Codex Alimentarius Commission
DRAFT REPORT OF THE 26th SESSION
OF THE CODEX COMMITTEE ON NUTRITION AND FOODS
FOR SPECIAL DIETARY USES
Bonn, Germany 1-5 November 2004
Appendix IV

Codex Draft Guidelines for Vitamin and Mineral Food Supplements
(at Step 8 of the Procedure)

PREAMBLE

Most people who have access to a balanced diet can usually obtain all the nutrients they require from their normal diet. Because foods contain many substances that promote health, people should therefore by encouraged to select a balanced diet from food before considering any vitamin and mineral supplement. In cases where the intake from the diet is insufficient or where consumers consider their diet requires supplementation, vitamin and mineral food supplements serve to supplement the daily diet.

1. SCOPE

1.1 These guidelines apply to vitamin and mineral food supplements intended for use in supplementing the daily diet with vitamins and/or minerals.

1.2 Food supplements containing vitamins and/or minerals as well as other ingredients should also be in conformity with the specific rules on vitamins and minerals laid down in these Guidelines.

1.3 These Guidelines apply in those jurisdictions where products defined in 2.1 are regulated as foods.

1.4 Foods for special dietary uses as defined in the General Standard for the Labelling of and Claims for Prepackaged Foods for Special Dietary Uses (CODEX STAN 146-1985) are not covered by these Guidelines.

2. DEFINITIONS

2.1 Vitamin and mineral food supplements for the purpose of these guidelines derive their nutritional relevance primarily from the minerals and/or vitamins they contain. Vitamin and mineral food supplements are sources of concentrated forms of those nutrients alone or in combinations, marketed in forms such as capsules, tablets, powders, solutions, etc., that are designed to be taken in measured small-unit quantities1 but are not in a conventional food form and whose purpose is to supplement the intake of vitamins and/or minerals from the normal diet.

They are designed to be taken as measured [small unit quantities].

3. COMPOSITION

3.1 SELECTION OF VITAMINS AND MINERALS

3.1.1. Vitamin and mineral food supplements should contain vitamins/ provitamins and minerals whose nutritional value for human beings has been proven by scientific data and whose status as vitamins and minerals is recognized by FAO and WHO.

3.1.2. The sources of vitamins and minerals may be from either [natural or synthetic sources] and their selection should be based on considerations such as safety and bioavailability. In addition, purity criteria should take into account FAO/WHO standards, or if FAO/WHO standards are not available, international Pharmacopoeias or recognized international standards. In the absence of criteria from these sources, and national legislation may be used.

3.1.3 Vitamin and mineral food supplements may contain all vitamins and minerals that comply with the criteria in 3.1.1. a single and/or mineral or an appropriate combination of vitamins and/or minerals.

3.2 CONTENTS OF VITAMINS AND MINERALS

3.2.1 The minimum level of each vitamin and/or mineral contained in a vitamin and mineral food supplement per daily portion of consumption as suggested by the manufacturer should be 15% of the recommended daily intake as determined by FAO/WHO.

3.2.2 Maximum amounts of vitamins and minerals in vitamin and mineral food supplements per daily portion of consumption as recommended by the manufacturer shall be set, taking the following criteria into account.

(a) upper safe levels of vitamins and mineral established by scientific risk assessment based on generally accepted scientific data, taking into consideration, as appropriate, the varying degrees of sensitivity of different consumer groups;

(b) the daily intake of vitamins and minerals from other dietary sources.

[When the maximum levels are set, due account mayshould be taken ofto the reference intake values of vitamins and minerals for the population.] This provision should not lead to setting of maximum levels that are solely based on recommnded nutrient intakes( e.g. Pupulation Reference Intake or Recommended Daily Allowance values).

4. PACKAGING

4.1 The product shall be packed in containers which will safeguard the hygienic and other qualities of the food.

4.2. The containers, including packaging material, shall be made only of substances which are safe and suitable for their intended use. Where the Codex Alimentarius Commission has established a standard for any substance used as packaging material, that standard shall apply.

5. LABELLING

5.1 Vitamin and mineral food supplements should beare labelled according to the Codex Standard for the Labelling of Prepackaged Foods (Codex-Stan 1-1985, Rev. 1-1991) as well as according to the General Guidelines on Claims (CAC/GL 1-1979).

5.2 The name of the product shall be "food supplement" with an indication of the category(ies) of nutrients or of the individual vitamin(s) and/or mineral(s) contained in the product as the case may be.

5.3 The amount of the vitamins and minerals present in the product should be declared in the labelling in numerical form. The units to be used should be units of weight consistent with the Codex Guidelines on Nutrition Labelling.

5.4 The amounts of the vitamins and minerals declared should be those per portion of the product as recommended for daily consumption on the labelling [ and if different, the amount per single unit for single use may also be given].

5.5 Information on vitamins and minerals should also be expressed as a percentage of the nutrient reference values mentioned, as the case may be, in the Codex Guidelines on Nutrition Labelling.]

5.6 The label mustshould indicate how the recommendations on how to take the product should be used (quantity, frequency, special conditions).

5.7 The label shall contain advice to the consumer not to exceed the maximum one-day amount.

5.8 The label should not state or imply that supplements can be used for the replacement of meals or a varied diet.

5.9 The label shall contain a statement that the product should be stored out of the reach of young children.

1 This refers to the physical forms of the vitmin and mineral food supplements not to the potency of the supplements.