Document ID: chunk:federal_register_of_legislation:F2024C01255:schedule:1:p3
Version: federal_register_of_legislation:F2024C01255
Segment Type: schedule
Provision Reference: sch 1 (pt 3/4)
Character Range: 111629–120547

from vegetable oil sterols from soybean sources.
sorbic acid and sorbic acid salts, including:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            All                                                    sorbates
  potassium sorbate
sucralose                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Oral                                                   sucralose
sugar alcohols (see Note 5A), including:                                                                                                                                                                                                                                                                                                                                                                                                                                                   Circumstance: Where the total sugar alcohol content of the formulation exceeds 2 g per maximum recommended daily dose.                                                                                                        Oral                                                   sugar alcohols; or name of sugar alcohol
  erythritol
  isomalt                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Requirement: To declare on the label the quantity of sugar alcohols present per recommended maximum daily dose; and a statement 'Products containing (name of sugar alcohol) may have a laxative effect or cause diarrhoea'.
  lactitol
  maltitol
  mannitol
  polydextrose
  sorbitol
  xylitol
sugars – monosaccharides and disaccharides (see Note 6), including:                                                                                                                                                                                                                                                                                                                                                                                                                        Circumstance: Where the presence of sugars may have a significant glycaemic effect and the total sugar content (including lactose which requires a separate declaration) exceeds 100 mg per maximum recommended daily dose.   Oral                                                   sugars
  fructose
  glucose
  honey (as a mixture of sugars)
  invert sugar
  lactose
  maltose
  sucrose
sulfites, including: (see Note 7)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        All                                                    sulfites
  potassium metabisulfite
  sodium bisulfite
  sodium metabisulfite
  sodium sulfite
  sulfur dioxide
tartrazine                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               All                                                    tartrazine
tree nuts and tree nut products (see Note 8), including:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 All                                                    tree nuts; or
  almond oil                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    tree nut products
  Juglans nigra
  macadamia nut oil
  Macadamia ternifolia
  Prunus dulcis
  walnut
Note 1: Crustacea include various species of aquatic animals which have an inedible chitinous outer shell.  These include but are not limited to crab, crayfish, lobster, prawn and shrimp.

Note 2: Fish includes freshwater fish, diadromous fish and marine fish, including shark.

Note 3: Gluten – some formulations of medicines may contain gluten that is present naturally as a constituent of an ingredient such as wheat starch.

Note 4: Lactose, where obtained from milk, does not require the 'contains milk product' statement.

Note 5: Phenylalanine - In the context of complementary medicines that contain phenylalanine, the Schedule 1 requirements apply in the following instances:
              Where phenylalanine is an ingredient in a medicine formulation.
              For medicines containing ingredients such as Spirulina, legumes, nuts or soy products that are naturally high in phenylalanine.
              Where processing of an ingredient, prior to inclusion in a pharmaceutical dosage form, results in enrichment of the phenylalanine content.

Note 5A: Sugar alcohols – It is generally accepted that while glycerol is a sugar alcohol, it does not have a laxative effect. Therefore, glycerol is not required to be declared in relation to sugar alcohols and their associated laxative effect.

Note 6: Sugars – monosaccharides and disaccharides – some sugar derivatives may not have a significant impact on glycaemic control.  Lactose forms part of total sugars for the purposes of determining if the sugars will have a significant glycaemic effect and for calculating the total daily dose. Where lactose is present in the medicine, the