Document ID: chunk:federal_register_of_legislation:F2023C00856:reg:9:p1
Version: federal_register_of_legislation:F2023C00856
Segment Type: reg
Provision Reference: reg 9 (pt 1/2)
Character Range: 4998–8219

9  Labelling

        (1) The primary pack must be permanently and legibly marked with the following information:

         (a) words identifying the brand name;
         (b) the name and address of the manufacturer or supplier;
          (c) if the primary pack contains more than one unit pack, the name and quantity of all the menstrual cups within the primary pack;
          (d) the batch number of the menstrual cup(s), identified with the use of the words "Batch No." or "Lot No.";
          (e) words identifying the size (if applicable) of the menstrual cup; and
          (f) the following warning in letters with a height of not less than 1mm:

          "IMPORTANT: Menstrual cups have been associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and keep the enclosed information."

         10  Information to be supplied with menstrual cups

        (1) The following information must be supplied with the menstrual cup, in a form that is legible and accessible to the consumer:

            (a)    the manufacturer's or supplier's identifying information, including their name and address;
            (b)    an information leaflet containing the following information:
                  (i)              detailed instructions for use, including the need for hygiene and care in insertion;
                  (ii)            a limit to the duration of use, not exceeding 12 hours;
                  (iii)          detailed instructions for cleaning and maintaining the integrity of the menstrual cup;
                  (iv)          a notification that the menstrual cup is not supplied in a sterile state;
                  (v)            information about Toxic Shock Syndrome, noting that while it is rarely associated with the use of menstrual cups, it can still occur;
                  (vi)          the following warning in letters with a height of not less than 1mm:

              "IMPORTANT: Menstrual cups have been associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and keep the enclosed information."

Endnotes

Endnote 1—About the endnotes
The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history

Abbreviation key—Endnote 2
The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with