Video — reporting and record-keeping obligations

Slide 1

Hi, this video provides a general overview of your reporting and recording keeping obligations under AICIS, the Australian Industrial Chemicals Introduction Scheme.

Slide 2

All introducers, which simply means anyone who imports or manufactures an industrial chemical into Australia, have certain obligations under the Industrial Chemicals Act (the Act).

These obligations are highlighted in this chart. Starting from registering your business on the Register of Industrial Chemical Introducers, to knowing the details of your introductions and categorising them appropriately. Details of these obligations, including applying for an assessment certificate, and chemicals listed on the inventory, are covered under separate videos and guidance.

The focus of this video will be on the information you may be required to submit to us as part of your reporting obligations, and the types of records you will need to keep and provide to us if asked.

Slide 3

Each introduction category has its own set of regulatory obligations. The first part of this video will step you through the information you are required to submit to us for Exempted and Reported introductions.

Slide 4

The first scenario we’ll discuss is if you have categorised your introduction as Exempted. These are chemical introductions that are considered to be very low risk. In this case, you may need to provide a once-off ‘post-introduction declaration’ for the relevant chemicals introduced for the first time during the previous registration year. You’ll be able to submit this declaration online via your AICIS business services account.

All post-introduction declarations must be submitted by 30 November with the first not due until 2021, but I’ll provide more details on this later in this video.

Next we’ll go through which types of Exempted introductions this declaration applies to.

Slide 5

So a post introduction declaration only applies to introductions categorised as Exempted where either the highest indicative risk is very low risk, the chemical is a polymer of low concern, or a low concern biological polymer. There are differences in the prescribed information you will need to provide for these types of Exempted introductions, which we will go through on the next slide.

Slide 6

For polymers of low concern and low concern biological polymers, you need to provide the number of different polymers introduced.
For Exempted introductions where you have determined the highest indicative risk is very low risk you need to provide the following:

• The proper name of the industrial chemical—including the CAS name or IUPAC name and the CAS number if assigned
• The total volume of the industrial chemical introduced during the registration year
• The end use and the maximum concentration at end use.

In addition, if your chemical was introduced for an end use in cosmetics, you need to include a statement as to the specified circumstances that apply in regards to the use of animal test data, if any, in determining the highest indicative risk of your introduction. This is because there are only limited circumstances in which you can use animal test data for these introductions. The circumstances are specified in section 36 (3) of the Industrial Chemicals (General) Rules. More information is provided in another video called ‘Ban on animal test data: meeting your obligations’ available on our website.

Slide 7

You might find in some circumstances that you don’t know the proper chemical name for your introduction as this information is not provided to you by the chemical identity holder.

If this is the case, and the chemical is introduced at 10kg or less during the registration year, you need to provide the names by which you know the chemical, which could be the trade name, and the name of the chemical identity holder, usually your supplier.

If the chemical is introduced at greater than 10kg during the registration year, just like before, you will need to provide the names by which you know the chemical and the name of the chemical identity holder. However, in this case the chemical identity holder will need to provide the proper name and CAS number (if assigned) directly to us before you can submit your declaration.

Slide 8

The next scenario we’ll discuss is if you have categorised your chemical as a Reported introduction. These are chemical introductions considered to be low risk. In this case, you will need to provide a pre-introduction report before you first introduce the chemical. The pre-introduction report must be submitted online via your AICIS business services account. The online form will guide you through the prescribed information specific to your reported introduction type listed from sections 38 to 43 of the Rules

Slide 9

There are 6 different types of Reported introductions as outlined here. Chemicals that are:

• Internationally assessed for both human health and the environment,
• Internationally assessed for human health but not the environment,
• Internationally assessed for the environment but not human health,
• Solely for use in research and development,
• Low risk flavour or fragrance blend introductions; and finally
• Categorised with a highest indicate risk of low risk.

Slide 10

Once you have submitted your pre-introduction report you can immediately introduce your chemical. If any circumstances change in regards to your introduction, you must advise us to vary your pre-introduction report.

