The Australian Pesticides and Veterinary Medicines Authority is responsible for the registration, approval, and restriction of agrochemicals sold in Australia (APVMA). The use of pesticides is regulated by the Environmental Protection Agency (EPA) under the Pesticides Act of 1999 and Regulation 2017. The EPA, Commonwealth and NSW government agencies, as well as other stakeholder organisations, oversee pesticide management to guarantee no harm to human health or the environment. 

Authorties 

APVMA administers Australia’s agvet legislation and has a duty to not only manage potential risks, but also enforce compliance when required. 

The legislation includes: 

• the Agricultural and Veterinary Chemicals Act 1994 (the Agvet Act) 

• Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code) 

• the Agricultural and Veterinary Chemicals (Administration) Act 1992 (the Admin Act) 

• the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994 (the Collection Act). 

APVMA has the following duties:  

• issue substantiation notices 

• issue formal warnings 

• enter enforceable undertakings 

• issue enforceable directions 

• issue infringement notices 

• issue stop supply and recall notices 

• cancel or suspend permits for noncompliance or prior convictions 

• cancel or suspend permits to prevent imminent risk 

• issue a notice to attend, give information, or produce documents or things 

• obtain and execute monitoring warrants 

• obtain and execute investigation warrants. 

 Companies involved in the manufacturing, formulation, repackaging, exportation, importation, marketing, and application service of pesticides in Australia shall file the registration application 

Agricultural and Veterinary Chemicals (Administration) Act 1992

The APVMA is established as an independent Commonwealth statutory authority responsible for the regulation and management of agricultural and veterinary chemicals in Australia up to the point of retail sale under this Act. This Act provides all of the internal details of the APVMA's establishment, as well as its functions and powers. It also includes laws governing chemical import and export, as well as enforcement and inspections. 

Agricultural and Veterinary Chemicals Act 1994

This act provides the constitutional and other legal elements necessary for the Agvet Code's implementation. The Agvet Code is to be applied as a law of the participating areas, according to the agreement. The Australian Capital Territory and any other territory designated as a participating territory by Regulations in force under section 25 of the act are considered participating territories. 

Agricultural and Veterinary Chemicals Code Act 1994

The Agvet Code is included as a schedule in this Act. The Agvet Code provides extensive rules that enable the APVMA to analyze, authorize, register, and review active ingredients and agricultural and veterinary chemical products (and their accompanying labels), as well as give permits and licenses for chemical product manufacturing. It also includes regulations to manage the supply of chemical products, as well as provisions to ensure that the Agvet Code is followed and enforced. 

The National Registration Authority for Agricultural and Veterinary Chemicals (NRA) later became the APVMA. The AGVET Code is used by the APVMA of the participating states and territories for addressing the registration process of the active ingredients or chemicals.  

In July 1991, the Commonwealth, states and territories agreed for establishing the National Registration Scheme (NRS) for agricultural and veterinary chemicals. The development of the NRS contributes to the process of assessment and registration of all AGVET chemical products which was independently undertaken by the commonwealth states and territories.  

The APVMA partners between the Commonwealth and the states and territories within which the establishment of NRA and APVMA took place as a Commonwealth statutory authority, that is responsible for the evaluation, registration and review of agricultural and veterinary chemicals and their control.  

The APVMA is also termed as an independent statutory authority that implements the legislative powers, functions and AGVET Codes. 

The product label is the primary and most effective means of communicating to users' critical information about pesticide and veterinary drug use that is both safe and effective. Current pesticide and veterinary medicine labelling, on the other hand, is complex, confusing, and inflexible, with separate labelling codes and information for different statutory needs. Because labels have become more extensive and comprehensive, vital information can be difficult to locate. Furthermore, updating information on labels takes time, which can result in different labels for the same product along the supply chain. 

By focusing pre-market regulatory effort on those label features that are unique to pesticides and veterinary pharmaceuticals, the Panel advises simplifying labelling and expediting label evaluation. Content that does not require assessment would be subject to the label.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) is in charge of regulating agricultural and veterinary (agvet) chemicals (active components) and the goods that contain them in Australia, up to and including retail sales.

The Agvet Code specifies which items and chemicals require registration or approval and which are exempt. The National Registration Scheme for Agricultural and Veterinary Chemicals in Australia is the regulatory framework for controlling agricultural and veterinary (AgVet) chemicals (NRS). The NRS is a collaborative effort between the Commonwealth and the states and territories, with duties shared equally. The NRS is administered by the Australian Pesticides and Veterinary Medicines Authority (APVMA) in collaboration with state and territory government agencies, as well as other Commonwealth agencies, law enforcement, and the judiciary.

