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1. When a vitamin or a mineral is added to foods, the total amount of the vitamin or mineral present, for whatever purpose, in the food as sold shall not exceed maximum amounts. Measures setting that amount and designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3). The Commission may, to this end, submit a draft of measures for the maximum amounts by 19 January 2009. For concentrated and dehydrated products, the maximum amounts set shall be those present in the foods when prepared for consumption according to the manufacturer's instructions.

2. Any conditions restricting or prohibiting the addition of a specific vitamin or mineral to a food or a category of foods and designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).

3. The maximum amounts referred to in paragraph 1 and the conditions referred to in paragraph 2 shall be set taking into account:

(a) upper safe levels of vitamins and minerals established by scientific risk assessment based on generally acceptable scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different groups of consumers; and (b) intakes of vitamins and minerals from other dietary sources.

4. When the maximum amounts referred to in paragraph 1 and the conditions referred to in paragraph 2 are set, due account shall also be taken of reference intakes of vitamins and minerals for the population.

5. When the maximum amounts referred to in paragraph 1 and the conditions referred to in paragraph 2 are set for vitamins and minerals whose reference intakes for the population are close to the upper safe levels, the following shall also be taken into account, as necessary:

(a) the contribution of individual products to the overall diet of the population in general or of sub-groups of the population;

(b) the nutrient profile of the product established as provided for by Regulation (EC) No 1924/2006.

6. The addition of a vitamin or a mineral to a food shall result in the presence of that vitamin or mineral in the food in at least a significant amount where this is defined according to the Annex to Directive 90/496/EEC. Measures determining the minimum amounts, including any lower amounts, by derogation from the significant amounts mentioned above, for specific foods or categories of foods and designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3) of this Regulation.