Stakeholder feedback on the General Rules and Categorisation Guidelines and our responses
On this page we describe how we considered community and industry feedback we received in 2018 and 2019 while we developed the General Rules and the Categorisation Guidelines.
In 2018 we received 29 submissions on our consultation on an exposure draft of the General Rules and the Categorisation Guidelines.
In 2019 we received 26 submissions on proposed changes to the General Rules arising from the passage of the Industrial Chemicals Act 2019 (the IC Act).
We took all of these views into account when finalising the General Rules and the Categorisation Guidelines.
Our responses that you’ll see on this page have been broken down into the main themes for clarity and ease of understanding.
All feedback is valuable and we would like to thank all our stakeholders for their comments and suggestions.
On this page:
Making decisions and balancing stakeholder views
We took all feedback into account when making decisions about the new scheme, but we had to balance a variety of views. For example:
- some industry groups felt the new scheme had prohibitively small volume thresholds that were inconsistent with those accepted overseas, and wanted to use new animal test data that were mandated or approved by other jurisdictions
- some community groups felt the new scheme significantly relaxed the requirements on introducers as a result of the increase in allowable volumes, and wanted to ban animal testing in all circumstances
We have adjusted our proposed implementation approach to accommodate these views where they are in line with government decisions about the reforms.
We were unable to include all of the suggested changes for various reasons:
- they were not consistent with government decisions or the fundamental objectives of the reforms
- we had to balance competing interests and views
Some stakeholders provided feedback in the form of alternative models for consideration. We have summarised their proposals into key concepts, and included our rationale on why we could not accommodate them.
Some stakeholders asked questions about the new scheme, but not all of them are answered here. Our guidance and tools will help to answer these questions.
Feedback on transitional arrangements
We originally proposed a 12-month period to transition all chemicals to the new scheme, but our stakeholders felt this wasn’t enough time. The Transitional Rules now allow for a 2-year transition period when the new scheme starts on 1 July 2020.
This means we will extend the transition time:
- for current exemptions to 2 years
- for permits to 2 years or the permit period (whichever is longer)
- for exemption criteria to cover introductions after 1 July 2020 so introducers can continue to use current scheme criteria while waiting for the full details of the new scheme
The Transitional Rules, which support the operation of the Industrial Chemicals (Consequential Amendments and Transitional Provisions) Act 2019, explain in detail the transitional processes of existing exemptions, secondary notifications and new chemical introduction certificates.
Feedback on use of animal test data
Some community groups wanted:
- the restrictions on the use of new animal test data to apply to all chemicals
- animal test data not to be used to introduce any cosmetic chemicals, even if the data were available
- to remove the exceptions to the restrictions on animal test data
Some industry groups thought that the restrictions on the use of animal test data for chemicals with multiple end uses (that include cosmetics):
- go beyond the intention of the ban
- add additional administrative burden
Some industry stakeholders also wanted new animal test data that were approved overseas to be used in Australia.
The Australian Government made a commitment to explore how the new scheme could determine chemical safety while reducing the reliance on animal test data.
The Industrial Chemicals Act 2019 restricts the use of new animal test data for chemicals used solely in cosmetics, and chemicals with several end uses that include an end use in cosmetics.
- align with the approach taken in the European Union (EU)
- encourage the use of information from new methods that do not rely on the use of animals (detailed in the Guidelines)
- continue to allow for the use of new animal test data where necessary to protect human health (such as workers exposed to the chemical in high concentrations) and the environment, for chemicals with end uses in cosmetics and non-cosmetics
- allow for the submission of new animal test data in limited circumstances for chemicals with multiple end-uses, including cosmetics, where this is necessary to protect human health and the environment from known harmful effects and there is no available alternative test
The Rules provide further details about the restrictions on using animal test data for introductions where the chemical has multiple end uses, including an end use in cosmetics.
Community feedback on the use of animal test data
|Stakeholder feedback||Our response|
The use of new animal test data in relation to multi-end-use cosmetic introductions for categorisation into exempted and reported categories, and for applications for assessment certificates, should be limited.
The Australian Government committed to exploring further measures to achieve this while maintaining human health and environment protections. The General Rules outline a ban on the use of new animal test data for applications for assessment, and for categorisation, of industrial chemicals with end uses solely in cosmetics. The Rules also describe restrictions on the use of new animal test data for applications for assessment, and for categorisation of industrial chemicals with multiple end uses including an end use in cosmetics. These restrictions represent the outcomes of further consideration as to how the use of new animal test data can be reasonably limited whilst continuing to protect human health and the environment. The restrictions are also aligned as far as possible with comparable international restrictions on the use of animal test data.
The exceptions to the animal test ban should be removed so that there is no incentive to generate new animal test data for Australian regulatory requirements relating to cosmetic end uses.
The ban on animal test data applies in all circumstances except for 3 limited exceptions.These exceptions are necessary to continue to protect human health and the environment, and to align as far as possible with comparable international bans on animal test data.
The first circumstance is where the animal test data both demonstrates that the industrial chemical has a hazard characteristic and conflicts with the other information in the application for this hazard characteristic. In this case, the applicant can only include the animal test data if it's showing an adverse result that the non-animal test data does not show.
