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Proposed changes to the Rules for chemical introductions of 10 kg or less in a registration year

Stakeholder views were sought on proposed changes to the Industrial Chemicals (General) Rules 2019 (the Rules). These changes would affect the requirements for certain lower risk chemical introductions, where the introduction volume is 10 kg or less in a registration year.

This consultation closed at 11.59pm AEDT on 11 October 2022. The consultation period was shorter than usual to address issues identified by companies when transitioning their introductions to AICIS and to provide certainty to introducers of chemicals at 10 kg or less in a registration year, in the shortest possible time frame.
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A webinar on this consultation was held on Thursday 29 September 2022.


Before you start - information you need to know

  • AICIS requirements apply to each industrial chemical that an introducer will import or manufacture, either on its own or as a component of a product.
  • Introducers need to categorise their introductions into one of 5 categories (for example, listed or reported introductions). They must comply with all reporting and record-keeping obligations for the applicable category.
  • The AICIS registration year is from 1 September – 31 August. 
  • The total volume of chemical introduced in a registration year is the total volume of the chemical in all products that an introducer imports and manufactures that contain the chemical.
  • The risk from introduction and use of a chemical is a function of the hazards of the chemical and the level of human and environmental exposure to the chemical.
  • Relevant terms related to the identity of an industrial chemical are:
    • CAS number, which means the Chemical Abstract Service Registry Number
    • CAS name, which means that Chemical Abstracts Index Name
    • IUPAC name, which means the International Union of Pure and Applied Chemistry name
    • INCI name, which means the International Nomenclature of Cosmetic Ingredients name 

Main consultation points

  1. Under the amended rules, it would be easier for introducers of chemicals at volumes of 10 kg or less in a registration year to meet their AICIS obligations.
  2. Eligibility criteria and exclusions would apply, to ensure that:
    1. appropriate information is known about chemicals being introduced; and
    2. higher concern chemicals could not be categorised as low risk (reported) introductions by accessing these proposed amendments. 
  3. Instead of holding a written undertaking from the chemical supplier, where the CAS number (if assigned) and CAS name of the chemical is confidential, the introducer would need to know information that is more proportionate to the risk of introduction of a chemical at 10 kg or less. For example, the INCI name of a chemical would be accepted for the identity of the chemical.

Why are we proposing these changes?

 We have reconsidered the information that introducers of chemicals, at volumes of 10 kg or less in a registration year, need to know and keep to meet their obligations under AICIS. 

This was prompted by advice from industry indicating that a significant number of introducers were unable to get the required information from their chemical suppliers to meet the categorisation and record-keeping requirements under AICIS before the end of the transition period on 31 August 2022. However, the proposed amendments are the outcome of broader considerations of what is reasonable and appropriate for introducers of chemicals at lower volumes to know and keep as records about their introductions, whilst maintaining protections for human health and the environment. 

The objectives of the industrial chemicals legislation regarding the protection of human health and the environment remain unchanged. The Rules made by the Minister, which establish the technical and operational details of AICIS, allow flexibility to adapt to scientific and regulatory developments within these objectives. 

Industry representatives have advised that if an introducer is importing lower volumes of chemicals in a registration year, it is more difficult for them to persuade an overseas supplier to provide the information that they need to meet their current obligations under AICIS, where information about the chemical is confidential or commercially sensitive. This is particularly true if there are multiple stages in the supply chain and/or if Australia’s requirements are stricter than the requirements of comparable international regulatory schemes. Introductions of 10 kg or less of chemical in a registration year will generally be lower risk introductions, based on the lower levels of human and environmental exposure. The quality and type of information that introducers would need to know and keep for these lower-volume chemical introductions, under the amended Rules, would be appropriate and risk-proportionate. Compliance monitoring of introductions would still occur. 

The proposed exclusions for reported introductions would mean introductions of higher concern chemicals at volumes of 10 kg or less are likely to be categorised as medium to high risk (assessed), requiring an application for an assessment certificate to be made and finalised before introduction of these chemicals could be authorised.

Summary of proposed changes

The proposal has 2 parts, which together aim to provide more risk proportionate requirements for certain lower risk chemicals introductions at volumes of 10 kg or less in a registration year. These are summarised here.

