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Is the chemical exempt from notification?

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Is the chemical exempt from notification?

Once you have established through AICS that the chemical to be imported or manufactured in Australia is a new industrial chemical, the next step is to determine if it is exempt from notification.

Figure: Deciding whether you need to notify your new chemical

For an explanation of the options/material presented in this diagram, please call 1800 638 529

For most exemption categories no further action is required before you introduce the new chemical. However, in some cases you need to provide NICNAS with information before you import or manufacture. And with most exemption categories you also have to report to NICNAS every year.

Table:   Summary of exemption categories and provisions

Exemption

Volume or concentration restriction

Other criteria

Advice required before introduction

Other reporting requirements

Reference

Research, development or analysis
(manufactured)

N/A

Yes

Yes—Form 6

No

see below

Research, development or analysis

Not more than 100 kg in a 12-month period

No

No

Annual

see below

Transhipment

N/A

Yes

No

Annual

see below

Non-cosmetic exemption (NCE)
no unreasonable risk

Not more than
100 kg in a 12-month period

Yes

No

Optional NCE-Form 1

Annual*

see below

Cosmetic no unreasonable risk

Greater than 10 kg but not more than 100 kg in a 12-month period

Yes

Yes—Form CE-1

Annual*

see below

Not more than 10 kg in a 12-month period

Yes

No

Annual*

see below

Cosmetic non-hazardous (<1%)

Introduced in a product at 1% or less

Yes

No

Annual*

see below

* If you are introducing the chemical you must keep in writing, for five years after introduction, information on the occupational health and safety, public health and environmental effects of the chemical. You must also submit an annual report to NICNAS before or on 28 September each year. Detailed information on annual reporting requirements is in Record keeping and annual reporting requirements.

New chemical introduced for research, development or analysis

You introduce a new chemical for research, development or analysis purposes only, either manufactured in a fixed apparatus in a specific location, or in a quantity between 100g and 100kg in a 12-month period:

1. Manufactured in a fixed apparatus in a specific location. There is no volume restriction if the new chemical is:

  • solely for research, development or analytical work
  • site-limited
  • in an apparatus that cannot operate effectively to produce smaller quantities.

Checklist

  • advice of introduction submitted to NICNAS
  • procedures in place related to the safe disposal and hazardous degradation products
  • records kept and available showing type and location of the apparatus
  • records kept and available showing use (research, development or analysis)
  • procedures in place to monitor manufactured volume of the chemical

2. Imported and/or manufactured at a maximum of 100 kg in a 12-month period. You import or manufacture the new chemical only for research, development or analytical work in a quantity of not less than 100 g and not more than 100 kg in any 12-month period.

Checklist

  • procedures in place to monitor manufactured or imported volume of the chemical
  • information submitted on the research, development or analysis of the new chemical
  • annual reports, using approved NICNAS format, submitted at the end of the registration year

NOTE: This exemption cannot be used to introduce new chemicals sold to an end user for research, development or analysis.

New chemical introduced under the transhipment category

You introduce the new chemical in Australia and it remains subject to the control of the Australian Customs and Border Protection Service and leaves Australia less than 30 days after the day you introduce it. There is no volume restriction on this category.

Checklist

  • the chemical is stored in a bonded warehouse for not more than 30 days and is subject to Customs control during this time
  • import and export records relating to the new chemical are kept and are available
  • annual reports, using approved NICNAS format, submitted at the end of the registration year

New chemical intended for non-cosmetic use that does not exceed 100 kg in any 12-month period

You introduce the new chemical in quantities not exceeding 100 kg in a 12-month period for non-cosmetic use and it poses no unreasonable risk to occupational health and safety, public health or the environment.

Some chemicals are not eligible for exemption. Further details and guidance on how to determine the chemical poses no unreasonable risk are in How to determine the chemical poses no unreasonable risk.

Checklist

  • evidence kept and available that the chemical poses no unreasonable risk to occupational health and safety, public health and the environment
  • advice concerning the chemical submitted to NICNAS (Form NCE-1)
  • import and/o rmanufacture volumes monitored
  • records kept and available relating to the use of the new chemical, demonstrating no unreasonable risk
  • annual reports, using the approved NICNAS format, submitted at the end of the registration year

NOTE: Nanomaterials are not eligible for this exemption category.

New chemical intended for cosmetic use that does not exceed 100 kg in any 12-month period

The new chemical poses no unreasonable risk to occupational health and safety, public health or the environment (see: Guidance note—How to determine the chemical poses no unreasonable risk).

You must also ensure the new chemical meets all of these criteria:

  • is not used in the cosmetic as a preservative, colouring agent or ultraviolet filter
  • is not prohibited or restricted for use in cosmetics in the European Union under Council Directive 76/768/EEC (aas in force on 1 December 2011) or in the United States under the Food Drugs and Cosmetics Act 1938 (as in force on 1 December 2011)
  • is not at a concentration of greater than 1% in the cosmetic product, unless you have information indicating that the chemical will be safe for use by potentially high-risk groups, including infants, elderly persons and atopic persons, consistent with the anticipated pattern of consumer exposure.

