Vol. 146, No. 7 — March 28, 2012

Registration

SOR/2012-43 March 15, 2012

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1557 — Food Additives)

P.C. 2012-292 March 15, 2012

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), hereby makes the annexed Regulations Amending the Food and Drug Regulations (1557 — Food Additives).

REGULATIONS AMENDING THE FOOD AND DRUG
REGULATIONS (1557 — FOOD ADDITIVES)

AMENDMENTS

1. (1) Paragraph B.04.005(4)(c) of the Food and Drug Regulations (see footnote 1) is replaced by the following:

1. (c) tartaric acid.
   

(2) Paragraph B.04.005(6)(a) of the French version of the Regulations is replaced by the following:

1. a) la quantité totale d’acide phosphorique, en masse, ne peut dépasser 0,5 partie, exprimée en P₂O₅, par 100 parties, en masse, du produit du cacao, calculée sans matières grasses;
   

(3) Paragraph B.04.005(6)(b) of the Regulations is replaced by the following:

1. (b) the total quantity of citric acid and tartaric acid, singly or in combination, shall not be greater than 1.0 part by mass for each 100 parts by mass of cocoa product, calculated on a fat-free basis.
   

2. Subparagraph B.08.033(1)(b)(v) of the French version of the Regulations is replaced by the following:

1. (v) du chlorure de calcium comme agent raffermissant, en quantité n’excédant pas 0,02 pour cent du lait et des produits du lait utilisés,

3. Subparagraph B.08.034(1)(b)(v) of the French version of the Regulations is replaced by the following:

1. (v) du chlorure de calcium comme agent raffermissant, en quantité n’excédant pas 0,02 pour cent du lait et des produits du lait utilisés,

4. (1) Paragraph B.11.002(c) of the Regulations is amended by striking out the word “and” at the end of subparagraph (iii) and by replacing subparagraph (iv) by the following:

1. (iv) a firming agent, and
2. (v) citric acid; and

(2) Clauses B.11.002(d)(iii) (A) to (C) of the Regulations are replaced by the following:

1. (A) canned asparagus, acetic acid, malic acid and tartaric acid in an amount consistent with good manufacturing practice, and
2. (B) canned white asparagus, acetic acid, ascorbic acid, malic acid and tartaric acid in an amount consistent with good manufacturing practice,

(3) Subparagraphs B.11.002(d)(v) to (vii) of the Regulations are replaced by the following:

1. (v) in the case of canned legumes, other than canned green beans, canned peas and canned wax beans, calcium disodium ethylenediaminetetraacetate in an amount not exceeding 365 parts per million calculated as the anhydrous form, or disodium ethylenediaminetetraacetate in an amount not exceeding 165 parts per million, and

5. Paragraph B.11.003A(b) of the Regulations is replaced by the following:

1. (b) may contain citric acid, sodium metabisulphite, sodium phosphate, dibasic, sodium sulphate and salt.
   

6. Section B.11.004 of the Regulations is replaced by the following:

B.11.004. [S].Frozen (naming the vegetable) shall be the product obtained by freezing the named fresh vegetable after it has been prepared and subjected to a blanching treatment and may contain citric acid and added salt.

7. Section B.11.007 of the Regulations is replaced by the following:

B.11.007. [S].Tomato Juice shall be the unconcentrated, pasteurized liquid containing a substantial portion of fine tomato pulp extracted from sound, ripe, whole tomatoes from which all stems and other portions unfit for consumption have been removed by any method that does not add water to the liquid and may contain citric acid, salt and a sweetening ingredient in dry form.

8. Section B.11.009 of the Regulations is replaced by the following:

B.11.009. [S].Tomato Paste shall be the product made by evaporating a portion of the water from tomatoes or sound tomato trimmings, may contain citric acid, salt and a Class II preservative and shall contain not less than 20 per cent tomato solids as determined by official method FO-19, Determination of Tomato Solids, October 15, 1981.

9. Section B.11.011 of the Regulations is replaced by the following:

B.11.011. [S].Tomato Pulp shall be the heat-processed product made from sound, whole and ripe tomatoes or sound tomato trimmings, concentrated to yield a product with a specific gravity of not less than 1.050 (20°C/20°C) and may contain citric acid, salt and a Class II preservative.

10. Section B.11.012 of the Regulations is replaced by the following:

B.11.012. [S].Tomato Puree shall be the heat-processed product made from sound, whole and ripe tomatoes with the skins and seeds removed, concentrated to yield a product with a specific gravity of not less than 1.050 (20°C/20°C) and may contain citric acid, salt and a Class II preservative.

