Our responses to stakeholder feedback on amendments to the General Rules (introductions of 10 kg or less)

Introduction

We proposed changes to the General Rules (the Rules) to address concerns about regulatory obligations on introducers that are importing or manufacturing 10 kg or less of chemicals in a registration year.

We received more than 40 submissions, and most indicated support for the proposed changes. In the submissions that did not support part 1 or part 2 (or both), one or more of the following applied:

• they sought changes that were broader in scope, for example – changes to the requirements for introductions of more than 10 kg of chemical in a registration year
• they misunderstood the impact and relevance of the proposed changes to certain introductions 
• they did not explain why they weren’t supporting the changes 

We considered all feedback, which is presented in Q&A format below. Feedback and responses on similar topics have been combined and presented together. Issues outside the scope of this consultation or specific to the company providing the feedback are not addressed here. 

We will consider feedback that’s outside of the scope of this consultation over the next 12 months.

Next steps

Question 1: When and how will the Rules be amended?

Answer: The Rules have been amended and introducers can now import or manufacture industrial chemicals in accordance with these Rules.

The following changes have been made as a result of feedback.

Schedule 1, Clause 1: Definition of ‘GHS’

Instead of referring to a specific edition of the GHS, the definition now refers to the edition in use by SafeWork Australia. This means that the Rules will not need to be updated when SafeWork Australia updates the GHS edition that it uses. This change was made as a result of internal stakeholder feedback.

Schedule 1, Clause 3: Criteria to categorise introductions of chemicals at 10 kg or less in a registration year as reported

The criterion was amended to add the concept of the GHS hazard class being known to the introducer. This means the criterion is not met if the industrial chemical “…is known by the person…” to satisfy the criteria for germ cell mutagenicity, carcinogenicity or reproductive toxicity hazard classes in the GHS. This change was made as a result of external stakeholder feedback. See Question 13 for further information. 

Schedule 1, Clause 4: Prescribed information for pre-introduction reports for reported introductions of chemicals that are solely for use in research and development 

The wording of subsection 41(2), table item 6 was changed. This relates to the prescribed information for pre-introduction reports for reported introductions of chemicals that are solely for use in research and development. The wording was changed to say “A declaration that the requirements of subsection 27(2) or (3) (as the case requires) are being met for the introduction.” This wording is more appropriate, as the requirements can only be met at the time of introduction, rather than at the time the pre-introduction report is submitted. This change was made as a result of internal stakeholder feedback, and for consistency with the change in clause 5.

Schedule 1, Clause 5: Prescribed information for pre-introduction reports for introductions of 10 kg or less of a chemical in a registration year

The wording of table item 8 was changed to say “A declaration that the requirements of subsection 27(6) are being met for the introduction.” This wording is more appropriate, as the requirements can only be met at the time of introduction, rather than at the time the pre-introduction report is submitted. This change was made as a result of internal stakeholder feedback.

Question 2: Will further changes to the General Rules be considered?

Answer: Yes. We are always open to feedback on ways to improve the scheme. However, any amendments must be risk proportionate and consistent with the objects of the Industrial Chemicals Act 2019, including in the protection of human health and the environment. 

It takes time to make changes to the Rules. The process includes developing proposed new rules (or amendments to existing rules), publicly consulting on them, as well as legislative procedures. Over the next year, we will explore more options to address relevant issues raised by stakeholders (including both industry and community) in complying with regulatory requirements under AICIS. This exploration will focus on changes to address issues faced by introductions previously introduced under NICNAS exemptions. This will not be a review of AICIS itself.

Specific feedback related to Part 1 of the consultation: Changes to the record-keeping requirements for listed introductions at 10 kg or less.

Question 3: The administrative record-keeping arrangement for listed introductions has been extended until 30 November 2023. What is the benefit of changing the rules on the record-keeping requirements for listed introductions now? 

Answer: The new rule provides immediate certainty for introducers of listed chemicals at 10 kg or less in a registration year. 

The administrative arrangement only applies to an introducer who doesn’t know the identity of an inventory-listed chemical that they imported or manufactured under NICNAS. It does not apply to an introducer who commenced import or manufacture of that same chemical under AICIS (that is, from 1 July 2020). In other words, an introducer can only use the administrative arrangement for listed introductions if:

• they imported or manufactured a certain listed chemical under NICNAS; and
• they continue to import or manufacture the same chemical under AICIS.

