5ADefinition of meets the safety criteria

#### 5A Definition of meets the safety criteria (1) An active constituent or chemical product meets the safety criteria if use of the constituent or product, in accordance with any instructions approved, or to be approved, by the APVMA for the constituent or product 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; and (b) is not, or would not be, likely to have an effect that is harmful to human beings; and (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. (2) For the purposes of being satisfied as to whether an active constituent meets the safety criteria, the APVMA: (a) must have regard to the following: (i) the toxicity of the constituent and its residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings; (ii) the method by which the constituent is, or is proposed to be, manufactured; (iii) the extent to which the constituent will contain impurities; (iv) whether an analysis of the chemical composition of the constituent has been carried out and, if so, the results of the analysis; (v) any conditions to which its approval is, or would be, subject; (vi) any relevant particulars that are, or would be, entered in the Record for the constituent; (via) whether the constituent conforms, or would conform, to any standard made for the constituent under section 6E to the extent that the standard relates to matters covered by subsection (1); (vii) any matters prescribed by the regulations; and (b) may have regard to such other matters as it thinks relevant. (3) For the purposes of being satisfied as to whether a chemical product meets the safety criteria, the APVMA: (a) must have regard to the following: (i) the toxicity of the product and its residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings; (ii) the relevant poison classification of the product under the law in force in this jurisdiction; (iii) how the product is formulated; (iv) the composition and form of the constituents of the product; (v) any conditions to which its registration is, or would be, subject; (vi) any relevant particulars that are, or would be, entered in the Register for the product; (via) whether the product conforms, or would conform, to any standard made for the product under section 6E to the extent that the standard relates to matters covered by subsection (1); (vii) any matters prescribed by the regulations; and (b) may have regard to one or more of the following: (i) the acceptable daily intake of each constituent contained in the product; (ii) 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 the APVMA under subsection 82(4) of that Act; (iii) 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 the APVMA has approved or approves; (iv) the stability of the product; (v) the specifications for containers for the product; (vi) such other matters as it thinks relevant.