Division 2: Mineral Nutrients In Foods

Consolidated Statutes and Regulations
Enabling statute: Food and Drugs Act
Food and Drug Regulations
PART D: VITAMINS, MINERALS AND AMINO ACIDS
Disclaimer: These documents are not the official versions (more).
Source: http://laws.justice.gc.ca/en/F-27/C.R.C.-c.870/238313.html
Regulation current to September 15, 2006

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Division 2

Mineral Nutrients In Foods

D.02.001. (1) In this Division, “mineral nutrient” means any of the following chemical elements, whether alone or in a compound with one or more other chemical elements:

(a) sodium;

(b) potassium;

(d) phosphorus;

(e) magnesium;

(f) iron;

(g) zinc;

(h) iodide;

(i) chloride;

(j) copper;

(k) fluoride;

(l) manganese;

(m) chromium;

(n) selenium;

(o) cobalt;

(p) molybdenum;

(q) tin;

(r) vanadium;

(s) silicon; and

(t) nickel. (minéral nutritif)

(2) This Division applies only in respect of foods that are represented as containing a mineral nutrient for use in human nutrition.

SOR/88-559, s. 34; SOR/90-830, s. 9(F).

D.02.002. (1) No person shall, on the label of or in any advertisement for a food, other than salt for table or general household use containing added iodide, prepackaged water and ice, a formulated liquid diet, a human milk substitute or a food represented as containing a human milk substitute, make a statement or claim concerning the mineral nutrient content of the food unless

(a) the mineral nutrient is set out in column I of Table I to this Division;

(b) the percentage of the recommended daily intake of the mineral nutrient, per serving of stated size, is 5% or more; and

(c) the mineral nutrient content is declared on the label or in the advertisement as a percentage of the daily value, per serving of stated size.

(2) If a statement or claim described in subsection (1) is made in an advertisement for a food that is not a prepackaged product or in an advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the percentage of the daily value, per serving of stated size, shall,

(a) in the case of an advertisement, other than a radio or television advertisement, be

(i) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and

(ii) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once;

(b) in the case of a radio advertisement or the audio portion of a television advertisement, immediately precede or follow the statement or claim; or

(i) in the audio mode, if the statement or claim is made only in the audio portion of the advertisement or in both the audio and visual portions, or

(ii) in the audio or visual mode, if the statement or claim is made only in the visual portion of the advertisement.

(3) The percentage of the daily value, per serving of stated size, that is communicated in the visual mode of a television advertisement in accordance with subparagraph (2)(c)(ii) shall

(a) appear concurrently with and for at least the same amount of time as the statement or claim;

(b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and

(c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.

(4) Subsection (1) does not apply to a statement or claim made in respect of the sodium or potassium content.

(5) Paragraphs (1)(a) and (c) do not apply in respect of a declaration of the total fluoride ion content as required by sections B.12.002 and B.12.008.

(6) Paragraph (1)(b) does not apply in respect of a declaration of the mineral nutrient content in a nutrition facts table.

(7) Paragraph (1)(c) does not apply in respect of a declaration of the chromium, copper, manganese, molybdenum and selenium content as required by subparagraph B.24.202(a)(v).

SOR/84-300, s. 60(E); SOR/88-559, s. 34; SOR/90-830, s. 10; SOR/96-259, s. 9; SOR/2003-11, s. 34.

D.02.003. [Repealed, SOR/2003-11, s. 34]

D.02.004. No person shall, on the label of or in any advertisement for a food, make any claim concerning the action or effects of a mineral nutrient contained in the food, except to the effect that the mineral nutrient

(a) is a factor in the maintenance of good health; and

(b) is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health and normal growth and development.

SOR/84-300, s. 61(E); SOR/88-559, s. 34.

D.02.005. (1) If a component of an ingredient of a prepackaged product set out in the table to subsection B.01.009(1) is a mineral nutrient, no person shall, on the label of or in any advertisement for the prepackaged product, make a statement or claim concerning the mineral nutrient as a component of that ingredient unless

(a) despite subsection B.01.008(6), the mineral nutrient is declared by its common name immediately following the declaration of the ingredient in such a manner as to indicate that it is a component of that ingredient; and

(b) all components of the ingredient are declared.

(2) Paragraph (1)(b) does not apply to flour used as an ingredient in the manufacture of a prepackaged product referred to in subsection (1).

SOR/88-559, s. 34; SOR/2003-11, s. 35.

