Chemicals exempt from notification

If the chemical qualifies for an exemption from notification you will still need to comply with annual reporting and record-keeping requirements.

For some introductions you also need to provide us with information before you import and/or manufacture and keep evidence that the chemical poses no unreasonable risks to work health and safety, human health and the environment.

Learn more about the annual reporting, record-keeping and information requirements for the following 6 exemption categoriesclick on the arrows to read guidelines/information/checklists.

New: Polymers of low concern are now exempt from notification read more about this here or read the PLC exemption information below.

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  • Research, development or analysis
    Quantities cannot be more than 100kg/year

    There are 2 different situations when the research, development of analysis exemption may apply.

    1. Manufactured in a fixed apparatus in a specific location

    To qualify for this exemption, the new chemical must be:

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

    There is no volume restriction on this category.

    Checklist

    You will need to:

    • advise NICNAS before manufacturing using Research and development exemption application Form 6 [Word 163.7 KB]
    • maintain:
      • procedures for safe disposal
      • procedures for hazardous degradation products
      • records showing the type and location of the apparatus
      • records on the use of the chemical (research, development or analysis), and monitor the manufactured volume of the chemical.

    2. Imported and/or manufactured at a maximum of 100kg in a 12-month period

    This is when 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

    You will need to:

    • monitor the manufactured and/or imported volume of the chemical
    • submit an annual report to NICNAS at the end of the registration year (chemicals introduced at a total quantity of < 100 grams do not need to be reported).
  • Transshipment
    Introduced at a port or airport

    To be exempt from notification, the new chemical introduction:

    • must be introduced at a port or airport in Australia
    • remain subject to customs control at all times before leaving Australia (per the Customs Act 1901) and
    • leave Australia less than 30 days after the day of introduction.

    There is no volume restriction on this category.

    Checklist

    You will need to:

    • ensure that the the chemical you have introduced is subject to customs control under the Customs Act 1902 at all times before leaving Australia
    • maintain import and export records about the chemical you have introduced, and
    • submit an annual report to us at the end of the registration year.
  • Non-cosmetic use not exceeding 100kg
    Must pose no unreasonable risk to human health and the environment

    To be exempt from notification the new chemical introduction must:

    • poses no unreasonable risk to occupational health and safety, public health or the environment
    • imported or manufactured in a volume no greater than 100 kg in any 12-month period, and
    • neither intended for cosmetic use, nor an industrial nanomaterial.

    Checklist

    You will need to:

    • maintain:
    • monitor import and/or manufacture volumes, and
    • submit an annual report to NICNAS at the end of the registration year.

    You may:

  • Cosmetic use not exceeding 100kg
    Must pose no unreasonable risk to human health and the environment

    To be exempt from notification, the new chemical introduction must not:

    If the chemical is present in the cosmetic at a concentration ≥1%, you must have information that indicates 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.

    Checklist

    You will need to:

    • maintain:
      • evidence that the chemical poses no unreasonable risk to occupational health and safety, public health and the environment, and
      • records relating to the occupational health and safety, public health and environmental effects for 5 years after the chemical is introduced
    • monitor import and manufacture volumes
    • submit an annual report to us at the end of the registration year

    If your chemical is for a volume between 10 kg and 100 kg in any 12-month period you must also advise us before importing and/or manufacturing the chemical by using the  Cosmetic exemption advice Form CE-1 [Word 1MB].

  • Cosmetic use at a concentration of 1% or less
    Must be non-hazardous

    Your new chemical must meet all the following requirements to qualify for this exemption.

    The chemical must:

    • be intended for use as an ingredient in a cosmetic product at a concentration of 1% or less
    • have a very low aquatic toxicity to fish, aquatic invertebrates and algae—that is, LC50 or EC50 100 mg/L or greater
    • have one of the following characteristics:
      • dissolves in water without dissociation or association, is not surface-active and the partition coefficient (n‑octanol/water) at 20oC 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 and
      • readily biodegradable.

    The chemical must not:

    Checklist

    You need to:

    • establish that the chemical is not a hazardous chemical, not a dangerous good and meets prescribed environmental criteria
    • ensure records are kept and available relating to the use of the new chemical and its percentage in the cosmetic
    • provide us with an annual report, which is due at the end of each registration year
  • Polymers of low concern
    Must meet PLC criteria

    If your polymer meets the polymer of low concern (PLC) criteria, it qualifies as exempt and you do not need to notify us. There is no fee for introducing under the PLC exemption category. However, you must meet our record keeping and annual reporting requirements.

    Note: If you introduce a PLC under the exemption category, your polymer will not be listed on the Inventory. If you wish to achieve Inventory listing, you can still apply for a permit or certificate assessment (fee applies). You can use the non-cosmetic and cosmetic less than 100kg exemption categories (provided you meet the relevant requirements), but this also does not lead to Inventory listing for your polymer.

    Is my polymer a PLC?

    Please read the PLC criteria section so you can be certain your polymer qualifies for an exemption. This section also has examples of when a polymer is not a PLC.

    Do this online questionnaire to guide you through the PLC criteria


    PLC criteria — a summary

    The following is a summary of PLC criteria. To meet our PLC crtieria, the polymer must

    • have a number average molecular weight greater than or equal to 1,000 g/mol and meet the low molecular weight species and reactive functional group requirements

    OR

    • be a polyester manufactured solely from allowable reactants

    The polymer must also meet the following criteria:

    • have a low charge density
    • contain approved elements only
    • not contain fully fluorinated carbon chains
    • be stable under the conditions in which it is used
    • not be a high molecular weight (≥10,000 g/mol) water absorbing polymer
    • not be a hazardous chemical

    Go to our PLC criteria section for full details


    Checklist on introducing a PLC exempt from notification

    You must:

    • maintain evidence that your polymer meets the PLC criteria
    • submit an annual report to us at the end of the registration year.

Go to exemption forms

Last update 8 April 2019