You might find again in some circumstances that you don’t know the proper chemical name for your introduction if this information is not provided to you by the chemical identity holder. In this case, you need to tell us the name by which you know the chemical and nominate your chemical identity holder who will provide this information directly to us. Our online system will facilitate this process.

Slide 11

There are 2 important things to note for low risk flavour or fragrance blend introductions. Firstly, unlike the other types, a single pre-introduction report can be submitted for multiple industrial chemicals that are in the flavour or fragrance blend. And secondly, if at the time a pre-introduction report is submitted, the chemical is not listed on the IFRA Transparency list, then additional information is required to be provided to us before you first introduce the chemical. This information can either be provided by the introducer or the chemical identity holder. On the next slide we will briefly go through this additional information required under section 27(5) of the Rules.

Slide 12

The additional information requirements just mentioned are listed on this slide. These are the following:

• The chemical’s proper name (including the CAS name or IUPAC name) and the CAS number (if assigned) 
• Any hazard characteristics of the chemical that you know
• The maximum concentration of the chemical in the flavour or fragrance blend at introduction and end use.

Slide 13

All introducers are required to submit an annual declaration by 30 November of each year. This declaration is about compliance with the categorisation obligations of the Act. Not to be confused with the post-introduction declaration for exempted introductions, no chemical specific information is required to be provided as part of your annual declaration.

Slide 14

This slide shows a high-level timeline of the first year of AICIS to help illustrate a number of key dates as we commence the new scheme. 

Both the post-introduction declaration for Exempted introductions and the Annual declaration for all introducers will not be required for the first year of AICIS as indicated on the timeline in red text. These declarations will be first due on 30 November 2021 and will cover the 14-month period from 1 July 2020 to 31 August 2021.

You will also see, that the new Scheme commences on 1 July 2020 at which point your NICNAS registration – shaded in blue – will transition to an AICIS registration – shaded in Purple – for the remaining 2 months of the registration year. More details on the transitional arrangements are available in another video titled ‘NICNAS to AICIS – Transitions’

Slide 15

This slide illustrates what will be the regular future timeline of AICIS beyond the first year.

Both the post-introduction declaration for Exempted introductions and the annual declaration for all introducers—due on 30 November of each year—will be for the industrial chemicals introduced during the prior registration year, which is represented by the line shaded blue on this slide.

Slide 16

The second part of this video will outline your record keeping obligations that relate to industrial chemicals introduced during a registration year.

Slide 17

The purpose of recording keeping obligations is to ensure that you know the specific details of your introductions and that you are able to demonstrate that you have categorised your introductions correctly.

Slide 18

Starting with the general record keeping requirements, anyone who introduces an industrial chemical (other than an excluded introduction) during a registration year is required to keep records that are necessary to demonstrate the following:

• Each industrial chemical you introduced during the year
• The category of each of those introductions
• The basis on which you determined the category of the introduction, and
• The amount of registration charge payable by you.

In addition to these requirements, you must also keep records that are of a kind prescribed in chapter 4 of the Rules specific to your introduction category. We will shortly go through in more detail the prescribed record keeping requirements for both Listed introductions and then Reported introductions where you have determined that the highest indicative risk is low risk.

It’s important to also note that you must keep records for approximately 5 years, even after you have stopped introducing your chemical.

Slide 19

We will now go through the records you must keep for Listed introductions.

You must keep records of the CAS name and CAS number, or the CAS number and INCI name of your chemical if known to you. If however, a CAS number is not assigned, or you don’t know the CAS number for your industrial chemical, then you must either keep records of the CAS name or the name by which you know the chemical and a written undertaking from the chemical identity holder. The written undertaking must state that the chemical identity holder will provide the CAS name and CAS number (if assigned) to us if requested.

Slide 20

In addition to the chemical identity records, you must keep the following records for your listed introductions.

If there is a defined scope of assessment, then you need to keep records to demonstrate you are introducing the industrial chemical within the defined scope of assessment.

If there are any conditions relating to the chemical’s introduction or use, then you need to keep records demonstrating those conditions are being complied with.
If it includes a specific requirement to provide information to us in relation to your introduction, then you need to keep records that demonstrate those requirements are being met.

Slide 21

Next, we will outline the types of records you must keep for chemicals you have categorised as Reported introductions where the highest indicative risk was determined to be low risk.

These records are in addition to the information you had provided, and support the claims you had made, in your pre-introduction report.

Where appropriate, we will accept written undertakings from your chemical identity holder that confirm that the applicable categorisation criteria have been met and all relevant information will be given to us if requested.

Slide 22

This chart intends to help you visualise the high-level record types you are required to provide us to demonstrate that your introduction is authorised as a Reported introduction where the highest indicative risk is low risk. 

Starting from the left, you must keep records to demonstrate the chemical identity, that your introduction is not medium to high risk, the use and exposure of your introduction, any hazard characteristics, and finally if your introduction is a specified class.

We will now step though each section in more detail and provide examples of records we will accept. These details are also available in a record keeping checklist, which you can download from our website. It’s worth noting that the records we will accept indicate the type and level of information you must keep.

Slide 23

Starting with chemical identity, you need to keep a record of the proper chemical name. This includes the CAS number and either the CAS name or INCI name of your introduction. If a CAS number has not been assigned to your chemical, we will accept either just the CAS name or the IUPAC name.

If you don’t know the proper chemical name, you will need to keep a record of the name you used to refer to the chemical in your pre-introduction report.

You will need to keep a record of the names of any product containing your chemical you have imported.

If your chemical is a high molecular weight polymer and its human health exposure band is 4, we will accept a GPC analysis report to demonstrate the:

• number-average molecular weight
• weight-average molecular weight 
• polydispersity index
• percentage by mass of molecules with molecular weight that is < 1000g/mol 
• percentage by mass of molecules with molecular weight that is < 500g/mol.

If you don’t have this information we will accept a written undertaking from your supplier or manufacturer confirming it is a high molecular weight polymer. They must provide records to prove the polymer molecular weight details if we ask for them.

Slide 24

The next type of records are those required to demonstrate that your introduction is not medium to high risk.

If you don’t know the proper chemical name, we will accept a written undertaking from the chemical identity holder (usually your supplier or manufacturer) confirming that your introduction does not meet the criteria for medium to high risk and that they will be able to provide the following types of records if we ask for them.

To demonstrate that your chemical: is not listed in Annex III of the Rotterdam Convention; Part 1 of Annex A, B or C of the Stockholm Convention; or section 71, 72 or 73 of the General Rules, we will accept a signed and dated declaration that these checks took place.

We will also accept a declaration that a search of the Inventory was also carried out confirming that the chemical was not listed on the Inventory with conditions that would be contravened.

To demonstrate that your chemical is not fully fluorinated you must keep records to prove the chemical does not contain a sequence of greater than or equal to 4 but no more than 20 fully fluorinated carbon atoms.

To demonstrate that your chemical is not a medium to high risk polyhalogenated introduction, we will accept these record types to prove one of the following:

• a signed and dated declaration that a check took place in which you determined the chemical is not a polyhalogenated organic chemical,
• shipping documents and any associated calculations that shows the total volume introduced in a registration year is ≤ 100kg, or
• a relevant study report demonstrating that the chemical and its known environmental degradation products is not persistent as defined in the Guidelines.

To demonstrate that your chemical is not a medium to high risk nanoscale introduction, we will accept these record types to prove one of the following:

• a safety data sheet or a product information sheet that confirms that the chemical is not introduced as a solid or in a dispersion (if applicable).
• relevant study reports that demonstrate: the chemical does not meet the definition of not soluble as specified in the Guidelines; or the chemical does not consist of particles in an unbound state or as an aggregate or agglomerate, at least 50% of which (by number size distribution) have at least one external dimension in the nanoscale.
• We will also accept an appropriate justification that the introduction of the nanoscale portion of the chemical is incidental to the non-nanoscale portion.

To demonstrate that your chemical is not a persistent gas, we will accept these record types to prove one of the following:

• a Safety Data Sheet or product information sheet that confirms that the chemical is not a gas
• shipping documents and any associated calculations that shows the total volume introduced in a registration year is ≤ 100kg, or
• a relevant study report demonstrating that the chemical is not persistent as defined in the Guidelines.

To demonstrate that your chemical is not an organotin, we will accept these record types to prove one of the following:

• a signed and dated declaration that a check took place in which you determined the chemical is not an organotin, or
• shipping documents and any associated calculations that shows the total volume introduced in a registration year is ≤ 10kg.

Slide 25

The next type of records are those required to demonstrate the use and exposure of your introduction.

To demonstrate your chemical’s end use we will accept a list of product names and their uses, or relevant technical information sheets related to the products containing the chemical.

If the applicable human health exposure band criteria include a concentration upper limit, we will accept a safety data sheet, product labels, technical information sheets or other relevant documents from your supplier to demonstrate the maximum concentration at introduction and at end use. 

If the applicable exposure band criteria includes a human health or environment categorisation volume upper limit, we will accept shipping documents and any other associated calculations to demonstrate that your introduction does not exceed the categorisation volume limit specified in the relevant exposure band criteria. 

If your introduction involves a designated kind of release, we will accept any relevant information you keep on the chemical that demonstrates the type of release.

Slide 26

So moving onto records to demonstrate your chemical’s hazard characteristics.

You will need to keep records to demonstrate any known hazard classifications of the chemical. In this case we will accept a safety data sheet.

If the highest indicative risk for your introduction was determined based on the absence of certain hazard characteristics, we will accept full study reports of the kind mentioned in the Guidelines to demonstrate the absence of these human health and environment hazards that would otherwise result in a medium to high risk introduction. If you don’t have this information you will need to keep the outcomes of the information specified in the guidelines, and a written undertaking from the person who has this information that they will provide it to us if asked.

Slide 27

The final types of records are the additional records you will need to keep if your introduction is considered a specified class of introduction as defined in the Rules.

The first specified class of introduction are ones that involves a designated kind of release into the environment. In this case, we will accept any relevant information you keep on the chemical that contains a record of the location of the release in the environment including all receiving water bodies, and the frequency of the release into the environment. 

The next specified class are biochemicals. In this case, we will accept documentation from your supplier that demonstrates the concentration of any remaining viable cell or cellular components of the organisms used to produce the biochemical; and any known adverse effects of any remaining viable cell or cellular components of the organisms used to produce the biochemical.

For genetically modified products, we will accept documentation from your supplier containing the name of the genetically modified organism from which the GM product was derived or produced; and details of any genetically modified organisms that remains in the GM product as an impurity.

For introductions of UV filters where the human health exposure band is 4, we will accept study reports that contain information about the toxicokinetics and photostability of the chemical both within the meanings given by the guidelines.

If the chemical has an end use in an article with food contact, we will accept study reports or other relevant information that demonstrates the potential for the chemical to migrate to food, as defined in the Guidelines. You will also need to keep a record of any known approvals for your chemical for this type of use by an agency or authority in another country.

And finally, If the chemical has an end use in an article that is a children’s toy or children’s care product, you will need to keep records of whether the article can be placed in the mouth, and if so, the potential for the chemical to be release into the mouth during end use or mouthing. We will accept quantitative information on the extent of the chemical’s transfer to the mouth.

Slide 28

So we have covered off quite a bit of detail relating to the types of records you are required to keep. We will conduct audits as part of our compliance monitoring activities to ensure introducers are complying with their record keeping obligations to demonstrate their introductions are authorised. If we audit your introductions, all requested information must be provided to us within 20 working days. More information on compliance monitoring activities under AICIS will be covered in another video.

Slide 29

And that brings us to the end of this video. I hope it has helped you to gain a general understanding of your reporting and record keeping obligations under AICIS. For further information including guidance materials, helpful record keeping checklists, and links to our legislation, please visit our website.