11. Section B.11.040 of the Regulations is replaced by the following:

B.11.040. [S].Beans with Pork or Beans and Pork shall be the food prepared from dried beans and pork, may contain calcium disodium ethylenediaminetetraacetate, citric acid, disodium ethylenediaminetetraacetate, sauce, seasoning, spices or a sweetening agent and shall contain not less than 60 per cent drained solids as determined by official method FO-20, Determination of Drained Solids of Beans with Pork or Beans and Pork and Beans or Vegetarian Beans, October 15, 1981.

12. Section B.11.041 of the Regulations is replaced by the following:

B.11.041. [S].Beans or Vegetarian Beans shall be the food prepared from dried beans, may contain calcium disodium ethylenediaminetetraacetate, citric acid, disodium ethylenediaminetetraacetate, sauce, seasoning, spices or a sweetening agent and shall contain not less than 60 per cent drained solids as determined by official method FO-20, Determination of Drained Solids of Beans with Pork or Beans and Pork and Beans or Vegetarian Beans, October 15, 1981.

13. (1) Section B.11.051 of the Regulations is amended by adding the following after paragraph (h):

1. (h.1) citric acid;

(2) Paragraph B.11.051(i) of the French version of the Regulations is replaced by the following:

1. i) des huiles végétales;
   

14. Paragraphs B.11.101(b) and (c) of the Regulations are replaced by the following:

1. (b) shall be packed in hermetically sealed containers;
2. (c) may contain
   
   1. (i) a sweetening ingredient,
   2. (ii) water,
   3. (iii) concentrated (naming the fruit) juice, (naming the fruit) juice, (naming the fruits) juice, (naming the fruit) juice from concentrate or any combination thereof, and
   4. (iv) citric acid; and
3. (d) may contain
   
   1. (i) in the case of canned pears, lactic acid, lemon juice, malic acid, mint, spice oils, spices, tartaric acid and a flavouring preparation other than that which simulates the flavour of canned pears,
   2. (ii) in the case of canned apples, a firming agent,
   3. (iii) in the case of canned applesauce, ascorbic acid, isoascorbic acid, malic acid, salt, spices and a flavouring preparation other than that which simulates the flavour of canned applesauce,
   4. (iv) in the case of canned grapefruit, calcium chloride, calcium lactate, lemon juice, spices and a flavouring preparation other than that which simulates the flavour of canned grapefruit,
   5. (v) in the case of canned mandarin oranges, ascorbic acid,
   6. (vi) in the case of canned peaches, peach kernels, peach pits and spices intended for flavour development, ascorbic acid
      
   7. and a flavouring preparation other than that which simulates the flavour of canned peaches,
      
   8. (vii) in the case of canned pineapple, dimethylpolysiloxane when pineapple juice is used as a packing medium, mint, spice oils, spices and a flavouring preparation other than that which simulates the flavour of canned pineapple,
      
   9. (viii) in the case of canned plums, a flavouring preparation other than that which simulates the flavour of canned plums,
   10. (ix) in the case of canned strawberries, lactic acid, malic acid or tartaric acid, and
   11. (x) in the case of canned apricots, calcium chloride.

15. Paragraph B.13.021(k) of the French version of the Regulations is replaced by the following:

1. k) de la lécithine ou du sel d’ammonium de glycéride phosphorylé;
   

16. The portion of subitem 1(1) of Table III to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II Permitted in or Upon

1.

(1) Apple (or rhubarb) and (naming the fruit) jam; Bread; Butter; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Fish roe (caviar); Ice cream mix; Ice milk mix; Icing sugar; Liqueur; Lobster paste; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; Packaged fish and meat products that are marinated or otherwise cold-processed (Division 21); Pickles; Pineapple marmalade with pectin; Relishes; Sherbet; Smoked fish; Tomato catsup

17. The portion of subitem 1A(1) of Table III to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II Permitted in or Upon

1A.

(1) Apple (or rhubarb) and (naming the fruit) jam; Bread; Butter; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Fish roe (caviar); Ice cream mix; Ice milk mix; Icing sugar; Liqueur; Lobster paste; Margarine; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; Pickles; Pineapple marmalade with pectin; Relishes; Sherbet; Smoked fish; Tomato catsup

18. The portion of subitem 2(1) of Table III to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II Permitted in or Upon

2.

(1) Ale; Apple (or rhubarb) and (naming the fruit) jam; Beer; Brandy; Bread; Brown bread; Butter; Cider; Cider vinegar; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Fish roe (caviar); Hollands gin; Honey wine; Ice cream mix; Ice milk mix; Icing sugar; Liqueur; Lobster paste; Malt liquor; Malt vinegar; Mincemeat; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; Pickles; Pineapple marmalade with pectin; Porter; Relishes; Rum; Sherbet; Smoked fish; Stout; Tomato catsup; Whisky; Wine; Wine vinegar

19. The portion of subitem 3(1) of Table III to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II Permitted in or Upon

3.

