Applications, notification statements and other documents
- must be legible and submitted in English
- for any data not in English, this must be accompanied by a translated version along with a signed statement certifying the translation was carried out by a competent translator (person or organisation)
- SDS must be legible and suitable for publication
- must declare that you are entitled to use the data provided and authorised to give it to NICNAS.
To ensure that the application process runs smoothly:
- Use the relevant forms for each notification category to submit required data and information. There are additional forms you may need to submit, such as a request for confidentiality if you wish to apply for certain information to be exempt from publication.
- Provide all the mandatory data for the notification category that you are applying for. Omitting required information can add delays to your application process.
- You should submit your application in loose-leaf form rather than bound.
For some notification categories, you can attach data such as toxicity studies, SDS and occupational data using your own format. Where possible, we recommend that you use the forms provided by NICNAS to ensure the application process runs smoothly.
You can use professional help to prepare and lodge your application.
Number of copies
For certificate notifications, you must submit:
- Two copies of the complete notification statement
- Two copies of the supporting physico-chemical and environmental effects data
- One copy of the supporting health effects data
For permits you must submit one copy of all information.
For most notification categories, the data requirements reflect the Schedule to the Act (see Data requirements for new chemicals applications). For STD and LTD notifications, different data are required, depending on whether it is a chemical or a polymer. Scheduled data requirements represent the minimum data required. If you have access to additional information, you must provide it to NICNAS with your application.
Submitting test results
It is best to obtain data, including test results, in support of your application by following the OECD Principles of Good Laboratory Practice (GLP) and Mutual Acceptance of Data (MAD). Find up-to-date guidance in the 2015 OECD Q&A on GLP and MAD [PDF 528KB].
It is recommended that you:
- indicate the test method and the testing organisation used for each data item
- indicate whether testing carried out in Australia was in accordance with the National Association of Testing Authorities' standards
- ensure you carry out your responsibilities for observing GLP during testing
- consider the need to meet GLP when engaging a testing laboratory
- provide a quality assurance statement for each test (usually part of the study report).
Other testing techniques are acceptable if they are a validated test method and NICNAS determines this case-by-case.
NOTE: Tests conducted before 1981 may not have been carried out in accordance with GLP.
Variation of data requirements
If you cannot provide all of the test data required for the notification, you may apply to omit certain test data, or substitute data specified in the schedule of data requirements. NICNAS will consider your application and make a decision on whether or not to grant the variation to the scheduled data requirements.
NOTE: you cannot apply to omit or substitute basic information such as the identity of your chemical or polymer.
You may be able to omit certain data items if NICNAS is satisfied that:
- the introduction of the chemical is not against the public interest
- the omissions or substitutions are justified (when the substitution is for data from an analogue chemical this includes justification for why the proposed analogue chemical is suitable)
- an adequate assessment of the occupational health and safety, public health and environmental hazards of the chemical can be made without submitting the data items.
You must include the required fee with your application. The only time the fee may be waived is when it is physically impossible to conduct a particular test or study. NICNAS will consider this case-by-case.
More information is available in:
- Data requirements for new chemicals applications
- Data requirements for notification of new industrial nanomateriials.
Last update 17 August 2017