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

Tabs

Article
Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2016;14(3):4434 [13 pp.].
doi
10.2903/j.efsa.2016.4434
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.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Applications 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. 

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2015-00136
Adopted
9 March 2016
Published
18 March 2016
Last Updated
13 April 2016. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (490.92 KB)
Abstract

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.

Summary

Following a request from the European Commission, the European Food Safety Authority (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 additive synthetic β-carotene 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.

However, 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. Their diet is based on FSMPs, which either fulfil their daily nutrient requirements or supplement an inadequate dietary intake. The applicant stated that the FSMPs with added synthetic β-carotene were designed to cover or supplement dietary protein requirement in order to maintain physiological growth and development of the target population.

The safety of mixed carotenes and β-carotene was re-evaluated by EFSA in 2012 (EFSA ANS Panel, 2012). EFSA concluded that the use of (synthetic) β-carotene and mixed β-carotenes obtained from palm fruit oil, carrots and algae as food colour is not a safety concern provided that the intake from this use as a food additive and as food supplement is not more than the amount likely to be ingested as a result of the regular consumption of foods in which they occur naturally (5–10 mg/day).

The Panel considered that the available toxicological assessments of synthetic β-carotene would remain valid and, in principle, there would be no need to reconsider this to address the Terms of Reference.

In consideration of the medical condition of the recipients of the FSMPs, a different dietary pattern compared to their counterparts from the general population should be considered. These specific aspects were taken into account by the Panel when estimating exposure to synthetic β-carotene by different scenarios. With this aim, the applicant has proposed the assessment of two exposure scenarios with a typical FSMP product. In the application it is reported that FSMP products in liquid or powdered form contain 8–10 g of protein equivalent per 100 g or 100 mL of product and that the proposed use level of synthetic β-carotene in FSMP is 5 mg/L of final product. Based on the information provided by the applicant, the Panel calculated that the proposed use level of β-carotene of 5 mg/Kg or L in the final diluted product would correspond to 0.05–0.06 mg β-carotene /g protein. The first exposure scenario proposed was based on standard recommendations of 14.5 g/day for protein in children aged 1–3 years, whereas the second scenario would require the patients to meet their daily protein need set up by the applicant to 3 g/kg bw per day of protein equivalent, solely from the FSMP coloured with synthetic β-carotene at the proposed use level.

According to this last maximum scenario, the protein intake can be fully ensured (3 g protein/kg bw) by a FSMP product coloured with synthetic β-carotene resulting in an approximate maximum intake of synthetic β-carotene of 1.4–2.6 mg/day, which is not more than the amount of β-carotenes likely to be ingested from the regular diet as estimated for the same age group (i.e. 0.5–2.9 mg/day). Also other exposure scenarios based on different assumptions were within the range of the amount of β-carotene likely to be ingested from the regular diet.

The ANS Panel concluded that the proposed extension of use of synthetic β-carotene [E 160a(i)] at the requested level of 5 mg/L in the final diluted FSMP in young children aged 1–3 years would not be of safety concern. 

Keywords
food additive, colour, synthetic β-carotene, E160a(i), extension of use, FSMP, children
Print on demand
Number of Pages
13