(1) Apple (or rhubarb) and (naming the fruit) jam; Bread; Butter; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Fish roe (caviar); Ice cream mix; Ice milk mix; Icing sugar; Liqueur; Lobster paste; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; Pickles; Pineapple marmalade with pectin; Relishes; Sherbet; Smoked fish; Tomato catsup

20. The portion of subitem 4(1) of Table III to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II Permitted in or Upon

4.

(1) Apple (or rhubarb) and (naming the fruit) jam; Bread; Butter; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Fish roe (caviar); Ice cream mix; Ice milk mix; Icing sugar; Liqueur; Lobster paste; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; Pickles; Pineapple marmalade with pectin; Relishes; Sherbet; Smoked fish; Tomato catsup

21. The portion of subitem A.4(1) of Table IV to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II Permitted in or Upon

A.4

(1) Brawn; Canned (naming the poultry); Cream; Headcheese; Meat binder or (naming the meat product) binder where sold for use in prepared meat or prepared meat by-product in which a gelling agent is a permitted ingredient; Meat by-product loaf; Meat loaf; Mustard pickles; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; (naming the fruit) Jelly with pectin; Potted meat; Potted meat by-product; Prepared fish or prepared meat (Division 21); Relishes

22. The portion of subitem A.5(1) of Table IV to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
A.5	(1) Ale; Beer; Cream; French dressing; Malt liquor; Mustard pickles; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; Porter; Relishes; Salad dressing; Stout

23. The portion of subitem A.9A(1) of Table IV to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
A.9A	(1) Bread; Cream; Mustard pickles; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; Relishes

24. The portion of subitem C.14(1) of Table IV to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
C.14	(1) Cream; French dressing; Mustard pickles; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; Relishes; Salad dressing

25. The portion of subitem G.1(1) of Table IV to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II Permitted in or Upon

G.1

(1) Brawn; Canned (naming the poultry); Cream; Headcheese; Meat binder or (naming the meat product) binder where sold for use in prepared meat or prepared meat by-product in which a gelling agent is a permitted ingredient; Meat by-product loaf; Meat loaf; Mustard pickles; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids;(naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; (naming the fruit) Jelly with pectin; Potted meat; Potted meat by-product; Prepared fish or prepared meat (Division 21); Prepared hams, shoulders, butts, picnics and backs; Relishes

26. The portion of subitem P.1(1) of Table IV to section B.16.100 of the French version of the Regulations in column II is replaced by the following:

Article

Colonne II Permis dans ou sur

P.1

(1) Achards (relish); confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) et de (nom du fruit); cornichons à la moutarde; crème; gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; lait écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; marmelade d’ananas; marmelade d’ananas avec pectine; marmelade de figues; marmelade de figues avec pectine; marmelade de (nom de l’agrume) avec pectine; mincemeat; sauce à salade; sauce vinaigrette

27. The portion of subitem S.3(1) of Table IV to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
S.3	(1) Cream; French dressing; Mustard pickles; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; Relishes; Salad dressing

28. The portion of subitem S.11(1) of Table IV to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
S.11	(1) Mustard pickles; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; Relishes

29. (1) The portion of subitem C.1(2) of Table VI to section B.16.100 of the Regulations in column III is replaced by the following:

Item No.	Column III Maximum Level of Use
C.1	(2) 0.035% of the total calcium content, whether added or otherwise present

(2) Item C.1 of Table VI to section B.16.100 of the Regulations is amended by adding, in columns II and III, the following after subitem (9):

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
C.1	(10) Canned apricots	(10) 0.022% calculated as calcium

30. The portion of subitem C.3A(1) of Table VI to section B.16.100 of the Regulations in column III is replaced by the following:

Item No.	Column III Maximum Level of Use
C.3A	(1) 0.035% of the total calcium content, whether added or otherwise present

31. The portion of subitem G.2A(1) of Table VIII to section B.16.100 of the French version of the Regulations in column II is replaced by the following:

Article	Colonne II Permis dans ou sur
G.2A	(1) Pain de viande; saucisse cuite

32. The portion of subitems C.14(1) to (7) of Table X to section B.16.100 of the Regulations in columns II and III is replaced by the following:

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
C.14	(1) Ale; Beer; Cider; Honey wine; Malt liquor; Porter; Stout; Wine (2) Apple (or rhubarb) and (naming the fruit) jam; Apricot nectar; Beans; Beans with pork; Canned mushrooms; Canned (naming the fruit); Canned (naming the vegetable); Canned tomatoes; Concentrated tomato paste; Fig marmalade; Fig marmalade with pectin; Frozen mushrooms; Frozen (naming the fruit); Frozen (naming the vegetable); Grape juice; Mincemeat; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; Olives; Peach nectar; Pear nectar; Pickles; Pineapple marmalade; Pineapple marmalade with pectin; Relishes; Tomato juice; Tomato paste; Tomato pulp; Tomato puree (3) Canned shellfish; Canned spring mackerel; Dried egg-white (dried albumen); Dried whole egg; Dried yolk; Frozen cooked shrimp; Frozen egg-white (frozen albumen); Frozen whole egg; Frozen yolk; Gelatin; Liquid egg-white (liquid albumen); Liquid whole egg; Liquid yolk (4) Cocoa products (5) Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cottage cheese; Cream cheese spread; Cream cheese spread with (naming the added ingredients); Creamed cottage cheese; Ice cream mix; Ice milk mix; (naming the variety) Whey cheese; Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Sherbet (6) French dressing; Margarine; Mayonnaise; Salad dressing (7) Infant formula (8) Unstandardized foods	(1) Good Manufacturing Practice (2) Good Manufacturing Practice (3) Good Manufacturing Practice (4) 1.0%, singly or in combination with tartaric acid, calculated on a fat-free basis (5) Good Manufacturing Practice (6) Good Manufacturing Practice (7) Good Manufacturing Practice (8) Good Manufacturing Practice

33. The portion of subitem L.1(2) of Table X to section B.16.100 of the Regulations in column III is replaced by the following:

Item No.	Column III Maximum Level of Use
L.1	(2) Good Manufacturing Practice

34. The portion of subitem M.8(2) of Table X to section B.16.100 of the Regulations in column III is replaced by the following:

Item No.	Column III Maximum Level of Use
M.8	(2) Good Manufacturing Practice

35. The portion of subitem P.1(5) of Table X to section B.16.100 of the French version of the Regulations in column III is replaced by the following:

Article	Colonne III Limites de tolérance
P.1	(5) 0,5 %, exprimé en P2O5, calculé sans matières grasses

36. (1) The portion of subitem T.1(2) of Table X to section B.16.100 of the Regulations in column III is replaced by the following:

Item No.	Column III Maximum Level of Use
T.1	(2) Good Manufacturing Practice

(2) The portion of subitem T.1(6) of Table X to section B.16.100 of the French version of the Regulations in column III is replaced by the following:

Article	Colonne III Limites de tolérance
T.1	(6) 1,0 %, seul ou en association avec de l’acide citrique, calculé sans matières grasses

37. Item A.2 of Part Ⅰ of Table XI to section B.16.100 of the Regulations is amended by adding, in columns II and III, the following after subitem (4):

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
A.2	(5) Canned mandarin oranges	(5) 400 p.p.m.

38. The portion of subitem B.1(1) of Part Ⅱ of Table XI to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II Permitted in or Upon

B.1

(1) Apple (or rhubarb) and (naming the fruit) jam; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Mincemeat; (naming the citrus fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; (naming the fruit) Juice; (naming the fruits) Juice; Packaged fish and meat products that are marinated or otherwise cold-processed (Division 21); Pickles; Pineapple marmalade with pectin; Relishes; Tomato catsup; Tomato paste; Tomato pulp; Tomato puree

39. The portion of subitem M.1(1) of Part Ⅱ of Table XI to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II Permitted in or Upon

M.1

(1) Apple (or rhubarb) and (naming the fruit) jam; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Mincemeat; (naming the citrus fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; (naming the fruit) Juice; (naming the fruits) Juice; Packaged fish and meat products that are marinated or otherwise cold-processed (Division 21); Pickles; Pineapple marmalade with pectin; Relishes; Tomato catsup; Tomato paste; Tomato pulp; Tomato puree

40. The portion of subitem P.5(1) of Part Ⅱ of Table XI to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II Permitted in or Upon

P.5

(1) Apple (or rhubarb) and (naming the fruit) jam; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Mincemeat; (naming the citrus fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; (naming the fruit) Juice; (naming the fruits) Juice; Packaged fish and meat products that are marinated or otherwise cold-processed (Division 21); Pickles; Pineapple marmalade with pectin; Relishes; Tomato catsup; Tomato paste; Tomato pulp; Tomato puree

41. The portion of subitem S.9(1) of Part Ⅱ of Table XI to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II Permitted in or Upon

S.9

(1) Apple (or rhubarb) and (naming the fruit) jam; Cold-processed smoked and salted fish paste; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Mincemeat; (naming the citrus fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; (naming the fruit) Juice; (naming the fruits) Juice; (naming the source of the glucose) Syrup; Pickles; Pineapple marmalade with pectin; Relishes; Smoked or salted dried fish; Tomato catsup; Tomato paste; Tomato pulp; Tomato puree

42. The portion of subitem S.10(3) of Part Ⅱ of Table XI to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II Permitted in or Upon

S.10

(3) Apple (or rhubarb) and (naming the fruit) jam; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fancy molasses; Fig marmalade with pectin; Frozen sliced apples; Gelatin; Mincemeat; (naming the citrus fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; (naming the fruit) Juice; (naming the fruits) Juice; (naming the source of the glucose) Syrup; Pickles; Pineapple marmalade with pectin; Refiners’ molasses; Relishes; Table molasses; Tomato catsup; Tomato paste; Tomato pulp; Tomato puree