APVMA defines a nanomaterial as “A nanomaterial should be an intentionally produced, manufactured or engineered substance with unique properties that are directly caused by size features with 10 per cent or more of the number size distribution of these features lying in the range approximately 1–100 nm (the nanoscale). There should be recognition that biological and EHS issues may require a different size range above 100 nm.”

Both Nano pesticides and veterinary nanomedicines must be compatible with the proposed APVMA working definition of a nanomaterial. There is currently no universal agreement on what constitutes a nano pesticide or a veterinary nanomedicine. Several researchers have raised a variety of concerns that should be considered while defining a definition for nanopesticides15. For example, the nanomaterial in a nano pesticide could be the active ingredient or a non-active 'carrier; the size of a nano pesticide could be larger than the traditionally accepted upper limit of the nanoscale dimension (100 nm); and the durability of a nano pesticide could be either transient or persistent. According to the SCENIHR (2010) study, "further guidance (requirements) unique for the planned rule" may be required. The APVMA working definition of a nanomaterial is intended to have a nanoscale dimension of 100 nm as the maximum limit; nevertheless, a size range greater than 100 nm may be required to address human health and environmental safety concerns. On a case-by-case basis, the need will be evaluated. For the purposes of risk assessment and APVMA enforcement, the definition applies to Nano pesticides and veterinary nanomedicines.

• Agricultural and Veterinary Chemicals (Administration) Act 1992- The Australian Pesticides and Veterinary Medicines Authority (APVMA) is established as an independent Commonwealth statutory authority responsible for the regulation and management of agricultural and veterinary chemicals in Australia up to the point of retail sale under this Act. This Act provides all the internal details of the APVMA's establishment, as well as its functions and powers. It also includes laws governing chemical import and export, as well as enforcement and inspections.
• Agricultural and Veterinary Chemicals Act 1994- This Act provides the constitutional and other legal elements necessary for the Agvet Code's implementation. The Agvet Code is to be applied as a law of the participating areas, according to the agreement. The Australian Capital Territory and any other territory designated as a participating territory by Regulations in force under section 25 of the Act are considered participating territories.
• Agricultural and Veterinary Chemicals Code Act 1994- The Agvet Code is included as a schedule in this Act. The Agvet Code provides extensive rules that enable the APVMA to analyze, authorize, register, and review active ingredients and agricultural and veterinary chemical products (and their accompanying labels), as well as give permits and licenses for chemical product manufacturing. It also includes regulations to manage the supply of chemical products, as well as provisions to ensure that the Agvet Code is followed and enforced.

Individuals, companies, organisations, trade associations, and other groups can apply online to the APVMA to:

• approve a new active constituent – or change one that has already been approved
• register a new agvet chemical product containing an active constituent – or change one that has already been registered
• approve relevant details of a product label, or change details that have already been approved
• renew a product's registration or the approval on an active constituent
• and obtain a permit.
• obtain an export certificate from the APVMA for an agvet chemical product
• receive pre-application help from the APVMA before applying
• have an APVMA technical assessment completed before applying
• have an APVMA decision reviewed

Before filing an application, have the APVMA conduct a technical examination. Have the APVMA's decision reviewed.

Within a month of receiving an application, the APVMA conducts a preliminary assessment. This is to see if the application fits the application requirements, in other words, if the applicant has provided the APVMA with all the necessary information and paperwork. If this is not the case, additional information may be asked.

The APVMA then evaluates each application within the timeframe set by law before deciding whether to approve, register, or deny it.

The APVMA takes a scientific, evidence-based approach to regulation, aligning its efforts with the hazards posed by each active element or product. Both the likelihood of exposure and the potential effects of exposure are considered when assessing risks.

Approval and register

The APVMA allows databases and publishes certain information regarding products and active constituents on our PubCRIS. Some of this data is made public throughout the evaluation process, while others are made public after approval or registration.

The pertinent details of a product's label, such as the product name and key ingredients – as well as the safety and usage guidelines – are some of the information presented on each database record. If it has been included as a reference product in another application, the information released will indicate which products it has been listed for.

The APVMA is responsible for maintaining the PubCRIS and permits databases, as well as updating records as needed to reflect variations or modifications to a product, permit, licence, label, or active constituent.

