1. NICNAS Reforms Consultation Paper 1

2. Purpose of workshop Explaining Consultation Paper 1 and seeking your input. Gathering information to inform Consultation Paper 2.

3. Structure of the workshop Topics to be covered: Objectives of reform Consultation process and timing Categorisation of chemicals Class 1, 2 and 3 chemicals Assessment process Transitional arrangements NICNAS initiated assessments Confidential information The matrix—exposure and hazard bands Short break 10.45 – 11.00am Short break 10.45 – 11.00am

4. Objectives of reform Assessment effort is more proportionate to risk. Maintain Australia’s health, safety and environmental protection standards. Greater use of international assessment materials. Reduction in regulatory burden ̴ $23 million annually.

5. To deliver the reforms.. Changes required to: NICNAS’s legislation (ICNA Act) and associated regulations Guidance materials, application forms, standard operating procedures, and other supporting materials NICNAS’s information and communications technology (ICT) system.

6. Proposed consultation Consultation with the new NICNAS Strategic Consultative Committee Public release of detailed Consultation Papers Public workshops Consultation with all relevant Commonwealth agencies

7. Consultation process and timing

8. Any queries before we start?

9. Key elements of reforms

10. Chemicals not on the AICS will be categorised by industry into 3 classes based on risk Class 1 (very low risk chemicals)—automatic entry, no notification to NICNAS (↓ time to market), post-market audits Class 2 (low risk chemicals)—notification to NICNAS, immediate entry to market (↓ time to market), post-market audits Class 3 (medium–high risk chemicals)—streamlined NICNAS assessment, pathway to AICS, post-market audits

11. Process for chemical introduction

12. Categorisation of chemicals

13. Class 1 chemicals

14. Very low risk chemicals. Low exposure and/or not hazardous to people/environment. Current exemptions will fall mostly under Class 1 (estimated ̴70%). No notification requirements. Subject to any risk management requirements imposed by other Australian regulators. Subject to auditing by NICNAS.

15. Class 2 chemicals

16. Chemicals that meet hazard and exposure criteria for health and/or environment Additional information required in notification Eligibility for international pathway based on “criteria for the adoption of international standards and risk assessments by Health portfolio regulators” Risk Matrix pathway Chemicals that meet Class 3 criteria with: a comparable risk assessment (use, volume, concentration, conditions) AND risk assessment assumptions and outcome relevant in Australian context AND assessment from certain agencies International pathway

17. Assessed by: Environment & Health Canada SCCS and adopted by EU evaluated by EU MSCA Assessed both health and environment Same use, volume and concentration (or less) Relevant to Australia International conditions of use Assessment report available to NICNAS

18. We seek your input What is your advice regarding the international pathway? What are the strengths and limitations of the proposed approach?

19. Class 3 chemicals

20. Require pre-market assessment by NICNAS. Streamlined; international information (Health portfolio criteria). Flexible assessment process. A summary of the assessment published online. Targeted post-market audit/assessment. Estimated to be ̴ 0.75% of new chemicals introduced ( ̴ 100 assessments per year). NOTE: An introducer may also choose to seek NICNAS assessment of a Class 1 or Class 2 chemical—to provide a pathway to the AICS (does not make it a Class 3 chemical).

21. Assessment process

22. Streamlined assessment process. Overseas applicants could appoint a nominated local agent (harmonises with REACH). Electronic notifications and payment—ICT system. Automated completeness check of application. Changes to assessment timeframe, with increased certainty. Some proposed changes

23. NICNAS must consult with relevant risk managers if considering: a) imposing any conditions of use; or b) refusing an assessment certificate. NICNAS may consult risk managers at any time. NICNAS must consider the advice of risk managers. Proceed with assessment decision if no response received. Consultation with risk managers

24. Assessment outcomes Issue assessment certificate that: is subject to a defined assessment scope; may include recommendations to risk managers; may include conditions of use—limited to volume, site or duration. These will be on the certificate and transferred to the AICS. Refuse assessment certificate: If risk cannot be managed by existing risk management frameworks or conditions of use. Defined assessment scope: As a component of rinse-off cosmetic products at concentration of less than 10%.

25. NICNAS to publish a summary report. NICNAS to maintain a public register of risk management recommendations and responses. Transparency

26. We seek your input Process and timeframes for input from risk managers? Information that should be included in a summary report? Overall timeframes?

27. Transitional arrangements

28. Transitional arrangements: new chemicals Proposed 6 month transition period to self-categorise chemicals into classes and meet requirements if they fall into Classes 1 or 2. Chemicals under permit that fall into Class 3 certificate for the duration of the permit. Chemicals under certificate that fall into Class 3 a.Certificate continues and chemical entered on AICS at 5 years; or b.Introducer may apply for early listing.