The administrative arrangement relates to record keeping. The records an introducer must keep when using this arrangement are similar (but not identical) to the records required under NICNAS for a particular chemical introduction– which gives the introducer more time to transition to the AICIS requirements. Under this arrangement, the introducer must:

• keep correspondence to show that they have requested a written undertaking be provided for their chemical introduction to meet their AICIS record-keeping obligations
• keep written confirmation from their supplier (or whoever holds the identity of their chemical) that they would have had under NICNAS to confirm that the chemical was listed on the NICNAS Inventory. 

In contrast, under the amended Rules, introducers can keep information that they should already have or can easily find, such as the INCI name of the chemical. They don’t need to source a written undertaking (see question 4 for more information about written undertakings compared with the requirements of the amended Rules). This means introducers can comply with the AICIS obligations sooner.

Question 4: What’s the difference between a written undertaking and the requirements in the Rules for introductions at 10 kg or less in a registration year, where the introducer doesn’t know the chemical’s CAS number or CAS, IUPAC or INCI name?  

Answer: It’s easier for the introducer (and chemical identity holder) to comply with the amended requirements for introductions at 10 kg or less in a registration year. 

The introducer must keep a record of who they believe, on reasonable grounds, would give the CAS number (if assigned) and CAS, IUPAC or INCI name of the chemical to the Executive Director (if asked to supply this information). The introducer needs to have a business relationship with their chemical supplier and know who holds the identity of the chemical. 

The introducer no longer needs to ask for – and keep – a written undertaking from the person who knows the identity of the chemical that “…the CAS name and number (if assigned) for the industrial chemical will be provided to the Executive Director, if requested, within 40 working days after the day the request is made.”  

For introductions that are 10 kg or less in a registration year, an introducer can be confident that:

• their introduction is a listed introduction and 
• they can meet their obligations 

through access to and holding of information other than what is provided in a written undertaking. 

Information about the chemical introduction would still be provided to us, if requested as part of our compliance monitoring program. 

Question 5: The overseas supplier says the CAS number or CAS name of a chemical is confidential. Do they need to give this information to the Australian introducer?  

Answer: No, but the introducer needs to be confident that:

• their introduction is a listed introduction and 
• they can meet the record-keeping requirements. 

The introducer will need some information from the supplier to give them this confidence, such as, confirmation that the chemical is listed on our Inventory. The supplier can give the CAS number and CAS name of the chemical directly to AICIS, without disclosing it to the Australian introducer, if requested. This is similar to the arrangements that were in place under NICNAS.

Question 6: It can be hard to track volumes of imported chemicals. Why is a volume threshold used and not concentration?

Answer: If a product containing a low concentration of a chemical is widely used, then the volume of imported chemical may be very high. This may be a particular concern for effects of the chemical on the environment. 

Question 7: It can be hard to track volumes of imported chemicals – won’t this make record-keeping more complicated?

Answer: The amended Rules provide an extra record-keeping option for listed chemical introductions of 10 kg or less in a registration year. For example:

• If an introducer knows the CAS number or CAS name of their chemical, then they can choose to keep records as per other listed introductions. They don’t need to track volumes (even if they’re 10 kg or less in a registration year).
• If an introducer can demonstrate that the volume of chemical introduced in a registration year is 10 kg or less, they can choose to keep the records for these lower volume introductions. For example, the introducer can keep a record of the INCI name where the CAS number is not known.
•  If an introducer can’t easily track the volume of a chemical they import to demonstrate that 10 kg or less is introduced in a registration year, they should keep records as per other listed introductions.

Question 8: Do these changes apply to all introduced listed chemicals, regardless of end use?

Answer: Yes. Records must be kept for all listed chemical introductions. The extra option for the types of records that can be kept for introductions of chemicals at 10 kg or less in a registration year, can be used for all listed introductions of industrial chemicals – regardless of end use. For example, chemicals in soaps, other cosmetics, adhesives, inks and coatings.

Question 9: An introducer must keep a record of ‘any known hazard classification for the industrial chemical’. Can this just be based on the SDS, or do they need to have access to the study information? 

Answer: For listed introductions, an introducer just needs to keep a copy of any relevant SDSs. They don’t need to have access to full study reports.

