54Introductions of industrial chemicals that are internationally‑assessed for the environment but not internationally‑assessed for human health

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

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

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

Proper name for industrial chemical known to person (2) If the proper name for the industrial chemical is known to the person, for the purposes of paragraph 104(2)(b) of the Act, the following kinds of record are prescribed: (a) if a CAS number for the industrial chemical is assigned: (i) the CAS number for the industrial chemical; and (ii) the CAS name, IUPAC name or INCI name for the industrial chemical; (b) if a CAS number for the industrial chemical is not assigned—the proper name for the industrial chemical (including the CAS name, the IUPAC name or an eligible INCI plant extract name); (c) the names of any products containing the industrial chemical that are imported into Australia by the person; (d) records to demonstrate that the introduction is not covered by any of the provisions of section 25, items 1 to 3 of the table in subsection 28(1), or items 1 to 5 of the table in subsection 29(1) of this instrument; (e) if the industrial chemical is a high molecular weight polymer and the human health exposure band for the introduction is 4—records to demonstrate the polymer molecular weight details of the industrial chemical; (f) records to demonstrate that the total volume of the industrial chemical introduced by the person in a registration year: (i) does not exceed the volume specified in the pre‑introduction report for the industrial chemical as the maximum volume of the industrial chemical the person intends to introduce in a registration year; and (ii) does not exceed the volume of the industrial chemical assessed in the international assessment or evaluation; (g) if item 1A, 2 or 4 of the table in subclause 1(1) of Schedule 1 to this instrument applies to the introduction: (i) the human health categorisation volume for the industrial chemical; and (ii) records to demonstrate that that volume does not exceed the human health categorisation volume specified in item 1A, 2 or 4 of the table (as the case requires); (h) records to demonstrate any known hazard classification for the industrial chemical; (i) if: (i) the indicative human health risk for the introduction is determined on the basis of the absence of certain hazard characteristics; and (ii) the person has detailed information, including full study reports, of the kind specified in the Guidelines to demonstrate the absence of the hazard characteristics; that detailed information; (j) if: (i) the indicative human health risk for the introduction is determined on the basis of the absence of certain hazard characteristics; and (ii) the person (the introducer) does not have detailed information, including full study reports, of the kind specified in the Guidelines to demonstrate the absence of the hazard characteristics; the following: (iii) the outcomes of the information specified in the Guidelines to demonstrate the absence of the hazard characteristics; (iv) the name of a person whom the introducer believes on reasonable grounds would, if requested to do so by the introducer following a request by the Executive Director, give to the Executive Director detailed information, including full study reports, of the kind specified in the Guidelines to demonstrate the absence of the hazard characteristics; (v) records of the basis on which the introducer holds the belief, mentioned in subparagraph (iv), that the person mentioned in that subparagraph has detailed information, including full study reports, of the kind specified in the Guidelines to demonstrate the absence of the hazard characteristics; (vi) records of the basis on which the introducer holds the belief, mentioned in subparagraph (iv), that the person mentioned in that subparagraph would, if requested to do so by the introducer following a request by the Executive Director, give that detailed information to the Executive Director; (k) if the international assessment or evaluation applied any restrictions or conditions on the introduction or use of the industrial chemical in the overseas jurisdiction—records to demonstrate that those restrictions or conditions are being met by the person in Australia; (l) records to demonstrate how it was determined that the risks to the environment from the introduction and use of the industrial chemical are no higher in Australia than in the overseas jurisdiction; (m) if the introduction is a specified class of introduction of a kind mentioned in column 1 of an item in the table in subsection (4)—records of the kind mentioned in column 2 of the item. Proper name for industrial chemical not known to person (3) If the proper name for the industrial chemical is not known to the person, for the purposes of paragraph 104(2)(b) of the Act, the following kinds of record are prescribed: (a) the names by which the industrial chemical is known to the person (which must include the name included in the