assessment of pest control products. For instance, Health Canada considers requests from pesticide manufacturers to waive requirements for animal studies or to consider validated non-animal alternatives in hazard assessment when feasible and supported scientifically. In addition, Health Canada issued guidance for industry on the waiving of mammalian acute toxicity studies in 2013 and revised the data requirements for pesticides in 2016 and 2018 to remove the routine requirement for certain animal studies. While non-animal alternatives exist for certain types of tests (e.g. in vitro tests for irritation), animal testing continues to provide a more accurate assessment of a variety of other potential effects, and more importantly, at what dose level effects may occur, so that this information can then be used to protect human health and the environment. Continued analysis of international trends and approaches is important to ensure continued alignment and harmonization. To this end, Health Canada is an active participant in various international activities aimed at reducing animal testing while ensuring the protection of human health and the environment.

Outcome: Health Canada will maintain the prepublication proposal to incorporate by reference on an ambulatory basis the PDCAAS method as well as the existing FO methods, including methods FO-1 and FO-42 methods.

1. Food compositional standards

Comments on the separation of health and safety rules from food compositional standards and reference tools to facilitate compliance: Although the majority of stakeholders were generally supportive of separating out health and safety rules from food compositional standards and incorporating by reference the details into distinct documents, eight industry associations and two consultants noted that this could result in challenges for regulated parties given the need to navigate multiple documents to identify applicable requirements. They suggested the CFIA and Health Canada update or create comprehensive, user-friendly reference tools to facilitate compliance and assist stakeholders in identifying applicable regulatory requirements, such as updating the CFIA’s Industry Labelling tool and relevant guidance; including cross-references between documents incorporated by reference; and developing guidance that maps out where rules previously prescribed in the FDR were moved to documents incorporated by reference.

The CFIA and Health Canada’s response: Under these Regulations, the CFIA and Health Canada are not proposing any new requirements other than those related to pre-mixes with food additives that are intended for further manufacturing or preparation, meaning that existing guidance applies. For instance, CFIA’s Industry Labelling Tool provides guidance on labelling, food compositional standards, food additives and fortification requirements for foods. As part of this initiative, the CFIA is reviewing the Industry Labelling Tool and will be updating regulatory references to provide clear linkages to requirements set out in various documents incorporated by reference. The CFIA and Health Canada will also work together to develop reference tools to help regulated parties become familiar with the transfer of various requirements into documents incorporated by reference into the FDR.

Outcome: The CFIA and Health Canada will maintain the prepublication proposal with respect to the contents of documents incorporated by reference. However, as a result of the comments received, the CFIA and Health Canada will develop a reference tool to help stakeholders navigate the new regulations and the regulatory provisions that have been transferred to a number of documents incorporated by reference into the FDR.

Comments on future modernization of food compositional standards: Three industry associations and a provincial government highlighted the need for clear direction on how the CFIA will proceed with the modernization of food compositional standards once the Canadian Food Compositional Standards is incorporated by reference into the FDR. Two associations and one provincial government in particular noted that provincial and territorial governments should be involved in this process.

The CFIA’s response: As noted above, in 2023 the CFIA carried out a consultation on an approach that will guide the CFIA’s future modernization of food compositional standards. The consultation proposed principles that the CFIA will use to guide its triage and prioritization of requests for changes to the food compositional standards and sought specific feedback from industry stakeholders that will allow the CFIA to quantify the demand for future changes. As indicated in the What we heard report published on August 15, 2024, stakeholders supported the CFIA’s proposed approach and feedback from this process will be incorporated into a food compositional standards modernization strategy that the CFIA will finalize by fall 2024. This will provide clarity to industry stakeholders regarding how the CFIA will screen, prioritize, and consolidate requests for modifications and communicate its forward modernization plan in a way that provides clarity for stakeholders while respecting CFIA resources available for this activity.

Where required, future modernization of standards will include consultation with all implicated stakeholders which would include consultation with any affected provincial or territorial governments.

Outcome: These comments will be addressed by the CFIA’s publication of its strategy for the modernization of food compositional standards.

Comments on the food compositional standards incorporated by reference into the FDR and/or the SFCR: Two consultants and three industry associations noted a number of differences between the food compositional standards set out under the FDR (Canadian Food Compositional Standards) and those set out under the SFCR (Canadian Standards of Identity). They all recommended that these two documents incorporated by reference should be consolidated to avoid confusion and unnecessary duplication. One consultant recommended adopting the same title of the document under both regulations and clarifying the title by including a reference to the FDR, while one of the industry associations suggested aligning the volume orders between the two documents in the meantime.

The CFIA’s response: The presence of food compositional standards in the FDR and standards of identity in the SFCR (formerly in the commodity-specific regulations under the Canada Agricultural Products Act, Meat Inspection Regulations, 1990 and Fish Inspection Regulations) is longstanding. While changes to the requirements currently set out in the food compositional standards in the FDR and the SFCR (Canadian Standards of Identity) is not within the scope of this regulatory initiative, the CFIA will take these comments into consideration. This will include consideration of consolidating standards where it is possible and appropriate to do so.

The Canadian Food Compositional Standards will provide information (either through a cover page or banner) that clarifies the scope of the document and that it is incorporated by reference into the FDR. In addition, the CFIA’s Inventory of documents incorporated by reference specifies the regulation under which the document is incorporated by reference.

Outcome: The CFIA will maintain the prepublication proposal with respect to the Canadian Food Compositional Standards, including its title and incorporation by reference into the FDR and future modernization of standards will consider consolidation where it is possible and appropriate to do so.

Comments on existing FDR rules moving to the Canadian Food Compositional Standards: Eleven industry associations, one government, two industry consultants and eight industry representatives proposed technical changes to Volume 2 (Alcoholic Beverages), Volume 6 (Spices, Seasonings and Dressings for Salads), Volume 7 (Dairy Products), Volume 8 (Fats and Oils), Volume 9 (Flavouring Preparations), Volume 12 (Grain and Bakery Products), Volume 13 (Meat, its Preparations and Products), Volume 16 (Vinegar) and Section 19.4 (Egg Products) of the Canadian Food Compositional Standards. The type of technical requests included repealing food compositional standards that are deemed to be outdated, adding new food compositional standards, and amending existing food compositional standards to reflect current industry practices and allow for use of more ingredients in standardized foods.

The CFIA also received a number of requests to amend the Canadian Food Compositional Standards to align more closely with those in the Canadian Standard of Identity. One industry association asked why fruit flavoured drinks weren’t included in Volume 10 (Fruits, Vegetables, Their Products and Substitutes) and another questioned the placement of the definitions of “Table of Permitted Nutrient Content Statements and Claims” and “ultrafiltered milk” in proposed section 7.4.0 of Volume 7. Another industry association requested a standard for “simulated” or “imitation” egg product alternatives.

A few other industry associations recommended changes within certain food compositional standards or the Canadian Food Compositional Standards to mention where there are mandatory rules in the FDR related health and safety rules that stakeholders should be aware of. In particular, one government stakeholder wanted clarification that food colours would remain authorized for liqueurs the same way they are currently and recommended providing a reference to the List of Permitted Food Colours (formerly the List of Permitted Colouring Agents) in the standard for liqueur to help ensure regulatory certainty and reduce compliance complexity for producers. As another example, one industry association requested clarification about phosphate salts in prepared meats and prepared meat by-products and gelling agents in preserved meats. Another industry association had concerns with the language used in the proposed Baking Powder standard since they were of the view that the food compositional standard allowed for any neutral materials, not only those neutral materials that are permitted via the List of Permitted Food Additives with Other Purposes of Use (formerly the List of Permitted Food Additives with Other Accepted Uses), to be added to baking powder. Another two industry associations wanted further clarity on how the composition of foods with mandatory fortification would link with the Canadian Food Compositional Standards.

