About chemical evaluations
Evaluations help us to achieve our main goal of helping to protect human health and the environment by providing information and recommendations about managing the risks of industrial chemicals.
Chemicals already available for an industrial use in Australia, or matters related to such chemicals, can be evaluated under AICIS. This includes chemicals that are:
- listed on the Inventory
- under a current certificate
- introduced under the Assessed, Reported or Exempted categories
- excluded from other parts of the Industrial Chemicals Act 2019 (the Act)
For example, we can evaluate transshipped chemicals. This is despite the fact that they are excluded chemicals and do not need to be categorised.
Evaluations allow us to:
- continue to assess chemicals listed on the Inventory
- identify and quickly assess chemicals of concern
- respond to emerging concerns and/or new information, including new information provided by chemical introducers
- generate and publish up-to-date information on chemicals and their risks (this information will support risk management across Australia and promote public awareness)
- maintain the Inventory's accuracy (if a chemical is wrongly listed on the Inventory, we can remove it and replace it with the correct chemical)
What can evaluations cover
- a single chemical
- a class or group of chemicals
- a specific use
- a specific hazard
- a specific exposure
- specific circumstances of a chemical introduction
What prompts us to do an evaluation
The main reason we will do an evaluation is to protect human health and/or the environment from any risks associated with industrial chemicals. This broad aim covers a range of possible circumstances where an evaluation might be needed. Here are the most likely scenarios.
Ongoing work evaluating chemicals
We will continue to evaluate previously unassessed chemicals that are listed on the Inventory, continuing the work started under the NICNAS IMAP framework.
We will publish a list of planned evaluations under AICIS.
New information from industry or the public
New information can be voluntarily supplied to us. It can also be information that chemical introducers must legally provide (under the terms of an assessment certificate or an Inventory listing).
Examples of new information
A new or changed use
A new or changed use for a chemical may lead to more or different human exposure, or more or different release to the environment. This can be from changes in volume, concentration, formulation method or product types, or changes to the method(s) of disposal.
In some circumstances, you may have to apply for a variation to a certificate/authorisation or to the Inventory listing.
New hazard information
New hazard information might include toxicological test data that were not available to us when we previously assessed a chemical. It could also be derived from a workplace incident that showed an adverse effect. New ecotoxicological data might suggest that there are new or changed environmental consequences of the chemical’s use.
This information may indicate that current known exposure can lead to greater risk than previously determined and we may decide to do an evaluation.
New information or requests from risk managers
A risk manager might report the following new information to us:
the identification of nanoforms of a chemical, for which the hazards or behaviour are not well characterised
health effects from consumer products that can be linked to a common chemical ingredient, such as allergic reactions associated with a particular preservative
In these circumstances, we may decide to do an evaluation.
New information from international regulators
An international regulator might tell us that a chemical is now banned or restricted in their country. If the chemical can be introduced in Australia without comparable controls, we may do an evaluation to consider the risks and determine appropriate controls.
Use of available information
A diverse range of information is required to produce robust evaluations. These data include hazard characteristics and potential exposure to humans and the environment. In most cases, this information will describe:
- a substance's toxicity
- the volume and circumstances in which the chemical is imported, manufactured and/or used in Australia.
We will draw on a range of publicly available sources for evaluations including:
- international and national assessments and databases
- assessments conducted under NICNAS or AICIS
- literature reviews
- environmental and biomonitoring data
- advice from other regulators, both national and international
- external peer reviews
- analogue, in vitro, in chemico and in silico data
- biological and environmental monitoring data, and
- computational modelling data.
Post-market monitoring activities
Our post-market monitoring activities will help us identify whether we need to evaluate a potential risk relating to a chemical introduction.
Misidentified chemicals on the Inventory
We will do an evaluation if we find a mistake in the identity of a chemical listed on the Inventory. We do this to address any concern about chemical risks arising from the mistake. The evaluation means we can correct any misidentification and remove the wrongly listed chemical. We can then add the correct chemical to the Inventory, provided the risks of the chemical introduction are manageable.
What happens during an evaluation
Chemicals under certificate
We will send a notice to each certificate holder that states the reason(s) for the evaluation and the time period for it.
What this means to a certificate holder
While we do the evaluation, your certificate authorisation does not change. In other words, you can still introduce the chemical. We will consult with you if we are considering the need to change your authorisation to continue introducing. This might be, for example, to add a condition to a certificate.
Chemicals not introduced under a certificate
These type of evaluations include chemicals that are:
- listed on the Inventory
We will publish a website notice about the evaluation with details of the:
- subject of the evaluation (what we are evaluating)
- reason(s) for the evaluation
- time period for the evaluation
If this evaluation is part of our ongoing evaluations work, it will also be on our evaluations list.