The second circumstance is where the animal test data is the only information that can demonstrate whether or not the industrial chemical has a particular environment hazard characteristic. Allowing the use of this animal test data in this circumstance provides continued environmental protection and aligns with the EU REACH regulation restrictions on animal test data.
The third circumstance is where the animal test data results from tests conducted with an industrial chemical that is not the industrial chemical for which the application has been submitted, and that other chemical is not being introduced by the person for an end use solely in cosmetics. This allows the use of read-across information, such as data on an analogue chemical. For some hazard characteristics, read-across information is the only non-animal option currently available.
|The last-resort principle should be clearly articulated within the General Rules where appropriate.||The principle of 'animal testing as a last resort' has been articulated in the Categorisation Guidelines (part 6.2) and the Explanatory Statement for the General Rules. This was a commitment from the Government.|
Online guidance and tools helping introducers to comply with the new scheme and cosmetic specific ban should be provided.
Now the final General Rules have been finalised, we'll work towards publishing guidance material giving more details to assist introducers to understand them and the Categorisation Guidelines. This will include case study examples and online decision tools.
The AICIS Stakeholder Education Program will also assist stakeholders in understanding their obligations, including those related to cosmetics and animal test data.
Statistics on the use of animal test data should be provided.
The Executive Director of AICIS will publish statistics on the use of animal test data and declarations in relation to compliance with the animal test data ban.
Information requirements associated with the General Rules and Categorisation Guidelines should be updated at least annually when new testing methods that would replace, reduce or refine animal use become available.
The Government committed to facilitating rapid uptake of new non-animal approaches as they become available. The information requirements in the Categorisation Guidelines will be updated to keep in line with technical progress internationally, such as the development of non-animal tests for identifying hazards. Introducers will be notified of any changes to the Categorisation Guidelines in advance of changes being made and supporting guidance materials will be updated in line with this.
Pre- and post-introduction declaration requirements must be amended to include compliance with the new animal test data ban and other measures relating to limiting the use of new animal test data for multi-end-use cosmetic introductions.
The Government committed to requiring a declaration of compliance with the animal test data ban as part of the pre-introduction reporting or post-introduction annual declarations as appropriate to the category of industrial chemical introduction.
For reported introductions, a statement must be provided as part of a valid pre-introduction report being submitted about the use of animal test data for the categorisation of the industrial chemical introduction (i.e. if the end uses for the industrial chemical include one or more end uses in cosmetics). The statement must state which of the circumstances in subsection 39(3) of the General Rules apply to the introduction.
Similarly, for exempted introductions, if the chemical has an end use in cosmetics, the post-introduction declarations for exempted introductions must include a statement about the use of animal test data, by stating which of the circumstances in subsection 36(3) of the General Rules apply to the introduction.
A declaration of compliance with the new animal test data ban should be added to the annual declaration for all introduction categories section.
The new scheme requires an annual declaration by introducers for all introduction categories (see s44 of the General Rules).This annual declaration is a way to confirm that all introductions made by the person during the registration year were authorised under one of the new scheme's introduction categories. This requirement is in addition to any requirements that are specific to a particular introduction category, such as a post-introduction declaration for exempted introductions, or a pre-introduction report for a reported introduction.
Declarations on animal test ban and restrictions are appropriately placed in post-and pre-introduction declarations, not as part of the annual declaration for all introduction categories.
For assessed introductions, the scheme will have all the available information following an application to determine compliance regarding the animal test ban and restrictions.
Post-introduction monitoring should prioritise multi-end use introductions for which a cosmetic end use and the use of new animal test data was declared.
The new scheme provides for enhanced post-introduction monitoring and compliance powers for all industrial chemicals and not just those with cosmetic uses. This will ensure that the safeguards necessary to ensure that protections of health and safety of consumers, workers and the environment are maintained.
The new scheme will be able to:
Also, the Government has committed to consulting with key community stakeholders on publication of targets for the post-introduction monitoring program, which will include chemicals with multiple end uses.
The ban on new animal test data should apply to all chemicals.
The General Rules cannot go further than the ban in the IC Act – so cannot extend it to all industrial chemicals.
Non-cosmetic end uses of industrial chemicals can expose workers to relatively high concentrations and thus, higher risks. More comprehensive assessment is required to ensure that there is no reduction in the protection of human health and the environment. While there is a trend away from animal testing, it does remain an important tool available for understanding some of these risks.
Industry feedback on the use of animal test data
|Stakeholder feedback||Our response|
The requirements on the use of new animal test data for chemicals with multiple end uses should be clearer.
Applying to the Executive Director to allow animal test data to be used for chemicals with multiple end uses would create additional administrative burden for industry.
The process for limiting use of animal test data for multi-end-use chemicals was designed to satisfy community concerns as well as minimising administrative burden on industry and the scheme. The requirements on the use of animal test data where the chemical has multiple end uses, including an end use in cosmetics, are clearly laid out in the General Rules. The General Rules set out the process for applying to the Executive Director to allow new animal test data to be used for applications or for categorisation purposes for introductions that involve multiple end uses. The time frames are specified in the rules and they also make it clear that these decisions are reviewable. (Refer to s78 of the General Rules.)
