Industrial Chemicals (General) Rules 2019

Part 1—Preliminary

1 Name

This instrument is the Industrial Chemicals (General) Rules 2019.

3 Authority

This instrument is made under the Industrial Chemicals Act 2019.

4 Simplified outline of this instrument

This instrument prescribes various matters for the purposes of the Industrial Chemicals Act 2019.

This Chapter contains preliminary provisions, including definitions for the purposes of the Act and this instrument. It also sets out certain circumstances in which the use of animal test data will be restricted for applications relating to industrial chemicals that are to be introduced for an end use in cosmetics.

Chapter 2 deals with the categorisation of industrial chemical introductions. Under the Act, there are 6 different categories of introductions, with provision for the rules to specify the circumstances in which an introduction of an industrial chemical will be an exempted introduction or a reported introduction. It sets out how introductions can be categorised as exempted or reported by dealing with certain circumstances in which introductions will be exempted or reported, as well as providing a means to determine the level of indicative risk posed by the introduction of an industrial chemical.

Chapter 3 deals with reporting obligations. It sets out the requirements that must be met for post‑introduction declarations for exempted introductions and pre‑introduction reports for reported introductions. It also sets out the requirements for annual declarations that must be made by all persons who introduce industrial chemicals in a registration year (other than excluded introductions).

Chapter 4 sets out the record keeping obligations in relation to all introductions under the Act by reference to the category of introduction, and in some cases the sub‑category of introduction.

Chapter 5 deals with the confidentiality and disclosure of information, including the circumstances in which an AACN or a generalised end use must be used.

Chapter 6 deals with the movement of industrial chemicals into and out of Australia in accordance with international agreements and arrangements, and the Executive Director’s power to approve the import or export of certain industrial chemicals that relate to those agreements and arrangements on application.

Chapter 7 deals with miscellaneous matters, including additional functions for the Executive Director and reviewable decisions.

5 Definitions

Note: A number of expressions used in this instrument are defined in the Act, including the following:

(a) AACN;
(b) end use;
(c) industrial chemical;
(d) manufacture;
(e) use.

In this instrument:

Act means the Industrial Chemicals Act 2019.

biochemical means a biological chemical that:

(a) is directly produced by a microscopic organism; or
(b) is a protein or a nucleic acid.

biocidal active means an industrial chemical that is intended to act by chemical means on or against a harmful organism by destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, the harmful organism.

biological chemical means an industrial chemical that:

(a) is derived from a living or once‑living organism, without further modification; or
(b) is produced by a living or once‑living organism, without further modification.

chemical identity holder has the meaning given by the Guidelines.

children’s care product means a product that is intended to facilitate:

(a) children’s sleep, relaxation or hygiene; or
(b) the feeding of children; or
(c) sucking by children.

designated fluorinated chemical means an industrial chemical that contains a sequence of atoms (whether linear, branched or cyclic) to which all of the following paragraphs apply:

(a) subject to paragraph (b), the sequence consists only of at least 4, but no more than 20, fluorinated carbon atoms, none of which are fluorinated carbon atoms that are part of conjugated double bonds;
(b) if the sequence is broken in any place, the break consists only of a single atom or single substituted atom;
(c) the sequence includes at least one perfluorinated methyl group (CF3) or perfluorinated methylene group (CF2).

designated kind of release into the environment has the meaning given by subclause 3(2) of Schedule 1.

eligible INCI plant extract name: the INCI name for an industrial chemical is an eligible INCI plant extract name if:

(a) the industrial chemical is a plant extract that has not intentionally undergone any chemical processes, or treatments, to change its chemical structure; and
(b) the INCI name is based on a botanical name for the relevant plant.

end use in an article with food contact: an industrial chemical has an end use in an article with food contact where the industrial chemical becomes part of an article that will come into contact with food, other than:

(a) where the end use of the industrial chemical is at the non‑food contact surface of a glass or metal article; or
(b) if the food that the article will come into contact with is rainwater—where the contact with the rainwater is transient.

environment categorisation volume, for an industrial chemical, means the environment categorisation volume for the industrial chemical worked out in accordance with the Guidelines.

Environment Department means the Department administered by the Minister administering the Environment Protection and Biodiversity Conservation Act 1999.

environment exposure band, for the introduction of an industrial chemical, has the meaning given by clause 3 of Schedule 1.

environment hazard band that applies to the environment hazard characteristic of an industrial chemical has the meaning given by clause 4 of Schedule 1.

environment hazard characteristic, of an industrial chemical, means a hazard characteristic, of the industrial chemical, that is mentioned in the table in clause 4 of Schedule 1.

flavour blend means a mixture of industrial chemicals that is formulated to impart a taste.

flavour blend introduction: an introduction of an industrial chemical is a flavour blend introduction if:

(a) the industrial chemical is introduced as part of a flavour blend; and
(b) the introduction is either of the flavour blend on its own or of the flavour blend in combination with one or more other industrial chemicals.

fluorinated carbon atom means a carbon atom attached to at least one fluorine atom.

food has the same meaning as in the Food Standards Australia New Zealand Act 1991.

fragrance blend means a mixture of industrial chemicals that is formulated to impart a scent or to cover a malodour.

fragrance blend introduction: an introduction of an industrial chemical is a fragrance blend introduction if:

(a) the industrial chemical is introduced as part of a fragrance blend; and
(b) the introduction is either of the fragrance blend on its own or of the fragrance blend in combination with one or more other industrial chemicals.

fuel has the same meaning as in the Fuel Quality Standards Act 2000.

GHS has the same meaning as in the Work Health and Safety Regulations 2011.

Note: GHS is short for Globally Harmonised System of Classification and Labelling of Chemicals.

Guidelines means the Industrial Chemicals Categorisation Guidelines issued by the Executive Director, as existing from time to time.

harmful organism means an organism that has an unwanted presence or a detrimental effect on humans, human activities, products used or produced by humans, or the environment.

hazard characteristic, of an industrial chemical, means a human health hazard characteristic, or an environment hazard characteristic, of the industrial chemical.

hazard class means the nature of a physical, health or environmental hazard under the GHS.

Health Department means the Department administered by the Minister administering the National Health Act 1953.

highest indicative risk, in relation to the introduction of an industrial chemical, has the meaning given by step 6 of the method statement in section 24.

highly branched organic chemical means an industrial chemical that:

(a) is carbon based; and
(b) is branched at:
(i) more than one tertiary carbon; or
(ii) more than one quaternary carbon; or
(iii) a combination of tertiary and quaternary carbons; and
(c) is not a polymer.

high molecular weight polymer means a polymer that has a number average molecular weight that is greater than or equal to 1,000 g/mol.

Home Affairs Department means the Department administered by the Minister administering the Australian Border Force Act 2015.

human health categorisation volume, for an industrial chemical, means the human health categorisation volume for the industrial chemical worked out in accordance with the Guidelines.

human health exposure band, for the introduction of an industrial chemical, has the meaning given by clause 1 of Schedule 1.

human health hazard band, that applies to the human health hazard characteristic of an industrial chemical, has the meaning given by clause 2 of Schedule 1.

human health hazard characteristic, of an industrial chemical, means a hazard characteristic, of the industrial chemical, that is mentioned in the table in clause 2 of Schedule 1.

IFRA Transparency List means the IFRA Transparency List published by the International Fragrance Association, as existing from time to time.

Note: The IFRA Transparency List could in 2019 be viewed on the International Fragrance Association’s website (https://ifrafragrance.org).

INCI name, for an industrial chemical, means the International Nomenclature of Cosmetic Ingredients name for the industrial chemical.

indicative environment risk, in relation to the introduction of an industrial chemical, has the meaning given by subsection 29(1).

indicative human health risk, in relation to the introduction of an industrial chemical, has the meaning given by subsection 28(1).

international assessment body:

(a) in relation to an industrial chemical that is internationally‑assessed for human health—has the meaning given by paragraph 6(1)(a); and
(b) in relation to an industrial chemical that is internationally‑assessed for the environment—has the meaning given by paragraph 6(2)(a).

international assessment report:

(a) in relation to an industrial chemical that is internationally‑assessed for human health—has the meaning given by paragraph 6(1)(d); and
(b) in relation to an industrial chemical that is internationally‑assessed for the environment—has the meaning given by paragraph 6(2)(d).

internationally‑assessed for human health: see subsection 6(1).

internationally‑assessed for the environment: see subsection 6(2).

IUPAC name, for an industrial chemical, means the International Union of Pure and Applied Chemistry name for the industrial chemical.

known environmental degradation products, in relation to an industrial chemical, has the meaning given by the Guidelines.

known hazard classification, for an industrial chemical, has the meaning given by the Guidelines.

low cationic density: a chemical has a low cationic density if:

(a) it is not cationic or potentially cationic; or
(b) the chemical contains one or more cationic, or potentially cationic, groups and at least one of the following applies:
(i) the total combined functional group equivalent weight of any cationic or potentially cationic groups is at least 5,000 g/mol;
(ii) the chemical has a solubility in water of less than 0.1 mg/L and will only be used in its solid phase;
(iii) the chemical is not dispersible in water and will only be used in its solid phase.

Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.

Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).

monomer means a chemical that is capable of forming covalent bonds with 2 or more like or unlike molecules under the conditions of a polymer‑forming reaction used for a process of polymer formation.

monomer unit means the reacted form of a monomer in a polymer.

nanoscale means the particle size range of 1 to 100 nm.

organism means a biological entity that is:

(a) viable; or
(b) capable of reproduction; or
(c) capable of transferring genetic material.

organotin chemical means a chemical that contains at least one tin atom that is covalently bound to at least one carbon atom.

overseas jurisdiction:

(a) in relation to an industrial chemical that is internationally‑assessed for human health—has the meaning given by paragraph 6(1)(b); and
(b) in relation to an industrial chemical that is internationally‑assessed for the environment—has the meaning given by paragraph 6(2)(b).

particle means a minute piece of matter with defined physical boundaries.

persistent, in relation to an industrial chemical or its known environmental degradation products, has the meaning given by the Guidelines.

polyhalogenated organic chemical means a chemical that:

(a) is carbon based; and
(b) contains more than one covalently bound bromine, chlorine, fluorine or iodine substituent.

polymer means a chemical that consists of molecules that:

(a) are characterised by the sequence of one or more types of monomer units; and
(b) are distributed over a range of molecular weights where the difference in molecular weights is primarily attributable to differences in the number of monomer units; and
(c) greater than 50% by weight of which have a sequence of at least 3 monomer units covalently bound to at least one other:
(i) monomer unit; or
(ii) molecule that is linked to one or more sequences of monomer units but cannot, under the conditions of the relevant reaction used for the particular process of polymer formation, become a repeating unit in the polymer structure.

polymer molecular weight details, of an industrial chemical that is a polymer, means the following:

(a) the number average molecular weight of the industrial chemical;
(b) the weight average molecular weight of the industrial chemical;
(c) the polydispersity index for the industrial chemical;
(d) the percentage (by mass) of molecules with a molecular weight that is less than 1,000 g/mol;
(e) the percentage (by mass) of molecules with a molecular weight that is less than 500 g/mol.

polymer of low concern has the meaning given by Schedule 2.

potentially cationic: a chemical is potentially cationic if the chemical is likely to become cationic in an aquatic environment that has a pH value greater than 4 and less than 9.

pre‑introduction report, for an industrial chemical, means a report for the industrial chemical prepared and given to the Executive Director in accordance with section 97 of the Act, including such a report as varied in accordance with section 98 of the Act.

radioactive chemical means a chemical that:

(a) is a controlled material (within the meaning of the Australian Radiation Protection and Nuclear Safety Act 1998); and
(b) is a nuclide mentioned in the table in Part 1 of Schedule 1 to the Australian Radiation Protection and Nuclear Safety Regulations 2018; and
(c) has an activity concentration value (within the meaning of the Australian Radiation Protection and Nuclear Safety Regulations 2018) greater than the activity concentration value for the nuclide set out in the table in Part 1 of Schedule 1 to those Regulations.

REACH Regulation means Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals.

reactant, in relation to a polymer, means a chemical (including a monomer) that is used in the polymer‑forming reaction to become chemically a part of the polymer composition.

reactive functional group means an atom, or an associated group of atoms, in an industrial chemical that is intended, or may reasonably be expected, to undergo chemical reaction.

research and development: an introduction of an industrial chemical is for research and development if:

(a) the introduction is for the purposes of systematic investigation or research, by means of experimentation or analysis, including for the analysis of other chemicals; and
(b) the introduction is not for distribution of the industrial chemical, or a product containing the industrial chemical, to potential customers in order to explore market capability in a competitive situation.

specified class of introduction: see section 7.

Stockholm Convention means the Stockholm Convention on Persistent Organic Pollutants done at Stockholm on 22 May 2001, as amended and in force for Australia from time to time.

Note: The Stockholm Convention is in Australian Treaty Series 2004 No. 23 ([2004] ATS 23) and in 2019 could be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).

supply has the same meaning as in the Fuel Quality Standards Act 2000.

tattoo ink means a combination of industrial chemicals that:

(a) contains one or more colouring agents; and
(b) is applied to the dermal layer of the skin for the purposes of colouring the skin.

UVCB substance description means a description of a UVCB substance that provides specific identity information about the UVCB substance, including one or more of the following:

(a) the manufacturing process for the UVCB substance;
(b) raw material sources of the UVCB substance;
(c) carbon number ranges for the UVCB substance;
(d) physical property ranges for the UVCB substance;
(e) biological sources of the UVCB substance.

UV filter: an industrial chemical is a UV filter if the industrial chemical is intended to protect the skin against ultraviolet radiation in the range of 290 to 400 nm by absorption, reflection or scattering of ultraviolet radiation.

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>

(4) To avoid doubt, an industrial chemical may be internationally‑assessed for human health and internationally‑assessed for the environment on the basis of a single assessment or evaluation by an international assessment body (other than the bodies mentioned in column 2 of items 3, 4, 5 and 10 of the table in subsection (3)).

Note: For the definition of international assessment body, see section 5.

7 Specified classes of introductions

(1) An introduction of an industrial chemical is a specified class of introduction if subsection (2), (3) or (4) applies to the introduction. (2) For the purposes of subsection (1), this subsection applies to the following classes of introductions: (a) introductions of an industrial chemical that: (i) is a gas; and (ii) is persistent; (b) introductions of an industrial chemical that is a highly branched organic chemical; (c) introductions of an industrial chemical for an end use as a biocidal active; (d) introductions of an industrial chemical that involve a designated kind of release into the environment.

Note 1: For the definition of persistent, see section 5.

Note 2: For when the introduction of an industrial chemical involves a designated kind of release into the environment, see subclause 3(2) of Schedule 1.

(3) For the purposes of subsection (1), this subsection applies to the following classes of introductions: (a) introductions of an industrial chemical that is a biochemical; (b) introductions of an industrial chemical that is a GM product; (c) introductions of an industrial chemical that: (i) is a solid, or is in a dispersion, at the time of introduction; and (ii) consists of solid particles, in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale; (d) introductions of an industrial chemical that is a polyhalogenated organic chemical; (e) introductions of an industrial chemical that is a designated fluorinated chemical. (4) For the purposes of subsection (1), this subsection applies to the following classes of introductions: (a) introductions of an industrial chemical that is a UV filter; (b) introductions of an industrial chemical for an end use in an article with food contact; (d) introductions of an industrial chemical for an end use in tattoo ink; (e) introductions of an industrial chemical for an end use in an article that is a children’s toy or a children’s care product.

Note: For the definition of end use in an article with food contact, see section 5.

Part 2—Provisions relating to defined terms in the Act

8 Kinds of data or information that relate to tests conducted on animals

For the purposes of the definition of animal test data in section 9 of the Act, any data or information that results from tests involving either of the following is prescribed: (a) application of an industrial chemical, either on its own or in combination with one or more other chemicals, to: (i) a live vertebrate animal (other than a human being); or (ii) an animal of a kind prescribed by section 9 of this instrument; (b) experimentation to test any effects of an industrial chemical, either on its own or in combination with one or more other chemicals, using: (i) a live vertebrate animal (other than a human being); or (ii) an animal of a kind prescribed by section 9 of this instrument.

9 Additional kind of animal for the purposes of the definition of animal test data

For the purposes of paragraph (b) of the definition of animal test data in section 9 of the Act, cephalopods are prescribed.

10 Kinds of objects that are not articles

For the purposes of the definition of article in section 9 of the Act, the following kinds of objects are prescribed: (a) objects that are a piece of matter whose purpose is determined to a lesser degree by the object’s shape, surface or design, than by the object’s chemical composition; (b) objects that are wholly fluid.

11 Prescribed international agreements

For the purposes of paragraph (b) of the definition of prescribed international agreement in section 9 of the Act, the following international agreements are prescribed: (aa) the Minamata Convention; (a) the Rotterdam Convention; (b) the Stockholm Convention.

12 Days that are not working days

For the purposes of the definition of working day in section 9 of the Act, the following days are prescribed: (a) 27 December; (b) 28 December; (c) 29 December; (d) 30 December; (e) 31 December.

12A Mixtures of mercury

Mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight are prescribed: (a) for the purposes of paragraph 10(1)(f) of the Act; and (b) as a kind of industrial chemical for the purposes of paragraph 11(2)(e) of the Act.

13 Chemicals or substances that are not industrial chemicals

For the purposes of subsection 10(2) of the Act, radioactive chemicals are prescribed.

14 Circumstances in which introductions are excluded introductions

(1) For the purposes of subsection 11(4) of the Act, an introduction of an industrial chemical is an excluded introduction if subsection (2) or (3) of this section applies to the introduction. (2) This subsection applies to the introduction of an industrial chemical if: (a) the industrial chemical is introduced incidentally to the carriage of passengers, or the importation of other products, on an aircraft or a ship that leaves Australia within 25 working days beginning the day the industrial chemical is introduced; and (b) the industrial chemical is used to support the operation of the aircraft or ship; and (c) the industrial chemical is not freight. (3) This subsection applies to the introduction of an industrial chemical by a person if: (a) the introduction of the industrial chemical by the person occurs only by manufacture; and (b) the industrial chemical is manufactured by the person in a saponification reaction using: (i) a fat or an oil; and (ii) aqueous sodium hydroxide or aqueous potassium hydroxide; and (c) the fat or oil is listed on the Inventory; and (d) the total volume of the fat or oil used by the person to manufacture the industrial chemical in a registration year does not exceed 10 kg.

15 Introductions that are taken not to be for personal use

For the purposes of subsection 11(6) of the Act, introduction of an industrial chemical for the purposes of carrying on an enterprise (within the meaning of the A New Tax System (Goods and Services Tax) Act 1999) is prescribed.