Existing authorisations are not affected/do not change while we do our evaluation. For example, you can continue introducing by meeting the current Exempted criteria.
We will consult stakeholders if we are considering the need to change the regulatory approach to a chemical. For example, a change might include adding a condition to an Inventory listing.
What we'll consult about
We consult during evaluations to get feedback from stakeholders and the public on:
- the reason(s) for the evaluation
- details of our risk assessment, including hazard and exposure assessment, approach and conclusions
- our risk recommendations
- national or international concerns
- proposed regulatory changes, such as adding a condition to an Inventory listing or certificate
Consultation is also an opportunity for anyone to give us new information about the subject of the evaluation.
We consult publicly on evaluations except for chemicals under a current certificate.
Consultation is critical. We will ask for feedback from industry and the general public.
When do we consult?
Public consultation can occur:
- during the course of the evaluation
- after we publish the draft evaluation statement online with our preliminary conclusion. We consider feedback before we issue the final evaluation statement
Certificate holder consultation
We will consult with certificate holders when our draft evaluation statement is ready. We will send the draft evaluation statement to each certificate holder. You will have at least 20 working days to provide a written response.
Prescribed bodies consultation
During an evaluation, we may consult with 'prescribed bodies'. These are generally Australian standard-setting bodies and/or state and territory risk-management agencies. We will most likely do this if we are considering recommending a change to the regulatory status of a chemical, such as
- varying a certificate
- varying an Inventory listing
- cancelling a certificate
- removing a chemical from the Inventory
Calls for information
Voluntary calls for information
These usually apply to evaluations of chemicals other than those solely covered by assessment certificate(s).
Most of the time, we can finish an evaluation with the information we already have or information obtained through consulting.
We may initiate a voluntary call for information if we need more targeted information and if we think it will help to ensure the evaluation’s quality and accuracy. We will make these requests during the course of an evaluation.
We may send calls for information to specific stakeholder(s) such as introducers of a particular chemical and industry sector(s) that represent particular uses.
For chemicals under certificate, we usually send an information request to a holder of, or a person covered by, an assessment certificate. These requests may be mandatory.
Website notice – Voluntary calls for information
We will publish voluntary calls for information notices on our website, including details of the information we need. The time frame to respond will be at least 20 working days.
Mandatory calls for information
If we think a stakeholder has the information we need for an evaluation, we can issue a mandatory call for information. Our legislation only permits us to make a mandatory call for information if:
- we haven’t been able to get the information by any other means
- the information is necessary to confirm whether a chemical or class of chemicals is being introduced, or is in use, in Australia
- the information is necessary to establish if there are risks to human health or the environment associated with the chemical
- the information is necessary for Australia to meet its obligations under international agreements or arrangements
We can make a mandatory call for information to introducers of a chemical during the previous 12 months or in the next 12 months and other people we believe have information relevant to the evaluation.
For an evaluation of a chemical under a current certificate, we can make a mandatory call for information by written notice to any holder of, or person covered by, the certificate.
We will make a mandatory call for information during the course of an evaluation if needed. The time frame to respond will be at least 20 working days.
Penalties apply if you receive a mandatory notice and do not provide the information in the time stipulated.
We had similar powers to make a mandatory call for information under our previous legislation. We rarely used that power, and expect that we will rarely use mandatory calls for information under our new legislation.
Why would we make a call for information?
We will make a mandatory call for information if we think we can obtain information that will:
- help us make more risk-proportionate decisions through the provision of evidence that will remove the need to make precautionary assumptions because we only have limited information
- avoid uncertainty in risk assessments and conservative estimates and ‘uncertainty factors’ that multiply the level of perceived potential risk
- help us gather more evidence about the actual use and effects of a chemical so we can make less precautionary conclusions
Information we call for can be used to identify:
- any new risks, including new hazards and/or new exposure
- risk management actions and options
We can also make calls for information about newly identified hazards or sources of exposure when there is limited reference material available. In this case, we will need to gather more current and up-to-date information about real-time use and effects.
Calls for information will not mean anyone has to conduct more tests or otherwise generate additional data. They will request or require information that is already available or easily accessed.
What about confidential information?
When you send us information in response to a consultation or call for information, you can flag it as confidential. To do this you must submit a form and nominate a contact person. We will then treat this information as confidential. If we need to publish the information that you have flagged as confidential (for example, in an evaluation statement), we will send a notice to the nominated contact person. The notice will outline our intent to publish the information and provide information holder an opportunity to formally apply for protection of the information as 'confidential business information' (CBI). If we approve your CBI application, your information becomes 'protected information'. We are not allowed to disclose it except in certain defined circumstances, with penalties for unauthorised disclosure.
