1

A variation of either or both of the following particulars:

(a) the name of a manufacturer in Australia of a chemical product;

(b) the address of each site in Australia at which the product is manufactured by a manufacturer;

but only if, under the varied particulars:

(c) the manufacturer and the address of each manufacturing site are in Australia; and

any registration of a chemical product other than a chemical product that is prescribed under subregulation 59(1)

(d) either:

(i) the manufacturer is the holder of a valid licence under Part 8 of the Code that authorises carrying out a step in the manufacture of the product at premises at a site mentioned in paragraph (b); or

(ii) the manufacturer is an exempt person as mentioned in paragraph 121(4)(a) of the Code in relation to the manufacture of the product

2

A variation of the name of a manufacturer of a chemical product, if the manufacturer is outside Australia

any registration of a chemical product other than a chemical product that is prescribed under subregulation 59(1)

3

A variation of one or more constituents of a chemical product if:

(a) the constituent (the original constituent) is replaced with another constituent (the replacement constituent); and

(b) the original constituent is not an active constituent of the product; and

(c) the replacement constituent will not be an active constituent of the product; and

(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

a registration of a chemical product, other than a chemical product that is:

(a) an antibiotic product; or

(b) an immunobiological product; or

(c) a product that is administered through direct injection into an animal