Carotenes is a chemical compound, an ingredient included in the list of European food additives as dye E160a.

It is obtained, with a synthetic and therefore a chemical process, mainly from the carrot.

It is specified as follows:

• E160a (i): mixture of carotenes
• E160a (ii): beta carotene obtained by fermentation of the fungus Blakeslea trispora, palm fruit oil, carrots and algae.

A first opinion of the Panel in 2012 had concluded that based on the presently available dataset, no ADIs for mixed carotenes and β-carotene can be established and that the use of (synthetic) β-carotene and mixed β-carotenes obtained from palm fruit oil, carrots and algae as food colour is not of safety concern, provided the intake from this use as a food additive and as food supplement, is not more than the amount likely to be ingested from the regular consumption of the foods in which they occur naturally (5–10 mg/day). This would ascertain that the exposure to β-carotene from these uses would remain below 15 mg/day, the level of supplemental intake of β-carotene for which epidemiological studies did not reveal any increased cancer risk. Furthermore, the Panel could not conclude on the safety in use of mixed carotenes [E 160a (i)] (1).

 In 2016, 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(ii)] 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 [E 160a(ii)] 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(ii)] 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 (2).

E160a is not subject to restrictions on use but has been authorised 'quantum satis' (3).

References_______________________________________________________________________

(1) Scientific Opinion on the re-evaluation of mixed carotenes (E 160a (i)) and beta-carotene (E 160a (ii)) as a food additive  EFSA Journal First published: 14 March 2012  DOI: 10.2903/j.efsa.2012.2593

(2) Safety of the proposed extension of use of synthetic β-carotene [E 160a(ii)] in foods for special medical purposes in young children  EFSA Journal First published: 18 March 2016, DOI: 10.2903/j.efsa.2016.4434

(3) Bogacz-Radomska, L., Harasym, J., & Piwowar, A. (2020). Commercialization aspects of carotenoids. In Carotenoids: Properties, Processing and Applications (pp. 327-357). Academic Press.