The Australian Industrial Chemicals Introduction Scheme (AICIS) replaces NICNAS on 1 July 2020 as the new national regulator of the importation and manufacture of industrial chemicals in Australia.
The Scope of New Chemical Substances Required for Notification
A new substance is defined as a substance that is not on the Australian Inventory of Industrial Chemicals (AIIC). AIIC is a list of industrial chemicals that are available for use in Australia. Currently, more than 40,000 industrial chemicals are listed on AIIC. AIIC contains two sections: public section and confidential section. Companies can search the chemicals in public section from the website below:
For confidential section of AIIC, Companies need to submit an inquiry to authority by completing a related form.
Unless an exemption applies, the new industrial chemical will need to be assessed by the authority for risks to the environment and human health before it can be imported and/or manufactured.
What is industrial chemicals?
Relevant industrial chemicals are defined by exclusion of other types of chemicals. There is no list of relevant industrial chemicals. However, a chemical is not a relevant industrial chemical if it is:
- a naturally-occurring chemical
- any biological material (matter derived from or constituting a living organism, except a whole animal or a whole plant)
- an incidentally-produced chemical
- a reaction intermediate, or
- a chemical intended for an excluded use, meaning it is used solely as:
- an agricultural chemical
- a veterinary chemical
- a medicine or therapeutic, or
- a food or food additive.
Obligations under AICIS
Anyone who imports or manufactures (introduces) industrial chemicals — or products that release industrial chemicals — into Australia for commercial purposes must:
- register their business and pay a fee (if enterprises are not already registered with NICNAS)
- categorise each chemical importation or manufacture (introduction) into 1 of 5 categories
Enterprises must register their business in any given registration year before importing or manufacturing (introduce) an industrial chemical. The registration year is from 1 September to 31 August.
About introduction categories:
A chemical introduction that is categorised as ‘listed’ means that it is on the Inventory and already available for industrial use in Australia. Enterprises must meet any terms of Inventory listing for that chemical.
A chemical introduction that is categorised as ‘exempted’ means that the substance is considered has very low risk to human health and the environment. Enterprises can introduce it without telling beforehand. For some types of chemicals, enterprises must submit a once-off exempted introduction declaration.
A chemical introduction that is categorised as ‘reported’ means that the substance is considered has low risk to human health and the environment. Enterprises must submit a once-off report before starting introducing it.
A chemical introduction that is categorised as ‘assessed’ means that the substance is considered has medium to high risk to human health and the environment. The introduction will be assessed and an assessment certificate will be issued before enterprises can import or manufacture. The chemical will be listed on the Inventory after 5 years (or earlier if enterprises apply for an early listing).
Information about each chemical introduction that is assessed will be published, including an assessment or evaluation statement.
Under this category, enterprises can apply for a time-limited Commercial Evaluation Authorisation for the purpose of testing a chemical's commercial viability in Australia.
Reporting and record-keeping requirements
Regardless of the introduction category, every introducer must submit an annual declaration at the end of every registration year. This is a declaration enterprises make about the industrial chemicals they imported or manufactured in the previous registration year and confirms that their introductions were authorised under Australian laws.
Pre-introduction reports only apply to first-time reported introductions.
Post-introduction declaration for exempted introductions is a once-off declaration that you must submit after you introduce the following exempted introductions for the first time:
polymers of low concern
chemicals that you have categorised as very low risk for human health and the environment.
Your first post-introduction declaration (PID) is due by 30 November 2021 and covers the period 1 July 2020 - 31 August 2021.
You must keep certain records about your chemical introductions to confirm they are authorised as listed introductions. This also ensures you’re aware of any changes that could impact your categorisation. You must keep these records for 5 years, even after you’ve stopped introducing your chemical.
Annual declarations will replace annual reports. There is no annual declaration in 2020. The first annual declaration is due by 30 November 2021 and covers the 14 month period from 1 July 2020 - 31 August 2021.
An ‘annual declaration’ confirms that the introduction complies with AICIS rules, and applies for all 6 AICIS introduction categories:
- Listed introductions
- Exempted introductions
- Reported introductions
- Assessed introductions
- Commercial evaluation authorisations
- Exceptional circumstances authorisations
The declaration must be completed by the person/party who introduced the chemical, and submitted via AICIS Business Services. A reminder will be sent to enterprises before the due date.
- AIIC list check
- GLP laboratory agency
- Business registration
- Introduction categorisation
- Annual declarations preparing