The applicability of the ADI (Acceptable Daily Intake) for food additives to infants and children.

Children are not little adults. Children may respond differently from adults because they are in a state of growth and development; or because of differences in toxicokinetics or toxicodynamics. Infants and children are often assumed to be more susceptible to toxic effects, but this generalization is founded on assumptions rather than on facts. Available data are mostly concerned with toxicity and therapeutic effects of pharmaceuticals, while the effects in children of industrial chemicals are less well documented. Childhood is characterized by growth and development. Toxicants may interfere with these processes, and therefore toxic exposure may have more serious consequences for children than for adults, irrespective of sensitivity. Immature physiological functions of the foetus and young child theoretically make these age groups more vulnerable to toxicants, at least up to 1 year of age. The existing data on effects of chemical exposure in children point in the direction that susceptibility depends on the substance and on the exposure situation. For a particular compound children may be more sensitive than adults, or they may be less sensitive. Further, the sensitivity of children to a particular substance varies greatly with age. It is necessary to view premature neonates, neonates, infants, and children of different ages as separate risk groups. The long-term studies used as the basis for establishing ADIs cover lifetime for laboratory animals. Methods which have special emphasis on reproductive cells, on the foetus, and on the immature organism are used. Taken together, these studies cover exposure during all life stages. However, some specific types of effects, and delayed effects of perinatal exposure are not always included in standard toxicity test protocols. Exposure may also differ between children and adults. The food intake of children is qualitatively and quantitatively different form that of adults, and the EU Scientific Committee for Food has recommended that intake assessment of children be considered separately from that of adults because patterns of consumption are different. The ADI should cover the entire population including children. Special considerations regarding the use of food additives do apply to infants below the age of 12 weeks, who depend entirely on infant formula for nutrition.