Part 3—Prescribed bodies

16 Bodies from which the Executive Director must seek advice

For the purposes of subsections 34(1), 46(1), 71(1) and 91(1) of the Act, the following table sets out the bodies from which the Executive Director must seek advice if the Executive Director is considering taking action under the relevant subsection based on a risk mentioned in an item in the table.

<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>Prescribed bodies</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>If the Executive Director is considering the action based on …</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>then the prescribed body is …</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>risks to the environment</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="Tabletext"><span>the Environment Department</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>risks to human health related to consumer products</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 Australian Competition and Consumer Commission</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>risks to human health related to drinking water</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 National Health and Medical Research Council</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>risks to human health related to exposure via the environment</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 Environment Department; and</span></p><p class="Tablea"><span>(b) the Health Department</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>risks to human health related to food</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>Food Standards Australia New Zealand</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>risks to human health related to the health of workers</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>Safe Work 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>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>risks to human health related to public health</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 Health Department</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>risks to human health or the environment related to transport of an industrial chemical</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 National Transport Commission</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>9</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>risks to human health or the environment where there may be national security implications</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 Home Affairs Department</span></p></td></tr></tbody></table>

17 Bodies from which the Executive Director may seek advice

For the purposes of subsections 34(2), 46(2), 56(1) and 71(2), paragraph 75(a) and subsections 91(2), 107(1) and 111(5) of the Act, the following bodies are prescribed: (a) the Australian Competition and Consumer Commission; (b) the Environment Department; (c) Food Standards Australia New Zealand; (d) the Gene Technology Regulator; (e) the Health Department; (f) the Home Affairs Department; (g) the National Health and Medical Research Council; (h) the National Transport Commission; (i) Safe Work Australia; (j) each body in a State or Territory that has responsibility for matters relating to protection of the environment; (k) each body in a State or Territory that has responsibility for matters relating to public health; (l) each body in a State or Territory that has responsibility for matters relating to work health and safety.

Part 4—Commercial evaluation authorisations

18 Circumstances in which an application cannot be made

(1) For the purposes of subparagraph 53(1)(b)(i) of the Act, the following circumstances are prescribed: (a) making the industrial chemical available to the general public on its own; (b) making the industrial chemical available to the general public in combination with one or more other industrial chemicals; (c) making the industrial chemical available to the general public as part of an article if: (i) the article was designed to release the industrial chemical; or (ii) the industrial chemical is for an end use in an article with food contact; or (iii) the article is a children’s toy or a children’s care product. (2) For the purposes of subparagraph 53(1)(b)(iv) of the Act, introduction of a volume of an industrial chemical under a commercial evaluation authorisation must not, over the period for which the authorisation is to be in force, exceed 10 tonnes.

Part 5—Restrictions on animal test data for applications relating to end use in cosmetics

19 Restriction on animal test data for applications for industrial chemicals with multiple end uses including an end use in cosmetics

(1) This section applies if: (a) an industrial chemical is to be introduced for multiple end uses; and (b) one of those end uses is in cosmetics. (2) For the purposes of paragraph 167(1)(da) of the Act, an application by a person under the Act in relation to the introduction of the industrial chemical must not contain any animal test data obtained from tests conducted on or after 1 July 2020 other than: (a) animal test data that: (i) demonstrates that the industrial chemical has a hazard characteristic; and (ii) conflicts with other information contained in the application regarding whether the industrial chemical has that hazard characteristic; or (b) animal test data that is the only information that can demonstrate whether the industrial chemical has a particular environment hazard characteristic; or (c) animal test data that is derived from tests conducted on animals involving a chemical that: (i) is not the industrial chemical to which the application relates; and (ii) is not an industrial chemical introduced by the person for an end use in cosmetics.

Note: This restriction does not apply if the inclusion of the animal test data is approved by the Executive Director: see section 20.

20 Applications for industrial chemicals with multiple end uses including an end use in cosmetics

(1) For the purposes of subsection 167(1B) of the Act, section 19 of this instrument does not apply in relation to animal test data (other than animal test data of a kind described in paragraphs 19(2)(a), (b) and (c)) if the inclusion of the animal test data is approved by the Executive Director under section 21 of this instrument. (2) A person may apply, in writing, to the Executive Director for approval to include the animal test data in an application (the original application).

Note: For general requirements relating to applications, see section 167 of the Act.

(3) A joint application under subsection (2) may be made by 2 or more persons. Further information (4) The Executive Director may, by written notice given to an applicant, request further information to be provided for the purposes of considering the application. (5) The requested information must be provided within the period specified in the notice, which must not be less than 10 working days after the day the notice is given. (6) If the requested information is not provided within the period mentioned in subsection (5), the Executive Director may take the application to be withdrawn.

21 Decision on application

(1) The Executive Director must: (a) consider the application under section 20 in accordance with this section; and (b) make a decision on the application within 10 working days after the day the application is made. (2) In considering the application, the Executive Director must have regard to the following: (a) if the animal test data is for the purpose of identifying a human health hazard characteristic of the industrial chemical—whether the non‑cosmetic end use of the industrial chemical to which the original application relates involves, or potentially involves, exposure of humans to the industrial chemical; (b) if the animal test data is for the purpose of identifying an environment hazard characteristic of the industrial chemical—whether the non‑cosmetic end use of the industrial chemical to which the original application relates involves, or potentially involves, exposure of the environment to the industrial chemical; (c) any further information provided by the applicant under subsection 20(5); (d) any other information the Executive Director considers relevant. (3) After considering the application, the Executive Director must decide to: (a) approve the inclusion of the animal test data in the original application; or (b) not approve the inclusion of the animal test data in the original application. (4) The Executive Director must give the applicant written notice of: (a) the decision; and (b) if the decision is to refuse the application—the reasons for the decision. (5) If the Executive Director has requested further information under subsection 20(4), the 10 working day period mentioned in paragraph (1)(b) of this section excludes the number of days falling within the period: (a) beginning on the day on which the notice is given under subsection 20(4); and (b) ending on the earlier of: (i) the day a complete response to the notice is provided to the Executive Director in accordance with subsection 20(5); or (ii) the last day of the period specified in the notice.

22 Ban on animal test data for applications for industrial chemicals with end use solely in cosmetics

For the purposes of subsection 168(2) of the Act, all circumstances are prescribed, other than circumstances where: (a) the animal test data: (i) demonstrates that the industrial chemical has a hazard characteristic; and (ii) conflicts with other information contained in the application regarding whether the industrial chemical has that hazard characteristic; or (b) the animal test data is the only information that can demonstrate whether the industrial chemical has a particular environment hazard characteristic; or (c) both: (i) the animal test data has been derived from tests conducted on animals involving a chemical other than the industrial chemical to which the application by the person relates; and (ii) the other chemical is not an industrial chemical introduced by the person solely for an end use in cosmetics.

Chapter 2—Categorisation of introductions of industrial chemicals

23 Simplified outline of this Chapter

Under the Act, there are 6 categories of introductions of industrial chemicals: listed introductions, exempted introductions, reported introductions, assessed introductions, commercial evaluation introductions and exceptional circumstances introductions.

This Chapter deals with the circumstances in which an introduction is an exempted introduction or a reported introduction.

In order to determine whether an introduction of an industrial chemical is exempted or reported, it is first necessary to determine whether the introduction falls within certain circumstances in which an introduction is exempted or reported, or is not exempted or reported.

If an introduction does not fit within those circumstances, the introduction may still be exempted or reported depending on the level of risk to human health and the environment from the introduction.

The level of risk can be determined in accordance with this Chapter and can be used to determine the highest indicative risk for the introduction. If:

(a) the highest indicative risk is very low, the introduction may be categorised as exempted; and

(b) the highest indicative risk is low, the introduction may be categorised as reported.

24 Determining if an introduction is exempted or reported

Whether the introduction of an industrial chemical is an exempted introduction or a reported introduction is worked out as follows:

Method statement

Step 1: Work out whether the introduction is covered by section 25.

If the introduction is covered by section 25:

(a) for the purposes of paragraph 26(2)(b) of the Act, the introduction is not an exempted introduction; and

(b) for the purposes of paragraph 27(2)(b) of the Act, the introduction is not a reported introduction.

Otherwise, go to step 2.

Step 2: Work out whether the introduction is covered by section 26.

If the introduction is covered by section 26, for the purposes of paragraph 26(2)(a) of the Act, the introduction is an exempted introduction.

Otherwise, go to step 3.

Step 3: Work out whether the introduction is covered by section 27.

If the introduction is covered by section 27, for the purposes of paragraph 27(2)(a) of the Act, the introduction is a reported introduction.

Otherwise, go to step 4.

Step 4: Work out the indicative human health risk for the introduction (see section 28).

Step 5: Work out the indicative environment risk for the introduction (see section 29).

Step 6: Taking the indicative risks from steps 4 and 5, determine which is the highest indicative risk. The result is the highest indicative risk for the introduction.

If the highest indicative risk for the introduction is very low risk, for the purposes of paragraph 26(2)(a) of the Act, the introduction is an exempted introduction.

If the highest indicative risk for the introduction is low risk, for the purposes of paragraph 27(2)(a) of the Act, the introduction is a reported introduction.

If the highest indicative risk for the introduction is medium to high risk:

(a) for the purposes of paragraph 26(2)(b) of the Act, the introduction is not an exempted introduction; and

(b) for the purposes of paragraph 27(2)(b) of the Act, the introduction is not a reported introduction.

