AICIS

Chemical Regulation

The legal framework for the regulation of the introduction (importation and manufacture) of industrial chemicals in Australia is the Industrial Chemicals Act 2019 (IC Act). It came into force on 12 March 2019 and establishes the Australian Industrial Chemicals Introduction Scheme (AICIS) and its Executive Director. The IC Act is supported by the Industrial Chemicals (General) Rules and the Industrial Chemicals Categorisation Guidelines, which set out technical and operational details of the AICIS and the requirements introducers need to meet to categorise their chemicals if they are not already listed on the AIIC. The IC Act regulates the importation and manufacture of industrial chemicals in Australia. 

Authority

The Australian Industrial Chemicals Introduction Scheme (AICIS) under the Office of Chemical Safety (OCS) within the Department of Health and Aged Care, is the authority which regulates the importation and manufacture (known as introduction in Australia) of industrial chemicals. The AICIS came into force on 1 July 2020, replacing the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). The objective of the AICIS is to protect human health and the environment through restriction, regulation, assessment, evaluation, and by managing risks arising from the introduction of industrial chemicals. The AICIS regulates chemicals (including polymers) introduced to Australia, such as chemicals in inks, paints, adhesives, cosmetics, soaps, and solvents.

In Australia, chemicals are regulated under both state/territory and national laws. At the national level, chemicals are regulated according to their use. There are 4 main regulatory authorities for chemicals, each focusing on a specific sector:

• The Australian Industrial Chemicals Introduction Scheme (AICIS) regulates industrial chemicals such as paints, adhesives, inks, plastics, glues, solvents, soaps, and ingredients in cosmetics.

• The Australian Pesticides and Veterinary Medicines Authority (AVPMA) regulates agricultural and veterinary chemicals, such as pesticides, medicines for animals, insect repellents, garden weed sprays, and some pool chemicals.

• The Therapeutic Goods Administration (TGA) regulates medicines and products marketed as having therapeutic effects, such as skin-whitening lotions, complementary medicines, and blood products.

• Food Standards Australia and New Zealand (FSANZ) regulates ingredients in food and food additives for human consumption, such as processing aids, colourings, vitamins, and minerals.

Inventory

Under the Industrial Chemicals Act 2019 (IC Act), an introduction means the importation or manufacture of an industrial chemical in Australia. The term used for importers or manufacturers of industrial chemicals is introducers. The IC Act includes a requirement that makes introducers responsible for categorising their introductions themselves based on the criteria given by the AICIS. The categorisation process requires the introducers to consider both hazard and exposure. The hazard of a chemical is an intrinsic property that cannot be changed. The factors affecting exposure relate to how the introduced chemical is intended to be used or the circumstances of the introduction.

Non-Australian introducers must register their business and apply for an Australian Registered Business Number (ARBN). If an overseas company is unable to obtain an ARBN, it can appoint an Australian Agent or distributor as its Authorised Representative (AR) to meet the compliance requirements. In that case the Australian agent will be the introducer and the overseas company will be termed as Chemical Data Provider.

Who should comply?

Under the Industrial Chemicals Act 2019 (IC Act), an introduction means the importation or manufacture of an industrial chemical in Australia. The term used for importers or manufacturers of industrial chemicals is introducers. The IC Act includes a requirement that makes introducers responsible for categorising their introductions themselves based on the criteria given by the AICIS. The categorisation process requires the introducers to consider both hazard and exposure. The hazard of a chemical is an intrinsic property that cannot be changed. The factors affecting exposure relate to how the introduced chemical is intended to be used or the circumstances of the introduction.

Non-Australian introducers must register their business and apply for an Australian Registered Business Number (ARBN). If an overseas company is unable to obtain an ARBN, it can appoint an Australian Agent or distributor as its Authorised Representative (AR) to meet the compliance requirements. In that case the Australian agent will be the introducer and the overseas company will be termed as Chemical Data Provider.

