1. NICNAS Reforms Consultation Paper 2

2. Overview of NICNAS Reforms Summary of consultation process and outcomes New approaches in Consultation Paper 2 Workshop overview

3. Regulation proportionate to risk Regulatory treatment of new chemicals - using the risk matrix Exempted chemicals Reported chemicals - particularly the international pathway Assessed chemicals NICNAS initiated assessments (NIA) Australian Inventory of Chemical Substances (AICS) Information to be published and Confidential Commercial Information (CCI) The risk matrices - exposure and hazard bands. Nine key areas of focus

4. Assessment effort is more proportionate to risk Maintain health, safety and environmental protection standards Greater use of international assessment materials Reduce regulatory burden saving $23 million annually Information and communications technology (ICT) Guidance materials, application forms, standard operating procedures, and other supporting materials NICNAS legislation (ICNA Act) and associated regulations Changes requiredObjectives NICNAS Reforms

5. Consultation (CP1) SCC feedback Government agencies feedback Workshop -104 attendees 37 submissions Consultation Paper 1 (CP1) Consideration of feedback Submissions published Refinement of proposals Consultation Paper 2 (CP2) Aim Provide ‘Principles-based’ legislation Details will be in Regulations and Standards/Guidance Multiple opportunities for input, feedback and consultation Consultation process

6. Principle of the reforms: risk-based proportionate regulation Assumes familiarity with proposals in CP1 Presents: - original proposal - stakeholder feedback - how NICNAS is responding to that feedback Issues raised in CPs are proposals until Government agreement is received This workshop

7. Change to Q&A format to help - clear up misconceptions - address concerns more directly using simpler language Amendments to some initial proposals based on stakeholder feedback Beds down some CP1 proposals and introduces some new elements Consultation includes community focussed workshops and technical workshops (risk matrices and CCI) New approach to CP2

8. Ensuring balance for industry, community and environment Regulation proportionate to risk

9. Proposed changes A lighter regulatory touch using Hazard and Exposure bands to categorise low risk new chemicals, allows a faster time to market Using release volume (instead of introduction volume) allows compensation for reduced environmental exposure Specific changes to non-hazardous chemicals at <1% concentration New information system enables streamlining, tracking and ease of processing and notifying Improving status quo

10. Proposed changes Focus on higher risk chemicals Review chemicals already in use Medium to high risk new chemicals will continue to have pre-market assessment before introduction Greater acceptance of analogues and non-animal test methods Encourages introduction of newer and safer chemicals to consumers Increase transparency for workers and other stakeholders by linking NICNAS Assessment Statements to AICS Improving status quo

11. Regulatory treatment of new chemicals using the risk matrices

12. Categorisation of new chemicals Health Concerns Terminology confusing Complexity of matrix technical capacity of industry to apply matrix Data requirements onerous Support Proportionate and risk based categorisation using a matrix approach Initial proposal (5 x 4 matrix)

13. Health Concerns Terminology confusing Complexity of matrix Technical capacity of industry to apply matrix Data requirements onerous Support Proportionate and risk based categorisation using a matrix approach Initial proposal (5 x 4 matrix) Used in CP1Proposed new term Class 2 notificationPre-market advice Data requirementsInformation requirements Summary reportAssessment Statement Reported Assessed Exempted Categorisation of new chemicals

14. Concerns Terminology confusing Complexity of matrix technical capacity of industry to apply matrix Data requirements onerous Support Proportionate and risk based categorisation using a matrix approach Reported Assessed Exempted Assessed Proposed change Simplify and refine hazard and exposure bands Proposal: 4x4 matrix Health Categorisation of new chemicals

15. Concerns Terminology confusing Complexity of matrix Technical capacity of industry to apply matrix Data requirements onerous Proposed change Advisory service Online chemical categorisation tool Support Proportionate and risk based categorisation using a matrix approach Help for industry

16. Concerns Terminology confusing Complexity of matrix Technical capacity of industry to apply matrix Data requirements onerous Support Proportionate and risk based categorisation using a matrix approach Proposed change Greater acceptance of analogues and non-animal test methods Expansion of chemicals that do not require pre-market assessment (fewer chemicals require information on all hazard endpoints) Waivers for reducing toxicological testing (e.g. animal testing) Change to data requirements

17. Please bring your questions about the categorisation of new chemicals to the Risk Matrices workshop. We will work through examples. 1:00 – 2:00 pm Have your say!

