Video — assessed chemical introductions

Slide 1

Hello, in this presentation you’ll get a general overview on assessed chemical introductions under AICIS, the Australian Industrial Chemicals Introduction Scheme.

Slide 2

You’ll learn about: 

• assessed introductions and the different types of certificate assessments
• the assessment process and 
• your rights as a certificate holder 

I’ll also briefly touch on our assessment application process.

Slide 3

This part covers assessed introductions and the different types of assessment certificates you can apply for. 

Slide 4

What is an Assessed Introduction?

An introduction is generally categorised as assessed if it doesn’t meet the criteria for an exempted or reported introduction, and it’s not a listed introduction (which is a chemical on the Inventory).

An assessed introduction means that, because its risk is medium-to-high, we need to assess the chemical before you can introduce it. 

Your introduction is authorised as assessed if:

• the introducer holds or is covered by an assessment certificate issued by AICIS, and 
• the introduction is within the terms of the assessment certificate. 

This introduction category is the only pathway for listing on the Inventory. It’s generally comprised of industrial chemical introductions that pose a medium to high risk to human health and/or the environment. However, even if your chemical introduction does not pose a medium to high risk to human health and/or the environment you may access the assessed introduction pathway if you wish your chemical to become listed on the Inventory. I will provide more details on this aspect later in the presentation. 

Slide 5

A major objective of the reforms that led to AICIS is to reduce red tape and regulatory congestion. The reforms do this by reducing pre-market assessments by approximately 70%. Chemical introductions categorised as exempted or reported do not require premarket assessments. These chemicals can be introduced to the market more quickly. 

Medium and high risk introductions fall into the assessed category, which require risk assessment by us before you get a certificate authorising you to start introducing. 

Looking at this table, if your introduction meets the criteria for the area coloured red, it poses a medium to high risk to human health and/or the environment. For example, if the indicative human health risk is medium to high and the indicative environment risk is very low or low, your introduction is still categorised as assessed. 

You may wish to watch our categorisation videos to fully understand how to categorise your chemical introduction and determine the indicative human health and environment risks.

Slide 6

If your introduction is in the assessed category, you must obtain an assessment certificate before you can introduce the chemical. The type of assessment you apply for depends on its indicative risk to human health and the environment. 

If the indicative risk for both human health and environment is medium to high, you must apply for an assessment with a health and environment focus. 

If the indicative risk for human health is medium to high and the indicative environment risk is very low or low, you must apply for an assessment with a health focus. In this situation, we don’t need to undertake a detailed assessment of the risk to the environment because there is less concern for the environment risk based on the categorisation results. 

If the indicative risk for human health is very low or low and the indicative risk for the environment is medium to high, you must apply for an assessment with an environment focus. 

If the indicative risk for both human health and the environment is very low or low, then you can introduce under the reported or exempted categories. Alternatively, you can choose to apply for an assessment, which you might do if you want the chemical listed on the Inventory. In this case you’d apply under the very low to low risk assessment type. 

Slide 7

This rather busy slide sets out an overview of the information we require for each different type of assessment certificate. The reason it’s so busy is because the information we require for an assessment application varies by the type of assessment certificate. So across the top we’ve got the application types in different colours, and down the side we’ve got all the kinds of information that you might need. 

A new feature of AICIS is the integration of IUCLID into the Business Services Portal for chemical information submission. IUCLID is the international standard for exchanging chemical information and includes OECD harmonised templates for submitting chemical information to regulatory agencies in a growing number of countries globally. If you are importing a chemical, you could ask your overseas supplier to provide you with the relevant information already in the IUCLID format.

For this reason, we have referenced IUCLID sub-sections and document types down the side to identify the information requirements for each of the certificate assessment application types. The sub-sections indicate the type of information that is required to be submitted, for example physico-chemical properties of a chemical are required in each application type whereas toxicological information is only required for the first two applications. The document type refers to the specific endpoint information for each sub-section. For example identification, composition and analytical information are required in the general sub-section.

You will note that the first application type, which is health and environment focus, requires an applicant to provide the most chemical information. As we move from left to right, the information requirements decrease. You’ll need the lowest level of information to support a very low to low risk assessment application. 

Again, this slide is just an overview of the information requirements by application type. We will add a full list of information requirements for each type of application on our website. 

It’s important to note that even though information for an endpoint may not be required based on the application type, you must provide all the information you hold. This means that if you have information for such an end point, you must give it to us with your application. Also, if you receive or find out about additional information while we are assessing the application, you must give that information to us as soon as you have got it. If you do not have the required information (for example, because your overseas supplier regards this information as their confidential business information), you can organise for a chemical data provider to give the required information in the application directly to AICIS via the Business Services Portal. 

Slide 8

As with NICNAS, there will be situations under AICIS when we can reduce your assessment fees. 

