Document ID: chunk:federal_register_of_legislation:F2022L01068:front:0:p1
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Agricultural and Veterinary Chemicals Code (Allowable Variation in Concentrations of Constituents in Agricultural Chemical Products) Standard 2022

I, Sheila Logan, Delegate of the Australian Pesticides and Veterinary Medicines Authority, make the following instrument.

Dated  9 August 2022

Sheila Logan
Delegate

Part 1 Introduction

      1 Preamble

        Section 5AA(1) of the Code states that a registered chemical product must comply with the relevant particulars entered into the Register for the product. Section 5AA(3) further states that the concentration of the constituents of a chemical product must not differ from the concentrations entered into the Register by more than the extent prescribed by regulations in force for the purposes of section 83(1)(b) of the Code.

        Regulation 41(2) of the Regulations, made for the purposes of section 83(1)(b) of the Code, states that the prescribed extent of the variation in the concentrations of constituents is the extent permitted by the standards prescribed by Regulation 42 of the Regulations.

        Regulation 42(3) of the Regulations states that a standard made under section 6E(1) is prescribed for a constituent in a chemical product or for a chemical product, provided that it is not already dealt with in an order under section 7 of the Agricultural and Veterinary Chemicals Code Act 1994.

        This Instrument prescribes the extent to which the concentrations of constituents, including both active constituents, and non-active constituents (commonly referred to as excipients) in registered agricultural chemical products may differ from the concentrations entered into the Register when measured using a suitable validated analytical method. It is made under section 6E of the Code following the procedures set out in regulation 8AF of the Regulations.

        This Instrument does not permit the deliberate variation of the nominal or 'target' concentrations of the constituents in a registered agricultural chemical product without recourse to an appropriate application to the APVMA for variation of the relevant particulars, even where such a change of the nominal concentration is within the tolerances defined within the Instrument. This Instrument manages variations in concentrations from the nominal value that arise from normal variability in manufacturing processes and/or analytical methods.

        Further, this Instrument does not in itself provide any guidance or prescription on changes or differences in concentrations in constituents in agricultural chemical products that meet the definition of 'closely similar' as set out in Clause 1.2(1) of Schedule 6 of the Regulations.

      2 Name of instrument and power
        This Instrument is the Agricultural and Veterinary Chemicals Code (Allowable Variation in Concentrations of Constituents in Agricultural Chemical Products) Standard 2022 and is made under section 6E of the Code.

      3 Commencement
        This Instrument commences on the day after the day it is registered.

      4 Definitions
      (1)    Unless the contrary intention appears:

          (a)   words and expressions