29. We seek your input on transitional arrangements Is there a balance between allowing adequate time for transition, while minimising uncertainty (with two systems operating)?

30. NICNAS initiated assessments

31. NICNAS Initiated Assessments (NIA) NICNAS can initiate assessment (or reassessment) of a chemical on AICS or under Class 1, 2 or 3 (i.e. any industrial chemical). Will replace the IMAP framework and PEC process. Key features of the IMAP framework will be relevant—e.g. prioritisation of chemicals for assessment, risk-based assessment approach, flexible approach to exposure information. IMAP review will inform approach to NIA.

32. National Industrial Chemicals Notification and Assessment Scheme NICNAS Initiated Assessment Triggers Chemical on AICS Or Class 1, 2, or 3 certificate Info gathering Regulatory outcomes

33. NICNAS Initiated Assessments (NIA) New health, safety or environmental information Adverse event Inter/national regulatory action Requested by risk manager Actions that may trigger process Examples of information gathering ExternalInternal Voluntary call for information Mandatory call for information—only under restricted conditions Specific concerns Systematic NICNAS activity NICNAS compliance activity Published literature, databases Inter/national liaison NICNAS compliance activity

34. Mandatory calls for information May be required if: a voluntary call has not provided adequate information confirmation needed that a chemical is not being introduced information is held by introducers significant health or environmental concerns banned by an international regulator a defined assessment scope needs to be determined required for international reporting obligations.

35. Possible outcomes of NIA Recommendations to risk managers. Add or change:  defined assessment scope (on assessment certificate or AICS)  conditions of use (assessment certificate or AICS). Remove chemical from the AICS. Revoke assessment certificate. Recommendations to government for changes to legislative criteria for classes 1, 2 or 3.

36. Confidential information

37. Option of introducing a system using masked names in certain circumstances. Masked name = one or more chemical elements have been removed (or made generic) in chemical name. Better international harmonisation (ECHA, US EPA and Environment Canada).

38. Confidential information Consideration of: A single, one-off application for masking chemical name, not using the confidential section on the AICS Using agreed masked name for all publication purposes, including published assessment report and listing on the AICS, linking the report directly to chemical names on the AICS. Your thoughts on this?

39. Cost recovery Government policy of industry cost recovery will continue. New Cost Recovery Implementation Statement (CRIS) to be developed as detail of reforms becomes more settled. NICNAS fees and charges to be recalibrated, to match regulatory effort required.

40. Impact of reforms Continued public health and safety and environment protections. Reduced time to market. Reduced annual reporting requirements. Increased international harmonisation. Anticipated increase in post-market compliance monitoring and assessment effort. Estimated overall decrease of >70% pre-market assessments: from ̴3.3% to ̴0.75% of all new chemicals introduced.

41. The risk matrix

42. Indicative risk matrix RIS Option 3—concept of indicative risk matrix: concept of chemical classes based on chemical’s indicative risk given its proposed use. Criteria examples used in RIS were representative, not definitive.

43. Indicative risk matrix Following publication of NICNAS reforms implementation plan, the concept was further developed with a focus on how the matrix would be used in practice. Practical considerations led to a number of improvements, articulated in Attachment A of Consultation Paper 1.

44. The current risk matrices Health and Environment risks are evaluated separately, using a consistent approach: HumanEnvironment

45. Criteria for exposure Exposure band 1 2 3 4 Research and development ≤100 kg per annum; or Transshipment. Volume ≤1,000 kg non-consumer use per annum; or Volume ≤100 kg consumer use per annum; or Concentration ≤1 % as introduced; or Research and development >100 kg per annum. Volume >1,000 kg non-consumer use per annum; or Volume >100 kg consumer use per annum with secondary exposure. Volume >100 kg consumer use per annum with primary exposure. Human ≤1,000 kg per annum release volume and no direct release to the environment. >1000 and ≤10,000 kg per annum release volume and no direct release to the environment; or Unlimited volume only if bound within an inert matrix (but not irreversibly chemically transformed). Does not meet the criteria for environmental exposure bands 1, 2, or 3. Research and development <100 kg/year release volume, provided no direct release to the environment; chemical treated prior to release into sewer or landfill; or Transhipment. Environment

46. Criteria for hazard—Hazard band A Additional assessment considerations apply to engineered nanomaterials, poly- or per-fluorinated substances, ultraviolet filters in cosmetics applied to skin, and chemical transformation and degradation products of environmental concern. Hazard band HealthEnvironment A All indicators fall outside the criteria for Hazard Bands B–E; and Not a hazardous chemical for human health; Low acute toxicity via oral, dermal and inhalation routes of exposure; and Not irritating; and Not sensitising; and Not toxic to specific target organs following single or repeated exposure; and Not mutagenic. Chemicals that:  do not meet the criteria for Hazard Bands B–E; and  are readily biodegradable: >70% degradation in 28 days (and >60% degradation within a 10-day window); and  are not bioaccumulative: bioconcentration factor (BCF) <2000 (or log KOW <4.2); and  are not harmful to any aquatic life (fish, invertebrates and/or algae); and  have high molecular weight: MW >1000 Da.