The new information requirements will include greater acceptance of data from similar chemicals (i.e. read across from analogues) and alternative (non-animal) test methods. This will encourage the development and uptake of alternative test methods, and also potentially reduce costs from expensive animal testing.
Waivers to information requirements will also offer an avenue for reducing toxicological testing (especially of animal testing).
As the ban is aligned with the EU, it means that it will minimise the impact on business and trade. Consistent with the EU, the ban is not retrospective and will allow the use of animal test data generated before 1 July 2020. The ban also will not affect cosmetic products currently on the market.
|The ban on new animal test data should be internationally harmonised.|
The ban on animal testing is aligned as closely as possible internationally with the approach taken by the EU. The EU and Australia bans both:
|New animal test data that are mandated or approved by other jurisdictions should be allowed to be used to show safety.|
The ban is on the use of new animal test data, not the purpose for which it was generated. This means that we cannot allow use of data just because it was generated for other jurisdictions.
Feedback on categorisation of industrial chemicals
Some community groups sought pre-introduction assessment of a wider range of chemicals. They were also concerned about the proposed categorisation of some chemical introductions, particularly nanomaterials.
Industry stakeholders sought higher volume thresholds that better aligned internationally. They also wanted to ensure that the regulatory obligations for fragrances are practical and account for the known difficulties in getting information about the ingredients in fragrances.
Our proposed approach:
- focuses on higher risk chemicals
- strengthens our post-introduction monitoring to ensure that introductions of lower risk chemicals are safe and in line with self-categorisation requirements
When drafting the General Rules and Categorisation Guidelines, we took several measures to simplify the categorisation process and improve clarity.
Before the new scheme starts, we'll help introducers by publishing:
- guidance on how to determine indicative risk
- online tools to help with the categorisation process
- guidance on categorising chemical introductions and meeting your obligations, such as record-keeping and pre-introduction reporting
- categorisation examples
Community feedback on categorisation
|Stakeholder feedback (by topic)||Our responses|
|Volume thresholds for lower exposure bands should not be increased.|
The volume threshold for 1 of the scenarios in what is now exposure band 2 has increased from 10kg to 25kg or 250kg (depending on the end uses). This more closely aligns internationally and allows the importation of a standard size drum to be categorised as very low risk (as long as the chemical does not have any of the highest hazards). This is considered a risk-proportionate change that balances protection of human health and the environment with regulatory burden on industry.
Human health categorisation volume should not be used for determining human health exposure band, as it is not reflective of risk.
Risk is a function of hazard and exposure. Exposure refers not just to the annual volume of a chemical introduced in Australia, but to the
The addition of the concept of ‘human health categorisation volume’ provides a more accurate determination of indicative risk, as is appropriate for a risk-proportionate regulatory framework.
Also, the human health categorisation volume has been introduced to address these issues raised by stakeholders:
Stakeholders did not want to subject the total volume of their introduction to the lower volume thresholds that would apply to cosmetic products that have a much greater public exposure.
Concern that the post-introduction declaration for exempted introductions will only be once-off and only occur after the chemicals have been introduced into Australia.
Under the new scheme, no pre-introduction reporting is required for exempted introductions. This is as long as introducers can show that the introductions are very low risk by meeting established criteria. This is consistent with the policy intent to make regulatory effort more proportionate to risk, while still protecting the Australian people and the environment from any harmful effects of industrial chemicals.
Introducers must also make an annual declaration after the end of each registration year that shows:
Introducers will also be subject to audit, with the new scheme having enhanced compliance monitoring and enforcement powers.
The criteria for the exempted introduction category should not be expanded to allow more chemicals to be introduced under this category.
The new scheme applies risk-proportionate regulation of risks to human health and the environment, i.e. by matching appropriate regulatory treatment to indicative risk.
The exposure draft of the General Rules defined criteria for exempted introductions based on a lower level of regulatory oversight set out in the Industrial Chemicals Bill 2017 compared to the requirement for once-off declarations included in the Industrial Chemicals Act 2019.
Due to the increased regulatory oversight of introductions in the exempted category, it is appropriate, in a risk-proportionate scheme, to adjust criteria for inclusion in the exempted category.
The exempted introduction category is for very low risk chemicals. To ensure higher risk chemicals are not inappropriately introduced under the exempted introduction category, a post-introduction compliance monitoring program will target exempted introductions as well as reported introductions. The monitoring program will utilise techniques and tools gained from the NICNAS Inventory Multi-tiered Assessment and Prioritisation (IMAP) program
The proposal in the April 2019 consultation paper (pages 14 and 20)* to change the human health and environment indicative risk outcomes for cell 3A of the human health and environment matrices from low risk to very low risk would result in a significant increase in the number of chemicals in the exempted introduction category
The outcomes in cell 3A of the human health and the environment risk matrices have been changed back to low risk (see s28 and s29 of the General Rules).
Polymers with sequences of fully fluorinated carbon atoms should not be categorised as exempted introductions.
All chemicals (including polymers) that contain a sequence of fully fluorinated carbon atoms with a length between 4 and 20 will be categorised as assessed introductions. This is because they are considered to be medium to high risk for human health and the environment. (See table item 1 of subsection 28(1) and table item 1 of subsection 29(1) of the General Rules.) This means they cannot be lawfully categorised as exempted introductions.
