9Ingredient determinations

#### 9 Ingredient determinations (1) The APVMA may, by legislative instrument, determine that one or more ingredients, or classes of ingredients, are authorised to be used in one or more classes of substances or mixtures of substances. > Note 1: An ingredient may be used in a substance or a mixture of substances if the use of the ingredient in the substance or mixture is authorised by the ingredient determination (see item 8 of the table in subclause 5(3)). > Note 2: A determination under this subclause is referred to in this Schedule as an ingredient determination (see clause 1). > Note 3: For variation and revocation, see subsection 33(3) of the Acts Interpretation Act 1901. (2) Without limiting subclause (1), an ingredient determination may do either or both of the following: (a) authorise an ingredient’s use only for one or more specified purposes in a class of substances or mixtures of substances; (b) authorise an ingredient’s use in a class of substances or mixtures of substances for a particular purpose only if one or more requirements specified in the ingredient determination are met. (3) The power under subclause (1) may be exercised on the APVMA’s own initiative or on application under clause 10. APVMA to be satisfied of certain matters (4) Before making or varying an ingredient determination, the APVMA must be satisfied that the use of a substance or a mixture of substances in a class covered by the ingredient determination as made or varied: (a) 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) would not be likely to have an effect that is harmful to human beings; and (c) would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and (d) would not unduly prejudice trade or commerce between Australia and places outside Australia. (5) The APVMA must revoke or vary an ingredient determination if the APVMA is no longer satisfied as to any of the matters mentioned in subclause (4) in relation to the ingredient determination. (6) For the purposes of being satisfied as to the matters mentioned in paragraphs (4)(a), (b) and (c), the APVMA: (a) must have regard to the following: (i) the toxicity of substances or mixtures in the class and their residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings; (ii) the relevant poison classification of substances or mixtures in the class under the law in force in this jurisdiction; (iii) how substances or mixtures in the class are formulated; (iv) the composition and form of the ingredients of substances or mixtures in the class; and (b) may have regard to such other matters as it thinks relevant. (7) For the purposes of being satisfied as to the matter mentioned in paragraph (4)(d): (a) if it can reasonably be expected that a substance or mixture in a class covered by an ingredient determination will be used in relation to an animal, a product of which might be provided to a place outside Australia—the APVMA must have full regard to the matter mentioned in that paragraph; and (b) otherwise—the APVMA is to have regard to the matter mentioned in that paragraph to the extent that the APVMA thinks is relevant. Publishing ingredient determinations (8) The APVMA must publish an ingredient determination, as existing from time to time, on its website.