D.02.006. [Repealed, SOR/2003-11, s. 35]

TABLE I

RECOMMENDED DAILY INTAKE

	Column I		Column II	Column III
				Intake of
	Mineral		Intake of persons	infants and children less
Item	Nutrient	Units*	2 years of age or older	than 2 years of age

1.	Calcium	(mg)	1100	500
2.	Phosphorus	(mg)	1100	500
3.	Magnesium	(mg)	250	55
4.	Iron	(mg)	14	7
5.	Zinc	(mg)	9	4
6.	Iodide	(µg)	160	55
7.	Selenium	(µg)	50	15
8.	Copper	(mg)	2	0.5
9.	Manganese	(mg)	2	1.2
10.	Chromium	(µg)	120	12
11.	Molybdenum	(µg)	75	15
12.	Chloride	(mg)	3400	1000
* mg = milligrams
µg = micrograms

SOR/88-559, s. 34; SOR/96-259, s. 6; SOR/2003-11, s. 36.

TABLE II

WEIGHTED RECOMMENDED NUTRIENT INTAKE

	Column I	Column II	Column III
Item	Mineral Nutrient	Units	Amount

1.	Calcium	milligrams	780
2.	Iodide	micrograms	155
3.	Iron	milligrams	10
4.	Phosphorus	milligrams	885
5.	Magnesium	milligrams	210
6.	Zinc	milligrams	10

SOR/96-259, s. 7.

D.02.007. [Repealed, SOR/88-559, s. 34]

D.02.008. No person shall, in advertising a food that is represented as containing a mineral nutrient or on a label of such food,

(a) give any assurance or guarantee of any kind with respect to the result that may be, has been or will be obtained by the addition of the mineral nutrient to a person’s diet; or

(b) refer to, reproduce or quote any testimonial.

D.02.009. No person shall sell a food to which any of the following mineral nutrients have been added unless a reasonable daily intake of that food by a person would result in the daily intake by such person of not less than,

(a) in the case of calcium, 300 milligrams;

(b) in the case of phosphorus, 300 milligrams;

(d) in the case of iodine, 0.10 milligram.

D.02.010. (1) No person shall sell elemental iron powder for use in foods as a source of iron as a mineral nutrient unless

(a) subject to paragraph (b), the powder meets the specifications for

(i) Iron, Carbonyl,

(ii) Iron, Electrolytic, or

(iii) Iron, Reduced,

as set out in the Food Chemicals Codex, Third Edition, 1981, published by the National Academy of Sciences of the United States of America; and

(b) in the case of Iron, Reduced, 100 per cent by weight of the particles pass through a 100 mesh sieve and at least 95 per cent by weight of the particles pass through a 325 mesh sieve.

(2) No person shall sell a food to which elemental iron powder has been added as a source of iron as a mineral nutrient unless the powder meets the requirements referred to in paragraphs (1)(a) and (b).

SOR/84-303, s. 1.

D.02.011. No person shall sell a food to which sodium iron pyrophosphate has been added as a source of iron as a mineral nutrient unless

(a) the bioavailability of the iron in the food is not less than 50 per cent of the bioavailability of ferrous sulphate as determined by official method FO-42, Determination of Bioavailability of Iron, December 15, 1982; and

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

SOR/84-303, s. 1.

Division 3

Addition Of Vitamins, Mineral Nutrients Or Amino Acids To Foods

D.03.001. (1) In this Division, the expressions “vitamin” and “mineral nutrient” have the same meaning as in Divisions 1 and 2.

(2) This Division applies only in respect of foods that are represented as containing a vitamin, mineral nutrient or amino acid for use in human nutrition.

SOR/88-559, s. 35.

D.03.002. (1) Subject to section D.03.003, no person shall sell a food to which a vitamin, mineral nutrient or amino acid has been added unless the food is listed in Column I of the Table to this section and the vitamin, mineral nutrient or amino acid, as the case may be, is listed opposite that food in Column II of the Table.

(2) No milk or milk product or derivative listed in Column I of the Table to this section applies to the lacteal secretion obtained from the mammary gland of any animal other than a cow, genus Bos, or a product or derivative of such secretion unless that animal is identified therein.