18. Exempted chemicals

19. Concerns What records will need to be kept? How will NICNAS audit if NICNAS has not been provided with a list of exempted chemicals? Support Proposed approach to Exempted chemicals Proposed approach Maintain record of all chemicals introduced under this category and record that chemical meets Exempted requirements Capacity to produce records within 28 days if requested NICNAS will undertake risk-based auditing of registrants. Exempted chemicals

20. Reported chemicals

21. Concerns International pathways Use of international assessment materials Application of Health portfolio regulator criteria Differing understanding of international approaches

22. Concerns Differences between stakeholder groups No agreement on acceptable sources for Reported chemicals international pathway Same chemical with different regulatory outcomes Suggestion to accept wider range of organisations e.g. OECD, IFRA, CIR and Chinese Ministry of Environmental Protection. Stakeholder views on use of international assessments

23. Reflect Australian Government requirements Industry Innovation and Competitiveness agenda Health portfolio regulator criteria for adoption of international standards and risk assessment. Criteria A risk assessment, with a corresponding regulatory decision Comparable regulator – quality, robustness and transparent regulatory processes Compatibility with Australian policy and legislative framework Comparable scope – human health, environment and worker safety Using international materials

24. Criteria Consider differences Environmental factors and infrastructure (e.g. climate, disposal methods) Risk management - compatibility with Australian RM frameworks Community expectations (stakeholder confidence in regulatory system). Using international materials

25. Proposed approach Reflect Australian Government requirements Clarify proposed approach (e.g. US EPA, IFRA and CIR reports) Reiterate opportunities for industry and NICNAS to use international assessment materials Confirm current practice using international material in NICNAS assessments. Using international materials

26. Reported new chemicals Assessed new Chemicals NICNAS initiated assessments Industry self categorisation and international pathway Industry self categorisation Input to NICNAS risk assessment International data, regulations and alerts used to prioritise chemicals for assessment Input to NICNAS assessment Exempted new chemicals Industry self categorisation Building a framework for managing diversity of approaches

27. Do you have any further questions about the use of international material? Have your say!

28. Assessed chemicals

29. Proposed change in CP2 Deferring the final decision Confirm the period will be > 6 months Concerns Period too short or decision cannot be made this early Proposal in CP1 6 month transition period Proposed change in CP2 Reduced to 90 calendar days Concerns Period too long Period too short Proposal in CP1 Timeframe 120 days Proposed changes to assessment timeframe and transition period

30. Concerns Confusion regarding ‘summary of assessment’ – now Assessment Statement Assessment Statement includes all information relevant to outcome and any recommended risk mitigation measures is given to applicant and risk managers is published Assessment statement

31. NICNAS initiated assessments (NIA)

32. Current NICNAS may initiate an assessment of an existing chemical - Administrative = IMAP - Legislative = PEC and secondary notification Proposal NIA on any chemical - existing or new chemical (Exempted, Reported, Assessed) Replace PECs, IMAP and secondary notifications Tailored size and extent of the assessment Proposed NIA process

33. Concerns Flow diagram too complicated Will IMAP lessons be incorporated? Mandatory calls for information – checks and balances Removal of chemicals from AICS – checks and balances CP1 proposed NIA process

34. NIA Proposed in CP2

36. Proposal Simplified flow chart shows NIA: may be used for any chemical under a variety of circumstances dominant pathway – referral to risk managers can be used to: - broaden or narrow scope of assessment - broaden or narrow conditions of use - remove from AICS e.g. unmanageable risk or non-industrial chemical Key lessons learnt from IMAP review will be incorporated Clear justifications for mandatory calls for information Consultation with risk managers and public before removal from AICS NIA proposal in CP2