Note: If an introduction of an industrial chemical is not categorised as an exempted introduction or a reported introduction and is not listed on the Inventory, it is generally an assessed introduction: see Division 2 of Part 3 of the Act.

25 Circumstances in which introductions are not exempted or reported

(1) For the purposes of step 1 of the method statement in section 24, the introduction of an industrial chemical is covered by this section if subsection (2), (3) or (4) of this section applies to the introduction. Introduction of industrial chemical subject to an international agreement or arrangement etc. (2) Subject to subsection (2A), this subsection applies to the introduction of an industrial chemical by a person if: (a) the industrial chemical is listed in: (i) Annex III to the Rotterdam Convention; or (ii) Part 1 of Annex A, B or C to the Stockholm Convention; or (b) the Persistent Organic Pollutants Review Committee (within the meaning of the Stockholm Convention) has decided that it is satisfied that the screening criteria specified in Annex D of that Convention have been fulfilled in relation to the industrial chemical; or (c) the Executive Director is satisfied: (i) as a result of deciding whether or not to issue an assessment certificate for the industrial chemical; or (ii) based on an evaluation under Part 4 of the Act relating to the introduction of the industrial chemical; that the screening criteria specified in Annex D of the Stockholm Convention have been fulfilled in relation to the industrial chemical. (2A) Subsection (2) does not apply to the introduction of an industrial chemical by a person if: (a) the industrial chemical is to be introduced solely for use in research or analysis; and (b) the total volume of the industrial chemical introduced by the person in a registration year does not exceed 100 kg. Introduction of industrial chemical listed on Inventory (3) This subsection applies to the introduction of an industrial chemical by a person if: (a) the industrial chemical is listed on the Inventory; and (b) the terms of the Inventory listing include one or more conditions relating to the introduction or use of the industrial chemical; and (c) the introduction or use is not in accordance with those conditions.

Note: An application may be made to vary the terms of the Inventory listing: see section 88 of the Act.

Introduction of industrial chemical where request for information is not complied with (4) This subsection applies to the introduction of an industrial chemical by a person if: (a) the Executive Director has, by written notice under section 102 or 104 of the Act: (i) requested the person to provide information relating to the introduction of the industrial chemical; and (ii) to do so within the period specified in the notice; and (b) the information is not given to the Executive Director within the period specified in the notice.

Note: The information may be given to the Executive Director by the person to whom the Executive Director gave the notice or by another person.

(5) However, subsection (4) ceases to have effect in relation to the introduction if: (a) the information requested is given to the Executive Director; or (b) the Executive Director agrees, in writing, that the information requested is no longer required.

Note: For example, the Executive Director may agree that the information requested is no longer required if the Executive Director is satisfied that the industrial chemical can be introduced under another category of introduction.

26 Circumstances in which introductions are exempted introductions

(1) For the purposes of step 2 of the method statement in section 24, the introduction of an industrial chemical by a person is covered by this section if any of subsections (2) to (9) of this section apply to the introduction. Introduction of industrial chemicals that are imported and subsequently exported (2) This subsection applies to the introduction of an industrial chemical by a person if: (a) the industrial chemical is introduced at a port or airport in Australia; and (b) the total volume of the industrial chemical is subsequently exported out of Australia; and (c) at all times whilst the industrial chemical is in Australia, the packaging in which the industrial chemical is immediately contained is not opened; and (d) at all times whilst the industrial chemical is in Australia, the industrial chemical is either: (i) subject to customs control under the Customs Act 1901; or (ii) subject to the control of the person who introduces the industrial chemical; and (e) subsection 11(3) of the Act does not apply to the introduction.

Note: Under subsection 11(3) of Act, if the industrial chemical leaves Australia within 25 working days and is subject to customs control under the Customs Act 1901 at all times before leaving Australia, the introduction of the industrial chemical is an excluded introduction. Therefore, subparagraph (d)(i) of this subsection may only apply where the industrial chemical is subject to customs control for longer than 25 working days.

Introduction of industrial chemicals that are solely for use in research and development (3) This subsection applies to the introduction of an industrial chemical by a person if: (a) the introduction of the industrial chemical is: (i) solely for the industrial chemical to be used in research and development by the person; or (ii) solely for the purposes of making the industrial chemical available to another person for that other person to use solely in research and development; and (b) the industrial chemical is not made available to the general public: (i) on its own; or (ii) in combination with one or more other industrial chemicals; or (iii) as part of an article, including where the industrial chemical undergoes a physical or chemical change to produce the article; and (c) control measures are used to eliminate or minimise the risks from the introduction and use of the industrial chemical to: (i) persons involved in the research and development for which the industrial chemical is introduced; and (ii) the environment; and (d) the total volume of the industrial chemical introduced in a registration year by the person does not exceed: (i) if subsection (3A) applies to the industrial chemical—10 kg; or (ii) otherwise, and subject to subsection (3B)—250 kg. (3A) This section applies to an industrial chemical if: (a) the industrial chemical is a solid, or is in a dispersion, at the time of introduction and it consists of solid particles, in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale; or (b) it had not been determined, at the time of introduction, whether the industrial chemical meets the description in paragraph (a). (3B) Subparagraph (3)(d)(ii) does not apply to the introduction of an industrial chemical by a person in a registration year if an amount of the industrial chemical to which paragraph (3A)(a) applies has been introduced by the person in the registration year. Introduction of polymers that are comparable to listed polymers (4) This subsection applies to the introduction of an industrial chemical by a person if: (a) the industrial chemical is a polymer; and (b) the polymer contains each of the reactants that another polymer that is listed on the Inventory (the listed polymer) does; and (c) the polymer contains one or more other reactants (the additional reactants) that the listed polymer does not; and (d) each additional reactant does not constitute more than 2% by weight of the polymer; and (e) the introduction complies with the following terms of the Inventory listing for the listed polymer: (i) any defined scope of assessment for the industrial chemical; (ii) any conditions relating to the introduction or use of the industrial chemical; (iii) any specific requirements to provide information to the Executive Director in relation to the introduction of the industrial chemical; (iv) any other information relating to the industrial chemical that is prescribed by this instrument for the purposes of paragraph 81(1)(f) of the Act. Introduction of industrial chemicals that are comparable to listed industrial chemicals (5) This subsection applies to the introduction of an industrial chemical by a person if: (a) the introduction is of an industrial chemical mentioned in column 1 of an item in the following table; and (b) the introduction complies with the following terms of the Inventory listing for the industrial chemical mentioned in column 3 of that item: (i) any defined scope of assessment for the industrial chemical; (ii) any conditions relating to the introduction or use of the industrial chemical; (iii) any specific requirements to provide information to the Executive Director in relation to the introduction of the industrial chemical; (iv) any other information relating to the industrial chemical that is prescribed by this instrument for the purposes of paragraph 81(1)(f) of the Act.

