Conditions of approval or registration and label approval

Under section 23 of the Agvet Code, approvals and registrations are subject to two types of conditions: mandatory statutory conditions that apply in all cases of a particular kind (as prescribed by the Agvet Code Regulations), and the case by case conditions imposed on a particular approval or registration as the APVMA thinks appropriate. Conditions of active constituent approval, chemical product registration, and label approval are a means by which we manage the risks posed to people, plants, animals and the environment by agvet chemicals.

The mandatory statutory conditions prescribed by the Agvet Code Regulations address the general risks posed by all agvet chemicals. These conditions, together with our compliance monitoring, reviewing and enforcement activities, ensure that people, plants, animals and the environment remain safe from agvet chemicals.

The case by case conditions address the specific risks associated with particular agvet chemicals and will be imposed on approvals and registrations when we think it is appropriate. These conditions, together with our compliance monitoring, reviewing and enforcement activities, means that we are able to provide a higher level of assurance that the risk posed by these agvet chemicals will be better managed, which enables us to ensure that people, plants, animals and the environment remain safe from agvet chemicals.

The conditions of approvals and registrations may require certain things to be done before the supply of an agvet chemical product occurs, to ensure the chemical product supplied meets the statutory criteria considered by the APVMA. For example, conditions may require specific types of packaging for products, or for labels to carry use-by dates.

In approving a label for a container for chemical products, we must be satisfied that the label contains adequate instructions. This allows us to ensure that the risks of using the agvet chemical product are adequately mitigated through appropriate instructions. Appropriate instructions include:

  • circumstances in which the product should be used
  • how the product should be used
  • times when the product should be used
  • frequency of use of the product
  • withholding period after use of the product
  • re-entry period after use of the product
  • disposal of the product when it is no longer required
  • disposal of the containers of the product
  • safe handling of the product and first aid in the event of an accident caused by the handling of the product
  • the appropriate signal words required by the current Poisons Standard.

The APVMA’s Agricultural Labelling Code and Veterinary Labelling Code also contain further labelling requirements that further help in mitigating the risk of using agvet chemical products when used in accordance with the label instructions.

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