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

Abstract

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.

Natural food pigments application in food products

“…In 2008 lycopene (E 160d) was subjected to analyses, in 2014 some changes were introduced, among others, concerning the use of aluminium lakes of riboflavins (E 101), cochineal (E 120a), carminic acid (E 120b), carmines (E 120c) or caramel pigments (E 150 a-d), as well as certain colours in flavoured ripened cheeses (Florowska et al, 2013;Scotter, 2015). In 2015, in accordance with the designations (Commission Regulation..., 2014a, 2014b, 2014cEuropean Parliament..., 1994), successive pigments were analysed including chlorophyllin (E 141), betalain (E 162), cochineal (E 120), paprika extract (E 160c), anthocyanins (E 163), as well as chlorophyll (E 140) (EFSA, 2015a(EFSA, , 2015b(EFSA, , 2015c(EFSA, , 2015d. All the sweeteners and the other pigments not evaluated by December 2015 will have been evaluated by December 2020.…”

Safety of the proposed extension of use of beetroot red (E 162) in foods for special medical purposes in young children

“…The safety of beetroot red (E 162) as a food additive was previously considered by this Panel under the re-evaluation programme for food additives already permitted in the EU before 20 January 2009, as foreseen by the Commission Regulation (EU) No 257/2010 7 (EFSA ANS Panel, 2015).…”

“…As already stated, beetroot red (E 162) was recently re-evaluated for its use as a food additive by this Panel, also taking into account previous evaluations and authorisations (EFSA ANS Panel, 2015).…”

“…Given the Panel's observations on the SCF conclusions on allergy and intolerance from 1995, the Panel considered that there was no higher risk of sensitivity or intolerance to beetroot red extract for this population. Therefore, the risk assessment can be based on the recent re-evaluation of beetroot red as a food colour (EFSA ANS Panel, 2015).…”

“…The exposure estimates obtained from the proposed use in FSMP were compared to the high level (95th percentile) daily intake of betanin (expressed in mg/kg bw per day) estimated from a refined exposure scenario (brand-loyal) from the use of beetroot red (E 162) as a food additive in the same age group (toddlers, from 12 months up to and including 35 months of age) as calculated by the Panel for the 2015 re-evaluation opinion (EFSA ANS Panel, 2015). This comparison was based on the assumption that the proposed use levels of 20 mg/L in the final diluted product are expressed as the colouring principle betanin.…”