For a chemical product, the Australian Pesticides and Veterinary Medicines Authority (APVMA) must be satisfied that the product meets the safety criteria, the efficacy criteria, the trade criteria, and the labelling criteria.

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Safety criteria

A chemical product meets the safety criteria if use of the product, in accordance with any instructions approved or to be approved by the APVMA, or contained in an established standard, is not, or would not be:

  • an undue hazard to the safety of people exposed to the product during its handling or people using anything containing its residues 
  • likely to have an effect that is harmful to human beings
  • likely to have an unintended effect that is harmful to animals, plants or things or to the environment.

We must have regard to the following for the purposes of being satisfied as to whether a chemical product meets the safety criteria:

  1. The toxicity of the product and its residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings
  2. The relevant poison classification of the product as determined under the law in this jurisdiction
  3. How the product is formulated
  4. The composition and form of the constituents of the product
  5. Any conditions to which its registration is, or would be, subject
  6. Any relevant particulars that are, or would be, entered in the Register for the product
  7. Whether the product conforms or would conform, to any standard made for the product, to the extent that the standard relates to the safety of the product
  8. Any matters prescribed by the Agvet Code Regulations, including:
    • for all chemical products, the method of analysis (if any) of the chemical composition and form of the constituents of the chemical product
    • for a product manufactured in Australia, whether each step in the manufacture of the product complies, or will comply, with the Manufacturing Principles  and the Australian Good Manufacturing Practice (GMP) Code (this does not apply if the product is an exempt product, a listed chemical product, or a reserved chemical product)
    • for a product manufactured outside Australia, whether each step in the manufacture of the product complies, or will comply, with a standard that the APVMA has determined is comparable to manufacturing principles and the Australian GMP Code (this does not apply if the product is an exempt product, a listed chemical product, or a reserved chemical product)
    • for a molluscicide in the form of a bait, where the active constituent is either metaldehyde or methiocarb, whether the product contains:
      • sufficient pigment or dye to colour the bait a distinctive colour (green for metaldehyde and blue for methiocarb)
      • in the bait, any bone meal or other product of animal origin
    • for an agricultural chemical product to be applied to seeds to be supplied and stored before planting or sowing, whether the product contains sufficient pigment or dye to colour the seed to enable it to be readily distinguished from untreated seed to which the chemical product has not been applied

We may consider one or more of the following for the purposes of being satisfied as to whether a chemical product meets the safety criteria:

  1. The acceptable daily intake of each constituent contained in the product
  2. Any dietary exposure assessment prepared under subsection 82(4) of the Food Standards Australia New Zealand Act 1991 as a result of any proposed variation notified under subsection 82(3) of that Act in relation to the product, and any comments on the assessment given to us under subsection 82(4) of that Act
  3. Whether any trials or laboratory experiments have been carried out to determine the residues of the product, and if so, the results of those trials or experiments, and whether those results show that the residues of the product will not be greater than the limits that we have approved or will approve
  4. The stability of the product
  5. The specifications for containers for the product
  6. Other matters as we think relevant

Efficacy criteria

A chemical product meets the efficacy criteria if the use of the product, in accordance with any instructions approved or to be approved by the APVMA, is or would be effective according to criteria determined by the APVMA by legislative instrument or contained in an established standard.

We must have regard to the following for the purposes of being satisfied as to whether a chemical product meets the efficacy criteria:

  1. Whether any trials or laboratory experiments have been carried out to determine the efficacy of the product and, if so, the results of those trials or experiments
  2. Any conditions to which its registration is, or would be, subject
  3. Any relevant particulars that are, or would be, entered in the Register for the product
  4. Whether the product conforms or would conform, to any standard made for the product
  5. Any matters prescribed by the Agvet Code Regulations

However, we are required to have regard to the matters set out above only to the extent prescribed by the Agvet Code Regulations or, if no regulations exist, to the extent we consider relevant. 

Trade criteria

A chemical product meets the trade criteria if use of the product, in accordance with any instructions approved or to be approved by the APVMA or contained in an established standard, does not, or would not, unduly prejudice trade or commerce between Australia and places outside Australia.

We must have regard to the following for the purposes of being satisfied whether a chemical product meets the trade criteria:

  1. Any conditions to which its registration is, or would be, subject
  2. Any relevant particulars that are, or would be, entered in the register for the product
  3. Whether the product conforms, or would conform, to any standard made for the product
  4. Any matters prescribed by the Regulations

The extent to which the APVMA must have regard to those matters is prescribed by the Agvet Code Regulations to be:

  • in full where it can be reasonably expected that the chemical product will be used in relation to a:
    • crop or animal, a product of which might be provided to a place outside Australia
    • crop that will be fed to an animal, a product of which might be provided to a place outside Australia
  • in any other case, to the extent that the APVMA thinks is relevant.

Labelling criteria

A chemical product meets the labelling criteria if the label contains adequate instructions relating to the following as appropriate:

  1. The circumstances in which the product should be used
  2. How the product should be used
  3. The times when the product should be used
  4. The frequency of the use of the product
  5. The withholding period after the use of the product
  6. The re-entry period after the use of the product
  7. The disposal of the product when it is no longer required
  8. The disposal of containers of the product
  9. The safe handling of the product and first aid in the event of an accident caused by the handling of the product
  10. Any matters prescribed by the Agvet Code Regulations, including:
    • For a chemical product that is a veterinary chemical product, the duration of any treatment using the product
    • The prevention of undue prejudice to trade or commerce between Australia and places outside Australia
    • The appropriate signal words (if any) required by the current Poisons Standard
    • For a chemical product that is a date-controlled chemical product, the storage of containers for the product
    • Any other matter determined by the CEO

The APVMA must have regard to the following for the purposes of being satisfied whether a label meets the labelling criteria:

  1. Any conditions to which its approval is, or would be, subject
  2. Any relevant particulars and instructions that are, or would be, entered in the relevant APVMA file for the label
  3. Whether the label conforms or would conform, to any standard made for the label

To grant an application, we must also be satisfied that you meet the application requirements, and have complied with any requirements made during the course of the evaluation.

An application meets the application requirements if:

  1. it is in writing in the approved form
  2. it is signed by the applicant
  3. it is accompanied by as much of the prescribed fee as is required to be paid when the application is made
  4. it is lodged with the APVMA
  5. it contains or is accompanied by, any information specified by a legislative instrument made by us under section 8B of the Agvet Code – Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014
  6. the constituent, product or label in relation to which the application is made complies or will comply, with any requirement prescribed by the Regulations
  7. any requirement of you made by us under section 157 or 159 of the Agvet Code in relation to your application has been complied with
  8. any requirement prescribed by another provision of the Code in relation to the application has been complied with
  9. any amount (including an amount in respect of a tax or penalty) that is payable by the applicant to the APVMA (including under a law of another jurisdiction or the agvet law) has been paid.

 

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