<table cellspacing="0" cellpadding="0" style="width:104.32%; border-collapse:collapse"><thead><tr><td colspan="4" 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>Industrial chemicals comparable to listed industrial chemicals</span></p></td><td style="width:17.52%; 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></span></p></td></tr><tr><td style="width:7.6%; 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:30.28%; 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:17.54%; 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><td style="width:27.06%; 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 3</span></p></td><td style="width:17.52%; 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 4</span></p></td></tr><tr><td style="width:7.6%; 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:30.28%; 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>Industrial chemical to be introduced</span></p></td><td style="width:17.54%; 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>CAS no. of industrial chemical to be introduced</span></p></td><td style="width:27.08%; 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>Listed industrial chemical</span></p></td><td style="width:17.5%; 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>CAS no. of listed industrial chemical</span></p></td></tr></thead><tbody><tr><td style="width:7.6%; 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:30.28%; 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>Aloe barbadensis, extract</span></p></td><td style="width:17.54%; 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>94349</span><span>‑</span><span>62</span><span>‑</span><span>9</span></p></td><td style="width:27.06%; 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>Aloe vera, extract</span></p></td><td style="width:17.52%; 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>85507</span><span>‑</span><span>69</span><span>‑</span><span>3</span></p></td></tr><tr><td style="width:7.6%; 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:30.28%; 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>Brassica oleracea botrytis, extract</span></p></td><td style="width:17.54%; 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>223749</span><span>‑</span><span>36</span><span>‑</span><span>8</span></p></td><td style="width:27.06%; 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>Cabbage, extract</span></p></td><td style="width:17.52%; 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>89958</span><span>‑</span><span>13</span><span>‑</span><span>4</span></p></td></tr><tr><td style="width:7.6%; 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:30.28%; 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>Brassica oleracea, extract</span></p></td><td style="width:17.54%; 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>91771</span><span>‑</span><span>39</span><span>‑</span><span>0</span></p></td><td style="width:27.06%; 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>Cabbage, extract</span></p></td><td style="width:17.52%; 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>89958</span><span>‑</span><span>13</span><span>‑</span><span>4</span></p></td></tr><tr><td style="width:7.6%; 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:30.28%; 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>Brassica oleracea gemmifera, extract</span></p></td><td style="width:17.54%; 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>1174275</span><span>‑</span><span>27</span><span>‑</span><span>4</span></p></td><td style="width:27.06%; 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>Cabbage, extract</span></p></td><td style="width:17.52%; 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>89958</span><span>‑</span><span>13</span><span>‑</span><span>4</span></p></td></tr><tr><td style="width:7.6%; 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:30.28%; 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>Fatty acids, palm</span><span>‑</span><span>oil, sodium salts</span></p></td><td style="width:17.54%; 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>61790</span><span>‑</span><span>79</span><span>‑</span><span>2</span></p></td><td style="width:27.06%; 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>Fatty acids, C14</span><span>‑</span><span>18 and C16</span><span>‑</span><span>18</span><span>‑</span><span>unsaturated, sodium salts</span></p></td><td style="width:17.52%; 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>67701</span><span>‑</span><span>11</span><span>‑</span><span>5</span></p></td></tr><tr><td style="width:7.6%; 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:30.28%; 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>Jojoba, extract</span></p></td><td style="width:17.54%; 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>90045</span><span>‑</span><span>98</span><span>‑</span><span>0</span></p></td><td style="width:27.06%; 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>Jojoba oil</span></p></td><td style="width:17.52%; 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>61789</span><span>‑</span><span>91</span><span>‑</span><span>1</span></p></td></tr><tr><td style="width:7.6%; 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:30.28%; 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>3,6,9,12,15,18,21,21,24,27</span><span>‑</span><span>Nonaoxanonatriacontan</span><span>‑</span><span>1</span><span>‑</span><span>ol</span></p></td><td style="width:17.54%; 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>3055</span><span>‑</span><span>99</span><span>‑</span><span>0</span></p></td><td style="width:27.06%; 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>Poly(oxy</span><span>‑</span><span>1,2</span><span>‑</span><span>ethanediyl), α</span><span>‑</span><span>dodecyl</span><span>‑</span><span>ω</span><span>‑</span><span>hydroxy</span><span>‑</span></p></td><td style="width:17.52%; 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>9002</span><span>‑</span><span>92</span><span>‑</span><span>0</span></p></td></tr><tr><td style="width:7.6%; 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:30.28%; 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>Matricaria recutita, extract</span></p></td><td style="width:17.54%; 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>84082</span><span>‑</span><span>60</span><span>‑</span><span>0</span></p></td><td style="width:27.06%; 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>Oils, Chamomile, German</span></p></td><td style="width:17.52%; 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>8002</span><span>‑</span><span>66</span><span>‑</span><span>2</span></p></td></tr><tr><td style="width:7.6%; 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:30.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt"><p class="Tabletext"><span>Orange, extract</span></p></td><td style="width:17.54%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt"><p class="Tabletext"><span>84012</span><span>‑</span><span>28</span><span>‑</span><span>2</span></p></td><td style="width:27.06%; 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>Orange, sweet, extract</span></p></td><td style="width:17.52%; 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>8028</span><span>‑</span><span>48</span><span>‑</span><span>6</span></p></td></tr><tr><td style="width:7.6%; 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:30.28%; 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>Pelargonium roseum, extract</span></p></td><td style="width:17.54%; 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>90082</span><span>‑</span><span>55</span><span>‑</span><span>6</span></p></td><td style="width:27.06%; 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>Pelargonium graveolens, extract</span></p></td><td style="width:17.52%; 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>90082</span><span>‑</span><span>51</span><span>‑</span><span>2</span></p></td></tr><tr><td style="width:7.6%; 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:30.28%; 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>Soya lecithins</span></p></td><td style="width:17.54%; 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>8030</span><span>‑</span><span>76</span><span>‑</span><span>0</span></p></td><td style="width:27.06%; 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>Lecithins</span></p></td><td style="width:17.52%; 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>8002</span><span>‑</span><span>43</span><span>‑</span><span>5</span></p></td></tr><tr><td style="width:7.6%; 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:30.28%; 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>Soya phospholipids</span></p></td><td style="width:17.54%; 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>308069</span><span>‑</span><span>41</span><span>‑</span><span>2</span></p></td><td style="width:27.06%; 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>Phospholipids</span></p></td><td style="width:17.52%; 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>123465</span><span>‑</span><span>35</span><span>‑</span><span>0</span></p></td></tr><tr><td style="width:7.6%; 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:30.28%; 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>Spiro[isobenzofuran</span><span>‑</span><span>1(3H),9’</span><span>‑</span><span>[9H]xanthen]</span><span>‑</span><span>3</span><span>‑</span><span>one, 2’,4’,5’,7’</span><span>‑</span><span>tetrabromo</span><span>‑</span><span>4,5,6,7</span><span>‑</span><span>tetrachloro</span><span>‑</span><span>3’,6’</span><span>‑</span><span>dihydroxy</span><span>‑</span><span>, aluminum salt (3:2)</span></p></td><td style="width:17.54%; 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>15876</span><span>‑</span><span>58</span><span>‑</span><span>1</span></p></td><td style="width:27.06%; 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>Spiro[isobenzofuran</span><span>‑</span><span>1(3H),9’</span><span>‑</span><span>[9H]xanthen]</span><span>‑</span><span>3</span><span>‑</span><span>one, 2’,4’,5’,7’</span><span>‑</span><span>tetrabromo</span><span>‑</span><span>4,5,6,7</span><span>‑</span><span>tetrachloro</span><span>‑</span><span>3’,6’</span><span>‑</span><span>dihydroxy</span><span>‑</span><span>, aluminum salt (3:1)</span></p></td><td style="width:17.52%; 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>27532</span><span>‑</span><span>17</span><span>‑</span><span>8</span></p></td></tr><tr><td style="width:7.6%; 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:30.28%; 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>Tridymite (SiO</span><span style="font-size:6.67pt; vertical-align:sub">2</span><span>)</span></p></td><td style="width:17.54%; 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>15468</span><span>‑</span><span>32</span><span>‑</span><span>3</span></p></td><td style="width:27.06%; 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>Silica</span></p></td><td style="width:17.52%; 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>7631</span><span>‑</span><span>86</span><span>‑</span><span>9</span></p></td></tr><tr><td style="width:7.6%; 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>15</span></p></td><td style="width:30.28%; 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>Wheat germ oil</span></p></td><td style="width:17.54%; 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>313258</span><span>‑</span><span>61</span><span>‑</span><span>6</span></p></td><td style="width:27.06%; 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>Oils, wheat</span></p></td><td style="width:17.52%; 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>68917</span><span>‑</span><span>73</span><span>‑</span><span>7</span></p></td></tr></tbody></table>

Introduction of polymers of low concern (6) This subsection applies to the introduction of an industrial chemical by a person if: (a) the industrial chemical is a polymer of low concern; and (b) the industrial chemical is not a high molecular weight polymer that has lung overloading potential (within the meaning given by the Guidelines). Introduction of low concern biological polymers (7) This subsection applies to the introduction of an industrial chemical by a person if: (a) the industrial chemical is a biological chemical; and (b) the industrial chemical is a polymer; and (c) the industrial chemical would be a polymer of low concern if the definition of polymer of low concern in Schedule 2 did not include a requirement that the polymer is stable (within the meaning given by the Guidelines). Introduction of industrial chemicals resulting from non‑functionalised surface treatment of listed industrial chemicals (8) This subsection applies to the introduction of an industrial chemical by a person if: (a) the industrial chemical is the result of a reaction between 2 or more chemicals where the reaction occurs at the surface of one of the chemicals (the substrate chemical); and (b) the substrate chemical and each of the other chemicals that reacts with the substrate chemical is listed on the Inventory; and (c) the industrial chemical is not an industrial chemical that: (i) is a solid, or is in a dispersion, at the time of introduction; and (ii) consists of solid particles, in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale; and (d) the industrial chemical does not have any reactive functional groups that were not present on the substrate chemical. Introduction of manufactured soap (9) This subsection applies to the introduction of an industrial chemical by a person if: (a) the introduction of the industrial chemical by the person occurs only by manufacture; and (b) the industrial chemical is manufactured by the person in a saponification reaction using: (i) a fat or an oil; and (ii) aqueous sodium hydroxide or aqueous potassium hydroxide; and (c) the total volume of the fat or oil used by the person to manufacture the industrial chemical in a registration year does not exceed 100 kg.

