A Revised Monograph for BP and Ph Eur to align with ISO 4730: 2017

Summary

In late December 2018 the Australia Tea Tree Oil Industry, through the peak organisation ATTIA, was advised by the Therapeautic Goods Administration "to modify the current BP monograph line by line, exactly as necessary and send this with reference to the already provided data and samples to BP (British Pharmacopeia). When this proposal is assessed it will be dealt with much faster, as it will be an evaluation of a revised method proposal." In Australia the TGA exclusively uses the BP Standard to define TTO and have refused to change to ISO 4730 for more than 8 years.

Program

Tea Tree Oil

Research Organisation

Tony Larkman

Objective Summary

1. Modify the current British Pharmacopeia (BP) monograph line by line and send this with reference to the already provided batch data and samples to BP. 2. The BP & Ph Eur proposal is revised to achieve a shorter assessment period by the relevant expert committee (13A). 3. The principal investigator to request both BP and Ph Eur to provide a Standard that is identical to the ISO 4730: 2017 Standard. The request to include the enantiomeric abundances for terpinen4ol, limonene and alphaterpineol. 3. The principal investigator to request both BP and Ph Eur to provide a Standard that is identical to the ISO 4730: 2017 Standard. The request to include the enantiomeric abundances for terpinen4ol, limonene and alphaterpineol.