5

5 Safety criteria information

(1) For an active constituent, safety criteria information means information relevant to whether the constituent would meet the safety criteria. Where this Instrument requires the provision of safety criteria information, the requirement includes the provision of the following information: (a) information about the toxicity of the constituent and its residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings; (b) the method by which the constituent is, or is proposed to be, manufactured; (c) information about the extent to which the constituent will contain impurities; (d) whether an analysis of the chemical composition of the constituent has been carried out and, if so, the results of the analysis. (2) For a chemical product, safety criteria information means information relevant to whether the product would meet the safety criteria. Where this Instrument requires the provision of safety criteria information, the requirement includes the provision of the following information: (a) information about the toxicity of the chemical product and its residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings; (b) the relevant poison classification of the product under the law in force in this jurisdiction; (c) the method of analysis (if any) of the chemical composition and form of the constituents of the chemical product; (d) if paragraph 8AB(1)(b) of the Regulations applies – information about whether each step in the manufacture of the product complies, or will comply, with the manufacturing principles and the Australian GMP Code; (e) if paragraph 8AB(1)(c) of the Regulations applies – information about whether each step in the manufacture of the product complies, or will comply, with a standard that the APVMA has determined for the purposes of that paragraph;

Note: Paragraphs 8AB(1)(b) and (c) of the Regulations do not apply in the circumstances set out in subregulation 8AB(2) (for example, when the product is an exempt product pursuant to regulation 59).

(f) for a molluscicide in the form of a bait and of which the active constituent is metaldehyde, information about:
(i) whether the product contains sufficient green pigment or dye to colour the bait a distinctive green colour; and
(ii) whether the product contains, in the bait, any bone meal or other product of animal origin;
(g) for a molluscicide in the form of a bait and of which the active constituent is methiocarb, information about:
(i) whether the product contains sufficient blue pigment or dye to colour the bait a distinctive blue colour; and
(ii) whether the product contains, in the bait, any bone meal or other product of animal origin;
(h) for a product to be applied to seeds to be stored before planting or sowing – information about whether the product contains sufficient pigment or dye to colour the seed to enable the seed to be readily distinguished from seed to which the product has not been applied;
(i) 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;
(j) unless the application is for a research permit—information about:
(i) the stability of the product; and
(ii) the specifications for containers for the product.