The CFIA and Health Canada’s response: The Canadian Food Compositional Standards clarifies only food compositional standards from the FDR are set out in the document. Only requirements related to the composition, strength, potency, purity, quality or other property of a standardized food will be in the Canadian Food Compositional Standards, as well as some provisions that are tightly linked to the standards and are compositional in nature. This means all foods that were previously identified by the symbol “[S]” in Part B of the FDR were considered food compositional standards and were moved over to the Canadian Food Compositional Standards. Similar to breakfast cereals and alimentary paste, fruit flavoured drinks are not standardized foods (i.e. the FDR does not set out a standard prescribing their composition, quality or purity) and were not moved over for this reason.

With respect to the comment regarding the composition of standardized foods in the Canadian Food Compositional Standards and mandatory fortification rules, the CFIA and Health Canada acknowledge that it may take time for industry to adjust to the new framework given that some fortification rules currently form part of a standard. Under the current framework, food compositional standards apply to imported food products and food products traded interprovincially whereas health and safety elements of a standard (e.g. fortification), whether mandatory or voluntary, apply to a food regardless of the level of trade. The proposed amendments to the FDR as prepublished in the Canada Gazette, Part I, clarified the scope of the existing fortification rules when they applied to a food which had a standard set out for it and these rules were amended to be prohibitions of sale. For example, margarine is a standardized food and the compositional rules were proposed to be moved from section B.09.016 to section 8.3.2 of Volume 8 of the Canadian Food Compositional Standards. The remaining fortification rules were proposed to stay in the FDR in a revised section B.09.016 and were converted to prohibitions of sale. This will mean that a food sold as margarine, including that sold within a province, will be subject to the mandatory fortification rules for vitamin A and D as per subsection B.09.016(1) and the voluntary fortification rule for vitamin E in subsection B.09.016(2). Despite changes to the regulatory framework, the fortification rules will continue to be supported by CFIA guidance on mandatory and voluntary fortification requirements.

The cover page of the Canadian Food Compositional Standards mentions other rules related to health and safety, adulteration or deception may also apply to a standardized food in the FDA and the FDR that regulated parties should be aware of, including those concerning food additives, labelling, microbiological, chemical or physical characteristics and nutrition. Only a few general references to food additive rules remain in the Canadian Food Compositional Standards and that is because they could not be captured through other means. To confirm, food colours remain permitted for liqueurs and will remain subject to the conditions in the List of Permitted Food Colours (formerly the List of Permitted Colouring Agents). In addition, phosphate salts will also remain permitted in prepared meat and prepared meat by-products in accordance with the List of Permitted Sequestering Agents and gelling agents remain permitted in preserved meats in accordance with the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents. The CFIA recognizes that the food compositional standard set out for baking powder in section B.03.002 did allow some flexibility as to the neutral material permitted to be added to baking powder. The CFIA has amended the standard for baking powder in the Canadian Food Compositional Standards to more closely reflect the flexibility of using any neutral material, including, but not limited to, neutral fillers set out in the List of Permitted Food Additives with Other Purposes of Use (formerly the List of Permitted Food Additives with Other Accepted Uses).

With respect to the technical changes proposed in Volumes 2, 6, 7, 8, 9, 12, 13, 16 and 19 of the Canadian Food Compositional Standards, the CFIA will consider these comments as they move forward with their food compositional standards modernization work. To clarify the proposed placement of the definition of “ultrafiltered” milk in section 7.4.0 of Volume 7, it is acknowledged that this term is currently defined in section B.08.001.1 of the FDR. The definition of the term “ultrafiltered” milk was added to the FDR when the FDR were amended to clarify how ultrafiltered milks may be used in the manufacture of cheese (refer to the Regulations Amending the Food and Drug Regulations and the Dairy Products Regulations [SOR/2007-302]). It is also noted that the term is only used in the (Naming the variety) Cheese (former section B.08.033) and Cheddar Cheese (former section B.08.034) food compositional standards, which have both moved over to section 7.4 of Volume 7 of the Canadian Food Compositional Standards. Given that this term doesn’t appear elsewhere in Volume 7, it is not needed to be defined outside of the section specific to cheese. The CFIA notes that the definition of “Table of Permitted Nutrient Content Statements and Claims” is not needed in section 7.4.0 given that the new interpretation provision in section B.01.001.2 will apply. However, this definition is added to the Canadian Food Compositional Standards for clarity.

Outcome: The CFIA and Health Canada will maintain the prepublication proposal with respect to the separation of health and safety rules from the food compositional standard rules, including the language to point to the remaining rules in the FDR when they are in respect to foods that also have a standard. Further supporting tools will be developed to help regulated parties navigate between these rules remaining in the FDR and in the new Canadian Food Compositional Standards.

Comments on definitions and interpretation related provisions in the FDR: One consultant, one industry association and one non-government organization asked for clarification regarding the move of certain terms from commodity specific Divisions to Division 1 of the FDR. For example, comments were received on the terms “infant” and “infant food,” (previously in section B.25.001) and the meaning of “solid cut meat,” (previously in section B.14.020) and “solid cut poultry meat” (previously in section B.22.011) being moved as definitions to subsection B.01.001(1) but not to the Canadian Food Compositional Standards. The same industry association noted that the addition of section B.01.001.2 would benefit from an example of how it will function. The non-government organization noted inconsistency in the proposed location of definitions in this Canada Gazette, Part I, consultation relative to the Regulatory modernization of foods for special dietary use and infant foods: Divisions 24 and 25 of the Food and Drug Regulations pre-consultation paper. Another two industry associations suggested a change to the wording in the table to subsection B.01.009(1) of the FDR from “that comply with the standards” back to “subject to compositional standards.”

The CFIA and Health Canada’s response: The definitions of “infant,” “infant food,” “solid cut meat,” and “solid cut poultry meat” were added to subsection B.01.001(1) to inform the meaning of provisions that use these foods or terms throughout Part B of the FDR and not only in Divisions 14, 22 or 25 where they previously were prescribed. For example, the prohibition of sale in section B.01.090 applies to solid cut meat or solid cut poultry meat. Regulated parties must use the definition of “solid cut meat” and “solid cut poultry meat” to understand how to apply/interpret this prohibition. The definitions in subsection B.01.001(1) do not only apply to Division 1 but to all of Part B of the FDR.

Section B.01.001.2 will apply the same meaning to any terms or expressions used in parts A, B or D of the FDR that are also used in a food-related document published by the Government of Canada and incorporated by reference into those parts but that are not defined in that document. This facilitates the application of the regulations by ensuring the consistent interpretation of terms appearing in both the regulations and documents that are incorporated by reference into the FDR. An example will be the term “parts per million” (or “p.p.m.” or “ppm”) which is defined in subsection B.01.001(1) as “means parts per million by weight unless otherwise stated.” This term appears in a number of food-related documents created by Health Canada and/or the CFIA that are incorporated by reference into the FDR including the Canadian Food Compositional Standards, the Lists of Permitted Food Additives as well as the List of Contaminants and Other Adulterating Substances in Foods. Similarly, the definitions of “solid cut meat” or “solid cut poultry meat” do not need to be repeated in the Canadian Food Compositional Standards in the respective Volumes with the application of this interpretation provision.

The Divisions 24 and 25 pre-consultation paper is based on the current text of the FDR and did not consider any proposed changes to definitions or their locations since these were not finalized. Stakeholders can be assured that future projects will recognize the amendments to the FDR made by these Regulations once they have come into force.

The CFIA and Health Canada both interpret “subject to” language to mean the same thing as “that comply with” and revised this language to be consistent throughout Parts B and D of the FDR where possible. This includes the proposed revision to item 16 of the table to subsection B.01.009(1) of the FDR that was made.

