Exemption categories

Last update 30 November 2016

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 heath 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:

  • advise NICNAS before importing and/or manufacturing the chemical using Non-cosmetic exemption application Form NCE-1 [Word 180.9 KB]
  • maintain:
    • evidence that the chemical poses no unreasonable risk to work health and safety, public health and the environment, and
    • records about the use of the new chemical, demonstrating no unreasonable risk
  • monitor import and/or manufacture volumes, and
  • submit an annual report to NICNAS at the end of the registration year.

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