Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_3526
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 3526
Character Range: 1646881–1650106

3526                                      OCIMUM BASILICUM                                                                              A, E, H   When the plant preparation is oil or distillate, Methyl chavicol, eugenol, methyleugenol and cineole are mandatory components of Ocimum basilicum.
                                                                                                                                                  The concentration of methyleugenol in the medicine must not exceed 1%.
                                                                                                                                                  When the concentration of Methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25 millilitres.
                                                                                                                                                  When the concentration of Methyl chavicol in the medicine is more than 5% and the nominal capacity of the container is 25 millilitres or less, a restricted flow insert must be fitted on the container, and requires the following warning statement on the medicine label:
                                                                                                                                                  - (CHILD) 'Keep out of reach of children' (or words to that effect). When the concentration of cineole OR eugenol in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 millilitres and the following warning statements must be included 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 cineole OR eugenol 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.
                                                                                                                                                  When the concentration of cineole OR eugenol 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.
                                                                                                                                                  When the preparation is for topical use in the mouth, the preparation may not contain more than 5 millilitres of eugenol and the concentration of eugenol in the product must not be greater than 25%.