Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_2270
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 2270
Character Range: 1099514–1101387

2270                                      GALACTOOLIGOSACCHARIDES                                    A         Only to be used in a medicine where FrieslandCampina Ingredients B V (Client ID 79530), 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 May 2025.
                                                                                                               Lactose and glucose are mandatory components of galactooligosaccharides.
                                                                                                               The route of administration for medicines that contain galactooligosaccharides must be limited to oral.
                                                                                                               The maximum recommended daily dose of the medicine must not provide more than:
                                                                                                               (a) 8 g of galactooligosaccharides to individuals aged 0 to 3 years (inclusive); and
                                                                                                               (b) 16.2 g of galactooligosaccharides to individuals aged 4 years and older.
                                                                                                               The following warning statement (or words to the same effect) is required on the medicine label:
                                                                                                               (GOS) 'Not to be taken on the same day with other products containing galactooligosaccharides.'