Exemption categories

Last update 12 January 2017

Our Do I need to notify? questionnaire will tell you if you qualify for an exemption

Determine whether a chemical poses no unreasonable risk

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

For some exemptions 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, recording-keeping and information requirements for the 5 exemption categories.

Research, development or analysis

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.

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

Checklist

You will need to:

  • monitor the manufactured and/or imported volume of the chemical
  • submit:
    • information on the research, development or analysis of the new chemical, and
    • 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

This exemption applies if you introduce a new chemical to Australia and it:

  • remains under the control of 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

You will need to:

  • store the chemical in a bonded warehouse that is subject to Australian Customs and Border Protection Service control for no more than 30 days
  • maintain import and export records about the new chemical, and
  • submit an annual report to NICNAS at the end of the registration year.

Non-cosmetic use not exceeding 100kg

Your new chemical may qualify for this exemption if it:

  • is not intended for cosmetic use
  • poses no unreasonable risk to occupational health and safety, public health or the environment
  • is imported or manufactured in a volume no greater than 100 kg in any 12-month period, and
  • is not 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:

  • advise NICNAS before importing and/or manufacturing the chemical using Non-cosmetic exemption application Form NCE-1 [Word 180.9 KB]

Cosmetic use not exceeding 100kg

This exemption category includes options for introducing the chemical in volumes up to 10 kg or between 10 kg and 100kg in any 12-month period.

To qualify for this exemption, the chemical must not:

Where 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 work 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, and
  • submit an annual report to NICNAS 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 NICNAS before importing and/or manufacturing the chemical by using Cosmetic exemption application Form CE-1 [Word 1MB] and include the:
    • Safety Data Sheet (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.

Cosmetic use at a concentration of 1% or less

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, or
    • readily biodegradable.

The chemical must not:

Checklist

You need to:

  • establish 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

Go to exemption application forms