27 Circumstances in which introductions are reported introductions

(1) For the purposes of step 3 of the method statement in section 24, the introduction of an industrial chemical is covered by this section if subsection (2), (3), (4), (4A) or (6) of this section applies to the introduction. Low volume introductions of industrial chemicals that are solely for use in research and development (2) This subsection applies to the introduction of an industrial chemical by a person if: (a) the introduction of the industrial chemical is: (i) solely for the industrial chemical to be used in research and development by the person; or (ii) solely for the purposes of making the industrial chemical available to another person for that other person to use solely in research and development; and (b) either: (i) the industrial chemical is a solid, or is in a dispersion, at the time of introduction and it consists of solid particles, in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale; or (ii) it had not been determined, at the time of introduction, whether the industrial chemical meets the description in subparagraph (i); and (c) the industrial chemical is not made available to the general public: (i) on its own; or (ii) in combination with one or more other industrial chemicals; or (iii) as part of an article, including where the industrial chemical undergoes a physical or chemical change to produce the article; and (d) control measures are used to eliminate or minimise the risks from the introduction and use of the industrial chemical to: (i) persons involved in the research and development for which the industrial chemical is introduced; and (ii) the environment; and (e) the total volume of the industrial chemical introduced in a registration year by the person is greater than 10 kg and less than or equal to 100 kg. Other introductions of industrial chemicals that are solely for use in research and development (3) This subsection applies to the introduction of an industrial chemical by a person if: (a) the introduction of the industrial chemical is solely for the industrial chemical to be used in research and development by the person (the introducer); and (b) the industrial chemical is not an industrial chemical that: (i) is a solid, or is in a dispersion, at the time of introduction; and (ii) consists of solid particles, in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale; and (c) the industrial chemical is not made available to the general public: (i) on its own; or (ii) in combination with one or more other industrial chemicals; or (iii) as part of an article, including where the industrial chemical undergoes a physical or chemical change to produce the article; and (d) control measures are used to eliminate or minimise the risks from the introduction and use of the industrial chemical to: (i) persons involved in the research and development for which the industrial chemical is introduced; and (ii) the environment; and (e) the total volume of the industrial chemical introduced in a registration year by the introducer is greater than 250 kg, and no amount of the industrial chemical that meets the description in subparagraph (2)(b)(i) has been introduced by the person in the registration year; and (f) the use of the industrial chemical is subject to the control of the introducer. Low‑risk flavour or fragrance blend introductions (4) This subsection applies to the introduction of an industrial chemical by a person if: (a) the introduction of the industrial chemical is either: (i) a flavour blend introduction; or (ii) a fragrance blend introduction; and (b) the concentration of the industrial chemical at introduction and at end use is 1% or less; and (d) the industrial chemical does not have: (i) any of the human health hazard characteristics in human health hazard band C; or (ii) any of the environment hazard characteristics in environment hazard band D; and (e) either: (i) when the pre‑introduction report for the industrial chemical is given to the Executive Director by the person, the industrial chemical is included on the IFRA Transparency List; or (ii) before the industrial chemical is first introduced by the person, the Executive Director is given written notice of the information specified in subsection (5). (4A) This subsection applies to the introduction of an industrial chemical by a person if: (a) the introduction of the industrial chemical is either: (i) a flavour blend introduction; or (ii) a fragrance blend introduction; and (b) either: (i) the concentration of the industrial chemical at introduction and at end use is 1% or less, and the total volume of the industrial chemical introduced by the person in a registration year does not exceed 1,000 kg; or (ii) the total volume of the industrial chemical introduced by the person in a registration year does not exceed 10 kg; and (d) the industrial chemical is not known by the person to satisfy the criteria for any of the following hazard classes in the GHS: (i) germ cell mutagenicity; (ii) carcinogenicity; (iii) reproductive toxicity; and (e) the industrial chemical is not known by the person to be persistent, bioaccumulative and toxic (within the meaning of subsection (8)); and (f) the industrial chemical is not known by the person to cause adverse effects mediated by an endocrine mode of action (within the meaning given by the Guidelines); and (g) either: (i) when the pre‑introduction report for the industrial chemical is given to the Executive Director by the person, the industrial chemical is included on the IFRA Transparency List; or (ii) before the industrial chemical is first introduced by the person, the Executive Director is given written notice of the information specified in subsection (5); and (h) use of the industrial chemical is in accordance with any applicable IFRA Standards, published by the International Fragrance Association (also known as the IFRA), as existing from time to time.

Note: The IFRA Standards could in 2024 be viewed on the website for the International Fragrance Association (http://www.ifrafragrance.org).

(5) For the purposes of subparagraphs (4)(e)(ii) and (4A)(g)(ii), the information is the following: (a) the CAS name, the IUPAC name or an eligible INCI plant extract name for the industrial chemical; (aa) the CAS number (if assigned) for the industrial chemical; (b) any hazard characteristics of the industrial chemical that are known to the person giving the notice; (c) the maximum concentration of the industrial chemical in the flavour blend or fragrance blend (as the case requires) at introduction and at end use; (d) the name by which the flavour blend or fragrance blend (as the case requires) is known to the person introducing the industrial chemical. Introductions of 10 kg or less of an industrial chemical (6) This subsection applies to the introduction of an industrial chemical by a person if: (a) the total volume of the industrial chemical introduced by the person in a registration year does not exceed 10 kg; and (b) the industrial chemical is not known by the person to satisfy the criteria for any of the following hazard classes in the GHS: (i) germ cell mutagenicity; (ii) carcinogenicity; (iii) reproductive toxicity; and (c) if the industrial chemical is introduced for an end use in cosmetics—the industrial chemical is not prohibited or restricted for use as a cosmetic, or for use in cosmetics: (i) in the European Union under Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, as in force from time to time; or (ii) in the United States of America under the Federal Food, Drug, and Cosmetic Act, as in force from time to time; and (d) the industrial chemical: (i) is not, to the person’s knowledge, to be introduced as a solid or in a dispersion; or (ii) is not known by the person to consist of solid particles, in an unbound state or as an aggregate or agglomerate, where any of the particles have at least one external dimension in the nanoscale; and (e) the industrial chemical: (i) is not known by the person to contain fluorine; or (ii) is known by the person to be an inorganic salt; and (f) the industrial chemical is not known by the person to be persistent, bioaccumulative and toxic (within the meaning of subsection (8)); and (g) neither of the following subparagraphs apply: (i) the Executive Director has cancelled an assessment certificate for the industrial chemical under section 52 of the Act; (ii) the Executive Director has removed an Inventory listing for the industrial chemical under section 95 of the Act in circumstances to which subparagraph 95(1)(c)(i) of the Act applied. (7) To avoid doubt, for the purposes of subparagraph (6)(g)(i), it does not matter: (a) who was the holder of the assessment certificate; or (b) who was covered by the certificate. (8) For the purposes of this section, an industrial chemical is persistent, bioaccumulative and toxic if the industrial chemical is: (a) persistent within the meaning of the document (the Australian PBT Criteria) titled Australian Environmental Criteria for Persistent, Bioaccumulative and/or Toxic Chemicals published by the Environment Department and as existing from time to time; and (b) bioaccumulative within the meaning of the Australian PBT Criteria; and (c) toxic within the meaning of the Australian PBT Criteria.

Note: The Australian PBT Criteria could in 2024 be viewed on the Environment Department’s website (http://www/dcceew/gov.au).

28 Indicative human health risk for introduction of an industrial chemical

(1) For the purposes of step 4 of the method statement in section 24, the following table sets out the indicative human health risk for the introduction of an industrial chemical.