Part 1: Listed introductions (chemicals on the Inventory)

This proposed change would apply to introductions of chemicals on the Inventory at volumes of 10 kg or less in a registration year. It is designed to simplify the record-keeping requirements in situations where it is difficult for an introducer to obtain the CAS number and name of a chemical because it is confidential or commercially sensitive to the overseas chemical supplier. Introducers of chemicals at these lower volumes would instead need to keep information that they should have or should be able to easily access. 

See full Part 1 details

Part 2: Reported introductions (low risk introductions)

This proposed change would apply to certain introductions of chemicals at volumes of 10 kg or less in a registration year. It would streamline the categorisation process so that introductions meeting the eligibility criteria could be categorised as reported. Introductions of certain higher concern chemicals – such as those that are carcinogenic, fluorinated or persistent, bioaccumulative and toxic to the environment – would not meet the criteria. The change is also intended to reduce the reporting and record-keeping requirements associated with these introductions, particularly in situations where it is difficult for an introducer to obtain the CAS number and name of a chemical because it is confidential or commercially sensitive to the overseas chemical supplier. Introducers of chemicals at these lower volumes would instead need to provide and keep information that they should have or should be able to easily access. 

See full Part 2 details

Download the exposure draft 

The proposed changes are explained in detail, with examples below. Read this consultation with the exposure draft.

Do you support the proposed changes? Have your say

This consultation is now closed.

 

All stakeholder views we have received will be considered. The level and type of feedback we receive will impact on what the next steps are and how long these steps will take. If the Minister agrees to amend the Rules, the amendments will take effect after that date. We will publish a summary of the feedback we receive, together with responses to the feedback.

Part 1: Changes to the record-keeping requirements for listed introductions at 10 kg or less in a registration year 

Schedule 1, Clauses 5, 6, and 8 of the Exposure Draft  

Note that this change is being presented here first but appears later in the Exposure Draft.

Records must be kept for all listed introductions and this information is prescribed in the Rules. The records help introducers to know that their chemical introductions are authorised and must be provided to the Executive Director, if requested. For example, if we ask for the information as part of our compliance monitoring. 

Following the broader reconsideration of AICIS requirements for introductions of chemicals at 10 kg or less, it is not considered practical for the same set of requirements to apply to all introductions, irrespective of the introduction volume. It is more appropriate for lower volume introductions to have a simplified, risk proportionate set of record-keeping requirements.

The proposed change would apply to anyone who imports or manufactures 10 kg or less of an Inventory-listed chemical in a registration year. This option will particularly benefit introducers who are having difficulty obtaining the information needed to meet their current record-keeping obligations, due to the CAS number and name of the chemical being confidential or commercially sensitive information. Instead of requiring information to be held that is difficult to obtain, introducers of chemicals at these lower volumes would need to keep information that they should have or should be able to easily access. 

Information about the chemical introductions would still be provided to us, if requested as part of our compliance monitoring program or, for example, in response to concerns identified (in Australia or overseas) from use of chemicals or products containing certain chemicals. AICIS would request the information from the introducer, who would need to liaise with the holder of the information to provide it directly to AICIS.  

What changes are we proposing in Part 1?

Proposed records to be kept

If the introducer knows the CAS number of the chemical

  • the CAS number; and
  • the CAS name, IUPAC name or the INCI name 

If a CAS number for the chemical is not assigned, or is not known, but the CAS name, IUPAC name or INCI name for the chemical is known to the introducer

  • records to indicate that the chemical is listed on the Inventory
  • the CAS name, IUPAC name or the INCI name
This means an introducer must have information (for example, provided by the chemical supplier) that indicates that the chemical is listed on the Inventory, despite not having the CAS number of the chemical that would enable them to search the Inventory.

If a CAS number for the chemical is not assigned, or it is not known to the introducer, and neither the CAS name, IUPAC name nor INCI name for the chemical is known to the introducer

  • records to indicate that the chemical is listed on the Inventory; and 
  • the names by which the chemical is known to the introducer; and 
  • the details of who they believe, on reasonable grounds, would provide the CAS number (if assigned) and CAS, IUPAC or INCI name of the chemical to the Executive Director, if requested.
This means an introducer must have information (for example, provided by the chemical supplier) that indicates that the chemical is listed on the Inventory, despite not having the CAS number of the chemical that would enable them to search the Inventory.