Compliance Procedure

The AICIS uses legislated and non-legislated options for promoting compliance and addressing non-compliance with the Industrial Chemicals Act 2019 (IC Act). These options range from providing information so that regulated entities understand their time frames, processes and how they need to meet their obligations under the IC Act. This includes emphasising the cost of not meeting obligations such as the various sanctions available to punish serious non-compliance.

Prior to introducing industrial chemicals or products that contain industrial chemicals into Australia the company must be registered with the AICIS and obtain an Australian Registered Business Number (ARBN) which is issued by the Australian Business Register (ABR).

The chemical substance that is going to be introduced must then be categorised into one of the following 5 introduction categories: Listed, Exempted, Reported, Assessed, or Commercial Evaluation. There is a sixth category (Exceptional Circumstances Introductions) which allows the Federal Minister of Health to authorize the introduction of a chemical because it is in the public interest and is needed to manage significant human health or environmental risks.

Categorisation procedure of chemicals before introduction under the AICIS

To begin with the introducer must check if the chemical substance is already listed on the Inventory by searching the AIIC. If the chemical is listed, then it is already available for industrial use in Australia. There is no fee for listed introductions. Listed chemicals fall within 4 different categories:

• Listed without requirements, conditions or ‘defined scope of assessment’: Companies registered with the AICIS can introduce the chemical as listed introduction without informing the AICIS, but records should be kept for 5 years, and an Annual Declaration must be submitted every year.

• Listed with a specific information requirement:  The chemical can be introduced as a listed introduction as above but in certain circumstances information about the introduction has to be submitted to the AICIS.

• Listed with a condition of introduction or use (restriction on volume of introduction or where the chemical is permitted to be introduced or used): If the introduction meets the conditions of use it can be introduced as a listed introduction as above. If the introduction does not meet the conditions of use, an application to vary the terms of the Inventory Listing is needed.

• Listed with a defined scope of assessment (describes the parameters of previous assessments such as how the chemical is use, volume/quantity and concentration in products): If the introduction is within the parameters of the defined scope of assessment, it can be introduced as a listed introduction as above. If the introduction is outside the parameters, the introducer must either change introduction category or apply to change the parameters of the defined scope of assessment.

If the introduction is not in the listed category, it must be authorised under one of the other four introduction categories.

Exempted Introduction

An exempted introduction means that the introduction is considered very low risk to both human health and the environment. The following groups are exempted:

• Chemicals that are imported and subsequently exported.

• Chemicals that are only use for research and development.

• Chemicals resulting from non-functionalised surface treatment of listed chemicals.

• Polymers of low concern (PLC)

• Low-concern biological polymers

• Polymers that are comparable to listed polymers.

• Chemicals that are comparable to listed chemicals.

Exempted chemicals will not be listed in the AIIC. If the chemical meets the criteria and the company is registered with the AICIS, the chemical can be introduced without notification.  Records must be kept, and an Annual Declaration must be submitted at the end of each registration year. For some exempted introductions a Post-Introduction Declaration (PID) is required the first time the chemical is introduced. There is no fee for exempted introductions.

Reported Introduction

A reported introduction means that the chemical is considered low risk to human health and the environment. The chemical will not be listed in the AIIC. The introducing company must be registered with the AICIS and must submit a Pre-Introduction Report (PIR) before the first introduction. Records must be kept, and an Annual Declaration must be submitted at the end of each registration year. There is no fee for neither the submission of the Pre-Introduction Report nor the introduction itself.

Assessed Introduction

An assessed introduction means that the chemical is considered medium to high risk for human health and the environment. The introduction must be assessed, and an Assessment Certificate must be issued by the AICIS before the introduction can take place.  Records must be kept, and an Annual Declaration must be submitted at the end of each registration year. There is an application fee for the Assessment Certificate. The chemical will be added to the AIIC 5 years after the Assessment Certificate was issued or earlier if the introducer applies for early listing. During the 5 years the chemical can only be introduced by the certificate holder(s).

