Safety of the proposed extension of use of sucralose (E 955) in foods for special medical purposes in young children


Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2016;14(1):4361 [11 pp.].
Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes.
The Panel wishes to thank the members of the Working Group on Applications: Maria Jose Frutos, David Gott, Lieve Herman, Claude Lambré, Jean-Charles Leblanc, Peter Moldeus, Alicja Mortensen, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen and Matthew Wright for the preparatory work on this scientific output and EFSA staff members: Paolo Colombo and Camilla Smeraldi for the support provided to this scientific output.
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
9 décembre 2015
Published in the EFSA Journal
19 janvier 2016
European Food Safety Authority (EFSA), Parma, Italy
Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion regarding the safety of the extension of use of the food additive sucralose (E 955) when added to dietary food for special medical purpose (FSMP) intended for young children aged from 1 to 3 years. Sucralose was evaluated by the EU Scientific Committee on Food (SCF) who established an acceptable daily intake (ADI) of 15 mg/kg body weight (bw). Sucralose 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 on the FSMP indicated that the total daily protein requirement (3 g protein/kg bw) could be covered by the product containing 400 mg sucralose/kg without exceeding the ADI. Also, exposure in other scenarios based on different assumptions was always below the ADI. Therefore, the ANS Panel concluded that the proposed extension of use of sucralose (E 955) in FSMP in young children aged from 1 to 3 years would not be of safety concern. 
food additive, sweetener, sucralose, E 955, extension of use, FSMP, children
Print on demand
Number of Pages