Use of overseas assessments

There are 5 arrangements in place for NICNAS to consider overseas assessments conducted elsewhere, as noted below:

Under these arrangements, we can consider, and use in our assessment report, an overseas health and environment hazard assessment, from one of these specified countries, for a new chemical. NICNAS must have access to the overseas assessment report/s. The other elements of the risk assessment and recommendations on safe use of the chemical in Australia will still be carried out by NICNAS.

Summary of the international assessment options

Arrangements for considering overseas assessments

The arrangements in place for NICNAS to consider the Canadian, US and EU overseas assessments are described below.

Detailed information on the OECD Parallel Process

Approved Foreign Scheme category—Canada

Applications under the Approved Foreign Scheme category can be made for a chemical that was notified and assessed in Canada as a new chemical under a comparable schedule (see table below) to a STD, LTD or PLC notification in Australia.

The time frame for these types of applications is generally 60 calendar days.

Summary of comparable notification categories in Australia and Canada

NICNAS category

Canada category
(current regulations—2005)

Canada category
(older regulations—1994)

Limited

5 or 10

II or VII

Standard

6 or 11

III or VIII

PLC*

9 (only reduced regulatory requirements—RRR)

VI or VII (only low concern polymers)

* Must meet Australian PLC criteria to be considered under the Approved Foreign Scheme.

The Approved Foreign Scheme provision does not apply—but the notification will be considered under the Modular Notification (comparable agency) category—in these types of cases:

  • the Canadian assessment was based on information that cannot be released to NICNAS or published
  • the assessment was based on third party analogue data
  • the information used in the Canadian assessment does not fulfil the data requirements for the notified category in Australia
  • significant additional information has become available since the Canadian assessment (for example, additional toxicological or ecotoxicological studies)
  • additional data is required—for the PLC category only— due to significant potential releases to the environment or intended wide dispersive use by the public (for example, cosmetics).

If you are unsure whether your application fulfils the requirements of the Approved Foreign Scheme category it is best to apply under the Modular Notification (comparable agency) category—Canada (see below). Contact NICNAS if you are not sure which category is appropriate.

After receipt of the notification and screening, NICNAS will advise you if your application will be assessed under an Approved Foreign Scheme or Modular Notification category.

Modular notification (comparable agency) category—Canada or the United States

Applications under this modular notification category (STD, LTD or PLC) are for new chemicals previously notified and assessed in Canada or the United States.

For chemicals previously assessed in Canada the Modular Notification category is suitable for chemicals not assessed under a comparable notification category, or where other circumstances, as outlined above, apply. If you are unsure, NICNAS strongly recommends you apply under the Modular Notification category.

Modular notification (comparable agency)—European Union

Application under this modular notification category covers LTD and STD applications where the chemical was previously assessed in the EU and you can provide NICNAS with the EU assessment report to be used in the Australian notification. You also need to submit a validation letter from the EU authority. Contact NICNAS if you wish to use this category. The arrangements apply to new chemicals assessed pre-REACH[1], as similar reports are not likely to be available under REACH.


[1] REACH is the European Community Regulation on chemicals and their safe use. It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances. The law entered into force on 1 June 2007.

Outline of the process

Notification category

You can apply under the Approved Foreign Scheme or the Modular Notification (comparable agency) categories for the STD, LTD and PLCs. You cannot, however, apply for a self-assessed assessment certificate under these provisions.

Provision of overseas assessment reports

A key requirement is that you must be able to arrange for the information and/or assessment reports to be released to Australia from Canada (Environment and Climate Change Canada) or the United States (United States Environmental Protection Agency [US EPA]).

For Canada you need to request to release information at least 60 days before you submit your notification to NICNAS.

To request release of the Canadian or US reports to NICNAS you should:

  • Contact your affiliate in Canada or USA to arrange release of the assessment reports. Only the notifier for assessment of the chemical in Canada or USA can authorise release of the reports for use in Australia. Where the chemical was assessed overseas as a foreign supplier notification, authorisation for release of the reports in Australia must be obtained from both the notifier and the foreign supplier.
  • Request release of the overseas reports using the pro-forma documents available from NICNAS:
    • the pro-forma letter for Canada [WORD 20KB]—you should forward this completed letter to Environment and Climate Change Canada at least 60 calendar days before you make notification to NICNAS.
    • Contact NICNAS to request the pro-forma agreement for the United States.
  • Send a copy of the request letter that was sent to Canada, to NICNAS for the attention of Admin, New Chemicals, with information about the new chemicals notification that will be made to NICNAS (for example: name of the Australian notifier, category of notification in Australia).

EU reports should be provided with the NICNAS notification.

Notification forms

You need to provide this information with your template notification:

  • A copy of all available information provided to the EU, Canada or the United States, including:
    • all test data
    • all other information submitted in the technical dossier
    • any information provided in response to a request for further information.
  • A copy of any other available information about the chemical (for example, toxicity test data, environmental test data and information) not provided for notification to Canada, the EU or the United States, or information or data generated since the foreign assessment. Address all NICNAS schedule data requirements for the relevant assessment category. You can also apply to vary the data requirements.
  • Information relevant to occupational health and safety in Australia.
  • Information about the use, volume, manufacture and disposal of the chemical, including exposure information in Australia.
  • Confirmation that the chemical notified to NICNAS is the same as the chemical assessed in the overseas assessment. For PLC notifications, the polymer must meet the NICNAS PLC criteria and have a similar molecular weight profile and monomer composition to the polymer assessed overseas.
  • An application for exempt (confidential) information where you want certain information not published, noting that information treated as confidential overseas is not automatically treated as such in Australia.

The NICNAS Director may ask for further information to enable an adequate assessment of the chemical.

Fees

You pay a specific reduced fee (either Approved Foreign Scheme or Comparable Agency). NICNAS will determine if your application fulfils the requirements for an Approved Foreign Scheme. If not, you can have it considered under the modular (comparable agency) category which will attract additional fees.  If unsure, it is best to make the application under the Modular Notification (comparable agency) category.

Reduced fees table

Last update 16 April 2019