Specific feedback about Part 2 of the consultation – changes to categorise introductions of chemicals at 10 kg or less in a registration year as reported

Introductions of chemicals at 10 kg or less in a registration year can be categorised as reported if the criteria in step 3 of the guide to categorising your chemical importation and manufacture are met. If the criteria are not met, the introducer should continue to steps 4-6 to work out:

• the categorisation outcome 
• which regulatory obligations apply

Question 10: Part 2 of the consultation relates to low-hazard chemicals. If these chemicals are introduced at volumes of 10 kg or less in a registration year, why aren’t the introductions categorised as exempted introductions (very low risk) at step 2 of the guide to categorising your chemical importation and manufacture, rather than as reported introductions (low risk) at step 3? 

Answer: Not all the chemicals that would meet the criteria set out in part 2 of the consultation are of ‘low’ hazard. 

• It is a requirement that the chemicals must not be known to the introducer to have certain high concern hazard characteristics. However, they could still be hazardous. For example, they could be skin sensitisers, toxic following repeated human exposure or be very toxic to aquatic life.
• The hazards of chemicals may not be ‘fully characterised’. This means they may not have been tested for all hazard characteristics. ‘Not hazardous’ and ‘not known to be hazardous’ are different.

Also noting that:

• there is reduced information that an introducer must know and keep about their introductions, and 
• that the criteria do not limit the concentration and end-uses associated with the introductions.

It is appropriate that these lower volume introductions are categorised as reported (low risk) and not exempted (very low risk). An introducer can still go through steps 4-6 of the guide to categorising your chemical importation and manufacture to work out if their introduction can be categorised as exempted.

Question 11: Can the volume threshold be increased to 100 kg or less in a registration year?

Answer: No. The focus of the amendments was to give regulatory certainty to introducers of chemicals at 10 kg or less in a registration year. We will explore and consult on options to address relevant issues raised by industry for introductions at greater than 10 kg in a registration year in the coming year. 

Question 12: Can introductions of chemicals with limited human exposure be categorised as exempted instead of reported?

Answer: No. While certain chemical introductions may have limited human exposure, the risks to workers or the environment may still be significant. 

There is reduced information that an introducer must know and keep about their introductions. It is appropriate that these lower volume introductions are categorised as reported (low risk) and not exempted (very low risk). 

An introducer can still go through steps 4-6 of the guide to categorising your chemical importation and manufacture to work out if their introduction can be categorised as exempted.

Question 13: Criterion 2 relates to certain GHS hazard classifications that the chemical cannot have. Is this criterion met if the SDS for the chemical doesn’t indicate that a chemical is classified as having carcinogenicity, germ cell mutagenicity or reproductive toxicity? 

Answer: Yes, as long as the introducer doesn’t hold other information (for example, in their product information sheets), to suggest that the criterion wouldn’t be met. 

Chemicals do not have to have been tested for these hazard characteristics. But if an introducer knows a chemical to have one or more of these characteristics, it’s not appropriate for the introduction of that chemical to be categorised as reported at step 3 of the guide to categorising your chemical importation and manufacture. Instead, the introducer should continue to steps 4-6 to work out:

• the categorisation outcome and 
• what regulatory obligations apply. 

To give more clarity, the wording in the amended Rules was updated (relative to the exposure draft), to reflect that the criterion would not be met if the industrial chemical “…is known by the person…” to satisfy the criteria for the GHS hazard classes mentioned in criterion 2.

Question 14: Criterion 2 relates to certain GHS hazard classifications that the chemical cannot have. Is the criterion met if the chemical is imported at a concentration below the cut-off concentration for the carcinogenicity, germ cell mutagenicity or reproductive toxicity hazard? 

Answer: Criterion 2 is not met if the introducer knows that the chemical is classified under the criteria set out in the GHS as having:

• carcinogenicity 
• germ cell mutagenicity or 
• reproductive toxicity

This applies regardless of the concentration of the chemical in the imported product. 

The introducer should continue to steps 4-6 of the guide to categorising your chemical importation and manufacture to work out:

• the categorisation outcome and 
• what regulatory obligations apply.

Question 15: Criterion 3 relates to chemicals that are prohibited or restricted in cosmetics in the EU or USA. Can this criterion be amended now to only reflect prohibitions, not restrictions?

Answer: No. Chemicals with restrictions in the EU or USA for use as a cosmetic or in a cosmetic also could not be introduced under the NICNAS cosmetic exemptions. 

To amend this criterion would involve substantial consideration that is not supported by:

• the shorter than usual consultation process, or 
• the intention of giving certainty to introducers of chemicals at 10 kg or less in a registration year in the shortest possible timeframe. 

