Review of the colouring substance tartrazine

Related information

17 March 2014

The TGA and Medsafe are currently undertaking a further program of harmonisation work that will progressively increase aspects of regulatory alignment between Australia and New Zealand.

The purpose of one of the harmonisation activities is to develop and publish a common list of colouring substances allowed for use in medicines for oral and topical use (Medicines ingredients - Colours).

A comparison of the two lists of colouring substances allowed in Australia and New Zealand revealed that the New Zealand list contains tartrazine allowed for both oral and topical use in New Zealand, but only allowed for topical use in Australia.

Given this, the TGA conducted a review of toxicity data for tartrazine and produced a report of the findings. As outlined in the report, it is recommended that the TGA allow the use of tartrazine for oral use and to label those products as to tartrazine content in line with New Zealand. This recommendation has since been accepted.