Our compliance monitoring program

Our goals

The objectives of our monitoring activities are to:

• promote awareness of obligations under our laws
• check that record-keeping obligations are being met
• identify and manage cases of non-compliance

We use a risk-based approach and focus on introducers at higher risk of non-compliance as well as introductions that pose a higher risk to human health and the environment. We also modify our monitoring activities to accommodate emerging risks.

Our monitoring activities 

• Check that an introducer is registered with us at the correct level. 
• Check that an introducer has correctly categorised their introductions and has the required information to justify their introduction category. 
• Identify non-compliance and manage it. 
• Check that an introducer has met their reporting obligations.

Learn more about how we work with introducers / regulated entities

The types of non-compliance we monitor

We continually evaluate compliance risks when planning and carrying out compliance monitoring activities. We monitor these compliance risks associated with our laws about introducers of industrial chemicals:

• failure to register their business, or register at the correct level
• failure to identify industrial chemicals that they are manufacturing or importing
• failure to categorise introductions
• incorrect categorisation of introductions, including:
  • use of new animal test data in contravention of the ban or restrictions
• provide false or misleading information to us
• failure to report new hazard information
• failure to provide information on request
• failure to keep records of chemical introductions

Risk indicators

To help inform our monitoring activities, we assess a regulated entity's compliance risk against obligations with our laws. The risk indicators may have a positive or negative effect on the introducer’s final risk rating. 

Our focus is on regulated entities we assess as being a higher relative risk of non-compliance. These entities will be subject to more regular and detailed monitoring to encourage compliance.

For example, a business with a history of non-compliance under AICIS or our previous scheme (NICNAS) is deemed to be a higher risk and we are likely to monitor their compliance more closely than a business with a good compliance history.

Our monitoring work by introduction category

We monitor compliance across a proportion of all categories. We present our findings to an introducer so they can respond before we finalise the outcome. We advise all introducers of the final outcome.

Listed introductions

A listed introduction is the introduction of a chemical on the Inventory (industrial chemicals database). Chemicals on the Inventory are available for industrial use in Australia, provided an introducer can meet terms and conditions we set (if any).

We check that:

• the introducer is meeting their record-keeping obligations
• that the chemicals they are introducing are on the Inventory
• the introduction is authorised under the defined scope of assessment (if there is one)
• the introducer is meeting any conditions related to the introduction or use of the chemical

Exempted introductions 

An exempted introduction is where the risk of the introduction to both human health and the environment is very low.

We check that the introducer can provide a list of their exempted chemical introductions and records of the information they used for categorisation. 

Reported introductions 

A reported introduction is where the risk to both human health and the environment is low.

We give priority to introductions that we consider to pose a higher risk based on the information given in the pre-introduction report. We will also select a proportion of reported introductions that we believe may present a higher risk of non-compliance.

We use the information given in the pre-introduction report and any other information we have to validate the reported categorisation.  

Assessed and commercial evaluation authorisation introductions

An assessed introduction is where the highest indicative risk of an introduction to human health or the environment is medium to high.

A commercial evaluation authorisation (CEA) is a time-limited authorisation we can grant for the purpose of testing a chemical's commercial viability in Australia.  

Introduction terms on a certificate or a CEA mainly inform our monitoring work. We generally focus on introductions of particular concern and may also consider an introducer’s compliance history.  

The main purpose of our monitoring is to check that an introducer is meeting their reporting obligations and the terms of their certificate or CEA.

If we identify non-compliance

All instances of non-compliance we identify will be referred for case management as an apparent contravention of the Industrial Chemicals Act 2019.

Learn about our compliance and enforcement powers

Evaluation and reporting

We regularly evaluate our compliance monitoring work for efficiency and effectiveness. 

We report on our compliance monitoring activities as part of the Department of Health and Aged Care's Annual report.

Our compliance monitoring principles

We follow a set of principles and aim to minimise impact on introducers.

• Risk-based: Our risk-based methods help inform our monitoring decisions and compliance activities. We use available information on the introducer and the chemicals they’ve introduced. 
• Proportionality: Apply a proportionate approach to non-compliance. A response is assessed based on all the available information about the identified issues. 
• Timeliness: Carry out regular compliance activities and respond to queries and concerns in a timely way. 
• Transparency: Clearly articulate our compliance findings to introducers, allowing them to respond before we finalise. 
• Accountability: Ensure that compliance activities are consistent with legislation and the compliance monitoring framework. Make well-considered and accurately documented decisions. 
• Fairness: Our trained staff and contractors carry out monitoring activities impartially and objectively. 
• Continual improvement: Regularly review our compliance monitoring activities based on knowledge gained from previous monitoring activities.