Commonwealth Consolidated Regulations

AGRICULTURAL AND VETERINARY CHEMICALS CODE REGULATIONS 1995 - REG 19AEA

APVMA may determine interchangeable constituents

  (1)   The APVMA may, by legislative instrument, determine that one or more constituents of a chemical product or a class of chemical products may be interchanged with another constituent.

  (2)   Without limiting subregulation   (1), the interchangeable constituent determination may authorise a constituent being interchanged with another constituent if one or more requirements specified in the determination are met.

  (3)   The power under subregulation   (1) may be exercised on the APVMA's own initiative or on application under regulation   19AEB.

  (4)   If an interchangeable constituent determination can be made in relation to a class of chemical products, or varied so that it applies to a class of chemical products, the APVMA must make or, if varying a determination, vary the determination accordingly.

APVMA to be satisfied of certain matters

  (5)   Before making or varying an interchangeable constituent determination, the APVMA must be satisfied that:

  (a)   the constituent to be interchanged is not an active constituent of the product; and

  (b)   the interchange of the constituents does not introduce material of human or animal origin into the product; and

  (c)   the interchange of the constituents would not require variation to:

  (i)   the signal words required by the current Poisons Standard to be contained on the label of the product; or

  (ii)   the formulation type of the product entered in the Register; and

  (d)   after the constituents are interchanged, the chemical product would continue to:

  (i)   meet the safety criteria, the trade criteria and the efficacy criteria; and

  (ii)   comply with any requirements prescribed for the purposes of paragraph   8A(b) or 41(1)(c) of the Code.

  (6)   For the purposes of being satisfied of the matters mentioned in subregulation   (5), the APVMA must have regard to any requirements to which the interchange of a constituent is, or could be, subject.

Variation or revocation of an interchangeable constituent determination

  (7)   If the APVMA proposes to vary or revoke an interchangeable constituent determination, the APVMA must:

  (a)   publish on its website a notice setting out the proposed variation or reasons for the proposed revocation; and

  (b)   invite written submissions on the variation or revocation to be made on or before a specified date (the consultation period ).

  (8)   The notice must:

  (a)   be published at least 28 days before the interchangeable constituent determination is so varied or revoked; and

  (b)   remain on the APVMA's website until the determination is so varied or revoked.

  (9)   The APVMA must consider submissions made during the consultation period.

  (10)   The APVMA may make a submission public, unless the person that made the submission has requested that the submission, or a part of it, be kept confidential.