Low molecular weight polymers should not be categorised as exempted introductions.
Low molecular weight polymers will have the same information requirements as chemicals. They will not have the same information waivers available to them as high molecular weight polymers (see the Categorisation Guidelines).
Chemicals deemed to be non-hazardous under the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals should be categorised as exempted introductions.
Classification under GHS must be made using physicochemical and hazard data. This involves collecting available information or carrying out tests, evaluating the adequacy and reliability of the information, and making a decision on classification based on the GHS classification criteria and decision logic. Under the new scheme, if a chemical can be demonstrated to be non-hazardous according to the GHS (based on evidence of lack of hazard, not just a lack of evidence), it will be categorised as exempted
Chemicals used in research and development (R&D)
The volume threshold for non-nanoscale chemicals used for R&D that are exempted introductions should not be increased.
The volume threshold per annum for R&D chemicals not at the nanoscale that are exempted introductions has increased to 250 kg (see subparagraph 26(3)(d)(i) of the General Rules) from the previous threshold of 100kg in the exposure draft of the Rules.
The increased volume will allow a standard size drum to be imported, as this is sometimes the smallest size that can be purchased from an overseas chemical supplier. This adjustment does not result in a significant increase in risk to workers.
The new reported introduction type for R&D chemicals not at the nanoscale that remain under the control of the introducer will expose workers and the environment to potential hazards. The new scheme is unable to enforce workplace control measures.
The Rules have added (since the exposure draft) a reported introduction scenario for chemicals that are introduced:
This is more aligned with similar categories overseas. This scenario reflects risk-proportionate regulatory treatment from a risk assessment perspective. The implementation of corresponding workplace control measures remains the responsibility of risk-management bodies and persons conducting a business or undertaking. However, these chemicals are reported introductions and AICIS will therefore have a 'pre-introduction report' available for immediate post-introduction monitoring.
The new scheme provides for enhanced post-introduction compliance monitoring and enforcement powers for all industrial chemicals. This will ensure that the safeguards necessary to protect health and safety of consumers, workers and the environment are maintained.
The new scheme will:
R&D activities involving chemicals at the nanoscale should only be exempted for very low volumes.
|Industrial chemicals at the nanoscale that are solely for use in R&D can only be exempted introductions if the volumes do not exceed 10kg per year (see subsection 26(3)(d)(i) of the General Rules).|
Industry feedback on categorisation
|Stakeholder feedback (by topic)||Our responses|
Concentration of an ingredient and its exposure mechanism are more appropriate hazard assessment criteria than volume.
The human health exposure band for an introduction can depend on the following parameters:
The environment exposure band for an introduction depends on the environment categorisation volume (which is dependent on end use). As such, more than just volume of introduction needs to be considered to determine the introduction category.
A risk assessment undertaken by AICIS will consider the hazards of the chemical and the exposure scenarios in more detail.
|Volume thresholds for very low volume and very low concentration introductions should be increased.|
These are considered to be risk-proportionate changes that balance protection of human health and the environment with regulatory burden to industry.
|Human health volume thresholds should be increased and align internationally.|
Higher volumes thresholds may result in higher levels of exposure, and potentially higher risk, to humans and the environment. Volume thresholds for certain human health exposure bands have been modified to create better international alignment. For example, the modified volume threshold of >10 tonnes for non-cosmetic end uses will allow for alignment of certain information requirements of Canada and the EU (such as the requirements for repeated dose toxicity – in the Categorisation Guidelines).
For chemicals used in cosmetics, the volume thresholds have not been aligned with EU REACH volume thresholds, as REACH does not consider the public health risks arising from use of cosmetic ingredients. In the EU, the management of these risks is governed by the Cosmetics Regulations, which requires safety assessments of each new product (not just each new ingredient) to be conducted by industry. No lower volume threshold applies to these cosmetic safety requirements. The product safety assessment is based on the ingredients within that product, and so any new ingredient within a product will need to have hazard characterisation to inform the safety assessment of the product. Thus, the Australian requirements are substantially equivalent to the regulation of cosmetic ingredients used in Europe.
|The portion of industrial chemical that is imported and then exported without the packaging being opened while in Australia should not be included for categorisation purposes.||The method for calculating the human health and environment categorisation volume, as described in the Categorisation Guidelines (see parts 2.1.2 and 2.1.3), gives effect to this suggestion.|
|Tattoo inks and personal vaporisers should not be considered together with cosmetics.||Introductions for end uses in tattoo inks or personal vaporisers will be in the highest human health exposure band and not considered together with cosmetics.|
|Record-keeping requirements should allow for INCI names.||For certain types of introductions, the INCI name for the industrial chemical can be kept as a record of the chemical name, where a CAS number for the industrial chemical has been assigned.|
|Any allowances for fragrances should extend to flavours.||We have extended the allowances for fragrances to also include flavours, as there is often an overlap between the functions of these chemicals.|
No regulatory obligations should apply to fragrances. The regulatory burden planned for these low-concentration, low-volume introductions is not proportionate to the level of risk they pose.