37. Australian Inventory of Chemical Substances (AICS)

38. Proposed changes to the AICS Current public AICSProposed public AICS CAS number Chemical name Molecular formula Associated names (if any) Condition of useConditions of use (volume, site, duration) Statement if NICNAS assessedLink to published assessment statement Statement if secondary notifications conditions apply Defined assessment scope Additional information (ie AHVIC, PFOS, SIDS, Ozone depleting, PEC) Link to published assessment statement Concerns: Will AICS continue? What information will be on AICS?

39. Linking assessment statements to AICS Proposal Consistent with government policy and designed for: - transparency - usefulness of assessment information - aligning internationally where possible Assessment statement contains less information than current reports (chemical identifiers, use, defined assessment scope, summary of risks and risk management measures and other relevant information) Industry can request protection for confidential material – current public interest test proposed to be maintained.

40. Current limitations of AICS Proposal in CP2: Expand the circumstances in which Director may make changes to AICS: application to have CAS descriptor added to existing AICS entry, or scientific reasons, the chemical is considered the same, or new information, or removing a chemical from AICS. Concerns Frustration with inability to amend AICS to reflect additional (legitimate) CAS numbers and names Identified by NICNAS as a legislative impediment Current Very limited ability to add, remove or vary chemicals not added in error

41. Tell us: if the proposed mechanism addresses multiple CAS numbers assigned to the same chemical the circumstances that may give rise to the need to amend an AICS entry the checks and balances that should be associated with the ability of the Director of NICNAS to amend the AICS Have your say!

42. Treatment of confidential commercial information (CCI)

43. Changes to publication requirements Current publication requirementsProposed publication requirements Exempt Chemicals Summary published annually Exempted No requirements Permits List of permits published annually Notice of permits issued published monthly Reported No requirements Assessment certificates Assessment report published excluding exempt information Assessed Assessment Statement published (including Exempted or Reported chemicals if assessed by NICNAS) NICNAS Assessment (PEC, IMAP, secondary notification) Assessment report published excluding exempt information NIA Assessment Statement published

44. Information to be made public Proposal: To balance the protection of CCI with transparency, NICNAS will make information public including: assessment statements entries on AICS (linked to Assessment Statement) to bona fide enquirers legislation to authorise NICNAS to release information to government risk management agencies.

45. Masked names or confidential AICS Concerns from CP1: Mixed support, for and against, masked names or removal of confidential AICS As a result: NICNAS consulted international regulators about their approaches (Canada and ECHA) Have your say Tell us: practical, reasonable solutions that address the deficiencies in the current system while maintaining appropriate protections for confidential commercial information at the CCI workshop at 2:00 – 3:00pm

46. Proposed new chemicals risk matrices

47. Current system Complex - multiple exemption, permit and certificate categories Level of assessment is largely based on the introduction volume Little consideration of the hazard  not risk based and proportionate

48. Risk matrices

49. Human HealthEnvironment Visual guide to help you understand hazard and exposure under the proposed framework.

50. Why use risk matrices? Human Health proposed framework replaces the need for large number of assessment categories accommodates risk in applying regulation stratification shows how NICNAS assessment will focus on higher risk chemicals Increasing hazard Increasing Exposure

51. Why two risk matrices? simplifies representation of human health and environment exposure and hazard criteria closer correlation to actual exposure to humans and the environment, e.g. release volume rather than introduction volume for environment

52. Revised human health risk matrix hazard and exposure bands rationalised and simplified stratification of certain hazard endpoints removed where there was no significant change in risk outcome matrix now makes it clear that a chemical known to be a CMR or EDC would require pre-market assessment CP1 matrix Revised matrix CP2