The person, corporation, or organisation in charge of a registered chemical product – or an approved active constituent – is accountable for adhering to the Agvet Legislation on an ongoing basis. This can include ensuring that their product or active constituent's labelling, advertising, manufacturing, importing, sales, and supply are all compliant with Agvet regulations.

The APVMA has specific authorities to oversee and monitor compliance with Agvet regulations, as well as to carry out enforcement actions as necessary. Law enforcement, the court, and other state, territory, and Australian government departments work together to enforce the law.

This can involve ensuring that agvet chemical products and active ingredients are sold, supplied, imported, exported, manufactured, labelled, packaged, stored, and advertised in accordance with the law. The APVMA is also in charge of performing chemical reviews, monitoring reports of Agvet regulation non-compliance, and examining allegations of adverse reactions to agvet chemical goods.

APVMA has set the maximum limit for chemical review up to 57 months. The time frame depends on factors to be reviewed such as efficacy, safety, chemistry, etc.

The APVMA has yet to issue any formal rules on the registration and regulation of nanomaterials-containing products. When the person applies to register a product that contains nanomaterials, the basic guideline is that one should include information that addresses the same criteria that APVMA evaluates when registering conventional products. Additional information about the nanomaterial, as well as any hazards that are different from or in addition to the primary hazard, should be included. APVMA will be able to deploy risk management measures on a case-by-case basis as a result of these.

“Until detailed guidelines are available, any person contemplating registering an agvet chemical product containing nanomaterials should first contact the APVMA for guidance on data specific to that product. Any advice given will reflect the practices current at the time for this developing science.”

Persistent Organic Pollutants (POPs), also referred to as “emerging contaminants”, include a range of chemical substances from diverse applications, ranging from medicines, personal care, household cleaning products, lawn care, agricultural products, among others.

The toxicity of POPs has been long investigated, and researchers found that these chemicals may have long-range mobility and long-lasting duration, leading to environmental contamination and pollution. POPs are often classified as Substance of Very High Concern (SVHC) with hormone disruption consequences, bioaccumulation and biomagnification through the food chain. The presence of POPs in the environment and in human health can lead to several complications, from mild effects to more serious consequences, for example, reproductive disruptions and immunological disorders.

Since POPs are not easily broken down, a characteristic that guarantees its continuation in the environment, the contaminant consequences are still being investigated. In other words, the emerging contaminants are mainly not from new pollutants that recently entered the environment. Instead, there is a good understanding of contaminants, but the consequences to their exposure are still being discovered.

Countries have created a set of rules and regulations to regulate, control, and mitigate POPs use and its effects on the environment and on human health. The essence of these legislations is to eliminate the production, trading, and use of such chemicals, including storage and waste management.

International effort in addressing POPs starts in late 1990s. The initial protocol to address POPs was implemented in 1998, signing 16 chemicals to phase out according to previously established risk criteria. The Aarhus Protocol also impose parties to reduce their emissions below 1990 levels.

The Stockholm Convention is an international conference specifically for POPs proposed in May 2001 in Sweden (complementing the Aarhus Protocol), entering into force in 2004. Among the objectives, the Stockholm Convention aims to:

• Prohibit, eliminate, and restrict several POPs in the production, use, import, and export.
• Ensure that waste contained POPs are managed safely and in an environmentally sound manner.
• Promote tools for information exchange, public access, awareness and education, research, development and monitoring, reporting, and implementation of plans to fight POPs pollution.

The Stockholm Convention is considered the main international instrument to address POPs. Most countries adhere to the Stockholm Convention.

Further, POPs provisions depend on the chemical category, i.e., if it is a pesticide or industrial chemical. It is also to be noted that chemicals may present additional compliance/control measures depending on the local state and territory government in which the chemical is intended to be present on the market.

In addition, the Australia government is creating several efforts to enforce and comply with the Stockholm Convention’s mandate. This includes several guidelines and national plans for chemicals, which highlights:

• The Guidelines for Disposal of waste containing POPs
• The Organochlorine Pesticide Management Plan
• The National Action Plan for Dioxins
• The Polychlorinated Biphenyls Management Plan
• The Hexachlorobenzene Waste Management Plan
• The Industrial Chemicals Environmental Management Standard

In the near future, all chemicals will be submitted to the administration of the Industrial Chemicals Environmental Management Standard.

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.

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.

aCompliance 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.

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.