ANNEX II

General criteria for the use of food additives 1. Food additives can be approved only provided that: there can be demonstrated a reasonable technological need and the purpose cannot be achieved by other means which are economically and technologically Practicable, they present no hazard to the health of the consumer at the level of use proposed, so far as can be judged on the scientific evidence available, they do not mislead the consumer. 2. The use of food additives may be considered only where there is evidence that the proposed use of the additive would have demonstrable advantages of benefit to the consumer, in other words it is necessary to establish the case for what is commonly referred to as 'need'. The use of food addicives should serve one or more of the purposes set out from points (a) to (d) and only where these purposes cannot be achieved by other means which are economically and technologically practicable and do not present a hazard to the health of the consumer: to preserve the nutritional quality of the food: an intentional reduction in the nutritional quality of a food would be justified only where the food does not constitute a significant item in a normal diet or where the additive is necessary for the production of foods for groups ofconsumers having special dietary needs; to provide necessary ingredients or cnstituents for foods manufactured for groups of consumers having special dietary needs; to enhance the keeping quality or stability of a food or to improve its organoleptic properties, provided that this does not so change the nature, substance or quality of the food as to deceive the consumer; to provide aids in manufacture, processing, preparation, treatment, packing, transport or storage of food, provided that the additive is not used to disguise the effects of the use of faulty raw materials or of undesirable (including unhygienic) practices or techniques during the course of any of these activities. 3. To assess the possible harmful effects of a food additive or derivatives thereof, it must be subjected to appropriate toxicological testing and evaluation. The evaluation should also take into account, for example, any cumulative, synergistic or potentiating effect of its use and the phenomenon of human intolerance to substances foreign to the body. 4. All food additives must be kept under continuous observation and must be re-evaluated whenever necessary in the light of changing conditions of use and new scientific information. 5. Food additives must at all times comply with the approved criteria of purity. 6. Approval for food additives must: specify the foodstuffs to which these additives may be added and the conditions under which they may be added; be limited to the lowest level of use necessary to achieve the desired effect; take into account any acceptable daily intake, or equivalent assessment, established for the food additive and the probable daily intake of it from all sources. Where the food additive is to be used in foods eaten by special groups of consumers, accound should be taken of the possible daily intake of the food additive by consumers in those groups.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-08 · Text as adopted (Official Journal); later amendments are not incorporated in this text.