Outcome: The CFIA and Health Canada will maintain the prepublication proposal with respect to keeping defined terms that apply throughout Part B of the FDR in Division 1 and keeping an interpretation provision to clarify meaning of terms and expressions in internally generated documents that are incorporated by reference into the FDR.

Comments related to geographical indications and distinctive products: One industry association asked that a list of standardized foods in Canada that could potentially be impacted by geographical indication protections in other countries be provided to industry. Another industry association and one government overall expressed their support in the proposed removal of the distinctive products from Division 2 of the FDR, not carrying over any redundant rules into the Canadian Food Compositional Standards and supported the removal of the term “Champagne.”

The CFIA’s response: Geographical indications are a category of intellectual property that tell consumers if a product is produced in a certain location, and that the product has a quality, reputation or other characteristic that is attributable to its place of production. Examples of food compositional standards that are geographical indications are “Champagne” from France, “Scotch Whisky” from the United Kingdom and “Canadian Rye Whisky” from Canada. A full list of geographical indications maintained by the Canadian Intellectual Property Office is available on the Government of Canada website.

These Regulations will make limited changes to the FDR to remove the distinctive products under the Spirit Drinks Trade Act and that are prescribed in Division 2 of the FDR – Scotch whisky, Irish whisky, Bourbon whisky, Tennessee whisky, Armagnac brandy, Cognac brandy, Tequila and Mezcal. No changes were made to the bilingual labelling exemption of the common names of these distinctive products as well as other spirits. At this time, the only food compositional standard that has been identified as presenting an issue with a geographical indication is “Champagne Cider.”

Outcome: The CFIA will maintain the prepublication proposal related to removing distinctive products from the FDR. Any proposal to amend a food compositional standard to resolve a geographical indication or distinctive product issue will be subject to the CFIA’s Incorporation by Reference Policy; this will include notifying domestic and international stakeholders of the proposal and providing stakeholders with an opportunity to provide feedback on the proposal prior to amending the food compositional standard.

Comments related to extending the list of ingredients and components exemption to certain distinctive products: One industry stakeholder recommended that Tennessee whisky, Tequila and Mezcal be provided the same exemptions from the list of ingredients (subsection B.01.008(2)) or component labelling declarations (table to subsection B.01.009(1)) as other alcoholic beverages. They noted it has been accepted practice within the alcohol beverage industry in Canada that all products in Division 2 of the FDR, including distinctive products, do not require a list of ingredients.

The CFIA’s response: Subsection B.01.008(2) exempts a prepackaged product consisting of more than one ingredient to declare a list of ingredients and the table to subsection B.01.009(1) exempts certain ingredients or classes of ingredients to be shown on a label of a prepackaged product. These provisions currently include Bourbon whisky as well as prepackaged products subject to food compositional standards in Division 2. Tennessee whisky, Tequila and Mezcal are distinctive products that are currently captured in Division 2 and contain a bolded and non-italicized common name, a format commonly associated with standardized common names, but have not been identified as food compositional standards through the use of the symbol “[S].” To maintain the ingredient listing rules in their current form, the CFIA proposed in the Canada Gazette, Part I, that subsection B.01.008(2) and the table to subsection B.01.009(1) be amended to only refer to Bourbon whisky, the common name of distinctive product provisions currently identified in Division 2 with the symbol “[S],” and food compositional standards that are being moved over to the Canadian Food Compositional Standards. Tennessee whisky is a type of straight Bourbon whisky and will be included in the two exemptions currently specified. The CFIA acknowledges that by being in Division 2 the exemptions in subsection B.01.008(2) and in item 22 of the table to subsection B.01.009(1) were commonly interpreted as also applying to Tequila and Mezcal.

Outcome: The CFIA has amended paragraph B.01.008(2)(f.1) and item 22 of the table to subsection B.01.009(1) to specifically include Tennessee whisky, Tequila and Mezcal. This is not a new mandatory labelling rule so no transition period is provided.

2. Microbiological criteria

Comments on the microbiological criteria set out in the Table of Microbiological Criteria for Food: A respondent from a food industry association as well as one non-government organization noted the absence in the Table of Microbiological Criteria for Food of criteria for other concerning microorganisms, namely Cronobacter spp, Listeria and Escherichia coli O157. The industry respondent also recommended minor revisions to the table’s criteria for Aerobic Colony Count and Coliforms in water represented as mineral water or spring water, water in sealed containers, and prepackaged ice. This same respondent also asked a number of questions regarding future updates to the criteria, accessibility to documents incorporated by reference under Division 30, Part B, and differences with the Health Products and Food Branch (HPFB) Standards and Guidelines for Microbiological Safety of Food – An Interpretive Summary found in Volume 1 of the Compendium of Analytical Methods.

Health Canada’s response: Health Canada acknowledged in the Canada Gazette, Part I, prepublication consultation as well as in stakeholder engagements preceding prepublication that the intention of this proposal was to modernize the framework for regulating microbiological criteria and will not include updated criteria. Having first updated the framework will allow the Department to make administrative updates in the future in response to new and evolving science and technology as well as emerging risks to health. Revisions to the Table of Microbiological Criteria for Food will be proposed following the coming into force of these Regulations. Per the Health Canada Incorporation by Reference Policy, stakeholders will be notified and provided the opportunity to comment on the proposed revisions through the established notification process. To confirm, the Health Products and Food Branch (HPFB) Standards and Guidelines for Microbiological Safety of Food – An Interpretive Summary found in Volume 1 of the Compendium of Analytical Methods will be revised accordingly.

Respecting the availability of documents incorporated by reference, as previously noted, Health Canada’s Incorporation by Reference Inventory provides an online repository of all food-related documents incorporated by reference by Health Canada, including the Table of Microbiological Criteria for Food.

Regarding the recommended revisions to the microbiological criteria for Aerobic Colony Count and Coliforms in water represented as mineral water or spring water, water in sealed containers, and prepackaged ice, Health Canada supports the proposed revisions and has revised the Table of Microbiological Criteria for Food as follows:

the units of measure of the entries in columns 5 and 6 for Aerobic Colony Count in water in sealed containers and Coliforms in prepackaged ice are revised from “g” to “mL” to be consistent with the units of measure for the other criteria applicable to water represented as mineral water or spring water, water in sealed containers, and prepackaged ice.
the entries in column 5 for Coliforms in water represented as mineral water or spring water, water in sealed containers, and prepackaged ice are revised from “0 MPN/100 mL” to “<1.8 MPN/100 mL” to accurately reflect the achievable limit of detection in the applicable reference method.

Outcome: Health Canada will maintain the prepublication proposal with respect to the incorporation by reference of the Table of Microbiological Criteria for Food into the FDR, with minor revisions to the table as noted above.

Comments on the microbiological criteria in the Canadian Standard of Identity (incorporated by reference into the SFCR): One consultant noted that the Table of Microbiological Criteria for Food only included microbiological criteria from Part B of the FDR and did not include any criteria set out in other food regulations, notably Volumes 2 and 4 of the Canadian Standards of Identity that is incorporated by reference into the SFCR. They recommended clarifying the scope of the Table of Microbiological Criteria for Food by revising its title to clearly reference the FDR and also noting within this Table that other microbiological criteria are found in other documents. Alternatively, they proposed that the microbiological criteria from FDR and the SFCR be reflected in the Table of Microbiological Criteria for Food.

Health Canada’s response: Health Canada acknowledges that it may take time for regulated parties to adjust to the new framework given that some microbiological criteria appear under two regulations (i.e. the FDR and SFCR). It is the Department’s intention, in collaboration with the CFIA, to re-examine the criteria set out in the Table of Microbiological Criteria for Food, the Canadian Standards of Identity, as well as in the Canadian Grade Compendium (under the SFCR) to address any duplications or discrepancies between these documents and ensure the appropriate criteria are housed in appropriate documents. This will not be possible without first incorporating by reference the microbiological criteria into the FDR through these Regulations. With respect to the title of the Table of Microbiological Criteria for Food, the introductory section of the document clarifies the scope of the document and that it is incorporated by reference into Division 30, Part B of the FDR.