TABLE

	Column I	Column II
	Food	Vitamin, Mineral Nutrient or Amino Acid

1.	Breakfast cereals	Thiamine, niacin, vitamin B6, folic acid, pantothenic acid, magnesium, iron and zinc.
2.	Fruit nectars, vegetable drinks, bases and mixes for vegetable drinks and a mixture of vegetable juices	Vitamin C.
2.1	Fruit flavoured drinks that meet all the requirements of section B.11.150	Vitamin C, folic acid, thiamine, iron, potassium.
2.2	Bases, concentrates and mixes that are used for making fruit flavoured drinks and that meet all the requirements of section B.11.151	Vitamin C, folic acid, thiamine, iron, potassium.
3.	Infant cereal products	Thiamine, riboflavin, niacin or niacinamide, calcium, phosphorus, iron, iodine.
4.	Margarine and other similar substitutes for butter	Vitamin A, Vitamin D, alphatocopherol
5.	Alimentary pastes	Thiamine, riboflavin, niacin or niacinamide, folic acid, pantothenic acid, vitamin B6, iron, magnesium
6.	Infant formulas and formulated liquid diets	Amino acids—alanine, arginine, aspartic acid, cystine, glutamic acid, glycine, histidine, hydroxyproline, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine;
		Minerals—calcium, chloride, chromium, copper, iodide, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc;
		Vitamins—alphatocopherol, biotin,dpantothenic acid, folic acid, niacin, riboflavin, thiamin, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin K.
6.1	Foods represented for use in a very low energy diet	Vitamins—alphatocopherol, biotin,dpantothenic acid, folic acid, niacin, riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin K Minerals—calcium, chloride, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc
7.	Flavoured beverage mixes and bases recommended for addition to milk	Vitamin A, thiamine, niacin or niacinamide, vitamin C, iron.
8.	Simulated meat products, simulated poultry meat products, meat product extenders and poultry product extenders	Thiamine, riboflavin, niacin, pyridoxine, dpantothenic acid, folic acid, vitamin B12, iron, magnesium, potassium, zinc, copper, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine.
9.	Meal replacements and nutritional supplements	Vitamins——alphatocopherol, biotin,dpantothenic acid, folic acid, niacin, riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D
9.	Meal replacements and nutritional supplements	Minerals——calcium, chloride, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc
9.1	Ready breakfast, instant breakfast and other similar breakfast replacement foods however described	Vitamin A, thiamine, riboflavin, niacin or niacinamide, vitamin C, iron
10.	Condensed milk, milk, milk powder, sterilized milk, (naming the flavour) milk	Vitamin D.
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, skim milk powder	Vitamin A, vitamin D.
12.	Evaporated milk	Vitamin C, vitamin D.
13.	Evaporated skim milk, concentrated skim milk, evaporated partly skimmed milk, concentrated partly skimmed milk	Vitamin A, vitamin C, vitamin D.
14.	Apple juice, reconstituted apple juice, grape juice, reconstituted grape juice, pineapple juice, reconstituted pineapple juice, apple and (naming the fruit) juice as described in section B.11.132, concentrated fruit juice except frozen concentrated orange juice	Vitamin C.
15.	Flour, White Flour, Enriched Flour or Enriched White Flour	Thiamine, riboflavin, niacin, vitamin B6, folic acid, dpantothenic acid, calcium, iron, magnesium.
16.	[Repealed, SOR/94689, s. 2]
17.	Table salt, table salt substitutes	Iodine.
18.	Dehydrated potatoes	Vitamin C.
19.	Products simulating whole egg	Vitamin A, thiamine, riboflavin, niacin or niacinamide, vitamin B6, dpantothenic acid, folic acid, vitamin B12, alphatocopherol, calcium, iron, zinc, potassium.
20.	[Repealed, SOR/90830, s. 11]
21.	Goat’s milk, goat’s milk powder	Vitamin D
22.	Partly skimmed goat’s milk, skimmed goat’s milk, partly skimmed goat’s milk powder, skimmed goat’s milk powder	Vitamins A and D
23.	Evaporated goat’s milk	Vitamins C, D, folic acid
24.	Evaporated partly skimmed goat’s milk, evaporated skimmed goat’s milk	Vitamins A, C, D, folic acid
25.	Precooked rice as defined in subsection B.13.010.1 (1)	Thiamine, niacin, vitamin B6, folic acid, pantothenic acid, iron
26.	Mineral water, spring water, water in sealed containers, prepackaged ice	Fluorine
27.	Liquid whole egg, dried whole egg, frozen whole egg, liquid yolk, dried yolk, frozen yolk, liquid egg white, (liquid albumen) , dried egg white (dried albumen) , frozen egg white (frozen albumen) , liquid whole egg mix, dried whole egg mix, frozen whole egg mix, liquid yolk mix, dried yolk mix, frozen yolk mix	Vitamin A, Vitamin D, Vitamin E, thiamine, riboflavin, niacin, vitamin B6, folacin, vitamin B12, pantothenic acid, calcium, phosphorus, magnesium, potassium, iron, zinc