<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>Indicative human health risk for an introduction</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:66.38%; 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>If …</span></p></td><td style="width:25.04%; 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>the indicative human health risk for the introduction is …</span></p></td></tr></thead><tbody><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>Medium to high risk</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>1</span></p></td><td style="width:66.38%; 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 industrial chemical is a designated fluorinated chemical</span></p></td><td style="width:25.04%; 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>medium to high risk</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:66.38%; 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 industrial chemical is a polyhalogenated organic chemical (other than an organic chemical that is covered by item</span><span> </span><span>1); and</span></p><p class="Tablea"><span>(b) the industrial chemical, or one or more of its known environmental degradation products, is persistent; and</span></p><p class="Tablea"><span>(c) the total volume of the industrial chemical to be introduced by the person in a registration year is greater than 100 kg</span></p></td><td style="width:25.04%; 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>medium to high risk</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:66.38%; 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 industrial chemical is an industrial chemical that:</span></p><p class="Tablei"><span>(i) is a solid, or is in a dispersion, at the time of introduction; and</span></p><p class="Tablei"><span>(ii) consists of solid particles, in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale; and</span></p><p class="Tablea"><span>(b) the industrial chemical is not soluble (within the meaning given by the Guidelines); and</span></p><p class="Tablea"><span>(c) the introduction of the nanoscale portion of the industrial chemical is not incidental to the introduction of the non</span><span>‑</span><span>nanoscale portion of the industrial chemical</span></p></td><td style="width:25.04%; 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>medium to high risk</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:66.38%; 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 human health exposure band for the introduction is 2 or 3; and</span></p><p class="Tablea"><span>(b) the industrial chemical has one or more of the human health hazard characteristics in human health hazard band C</span></p></td><td style="width:25.04%; 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>medium to high risk</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:66.38%; 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 human health exposure band for the introduction is 4; and</span></p><p class="Tablea"><span>(b) the industrial chemical has one or more of the human health hazard characteristics in human health hazard band B or C</span></p></td><td style="width:25.04%; 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>medium to high risk</span></p></td></tr><tr><td colspan="3" style="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>Low risk</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:66.38%; 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 industrial chemical is internationally</span><span>‑</span><span>assessed for human health; and</span></p><p class="Tablea"><span>(b) the international assessment or evaluation was:</span></p><p class="Tablei"><span>(i) for the same end use for which the industrial chemical is to be introduced in Australia by the person; and</span></p><p class="Tablei"><span>(ii) for a maximum concentration of the industrial chemical at end use that is the same or higher than the maximum concentration of the industrial chemical at the end use for which the industrial chemical is to be introduced in Australia by the person; and</span></p><p class="Tablea"><span>(c) the risks to human health from the introduction and use of the industrial chemical are no higher in Australia than in the overseas jurisdiction, as determined in accordance with the Guidelines; and</span></p><p class="Tablea"><span>(d) 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>(e) either of the following applies:</span></p><p class="Tablei"><span>(i) if 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)—the restrictions (if any) set out in Annex XVII of the REACH Regulation relating to the industrial chemical are able to be complied with in Australia;</span></p><p class="Tablei"><span>(ii) otherwise—the conditions (if any) that the international assessment body determines must be complied with in order to manage any risks to human health from the industrial chemical are able to be complied with in Australia; and</span></p><p class="Tablea"><span>(f) no further information becomes available to the person after the international assessment or evaluation is completed about:</span></p><p class="Tablei"><span>(i) a hazard to human health from the industrial chemical that is not identified in the international assessment or evaluation; or</span></p><p class="Tablei"><span>(ii) a hazard to human health from the industrial chemical that is identified in the international assessment or evaluation and indicates an increase in the severity of the hazard; and</span></p><p class="Tablea"><span>(g) none of table items</span><span> </span><span>1 to 3 or 12 to 14 apply to the introduction; and</span></p><p class="Tablea"><span>(h) introduction of the industrial chemical is not prohibited (however described) in the overseas jurisdiction</span></p></td><td style="width:25.04%; 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>low risk</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:66.38%; 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 industrial chemical is an industrial chemical that:</span></p><p class="Tablei"><span>(i) is a solid, or is in a dispersion, at the time of introduction; and</span></p><p class="Tablei"><span>(ii) consists of solid particles, in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale; and</span></p><p class="Tablea"><span>(b) the industrial chemical is not soluble (within the meaning given by the Guidelines); and</span></p><p class="Tablea"><span>(c) none of table items</span><span> </span><span>1 to 5 apply to the introduction</span></p></td><td style="width:25.04%; 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>low risk</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:66.38%; 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 industrial chemical is a UV filter; and</span></p><p class="Tablea"><span>(b) none of table items</span><span> </span><span>1 to 5 apply to the introduction</span></p></td><td style="width:25.04%; 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>low risk</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:66.38%; 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 human health exposure band for the introduction is 1; and</span></p><p class="Tablea"><span>(b) the industrial chemical has one or more of the human health hazard characteristics in human health hazard band C; and</span></p><p class="Tablea"><span>(c) none of table items</span><span> </span><span>1 to 3 apply to the introduction</span></p></td><td style="width:25.04%; 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>low risk</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:66.38%; 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 human health exposure band for the introduction is 3; and</span></p><p class="Tablea"><span>(b) the industrial chemical does not have any of the human health hazard characteristics in human health hazard band C; and</span></p><p class="Tablea"><span>(c) none of table items</span><span> </span><span>1 to 3 or 14 apply to the introduction</span></p></td><td style="width:25.04%; 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>low risk</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:66.38%; 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 human health exposure band for the introduction is 4; and</span></p><p class="Tablea"><span>(b) the industrial chemical does not have any of the human health hazard characteristics in human health hazard band B or C; and</span></p><p class="Tablea"><span>(c) none of table items</span><span> </span><span>1 to 3 or 14 apply to the introduction</span></p></td><td style="width:25.04%; 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>low risk</span></p></td></tr><tr><td colspan="3" style="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>Very low risk</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:66.38%; 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 human health exposure band for the introduction is 1; and</span></p><p class="Tablea"><span>(b) the industrial chemical does not have any of the human health hazard characteristics in human health hazard band C; and</span></p><p class="Tablea"><span>(c) none of table items</span><span> </span><span>1 to 3, 7 or 8 apply to the introduction</span></p></td><td style="width:25.04%; 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>very low risk</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:66.38%; 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 human health exposure band for the introduction is 2; and</span></p><p class="Tablea"><span>(b) the industrial chemical does not have any of the human health hazard characteristics in human health hazard band C; and</span></p><p class="Tabletext"><span>(c) none of table items</span><span> </span><span>1 to 3, 7 or 8 apply to the introduction</span></p></td><td style="width:25.04%; 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>very low risk</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>14</span></p></td><td style="width:66.38%; 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="Tablea"><span>(a) the human health exposure band for the introduction is 3 or 4; and</span></p><p class="Tablea"><span>(b) the industrial chemical does not have any of the human health hazard characteristics in human health hazard band A, B or C; and</span></p><p class="Tabletext"><span>(c) none of table items</span><span> </span><span>1 to 3, 7 or 8 apply to the introduction</span></p></td><td style="width:25.04%; 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>very low risk</span></p></td></tr></tbody></table>

Note 1: For the definitions of international assessment body, overseas jurisdiction and persistent, see section 5.

Note 2: To work out the human health exposure band for an introduction, or the human health hazard characteristics of an industrial chemical, see Part 1 of Schedule 1.

(2) For the purposes of table item 3, the introduction of the nanoscale portion of the industrial chemical is not incidental to the introduction of the non‑nanoscale portion of the industrial chemical if: (a) the manufacture (whether in Australia or otherwise) of the industrial chemical at the nanoscale is the result of a deliberate manufacturing decision; or (b) the manufacture (whether in Australia or otherwise) of the industrial chemical at the nanoscale is necessary for the manufacture (whether in Australia or otherwise) of the non‑nanoscale portion of the industrial chemical; or (c) the industrial chemical at the nanoscale has specific technical characteristics that are the intended result of changes in the manufacturing process.

29 Indicative environment risk for introduction of an industrial chemical

(1) For the purposes of step 5 of the method statement in section 24, the following table sets out the indicative environment risk for the introduction of an industrial chemical.

<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>Indicative environment risk for an introduction</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:66.38%; 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>If …</span></p></td><td style="width:25.04%; 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>the indicative environment risk for the introduction is …</span></p></td></tr></thead><tbody><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>Medium to high risk</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>1</span></p></td><td style="width:66.38%; 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 industrial chemical is a designated fluorinated chemical</span></p></td><td style="width:25.04%; 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>medium to high risk</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:66.38%; 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 industrial chemical is a polyhalogenated organic chemical (other than an organic chemical that is covered by item</span><span> </span><span>1); and</span></p><p class="Tablea"><span>(b) the industrial chemical, or one or more of its known environmental degradation products, is persistent; and</span></p><p class="Tablea"><span>(c) the total volume of the industrial chemical to be introduced by the person in a registration year is greater than 100 kg</span></p></td><td style="width:25.04%; 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>medium to high risk</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:66.38%; 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 industrial chemical is an industrial chemical that:</span></p><p class="Tablei"><span>(i) is a solid, or is in a dispersion, at the time of introduction; and</span></p><p class="Tablei"><span>(ii) consists of solid particles, in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale; and</span></p><p class="Tablea"><span>(b) the industrial chemical is not soluble (within the meaning given by the Guidelines); and</span></p><p class="Tablea"><span>(c) the introduction of the nanoscale portion of the industrial chemical is not incidental to the introduction of the non</span><span>‑</span><span>nanoscale portion of the industrial chemical</span></p></td><td style="width:25.04%; 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>medium to high risk</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:66.38%; 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 industrial chemical is a gas; and</span></p><p class="Tablea"><span>(b) the industrial chemical is persistent; and</span></p><p class="Tablea"><span>(c) the total volume of the industrial chemical to be introduced by the person in a registration year is greater than 100 kg</span></p></td><td style="width:25.04%; 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>medium to high risk</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:66.38%; 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 industrial chemical is an organotin chemical; and</span></p><p class="Tablea"><span>(b) the total volume of the industrial chemical to be introduced by the person in a registration year is greater than 10 kg</span></p></td><td style="width:25.04%; 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>medium to high risk</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:66.38%; 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 environment exposure band for the introduction is 1 or 2; and</span></p><p class="Tablea"><span>(b) the industrial chemical has one or more of the environment hazard characteristics in environment hazard band D</span></p></td><td style="width:25.04%; 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>medium to high risk</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:66.38%; 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 environment exposure band for the introduction is 3; and</span></p><p class="Tablea"><span>(b) the industrial chemical has one or more of the environment hazard characteristics in environment hazard band C or D</span></p></td><td style="width:25.04%; 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>medium to high risk</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:66.38%; 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 environment exposure band for the introduction is 4; and</span></p><p class="Tablea"><span>(b) the industrial chemical has one or more of the environment hazard characteristics in environment hazard band B, C or D</span></p></td><td style="width:25.04%; 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>medium to high risk</span></p></td></tr><tr><td colspan="3" style="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>Low risk</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:66.38%; 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 industrial chemical is internationally</span><span>‑</span><span>assessed for the environment; and</span></p><p class="Tablea"><span>(b) the international assessment or evaluation was:</span></p><p class="Tablei"><span>(i) for the same end use for which the industrial chemical is to be introduced in Australia by the person; and</span></p><p class="Tablei"><span>(ii) for a volume of the industrial chemical that is the same or higher than the volume of the industrial chemical that is to be introduced in Australia in a registration year by the person; and</span></p><p class="Tablea"><span>(c) the risks to the environment from the introduction and use of the industrial chemical are no higher in Australia than in the overseas jurisdiction, as determined in accordance with the Guidelines; and</span></p><p class="Tablea"><span>(d) 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>(e) either of the following applies:</span></p><p class="Tablei"><span>(i) if 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)—the restrictions (if any) set out in Annex XVII of the REACH Regulation relating to the industrial chemical are able to be complied with in Australia;</span></p><p class="Tablei"><span>(ii) otherwise—the conditions (if any) that the international assessment body determines must be complied with in order to manage any risks to the environment from the industrial chemical are able to be complied with in Australia; and</span></p><p class="Tablea"><span>(f) no further information becomes available to the person after the international assessment or evaluation is completed about:</span></p><p class="Tablei"><span>(i) a hazard to the environment from the industrial chemical that is not identified in the international assessment or evaluation; or</span></p><p class="Tablei"><span>(ii) a hazard to the environment from the industrial chemical that is identified in the international assessment or evaluation and indicates an increase in the severity of the hazard; and</span></p><p class="Tablea"><span>(g) none of table items</span><span> </span><span>1 to 5 or 15 to 17 apply to the introduction; and</span></p><p class="Tablea"><span>(h) introduction of the industrial chemical is not prohibited (however described) in the overseas jurisdiction</span></p></td><td style="width:25.04%; 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>low risk</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:66.38%; 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 industrial chemical is an industrial chemical that:</span></p><p class="Tablei"><span>(i) is a solid, or is in a dispersion, at the time of introduction; and</span></p><p class="Tablei"><span>(ii) consists of solid particles, in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale; and</span></p><p class="Tablea"><span>(b) the industrial chemical is not soluble (within the meaning given by the Guidelines); and</span></p><p class="Tablea"><span>(c) none of table items</span><span> </span><span>1 to 8 apply to the introduction</span></p></td><td style="width:25.04%; 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>low risk</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:66.38%; 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) one of the following applies:</span></p><p class="Tablei"><span>(i) the industrial chemical is an organotin chemical;</span></p><p class="Tablei"><span>(ii) the industrial chemical is a polyhalogenated organic chemical;</span></p><p class="Tablei"><span>(iii) the introduction of the industrial chemical is for an end use as a biocidal active; and</span></p><p class="Tablea"><span>(b) none of table items</span><span> </span><span>1 to 8 apply to the introduction</span></p></td><td style="width:25.04%; 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>low risk</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:66.38%; 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 environment exposure band for the introduction is 1 or 2; and</span></p><p class="Tablea"><span>(b) the industrial chemical does not have any of the environment hazard characteristics in environment hazard band D; and</span></p><p class="Tablea"><span>(c) none of table items</span><span> </span><span>1 to 5, 15 or 16 apply to the introduction</span></p></td><td style="width:25.04%; 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>low risk</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:66.38%; 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 environment exposure band for the introduction is 3; and</span></p><p class="Tablea"><span>(b) the industrial chemical does not have any of the environment hazard characteristics in environment hazard band C or D; and</span></p><p class="Tablea"><span>(c) none of table items</span><span> </span><span>1 to 5 or 17 apply to the introduction</span></p></td><td style="width:25.04%; 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>low risk</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:66.38%; 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 environment exposure band for the introduction is 4; and</span></p><p class="Tablea"><span>(b) the industrial chemical does not have any of the environment hazard characteristics in environment hazard band B, C or D; and</span></p><p class="Tablea"><span>(c) none of table items</span><span> </span><span>1 to 5 or 17 apply to the introduction</span></p></td><td style="width:25.04%; 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>low risk</span></p></td></tr><tr><td colspan="3" style="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>Very low risk</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:66.38%; 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 environment exposure band for the introduction is 1; and</span></p><p class="Tablea"><span>(b) the industrial chemical does not have any of the environment hazard characteristics in environment hazard band C or D; and</span></p><p class="Tablea"><span>(c) none of table items</span><span> </span><span>1 to 5, 10 or 11 apply to the introduction</span></p></td><td style="width:25.04%; 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>very low risk</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:66.38%; 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 environment exposure band for the introduction is 2; and</span></p><p class="Tablea"><span>(b) the industrial chemical does not have any of the environment hazard characteristics in environment hazard band B, C or D; and</span></p><p class="Tabletext"><span>(c) none of table items</span><span> </span><span>1 to 5, 10 or 11 apply to the introduction</span></p></td><td style="width:25.04%; 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>very low risk</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>17</span></p></td><td style="width:66.38%; 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="Tablea"><span>(a) the environment exposure band for the introduction is 3 or 4; and</span></p><p class="Tablea"><span>(b) the industrial chemical does not have any of the environment hazard characteristics in environment hazard band A, B, C or D; and</span></p><p class="Tabletext"><span>(c) none of table items</span><span> </span><span>1 to 5, 10 or 11 apply to the introduction</span></p></td><td style="width:25.04%; 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>very low risk</span></p></td></tr></tbody></table>