Evaluating a chemical with approved CBI (AACN or generalised end use)
If a chemical’s identity and/or end use are already protected as the result of a previous approved application for CBI, then we must not disclose the protected information in the course of an evaluation. This means that only the AICIS Approved Chemical Name (AACN) and/or generalised end use would be published .
The possible outcomes following publication of an evaluation statement are:
- no regulatory action is required
- varying an assessment certificate
- cancelling an assessment certificate
- varying an Inventory listing
- removing an Inventory listing
- adding an Inventory listing of a chemical previously regulated elsewhere
- adding an Inventory listing of a chemical previously misidentified
- reviewing confidential business information (CBI)
We must publish all evaluation statements on our website at the end of an evaluation. They summarise our conclusions about any risks posed by the chemical and any recommendations (if applicable) to control those risks.
An evaluation statement’s purpose is to provide introducers and the public with concise information about any identified risks and the means of managing those risks.
Risk recommendations can include recommendations to risk-management agencies, such as national standard-setting bodies and/or state and territory risk managers. If the evaluation concludes that regulatory changes under AICIS’s legislation are required to control the risk(s), this may lead to one of the further outcomes set out below.
For chemicals that are listed on the Inventory, evaluation statements will be linked to the corresponding Inventory listing. For chemicals under certificate, the evaluation statement will be linked to the corresponding assessment statement.
Assessment certificate variation or cancellation
An evaluation statement can recommend that we vary a term of assessment certificate. This could be a variation to:
- the defined scope of assessment
- conditions relating to introduction or use (which can only be in relation to volume, site or period of introduction/use)
- requirement(s) to give us information
Alternatively, an evaluation statement can recommend that we cancel an assessment certificate.
The statutory safeguards we must meet before we can vary or cancel a certificate are:
- the evaluation must conclude the variation or cancellation is necessary to manage risk. That is, the risk(s) cannot be managed any other way
- we must have consulted with prescribed bodies for a cancellation or variation that involves adding, removing or varying a condition of introduction or use
- we must give written notice to each certificate holder of our proposal to cancel or vary. Certificate holders must have at least 20 working days to make a submission. We must consider all submissions before we make a final decision
Any decision to vary an assessment certificate is reviewable under our legislation.
Inventory listings – variation or removal
An evaluation statement can recommend that we vary a term of an Inventory listing, which could be a variation to the:
- defined scope of assessment
- conditions of introduction or use (which can only be in relation to volume, site or period of introduction/use)
- specific requirement(s) to provide information to us
Alternatively, an evaluation statement can recommend that we remove a listing from the Inventory.
The statutory safeguards that must be satisfied before we can vary or remove an Inventory listing are:
- the evaluation must conclude that variation or removal is necessary to manage risk. That is, the risk(s) cannot be managed any other way. This is where we would consult with 'prescribed bodies' to make this conclusion
- OR that a chemical has been wrongly listed on the Inventory and must be removed
- public consultation must have occurred during the evaluation
- notice of the proposed variation or removal must be published at least 20 working days in advance
Listing a previously regulated chemical
A previously regulated chemical is a chemical that was previously regulated under another Commonwealth law. Under our legislation, we can transfer these chemicals to our Inventory. This process might happen because of a government decision to move regulatory responsibility for a set of chemicals to us.
For example, in the past we have added to our Inventory chemicals that are ingredients of products that were previously regulated as therapeutic goods, where a government decision was made to change the regulatory regime for those products.
The statutory requirements for this power to be exercised are:
- the evaluation concludes that any risk(s) can be managed. This is where we may have to consult with 'prescribed bodies' to make this conclusion
- no assessment certificate for the chemical is in force
- the chemical is currently in use in Australia
Correcting the Inventory
We can add a chemical to the Inventory to replace a chemical that was misidentified. That is, to correct a mistake in chemical identity in a current Inventory listing.
While there is no application process for this, we may conduct an evaluation of a potential misidentification based on information we receive from industry or the public.
The legislation requires:
- an evaluation, with public consultation
- the evaluation to conclude that there has been a misidentification
- that there is no assessment certificate in force for the proposed newly listed chemical.
Confidential business information (CBI) review
We will only review CBI if a completed evaluation recommends it is necessary because there may be public interest in disclosing the CBI. If this happens, the CBI will be subject to a re-application of the statutory test for CBI protection.