Outcome: Health Canada will maintain the prepublication proposal with respect to the Table of Microbiological Criteria for Food, including its title and incorporation by reference into the FDR.

Comments on the Table of Microbiological Reference Methods for Food: One industry association supported replacing the use of dated MFOs with the requirement that adherence to the proposed microbiological criteria be demonstrated by way of a microbiological reference method or an equivalent method. However, they, along with another industry respondent, noted that only a limited number of reference methods are included and requested that the content of the Table of Microbiological Reference Methods for Food be expanded to include additional internationally recognized methods as well as other validated methods currently set out in the Compendium of Analytical Methods. Another suggestion was that the FDR be further amended to include a provision that would provide flexibility to use methods other than the reference methods set out in this Table.

Health Canada’s response: The methods set out in the Table of Microbiological Reference Methods for Food correspond to microorganisms for which criteria are set out in the Table of Microbiological Criteria for Food. As the Table of Microbiological Criteria for Food is revised to include criteria for additional microorganisms in the future, the Table of Microbiological Reference Methods for Food will be concurrently revised to include a reference method for any new microorganism. Regarding the testing of microorganisms for which criteria are not set out in the Table of Microbiological Criteria for Food, methods in the Compendium of Analytical Methods in which the “application” section is appropriate for the intended purpose can be used.

With respect to the recognition and use of other microbiological methods, the new microbiological criteria framework under Division 30 was designed in such a way as to provide flexibility to the food industry while ensuring that methods meet a standard of performance. Division 30 will permit regulated parties to make use of a reference method as set out in the Table of Microbiological Reference Methods for Food or a method regulated parties deem equivalent based on the parameters and criteria set out in the Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis. Division 30 does not place an obligation on regulated parties to obtain pre-market approval from Health Canada to use an equivalent method. The obligation is on regulated parties to ensure that any methods chosen by them conform with section B.30.004 and the new framework. To confirm, methods set out in the Compendium of Analytical Methods are considered equivalent to the microbiological reference methods set out in the Table of Microbiological Reference Methods for Food and can be used for the purposes of applying section B.30.004.

Outcome: Health Canada will maintain the prepublication proposal with respect to microbiological reference methods and equivalent methods.

Comments on the Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis: One industry respondent proposed a number of technical revisions to this document, specifically to those sections pertaining to the “Requirements for qualitative and quantitative methods of analysis,” the “Additional requirements specific to qualitative methods of analysis” and the “Requirements specific to the quantitative method of analysis.”

Health Canada’s response: As previously noted in this Regulatory Impact Analysis Statement, the requirements set out in the Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis were modelled on the method validation guidelines and requirements presently set out in Volume 1 of the Compendium of Analytical Methods. The Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis does not introduce new information or concepts. The scope and focus of this regulatory initiative were purposefully limited to modernizing regulatory frameworks; not technical requirements. As such, the proposed revisions are considered out of scope and revisions to the Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis were not considered at this time. However, the recommendations will be retained and considered during a future review of the method validation guidelines.

Outcome: Health Canada will maintain the prepublication proposal with respect to the incorporation by reference of the Canadian requirements for determining the equivalence of food microbiological methods of analysis.

3. Official methods and protein quality

Comments related to protein quality and the draft Determination of the Protein Rating Using the Protein Digestibility Corrected Amino Acid Score (PDCAAS) document: Eleven industry associations provided comments on the proposed amendments related to protein quality. Most supported the proposal; however, some expressed concerns with the existing PER method (method FO-1) and aspects of the proposed PDCAAS method. Some associations also proposed the adoption of the Digestible Indispensable Amino Acid Score method for measuring protein quality. These comments and Health Canada’s responses are summarized in the sections below.

Additional comments were received from industry associations related to introducing a “high quality protein” claim, the use of protein ingredients, developing a standard for egg alternatives, and changes to the protein claim framework, reasonable daily intakes and the protein recommended dietary allowances. There were also general comments provided about dietary guidance on protein and the importance of high-quality proteins in the diet. These comments are out of scope of this regulatory initiative, but will be retained for future consideration.

Comments specific to the continued use of the PER method (FO-1): Some associations expressed support for the continued use of the PER method; however, others raised concerns with the method and recommended it no longer be used, except for infant foods. Key limitations raised were the reliance on a rat model which does not reflect human protein needs, and the focus on protein needs for growth and not maintenance phases. Some also raised that Canada is the only country continuing to use PER for regulating foods other than infant foods and infant formula and that PER is more useful for measuring protein quality in sole source diets.

Health Canada’s response: The PER method has limitations; however, it remains a validated method recognized by AOAC International and has some advantages over other methods. Other jurisdictions continue to use PER for regulatory and research purposes, beyond measuring the protein quality of infant foods. For example, the United States requires the use of PER for measuring the protein quality of infant formula, as well as other products such as acidified milks, peanut spreads and dried egg whites. The objective of these amendments is to help ensure that Health Canada has the ability to rapidly update methods of analysis in response to emerging science and to support economic growth and innovation. In the future, if evidence no longer supports the PER method, this could be addressed through its removal from the Table of Chemical, Physical and Nutritional Characteristics of Food.

Comments specific to the acceptance of the PDCAAS method: Several associations expressed support for including PDCAAS as a method for measuring the protein quality of foods and recognized this as a positive step towards a more modern evidence-based regulatory system with improved international alignment. Others raised concerns with aspects of the PDCAAS method, and some opposed the inclusion of PDCAAS in the Table of Chemical, Physical and Nutritional Characteristics of Food. General limitations raised were the overestimation of the quality of certain proteins, the use of protein needs of children two to five years old, the inaccurate reflection of protein bioavailability, and antinutritional factors not being adequately accounted for. Some provided comments on specific aspects of the PDCAAS methodology, including the truncation of PDCAAS values to 1.0 which does not permit proportional credit for higher quality proteins, and a proposal to accept in vitro digestibility data in place of animal data.

Some associations also raised concerns with the protein ratings proposed for PDCAAS in the Table of Chemical, Physical and Nutritional Characteristics of Food, as they appear to assume an equivalency between PER and PDCAAS and there may be discrepancies between which foods qualify for protein claims and comply with composition requirements depending on whether PER or PDCAAS is used. Some suggested that Health Canada assumed a linear relationship between PER and PDCAAS and used an inaccurate 2.5 conversion factor to establish the protein ratings. One specifically raised concerns about the discrepancy between protein ratings using PER and PDCAAS for products simulating whole egg and simulated meat products resembling side bacon. Another also raised concerns with allowing manufacturers to choose between PER and PDCAAS, as they could pick the method that gives their product a higher protein rating.

Health Canada’s response: The PDCAAS method is used globally for both research and regulatory applications, and its adoption is supported by many stakeholders. While there are recognized limitations with the method, it does offer advantages over other protein quality methods and aligns with jurisdictions such as the United States who use it for regulatory purposes. The adoption of PDCAAS for Canadian food regulations was recommended through the 2016 tripartite workshop hosted by the University of Toronto^{footnote 10}. During the stakeholder session in October 2023 there was support for adoption of PDCAAS in Canadian Regulations. Additionally, the use of PDCAAS to show compliance with most food regulations in Canada has been supported since 2020 through an interim policy which was well received by most stakeholders. As both PER and PDCAAS are valid methods, allowing manufacturers to choose their preferred method allows maximum flexibility without impacting health and safety, which will help support economic growth and innovation. For clarity, manufacturers only need to show compliance with one, not both, protein ratings.

