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.