53. Revised environment risk matrix stratification not changed as already targeted to introductions that may present an unacceptable risk (e.g. Risk Quotient >1) new exposure band added for very low release volumes - regulatory effort matches environmental risk CP1 matrix Revised matrix CP2

54. Key changes since Consultation Paper 1 greater emphasis on alignment with GHS classification for each hazard endpoint — human health closer international alignment of volume thresholds for Exposure Bands 3 and 4 — human health improved definition of ‘direct release to the environment’ — environment exposure categories for consumer use simplified — human health no hazard characterisation for Exposure Band 1 such as transshipment and R&D chemicals — human health and environment Scenario added into Exposure Band 2 for ‘Contained import/export’ — human health

55. Human health risk matrix DAssessed CReported BExempted A 1 R&D ≤100 kg; or Transshipment. 2 ≤1,000 kg non-cosmetic use ; or ≤100 kg cosmetic use; or ≤1 % as introduced; or R&D >100 kg; or Contained import/ export 3 >1,000 and ≤10,000 kg non-cosmetic use; or >100 and ≤1,000 kg cosmetic use 4 >10,000 kg non- cosmetic use; or >1,000 kg cosmetic use All volumes are introduction volumes per annum

56. Environment risk matrix E DAssessed CReported BExempted A 1 R&D ≤ 100 kg with: -‘no direct release’ - treatment prior to release ; or Transshipment. 2 ≤100 kg and ‘no direct release’ 3 >100 and ≤1,000 kg and ‘no direct release’ 4 > 1000 kg and ≤ 10,000 kg and ‘no direct release’ ; or unlimited volume only if irreversibly bound within an inert matrix 5 Does not meet the criteria for environmental exposure bands 1, 2, 3 or 4 All volumes are release volumes per annum

57. Summary of hazard criteria Hazard band Indicative criteria for hazard band Human healthEnvironment E N/A  PBT or  chemicals of concern to the environment D  Carcinogens or  Mutagens or  Reproductive/developmental toxicants or  Nanomaterials or  Endocrine disrupting chemicals  Very toxic to any aquatic life (acute or chronic) OR  PB or  vPvB or  vPB or  PvB C  Acute toxicity – fatal or toxic by any route or  STOT-RE or  STOT-SE or  Sensitisation (respiratory or skin) or  Corrosive or  Damaging to eyes  Toxic to any aquatic life (acute or chronic) B  Acute toxicity – harmful by any route or  STOT-SE or  Aspiration hazard or  Irritant (skin or eye) or  Physical hazards  Harmful to any aquatic life (acute or chronic) OR  Not harmful to any aquatic life but not readily biodegradable or are potentially bioaccumulative A Do not meet criteria for HBs B-D  Do not meet criteria for HBs B-E and  Readily biodegradable (unless stable polymer) and  Not bioaccumulative and  Not harmful to any aquatic life

58. Fewer Pre-Market Assessments (PMA) Under the revised reforms pre-market assessments are expected to reduce by more than 70%. Permits & Certificates Assessed category Chemicals that will no longer require PMA include: polymers of low concern (PLCs) chemicals characterised as non-hazardous chemicals with low introduction volume (≤100kg) and low release volume (≤1 tonne) that do not fall in highest hazard bands — not CMRs, PBTs, EDCs or nano

59. aligning as far as possible with EU-REACH and Canadian CEPA requirements vary according to the exposure band a higher exposure band requires -higher quality data e.g. type/quality/validation of an experimental test study -more stringent criteria for analogue acceptability e.g. degree of similarity of the analogue to the target chemical waivers and exclusions may apply, similar to current framework full hazard characterisation needed to confirm not hazardous e.g. to categorise as Exempted Proposed information requirements for human health

60. Proposed information requirements for human health Exposure Band 1 NO human health hazard information required. Human Health

61. If yes  Assessed chemicalIf no  Reported chemical Minimum information required: find out if the chemical is a known carcinogen, mutagen (or genotoxin), reproductive toxin (reprotoxin), endocrine disruptor (EDC) or nanomaterial by -comparison with specified authoritative lists and definitions -consideration of already available data and GHS classifications. Human Health Proposed information requirements for human health Exposure Band 2

62. Human Health If yes  Assessed chemicalIf no  Reported chemical Human Health Requirements are consistent with current treatment under low volume and low concentration exemption categories. Currently if the chemical is a known CMR or nano, the exemption categories do not apply and pre-market assessment by NICNAS is required.

