Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:1:p1
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 1 (pt 1/4)
Character Range: 74295–84068

Schedule 1

Substances or Groups of substances present in medicines that are required to be declared on the label of medicines

Column 1 includes a general descriptor for the substance or group of substances required to be declared on the label of medicines, and a number of indicative substances names for particular groups of substances.

Column 2 specifies the circumstance, such as specified concentration of the substance when present in the medicine or specified amounts of substances contained in the medicine, where if it occurs require the particular declaration on the label identifying the particular substance or group of substances set out in column 1, and provides additional required statements that are supplemental to the required declaration on the label.  Where there are no circumstances specified in column 2, then the presence of the substance or group of substances is required to be declared on the label irrespective of any circumstance, concentration or amount of the substance or group of substances present in the medicine.

Column 3 identifies those routes of administration of the medicine containing the substance or group of substances, where for the purposes of this Schedule and taking into consideration any circumstance specified in column 2, the substance or group of substances must be declared on the label.

Column 4 identifies the name of the substance, the group of substances or a general descriptor of the substance to be included on the label of the medicine where the particular substance or group of substances are present in the medicine.  The name also describes a group of substances that have similar characteristics and is to be used irrespective of whether one or more of the substances in the group are present in the formulation. Presentation on the label must be in the form "Contains 'Name (as set out under Column 4)'". Where more than one name (as set out under Column 4) is required to be declared, they may be combined to form simple sentences where appropriate.

Column 1                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Column 2                                                                                                                                                                                                                      Column 3                                               Column 4
Substance name or Group of substances name                                                                                                                                                                                                                                                                                                                                                                                                                                                 Circumstances (if any) and additional requirements (if any)                                                                                                                                                                   Route of administration                                Name to be included on the label
aspartame                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Oral                                                   aspartame

antibiotics                                                                                                                                                                                                                                                                                                                                                                                                                                                                                When the antibiotics is not an active ingredient and is present only as a residual impurity                                                                                                                                   All                                                    Contains residual 'antibiotic name'
benzoates, including:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    All                                                    benzoates
  benzoic acid
  sodium benzoate
crustacea and crustacean products (see Note 1), including:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               All                                                    crustacea; or
   crab                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         crustacean products
   lobster
   white shrimp
egg, egg products, and products manufactured in eggs including:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          All                                                    egg; or
   dried egg yolk                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               egg products or manufactured in eggs
   egg lecithin
   influenza vaccine

ethanol                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Circumstance: Where present in a concentration of 3% v/v or more.                                                                                                                                                             All