Earlier on January 11, 2019, the Australian government announced that it decided to further delay the implementation of the Australian Industrial Chemicals Introduction Scheme (AICIS), which is now scheduled to be implemented starting from July 1, 2020 (see CL news [1]).
The new scheme will replace the existing National Industrial Chemicals Notification and Assessment Scheme (NICNAS) as an overarching regulatory framework for introduction of industrial chemicals into the country.
Basics Remaining Unchanged and Persistent
According to explanations offered on the NICNAS website, notwithstanding some changes, the basics of the new scheme will be the same with those of the old one.
The AICIS will, in place of the NICNAS, continue defining industrial chemicals by exclusion and conducting risk assessment on introduction and use of industrial chemicals. The risk assessment information and relevant recommendations will be published in the form of Assessment Statements and Evaluation Statements, and all introducers of industrial chemicals are required to comply with AICIS regulations and obligations. Its aim will still be to ensure safe use of industrial chemicals so as to protect the health and environment of Australians.
Major Changes Made in AICIS
Overall, the new framework will be more risk proportionate by focusing on the likely risk of any industrial chemical. Under the AICIS, introducers will take on the obligation of categorizing the risk level of their own introduction, which will be the first step in introducing a chemical. And there will be six categories of introduction, as shown in the table below.
Category | Application scope | Compliance requirements |
Listed introductions | Chemicals already listed on the Australian Inventory of Chemical Substances (AICS) | Comply with terms in the AICS listings |
Exempted introductions | Chemical with very low risk | Keep records about the chemical and its use and make an once-off declaration to AICIS |
Reported introductions | chemicals with low risk | Submit a pre-introduction report to AICIS and keep records about the chemical and its use |
Assessed introductions | Chemicals with medium to high risk | Apply for risk assessment to get assessment certificate for the introduction; recordkeeping; the chemical will be listed into the AICS after 5 years |
Commercial evaluation authorizations | Time limited authorizations granted to help an introducer determine a chemical's commercial potential | Apply for commercial evaluation authorizations |
Exceptional circumstances authorizations | Granted to an introduction which is necessary in the public interest to manage significant human health or environment risks | Apply for exceptional circumstances authorizations |
To help businesses specify the category of their introductions, the AICIS website presents some case studies [2] to work them through the 6-step categorization process.
(Source: NICNAS)
In addition to the six categories of introduction, the AICIS will also feature:
Streamlined process for lower risk chemical introductions;
Enhanced protections against chemicals with higher risks;
Expanded use of assessment materials issued by international bodies;
Boosted monitoring and compliance powers;
Responsive and flexible approaches to reviewing chemicals on the market;
Increased transparency by striking a balance between confidentiality and publicly available information; and
Ban on the testing of cosmetics on animals
Regulatory Changes Already in Effect
Though the AICIS will commence on July 1, 2020, some regulatory changes have been in effect under the current scheme. These changes can reduce regulatory burden for introducers of some chemicals with lower risks, such as polymers of low concern (PLCs). They include:
No more annual reporting for permit holders and self-assessed assessment certificate holders
Shorter time frames for Approved Foreign Scheme assessments
PLCs are exempt from notification
Expansion of the PLC criteria
Changes to the definition of a new synthetic polymer
No more Safety Data Sheets (SDS) and labels required for cosmetics introduced at low volumes
The NICNAS has specified details of these changes [3], in a bid to facilitate industry understanding and compliance.
Key Documents under Development
There are three key documents which are being devised to promote the upcoming implementation of AICIS, namely the Industrial Chemicals (General) Rules 2018 (General Rules), the Industrial Chemicals Categorization Guidelines (Categorization Guidelines) and the Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2018 (Transitional Rules).
Currently, all of the three rules are awaiting their next draft, each focusing on different aspects. The General Rules (see the March 2018 draft General Rules [4] and latest consultation on it [5]) involves details as to how to regulate manufacture or import of chemicals in the country under the AICIS, such as how to categorize industrial chemical introductions, criteria for Commercial Evaluation Authorizations, reporting and recordkeeping requirements, etc.; the Categorization Guidelines (see the March 2018 draft Categorization Guidelines [6]) majorly lays out instructions concerning introduction categorization and relevant requirements; and the Transitional Rules (see the March 2018 draft Transitional Rules [7]) offers provisions for managing the transition from the old scheme to the new one.
Moreover, as businesses both within and outside Australia have been expressing their doubts and concerns about the AICIS implementation, the Australian government published FAQs (see CL news [8]) on AICIS on July 31, 2019, and plans to keep updating the section in the future.
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