6Internationally‑assessed industrial chemicals

6 Internationally‑assessed industrial chemicals

(1) For the purposes of this instrument, an industrial chemical is internationally‑assessed for human health if: (a) the industrial chemical has been subject to an assessment or evaluation of a kind mentioned in an item of the table in subsection (3) by the body mentioned in column 2 of the item (the international assessment body); and (b) the assessment or evaluation was conducted in another jurisdiction (the overseas jurisdiction); and (c) the assessment or evaluation was in relation to risks to human health; and (d) there is a report of the assessment or evaluation (the international assessment report). (2) For the purposes of this instrument, an industrial chemical is internationally‑assessed for the environment if: (a) the industrial chemical has been subject to an assessment or evaluation of a kind mentioned in an item of the table in subsection (3) (other than item 3, 4, 5 or 10) by the body mentioned in column 2 of the item (the international assessment body); and (b) the assessment or evaluation was conducted in another jurisdiction (the overseas jurisdiction); and (c) the assessment or evaluation was in relation to risks to the environment; and (d) there is a report of the assessment or evaluation (the international assessment report). (3) For the purposes of paragraphs (1)(a) and (2)(a), the following table sets out the kinds of assessments or evaluations, and the bodies that conduct the assessments or evaluations.

<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="3" 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>Assessments and evaluations conducted by international bodies</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="TableHeading"><span></span></p></td><td style="width:45.7%; 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="TableHeading"><span>Column 1</span></p></td><td style="width:45.72%; 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="TableHeading"><span>Column 2</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:45.7%; 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>Type of assessment or evaluation</span></p></td><td style="width:45.72%; 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>International assessment body</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:45.7%; 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>Risk assessments under the </span><span style="font-style:italic">Canadian Environmental Protection Act, 1999</span><span> (Canada) that are undertaken in accordance with Schedule</span><span> </span><span>5, 6, 9, 10 or 11 of the </span><span style="font-style:italic">New Substances Notification Regulations (Chemicals and Polymers) </span><span>(Canada) on or after 31</span><span> </span><span>October 2005</span></p></td><td style="width:45.72%; 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="Tablea"><span>(a) Environment and Climate Change Canada; or</span></p><p class="Tablea"><span>(b) Health Canada</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:45.7%; 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>Risk assessments under the </span><span style="font-style:italic">Canadian Environmental Protection Act, 1999</span><span> (Canada) that are undertaken in accordance with Schedule II, III, VI, VII or VIII of the </span><span style="font-style:italic">New Substances Notification Regulations (Chemicals and Polymers) </span><span>(Canada) before 31</span><span> </span><span>October 2005</span></p></td><td style="width:45.72%; 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>(a) Environment and Climate Change Canada; or</span></p><p class="Tablea"><span>(b) Health Canada</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:45.7%; 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>Opinions from the European Commission Scientific Committee on Consumer Products that:</span></p><p class="Tablea"><span>(a) have been finalised and adopted by that Committee; and</span></p><p class="Tablea"><span>(b) have terms of reference that include a question about the safety of a chemical in a cosmetic product; and</span></p><p class="Tablea"><span>(c) have a conclusion of safety with respect to the question about the safety of the chemical in a cosmetic product</span></p></td><td style="width:45.72%; 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 European Commission Scientific Committee on Consumer Products</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:45.7%; 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>Opinions from the European Commission Scientific Committee on Cosmetic Products and Non</span><span>‑</span><span>Food Products intended for Consumers that:</span></p><p class="Tablea"><span>(a) have been finalised and adopted by that Committee; and</span></p><p class="Tablea"><span>(b) have terms of reference that include a question about the safety of a chemical in a cosmetic product; and</span></p><p class="Tablea"><span>(c) have a conclusion of safety with respect to the question about the safety of the chemical in a cosmetic product</span></p></td><td style="width:45.72%; 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 European Commission Scientific Committee on Cosmetic Products and Non</span><span>‑</span><span>Food Products intended for Consumers</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:45.7%; 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>Opinions from the European Commission Scientific Committee on Consumer Safety that:</span></p><p class="Tablea"><span>(a) have been finalised and adopted by that Committee; and</span></p><p class="Tablea"><span>(b) have terms of reference that include a question about the safety of a chemical in a cosmetic product; and</span></p><p class="Tablea"><span>(c) have a conclusion of safety with respect to the question about the safety of the chemical in a cosmetic product</span></p></td><td style="width:45.72%; 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 European Commission Scientific Committee on Consumer Safety</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:45.7%; 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>Opinions from the European Chemicals Agency Committee for Risk Assessment and the Committee for Socio</span><span>‑</span><span>Economic Analysis that:</span></p><p class="Tablea"><span>(a) are in accordance with the REACH Regulation; and</span></p><p class="Tablea"><span>(b) have been the basis of a European Commission decision to include or update a restriction in Annex XVII of that Regulation</span></p></td><td style="width:45.72%; 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>(a) the European Chemicals Agency Committee for Risk Assessment; and</span></p><p class="Tablea"><span>(b) the European Chemicals Agency Committee for Socio</span><span>‑</span><span>Economic Analysis</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:45.7%; 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>Risk assessments that:</span></p><p class="Tablea"><span>(a) are in accordance with Regulation (EU) No.</span><span> </span><span>528/2012 of the European Parliament and of the Council of 22</span><span> </span><span>May 2012; and</span></p><p class="Tablea"><span>(b) are subsequently reviewed by the European Chemicals Agency Biocidal Products Committee; and</span></p><p class="Tablea"><span>(c) have been the basis of a European Commission decision to approve an active biocidal substance</span></p></td><td style="width:45.72%; 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>(a) an authority of a member state of the European Union; or</span></p><p class="Tablea"><span>(b) the European Chemicals Agency</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:45.7%; 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>Assessments:</span></p><p class="Tablea"><span>(a) that are risk assessments, under the </span><span style="font-style:italic">Canadian Environmental Protection Act, 1999 </span><span>(Canada), of substances that are not specified on the Domestic Substances List (within the meaning of that Act); and</span></p><p class="Tablea"><span>(b) for which Australia has been involved as a secondary jurisdiction in an international parallel process (within the meaning given by the Guidelines)</span></p></td><td style="width:45.72%; 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>(a) Environment and Climate Change Canada; or</span></p><p class="Tablea"><span>(b) Health Canada</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:45.7%; 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>Assessments:</span></p><p class="Tablea"><span>(a) that are new chemical risk assessments under the </span><span style="font-style:italic">Toxic Substances Control Act of 1976 </span><span>(United States of America) as amended by the </span><span style="font-style:italic">Frank R. Lautenberg Chemical Safety for the 21st Century Act of 2016</span><span> (United States of America); and</span></p><p class="Tablea"><span>(b) for which Australia has been involved as a secondary jurisdiction in an international parallel process (within the meaning given by the Guidelines)</span></p></td><td style="width:45.72%; 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 United States Environmental Protection Agency</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>10</span></p></td><td style="width:45.7%; 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>Opinions from the European Food Safety Authority under Article 10 of Regulation (EC) No.</span><span> </span><span>1935/2004 of the European Parliament and of the Council of 27</span><span> </span><span>October 2004 on materials and articles intended to come into contact with food</span></p></td><td style="width:45.72%; 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>the European Food Safety Authority</span></p></td></tr></tbody></table>