Commercial Evaluation Authorisation

If a company wants to test the commercial potential of an industrial chemical in Australia, it can apply for a Commercial Evaluation Authorisation (CEA). A CEA is valid for up to 4 years and authorises the introduction of a maximum volume of 10 tonnes over the 4 years. Records must be kept, and an Annual Declaration must be submitted at the end of each registration year. There is an application fee for the Commercial Evaluation Authorisation.

Cosmetics

In Australia, cosmetics are regulated by the Australian Industrial Chemicals Introduction Scheme (AICIS), which is administered by the Department of Health. Cosmetics must comply with the Consumer Goods (Cosmetics) Information Standard 2020, which sets out requirements for labelling, safety and approved ingredients. Manufacturers must register with AICIS and ensure their products contain only ingredients listed in the Australian Inventory of Industrial Chemicals (AIIC). The Therapeutic Goods Administration (TGA) independently regulates therapeutic claims made on cosmetic products. In addition, products must have appropriate labelling, ingredient lists and meet safety standards before they can be marketed.

Cosmetics Definition

Cosmetics are defined under the Industrial Chemicals Act 2019 and the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991 as[1]: “A substance or preparation intended for placement in contact with any external part of the human body, including: the mucous membranes of the oral cavity; and the teeth with a view to altering the odours of the body or changing its appearance or cleansing it and maintaining it in good condition or perfuming it or protecting it”.

Regulatory Body

Cosmetics are regulated under the Australian Industrial Chemicals Introduction Scheme (AICIS). Product safety and cosmetic labelling are regulated by the Australian Competition and Consumer Commission (ACCC). In Australia, cosmetic products such as sunscreen (above SPF 4) are classified as therapeutic goods under the Therapeutic Goods Act 1989[1]. These products are regulated by the Therapeutic Goods Administration (TGA) in terms of manufacturing, labelling and advertising requirements.

Regulation of Cosmetics

In Australia, cosmetics are regulated under a number of laws and standards to ensure safety and accurate labelling. The Therapeutic Goods Act (1989) applies to cosmetics that make therapeutic claims, such as anti-acne or anti-dandruff products. The Industrial Chemicals Act 2019 regulates the use of chemicals in cosmetics, requiring manufacturers and importers to register and comply with its guidelines. The Cosmetic Standard (2007) defines what constitutes a cosmetic and specifies permitted ingredients, ensuring that products are safe and not classified as therapeutic goods. In addition, the Consumer Protection Notice No. 4 of 1991 requires cosmetic products to be labelled [1].

Business Registration                                                                             

Compliance obligations under the Australian Industrial Chemicals Introduction Scheme (AICIS) include the registration of businesses intending to import or manufacture industrial chemicals, or products that contain industrial chemicals to sell commercially [2]. Registration is necessary unless foreign companies use Australian-based suppliers or use Australian-sourced ingredients and combine them to form the product [2].

To register, a business must obtain an Australian Registered Body Number (ARBN) from the Australian Business Services. Registration can be initiated by creating an account with AICIS Business Services and after logging into the account, registration can be accessed. After registration, a fee payment is required based on the previous year's financial level, i.e. for first time registrants and companies that did not import in the previous financial year, the fee is level 1. Following the payment, a receipt can be downloaded. Once the application has been submitted and verified, the applicant will receive an email with the registration certificate. The company name and registration number will also be published on the website. The company must be registered one year prior to importing the product and registration can be done throughout the year. The registration must be renewed every year as it expires on 31 August [2].

Categorisation

After registration, importers must categorise the chemical introduction based on exposure and hazards. This categorisation focuses on the introduction rather than the chemical itself, recognising that risk depends on the circumstances of manufacture, import and use. There are therefore the following five main categories based on risk [3]:

1. Listed

2. Exempted

3. Reported

4. Assessed

5. Commercial Evaluation Authorisation

Like most of the countries, Australia does not have annexes or schedules of prohibited, permitted and restricted chemicals in cosmetics. Instead, it has a database called the Australian Inventory of Industrial Chemicals (AIIC), which contains more than 40,000 chemicals in the Listed, Exempted and Reported categories. The Assessed category is not in the Inventory and requires Assessment Certificates depending on the risk to humans and the environment.