The methodology proposed for PDCAAS largely follows that of the Food and Agriculture Organization of the United Nations and the World Health Organization’s expert report. This includes the selected amino acid scoring pattern, as well as the truncation of PDCAAS values to 1.0. Importantly, this approach aligns with other jurisdictions such as the United States who continue to use truncated values. While Health Canada recognizes that truncation to 1.0 may under credit some high-quality proteins, non-truncated values are not recommended in the Food and Agriculture Organization of the United Nations and the World Health Organization’s expert report which form the basis of most PDCAAS methodologies used by regulators and researchers.

Health Canada recognizes that PER and PDCAAS generate different values, which is why new protein ratings specific to PDCAAS were introduced. In setting those new values, several approaches were analyzed, and alignment between the methods was a key consideration. The proposed values were developed through modelling and calculation of protein ratings, rather than a 2.5 conversion factor from PER. Due to the non-linear relationship between PER and PDCAAS, there are some outliers resulting in minor discrepancies for some products such as those simulating whole eggs and side bacon. However, the proposed protein ratings for PER and PDCAAS largely align. To fully address these differences, updates to the existing protein ratings using PER are required, which is outside the scope of this regulatory initiative. Health Canada intends to consult with stakeholders and make revisions as needed to the protein ratings in the Table of Chemical, Physical and Nutritional Characteristics of Food in the future.

Comments specific to the Digestible Indispensable Amino Acid Score method: Some associations proposed that in addition to PER and PDCAAS, Health Canada should accept the Digestible Indispensable Amino Acid Score method for measuring the protein quality of foods. Some even suggested the latter method be used in place of PER and/or PDCAAS. They raised that the Digestible Indispensable Amino Acid Score was recommended by the Food and Agriculture Organization of the United Nations and the World Health Organization in the 2013 expert panel report. Reasons noted include that it more accurately reflects human protein needs and protein and amino acid bioavailability than other methods, and that robust datasets are available to support routine use of this method. Conversely, some criticized this method and supported the proposal to not accept it at this time, suggesting instead to further consult and assess its appropriateness in the future.

Health Canada’s response: Health Canada recognizes that there are certain advantages of the Digestible Indispensable Amino Acid Score method over other protein quality assessments. However, there are also limitations to the method. While the method is supported by the Food and Agriculture Organization of the United Nations and the World Health Organization, it has not yet been widely adopted by other regulators, and some cautioned against Health Canada being one of the first to adopt it for regulatory purposes. This method also poses some challenges for current routine regulatory use as it uses a more complex animal model. The scope of this regulatory initiative focussed on modernizing frameworks to help enable more agile and responsive regulations, and therefore significant changes are not being proposed for most rules. Amendments to accept PDCAAS were proposed due to the existing interim policy supporting the use of PDCAAS, strong stakeholder support for PDCAAS shared with Health Canada over the last decade, and stakeholder support expressed during the information session held in October 2023. The inclusion of the Digestible Indispensable Amino Acid Score in the Table of Chemical, Physical and Nutritional Characteristics of Food will require more substantive assessment and consultation.

Outcome: Health Canada will maintain the prepublication proposal with respect to inclusion of both FO-1 (which utilizes PER) and PDCAAS as methods for measuring protein quality in the Table of Chemical, Physical and Nutritional Characteristics of Food, and continuing to only allow PER for the substantiation of protein claims on infant foods. At this time, the Digestible Indispensable Amino Acid Score is not being included as a method for showing compliance with protein quality regulations, however Health Canada will continue to monitor its suitability for regulatory purposes. Adjustments to the accepted methods can be assessed in the future.

The protein ratings proposed in the prepublication proposal are also being maintained, however Health Canada intends to analyze and consult on adjustments to reduce discrepancies between PER and PDCAAS in the future.

The methodology for PDCAAS described in the Determination of the Protein Rating Using the Protein Digestibility Corrected Amino Acid Score (PDCAAS) document is also being maintained. Adjustments to some technical aspects, such as the amino acid scoring pattern, truncation, and acceptance of in vitro digestibility data can be assessed in the future.

4. Food Additives

Comments on revisions to the regulatory definition of the term “food additive”: One consultant requested clarification regarding the proposed removal of “natural extractives” from the exclusion list of the definition of “food additive” and the impact of this change depending on the purpose behind the addition of natural extractives, for example, when they are added to a food not as a flavouring preparation but may cause an antioxidant effect on the food.

Health Canada’s response: Health Canada regulates natural extractives as non-additive ingredients when they are added to a food primarily to impart flavour to a food, and as food additives when they are added to a food primarily for a technical effect in or on the food, such as to prevent oxidation. The amendment to the food additive definition removes a potential source of confusion in this regard. The food additive definition will still exclude spices, seasonings and flavouring preparations, all of which are used to impart flavour to foods, from being food additives. Health Canada will continue to regulate rosemary extract and other spice extracts as non-additive ingredients when their characteristics and use correspond to the purpose of imparting flavour to foods. However, Health Canada will also continue to regulate natural extractives as food additives if, for example, they are manufactured to have a composition that imparts minimal aroma or flavour to the food but favours exerting a technical effect in or on the food.

Outcome: Health Canada will maintain the prepublication proposal to modify the definition of the term food additive to remove “natural extractives” from the exclusion list of the definition.

Comments on future revisions to flavouring preparations: One industry association requested clarity regarding food additives that are permitted in standardized flavouring preparations and the work Health Canada is intending to do to revise the Lists of Permitted Food Additives.

Health Canada’s response: The food compositional standards for “(naming the flavour) Extract” or “(naming the flavour) Essence,” and “(naming the flavour) Flavour” provide that flavouring preparations subject to these food compositional 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. Although the compositional standards provide for these functional classes of food additives to be used in these flavouring preparations, the Lists of Permitted Food Additives do not identify which specific food colours, preservatives and emulsifying agents are permitted in these standardized flavouring preparations nor their corresponding maximum levels of use. In April 2020, Health Canada published a Call for data on food additives in certain food flavouring preparations to determine which food colours, preservatives and emulsifying agents are used in these standardized flavouring preparations and their associated maximum levels of use. The Canada Gazette, Part I, prepublication proposal noted Health Canada’s intent to revise the Lists of Permitted Food Additives based on the data provided. In fall 2024, Health Canada published a notice entitled Modification to the Lists of permitted food additives to extend the use of certain emulsifying agents, food colours and preservatives to two types of standardized flavouring preparations.

Outcome: In light of the modifications to the Lists of Permitted Food Additives to set out specific permitted uses of food colours and preservatives in “(naming the flavour) Extract” or “(naming the flavour) Essence,” and “(naming the flavour) Flavour”, and specific uses of emulsifying agents in “(naming the flavour) Flavour”, the functional class provisions for food additives have been removed from these two food compositional standards.

General comments on the Lists of Permitted Food Additives: Although supportive of the proposed changes to the Lists of Permitted Food Additives, three industry associations requested that the Lists of Permitted Food Additives be presented in HyperText Markup Language format or be searchable as one list rather than individually, to facilitate finding all uses of a food additive across the 15 lists. Another industry association suggested Health Canada use consistent and standardized terminology, adopt a consistent food additive and ingredient naming system whenever feasible, provide clear criteria to classify a substance as a food additive or an ingredient, and adopt a structured process for periodic review of food additives.

Health Canada’s response: Health Canada intends to improve the searchability of the Lists of Permitted Food Additives, but it will be done as separate work, and it will not require regulatory amendments. The foods and food categories set out in the Lists of Permitted Food Additives generally correspond to specific unstandardized foods or standardized foods, or categories of unstandardized foods or standardized foods. In some cases, a description of the intended type of food is used (e.g. “Non-alcoholic carbonated water-based flavoured and sweetened beverages other than cola type beverages”). As future work, Health Canada, in consultation with the CFIA, could consider other naming and classification systems, however, this is considered outside of the current scope of work.

