Scientific Opinion on the re-evaluation of beetroot red (E 162) as a food additive

Beetroot red (E 162) is a natural colour containing a number of pigments, all belonging to the class known as betalains. The main colouring principle consists of a number of betacyanins. The Panel noted that the specification for the content of red colour (expressed as betanin) in beetroot red, as not less than 0.4%, may give rise to some confusion, given the number of different forms of beetroot red that may be on the market, including simple extracts, refined extracts and spray–dried powders. The Panel considered that revision of the current specification to reflect betanin content on a dried solids basis could be appropriate. The Panel noted that toxicological studies carried out on material conforming to the specifications for beetroot red are limited in number. Acute and short-term toxicity studies are too limited to draw conclusions on these endpoints. The genotoxic potential of beetroot red could not be evaluated based on the available data. There are only limited or inadequate studies available on the chronic toxicity and carcinogenicity of beetroot red and therefore the Panel could not conclude on these endpoints. No adequate studies on reproduction and developmental toxicity were available. The Panel concluded that the currently available toxicological database was inadequate to establish an acceptable daily intake (ADI) for beetroot red as defined by the specifications set for the food additive E 162. However, the colouring principles in E 162 are natural dietary constituents having a long history of food consumption. In addition, the betanin exposure resulting from the use of beetroot red (E 162) as food additive is in the same range as the exposure to the betanin from the regular diet. Therefore, the Panel concluded that, at the reported use levels, beetroot red (E 162) is not of safety concern as regards its current use as a food additive.