63. To be categorised as Exempted (and not hazardous): mutagenicity acute toxicity (oral or other relevant route) skin corrosion/irritation eye damage/irritation sensitisation toxicity after repeated exposure e.g. specific target organ toxicity - STOT whether the chemical is a known respiratory irritant or aspiration hazard physical hazards e.g. flammability information Human Health Proposed information requirements for human health Exposure Band 2

64. Minimum information required: is the chemical a known carcinogen, reprotoxin, endocrine disrupter or nanomaterial mutagenicity (at least one in vitro study) acute toxicity (oral or other relevant route) skin corrosion eye damage sensitisation. If criteria met  Assessed chemical If criteria not met  Reported chemical Human Health Proposed information requirements for human health Exposure Band 3

65. To be categorised as Exempted (and not hazardous): toxicity after repeated exposure (STOT) skin irritation eye irritation genotoxicity, for example, chromosome aberration information whether the chemical is a known respiratory irritant or aspiration hazard physical hazards e.g. flammability information Human Health Proposed information requirements for human health Exposure Band 3

66. find out if the chemical is a known carcinogen, reprotoxin, endocrine disrupter or nanomaterial mutagenicity/genotoxicity (at least two in vitro studies) acute toxicity (oral or other relevant route) skin corrosion/irritation eye damage/irritation sensitisation toxicity after repeated exposure (STOT) whether the chemical is a known respiratory irritant or aspiration hazard physical hazards e.g. flammability information Human Health Proposed information requirements for human health Exposure Band 4

67. These vary according to the exposure band and category: lower exposure bands have less information requirements measured data on the introduced chemical may only be needed if the chemical is categorised as Assessed based on other information (e.g. modelled data). Proposed information requirements for environment

68. NO environmental hazard information required. Environment Proposed information requirements for environment Exposure Band 1

69. Minimum - determination of whether or not the chemical is: known to be of concern to the environment e.g. a nanomaterial, an endocrine disrupting chemical, an ozone depleting chemical, a chemical containing a high concern inorganic element, or a perfluorinated or polyfluorinated chemical bioaccumulative, or ecotoxic to aquatic vertebrates, aquatic invertebrates, and aquatic plants. Persistence data is also required if the chemical is potentially bioaccumulative or very toxic, or to characterise as not hazardous. Proposed information requirements for environment categorisation

70. A range of information will be used: specified authoritative lists and definitions data already available for the chemical GHS classifications validated by international regulators structural considerations and associated simple rules data for a close analogue chemical modelled data e.g. ECOSAR. For Exposure Band 2 (release volumes ≤ 100kg) modelling will not be required, even if no information from other sources is available. => If a known PBT the chemical will be Assessed, otherwise it will default to Reported Environment

71. When categorised as Assessed, measured data will be required for the chemical (or a close analogue): persistence e.g. ready biodegradation data bioaccumulation e.g. Log Kow or BCF, BAF, or BMF ecotoxicity e.g. aquatic vertebrates, invertebrates and plants. This reduces uncertainty and ensures that risk management recommendations are reasonable and do not contribute unnecessarily to regulatory burden. Proposed information requirements for environment if Assessed

72. Categorisation step-by-step 1. Determine your human health exposure band (EB) 3. Determine your human health hazard band (HB) 4. Determine your human health categorisation (Exempted, Reported or Assessed) using online tool results for EB and HB Human Health 2. Collect the human health information requirements for the EB

