Document ID: chunk:federal_register_of_legislation:F2020C00811:reg:4:p1
Version: federal_register_of_legislation:F2020C00811
Segment Type: reg
Provision Reference: reg 4 (pt 1/2)
Character Range: 9108–13340

4                      A variation of one or more constituents of a chemical product if:                                                                                                                                                                                                                                                                  a registration of a chemical product, other than a chemical product that is:
                         (a) the constituent (the original constituent) is replaced with another constituent (the replacement constituent); and                                                                                                                                                                                                             (a) an antibiotic product; or
                         (b) the original constituent is not an active constituent of the product; and                                                                                                                                                                                                                                                      (b) an immunobiological product; or
                         (c) the replacement constituent will not be an active constituent of the product; and                                                                                                                                                                                                                                            (c) a product that is administered through direct injection into an animal
                         (d) the original and replacement constituents have the same purpose in the product; and
                         (e) the original and replacement constituents differ only in solvates or hydrates; and
                         (f) the original and replacement constituents have the same:
                            (i) pH; and
                            (ii) dissolution profile; and
                            (iii) hydrophilic or hydrophobic behaviour; and
                            (iv) hygroscopic behaviour; and
                         (g) neither the original nor replacement constituent are a nanomaterial; and
                         (h) in the case of the original and replacement constituents being a straight or branched unsaturated hydrocarbon—the change in the length of the hydrocarbon chain is not more than 33% of the length of the original constituent's hydrocarbon chain; and
                         (i) the replacement constituent does not introduce material of human or animal origin into the product; and
                         (j) the variation does not require variation to the signal words required by the current Poisons Standard to be on the label of the product; and
                         (k) in the case of a product that is a molluscicide in the form of a bait or a product applied to seeds to be stored before planting or sowing—the variation does not change the colour of the product; and
                         (l) the variation does not require the formulation type entered in the Register for the product to be varied; and
                         (m) in the case of a product that has 9 or more constituents entered in the Register for the product—the variation is to no more than 25% of the number of constituents entered in the Register for the product; and
                         (n) in the case of a product that has less than 9 constituents entered in the Register for the product—the variation is to one or 2 of the constituents entered in the Register for the product

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