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Appendix H: Guidance and requirements for notification of new chemicals that are industrial nanomaterials

Main Contents > Appendix H: Guidance and requirements for notification of new chemicals that are industrial nanomaterials

Appendix H: Guidance and requirements for notification of new chemicals that are industrial nanomaterials

As of 1 January 2011, a new industrial chemical that falls under the working definition of an 'industrial nanomaterial' is not permitted to be introduced under some exemption and self-assessment categories.

This applies to any new chemical meeting the working definition of 'industrial nanomaterial' provided in NICNAS working definition of industrial nanomaterial.

Sections of this appendix:

Table of Contents

  1. HANDBOOK: Main Content
    1. Registering with NICNAS
      1. Benefits of registering with NICNAS
      2. Defining an industrial chemical
      3. How NICNAS is funded
      4. Deciding to register with NICNAS
      5. How to register with NICNAS or renew registration
      6. Consequences of not registering
      7. Transferring registration
      8. Penalties NICNAS can impose, relating to registration
    2. Australian Inventory of Chemical Substances
      1. Overview
      2. AICS sections
      3. Listing chemicals on the AICS
      4. Records and restrictions on introducing chemicals
      5. Searching the AICS
    3. Notifying a new chemical
      1. How to decide to notify a chemical
      2. Does NICNAS define the substance as a chemical?
      3. Does NICNAS define the chemical as an industrial chemical?
      4. Is the industrial chemical a new industrial chemical?
      5. Is the industrial chemical defined as a nanomaterial?
      6. Is the chemical exempt from notification?
      7. How to determine the chemical poses no unreasonable risk
    4. Notification categories for new chemicals
      1. Permit or assessment certificate?
      2. Permit categories-an overview
      3. Assessment certificate categories-an overview
    5. Notification processes and procedures for new chemicals
      1. Who can make an application for notification and assessment of a new chemical?
      2. Statement and certification
      3. Submitting information
      4. Withdrawing notification
      5. Applications, notification statements and other documents
      6. Exempt information (information claimed as confidential from publication)
      7. Method of paying assessment fees
      8. Screening applications to notify a new chemical
      9. Requests for more information
      10. Providing new information during assessment
      11. Assessment process and reports
      12. Issuing an assessment certificate
      13. Transferring an assessment certificate
      14. Record keeping and annual reporting
      15. New Chemicals offences and penalties under the Act-a summary
    6. Submission tips for new chemical notifications
      1. Confirm chemical identity
      2. Provide complete payment
      3. Provide complete information on exposure and release
      4. Identify all uses
      5. Determine notification category
      6. Justify commercial evaluation for a CEC permit
      7. Ensure you have the data for a self-assessed Polymer of low concern category
    7. Assessing Existing chemicals
      1. Types of assessments
      2. Priority Existing Chemical assessments
      3. Priority Existing Chemical offences and penalties-a summary
    8. Secondary notifications
      1. Providing secondary notification information
      2. Making a secondary notification to NICNAS
      3. Assessment process and reports
      4. Penalties for failing to notify
    9. Chemical Gazette
      1. Summary of new chemicals assessments
      2. Notice calling for information about an existing chemical
      3. Declaration of a Priority Existing Chemical
      4. Publication of final assessment report for an existing chemical
      5. Other notices and/or declarations which must be published in the Chemical Gazette
    10. Compliance and enforcement
      1. NICNAS's compliance style
      2. The NICNAS Compliance and Enforcement Programme
      3. Detecting and managing non-compliance
      4. Enforcement provisions, offences and penalties
      5. Role of NICNAS's compliance inspectors
      6. Can a foreign company make an application under the ICNA Act?
    11. International obligations
      1. Rotterdam Convention
      2. Stockholm Convention on Persistent Organic Pollutants
      3. Other international treaties
      4. Offences and penalties relating to Australia's obligations under international agreements-a summary
  2. HANDBOOK: Appendixes
    1. Appendix A: Definitions
      1. Addendum: description of an article
    2. Appendix B: Abbreviations and acronyms
    3. Appendix C: Certificate categories for new chemicals