Outcome: Health Canada will maintain the prepublication proposal with respect to the incorporation by reference of the Lists of Permitted Food Additives into the FDR, including their revised titles and structures.

Comments on specific Lists of Permitted Food Additives: Four industry associations provided technical and detailed comments on specific Lists of Permitted Food Additives. In particular, one of the industry associations provided technical changes to the proposed List of Permitted Food Enzymes with respect to the names of the food enzymes in column 1, the way source organisms are identified in column 2 as well as the way foods are described in column 3. Another association requested additional information about the labelling of spices when used as food colours, amendments to the proposed List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents and the proposed List of Permitted Food Additives with Other Purposes of Use (formerly the List of Permitted Food Additives with Other Accepted Uses).

A third industry association was of the view that current sections B.14.004 and B.22.005 of the FDR provide for the use of caramel as a colour on prepared meat products and prepared poultry products. However, they noted the proposed amended sections B.14.004 and B.22.005 and the List of Permitted Food Colours (formerly the List of Permitted Colouring Agents) were not amended to reflect this rule either. This association also noted that citric acid is permitted in pumping pickle, cover pickle, and dry cure employed in the curing of preserved meat products in section B.14.009, but the List of Permitted Acidity Regulators and Acid-Reacting Materials (formerly the List of Permitted pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agents) was not amended. The fourth industry association requested that Health Canada review the safety conditions of permitted alkalizing agents in cocoa products in this same List.

Health Canada’s response: Health Canada has considered these comments as well as other technical comments received on the Lists of Permitted Food Additives. A summary of the comments received, and subsequent revisions made to the Lists of Permitted Food Additives are published in a separate notice entitled, Modification to the Lists of permitted food additives to complete the modernization of the food additive regulatory framework (Reference Number: M-FAA-RM-1).

With respect to caramel in meat products and poultry products, Health Canada first notes that section B.14.004 applies to meat, meat by-products, preparations of meat and preparations of meat by-product (including prepared meat products) and section B.22.005 applies to poultry, poultry by-products, preparations of poultry and preparations of poultry by-product (including prepared poultry products). However, sections B.14.004 and B.22.005 do not permit the use of caramel in these foods. These sections deem the foods to be adulterated if food colour had been present in or added to them, but exclude caramel from being a food colour that would cause this adulteration. To confirm, these standardized products are not permitted to have caramel directly added to them. The foods caramel may be added to are set out in the List of Permitted Food Colours (formerly the List of Permitted Colouring Agents). Health Canada also confirms that citric acid is permitted for use in pumping pickle, cover pickle, and dry cure employed in the curing of preserved meat products in accordance with the List of Permitted Sequestering Agents.

Outcome: Health Canada will maintain the prepublication proposal.

Comments on food additive regulations and foods for which a food compositional standard is set out in the Canadian Standard of Identity (under the SFCR): A consultant highlighted that the proposed definition of the term “unstandardized” in the FDR does not also scope out foods that have a compositional standard under the Canadian Standard of Identity. They noted that this can create confusion and be interpreted as meaning that food additives that are permitted to be added to unstandardized foods under the FDR can be added to a food for which a food compositional standard is set out in the Canadian Standard of Identity but not in the Canadian Food Compositional Standard. Another industry association asked for more clarity around food additive rules currently captured in the Canadian Standard of Identity (e.g. specifying the class of preservatives permitted to be used in meats standardized in Volume 7).

CFIA and Health Canada response: The CFIA and Health Canada acknowledge the long-standing issue with the interpretation of the term “unstandardized” and the proper application of food additive rules to foods for which a standard is prescribed under the SFCR. This issue could not be addressed within the scope of these regulatory amendments, but will be considered by both groups in the future based on priority and resources. Incorporating by reference the food compositional standards into the FDR will facilitate this work as concurrent revisions to the Lists of Permitted Food Additives, the SFCR’s Canadian Standards of Identity and the Canadian Food Compositional Standards to address any discrepancies between these documents can now be pursued under the respective incorporation by reference modification procedures.

Outcome: The CFIA and Health Canada will maintain the prepublication proposal.

Comments on pre-mixes containing a food additive: One industry association expressed concerns that Division 16, Part B of the FDR, as structured, effectively prohibits the sale of a “pre-mix” (e.g. a mixture of ingredients that includes food additives set out in column 1 of the Lists of Permitted Food Additives that is sold solely for use in the manufacture of a food set out in column 3 of the Lists of Permitted Food Additives, in which the food additives are intended to function) if they are not set out in the Lists of Permitted Food Additives. This association recommended that an exemption be added to the regulations to permit the sale of such blends/mixes.

Health Canada’s response: Health Canada acknowledges that Division 16, Part B, as currently written and as proposed, would result in certain pre-mixes of food additives and other ingredients being deemed adulterated and subsequently prohibited from sale in Canada if they do not appear in the Lists of Permitted Food Additives.

To address this gap, Health Canada will amend Division 16, Part B to prescribe a general provision that will not consider such pre-mixes from being adulterated in the following scenario:

the pre-mix is intended solely for use as an ingredient in the manufacture of another food intended for sale to a consumer at the retail level or as an ingredient in the preparation of another food by a commercial or industrial enterprise or an institution;
the food additive (or additives as the case may be) in the pre-mix is set out in column 1 of the Lists of Permitted Food Additives and is obtained from any corresponding source set out in column 2; and
the food additive is intended for any corresponding purpose of use set out in column 4 of the Lists of Permitted Food Additives in relation to a corresponding food set out in column 3.

In addition, a quantitative statement of the amount of each food additive in the pre-mix that is intended to function in the other food the pre-mix is made with, and directions for use that, if followed, will allow the user of the pre-mix to produce a food that complies with the permitted use of the food additive in that food as set out in the Lists of Permitted Food Additives must be shown and grouped together with the list of ingredients of the pre-mix.

Health Canada also considered setting out individual entries for these pre-mixes in the Lists of Permitted Food Additives. While this approach would have had the effect of not deeming the pre-mixes to be adulterated with respect to any food additives that are intended to function in, and are already permitted for use in, the food to be manufactured or prepared with the pre-mix, it would have placed an unnecessary burden on both the food industry and Health Canada. If this option were implemented, each pre-mix, including those that are custom-made, would need to be authorized for sale with respect to any food additives in the pre-mix that are intended to function in the food to be manufactured or prepared with the pre-mix. As a result, industry would need to file a food additive submission to request Health Canada authorize the pre-mix to contain the food additive and would then need to wait until the pre-market authorization process is completed before the pre-mix could be sold for use. In response, Health Canada would need to dedicate departmental resources to carrying out the pre-market authorization process. This demand on industry and Health Canada would exist even though the pre-mix is not consumed directly by anyone, and the food additive in question is already permitted for use in the food that will be made with the pre-mix and in which the food additive is intended to function, and is the food that people will consume. Rather than establishing such a pre-market authorization requirement for pre-mixes, a general exemption subject to certain conditions as well as a new labelling requirement, will help ensure that the foods that people do consume that are produced with such pre-mixes comply with the conditions of use for food additives in those foods set out in the Lists of Permitted Food Additives.

Outcome: Division 16, Part B of the FDR will be amended to prescribe an exemption for pre-mixes containing a food additive that are intended solely for use in the manufacture of another food intended for sale to a consumer at the retail level or for use as an ingredient in the preparation of food by a commercial or industrial enterprise or an institution.

Comments on the Table of Food Additive Specifications: Two consulted parties sought clarity on the purpose of the Table of Food Additive Specifications as well as information on any potential future changes.