If it would be reasonably practicable for the introducer to find out the CAS number (if assigned), and the CAS, IUPAC or INCI name of the chemical, then the introducer is taken to have known it. This ensures that an introducer would actively try to find this information. If unsuccessful, they can hold the names they know it by and the details of who they believe, on reasonable grounds, would give the Executive Director the CAS number (if assigned) and CAS, IUPAC or INCI name of the chemical, if requested. The details can be of a business or a specific person. For example, the chemical supplier may have indicated in an email that they would supply this information to AICIS if requested, and the introducer keeps a record of this email. 
  • the names of any products containing the chemical that the introducer imports into Australia
  • records to show that the total volume of chemical introduced in a registration year is 10 kg or less
This means that the introducer has information (for example, shipping records) to show that the total volume of the chemical in all products that an introducer imports and manufactures that contain the chemical is 10 kg or less.
  • any hazard classification for the chemical that is known to the introducer.

Important

  • Introducers could choose to keep the records currently prescribed in the Rules for listed introductions – for example, to avoid tracking volumes across many products.
  • If the CAS number, or the CAS or IUPAC name of the chemical is not known to the introducer, they would not need to keep a written undertaking from the chemical supplier or person who knows that information. Instead, they could have information that is proportionate to the risk, such as the INCI name as a record. 
  • An INCI name as a record, where a CAS number is not assigned or not known to the introducer, is not an option under the current record keeping requirements for listed introductions. Note that the proposed amendment would only apply if the total volume of chemical introduced, across all products that an introducer imports or manufactures containing the chemical, does not exceed 10 kg in a registration year. The use of INCI names more broadly to meet chemical identity requirements under AICIS will be considered at a later stage. 
  • Introducers would be required to keep information that they should have or should be able to easily access. Information about introductions would be provided to us, if requested, as part of our compliance monitoring of chemical introductions. For example, if there was a concern based on use of a product containing a chemical overseas, we could request information from introducers of that chemical, or products containing that chemical.

Listed introduction examples

These are examples only to illustrate changes we are proposing under this consultation.

Company LMN want to import a chemical in a face cream and no other products

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The scenario

  • Company LMN know the INCI name (but not CAS number or CAS name)

  • the supplier has indicated the chemical is listed on the Inventory

  • the total introduction volume of the chemical in the face cream would be 6 kg in a registration year based on the maximum advised concentration in the cream

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Would the option for record-keeping requirements for introductions at 10 kg or less apply?

Yes

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Company LMN must keep records about their introduction, including:

  • the names of the face cream products that they import

  • shipping information to show that the total volume of chemical introduced is 10 kg or less in a registration year

  • any hazard classification for the chemical that is known to them. 

They must give this information to AICIS, if asked to.

Company XYZ have imported a chemical in ink for several years 

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The scenario

  • the information from the supplier indicates the chemical was on the NICNAS Inventory, but Company XYZ don't know the CAS name or number

  • the total introduction volume in the ink products is not more than 10 kg in a registration year, based on the concentration of the chemical in the ink

  • the chemical supplier hasn’t given Company XYZ sufficient information to enable them to meet the current requirements in the Rules for listed introductions, but Company XYZ understand that the supplier would provide the CAS number and name to AICIS, if asked to

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Would the option for record-keeping requirements for introductions at 10 kg or less apply? 

Yes

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Company XYZ must keep records about their introduction, including:

  • the names of the ink products that they import that contain the chemical

  • shipping information to show that the total volume of chemical introduced is 10 kg or less in a registration year, across all products

  • any hazard classification for the chemical that is known to them

They must give this information to AICIS, if asked to.

Company ABC want to import a chemical that is an additive in specialist paint – red and orange lines

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The scenario

  • Company ABC know the CAS number and name of the chemical and they confirm that it would be a listed introduction

  • Company ABC know the concentration of the chemical in the paint and that the total volume of chemical that would be introduced is 7 kg (3 kg in red and 4 kg in orange)

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Would the option for record-keeping requirements for introductions at 10 kg or less apply? 

Yes – but Company ABC have options:

  • since Company ABC know the identity of the chemical, they could choose to keep records as per the current Rules for listed introductions (to avoid tracking the volume of paint introduced)
  • Company ABC choose to keep the records for introductions at 10 kg or less
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Company ABC must keep records about their introduction, including:

  •  the names of the red and orange paint that they import

  • shipping information to show that the total volume of chemical introduced is 10 kg or less in a registration year

  • any hazard classification for the chemical that is known to them

They must give this information to AICIS, if asked to.