NOTE: Nanomaterials are not eligible for this exemption category.

1. Cosmetic of between 10 and 100 kg a year (no unreasonable risk)

The new chemical in a cosmetic is introduced in an amount greater than 10 kg but not exceeding 100 kg in a 12-month period.

Checklist

  • evidence kept and available available that the chemical poses no unreasonable risk to occupational health and safety, public health and the environment
  • advice concerning the chemical submitted to NICNAS (Form CE-1), including copies of:
    • (Material) Safety Data Sheets ((M)SDS) relevant to the chemical or product containing the chemical
    • label to be attached to the packaging of the chemical or product containing the chemical
    • import and/or manufacture volumes monitored
    • records kept relating to the use of the new chemical
  • records kept on occupational health and safety, public health and environmental effects for five years after the chemical is introduced
  • if the new chemical is introduced in a cosmetic at 1% or more, information available that it will be safe for use by potentially high-risk groups (including infants, elderly persons and atopic persons)
  • annual reports, using the approved NICNAS format, submitted at the end of the registration year

NOTE: Nanomaterials are not eligible for this exemption category.

2. Chemical is introduced at up to 10 kg a year for use in a cosmetic (no unreasonable risk)

The new chemical in a cosmetic is introduced in an amount not exceeding 10 kg in a 12-month period.

Checklist

  • evidence kept and available that the chemical poses no unreasonable risk to occupational health and safety, public health and the environment
  • import and/or manufacture volumes monitored
  • records kept relating to the use of the new chemical
  • records kept on occupational health and safety, public health and the environmental effects of the chemical for five years after the chemical is introduced
  • if the new chemical is introduced in a cosmetic at 1% or more, information available that the chemical will be safe for use by potentially high-risk groups (including infants, elderly persons and atopic persons)
  • annual reports, using the approved NICNAS format,submitted at the end of the registration year

NOTE: Nanomaterials are not eligible for this exemption category.

Non-hazardous new chemical intended for cosmetic use introduced at less than 1%

The new chemical is a non-hazardous chemical introduced in a cosmetic product at a concentration at 1% or less (no volume restriction), and meets all of these criteria:

  • not a hazardous chemical (see Definitions)
  • not a dangerous good according to the Australian Code for the Transport of Dangerous Goods by Road and Rail
  • has one of these characteristics:
    • dissolves in water without dissociation or association, is not surface-active and the partition coefficient (n‑octanol/water) at 20o C as log Pow does not exceed 3
    • solubility in water is greater than 1 mg/litre
    • molecular weight (MW) or (number-average molecular weight (NAMW) in the case of a polymer) is greater than 1000
    • readily biodegradable
  • has a very low aquatic toxicity to fish, aquatic invertebrates and algae, that is, LC50 or EC50 100 mg/L or greater
  • introduction of the chemical is consistent with the reasonable protection of occupational health and safety, public health and the environment
  • not used in the cosmetic as a preservative, colouring agent or ultraviolet filter
  • not prohibited or restricted for use in cosmetics in the European Union under Council Directive 76/768/EEC (as in force on 1 December 2011) or in the United States under the Food Drugs and Cosmetics Act 1938 (as in force on 1 December 2011)

Checklist

  • not a hazardous chemical, not a dangerous good and meets prescribed environmental criteria
  • records kept and available relating to the use of the new chemical and its percentage in the cosmetic
  • annual reports, using the approved NICNAS format, submitted at the end of the registration year

More information is in Guidance note—How to determine the chemical poses no unreasonable risk.

NOTE: Nanomaterials are not eligible for this exemption category. This category is not appropriate for chemicals introduced into Australia for formulation into cosmetic products. The chemical must be introduced in the formulated cosmetic product at 1% or less.

Table of Contents

  1. Handbook: Main Content
    1. Registering with NICNAS (archived content)
      1. Benefits of registering with NICNAS (archived content)
      2. Defining an industrial chemical (archived content)
      3. How NICNAS is funded (archived content)
      4. Deciding to register with NICNAS (archived content)
      5. How to register with NICNAS or renew registration (archived content)
      6. Consequences of not registering (archived content)
      7. Transferring registration (archived content)
      8. Penalties for offences related to NICNAS 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 and exempt 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 (archived content)
    2. Appendix B: Abbreviations and acronyms (archived content)
    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
      10. PLC FLOW CHART
    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 (archived content)
      1. Definition of a naturally-occurring chemical (archived content)
      2. Application of the definition (archived content)
      3. Steam distillation (archived content)
      4. Extraction of essential oils (archived content)
    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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