Scientific Opinion on the re‐evaluation of Litholrubine BK (E 180) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re‐evaluating the safety of Litholrubine BK (E 180). Litholrubine BK has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), with the latest evaluation in 1987 and by the EU Scientific Committee for Food (SCF) in 1983. JECFA was unable to establish an Acceptable Daily Intake (ADI), whereas the SCF established an ADI of 0‐1.5 mg/kg bw/day. The Panel notes that SCF established the ADI of 0‐1.5 mg/kg bw/day based on a reported NOAEL of 150 mg/kg bw/day identified in a long‐term rat study. Overall, the Panel considers that the present database is too limited to continue supporting the ADI for Litholrubine BK set previously by the SCF or to establish a new ADI. The Panel was unable to identify a suitable NOAEL, LOAEL or BMD to establish an ADI from a combined repeated‐dose and reproductive/developmental toxicity study with Litholrubine BK in rats; males were exposed for 42 days and females exposed for 17 days, in accordance with OECD Test Guideline 422 and GLP conditions. The Panel thus concludes that the existing SCF ADI of 0‐1.5 mg/kg bw/day should be withdrawn. However, the Panel notes that the highest anticipated exposure to Litholrubine BK is 1700‐fold lower than the identified effect level in female rats (100 mg/kg bw/day). Therefore, the Panel considers that it is unlikely there would be a significant safety concern for humans from the current single authorised use of Litholrubine BK in edible cheese rinds. No conclusion on the induction of hypersensitivity by Litholrubine BK could be drawn from the limited scientific evidence available, although after Litholrubine BK exposure from cosmetics, cheilitis has been documented in one case report.