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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; and?
- is not, or would not be, likely to have an effect that is harmful to human beings; and
- 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 as to whether a chemical product meets the safety criteria:
- the toxicity of the product and its residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings
- the relevant poison classification of the product as determined under the existing health arrangements
- how the product is formulated
- the composition and form of the constituents of the product
- any conditions to which its registration is, or would be, subject
- any relevant particulars that are, or would be, entered in the Register for the product
- 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
- 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 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 methicoarb:
- whether the product contains sufficient pigment or dye to colour the bait a distinctive colour (green for metaldehyde and blue for methiocarb)
- whether the product contains, 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:
- the acceptable daily intake of each constituent contained in the product
- 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
- 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 limits that we have approved or will approve
- the stability of the product
- the specifications for containers for the product
- other matters as we think relevant.