Health Canada’s response: The general rule with respect to food additives specifications has been moved from section B.01.045 to Division 16, Part B of the FDR and will continue to require that a food additive meet the specifications, if any, set out in the FDR through the new Table of Food Additive Specifications. Where no specifications for the food additive are set out in the Table of Food Additive Specifications, the food additive will need to meet either the specifications, if any, in the Combined Compendium of Food Additive Specifications or the Food Chemicals Codex.

The purpose of incorporating by reference the new Table of Food Additive Specifications into the FDR is to enable Health Canada to set out, where needed, specifications for food additives through the open and transparent process. Examples where specifications could be set out in the new Table of Food Additive Specifications include cases where the Department authorizes the use of a new food additive for which there are no specifications in either the Food Chemicals Codex or the Combined Compendium of Food Additive Specifications or where the Department sets a more restrictive specification to correspond to the characteristic of the food additive that the Department has evaluated and authorized. Health Canada will include the new Table of Food Additive Specifications in Documents incorporated by reference into food regulations.

Outcome: Health Canada will maintain the prepublication proposal with respect to incorporating by reference the Table of Food Additive Specifications into the FDR.

5. Miscellaneous amendments and consequential amendments or revisions

Comments on revisions to section A.01.002 of the FDR: One industry association requested clarification about the proposed changes to section A.01.002 as it appeared to them that no changes have been made.

Health Canada and the CFIA’s response: A minor change was made to the English text of this provision to clarify that the term “which they refer” applied to the “which the standards refer” (rather than to the food or drug mentioned right before). The same change was made in the French text of this provision, as well as other changes to consider that the food compositional standards will be incorporated by reference into the FDR (and no longer be in a provision of the FDR). In addition, the French term “la substance alimentaire” was changed to “l’aliment” for better alignment with other references to food throughout the FDR.

Outcome: Health Canada and the CFIA will maintain the prepublication proposal with respect to section A.01.002.

Comments on consequential revisions to existing documents that are incorporated by reference into the FDR or the SFCR: Two industry associations had concerns about the immediate coming into force of the proposed changes to the List of Adulterating Substances and Contaminants and one of which suggested transition periods be considered as appropriate. The other stakeholder also noted that further international harmonization was needed to modernize this List.

Three other industry associations suggested technical amendments to the Common Names for Ingredients and Components related to updating common names of certain foods and two of these associations also provided numerous technical comments on the Canadian Standards of Identity.

Health Canada and the CFIA’s response: All comments on existing documents that are incorporated by reference into the FDR or the SFCR have been considered by Health Canada and the CFIA if they were in scope of the proposal.

Requests to introduce technical amendments to the Common Names for Ingredients and Components or the Canadian Standards of Identity are not within the scope of this proposal as these would result in changing current requirements and would have an impact on stakeholders. Technical amendments to incorporation by reference documents being administered by the CFIA must follow the process set out in the CFIA’s Incorporation by Reference Policy.

While the comments to make technical amendments to the Canadian Standards of Identity are not within the scope of this proposal, the CFIA is considering these requests as part of its strategy to modernize food compositional standards. Stakeholders are encouraged to request modifications to the document by referring to the guidance 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.

With respect to the comment about a transition period being provided for the proposed changes to the List of Adulterating Substances and Contaminants, Health Canada does not believe one is needed as no new mandatory labelling rules nor changes to maximum levels are being imposed. Specifically, the maximum levels related to the contaminant C₂₂ Monoenoic Fatty Acid that are proposed to be moved from the FDR are not changing in the List of Adulterating Substances and Contaminants.

Outcome: Health Canada and the CFIA will maintain the prepublication proposal.

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. 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 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 will not provide the means needed to update food compositional standards in an agile and efficient manner and will therefore not respond to industry concerns that these standards are outdated.

Option 2: Non-regulatory approach

Non-regulatory options will maintain prescriptive regulations that may hinder innovation and will 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 (selected option)

The regulatory option, which makes use of incorporation by reference, was selected 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 amendments will 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 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 will not be a viable option and will 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 will 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 people in Canada.

Option 3: Regulatory approach (selected option)

Proceeding with the incorporation by reference of the current regulatory microbiological criteria and official methods of analysis is the selected option, as it strengthens regulatory responsiveness by enabling Health Canada to revise critical food safety and quality measures in the future, 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 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 will bring greater coherence to the framework, which will 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 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 amendments to the FDR will help create a more agile, transparent and responsive set of regulations, benefiting industry in particular.

They will enable future 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 will be reduced. The use of the PDCAAS method is currently being permitted through policy but will be incorporated by reference into the FDR, which will provide far 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 ratings 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 amendments will also facilitate the modernization of all food compositional standards (i.e. those incorporated by reference into the FDR, and those incorporated by reference into the SFCR). They will also help enable future 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.

Amendments to the ingredient list exemptions to include Tennessee whisky, Tequila and Mezcal will be consistent with how the FDR were commonly interpreted, thus allowing industry to continue to exclude an ingredient list for these products, aligning with current enforcement practices.

The revisions to the food additives framework will help reduce 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 will simplify industry’s review of the regulatory requirements.

Benefit to the Government

These amendments to the FDR will enable future 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 will 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

When assessing the potential costs to industry for prepublication in the Canada Gazette, Part I, Health Canada and the CFIA indicated that the proposed amendments were not intended to introduce new regulatory requirements.

The amendments to the FDR will now consider certain pre-mixes to not be adulterated, provided they meet specific conditions. These pre-mixes will be required to show a quantitative statement and directions for use. Health Canada will not require this labelling information to be placed directly on the package of the pre-mix and will allow for the information to accompany the product through separate documentation. Targeted engagements with representatives of the meat, flavouring, and baking sectors determined that the labelling requirement is not expected to result in costs to industry, as it aligns with current practices.

Despite this alignment, a transition period until December 31, 2027, is provided as Health Canada and the CFIA’s food labelling coordination policy requires a transition period for any new labelling rule prescribed under the FDR, even if the rule aligns with existing industry practices.

Amendments to the FDR are also being made to clarify the ingredient list exemptions to reflect current industry practices and common interpretation of the FDR. As a result, these amendments, which simply provide increased clarity, will not introduce any new costs.

Moreover, current regulatory requirements and their specifics (e.g. levels, foods, methods of analysis, compositional standards) will be moved into documents incorporated by reference, where relevant, and will not introduce regulatory requirements or costs to industry.

Costs to Government

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

These 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 will be incorporated by reference into the existing FDR, following the final publication of the 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 nutrition labelling. 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 will need to be updated to include the new documents involved in this regulatory amendment, and to make appropriate linkages with the CFIA’s online repository, which will also need to be updated. This will be considered a one-time cost to Health Canada and the CFIA. However, the contents of the documents incorporated by reference will require some level of maintenance and resource time on an ongoing basis when updates to such documents are deemed necessary. Health Canada and the CFIA will prioritize future updates to the documents that have been incorporated by reference, based on what is manageable within existing resources. Both Health Canada and the CFIA already have established processes in place to conduct such activities and to modify their respective documents.

It is expected that there will be no increased costs to the CFIA for compliance and enforcement, as the new regulations on certain pre-mixes containing a food additive align with current industry practices.

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. These amendments will now consider certain pre-mixes to not be adulterated, provided they meet specific conditions. These pre-mixes will be required to show a quantitative statement and directions for use. Amendments are also being made to the ingredient list exemptions to Tennessee whisky, Tequila, and Mezcal. Both of these amendments reflect current industry practice and are not expected to result in costs for industry, including small businesses. Moreover, small businesses now have the flexibility to use the new 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 as there is no incremental change in the administrative burden on business. The new amendments will transfer existing requirements from the 15 food additive MAs, which are set to be repealed, into the documents that will be incorporated by reference into the FDR, leaving administrative burden on business unchanged.