      1. Polymer of low concern notification
      2. Standard or Limited notifications
      3. Extension of an original assessment certificate notification
      4. Self-assessment applications
      5. Modular notification categories - reduced fee options
      6. Use of overseas assessments in the notification of New Chemicals
    4. Appendix D: Polymers of low concern: additional information
      1. Reactive functional groups
      2. Functional group equivalent weight
      3. Molecular weight
      4. Cationic polymers
      5. Hazard classification
      6. Elemental criteria
      7. Degradable or unstable polymers
      8. Water absorbing polymers
      9. Polyesters
    5. Appendix E: Permit categories for new chemicals
      1. Commercial evaluation chemical permit
      2. Low volume chemical permit
      3. Controlled use (export only) permit
      4. Controlled use permit
      5. Early introduction permit
      6. Renewal of permits
    6. Appendix F: Data requirements for new chemicals applications
      1. Schedule Part A
      2. Schedule Part B
      3. Schedule Part C
      4. Schedule Part D
      5. Schedule Part E
      6. Variation to data requirements
    7. Appendix G: Data requirements for notification of new chemical substances containing a perfluorinated carbon chain
      1. Background
      2. Regulatory actions
      3. What perfluorinated chemicals are covered?
      4. What does this mean for a Notification?
      5. Refinement of NICNAS defaults
      6. What are the notification options for notifiers?
      7. Existing chemicals assessments
    8. Appendix H: Guidance and requirements for notification of new chemicals that are industrial nanomaterials
      1. NICNAS working definition of industrial nanomaterial
      2. Exemption categories
      3. Permit categories
      4. Certificate categories
      5. Specified conditions for requesting additional data requirements
      6. Guidance on providing additional data requirements
      7. Guidance on testing health effects of nanomaterials
      8. Guidance on testing the environmental fate and effects of nanomaterials
    9. Appendix I: Exposure criteria and scenarios for Controlled use permit: additional information
      1. Controlled use exposure criteria
      2. Controlled use exposure scenarios
    10. Appendix J: Structural alerts for permit categories
      1. Structural alert table 1 - C - Structure contains only C, H, (O)
      2. Structural alert table 2 - CHal - Structure contains only C, H, (O) and Halogen atoms
      3. Structural alert table 3 - CN - Structure contains only C, H, (O) and N atoms
      4. Structural alert table 4 - CNHal - Structure contains only C, H, (O), N and Halogen atoms
      5. Structural alert table 5 - CNS/CNSHal - Structure contains only C, H, (O), N and S atoms or Structure contains only C, H, (O), N, S and Hal atoms
      6. Structural alert table 6 - CS/CSHal - Structure contains only C, H, (O) and S atoms or Structure contains only C, H, (O), S and Hal atoms
      7. Structural alert table 7 - CSi and CSiHal - Structure contains only C, H, (O), and Si atoms or Structure contains only C, H, (O), Si and Halogen atoms
      8. Structural alert table 8 - Other - Structure contains atoms other than C, H, N, O, S, Si and Halogen atoms
    11. Appendix K: Assessment methodologies
      1. Risk assessment of chemicals: assessment of exposure from all sources
      2. Human health hazard assessment
      3. Occupational health and safety assessment
      4. Public health assessment
      5. Environmental assessment
      6. References
    12. Appendix L: Forms and paperwork notifiers must complete to support an application; fees and charges payable
    13. Appendix M: Confidentiality
      1. Initial notification (first five years)
      2. Initial confidential Australian Inventory of Chemical Substances listing
      3. Re-listing a chemical on the Australian Inventory of Chemical Substances confidential section
    14. Appendix N: Australian Inventory of Chemical Substances online searching advice
      1. Searching public section online
      2. Confidential AICS search
    15. Appendix O: Chemical Abstracts Service registry numbers
    16. Appendix P: Naturally-occurring chemicals
      1. Definition of a naturally-occurring chemical
      2. Application of the definition
      3. Steam distillation
      4. Extraction of essential oils
    17. Appendix Q: Stockholm Convention: (1) international persistent organic pollutants criteria (2) national environmental persistent bioaccumulative and toxic criteria
    18. Appendix R: Summary of applications under the Act
    19. Appendix S: Appeals
    20. Appendix T: Weblinks used in this Handbook
      1. NICNAS
      2. Other Australian Government regulators, Departments and agencies
      3. Relevant international bodies
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