Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_1390
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 1390
Character Range: 660126–663338

1390                                      CINNAMOMUM VERUM                                                                                 A, E, H   When used as an active ingredient coumarin is a mandatory component of Cinnamomum verum and the concentration of coumarin in the medicine must be no more than 0.001%.
                                                                                                                                                     Cinnamon bark oil is a mandatory component of Cinnamomum verum when the plant part is bark and the plant preparation is essential oil, distillate, fixed oil or infused oil.
                                                                                                                                                     The concentration of cinnamon bark oil in the medicine must be no more than 2%.
                                                                                                                                                     Cinnamon leaf oil is a mandatory component of Cinnamomum verum when the plant part is leaf.
                                                                                                                                                     When the concentration of cinnamon leaf oil in the preparation is more than 25%:
                                                                                                                                                     a) the nominal capacity of the container must be no more than 25 millilitres;
                                                                                                                                                     b) a restricted flow insert must be fitted on the container; and
                                                                                                                                                     c) the container must include the following warning statements on the medicine label:
                                                                                                                                                     - (CHILD) 'Keep out of reach of children' (or words to that effect); and
                                                                                                                                                     - (NTAKEN) 'Not to be taken'.
                                                                                                                                                     When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but no more than 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container.
                                                                                                                                                     When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the container must be fitted with a restricted flow insert.