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1. When establishing the conditions of use referred to in Article 10(2)(c):

(a) the level of use shall be set at the lowest level necessary to achieve the desired effect;

(b) the levels shall take into account:

(i) any acceptable daily intake, or equivalent assessment, established for the food additive and the probable daily intake of it from all sources;

(ii) where the food additive is to be used in foods eaten by special groups of consumers, the possible daily intake of the food additive by consumers in those groups.

2. Where appropriate, no maximum numerical level shall be fixed for a food additive (quantum satis). In that case, the food additive shall be used in accordance with the principle of quantum satis.

3. The maximum levels of food additives set out in Annex II shall apply to the food as marketed, unless otherwise stated. By way of derogation from this principle, for dried and/or concentrated foods which need to be reconstituted the maximum levels shall apply to the food as reconstituted according to the instructions on the label taking into account the minimum dilution factor.

4. The maximum levels for colours set out in Annex II shall apply to the quantities of colouring principle contained in the colouring preparation unless otherwise stated.