43. Items C.2 and C.3 of Table XII to section B.16.100 of the Regulations are replaced by the following:

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Maximum Level of Use
C.2	Calcium Disodium Ethylenediaminetetraacetate (Calcium Disodium EDTA)	(1) Ale; Beer; Malt liquor; Porter; Stout (2) French dressing; Mayonnaise; Salad dressing; Unstandardized dressings; Unstandardized sauces (3) Potato salad; Unstandardized sandwich spreads (4) Canned shrimp; Canned tuna (5) Canned crabmeat; Canned lobster; Canned salmon (6) Margarine (7) Canned clams (8) Beans; Beans with pork; Canned legumes except canned green beans, canned peas and canned wax beans (9) Canned sea snails; Canned snails (10) Ready-todrink teas; Soft drinks (11) Pasteurized sous-vide potatoes	(1) 25 p.p.m. calculated as the anhydrous form (2) 75 p.p.m. calculated as the anhydrous form (3) 100 p.p.m. calculated as the anhydrous form (4) 250 p.p.m. calculated as the anhydrous form (5) 275 p.p.m. calculated as the anhydrous form (6) 75 p.p.m. calculated as the anhydrous form (7) 340 p.p.m. calculated as the anhydrous form (8) 365 p.p.m. calculated as the anhydrous form (9) 300 p.p.m. calculated as the anhydrous form (10) 33 p.p.m. calculated as the anhydrous form (11) 100 p.p.m., singly or in combination with disodium EDTA, calculated as the anhydrous disodium EDTA form

44. (1) The portion of item D.1 of Table XII to section B.16.100 of the Regulations in Column I is replaced by the following:

Item No.	Column I Additive
D.1	Disodium Ethylenediaminetetraacetate (Disodium EDTA)

(2) The portion of subitem D.1(3) of Table XII to section B.16.100 of the Regulations in columns II and III is replaced by the following:

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
D.1	(3) Beans; Beans with pork; Canned legumes except canned green beans, canned peas and canned wax beans	(3) 165 p.p.m.

(3) The portion of subitem D.1(6) of Table XII to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
D.1	(6) Pasteurized sous-vide potatoes

45. Item D.2 of Table XII to section B.16.100 of the Regulations is repealed.

46. (1) Paragraph B.21.006(d) of the Regulations is replaced by the following:

1. (d) in the case of canned crabmeat, lobster, salmon, shrimp and tuna, contain aluminum sulphate and calcium disodium ethylenediaminetetraacetate;
   

(2) Paragraph B.21.006(k) of the Regulations is replaced by the following:

1. (k) in the case of canned clams, canned sea snails and canned snails, contain calcium disodium ethylenediaminetetraacetate;
   

47. The portion of item 23 of Schedule M of the Regulations in column 1 is replaced by the following:

Item	Column 1 Food
23.	Carbonated and non-carbonated beverages and wine coolers

48. (1) The portion of paragraph 26(b) of Schedule M of the Regulations in column 1 is replaced by the following:

Item	Column 1 Food
26.	(b) Flavoured and sweetened, prepared from mixes, such as iced tea

(2) Item 26 of Schedule M of the Regulations is amended by adding the following after paragraph (b):

Item	Column 1 Food	Column 2 Reference amount1
26.	(c) Flavoured and sweetened, ready-to-drink, such as iced tea	355 mL

COMING INTO FORCE

49. These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issue and objectives

The Food and Drug Regulations (“the Regulations”) regulate the sale and use of food additives in Canada, listing the permitted food additives and how they may be used. Health Canada has received submissions from industry requesting that the Regulations be amended to enable new uses of the following food additives:

• Citric acid in various standardized canned vegetables, standardized canned peaches and standardized canned apples at a maximum level of use consistent with good manufacturing practice;
• Ascorbic acid in canned mandarin oranges at a maximum level of use of 400 parts per million (p.p.m.);
• Calcium chloride in canned apricots at a maximum level of use of 0.022%, calculated as calcium;
• Calcium disodium ethylenediaminetetraacetate (calcium disodium EDTA) and disodium ethylenediaminetetraacetate (disodium EDTA) at maximum levels of use not exceeding 365 p.p.m. calculated as the anhydrous form, and not exceeding 165 p.p.m., respectively, in various standardized canned legumes, with the exception of canned green beans, canned wax beans and canned peas;
• Citric acid in pickled beets at a maximum level of use consistent with good manufacturing practice; and
• Citric acid in canned cut baby corn at a maximum level of use of 0.03%.