Parliament wanted all introductions of industrial chemicals that are not listed on the Inventory to be visible to the new scheme. This means that unlisted introductions that fall within the scheme’s scope must be categorised. Also, at a minimum, all introducers should keep relevant records and submit declarations.
Fragrance chemicals may have significant hazards, even at low concentrations, so it would not be appropriate to remove such regulatory obligations for chemicals to which the public is exposed.
Whilst fragrance chemicals will still have regulatory obligations, the General Rules allow for those that meet certain criteria to be reported introductions (see below for further details). This will reduce the regulatory burden for introducers of fragrance chemicals.
It is relevant to note that chemicals (fragrance or otherwise) introduced and used at low concentrations (<0.1%) and low volumes (≤25kg) may be exempted introductions, as long as they do not have any of the highest human health or environmental hazards. This means that they are only subject to a low level of regulatory burden.
|Chemicals on the IFRA Transparency List should be recognised as low risk introductions. Information on individual fragrance components is difficult to obtain, particularly for smaller companies.|
The General Rules include low-risk flavour or fragrance blend introductions as reported introductions (see s27(4)). To be considered low risk, these chemicals must meet certain criteria, including:
This introduction type accommodates the relatively common situation in which an introducer does not know all the ingredients in the fragrance or flavour blend they are introducing. It does this by allowing: :
The General Rules also allow for written undertakings in situations where the introducer does not have all the information due to confidentiality of chemical identity by the supplier. These measures will reduce the regulatory requirements for introducers of fragrance chemicals.
|It is difficult for industry to track volumes of fragrances.||If your fragrance introduction is a low-risk flavour or fragrance blend introduction, you will not need to track your volumes because there is no upper volume limit for these introductions. You will need to keep records to demonstrate the total volume of the blend you introduced in a year, or the total volume of products containing the blend that you introduced in a year.|
|Not all fluorinated chemicals should be assumed to have the same risks as PBT and CMR chemicals. They are not all of high risk to human health or the environment.|
Only chemicals that have a sequence of fully fluorinated carbon atoms with a chain length between 4 and 20 will be medium to high risk for human health and the environment (and categorised as assessed) under the General Rules.
Those with chain lengths shorter than 4, or higher than 20, could be categorised as exempted or reported. The medium to high indicative risk outcome for those with chain lengths between 4 and 20 reflects the uncertainty that remains about the hazard of many of these chemicals and the community concerns with them.
|Chemicals used in R&D|
|Volume thresholds for non-nanoscale R&D chemicals that are exempted should allow for the introduction of a standard sized drum.|
The volume threshold for non-nanoscale chemicals used for R&D increased from 100kg/year to 250kg/year (in subparagraph 26(3)(d)(i) of the General Rules) to allow for a standard drum size.
|All R&D chemicals should be categorised as exempted regardless of volumes.|
The new scheme applies risk-proportionate regulation of risks to human health and the environment to chemicals used for R&D.
Higher volumes of R&D chemicals may result in higher levels of exposure, and potentially higher risk, to humans and the environment. This means that it would not be appropriate for very high volumes of R&D chemicals to be exempted introductions. The Rules allow for R&D chemicals to be exempted if they meet certain criteria and are introduced at volumes up to:
This volume threshold has increased from the previous threshold of 100kg in the exposure draft of the General Rules.
The increased volume will allow a standard size drum to be imported (as this is sometimes the smallest size that can be purchased from an overseas chemical supplier).
The General Rules allow other R&D chemicals to be reported if they meet certain criteria and are introduced at volumes up to 100kg (for chemicals at the nanoscale) or volumes greater than 250kg (for chemicals that are not at the nanoscale and where use is subject to the control of the introducer). This separate reported introduction type will streamline the process for these low-risk introductions, and make their regulatory treatment more aligned with similar categories overseas.
|It should not be assumed that all insoluble chemicals at the nanoscale are higher risk based solely on their physical state without proper consideration of the toxicological properties and/or the level of exposure.|
The concerns about chemicals at the nanoscale raised by community stakeholders differed from those of industry stakeholders as to their general regulatory treatment. Community groups are of view that a precautionary approach should be maintained for introductions of nano scale chemicals.
The General Rules set out circumstances where nanoscale chemicals can be either categorised as low risk (reported) or medium to high risk (assessed).
Introductions of certain chemicals at the nanoscale (other than for R&D purposes):
|The technical details and application of the polymer of low concern (PLC) criteria should be consistent with international practices.||The PLC criteria are aligned closely with the equivalent criteria used in the US and Canada. The new scheme will have web-based tools to provide more assistance to introducers to help them work out if their polymer meets the PLC criteria.|
|Polymers that meet the 2% rule should not have record-keeping requirements, as it would be extremely difficult for introducers to obtain the relevant information for polymers that have been introduced using the 2% rule under the current scheme.|
Polymers that meet the ‘2% rule’ (comparable polymers) will be exempted introductions. We've changed record-keeping requirements for comparable polymers to address concerns. (See s49 of the Rules.)
Record-keeping requirements for polymers that are first introduced before the new scheme starts are lower, and easier to obtain, than introductions of comparable polymers that are first introduced after the new scheme starts.