47. Exposure Band Hazard Band How to read the risk matrix

48. Read across the exposure Exposure Band Hazard Band From left to right Determine the band by the criterion that first applies to your chemical Human Health Research and development ≤100 kg per annum; or Transshipment. Volume >100 kg consumer use per annum with primary exposure. Volume >1,000 kg non-consumer use per annum; or Volume >100 kg consumer use per annum with secondary exposure. Volume ≤1,000 kg non-consumer use per annum; or Volume ≤100 kg consumer use per annum; or Concentration ≤1 % as introduced; or Research and development >100 kg per annum.

49. Hazard Band Read down the hazard band No data means positive result assumed. Criterion first met for any of the hazards in a band, determines the band. The chemical’s hazard profile must be fully characterised.

50. Determine the chemical class The higher of the two classes applies HealthEnvironment

51. An industrial chemical is proposed for introduction: at up to 1,500 kg per annum as a component of finished printing inks for paper at concentrations of ˂1% used in commercial settings only (non-consumer use). Its human health hazards include: skin irritation serious eye damage serious damage to health by prolonged exposure through inhalation. The chemical has: negative in vitro test result for mutagenicity no positive flags for carcinogenicity, reproductive toxicity or endocrine activity. Example

52. Environmental considerations include: Expected environmental release:  50% of the import volume based on usage pattern (i.e. 750 kg)  Released to sewer during paper recycling (i.e. no direct release). Environmental hazards include:  Acute toxicity for fish = 57 mg/L  Molecular weight < 1000 Da  Not readily biodegradable  Not expected to be bioaccumulative. Example

53. Exposure Band Indicative criteria for exposure band Human Health Environment 1  Research and development ≤100 kg per annum; or  Transshipment.  Research and development ≤100 kg per annum release volume, provided:  No direct release to the environment; and  The chemical is treated prior to release to sewer or landfill; or  Transshipment. 2  Volume ≤1,000 kg non-consumer use per annum; or  Volume ≤100 kg consumer use per annum; or  Concentration ≤1 % as introduced; or  Research and development >100 kg per annum.  ≤1,000 kg per annum release volume and no direct release to the environment. 3  Volume >1,000 kg non-consumer use per annum; or  Volume >100 kg consumer use per annum with secondary exposure.  > 1000 and ≤ 10,000 kg per annum release volume and no direct release to the environment; or  Unlimited volume only if bound within an inert matrix. 4  Volume >100 kg consumer use per annum with primary exposure.  Does not meet the criteria for environmental exposure bands 1, 2, or 3 Determine the exposure band Proposed: Concentration ≤ 1% as introduced Non-consumer use Introduced at > 1,000 kg per annum Expected release volume at < 1,000 kg per annum No direct release

54. Determine the hazard band Due to: Acutely harmful to aquatic life Negative in vitro test for mutagenicity Serious damage to eyes

55. Determine the chemical class Human Health Environment Chemical in Exposure Band 2 and Hazard band D is categorised as Class 2 in proposed human health matrix. Chemical in Exposure Band 2 and Hazard band B is categorised as Class 1 in proposed environment matrix. The higher of the two classes applies. Chemical is in Class 2.

56. Considerations for Consultation Paper 2: not exceeding data requirements for current equivalent chemicals for hazards, data absence does not mean hazard absence hazard bands align with GHS classification separate guidance documents for analogues and (Q)SARs separate release volume calculators specific data requirements for polymers other than PLCs. Health hazard data requirements

57. Tiered approach Tier 1: in silico screening; flags from authoritative lists Tier 2: in vitro and/or in chemico, including AoP Tier 3: in vivo on chemical and/or suitable analogue(s) Confidence: Tier 1 < Tier 2 < Tier 3 – Tier 1: may be sufficient for Exposure Band 1 and 2 – Tier 2: may be sufficient for Exposure Band 2 and 3 – Tier 3: is required for Exposure Band 3 and 4 Evaluation of the chemical’s physical/chemical properties, metabolism in the body and environmental fate, inform all tiers. Health hazard data requirements

58. Next steps

59. For more information: www.nicnas.gov.au 1800 638 528