Health Canada anticipates repealing 16 out of 20 existing MAs in a subsequent regulatory package, to address redundant requirements between the FDR and those 16 MAs. Fifteen of these MAs are related to these amendments and the other is the Marketing Authorization for Vitamin D in Milk, Goat’s Milk and Margarine. As noted, the administrative burden on business will remain unchanged due to the redundancy of the requirements. Should those 16 regulatory titles be repealed, they will be considered as “OUTs” under the one-for-one rule, at the time of publication in the Canada Gazette, Part II, of that subsequent regulatory package. In this eventuality, the following four MAs will continue to be in force:

Marketing Authorization for Gluten-free Oats and Foods Containing Gluten-free Oats;
Marketing Authorization for Maximum Residue Limits for Veterinary Drugs in Foods;
Marketing Authorization to Permit a Lower Calcium Threshold for Exemptions from the Requirement for Prepackaged Products to Carry a Nutrition Symbol in the Case of Cheese, Yogurt, Kefir and Buttermilk; and
Marketing Authorization for Vitamin D in Yogurt and Kefir.

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 will be incorporated by reference will 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 Canadian Food Compositional Standards, the CFIA will be better able to align Canada’s standards with those adopted by Codex.

Interprovincial trade

The elements of the food compositional standards under the FDR that are not related to health or to safety apply to imported food and food traded interprovincially. They do not apply to food traded intraprovincially. While some provinces refer to the federal food compositional standards in provincial legislation, certain provinces have established food compositional standards that are applicable to foods produced and sold intraprovincially. Incorporating by reference the food compositional standards will serve to facilitate making amendments to the federal food standards and align them with provincial interests (e.g. address interprovincial barriers to trade). For clarity, the health and safety-related elements 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 11} 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 these Regulations do not change any existing provisions for uses of food additives in wine or spirit beverages, and the Department will retain its existing practice of notifying domestic and international stakeholders of any changes related to food additives, there are no significant 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 Canadian Food Compositional Standards. 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.

The incorporation by reference of the food compositional standards into the FDR also creates 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 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 Table of Chemical, Physical and Nutritional Characteristics of Food at a later time.

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 these Regulations aligns with its use in other jurisdictions. These amendments that incorporate by reference the methods from a static to an ambulatory basis into the FDR also allows 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.

Effects on the Environment

In accordance with the Cabinet Directive on the Environmental and Economic Assessment (SEEA Directive), a preliminary scan concluded that a strategic environmental and economic assessment is not required, because these amendments have no important 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 amendments to the FDR.

Implementation, compliance and enforcement, and service standards

Implementation

These Regulations will come into force on the day on which they are published in the Canada Gazette, Part II. A transition period will be provided for the labelling requirement of pre-mixes intended for further manufacturing. Following the coming into force of these Regulations, the intention is to issue a separate marketing authorization that will repeal the 15 food additive MAs.

Information on the implementation of these Regulations will be posted on the Government of Canada website. To support the updating of food compositional standards through incorporation by reference, the CFIA has developed a strategic approach. This strategic approach will be used to develop principles and processes to manage the anticipated requests for changes to food compositional standards, noting that the actual volume of requests is unknown at this time and could be significant. Stakeholders will be able to access information incorporated by reference into the FDR more easily through two single-window online inventories of such documents that will be managed respectively by Health Canada and the CFIA.

Compliance and enforcement, and service standards

The only service standard affected is the one previously prescribed in section B.16.003 pertaining to pre-market submissions for food additives which is repealed. Health Canada will 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

Footnotes

Footnote a

S.C. 2024, c. 17, s. 325(1)

Return to footnote a referrer

Footnote b

R.S., c. F-27

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Footnote c

S.C. 2002, c. 22

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Footnote d

S.C. 2002, c. 28

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Footnote e

S.C. 2014, c. 20, s. 234

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Footnote f

S.C. 2012, c. 24

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Footnote g

S.C. 2018, c. 16

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Footnote h

S.C. 2015, c. 2, s. 56

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Footnote i

R.S., c. F-9

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Footnote 1

C.R.C., c. 870

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Footnote 2

SOR/2022-168

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Footnote 3

SOR/2022-169

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Footnote 4

SOR/2005-22

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Footnote 5

SOR/2006-124

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Footnote 6

SOR/2017-9

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Footnote 7

SOR/2018-108

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Footnote 8

SOR/2018-144

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Footnote 9

SOR/2024-132

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Footnote 10

Wiggins, Ashleigh KA, G. Harvey Anderson, and James D. House. “Research and regulatory gaps for the substantiation of protein content claims on foods.” Applied Physiology, Nutrition, and Metabolism 44.1 (2019): 95-98.

Return to footnote 10 referrer

Footnote 11

The World Wine Trade Group is a group of government and industry representatives from the wine-producing countries of Argentina, Australia, Canada, Chile, Georgia, New Zealand, South Africa, the United States, and Uruguay. Founded in 1998, the Group aims to facilitate international trade in wine through information sharing, discussion of regulatory issues in wine markets, and joint actions for the removal of trade barriers. The World Wine Trade Group has negotiated three agreements and one memorandum of understanding that promote international wine trade.

Return to footnote 11 referrer

Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food: SOR/2024-244

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

Eau-de-vie de vin (brandy)

Ice Cream Mix and Ice Milk Mix

Sour Cream

Contaminants

Interpretation

Adulteration

Exemptions

Prohibitions

Specifications

Labelling and Packaging

Aliments peu acides emballés dans des récipients hermétiquement scellés

DIVISION 30 Microbiological Criteria

Interpretation

Adulteration

Exemption

Assessment

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

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

Excise Act, 2001

Denatured and Specially Denatured Alcohol Regulations

Pest Control Products Act

Pest Control Products Regulations

Pest Control Products Fees and Charges Regulations

Safe Food for Canadians Act

Safe Food for Canadians Regulations

Cannabis Act

Cannabis Regulations

Feeds Act

Feeds Regulations, 2024

Transitional Provisions

Coming into Force

REGULATORY IMPACT ANALYSIS STATEMENT

Executive summary

Issues

1. Outdated regulatory framework for food compositional standards

2. Outdated regulatory framework for microbiological criteria

3. Outdated regulatory frameworks for methods of analysis

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

5. Continuing the modernization of the food additives framework

Background

1. Food compositional standards

2. Microbiological criteria

3. Official methods of analysis

4. Protein quality of certain foods

5. Food additives

6. Regulatory Review

Objectives

Description

1. Food compositional standards

Definitions and interpretation

Incorporation by reference — Canadian Food Compositional Standards

Geographical indications and distinctive products

Future changes to the Canadian Food Compositional Standards

Consequential amendments/revisions — SFCR, Canadian Standards of Identity

Consequential revisions — Common Names for Ingredients and Components, Nutrition Labelling - Table of Permitted Nutrient Content Statements and Claims, Nutrition Labelling – Table of Reference Amounts for Food

2. Microbiological criteria and associated microbiological methods of analysis

Incorporation by reference — Table of Microbiological Criteria for Food

Adulteration and exemptions

Prohibitions outside of Division 30

Compliance with microbiological criteria

Incorporation by reference — Table of Microbiological Reference Methods for Food

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

Future changes to microbiological documents incorporated by reference

3. Chemical, physical and nutritional methods of analysis

Incorporation by reference — official methods of analysis

Protein quality method (FO-1) and protein ratings

Consequential revisions — Table of Permitted Nutrient Content Statements and Claims

Future changes to official (FO) methods documents

4. Food additives

Definitions and interpretation

Declaration of adulteration

Exemptions — general

Exemptions — infant food

Exemptions – mixes of food additives and other non-additive ingredients intended solely for use in the manufacture or preparation of other foods (“Pre-mixes”)

Exemptions — other requirements

Prohibitions

DIVISION 30
Microbiological Criteria