Reduced fees apply for consolidated applications. You can use this type of application when there is more than 1 chemical and the chemicals all have a similar structure and the same use. If this applies to your introduction, we can reduce the application fee for the second, third and subsequent chemicals. Under NICNAS, these types of applications are known as modular notifications – for a group assessment.

Reduced fees also apply for multi-component introductions. These are introductions that are made up of 2 or more components that are manufactured, brought into the country, and used together but do not meet the definition of a single UVCB substance. The UVCB criteria only define a proportion of chemicals that contain more than one component and are manufactured, brought into Australia and used together. There are chemicals that do not meet the UVCB criteria because they comprise of components which are identifiable and present in fixed proportions, and yet, as with UVCBs, those components are not separated during their introduction and use. 

An example of a multi-component introduction could be an application where there is more than one stereoisomer. In this case we’ll charge for the primary chemical only. Subsequent chemicals in the application will be free of charge. 

While we’ll issue a separate certificate for each component and list the components separately on the Inventory, the introduction will be limited by the scope of the assessment which will specify that the chemicals can only be introduced as part of the multi-component introduction. This limitation will become one of the terms of the Inventory listing, when the chemicals are eventually listed on the Inventory – for more information about how Inventory listings are defined by their terms including a defined scope of assessment, you can see the separate video dedicated to the Inventory. 

You can choose a comparable hazard assessment type for a reduced fee if your chemical has been assessed for human health and/or the environment by certain Australian or overseas agencies such as by Health or Environment Canada or the Therapeutics Goods Administration (TGA), similar to the arrangements in place for NICNAS assessments. 

To use a comparable hazard assessment, you must ensure that the assessment and data supporting your application provide enough information on the hazards of the chemical to enable us to do a risk assessment. Otherwise, we may ask for additional information during the assessment. The information requirements around using a comparable hazard assessment depend on your introduction’s indicative risk.

For use of this reduced fee category, if your introduction’s indicative risk is medium to high for environment only, the report you’re using to support your application must cover environment hazards. Similarly, if your introduction’s indicative risk is medium to high for human health only, the report you’re using to support your application must cover human health hazards. 

As well as a reduced fee for these assessments, international assessments can also be used to categorise your chemical introduction. If the assessment is from an overseas body listed in the Industrial Chemicals (General) Rules (or General Rules for short) and the risks to human health and/or the environment are the same or lower than overseas and can be managed in Australia, the indicative risk to human health and/or the environment can be low. If it’s low for both, this means that your introduction can be in the reported category.

Slide 9

This part of the presentation will cover the risk assessment process when you apply for a certificate.

Slide 10 

Who can apply for a certificate?

Under NICNAS (the Industrial Chemicals Notification and Assessment Act), a notifier – that is, a manufacturer or importer of a new industrial chemical with a genuine intent to introduce – may apply for an assessment certificate. 

By contrast, under the Industrial Chemicals Act, anyone can apply for an assessment certificate if they are an Australian business with an Australian Business Number (ABN), or an overseas business with an Australian Registered Body Number (ARBN). Like NICNAS, joint assessment certificate applications are allowed under AICIS. 

Slide 11

This is a basic flowchart for the assessment process after you submit an assessment certificate application under the Industrial Chemicals Act. 

As we do under NICNAS, we‘ll screen your application and ask you for any missing information. 

We’ll also ask for more information during our assessment if it’s needed to determine the introduction’s risk. We’ll ask for any extra information via our online portal and give you at least 20 working days to respond. You’ll also be able to apply for an extension of the deadline to respond. If you don’t provide the information or respond, we may consider the application to be withdrawn. 

During the assessment process we may seek risk management advice from Safe Work Australia, the Department of Health, the Australian Competition and Consumer Commission or other bodies that are listed for this purpose in the General Rules. Additionally, under the Industrial Chemicals Act we must seek the advice of relevant risk management bodies if we intend to not issue an assessment certificate or include a condition of introduction or use. I will talk about conditions relating to the introduction and use later in this presentation. 

We’ll give a draft assessment statement to each applicant before we make a final decision on the application. We’ll give you at least 20 working days to provide comments and we’ll consider any submission before we make our decision.

Before we issue an assessment certificate, we must be satisfied that any risks to human health or the environment can be managed. Our legislation says that we must not issue a certificate if we’re not satisfied that any risks to human health or the environment can be managed. 

If we decide to issue a certificate, we’ll issue one to each applicant and publish an assessment statement on our website. If we make risk management recommendations, we will forward them to risk managers and report on the outcome of our recommendations via our website.

Slide 12

There are some important differences between the old and new schemes when it comes to assessment timeframes and how the assessment clock works. 

Under NICNAS, we have a 90 calendar day clock which starts when we decide an application is valid. If we stop the clock, it restarts with another 90 calendar days. The clock is completed when we issue a draft assessment report. 

Under AICIS, the entire assessment timeframe is 70 working days from start to finish – kicking off when you submit your application. However, it can be adjusted by mutual agreement. We’ll pause the clock if we request information from you and when we provide a draft assessment statement. The clock resumes when you get back to us with the relevant information or submission. We will also pause the clock if we are consulting with a risk management body.

