This content is current only at the time of printing. This document was printed on 13 December 2018. A current copy is located at https://apvma.gov.au/node/650
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Active constituent - permit applications
For an active constituent, the APVMA must be satisfied that the constituent meets the safety criteria.
An active constituent meets the safety criteria if use of the constituent, in accordance with any instructions approved or to be approved by the APVMA or contained in an established standard:
a) is not, or would not be, an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues
b) is not, or would not be, likely to have an effect that is harmful to human beings
c) is not, or would not be, 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 whether an active constituent meets the safety criteria:
- the toxicity of the constituent and its residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings
- the method by which the constituent is, or is proposed to be, manufactured
- the extent to which the constituent will contain impurities
- whether an analysis of the chemical composition of the constituent has been carried out and, if so, the results of the analysis
- any conditions to which its approval is, or would be, subject
- any relevant particulars that are, or would be, entered in the Record for the constituent
- whether the constituent conforms, or would conform, to any standard made for it under section 6E of the Agvet Code to the extent that the standard relates to matters covered by points a, b and c above.
- any matters prescribed by the Agvet Code Regulations
- in relation to active constituents, the method of analysis (if any) of the chemical composition of the active composition as prescribed by the Regulations
We may have regard to other matters as we think relevant for the purposes of being satisfied as to whether an active constituent meets the safety criteria.