73. Categorisation step-by-step 5. Determine your environment exposure band (EB). 7. Determine your environment hazard band (HB). 8. Determine your environment categorisation (Exempted, Reported or Assessed) using online tool results for EB and HB. 6. Collect the environment information requirements for the EB. Environment

74. Categorisation step-by-step 9. Compare human health to environment categorisation. The higher of the two is your chemical’s category

75. Treatment of polymers

76. Assessed all polymers in Exposure Band 1 will be Exempted majority of polymers of low concern (PLCs) will be Exempted closer alignment of PLC criteria with USA and Canada majority of polymers with NAMW > 1,000 Da -hazard data not necessary -largely based on structural considerations -any existing information considered polymer categorisation: -use decision tree for human health -use risk matrix for environment

77. Polymers - Human health PLCs PLCs will be Exempted except polymers with lung overloading potential intended for use in aerosol cosmetics - to be Reported or Assessed Non-PLCs category depends on exposure band and level of concern associated with polymer majority will be Exempted or Reported small proportion will be Assessed no hazard data necessary except where there is a functional group in the polymer with concern for mutagenicity

78. Polymers - environment Categories for polymers with NAMW > 1,000 Da and no hazardous degradation products or toxic counter-ions. Chemical categorisation tool Cationic and amphoteric polymers: not bioaccumulative persistence in the environment is considered acceptable information on ecotoxicity required to determine hazard band: -structural considerations -defined structural activity relationships (SARs) → Exempted, Reported or Assessed Non-ionic and anionic polymers not bioaccumulative not ecotoxic if FGEW > 5,000 persistence in the environment is considered acceptable → Exempted

79. Case studies

80. Example chemicalCurrent schemeProposed new scheme Human healthEnvironment reprotoxic chemical for use in inks 10 tonnes per annum introduced at ˃ 1% concentration 5 tonne release volume not readily biodegradable harmful to algae Standard (STD) assessment category AssessedReported Case studies – Assessed

81. Example chemicalCurrent schemeProposed new scheme Human healthEnvironment reprotoxic chemical for use in inks 10 tonnes per annum introduced at ˃ 1% concentration 5 tonne release volume not readily biodegradable harmful to algae Standard (STD) assessment category AssessedReported ecotoxic chemical (toxic to fish) for use in detergents 15 tonnes per annum introduced as a raw material 15 tonne release volume skin irritant STD assessment category ReportedAssessed

82. Case studies – Reported Example chemicalCurrent schemeProposed new scheme Human healthEnvironment corrosive chemical for use in industrial sealants 100 tonnes per annum introduced at 0.5% concentration 5 tonne release volume toxic to aquatic invertebrates STD assessment category Reported for both

83. Case studies – Reported Example chemicalCurrent schemeProposed new scheme Human healthEnvironment corrosive chemical for use in industrial sealants 100 tonnes per annum introduced at 0.5% concentration 5 tonne release volume toxic to aquatic invertebrates STD assessment category Reported for both chemical for use in cosmetics damaging to the eye up to 100 kg per annum introduced at 0.8% concentration toxic to fish not bioaccumulative low volume exemption Reported for both

84. Case studies – Exempted Example chemicalCurrent schemeProposed new scheme Human healthEnvironment polymer that meets the criteria for low concern 10 tonnes per annum 90% concentration for use in surface coatings polymer of low concern (PLC) assessment category Exempted for both

85. Case studies – Exempted Example chemicalCurrent schemeProposed new scheme Human healthEnvironment polymer that meets the criteria for low concern 10 tonnes per annum 90% concentration for use in surface coatings polymer of low concern (PLC) assessment category Exempted for both chemical not hazardous for human health for use in plastics 200 tonnes per annum not harmful to any aquatic life readily biodegradable not bioaccumulative STD assessment category Exempted for both

86. Any questions about the categorisation of new chemicals? We will work through more examples at the risk matrices workshop. 1:00 – 2:00 pm Have your say!

87. More information: www.nicnas.gov.au 1800 638 528