Abstract
Food additives are substances added to food to maintain or improve its safety, freshness, taste, texture, or appearance. Until recently, the assessment of food additives taken up with the normal food was performed only for the population above an age of 12 weeks. With the better knowledge of the physiological specificities in the age group below 12 weeks of age and considering that milk formulae can be the unique dietary source for infants up to 16 weeks, special assessments are performed for food additives already on the market for this age group. This publication explains the background and relevant guidelines for the assessment, including special guidelines for the age group below 16 weeks, and the different sources of information used. The principles followed to assess food additives are described. The requirements for the assessment of food additives used in infants’ food includes testing in special animal models if human data are absent. The amount of food additives the infants are exposed to is estimated based on an exposure assessment. The aim of the assessment is to compare the estimated intake of the FA with milk formulae with safe concentrations taken from clinical studies in infants, special animal models and/or by comparing the exposure by the milk formulae with the content of breast milk whatever is appropriate. Two examples (locust bean gum, lecithin) illustrate the application of the principles. Of special interest is the concentration of impurities in the food additive with a toxic potential, such as lead, arsenic, cadmium, mercury, relevant for all food additives, or glycidyl esters, 3‐monochloropropane diol, erucic acid, and trans-fatty acids, relevant for mono- and diglycerides of fatty acids. The assessment of food additives intended to be used in food for infants below 16 weeks of age revealed that in most cases the maximum permitted regulatory levels of the food additive would result in an exposure which does not raise health concerns, besides lecithins and locust bean gum. However, the content of impurities with a toxic potential at the regulatory permitted levels is of concern for all food additives which indicates the need for lowering those levels.