If a chemical has:

• a cosmetic end use and 
• is prohibited or restricted in the EU or USA for use as a cosmetic or in a cosmetic 

then the introduction cannot be a reported introduction at step 3 of the guide to categorising your chemical importation and manufacture (for introductions of chemicals at 10 kg or less in a registration year). This applies even if a chemical is introduced according to the restrictions in place in the EU or USA. 

Introducers should instead continue to steps 4-6 to work out:

• the categorisation outcome and 
• what regulatory obligations apply.     

Question 16: Criterion 4 relates to certain chemicals introduced at the nanoscale. Does the wording in the Rules need to be expanded to provide further clarity?

Answer: No. We’ve added guidance and examples in the guide to categorising your chemical importation and manufacture to make the intent of this criterion clear.

Question 17: Criterion 5 relates to fluorinated chemicals. Is the criterion met if the chemical to be introduced is an inorganic fluoride salt?

Answer: Yes, it is met if the chemical is known by the introducer to be an inorganic salt. This is regardless of whether it contains fluorine or not. This is because there is a higher level of concern associated with organic chemicals that contain fluorine, rather than inorganic chemicals.

Question 18: Criterion 7 relates to chemicals for which an assessment certificate has been cancelled or the inventory listing removed, because the Executive Director concluded as part of an evaluation that the risks to human health or the environment from the introduction or use of the chemical couldn’t be managed. Will there be clear guidance on which chemicals this criterion applies to?

Answer: Yes - the 2 chemicals that this criterion currently applies to are:

• Benzene, 1,1'-(1,2-ethanediyl)bis[2,3,4,5,6-pentabromo- (decabromodiphenylethane or DBDPE; CAS number 84852-53-9)
• Benzene, 1,1'-oxybis-, pentabromo derivative (pentabromodiphenyl ether; CAS number 32534-81-9)

This information is also in Step 3 of the guide to categorising your chemical importation and manufacture. We will alert stakeholders of any other chemicals added in the future. If an introducer plans to introduce one of these chemicals, they should continue to steps 4-6 of the guide to categorising your chemical importation and manufacture to:

• work out the categorisation outcome and 
• what regulatory obligations apply.    

Question 19: An introducer needs to submit a pre-introduction report for all chemical introductions categorised as reported. Why can’t a single pre-introduction report per introducer be submitted for all introductions at 10 kg or less in a registration year, similar to single post-introduction declarations for PLC exempted introductions?

Answer: Part 2 of the proposal is not about changing the nature of pre-introduction reports (PIR) for reported introductions. PIRs are, and will remain, distinctly different to post-introduction declarations (PID).

A PID only applies to chemicals introduced under the exempted (very low risk) category. Because it is a very low risk introduction, the introducer provides limited information in their PID and can submit it at the end of the registration year in which the chemical was introduced. The introducer provides information about the introduction once and does not need to update a PID, even if their introduction circumstances change.

Similar to a PID, an introducer can provide information in a PIR about a reported introduction once. But reported introductions are a low-risk category whereas exempted introductions are a very low-risk category, so there are several differences between a PIR and a PID. Key differences are:

• A PIR for a reported introduction must be submitted before import or manufacture of the chemical is authorised
• The type of information provided to AICIS, with PIRs generally requiring more detailed information
• Reported introductions must be in accordance with the terms of the PIR
• Introducers must update (vary) their PIR in AICIS Business Services if the circumstances of the introduction change (if their introduction still meets the criteria for the reported category).

Introductions of chemicals at 10 kg or less in a registration year, that meet the criteria at step 3 of the guide to categorising your chemical importation and manufacture, are reported, low risk introductions. Certain information about the chemical and the way it is introduced and used is required as part of the PIR. Due to the larger information requirements and that the PIR needs to be able to be varied with changing circumstances, there would be no practical advantage in having the information on multiple chemicals as part of a single report. Rather, it may actually add complexity.

Question 20: If there are multiple introducers of the same chemical, having each introducer submit a pre-introduction report is time-consuming and provides no additional benefit. Does the information in a pre-introduction report need to be provided by all introducers of the same chemical?

Answer: Yes, this requirement stays the same. Under the current legislation, all types of reported introductions (including the new type for introduction volumes of 10 kg or less in a registration year) require the introducer to have submitted a pre-introduction report and to introduce the chemical in accordance with the terms of that report. 

The information given in a pre-introduction report is important and helps AICIS to understand:

• the types of chemicals being introduced into Australia 
• their use categories and 
• identified hazards. 