If the first introduction occurs before 1 July 2020 (under the current scheme)
The introducer must keep records about the chemical identity of the listed polymer (not the polymer that they're introducing).
If the introducer doesn't know the listed polymer's proper name, they can keep a written undertaking from the chemical identity holder to give the chemical identity to us if we ask for it.
If the first introduction occurs after 1 July 2020 (under the new scheme)
In contrast, after 1 July 2020, the introducer must keep records about the chemical identity of the comparable polymer itself (that is, the one not listed on the Inventory). Also, they must keep records to show that it is a comparable polymer and that it's not an introduction that is not permitted to be exempted or reported.
|The wording of the 2% rule for polymers should make it clearer that the rule applies to all reactants at or below the 2% level.||The wording of this section of the General Rules has been modified so that the intention is clearer. (Refer to subsection 26(4) of the General Rules.)|
|A chemical that is manufactured in Australia and leaves the site of manufacture at a concentration of 1% or less should not be disadvantaged compared with a chemical that is imported into Australia at a concentration of 1% or less (due to the ≤1% scenario in human health exposure band 3).||The new scheme has been designed so that the regulatory requirements are proportionate to the level of risk posed by an introduction. The process of manufacturing a chemical in Australia tends to involve a higher risk of exposing workers and the environment to the chemical (because of higher concentrations, and possibly higher volumes) compared with a chemical that is imported in a product at concentrations of 1% or less. This means it is appropriate for other manufactured chemicals to have higher levels of regulatory obligations, such as hazard information requirements, than chemicals imported at low concentrations. A chemical that is manufactured in Australia in situ and is only ever present at concentrations less than or equal to 1% can make use of the 1% scenario in human health exposure band 3.|
|Any restriction on the use of mixtures and articles made with chemicals introduced under a commercial evaluation authorisation (CEA) is likely to reduce innovation in Australia and also result in unnecessary waste. Chemicals that are the subject of a CEA should be able to be sold and supplied into the Australian market.|
The General Rules now state that a person cannot apply for a CEA that will be made available to the general public on its own, with other chemicals, or as part of an article if the:
Considering that a CEA will involve an abbreviated risk assessment whereby some uncertainty regarding the associated hazards and risk remain, the rules limit exposure to the general public. This approach is in line with criteria used in other jurisdictions, such as ECHA’s Product and Process Orientated Research and Development (PPORD).
|All mixtures should have the same concessions made as have been provided for fragrances.||Fragrances and flavours are inherently limited in their volume and concentration so their environmental risks should remain relatively low. This would not necessarily be the case with other mixtures.|
|Less information should be needed for an introduction to be exempted - otherwise too many introductions will end up being assessed and reported when they don't need to be.|
The level of hazard information required for an industrial chemical introduction increases as the exposure increases. For example, in Exposure Band 2 for human health, for the industrial chemical introduction to be of very low indicative human health risk, you only need to rule out the hazards in the highest hazard band. This can be determined based on existing information, including checking to see if the chemical is on our single consolidated list of chemicals that have high hazards for categorisation.
A number of chemicals that are not currently exempt from notification under NICNAS will become exempted introductions under AICIS. For example, polymers of low concern (PLCs) will be exempted introductions under the new scheme (see subsection 26(6) of the General Rules).
Under the new scheme, many introductions can be automatically categorised as exempted or reported (see s26 and s27 of the General Rules). For example, introductions that are imported into Australia and do not have the packaging opened before being exported will be automatically in the exempted introduction category. This will reduce the resources required to work out the category for many introductions.
Some chemicals that are exempt from notification under NICNAS will be reported introductions under AICIS due to differences in the criteria. Similarly, some introductions that would otherwise be categorised as assessed could be categorised as reported under specific circumstances. For example, by using the internationally assessed pathway. For those introductions that are categorised as reported, the time and resources of introducers to submit the pre-introduction report is equivalent to that required under NICNAS for ‘no unreasonable risk’ claims and/or submission of pre-introduction advice (as is currently required for some categories that are exempt from notification). Introducers will also continue to benefit from no direct costs and no delays in time to market for these introductions. Information detailed in Safety Data Sheet can now be used to show that a chemical has a hazard.
Industry feedback on information requirements
|Stakeholder feedback||Our response|
|Many of the specified lists are not based on the application of sound scientific principles and should be removed.|
The relevant chemicals from the specified lists will be consolidated into a single, searchable list. Introducers will be able to use the list to check whether their chemicals have high hazards for categorisation purposes. Based on stakeholder feedback, there have been some changes to the lists that will make up this consolidated, searchable list. For example, only a subset of chemicals will be included on the new list. For example, only a sub-set of chemicals will be included from the:
|A variety of information sources, such as Safety Data Sheets, should be able to be used for categorisation purposes.||An Safety Data Sheet is acceptable to show a chemical has a hazard characteristic. But more detailed information is needed to show that a chemical does not have a particular hazard characteristic.|
|Food ingredients used in cosmetic products that have a known safe history of use in food products in Australia (under Australia New Zealand Food Standards Code - Standard 1.3.1 - Food Additives) and around the world should be recognised as such in the consideration of their use in formulated products.|
Under certain circumstances, chemicals that have been assessed by:
are eligible for waivers of certain information requirements (where the determination is relevant). For example, repeated dose toxicity – see the Categorisation Guidelines.