Slide 13

We’ll issue assessment certificates through our online portal, AICIS Business Services. The certificate will include the proper name for the industrial chemical. But, if we’ve approved the proper name to be protected as confidential business information (CBI), we’ll replace it with an AICIS Approved Chemical Name or AACN for short. For more information about CBI and AACNs, you can watch the video dedicated to CBI. 

The terms of the assessment certificate will include the defined scope of assessment. This describes the parameters of our assessment. It defines the scope of the authorised introduction and use, which we use as the basis for any recommendations on risk management. The defined scope of assessment will become a term of the Inventory listing, when the chemical is eventually listed on the Inventory. This means that if any other new proposed introduction of the chemical falls outside this defined scope, introducers will need to re-categorise their introduction. 

We can also impose a condition of introduction or use as a term on your certificate. Under AICIS, conditions of introduction or use are limited to the following:

• a)    the total volume of the chemical that can be introduced 
• b)    the site of introduction or use and
• c)    the duration of introduction 

The terms of the certificate will also include any specific requirement to provide information. This is an obligation on an introducer to provide particular information about a chemical introduction similar to secondary notification requirements under NICNAS. This information requirement will also be transferred across to the subsequent Inventory listing, so that all introducers of the chemical will have the same obligation to provide information. For more information about the terms of Inventory listings and what they mean, you can watch the video dedicated to the Inventory. 

Slide 14

When we finish an assessment, we must publish an assessment statement on the AICIS website. The statement will include:

• the chemical’s proper name (unless we’ve approved an AICIS Approved Chemical Name, in which case we’ll publish the AACN instead of the proper name)
• the end use for the chemical (unless we’ve approved a generalised end use to protect the end use as confidential business information, in which case we’ll publish the GEU instead)
• the defined scope of assessment
• a summary of the assessment and any risks to human health or the environment from the introduction or use of the chemical 
• the means for managing any risks we’ve identified by way of:
  • i) recommendations about the introduction or use of the chemical
  • ii) any conditions imposed to manage risks from introduction or use
  • iii) specific requirements to provide information 

And lastly:

• any other information about the safe introduction and use of the chemical that we consider relevant

Don’t forget to check out our video that discusses protection of confidentiality of proper name or end use. We’ve also published information about these topics on our website.

Slide 15

This part covers certificate holder rights – what your certificate entitles you to do, and how you can change the operation of your certificate in the future.

Slide 16

A holder of an assessment certificate is a person that AICIS issues an assessment certificate to. There can be more than one certificate holder, if more than one person has applied together for the assessment certificate. If this is the case, they are known as joint holders of the certificate. Any certificate holder is authorised to introduce the industrial chemical under the terms of the certificate, provided they’re registered with AICIS.

Assessment certificate holders can apply to vary the terms of their certificate.

This includes applying to vary the defined scope of assessment. For example, an introducer might want to do this to expand the original use of the chemical authorised by the certificate as a surface coating to include a use in cosmetics. 

Other reasons you might need to apply for a variation include:    

• •    if you wish to vary a condition. For example, if we imposed a condition restricting the manufacture location of the chemical and you wish to change this location or 
• •    to vary a specific information obligation. 

If there’s more than 1 certificate holder, you must make a joint application to vary the terms of the certificate.

A holder of an assessment certificate can apply to add a person to be covered by a certificate. A person covered by a certificate is distinct from a joint holder of the certificate and has fewer rights. However, a person covered by a certificate is authorised to introduce the industrial chemical in accordance with the terms of the assessment certificate. If there is more than one certificate holder, each certificate holder must consent before a new person can be authorised to be covered by a certificate. A person covered by a certificate cannot apply to add another person to be covered by a certificate.

A certificate holder may apply to be removed as a holder of a certificate if there are joint certificate holders. Other holders of the certificate don’t need to consent but consent is required from each certificate holder if a person applies to be added as a holder of the certificate.

With the consent of each holder of the certificate, a certificate holder may also apply to cancel the certificate. 

Slide 17

This section of the presentation will cover applying for an assessment certificate.

Slide 18

You must apply for an assessment certificate via the AICIS Business Services portal. The portal will cater for joint applicants, chemical data providers and even agents nominated to complete the application on your behalf. You can apply to protect confidential business information in the portal as well. The Business Services portal will allow you to generate and pay invoices for your application, and even submit the required information online. As mentioned before, we’ve integrated IUCLID into our application process so that you can either upload a validated IUCLID dossier to satisfy your information requirements or add the required information via the Business Services Portal. We’ll publish a video on applying for an assessment on our website in the coming weeks. 

Slide 19

Thanks for your attention! We hope this helps you understand the new scheme and make it work effectively for you and your business. For more information, including guidance material and links to our legislation, please visit our website.