Safety of the proposed extension of use of acesulfame K (E 950) 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 deliver a scientific opinion regarding the safety of the extension of use of the food additive acesulfame K (E 950) when added to dietary food for special medical purpose (FSMP) intended for young children aged 1–3 years. Acesulfame K was re-evaluated by the European Union (EU) Scientific Committee on Food (SCF) in 2000 who confirmed an acceptable daily intake (ADI) of 9 mg/kg body weight (bw). Acesulfame K is authorised in the EU for food use with exception for foods for young children. According to the applicant, the use of sweeteners is required to ensure 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 exposure scenarios based on the proposed use by the applicant (4.1 or 5.9 mg acesulfame K/g protein) on the FSMPs and as specified in the mandate (9 mg acesulfame K/g protein, corresponding to 450 mg/kg (L)) indicated that if the daily protein intake (3 g protein/kg bw) is exclusively provided by the sweetened powdered product, the ADI would be exceeded. When the protein intake from the product is limited to either 10 or 20 g of protein/child at the concentration of 5.9 mg acesulfame K/g of protein, the ADI was exceeded in the 1 and 2 year age groups following consumption of 20 g protein/day. Considering the concentration of acesulfame K of 9 mg/kg day, only the 10 g protein scenario was below or close to the ADI. The ANS Panel concluded that the proposed extension of use of acesulfame K (E 950) at the level up to 9 mg/g protein while providing 10 g protein/day to 1- to 3- year-old children would not be of safety concern.