For example, there may be multiple introducers of the same chemical, but the end use of the chemical may differ with each introducer.
Information given to AICIS can also lead to: 

• targeted audits of introductions or introducers, and
• evaluations of chemicals or classes of chemicals. 

For example, if there are several introducers each reporting introductions of 10 kg or less in a registration year, and the hazards of the chemical are intrinsically high, AICIS might do an evaluation based on:

• the cumulative introduction volumes of that chemical and 
• the need to consider potential risk management recommendations.  

Question 21: It is time-consuming to submit a pre-introduction report for all chemical introductions categorised as reported.

Answer: A PIR is a once-off report that introducers need to provide for a reported introduction. Similar to the other reported introduction types, the information in a PIR for introduction volumes of 10 kg or less in a registration year is important and helps AICIS to understand the types of chemicals being introduced into Australia. Community stakeholders have a particular interest in compliance and monitoring activities coming out of AICIS introduction categories. For a PIR for introduction of a volume of 10 kg or less in a registration year, if an introducer cannot provide the CAS number, or the CAS/IUPAC/INCI name of the chemical they are introducing, they can provide the details of the chemical data provider that can give this information when AICIS requests it. The introducer can then submit the PIR. In contrast, many other types of PIRs require the chemical identity holder to separately provide the CAS or IUPAC name of the chemical, and its CAS number (if assigned) to AICIS before the PIR can be submitted. 

Question 22: If the CAS, IUPAC or INCI name of a chemical is not known to an introducer, then their pre-introduction report can include the names by which they know the chemical and details of who they believe, on reasonable grounds would, provide the CAS number (if assigned) and CAS/IUPAC/INCI name of the chemical to the Executive Director, if requested. Does the person or business that is nominated in a PIR as being able to provide this information need to know that they’ve been nominated?

Answer: The introducer must be aware of who holds the identity of the chemical. They must have a sound basis as to why they believe that the person they have nominated as the identity holder would, if asked, give AICIS the information. 

This could be for example, because the chemical supplier indicated it to the introducer in email correspondence. 
As part of our compliance monitoring of reported introductions, AICIS can ask the introducer for information. The introducer would need to liaise with the holder of the information, who will be able to give the information directly to AICIS. 

Question 23: An introducer is required to indicate in the pre-introduction report whether a chemical will be introduced as a solid or in dispersion, neither, or that this information is unknown. Why is this information required, if it is not required in most other pre-introduction reports?

Answer: The criteria for an introduction of 10 kg or less to be reported at step 3 includes consideration of what is known about: 

• the form of the chemical at the time of introduction (solid or in a dispersion), or
• certain nanoscale properties. 

This means it is appropriate for the pre-introduction report to require information about what is known about the form of the chemical at the time of introduction. This information will help AICIS to monitor introductions of chemicals that could be introduced at the nanoscale. It is provided as a pick-list response to a single question in the pre-introduction report, so is simple to comply with. 

An introducer can have less certainty about the nanoscale status of chemicals introduced at 10 kg or less in a registration year, where the criteria for the introduction to be categorised as reported at step 3 are met. This is balanced by an introducer having to indicate in their PIR the form in which the chemical is introduced (i.e. whether they know it is introduced as a solid, in a dispersion, neither, or that this information is unknown). 

Introductions of certain chemicals at the nanoscale can’t be categorised as reported introductions at steps 4-6 of the guide to categorising your chemical importation and manufacture. This is because the indicative human health and environment risks of the introduction would be medium-to-high (and they’d be categorised as assessed).

Question 24: Can the criteria and record keeping requirements for the new types of reported introduction be changed so that fragrances that meet the International Fragrance Association (IFRA) standards can also be reported and evidence of meeting these standards is sufficient for record keeping? 

Answer: No. Introductions of fragrances can already be reported introductions at step 3 of the guide to categorising your chemical importation and manufacture (that is, even before the Rules changes were made) if they meet the criteria to be a ‘low-risk flavour or fragrance blend introduction’ reported introduction type. The requirements for this introduction type can include that the chemical is listed on the IFRA Transparency List. In addition, low risk flavour or fragrance blend introductions have a concentration limit and not a volume limit. A fragrance introducer could choose to use the low-risk flavour or fragrance blend introduction, or the new reported introduction type for introductions of volumes of 10 kg or less in a registration year, as long as the relevant criteria and record keeping requirements are met. There are different record keeping requirements for these 2 types of reported introductions.

The focus of the amendments was to give regulatory certainty to introducers of chemicals at 10 kg or less in a registration year.