Feedback on the use of international information
Industry wanted us to accept more international approvals so that fewer chemicals would need to be assessed, or would be accepted as very low risk introductions with no assessment.
In contrast, the community were concerned that medium- to high-risk chemicals would be introduced without an assessment. Some also felt we should accept international bans and impose the same bans in Australia without an assessment.
We considered both viewpoints, and for internationally assessed industrial chemicals introductions, the General Rules now state:
- the international assessment bodies that can be used because they meet the criteria set by the Minister for Health
- a chemical that has been assessed overseas can be low indicative risk for human health and/or the environment — as long as it meets the criteria, such as having the same end use and similar risks
Chemicals introduced using this internationally assessed pathway will be subject to post-introduction monitoring. We may also make recommendations to risk managers.
Our responses to feedback on this topic are highlighted below.
Community feedback on the use of international information
|Stakeholder feedback||Our response|
If a chemical is banned overseas it should be automatically banned in Australia. Do not assess it first.
The Executive Director AICIS can decide to do an evaluation of a chemical that's been banned overseas (see s74 of the IC Act). This could result in the removal of the Inventory listing of the chemical.
Industry feedback on the use of international information
|Stakeholder feedback||Our response|
|More international assessment bodies should be accepted for the ‘internationally assessed pathway’.|
The purpose of this pathway is to allow for internationally assessed industrial chemicals to be introduced as low risk to human health and/or the environment.
Only chemical regulatory schemes listed in the General Rules (subsection 6(3)) can be used for this pathway. These schemes meet the criteria set by the Minister for Health. The new scheme will now also accept opinions:
Other international agencies suggested by stakeholders are not suitable at this time. Some reasons for this are because many of the agencies do not:
We are open to considering new information about how an international agency meets the requirements set out in the General Rules and the Minister's criteria.
|No information should be published about internationally assessed introductions.|
Limited information about internationally assessed introductions will be published (see s63 of the General Rules). This provides some transparency about the identity of these chemicals. This takes into account that they can be of medium to high indicative risk and would otherwise have to be assessed by AICIS before being introduced into Australia.
|There should be minimal regulatory obligations for chemicals with a proven history of safe use overseas, that are already subject regulatory requirements in the overseas jurisdiction.|
If an introducer is aware of relevant information on a chemical that has been relied on to meet overseas regulatory requirements, they’ll be able to use it to categorise the chemical introduction in Australia.
If there’s available information that shows low or very low risk, the introducer will have the option to import or the manufacture the chemical as an exempted or reported introduction.
The internationally assessed pathway can also be used where industrial chemicals have been assessed overseas for human health and/or the environment. In these cases, it could be categorised as a reported introduction.
The concept of history of safe use assumes that effective surveillance and biomonitoring regimes have been in place in the relevant overseas jurisdiction. But this is often not the case. A reliance on a history of safe use also assumes that effects of chronic exposure (repeat dose of toxicity) can be reliably detected by post-market surveillance methods (such as reports to Poisons Centres - this is also unlikely).
It's unclear why introducers have to consider certain overseas risk assessment assumptions that were mentioned in the exposure draft version of the Categorisation Guidelines.
We’ve changed the parts of the Categorisation Guidelines (see parts 4.1.2 and 4.2.2) that explain the criteria for internationally assessed chemical introductions that can be low indicative risk for human health or the environment.
We’ve made it clearer what you need to consider to work out if the risks of your chemical in Australia are no higher than the risks overseas. This also involved narrowing down the overseas risk assessment assumptions that need to be considered (see parts 4.1.2 and 4.2.2 of the Categorisation Guidelines). For human health, there are now no overseas risk assessment assumptions that need to be considered. For environment, only the risk assessment assumptions that could change the risk assessment outcome will need to be considered.
Compliance and record-keeping
Community feedback on compliance and record-keeping
|Stakeholder feedback||Our response|
|Use a combination of announced and unannounced audits.||We currently use both announced and unannounced inspections depending on the circumstances of the case. We aim to balance the need to maximise the efficiency of the inspection without compromising its effectiveness. We will monitor compliance with our new laws in the same way to ensure introducers are meeting their obligations and keeping appropriate records. Our focus will also shift to more post-introduction monitoring when the new scheme starts.|
|Consult with key community groups in developing the compliance monitoring program; publish and report on targets.|
We will consult with key stakeholder groups on compliance monitoring targets and reporting once AICIS starts.
