Approval of Industrial Chemicals in Australia
Industrial Chemical Approvals in Australia
Chemicals within Australia are regulated under a number of schemes and if a chemical is not for a therapeutic, agricultural, veterinary or food use, it is by default, considered to be an industrial chemical.
Australia’s industrial chemical regulation scheme, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), is being replaced by a new system known as, the Australian Industrial Chemicals Introduction Scheme (AICIS). It is hoped that processes under the new system will make regulatory effort more proportionate to risk, promote safer innovation by encouraging the introduction of lower risk chemicals and will greater protect the Australian people and the environment from any harmful effects of industrial chemicals.
This change in the industrial chemical regulatory scheme from NICNAS to AICIS has occurred from 1st of July 2020. Underpinning the change is the Industrial Chemicals Act 2019, which will be supported by the Industrial Chemicals Rules and Industrial Chemicals Categorisation Guidelines, which together set out technical and operational details of the new scheme and the requirements introducers need to meet to categorise their chemicals. In addition, transition rules have also been established to manage the changeover from the old scheme to the new system.
Regulation
Whether they are imported or developed here, and barring a few very low risk exceptions, new chemical entities introduced into Australia need to be approved and registered by the Australian Government. This applies to chemicals that can be used for a variety of purposes including;
· Agricultural and Veterinary
· Therapeutic
· Cosmetic
· Food Chemicals
· Industrial
Regulation of the chemicals in each of these groups falls to the relevant authorized agency and the table below shows which agency is responsible for the regulation of each chemical category.
What is Changing
The new scheme is the result of a reform process to improve the regulation of industrial chemicals in Australia. The main purpose of the new scheme will be to help protect the Australian people and the environment by assessing the risks of industrial chemicals and providing information and recommendations to promote their safe use. Key changes are summarized in the following table.
Six New Categories of Introduction
There are to be six new categories of chemical introduction under the new AICIS scheme. This will allow for greater flexibility and less regulatory effort.
For example, a chemical introducer may eventually desire to have a chemical listed on the AIIC inventory, but the chemical is not yet at commercial quality or volume. In this case the introducer may apply for an assessment certificate for chemical introductions meeting Exempted or Reported criteria.
Those chemicals already registered on the old NICNAS database will not have to reregister on the new system since registrations will automatically roll over to the new system.
The 6 categories are;
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