If the ingredients are in the Listed category, the product can be imported without notifying the AICIS, provided it meets the relevant conditions. For chemicals in the Exempted category ('very low risk' to human health and the environment), the importer must submit a Post Introduction Declaration (PID) to the AICIS after import. If the ingredient is in the Reported category, the importer must submit a once-off pre-introduction report prior to import. Substances in these three categories are listed in the inventory. If the product contains ingredients mentioned in the Assessed category, the importer should apply for an Assessment Certificate before import [4]. Figure 12 provides a graphical representation of the description above. Notification to the AICIS may be required for chemicals not listed in the Australian Inventory of Industrial Chemicals (AIIC) or that do not meet certain criteria, such as being "naturally occurring,". It is emphasised that notification to the AICIS is mandatory prior to import or manufacture of new industrial chemicals.

Cosmetic categorisation in Australia

Registration Fee 

The cost of registration depends on the registration level, i.e. it is important to understand that the company’s registration level is determined by the total value of the relevant industrial chemicals introduced in the previous financial year. The fees and charges (adapted from the AICIS website) for the financial year 2024-2025 (1 September 2024 to 31 August 2025) are listed in Table 7 below. Goods and Service Taxes (GST) does not apply.

Fees and charges for the 2024-25 registration year according to registration levels

Labelling Requirements

The Consumer Goods (Cosmetics) Information Standard 2020 [4] sets out the mandatory requirements for cosmetics labelling. Labelling must include:

• Product name

• Brand name

• Net content

• Manufacturer/distributor details

• List of ingredients

• Warnings (if any)

• Directions for use

• Symbols (cruelty-free etc.)

Key Requirements

• The list of ingredients must appear on the container or on the product itself if it is not packaged in a container.

• If the container cannot accommodate detailed ingredient labelling, the mandatory information must be provided.

• Ingredients must be listed in descending order by mass or volume. Alternatively, the mandatory standard allows ingredients to be listed as follows:

• Ingredients (excluding colour additives) present in concentrations of 1 percent or more should be listed in descending order by volume or mass.

• Ingredients (excluding colour additives) present in concentrations of less than 1 percent may be listed in any order.

• Colour additives, listed in any order.

Safety Standards

Australia maintains an inventory of introduced chemicals, which distinguishes it from other countries. Unlike those countries, Australia does not have specific schedules for prohibited, restricted, or allowed cosmetic ingredients. Instead, Australian Inventory of Industrial Chemicals (AIIC) comprises over 40,000 substances that have been assessed or introduced within the country. The chemicals listed in this inventory do not require any specific procedures before or after import. However, there are special requirements and restrictions associated with some of these chemicals [3].

For cosmetics falling under the category of therapeutics, Australia follows the Poison Standard 2024. These standard outlines detailed requirements for chemical ingredients, including permissible standards, labelling, container specifications, storage guidelines, disposal procedures, and record-keeping practices.

Other Requirements 

Record keeping and annual declaration is mandatory for registered businesses. The business registration documents, and chemical records should be maintained for a minimum of 5 years and every year an annual declaration should be made about the industrial chemicals that are imported during the previous registration year, confirming that these introductions were authorised under Australian law [5].

Penalties 

Under the Industrial Chemicals (Notification and Assessment) Amendment (Cosmetics) Act 2007, a penalty of 120 penalty units (approximately AUD 22,077) may be imposed for offences relating to non-compliance with existing standards of cosmetics when imported and manufactured in Australia. For therapeutic goods (sunscreen), under the Therapeutic Goods Act, the penalty for offence during import/manufacture is 300 penalty units and for failure to report the event of adverse effect is 3000 penalty units for individuals and 30,000 penalty units for corporate bodies.  

Recent Updates 

The Australian Inventory of Industrial Chemicals was updated and published on 2 January 2024, along with this AICIS has completed and published 20 evaluations related to human health and environment with chemicals in the Inventory.