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On September 15, 2023, the Australian Government invited the public to give their comments on a suite of proposed changes to the chemical introduction categorization, reporting and record-keeping obligations under the Australian Industrial Chemicals Introduction Scheme (AICIS). Comments are welcome before November 9, 2023.
These changes are proposed through the draft amendments to the Industrial Chemicals (General) Rules 2019 (hereinafter referred to as the General Rules) and the Industrial Chemicals Categorization Guidelines (hereinafter referred to as the Guidelines), aiming to address stakeholder advice that certain requirements are challenging to comply with and clarify the intent of certain requirements. According to the official announcement, major proposals for public comments this time include:
Proposals to help introducers (manufacturers or importers) meet their obligations, especially record-keeping requirements.
Proposals that strengthen the categorization criteria and reporting requirements to protect human health and the environment, e.g., to prevent persistent organic pollutants (POPs) from being categorized as exempted or reported Introductions.
Proposed changes
Regarding record-keeping requirements
In Australia, chemical introductions (manufacture or import) can be categorized into five types (see figure below). For different introductions, different obligations apply. The proposed changes to record-keeping obligations mainly relate to “Listed introductions”, “Exempted introductions”, and “Reported introductions”, which aim at making compliance simpler and easier.
Source: AICIS Website
According to the current record-keeping requirements, where an introducer is unable to get a CAS name of the chemical to be introduced, the introducer is required to obtain a written undertaking from the chemical identity holder. However, introducers often encounter difficulty in obtaining a written undertaking from their manufacturer or supplier who holds the chemical identity information. To address this issue, the proposed changes to the General Rules provide introducers with options to meet their record-keeping obligations, i.e., replacing written undertakings with a more practical set of records introducers could keep when they are unable to obtain the chemical identity information.
Example:
For “List introductions”, if the introducer doesn’t know the chemical’s CAS number, the introducer can replace the written undertakings with providing the chemical’s CAS name or IUPAC name and keeping a record that shows the chemical is listed on the Australian Inventory of Industrial Chemicals (AIIC).
However, the extent of the proposed changes and requirements differ depending on the type of introduction and/or level of exposure to humans or the environment. Details about the proposed more practical requirements can be accessed below:
Listed introductions: more practicable record-keeping requirements
Exempted and reported introductions: more practical requirements
Besides, if the introducer manufactured or imported chemicals under the NICNAS, the following requirements for record-keeping must be met:
Holding the written confirmation from the supplier (or other person who knows the chemical identity) that you would have had under NICNAS to confirm that the chemical was listed on the NICNAS Inventory; and
Providing the written correspondence to show that you’ve asked them for a written undertaking to meet your record-keeping obligations for listed introductions.
This temporary record-keeping arrangement for introducers who transitioned from NICNAS to AICIS will expire after April 1, 2024. See Temporary record-keeping provisions for NICNAS introducers extended to 1 April 2024.
Regarding annual declaration requirements
The annual declaration form for “Exempted introductions” is also proposed to be changed so that businesses that imported or manufactured a chemical under this introduction category must specify which type of exempted introduction they used.It would be a quick and easy process when an introducer submits the annual declaration in AICIS Business Services and selects ‘exempted introduction’ from a checkbox list appearing with these options:
Introductions where the highest indicative risk is very low risk;
Polymers of low concern;
Low-concern biological polymers;
Introductions that are only for use in research and development;
Chemicals that are comparable to listed chemicals;
Polymers that are comparable to listed polymers;
Chemicals resulting from non-functionalized surface treatment of listed chemicals; or
Chemicals that are imported and subsequently exported.
The introducer should select each type of exempted introduction relevant to their importation or manufacture for that registration year. Please click “Exempted introductions: annual declaration change to improve AICIS monitoring” for more information.
Regarding introduction categorization criteria
For some types of chemicals that are of high concern in Australia and worldwide, their introduction categorization criteria are proposed to be changed. The aim of these proposed changes is to ensure introductions of such chemicals could not be categorized as “Exempted introductions (very low risk)” or “Reported introductions (low risk)”. Involved types of chemicals in this regard are as follows:
Fluorinated chemicals: categorization changes for health and environmental protection
To clarify the types of fluorinated chemicals, including ‘next generation’ type fluorinated chemicals, that would warrant an AICIS assessment and approval before being introduced into Australia.
Persistent organic pollutants (POPs): categorization changes for health and environmental protection
Chemicals that meet the POPs screening criteria set out in Annex D of the Stockholm Convention (but are not listed in the Annex A, B or C to this convention) could not be categorized as “Exempted introductions” or “Reported introductions”. The introduction of such chemical would always be categorized as “Assessed introductions”.
Chemicals containing hazardous elements added to human health hazard band C
To add the following criteria to human health hazard band C: a) chemical is an inorganic arsenic compound; b) chemical contains beryllium, cadmium, chromium (VI), lead or nickel.
In addition to the abovementioned proposals, there are some other minor proposed changes to clarify information and requirements. All the proposed changes to the General Rules and Guidelines were developed using evidence- and risk-based approach that is appropriate to each circumstance. The following two documents are the whole exposure draft of the General Rules and the explanation of all proposals:
