The Australian Industrial Chemicals Introduction Scheme (AICIS), established by the Industrial Chemicals Act 2019, is an overarching framework to regulate the importation and manufacture (introduction) of industrial chemicals in Australia. It replaced the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) on July 1st, 2020.
The AICIS is underpinned by a package of six bills. Besides the Industrial Chemicals Act 2019, the other five bills are:
The aim of AICIS is to help protect Australians and the environment by assessing the risks of industrial chemicals and provide information to promote their safe use.
Scope of AICIS
AICIS regulates only the introduction of chemicals with any industrial use. As with the NICNAS, AICIS defines industrial chemicals by exclusion. This means that an industrial use describes any use that isn’t the following:
Ø An agricultural chemical product – as defined by the AgVet Code
Ø A veterinary chemical product - as defined by the AgVet Code
Ø Use as a substance or mixture of substances prepared by a pharmacist or veterinary surgeon, or in the preparation of these – as defined by paragraph 5(4)(a) of the AgVet Code
Ø A therapeutic good – as defined by the Therapeutic Goods Act 1989 or
Ø Use as food for humans or animals, or in the preparation of it.
NOTE: A chemical can have multiple types of uses. For each use of a chemical, businesses will need to follow the regulations for each responsible regulator.
Registration with AICIS
Who Must Register?
To keep track of those importing or manufacturing industrial chemicals in Australia, AICIS requires that they must register before the introduction of industrial chemicals in any given registration year (the registration year is September 1st – August 31st). Such registration is made by completing an online form and paying a fee. Note that this registration refers to a business registration, not a chemical or a product.
Businesses must register with AICIS before introducing industrial chemicals for any of the following:
Ø Import industrial chemicals, or products that release industrial chemicals into Australia
Ø Import finished and packaged products that release industrial chemicals - for example, labelled cosmetic products (soap, shampoo, lotion), paint, glues, engine oil and pens
Ø Import industrial chemicals and reformulate in Australia
Ø Manufacture industrial chemicals in Australia
Notably, registration must be made regardless of the quantity of chemicals to be imported or manufactured.
How to Register?
Before registration, businesses should determine: 1) whether or not they need to register with AICIS; 2) the value of the industrial chemicals imported and/or manufactured during the previous financial year (July 1st – June 30th) in $AUD, if any; 3) in the case of a foreign (non-Australian) businesses they’ll need an Australian Registered Body Number.
In determining the value of chemicals imported and/or manufactured, businesses could use relevant commercial documents such as commercial invoices, orders or confirmations, airway bills, insurance certificates or receipts for purchase of goods. All relevant commercial documents must be kept for at least five years.
There are four options for valuing chemical introductions, as seen in the table below.
Option 1 - Import chemicals only
Annual value of all relevant industrial chemicals = Customs value (AUD) + Insurance + Freight + Customs duty
Option 2 - Manufacture chemicals only
Total value of relevant industrial chemical manufactured = Cost of labor and materials (including all ingredients) involved in manufacture + factory overhead expenses
Note: Manufacturing involves making a different chemical. Blending or mixing chemicals without making a different chemical is not considered manufacturing a chemical.
Option 3 - Import AND manufacture chemicals (but imports are not used in manufacture)
Option 1 for imports + Option 2 for manufactured industrial chemicals
Option 4 - Import AND manufacture chemicals (but some, or all, imports are used in manufacture)
Use the method described in Option 3.
However, make sure the value of the imported chemicals (used to manufacture another chemical) is only counted once in the total value.
Businesses must keep records of how the calculations were done. Registrants are subject to random audits and it is an offence to provide false or misleading information.
The AICIS website offers a step-by-step guide for the registration of a business.
Registration Fees and Charges
The registration level of a business is based on the total value of the relevant industrial chemicals introduced in the previous financial year. See the table below for fees and charges applied to different registration levels.
(Source: AICIS website)
As mentioned above, the AICIS registration year lasts from September 1st to August 31st of the following year. If a business wants to continue to import or manufacture industrial chemicals, it must renew its registration by August 31st every year. If it continues to introduce industrial chemicals but renews after the 31 August deadline, it may be liable to pay a penalty. For step-by-step instructions for registration renewal, see the page “Renew your registration” on the AICIS website.
Categorization of the Introductions of Industrial Chemicals
Overall, compared with NICNAS, AICIS is more risk proportionate by focusing on the likely risk of any industrial chemical. Under the new framework, introducers will take on the obligation of categorizing the risk level of their own introduction, which will be the first step in introducing a chemical. There are six categories of introduction, as shown in the table below.
Chemicals listed on the Inventory and introduction is within the terms of the listing (if any)
Chemical with very low risk
Chemicals with low risk
Chemicals with medium to high risk
Commercial evaluation authorizations
Time limited authorizations granted to help an introducer determine a chemical's commercial potential
Exceptional circumstances authorizations
Ministerial authorization to allow urgent introduction to protect public health and the environment
The graph below illustrates the obligations entailed by different introductions.
