Safety of the proposed extension of use of beetroot red (E 162) in foods for special medical purposes in young children

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to provide a scientific opinion on the safety of the extension of use of the food colour beetroot red (E 162) when added to dietary food for special medical purposes (FSMP) intended for young children aged 1–3 years. Currently, the use of colours in foodstuffs is prohibited in any food for infants and young children, including FSMPs. According to the applicant, the use of food colours is required to ensure appealing and palatable foods for the dietary management of patients whose compliance with the dietary regime (prescribed by healthcare professionals) is a key factor to their health. The Panel considered that there was no higher risk of sensitivity or intolerance to beetroot red extract in the specific population of children with cow's milk allergy or other protein allergies. The exposure scenarios indicated that the total daily protein requirement (up to 3 g protein/kg bw) could be covered by the products containing beetroot red at the proposed use level of 20 mg/L (expressed as the colouring principle betanin) in the final diluted product as consumed without exceeding the amount of betanin likely to be ingested in the same age group from the use of beetroot red (E 162) as a food additive. Exposure in other scenarios based on different assumptions was always below the range of the high level intake of betanin in the same age group. The ANS Panel concluded that the proposed extension of use of beetroot red (E 162) at the proposed level of 20 mg/L in the final diluted FSMP in young children aged 1–3 years would not be of safety concern.