Safety of the proposed extension of use of synthetic β-carotene [E 160a(i)] in foods for special medical purposes in young children

food additive, colour, synthetic β-carotene, E160a(i), extension of use, FSMP, children
First published in the EFSA Journal
18 March 2016
9 March 2016
Last Updated
13 April 2016. This version replaces the previous one/s.
Scientific Opinion

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 on the safety of the extension of use of the food colour synthetic β-carotene [E 160a(i)] 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 exposure scenarios, based on the use level proposed by the applicant, indicated that the total daily protein requirement (up to 3 g protein/kg bw) could be covered by the products containing synthetic β-carotene at the level of 5 mg/L in the final diluted product as consumed, without exceeding the amount of β-carotene likely to be ingested from the regular diet as estimated for the same age group (i.e. 0.5–2.9 mg/day). Also, exposure in other scenarios based on different assumptions was always within the range of the typical dietary intake of β-carotene. The ANS Panel concluded that the proposed extension of use of synthetic β-carotene [E 160a(i)]  at the proposed level of 5 mg/L in the final diluted FSMP in young children aged 1–3 years would not be of safety concern.

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.
Panel on Food Additives and Nutrient Sources Added to Food
fip [at]
EFSA Journal 2016;14(3):4434 [13 pp.].
Question Number
On request from
European Commission