AICIS New Assessed Chemical Introduction

Jun 30, 2023

If you wish to use a chemical in Australia, then it must be listed with AICIS. If it is not, then it needs to be categorised.

The AICIS categories are based on health/environmental risks and the importation volumes of the individual chemical and are listed below.

The only instance in which a specific chemical must be approved by AICIS is after determining that it is not a listed chemical, and assessing the health and environmental risks, it is determined that the chemical is assessed.

The following is a guideline to the process we follow for an assessed chemical.



  • Confirm the type of assessment – human health and/or environment.
  • Data Gap analysis – review current data set with respect to the ACIS information requirements
  • Research and compile the required information including review of analogue data and applicability of information for submission. This includes reviewing international data (REACH).
  • Provide regulatory advice and preparation of reports and data for submission for an assessed’ application with AICIS. Access to a relevant IUCLID file can simplify this process.
  • Preparation of the IUCLID file for submission
  • Application submission
  • Application management with AICIS, finalisation and outcomes

The data gap analysis defines the issues and associated costs that will be encountered introducing a new assessed chemical into Australia.