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Toxicity of tartrazine
Scientific review report
The TGA and MedSafe are engaged in several ANTZPA harmonisation activities under the Common Regulatory Framework Programme. One of these involves the development of a common list of colouring substances allowed for use in medicines. 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 external use in New Zealand but is only allowed for external use in Australia. When used in products for internal use in New Zealand, the product label has to state that the product contains tartrazine. Tartrazine is a permitted food colour in both Australia and New Zealand.
In the interest of harmonisation, a proposal was put forward to the ANTZPA Trans-Tasman Senior Officials Group (TTSOG) that:
"Australia should consider adding tartrazine to its list of colours allowed in medicines for oral use and, consistent with international practice, require the medicine label to state that the product contains tartrazine".
In response to this proposal, this review of tartrazine was undertaken by the TGA.