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Australia Reach Regulation for Various Sectors

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.

Australia adopted the Stockholm Convention in 2004, imposing on 12 original POPs trading control on import, manufacture, use, and export throughout the territory. The Department of Agriculture, Water and the Environment (DAWE) supervises the application of the convention in such chemicals. Also, the Department ensures that POPs added to the convention on later amendments are recognized in Australia. However, Australia does not automatically adopt new amendment to the Stockholm Convention. It is necessary that the internal administration proposes the modifications though a legal text. Currently, the list of POPs ratified by the Australian government are:

 

  • Aldrin
  • Chlordane
  • Dieldrin
  • Endrin
  • Heptachlor
  • Hexachlorobenzene (HCB)
  • Mirex
  • Toxaphene
  • Polychlorinated biphenyls (PCB)
  • DDT
  • Dioxins
  • Furans

 

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:

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

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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. 

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.

The chemical inventory in Australia is the Australian Inventory of Industrial Chemicals (AIIC) under the Australian Industrial Chemical Introduction Scheme (AICIS). The AIIC has been in place from 1 July 2020 when it replaced the Australian Inventory of Chemical Substances (AICS).

The AIIC is a searchable database that contains around 40,000 chemicals that are being introduced (i.e. manufactured or imported) into Australia for industrial use. The inventory is divided into two parts, a public inventory, and a confidential inventory. This means that a chemical may be in the inventory but will not be searchable because the CAS name and CAS number are protected as confidential business information (CBI). If this is the case the AICIS can confirm whether the chemical is confidentially listed.  Confidentially listed chemicals are still available for introduction.

The AIIC includes all industrial chemicals in use in Australia between 1 January 1977 and 28 February 1990. In addition, it includes new assessed chemicals. During the transition from the AICS to AIIC a number of non-industrial chemicals were removed from the inventory.

In September 2021 the AICIS published an Evaluations Roadmap that outlines their approach to ensure that the introduction of chemicals to Australia is supported by contemporary information and recommendations about managing potential risks associated with their use. The target is to evaluate at least 20% of the chemicals in the AIIC for which current risk assessment is not available by 30 June 2024. So far, the AICIS has held consultations on approximately 1700 chemicals of the 4200 they expect to assess by 2024.

Chemicals listed in the AIIC inventory can be introduced to Australia provided the
terms of the listing are complied with. If a chemical is not already in the inventory it will have to be categorised based on the risk to human health and the environment before it can be introduced into Australia. The result of the process will assign the chemical to one of the following categories:

  • Exempted introduction: Very low-risk introductions. Introducers must submit a one-off declaration after the chemical has been introduced.

  • Reported introduction: Low-risk introductions. Introducers must submit a one-off declaration before the chemical can been introduced.

  • Assessed introduction: Medium to high-risk introductions. The AICIS will carry out a risk assessment and the introducer must obtain an Assessment Certificate before the chemical can be introduced.

Only chemicals categorised as assessed introductions will be included in the AIIC when the risk assessment is complete.

The AICIS defines industrial chemicals by exclusion of categories covered by other regulations or by exemption. This means that an industrial chemical is any chemical that is not:

  • A naturally occurring chemical (i.e. an unprocessed chemical occurring in a natural environment or a chemical occurring in a natural environment that is extracted without chemical change).

  • An agricultural chemical product (e.g. household gardening products, pesticides (including household products such as personal insect repellents, insect sprays, and weed killers), and pool sanitising chemicals such as sodium hypochlorite, sodium bromide and algaecides) as defined by the Agricultural and Veterinary Chemicals Code (AgVet Code).

  • A veterinary chemical product (e.g. veterinary medicine, pet food, and livestock feed) as defined by the AgVet Code.

  • A substance or mixture of substances prepared by a pharmacist or veterinary surgeon, or in the preparation of these – as defined by the AgVet Code.

  • A therapeutic good (e.g. medicines (including prescription, over-the-counter, and alternative medicines as well as sunscreen products, and sterilants/disinfectants) – as defined by the Therapeutic Goods Act 1989.

  • Food for humans and food additives.

 

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.

 

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.

All introducers of chemicals into Australia must, regardless of introduction category, submit an Annual Declaration that confirms that the introduction complies with the AICIS rules. The declaration must be submitted by 30 November for the period 1 July to 31 August of the previous registration year. The declaration should include the registration number for the introducer, the introduction categories for the chemicals introduced, and a declaration that all introductions during the registration year were authorised under the Industrial Chemicals Act 2019.

The Industrial Chemicals Act 2019 imposes an annual registration fee of 75 AU$ on all introducers of industrial chemicals. Furthermore, the IC Act imposes an annual registration charge that varies according to the value of the chemicals introduced by the company in the previous financial year (1 July - 30 June). There are 8 levels of registration charges varying from 0 AU$ to 36,700 AU$ (approximately US$ 24,600). New registrants are regarded as Level 1 and only pay the fee. Besides the registration fee and charge the AICIS also imposes fees on applications for certificates and authorisations. 

 

Fee Type

Charge (AU$/US$)

Application to search for confidentially listed chemicals on the Inventory

0

Submission of the Annual Declaration

0

Application for listing on the inventory before 5 years

1,490 / 1,000

Application for variation of listing

4,735 / 3,185

Application for a certificate – very low to low risk

7,435 / 5,000

Application for a certificate – health focus or environment focus

23,375 / 15,720

Application for a certificate – health and environment focus

34,965 / 23,520

Application for Commercial Evaluation Authorization

6,490 / 4,365

 

 

The AICIS monitors introducer compliance across all introduction categories aiming to protect human health and the environment without imposing unnecessary burden on regulated entities. The monitoring activities are based on risks and focus on introductions that pose a higher risk to human health and the environment as well as introducers at higher risk of non-compliance. All instances of non-compliance identified by the AICIS will be addressed as a violation of the Industrial Chemicals Act 2019.

The penalty for non-compliance depends on the severity of the case. For severe cases the penalty ranges from injunctions and infringement notices to civil penalties that may exceed AU$ 500,000 (approximately US$ 335,000) for a corporation and even criminal prosecution in cases when the non-compliance is deliberate, repeated or poses serious risk to human health and the environment.

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