(Source: AICIS website)
How to Work out the Category of a Chemical Introduction
A six-step guide is provided for the categorization of chemical introductions, as shown in the graph below.
(Source: NICNAS website)
Before starting the steps in this guide, a business must search the AICIS’s industrial chemicals database (namely the Inventory) first. Chemicals listed on the Inventory are available for industrial use in Australia. If a chemical is on the Inventory and its introduction meets any terms specified in the Inventory listing, the introduction is categorized as “Listed”.
On the page “Information you need to work out your introduction category” of the AICIS website, a business can read about:
Ø Information you must know
Ø Information you might need - if your introduction is not in the listed category
Ø Information it might be useful to have - if your introduction is not in the listed category
After determining a chemical introduction is not categorized as “listed” and obtaining the information needed for categorization, a business can go through the six steps following the instructions provided on the AICIS website:
Besides the instructions above, AICIS also offers a series of decision tools and extra resources (targeting specific chemicals, such as polymers and chemicals in cosmetics) to facilitate businesses’ understanding of and compliance with the new scheme.
Reporting and Record Keeping Obligations
Businesses may need to submit declarations, reports and records after the categorization of their chemical introductions.
At the end of each registration year, a business will need to provide certain information and confirm that its chemical introductions were authorized under law, which is called an “annual declaration”. To make such an annual declaration, the business will need to answer a few simple questions and complete a legal declaration via an online form provided by the AICIS.
Usually, an annual declaration is due by November 30th following the end of the registration year. Please note that there is no annual declaration in 2020. The first annual declaration under AICIS is due by November 30th, 2021 and covers the 14 month period from July 1st, 2020 to August 31st, 2021. After this, the usual registration year applies.
Record Keeping Obligations
Several types of introductions are subject to certain record keeping obligations. Click the links below to find out what records business must keep if they are making any of these introductions:
Businesses need to submit a once-off pre-introduction report for all introductions that are authorized under the reported category before importing or manufacturing them in Australia. There is no fee for submission.
Businesses only need to submit the report the first time they introduce the chemicals. Note that this is separate to annual declaration obligations. Once the pre-introduction report is submitted, businesses can introduce the chemicals immediately – except for low-risk flavor or fragrance blend and internationally assessed types with confidential business information which require additional steps before their introduction. For more details, see the AICIS website.
Exempted Introduction Declarations
Businesses are required to submit a once-off post-introduction declaration for some types of exempted introductions. Such a declaration is called “exempted introduction declaration”, which is on top of businesses’ usual annual declaration obligations.
More specifically, an exempted introduction declaration must be submitted for the following introductions on the first time that businesses import or manufacture these:
Ø Polymers of low concern
Ø Low-concern biopolymers
Ø Chemicals that have been categorized as very low risk for human health and the environment
The declarations are required to help the authority with audits and make sure that the risks of these chemical introductions remain at a very low level. The first exempted introduction declaration is due by November 30th, 2021 and covers the period from July 1st, 2020 to August 31st, 2021. Starting from 2022, businesses must submit their declarations by November 30th each year following the end of the previous registration year. For the information needed for the declarations, see the AICIS website.
Australian Inventory of Industrial Chemicals
Along with the implementation of the new scheme, the Australian Inventory of Industrial Chemicals (AIIC) is established to replace the old Australian Inventory of Chemical Substances (AICS). The AIIC includes only industrial chemicals according to Section 80 of the Industrial Chemicals Act 2019. A search page for the AIIC was made public, allowing businesses to search more than one CAS number at a time.
Industrial chemicals can be added to the AIIC in accordance with Section 82 of the Industrial Chemicals Act 2019 after 5 years have passed since the assessment certificates for the industrial chemicals are issued.
In addition to the Inventory, the AICIS website also offers the feature of assessment search, helping businesses to access information about the safety, hazard and risks associated with chemicals.
Use of Animal Test Data
Australia is implementing a ban on the use of new animal test data for cosmetics. The ban commenced on July 1st, 2020, stipulating that new cosmetic ingredients manufactured in, or imported into the country will not be able to use information from animal testing to prove safety. This move is aimed at aligning with the EU approach to ensure the ongoing protection of public health, workplace safety and the environment and minimal impact to business, and encouraging information from new methods not relying on the use of animals.
There are also restrictions on using new animal test data for chemicals with multiple end uses (including in cosmetics), as well as some exceptions which allow businesses to use animal test data.
Protection of Confidential Business Information
Businesses can apply online in AICIS Business Services for an AICIS approved chemical name (AACN) to protect the chemical name as confidential business information, and also apply for a generalized end use (GEU) to protect their chemical's specific end use.
Confidential business information (CBI) protection will be valid for five years, unless the authority decides it’s necessary to publish information earlier. After the five years, businesses can apply to continue the CBI protection.
The AICIS website provides guidance on how to apply for an AACN and how to apply for protection of end use. Businesses will also need to meet a statutory test that the AICIS applies to weigh up commercial and public interest.