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ARCHIVED - Interim Marketing Authorization to permit the optional addition of vitamins and mineral nutrients to plant-based beverages

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Government Notices - Department of Health - Food and Drugs Act / Food and Drug Regulations Amendment

November 1997

There is no provision in the Food and Drug Regulations to permit the addition of vitamins or mineral nutrients to beverages made from plant bases such as soy, rice, almond, etc. Health Canada has received a request to permit the optional addition of vitamins and mineral nutrients to plant-based beverages to enable them to be used as nutritionally adequate alternatives for milk for those individuals who are allergic to milk protein or are lactose intolerant.

Health Canada has completed a safety assessment of the proposal to fortify plant-based beverages as an alternative for milk and considers this request to be in the public interest. This fortification is consistent with the General Principles for the Addition of Essential Nutrients to Food published in the Codex Alimentarius, under the Joint Food and Agriculture Organization of the United Nations/World Health Organization Food Standards Programme. The General Principles state:

"5.1 Where a substitute food is intended to replace a food which has been identified as a significant source of energy and/or essential nutrients in the food supply, and particularly where there is demonstrated evidence of public health need, nutritional equivalence in terms of the essential nutrients of concern should be strongly recommended."

This rationale was used as a basis for the development of the current Regulations under the Food and Drugs Act governing the nutritional quality of simulated meat and poultry products, simulated whole egg products and substitutes for fruit juices.

Consultation with Canadian soy and dairy product producers, manufacturers and importers, industry associations, health professional associations, provincial governments and members of the public was conducted in 1996. There was general support for the fortification of plant-based beverages with vitamins and mineral nutrients. In order to inform consumers that not all of these products contain the levels of protein found in milk, the statement "Not a source of protein" would be required on the labels of products which do not have a minimum level and quality of protein.

Some respondents had concerns regarding the labelling and representation of these products. The Canadian Food Inspection Agency has determined that advertising and labelling should be covered by the general labelling provisions of the Food and Drugs Act and Regulations and the Guide to Food Labelling and Advertising.

Health Canada intends to recommend that the Regulations be amended to provide that:

(1) Notwithstanding sections D.01.009, D.01.011 and D.02.009 and subject to subsection (5), no person shall sell a beverage derived from legumes, nuts, cereal grains, or potatoes to which a vitamin or a mineral nutrient has been added unless the food, when ready-to-serve,

(a) contains not less than 2.5 g of protein of a nutritional quality equivalent to not less than 75% of casein per 100 mL;

(b) contains not more than 3.3 g of fat per 100 ml of which not more than 65% shall be saturated fatty acids, not more than 5% trans fatty acids and not less than 2.5% linoleic acid;

(c ) subject to subsection (3) and (4), contains the vitamins and mineral nutrients listed in column I of Table I to this Section in the amounts listed in column II.

(2) Subject to subsections (3) and (4), one or more of the vitamins and mineral nutrients listed in column I of Table II to this section may be added to a beverage meeting the requirements of subsection (1) provided that the beverage contains the added vitamin or mineral nutrient in the amount set out in column II of Table II.

(3) The amount of a vitamin or mineral nutrient that is not an added ingredient in the food may exceed the amount listed in column II of Table I and Table II to this Section.

(4) The amount of a vitamin or mineral nutrient listed in column II of Table I and Table II to this Section does not include overages.

(5) The label of a beverage that does not meet the requirements of paragraph (1)(a), but meets all other requirements of subsection (1) shall carry the expression " Not a source of protein" in close proximity to and in the same size type used for the common name.

(6) The common name of a beverage meeting the requirements of subsection (1) shall be " fortified (naming the plant) beverage".

(7) Ingredients or components derived from milk, goat's milk or milk products may not be used in the manufacture of a fortified (naming the plant) beverage.

(8) The label shall carry the following information per serving of stated quantity:

(i) the energy value of the food, expressed in Calories (Calories or Cal) and kilojoules (kilojoules or kJ),

(ii) the protein, fat, linoleic acid and carbohydrate contents expressed in grams,

(iii) the contents of the vitamin and mineral nutrients listed in Table I to this section and any of those vitamin and mineral nutrients, except potassium, listed in Table II to this section that have been added to the food, expressed as a percentage of the recommended daily intake specified in column II of the tables to Divisions 1 and 2 of Part D for those vitamin and mineral nutrients,

(iv) the content of sodium and potassium expressed in milligrams

Table I

 

Column I Column II
Item Vitamin or Mineral Nutrient Amount per 100 mL ready-to-serve
1. vitamin A 40 RE
2. vitamin D 0.85 ug
3. vitamin B12 0.4 ug
4. riboflavin 0.15 mg
5. calcium 125 mg
6. zinc 0.4 mg

Table II

  Column I Column II
Item Vitamin or Mineral Nutrient Amount per 100 mL ready-to-serve
1. vitamin B6 0.04 mg
2. vitamin C 1.0 mg
3. thiamine 0.04 mg
4. niacin 0.85 NE
5. folacin 5.0 ug
6. pantothenic acid 0.35 mg
7. phosphorus 100 mg
8. potassium 150 mg
9. magnesium 12 mg

This notice is, therefore, to advise the public of the intention to promulgate an amendment to the Food and Drug Regulations to permit the optional addition of vitamins and mineral nutrients to plant-based beverages at levels which are consistent with Codex General Principles for the Addition of Essential Nutrients to Foods as indicated in the Table above.

As a means to improve the responsiveness of the regulatory system while enhancing the nutritional well-being of consumers, an Interim Marketing Authorization (IMA) is hereby being issued to permit the immediate sale of fortified plant-based beverages as nutritionally adequate alternatives for milk while the legal process to amend the Regulations formally is undertaken.

November 20, 1997

J.Z. LOSOS, M.D.
Deputy Minister
Health Protection Branch