EFSA Re-evaluates Food Additive

The European Food Safety Authority (EFSA) has ruled out any safety concern for humans from the current single authorised use of Litholrubine BK in edible cheese rinds.

Exposure to Litholrubine BK from an assumed maximum level of use of 100mg/kg in edible cheese rinds were from 0.02 to 0.06mg/kg bw/day in children and from 0.01 to 0.03mg/kg bw/day in adults, according to the EFSA.

The highest level of anticipated exposure (95th / 97.5th) is 1,700-fold lower than the identified effect level of 100mg/kg bw/day in female rats.

The panel notes that the only toxicokinetic data available on Litholrubine BK suggest that there is very limited absorption in animals.

Data available for genotoxicity suggest that Litholrubine BK is not mutagenic or clastogenic in vitro, the panel said.