Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4365
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4365
Character Range: 2050674–2053601

4365                                      ROSMARINUS OFFICINALIS                                                                   A, E, H   Camphor and cineole are mandatory components of Rosmarinus officinalis except when the plant preparation is an essential oil or distillate.
                                                                                                                                             In solid and semi-solid preparations, the concentration of camphor must not be more than 12.5%.
                                                                                                                                             In liquid preparations other than essential oils or distillates, the concentration of camphor must not be more than 2.5%.
                                                                                                                                             When the concentration of cineole in the preparation other than essential oils or distillates is more than 25%, the nominal capacity of the container must not be more than 25 millilitres.
                                                                                                                                             In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container and 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'.
                                                                                                                                             In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and 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'.