The evaluation of the available data supports the safety and efficacy of these food additives in the above specified uses. Therefore, the Regulations are amended to permit the use of the above noted food additives as described. Since there are no safety concerns regarding the use of citric acid as a pH adjusting agent, the amendments also permit its use in other standardized fruit and vegetable products, such as frozen vegetables, frozen mushrooms and canned plums, that are not currently the subject of submissions to Health Canada.

These amendments benefit consumers by allowing greater availability of food products while continuing to help protect their health and safety. In addition, these amendments benefit industry by facilitating the manufacture of food products.

Description and rationale

These amendments to the Regulations enable the use of the food additives as described above.

There is no anticipated increase in cost to government from the administration of these amendments to the Regulations. Furthermore, compliance costs incurred by manufacturers are not considered to be a factor because the use of food additives is optional.

Interim Marketing Authorizations (“IMAs”) were issued to permit the immediate use of these food additives as described above while the regulatory process was undertaken to amend the Regulations. They were published in the government notices section of the Canada Gazette, Part Ⅰ, on

• February 3, 2001, for citric acid as a pH adjusting agent in canned peaches;
• August 18, 2001, for ascorbic acid as a preservative in canned mandarin oranges;
• August 10, 2002, for calcium chloride as a firming agent in canned apricots;
• September 13, 2003, for citric acid as a pH adjusting agent in various standardized canned vegetable products;
• March 11, 2006, for citric acid as a pH adjusting agent in standardized canned apples and various standardized canned vegetable products;
• December 23, 2006, for calcium disodium EDTA and disodium EDTA as sequestering agents in various standardized canned legumes, with the exception of canned green beans, canned wax beans and canned peas;
• December 13, 2008, for citric acid as a pH adjusting agent in the production of pickled beets; and
• July 30, 2011, for citric acid as a pH adjusting agent in the production of canned cut baby corn.

The IMA for citric acid in pickled beets ceased to have effect on December 13, 2010. All the other IMAs ceased to have effect on June 16, 2010, except the IMA for citric acid in canned cut baby corn that will cease to have effect when the Regulations come into force. Health Canada confirms that the results of the pre-market safety assessments that were conducted prior to the issuance of these IMAs remain valid.

The Minister has the option to recommend or not to the Governor in Council that the Regulations be amended to permit the uses described above for these food additives. Based on the safety and efficacy assessment and the history of safe use of these food additives since the publication of these IMAs, the Minister is recommending that the Regulations be amended to enable the new uses of these food additives.

In addition, these amendments update section B.11.101 of the Regulations, in particular by removing the reference to the pH for canned applesauce, grapefruit, mandarin oranges, pineapple and strawberries, since the requirement in this regard is set out in Division 27 of the Regulations.

With respect to the terminology for calcium disodium ethylenediaminetetraacetate (calcium disodium EDTA) and disodium ethylenediaminetetraacetate (disodium EDTA), the term “versenate” or “versénate” appearing in the French version of the Regulations is deleted as it is no longer used in the scientific literature. The duplicate listing for these food additives in Table XII to section B.16.100 is also repealed. These amendments also correct inconsistencies and spelling errors in the names of these food additives in both versions of the Regulations.

These amendments also correct inconsistencies between the English and French versions and spelling errors in the sections of the Regulations that are amended. They also add clarity and consistency to the expressions used to describe certain foods in the sections of the Regulations that are amended.

For example, in the French version of the provisions of the Regulations that are amended, the following expressions are modified as follows:

• The expression “acide L-tartarique” is replaced by “acide tartrique” in paragraphs B.04.005(4)(c) and B.04.005(6)(b);
• The expression “seule ou en combinaison” is replaced by “seule ou en association” in paragraph B.04.005(6)(b), and the expression “seul ou en combinaison” is replaced by “seul ou en association” in items C.14 and T.1 of Table X to section B.16.100;
• The expression “produit du cacao sans matières grasses” is replaced by “produit du cacao, calculée sans matières grasses” in paragraphs B.04.005(6)(a) and B.04.005(6)(b);
• The expression “agent d’affermissement” is replaced by “agent raffermissant” in subparagraphs B.08.033(1)(b)(v) and B.08.034(1)(b)(v);
• The expression “acide tartrique de la série L” is replaced by “acide tartrique” in section B.11.101;
• The expression “acide ascorbique de la série L” is replaced by “acide ascorbique” in section B.11.101;
• The expression “glycéride phosphorylé d’ammonium” is replaced by “sel d’ammonium de glycéride phosphorylé” in paragraph B.13.021(k);
• The expression “ketchup de tomates” is replaced by “catsup de tomates” in Table III and in Part Ⅱ of Table XI to section B.16.100;
• The expressions “jus de fruit concentré sauf le jus d’orange concentré congelé” and “jus de fruit sauf le jus d’orange concentré congelé” are replaced by “jus de (nom du fruit) concentré sauf le jus d’orange concentré congelé” in Table III and in Part Ⅱ of Table XI to section B.16.100, respectively;
• The expression “poisson et viande emballés, marinés ou conditionnés à froid par une autre méthode analogue (Titre 21)” is replaced by “produits de poisson ou de chair de poisson emballés, marinés ou conditionnés à froid par une autre méthode (Titre 21)” in Table III and in Part Ⅱ of Table XI to section B.16.100;
• The expressions “liant à viande (quand il est vendu pour servir dans les viandes ou dans les sous-produits de la viande conditionnés dans lesquels un agent gélatinisant est autorisé)” and “liant à viande (quand il est vendu pour servir dans les sous-produits de la viande conditionnés dans lesquels un agent gélatinisant est autorisé” are replaced by “liant à viande ou liant à (désignation du produit de viande) lorsqu’il est vendu pour servir dans la viande préparée et dans les sous-produits de viande préparés dans lesquels il est permis d’ajouter un agent gélatinisant” in items A.4 and G.1 of Table IV to section B.16.100, respectively;
• The expression “fromage de tête ou tête fromagée” is replaced by “tête fromagée” in items A.4 and G.1 of Table IV to section B.16.100;
• The expression “jambons, épaules, soc de porc et épaules de porc genre pique-nique préparés” is replaced by “jambons, épaules, socs de porc, jambons pique-nique et jambons de longe préparés” in item G.1 of Table IV to section B.16.100;
• The expression “viande en pain” is replaced by “pain de viande” in item G.2A of Table VIII to section B.16.100;
• The expression “acide tartarique” is replaced by “acide tartrique” in item C.14 of Table X to section B.16.100;
• The expressions “blanc d’œuf (albumen) et jaune d’œuf” and “œuf entier à l’état liquide; en poudre ou congelé” are replaced by “blanc d’œuf congelé (albumen congelé),” “blanc d’œuf liquide (albumen liquide),” “poudre de blanc d’œuf (poudre d’albumen),” “jaune d’œuf congelé,” “jaune d’œuf liquide,” “poudre de jaune d’œuf,” “œuf entier congelé,” “œuf entier liquide” and “poudre d’œuf entier” in item C.14 of Table X to section B.16.100;
• The term “tomates” is replaced by “tomates en conserve” in item C.14 of Table X to section B.16.100;
• The expression “bière légère” in item C.14 of Table X to section B.16.100 is deleted;
• The expression “0,5 %, en P₂O₅, sans matières grasses” is replaced by “0,5 %, exprimé en P₂O₅, calculé sans matières grasses” in item P.1 of Table X to section B.16.100;
• The expression “mélasse de raffinerie” is replaced by “mélasse de raffineur” in item S.10 of Part Ⅱ of Table XI to section B.16.100;
• The expression “sous forme anhydre” is replaced by “calculé sous forme anhydre” in item C.2 of Table XII to section B.16.100;
• The expression “sauces et mayonnaises non normalisées” is replaced by “sauces d’assaisonnements non normalisées” and “sauces non normalisées” in item C.2 of Table XII to section B.16.100;
• The expression “palourdes en conserve” is replaced by “clams en conserve” in item C.2 of Table XII to section B.16.100;
• The expression “pommes de terre pasteurisées sous vide” is replaced by “pommes de terre pasteurisées sous-vide” in items C.2 and D.1 of Table XII to section B.16.100;
• The expressions “escargots de mer en conserve” and “conserves d’escargots de mer” are replaced by “limaces de mer en conserve” in item C.2 of Table XII to section B.16.100 and in paragraph B.21.006(k), respectively;
• The expression “conserves d’escargots” is replaced by “escargots en conserve” in paragraph B.21.006(k);
• The expression “conserves de palourdes” is replaced by “clams en conserve” in paragraph B.21.006(k);
• Items 23 and 26 of Schedule M of the Regulations are amended to indicate that the food category “Thé et tisane” includes the beverage “aromatisé et sucré, préparé à partir d’un mélange, tel que thé glacé” as well as the beverage “aromatisé et sucré, prêt-à-boire, tel que thé glacé” and in order to specify the reference amount for the beverage “aromatisé et sucré, prêt-à-boire, tel que thé glacé.”

In the English version of the provisions of the Regulations that are amended, the following expressions are modified as follows:

