39Introductions of industrial chemicals that are internationally‑assessed for human health but not internationally‑assessed for the environment

39 Introductions of industrial chemicals that are internationally‑assessed for human health but not internationally‑assessed for the environment

(1) This section applies if: (a) an introduction of an industrial chemical by a person is a reported introduction in accordance with step 6 of the method statement in section 24; and (b) item 6 of the table in subsection 28(1) applies to the introduction but item 9 of the table in subsection 29(1) does not apply to the introduction.

Note: Item 6 of the table in subsection 28(1) deals with industrial chemicals that are internationally‑assessed for human health, and item 9 of the table in subsection 29(1) deals with industrial chemicals that are internationally‑assessed for the environment.

(2) For the purposes of paragraph 97(2)(b) of the Act, the information mentioned in an item of the following table is prescribed.

<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="2" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Pre</span><span>‑</span><span>introduction reports for reported introductions of industrial chemicals that are internationally</span><span>‑</span><span>assessed for human health but not for the environment</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Prescribed information</span></p></td></tr></thead><tbody><tr><td style="width:8.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:91.42%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>If the proper name for the industrial chemical (including the CAS name, the IUPAC name or an eligible INCI plant extract name) is known to the person:</span></p><p class="Tablea"><span>(a) the proper name for the industrial chemical (including the CAS name, the IUPAC name or an eligible INCI plant extract name); and</span></p><p class="Tablea"><span>(b) any other names by which the industrial chemical is known to the person; and</span></p><p class="Tablea"><span>(c) the CAS number (if assigned) for the industrial chemical</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>If the proper name for the industrial chemical is not known to the person:</span></p><p class="Tablea"><span>(a) the names by which the industrial chemical is known to the person; and</span></p><p class="Tablea"><span>(b) the name of the chemical identity holder who has provided to the Executive Director:</span></p><p class="Tablei"><span>(i) the proper name for the industrial chemical (including the CAS name, the IUPAC name or an eligible INCI plant extract name); and</span></p><p class="Tablei"><span>(ii) the CAS number (if assigned) for the industrial chemical</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Whether the industrial chemical is:</span></p><p class="Tablea"><span>(a) imported; or</span></p><p class="Tablea"><span>(b) manufactured in Australia</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>The maximum total volume of the industrial chemical the person intends to introduce in a registration year</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>The end use for the industrial chemical</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>The maximum concentration of the industrial chemical at the end use</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Whether the introduction of the industrial chemical involves a designated kind of release into the environment and, if so, which kind</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>The environment exposure band for the introduction, and the exposure band criteria on which the exposure band is based</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Any known hazard classification for the industrial chemical</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>10</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Any environment hazard characteristics of the industrial chemical that are known to the person</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>11</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>A declaration that the person has had regard to the information mentioned in subparagraphs</span><span> </span><span>30(2)(c)(iii) and (iv)</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>12</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>If the industrial chemical is to be introduced for an end use in cosmetics—a statement as to which of the circumstances specified in subsection</span><span> </span><span>(3) applies to the introduction</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>13</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Whether the introduction is a specified class of introduction to which subsection</span><span> </span><span>7(2) or (3) applies, and, if so, which such class</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>14</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>The name of the international assessment body that assessed or evaluated the industrial chemical for human health</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>15</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>Both:</span></p><p class="Tablea"><span>(a) the reference number (however described) for the international assessment or evaluation; and</span></p><p class="Tablea"><span>(b) the name by which the industrial chemical is identified in the international assessment or evaluation</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>16</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>The year the international assessment or evaluation was completed</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>17</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>If the international assessment or evaluation included any parameters relating to end use, introduction volume or the maximum concentration of the industrial chemical at the end use—those parameters</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>18</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>If:</span></p><p class="Tablea"><span>(a) the international assessment or evaluation is of a kind mentioned in item</span><span> </span><span>6 of the table in subsection</span><span> </span><span>6(3); and</span></p><p class="Tablea"><span>(b) there are restrictions set out in Annex XVII of the REACH Regulation relating to the industrial chemical;</span></p><p class="Tabletext"><span>what those restrictions are and how those restrictions will be complied with by the person in Australia</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>19</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>If:</span></p><p class="Tablea"><span>(a) the international assessment or evaluation is not of a kind mentioned in item</span><span> </span><span>6 of the table in subsection</span><span> </span><span>6(3); and</span></p><p class="Tablea"><span>(b) the international assessment body determined conditions that must be complied with in order to manage any risks to human health from the industrial chemical in the overseas jurisdiction;</span></p><p class="Tabletext"><span>what those conditions are and how those conditions will be complied with by the person in Australia</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>20</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>A declaration that:</span></p><p class="Tablea"><span>(a) the complete international assessment report for the industrial chemical is available and will be provided to the Executive Director if requested; and</span></p><p class="Tablea"><span>(b) the person has permission to use the report</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>21</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>A declaration that introduction of the industrial chemical is not prohibited (however described) in the overseas jurisdiction</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>22</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>A declaration that the risk to human health from the introduction and use of the industrial chemical in Australia is no higher than in the overseas jurisdiction, as determined in accordance with the Guidelines</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>23</span></p></td><td style="width:91.42%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>A declaration that no information has become available to the person after the international assessment or evaluation was completed about:</span></p><p class="Tablea"><span>(a) a hazard to human health from the industrial chemical that is not identified in the international assessment or evaluation; or</span></p><p class="Tablea"><span>(b) an increase in the severity of a hazard to human health from the industrial chemical that is identified in the international assessment or evaluation</span></p></td></tr></tbody></table>