Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4902
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4902
Character Range: 2288816–2290409

4902                                      THEANINE                                                                                 A         Only to be used in a medicine where Trans Chem Pty Ltd (Client ID 21878), 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 1 March 2026.
                                                                                                                                             The route of administration for medicines that contain theanine must be limited to oral.
                                                                                                                                             The maximum recommended daily dose of the medicine must not provide more than 450 mg of theanine.
                                                                                                                                             The following warning statements (or words to the same effect) are required on the medicine label:
                                                                                                                                             - (PREGNT) 'Not recommended for use by pregnant and lactating women'; and
                                                                                                                                             - (ADULT) 'Adults only'.