• The expression “L-tartaric acid” is replaced by “tartaric acid” in paragraphs B.04.005(4)(c) and B.04.005(6)(b) and in section B.11.101;
• The expression “L-ascorbic acid” is replaced by “ascorbic acid” in section B.11.101;
• The expressions “Concentrated fruit juice except frozen concentrated orange juice” and “Fruit juices except frozen concentrated orange juice” are replaced by “Concentrated (naming the fruit) juice except frozen concentrated orange juice” in Table III and in Part Ⅱ of Table XI to section B.16.100, respectively;
• The expression “Marinated or similar cold-processed packaged fish and meat (Division 21)” is replaced by “Packaged fish and meat products that are marinated or otherwise cold-processed (Division 21)” in Table III and in Part Ⅱ of Table XI to section B.16.100;
• The expressions “Meat binder (when sold for use in prepared meat or meat by-products in which a gelling agent is a permitted ingredient)” and “Meat binder (when sold for use in prepared meat by-products in which a gelling agent is a permitted ingredient)” are replaced by “Meat binder or (naming the meat product) binder where sold for use in prepared meat or prepared meat by-product in which a gelling agent is a permitted ingredient” in items A.4 and G.1 of Table IV to section B.16.100, respectively;
• The expression “Prepared hams, shoulders, butts and picnics” is replaced by “Prepared hams, shoulders, butts, picnics and backs” in item G.1 of Table IV to section B.16.100;
• The expressions “Egg white (albumen) and yolk” and “Liquid, dried or frozen whole egg” are replaced by “Dried egg-white (dried albumen),” “Dried whole egg,” “Dried yolk,” “Frozen egg-white (frozen albumen),” “Frozen whole egg,” “Frozen yolk,” “Liquid egg-white (liquid albumen),” “Liquid whole egg” and “Liquid yolk” in item C.14 of Table X to section B.16.100;
• The term “Tomatoes” is replaced by “Canned tomatoes” in item C.14 of Table X to section B.16.100;
• The expression “Light beer” in item C.14 of Table X to section B.16.100 is deleted;
• Items 23 and 26 of Schedule M of the Regulations are amended to indicate that the food category “Tea and herbal tea” includes the beverage “Flavoured and sweetened, prepared from mixes, such as iced tea” as well as the beverage “Flavoured and sweetened, ready-to-drink, such as iced tea” and in order to specify the reference amount for the beverage “Flavoured and sweetened, ready-to-drink, such as iced tea.”

Corrective amendments are also made to the French version of Table IV to section B.16.100 of the Regulations due to errors appearing in the amendments that were published in the Canada Gazette, Part Ⅱ, on November 14, 1979 (SOR/79-752). The intent of the amendments that were published in 1979 was to remove the listings of “skim milk process cheese” and “fromage au lait écrémé fondu” from Table IV to section B.16.100 of the Regulations. However, some of the listings appearing in the French version for that food were inadvertently omitted. Therefore, amendments are made to the French version of Table IV to section B.16.100 to remove the remaining listings of “fromage fondu au lait écrémé” and “fromage fondu de lait écrémé.”

Consultation

These amendments permit the use of these food additives in foods for which there are standards set out in Division 11 (Fruits, Vegetables, their Products and Substitutes) of the Regulations. Consequently, input regarding the use of citric acid in canned fruit and vegetables and in pickled beets and the use of calcium chloride in canned apricots was sought from the Food Processors of Canada and the Canadian Food Inspection Agency (“CFIA”). Input regarding the use of ascorbic acid in canned mandarin oranges was also sought from the Food Institute of Canada and the CFIA. All these organizations expressed support for these amendments.

In addition, Health Canada has announced the publication of the IMAs for these food additives through postings on its Web site. Health Canada also notified World Trade Organization members of the IMAs and the proposed regulatory amendments at the time of publication of these IMAs in the Canada Gazette, Part Ⅰ. The publication was followed by a 75-day comment period. Since the publication of the IMAs in the Canada Gazette, Part Ⅰ, between 2001 and 2011, the Government has received no comments regarding the safety of the use of these food additives.

The IMAs for citric acid in canned peaches and ascorbic acid in canned mandarin oranges were issued prior to June 2002. Citric acid and ascorbic acid are both accepted internationally in a range of foods in accordance with good manufacturing practice. Since these food additives have a history of safe use, it is not anticipated that the new uses of these food additives would have any impact on international requirements.

Implementation, enforcement and service standards

The CFIA is responsible for the enforcement of the Food and Drugs Act and the Regulations with respect to foods. The CFIA uses a science-based risk management approach to set its food safety priorities. Using this approach as its foundation, the CFIA plans its inspection and testing programs for foods, taking into account the degree of risk associated with a particular sector and concentrates its resources where the risk is the greatest. Each CFIA commodity inspection program performs ingredient verifications at which time inspectors compare formulation and list of ingredients, and perform on-site verification of the manufacture of the product. The frequency of inspection depends on the compliance history in relation to the manufacturing of a particular type of product, the compliance history of the manufacturer and the food safety risk.

Contact

Barbara Lee
Director
Bureau of Chemical Safety
Health Canada
251 Sir Frederick Banting Driveway
Tunney’s Pasture
Address Locator: 2203B
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-0973
Fax: 613-954-4674
Email: sche-ann@hc-sc.gc.ca

Footnote a
S.C. 2005, c. 42, s. 2

Footnote b
R.S., c. F-27

Footnote 1
C.R.C., c. 870