pre‑introduction report for the industrial chemical); (b) the names of any products containing the industrial chemical that are imported into Australia by the person; (c) the following: (i) the name of another person whom the person (the introducer) referred to in subsection (1) believes on reasonable grounds would, if requested to do so by the introducer following a request by the Executive Director, give to the Executive Director records to demonstrate that the introduction is not covered by any of the provisions of section 25, items 1 to 3 of the table in subsection 28(1), or items 1 to 5 of the table in subsection 29(1) of this instrument; (ii) records of the basis on which the introducer believes that the introduction is not covered by any of the provisions mentioned in subparagraph (i); (iii) records of the basis on which the introducer holds the belief mentioned in subparagraph (i); (d) if the industrial chemical is a high molecular weight polymer and the human health exposure band for the introduction is 4—records to demonstrate the polymer molecular weight details of the industrial chemical, or all of the following: (i) the name of another person whom the person (the introducer) referred to in subsection (1) believes on reasonable grounds would, if requested to do so by the introducer following a request by the Executive Director, give to the Executive Director records to demonstrate the polymer molecular weight details of the industrial chemical; (ii) records of the basis on which the introducer believes that the industrial chemical is a high molecular weight polymer; (iii) records of the basis on which the introducer holds the belief mentioned in subparagraph (i); (e) records to demonstrate that the total volume of the industrial chemical introduced by the person in a registration year: (i) does not exceed the volume specified in the pre‑introduction report for the industrial chemical as the maximum volume of the industrial chemical the person intends to introduce in a registration year; and (ii) does not exceed the volume of the industrial chemical assessed in the international assessment or evaluation; (f) if item 1A, 2 or 4 of the table in subclause 1(1) of Schedule 1 to this instrument applies to the introduction: (i) the human health categorisation volume for the industrial chemical; and (ii) records to demonstrate that that volume does not exceed the human health categorisation volume specified in item 1A, 2 or 4 of the table (as the case requires); (g) records to demonstrate any known hazard classification for the industrial chemical; (h) if: (i) the indicative human health risk for the introduction is determined on the basis of the absence of certain hazard characteristics; and (ii) the person has detailed information, including full study reports, of the kind specified in the Guidelines to demonstrate the absence of the hazard characteristics; that detailed information; (i) if: (i) the indicative human health risk for the introduction is determined on the basis of the absence of certain hazard characteristics; and (ii) the person (the introducer) does not have detailed information, including full study reports, of the kind specified in the Guidelines to demonstrate the absence of the hazard characteristics; the following: (iii) the outcomes of the information specified in the Guidelines to demonstrate the absence of the hazard characteristics; (iv) the name of a person whom the introducer believes on reasonable grounds would, if requested to do so by the introducer following a request by the Executive Director, give to the Executive Director detailed information, including full study reports, of the kind specified in the Guidelines to demonstrate the absence of the hazard characteristics; (v) records of the basis on which the introducer holds the belief, mentioned in subparagraph (iv), that the person mentioned in that subparagraph has detailed information, including full study reports, of the kind specified in the Guidelines to demonstrate the absence of the hazard characteristics; (vi) records of the basis on which the introducer holds the belief, mentioned in subparagraph (iv), that the person mentioned in that subparagraph would, if requested to do so by the introducer following a request by the Executive Director, give that detailed information to the Executive Director; (j) if the international assessment or evaluation applied any restrictions or conditions on the introduction or use of the industrial chemical in the overseas jurisdiction—records to demonstrate that those restrictions or conditions are being met by the person in Australia; (k) records to demonstrate how it was determined that the risks to the environment from the introduction and use of the industrial chemical are no higher in Australia than in the overseas jurisdiction; (l) if the introduction is a specified class of introduction of a kind mentioned in column 1 of an item in the table in subsection (4)—records of the kind mentioned in column 2 of the item. (4) For the purposes of paragraphs (2)(m) and (3)(l) and subject to subsection (5), the following table has effect.