Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4292
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4292
Character Range: 1993185–1994856

4292                                      REFINED BUGLOSSOIDES ARVENSIS SEED OIL                                                   A         Only to be used in a medicine where Phytolove Pty Ltd (Client ID 80651), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 3 July 2025.
                                                                                                                                             Stearidonic acid is a mandatory component of refined Buglossoides arvensis seed oil.
                                                                                                                                             The route of administration for medicines that contain refined Buglossoides arvensis seed oil must be limited to oral.
                                                                                                                                             The maximum recommended daily dose of the medicine must not provide more than 500 mg of stearidonic acid.
                                                                                                                                             The following warning statement (or words to that effect) is required on the medicine label:
                                                                                                                                             - (NTAKEN3) 'Not to be taken by children under 3 years old'.