SOR/78-64, s. 8; SOR/78-403, s. 29; SOR/78-478, s. 3; SOR/78-637, s. 11(E); SOR/78-698, s. 10; SOR/79-6, s. 1; SOR/81-60, s. 14; SOR/83-858, s. 2; SOR/84-300, s. 62; SOR/85-623, s. 4; SOR/86-320, s. 2; SOR/87-640, s. 10; SOR/88-559, s. 36; SOR/89-145, s. 3; SOR/89-198, s. 18; SOR/90-830, s. 11; SOR/94-35, s. 5; SOR/94-689, s. 2; SOR/95-474, s. 6; SOR/96-259, s. 8.

D.03.003. Section D.03.002 does not apply to a food when all of the following conditions are met:

(a) the food is

(i) a gluten-free food referred to in paragraph B.24.003(1)(g), or

(ii) represented for a special dietary use referred to in paragraph B.24.003(1)(h) or (i);

(b) no standard is prescribed in these Regulations for the food; and

SOR/78-64, s. 9; SOR/84-334, s. 2; SOR/90-830, s. 12; SOR/95-444, s. 3.

Division 4

Division 5

Minerals In Drugs

D.05.001. to D.05.007 [Repealed, SOR/2003-196, s. 106]

D.05.008. (1) Subject to subsection (2), no person shall sell a drug containing fluorine if the largest recommended daily dosage of that drug as shown on the label thereof would, if consumed by a person, result in a daily intake by that person of more than one milligram of fluoride ion.

(2) Subsection (1) does not apply to a drug sold by prescription.

SOR/81-196, s. 2.

D.05.009. Where a drug contains fluorine, both the inner and outer labels of the drug shall carry a cautionary statement that, if the drug is used in an area where the drinking water has a natural fluorine content in excess of 0.7 parts of fluoride ion per million parts of water or is artificially fluoridated, mottling of the tooth enamel of a user of the drug may result.

D.05.010. [Repealed, SOR/2003-196, s. 107]

PART E

CYCLAMATE AND SACCHARIN SWEETENERS

E.01.001. (1) In this Part,

“cyclamate sweetener” means

(a) cyclohexyl sulfamic acid or a salt thereof, or

(b) any substance containing cyclohexyl sulfamic acid or a salt thereof

that is sold as a sweetener; (édulcorant au cyclamate)

“saccharin sweetener” means

(a) saccharin or a salt thereof, or

(b) any substance containing saccharin or a salt thereof

that is sold as a sweetener. (édulcorant à la saccharine)

(2) Part B of these Regulations does not apply to any cyclamate sweetener or saccharin sweetener.

SOR/78-422, s. 4.

Sale

E.01.002. No person shall

(a) sell a cyclamate sweetener or saccharin sweetener that is not labelled as required by this Part; or

(b) commencing June 15, 1978, sell any saccharin sweetener to the general public except on the premises of a pharmacy.

SOR/78-422, s. 4.

Advertising

E.01.003. No person shall, in advertising to the general public a cyclamate sweetener or saccharin sweetener, make any representation other than with respect to the name, price and quantity of the sweetener.

SOR/78-422, s. 4.

Labelling

E.01.004. (1) Every cyclamate sweetener that is not also a saccharin sweetener shall be labelled to state that such sweetener should be used only on the advice of a physician.

(2) Commencing June 1, 1979, every saccharin sweetener shall be labelled to state that

(a) continued use of saccharin may be injurious to health; and

(b) it should not be used by pregnant women except on the advice of a physician.

SOR/78-422, s. 4.

E.01.005. Commencing June 1, 1979, every cyclamate sweetener or saccharin sweetener shall be labelled to show

(a) a list of all the ingredients and, in the case of

(i) cyclohexyl sulfamic acid,

(ii) a salt of cyclohexyl sulfamic acid,

(iii) saccharin,

(iv) a saccharin salt, or

(v) carbohydrates,

the quantity thereof contained in the sweetener; and

(b) the energy value of the sweetener expressed in calories

(i) per teaspoonful, drop, tablet or other measure used in the directions for use, and

(ii) per 100 grams or 100 millilitres

of the sweetener.

SOR/78-422, s. 4.

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