Document ID: chunk:federal_register_of_legislation:F2022L01068:reg:1:p1
Version: federal_register_of_legislation:F2022L01068
Segment Type: reg
Provision Reference: reg 1 (pt 1/2)
Character Range: 6521–9630

1                    Prescribed extent of allowable variation for concentrations of active constituents in agricultural chemical products

      (a)    The standard allowable variations from the concentration declared and recorded in the Register for active constituents in agricultural chemical products are given in the table below.

Declared content g/kg or g/L  Allowable variation
Up to 25                      ±15% of the declared content for homogeneous formulations or
                              ±25% for heterogeneous formulations
Above 25 up to 100            ±10% of the declared content
Above 100 up to 250           ±6% of the declared content
Above 250 up to 500           ±5% of the declared content
Above 500                     ±25 g/kg or g/L

Note: In each range the upper limit is included.

      (b)    Applicants may propose alternative allowable variations from those in the table at 1(a) above, provided an appropriate scientific justification is provided, and the APVMA is satisfied that the alternative allowable variation would still ensure that the product complied with the safety, efficacy and trade criteria as defined in sections 5A, 5B and 5C of the Code.

     2                         Prescribed extent of allowable variation for concentrations of non-active constituents in agricultural chemical products

      (a)    The standard allowable variations from the concentration declared and recorded in the Register for non-active constituents in agricultural chemical products are given in the table below.

Nominal concentration g/kg or g/L  Allowable variation
Up to 10                           ±10% of the declared content
Above 10 up to 200                 ±5% of the declared content
Above 200 up to 1000               ±3% of the declared content

      (b)   Applicants may propose alternative allowable variations from those in the table at 2(a) above, provided an appropriate scientific justification is provided, and the APVMA is satisfied that the alternative allowable variation would still ensure that the product complied with the safety, efficacy and trade criteria as defined in sections 5A, 5B and 5C of the Code.
      (c)   For constituents used as solvents or carriers in liquid chemical products or as fillers or carriers in solid chemical products and the quantities of these ingredients may be adjusted to balance variable amounts of other ingredients, tolerances may instead of a percentage tolerance as defined by (a) or (b) be declared as q.s. 1 L or q.s. 1 kg as appropriate.
      (d)   For constituents including but not limited to pH adjusters, salt-forming acids or bases, buffers, antifoams, or viscosity modifiers, whose concentrations may be adjusted to bring a parameter such as pH, persistent foam level or viscosity within a desired range, tolerances may instead of a percentage tolerance as defined by (a) or (b) be declared as, for example, q.s. pH 4.0-5.0, or q.s. 200-300 mPa.s.
      (e)   For any ingredient as described at (c) or (d), a nominal (mean expected or target) concentration must still be provided, for