Note 1: For the definitions of international assessment body, known environmental degradation products, overseas jurisdiction and persistent, see section 5.

Note 2: To work out the environment exposure band for an introduction, or the environment hazard characteristics of an industrial chemical, see Part 2 of Schedule 1.

(2) For the purposes of table item 3, the introduction of the nanoscale portion of the industrial chemical is not incidental to the introduction of the non‑nanoscale portion of the industrial chemical if: (a) the manufacture of the industrial chemical (in Australia or overseas) at the nanoscale is the result of a deliberate manufacturing decision; or (b) the industrial chemical at the nanoscale is necessary for the manufacture of the non‑nanoscale portion of the industrial chemical; or (c) the industrial chemical at the nanoscale has specific technical characteristics that are the intended result of changes in the manufacturing process.

30 Information required to demonstrate categorisation

(1) This section applies in relation to the introduction of an industrial chemical by a person during a registration year if: (a) the introduction is not authorised by section 25, 28, 29 or 30 of the Act; and (b) the introduction is not covered by section 25 of this instrument. (2) For the purposes of paragraph 102(1)(b) of the Act, the person must, in determining the category of the introduction, have regard to the following: (a) such introduction and use information as is necessary to determine whether the introduction is to be covered by section 26 or 27 of this instrument; (b) if the introduction is to be covered by subsection 27(4) of this instrument—the information detailed in the Guidelines to demonstrate the absence of the hazard characteristics; (c) if the introduction is not to be covered by section 26 or 27 of this instrument: (i) such introduction and use information as is necessary to determine the highest indicative risk for the introduction; and (ii) such information as is necessary to determine whether the introduction is covered by any of items 1 to 3 of the table in subsection 28(1), or any of items 1 to 5 of the table in subsection 29(1), of this instrument; and (iii) such information as is known to the person that demonstrates that the industrial chemical has hazard characteristics that are relevant for determining the highest indicative risk for the introduction; and (iv) if the highest indicative risk for the introduction is determined, in whole or in part, on the basis of the absence of certain hazard characteristics—the information detailed in the Guidelines to demonstrate the absence of the hazard characteristics.

Note: See section 31 for requirements regarding information that cannot be used to demonstrate categorisation.

31 Restriction on using animal test data for determining category of introduction for industrial chemicals with multiple end uses including an end use in cosmetics

(1) This section applies if: (a) an industrial chemical is to be introduced for multiple end uses; and (b) one of those end uses is in cosmetics. (2) For the purposes of paragraph 102(1)(b) of the Act, a person who introduces the industrial chemical during a registration year must not, in determining the category of the introduction, have regard to animal test data obtained from tests conducted on or after 1 July 2020, other than: (a) animal test data that: (i) demonstrates that the industrial chemical has a hazard characteristic; and (ii) if the person did not have regard to that data, the category of introduction would be a lower risk category; or (b) animal test data that is the only information that can demonstrate whether the industrial chemical has a particular environment hazard characteristic; or (c) animal test data that is derived from tests conducted on animals involving a chemical that: (i) is not the industrial chemical; and (ii) is not an industrial chemical introduced by the person for an end use in cosmetics; or (d) animal test data that the person is approved to have regard to under section 33 of this instrument.

Note 1: For paragraph (a), the category of introduction would be a lower risk category if, for example, the category of introduction would be exempted if the data were not had regard to but reported if the data were had regard to.

Note 2: For how to apply for Executive Director approval to have regard to animal test data in determining the category of introduction, see section 32.

32 Applying for approval to use animal test data for determining category of introduction for industrial chemicals with multiple end uses including an end use in cosmetics

(1) For the purposes of paragraph 102(3)(b) of the Act, a person may apply, in writing, to the Executive Director for approval to have regard to animal test data in determining the category of introduction.

Note: For general requirements relating to applications, see section 167 of the Act.

Further information (2) The Executive Director may, by written notice given to an applicant, request further information to be provided for the purposes of considering the application. (3) The requested information must be provided within the period specified in the notice, which must not be less than 10 working days after the day the notice is given. (4) If the requested information is not provided within the period mentioned in subsection (3), the Executive Director may take the application to be withdrawn.

33 Decision on application

(1) The Executive Director must: (a) consider the application under section 32 in accordance with this section; and (b) make a decision on the application within 10 working days after the day the application is made. (2) In considering the application, the Executive Director must have regard to the following: (a) if the animal test data is for the purpose of identifying a human health hazard characteristic of the industrial chemical—whether the non‑cosmetic end use of the industrial chemical involves, or potentially involves, exposure of humans to the industrial chemical; (b) if the animal test data is for the purpose of identifying an environment hazard characteristic of the industrial chemical—whether the non‑cosmetic end use of the industrial chemical involves, or potentially involves, exposure of the environment to the industrial chemical; (c) any further information provided by the applicant under subsection 32(3); (d) any other information the Executive Director considers relevant. (3) After considering the application, the Executive Director must decide to: (a) approve the person having regard to the animal test data in determining the category of introduction; or (b) not approve the person having regard to the animal test data in determining the category of introduction. (4) The Executive Director must give the applicant written notice of: (a) the decision; and (b) if the decision is to refuse the application—the reasons for the decision. (5) If the Executive Director has requested further information under subsection 32(2), the 10 working day period mentioned in paragraph (1)(b) of this section excludes the number of days falling within the period: (a) beginning on the day on which the notice is given under subsection 32(2); and (b) ending on the earlier of: (i) the day a complete response to the notice is provided to the Executive Director in accordance with subsection 32(3); or (ii) the last day of the period specified in the notice.