|Conduct proactive monitoring of introductions to ensure compliance with animal welfare and ‘last-resort’ requirements.||We'll focus our compliance monitoring on chemicals posing the greatest risk and on introducers we consider present a greater risk of non-compliance. Our activities will focus on the reported and exempted chemical categories to ensure introductions are authorised under s24 of the IC Act. Any unauthorised introduction (including those involving use of animal test data) will be managed as an offence under the IC Act.|
|A significant proportion of exempted introductions should be audited to ensure that the current protections are at least maintained.||AICIS will have dedicated resources to for post-introduction monitoring of exempted introductions. The proportion of effort dedicated to the post-introduction monitoring of exempted and reported introductions will be greater than that which is currently dedicated to monitoring chemicals exempt from notification.|
|Need more contemporary compliance powers to deal with the increased focus on post-introduction monitoring.|
The regulatory powers of the new scheme have been derived from the Regulatory Powers Act and are standardised across Commonwealth regulators . AICIS will have access to more contemporary tools to allow it to monitor compliance and take action when non-compliance occurs. Specifically, AICIS will be able to:
Industry feedback on compliance and record-keeping
|Stakeholder feedback||Our response|
|The reporting period should be aligned to the financial reporting cycle.||No changes were made to the reporting period as the registration year and reporting cycle is set in the IC Act.|
Publish a compliance plan that:
We will publish a document that outlines our approach to compliance and provide further information on our monitoring activities. Our monitoring activities will cover all introduction categories.
|Record-keeping requirements for listed introductions are too prescriptive.|
The records needed for listed introductions (s46 of the General Rules) relate to:
It is expected that an introducer would know this information to be able to ensure that their introduction is a listed introduction.
|Clarify the requirements for audits.||Introducers should be prepared to provide evidence that they hold the relevant records as detailed in the legislation and guidance material. For example, introducers will need to have information to show that their introductions are correctly categorised.|
Community — other feedback
|Stakeholder feedback||Our response|
|A large number of chemicals on the Inventory remain unassessed. Work started by NICNAS on these unassessed chemicals through its IMAP program should continue as an urgent priority||Work started by NICNAS on unassessed chemicals through its IMAP program will continue under strengthened arrangements under the Industrial Chemicals Act 2019 for evaluating listed chemicals. The draft AICIS Evaluation Roadmap 2020-24 will detail a strategic approach to identifying priorities for evaluating industrial chemicals and achieving outcomes from those evaluations. This will be published on our website soon.|
Industry — other feedback
|Stakeholder feedback||Our response|
|There may be no reduction in regulatory burden under the new scheme.|
The new scheme applies risk-proportionate regulation of risks to human health and the environment. As a result many chemicals that would currently require assessment under NICNAS may be categorised as being exempted or reported introductions under AICIS.
Industry should expect quicker time to market and regulatory savings from reduced reporting obligations (once off instead of annual) when introducing lower risk chemicals.
Views of all stakeholders were taken into account when finalising the General Rules, to meet the Government’s commitment to a more risk-proportionate scheme that maintains health and environmental protections.
|It is too onerous to expect introducers to check each one of the specified lists individually in order to determine whether a certain chemical has one of the high hazards for human health or the environment||A consolidated resource, with content from each of the individual specified lists, will be provided for introducers such that only one list will need to be checked|
|Research into the identification and mechanisms of endocrine disruptor chemicals remains ongoing worldwide.|
Considering the uncertainties in this area, we have taken a conservative approach. This should ensure that chemicals with potential endocrine activity will be assessed by us. Our List of chemicals with high hazards for categorisation will include chemicals from the following international lists that cover chemicals with endocrine disrupting properties:
|Record-keeping requirements for UV filters should be changed as they are too high.||The level of information required for UV filters has been reduced.|
|There should be a downloadable format for the Inventory.||We are exploring the option of providing a downloadable Inventory.|
|How can chemicals can be added to the list of comparable chemicals?||The Executive Director may consider new comparable chemicals upon submission of the relevant information and justification by introducers.|
|Non-industrial chemicals should not be removed from the Inventory. Introducers are not always aware of what chemicals are in their products and rely on advice from overseas suppliers. Removal from the Inventory could mean that in future some chemicals could be unintentionally introduced illegally.||Under s80 of the IC Act the new Inventory must only contain industrial chemicals. Certain chemicals currently on the current scheme's Australian Inventory of Chemical Substances (AICS) are not industrial chemicals. In the November 2019 Chemical Gazette, we published a notice requesting information on any known industrial uses of chemicals on the Inventory that we are proposing to remove at the start of the new scheme because we believe they do not have (and have not had) an industrial use.|
|The loss of the current 'no unreasonable risk' pathway is likely to impose more information requirements on industry.||The ‘no unreasonable risk’ criterion can be subjective and can result in difficulties for introducers in applying it. It can also result in difficulties in monitoring and enforcing compliance. The government chose a framework based on categorisation against objective hazard and exposure criteria, rather than a subjective self-assessment of ‘no unreasonable risk’.|
|Crucial elements of the proposal deviate from the regulatory frameworks and approaches of the other major economies, resulting in unwarranted burdens on the introduction of some chemistry in Australia.|
The details of the new scheme were the subject of extensive consultation with stakeholders. The finalised details:
|Low volume introductions should not have record-keeping requirements.|
The record-keeping requirements for exempted R&D introductions are different for low introduction volumes (≤10kg).
For other introductions, record-keeping requirements apply for all introduction volumes. The requirements largely relate to ensuring that your introduction has been correctly categorised.
|The new scheme should not disadvantage international trade.||Trade considerations are not an explicit object of the IC Act. We notified the World Trade Organisation Committee on Technical Barriers to Trade of the proposed changes to our scheme in 2016. Our notification was considered by the Committee. No adverse comments were received.|
Last update 27 February 2020