Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_692
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 692
Character Range: 320322–322363

692                                       ARTEMISIA DRACUNCULUS                                                             A, E, H   Thujone is a mandatory component of Artemisia dracunculus.

                                                                                                                                      The concentration of thujone from Artemisia dracunculus in the medicine must not be more than 4%.

                                                                                                                                      The following warning statement is required on the medicine label:

                                                                                                                                      - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect);

                                                                                                                                      unless the ingredient is:

                                                                                                                                      (a) a steam-distilled essential oil; and

                                                                                                                                      (b) for use in combination with other permitted ingredients as part of a fragrance or flavour proprietary excipient formulation where:

                                                                                                                                      (i) the total concentration of fragrance proprietary excipient formulations containing Artemisia dracunculus is not more than 1% of the total medicine; or

                                                                                                                                      (ii) the total concentration of flavour proprietary excipient formulations containing Artemisia dracunculus is not more than 5% of the total medicine.