Company QRS want to import an additive in a specialist adhesive

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The scenario

  • The SDS from their supplier indicates 'all chemicals on AICIS Inventory'

  • Company QRS don't know the CAS number or CAS name
  • Company QRS don’t know the concentration of the chemical in the adhesive, but they know that the total volume of adhesive imported will not exceed 10 kg in a registration year 

  • the chemical supplier indicated that they don’t know the identity of the chemicals in the adhesive and they don’t know who holds this information 

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Would the option for record-keeping requirements for introductions at 10 kg or less apply? 

 No – the introducer would not be able to meet their record-keeping requirements.

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Company QRS must:

  • ensure they can meet their reporting and record-keeping obligations before introducing the chemical. Company QRS may need to source the adhesive from a different chemical supplier who can provide the required information.


Part 2: Changes to categorise introductions of chemicals at 10 kg or less in a registration year as reported

Schedule 1, Clauses 2 and 3 of the Exposure Draft  

What changes are we proposing under Part 2? 

We’re proposing to add a new circumstance to section 27 of the Rules (step 3 of the Categorisation Guide) that would allow introductions of 10 kg or less of a chemical in a registration year to be categorised as ‘reported’ if they meet certain criteria.  

There is a 6-step process that helps an introducer work out if their introduction is categorised as exempted, reported or assessed. This process is summarised below and is described in detail in our Categorisation Guide. At step 3 of this 6-step process, an introducer can work out if their introduction is categorised as reported, and if it is, they do not need to continue with steps 4-6 of the categorisation process. We are proposing to add a new circumstance at step 3 of the process. 

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See our categorisation guide for more information

The introducer must also be able to meet the relevant pre-introduction reporting and record-keeping obligations.

This proposed new circumstance could be used for many different chemicals and end uses, where lower volumes of chemicals are required to be introduced. For example, in cosmetic products, specialty paint products, inks and adhesives.

Specific eligibility criteria will apply so that:

  • introducers would need less information, compared to current, from the chemical supplier or person who knows the chemical’s CAS number, or the CAS or IUPAC names to categorise the introduction as reported and meet their reporting and record-keeping obligations.
  • there are continued protections for human health and the environment from the introduction and use of the chemicals, as chemicals of higher concern would not be eligible to use the proposed new circumstance.    

These introductions would be considered to be low risk (reported chemical introductions); not without risk, but also not very low risk (these are exempted chemical introductions).

What are the criteria?

Introducers must meet all the following criteria:

  • The total volume of the chemical introduced in a registration year by an individual introducer must not be more than 10 kg.

It is expected that an introducer would know (for example, as reported in SDS or product information sheets), if their chemical had one of these hazard classifications. 

If the chemical has a cosmetic end use, it must not be prohibited or restricted in the EU or USA for use as a cosmetic, or in a cosmetic. 

This means that the chemical is not identified in any of: 


One of the following must apply:

  • the chemical is not, to the knowledge of the introducer, to be introduced as a solid or in a dispersion
  • the chemical is not known by the introducer to consist of particles, in an unbound state or as an aggregate or agglomerate, any of which have at least one external dimension in the nanoscale (1-100 nm)
For example, this criterion would be met if the chemical being introduced is a liquid (as indicated in the SDS or technical data sheets), or there are no claims related to the presence of particles at the nanoscale in technical data sheets and commercial labels for the introduced product containing the chemical.

  • The chemical must either:
    • not be known by the introducer to contain fluorine; or
    • be known by the introducer to be an inorganic salt.
A higher level of concern is associated with organic chemicals containing fluorine. This criterion is intentionally broad due to its technical nature and to avoid introductions of chemicals via this pathway that may have characteristics of per- or poly-fluorinated alkyl substance (PFAS).   

The chemical must not be known to the introducer to be persistent, bioaccumulative and toxic to the environment.

This information may be reported in the SDS or in product information from the chemical supplier.

Neither of the following applies:

  • an assessment certificate for the chemical has been cancelled
  • the chemical has been removed from the Inventory

because the Executive Director concluded as part of an evaluation that the risks to human health from the introduction or use of the chemical could not be managed.

It won’t matter who held or was covered by the cancelled certificate. This currently includes Benzene, 1,1'-(1,2-ethanediyl)bis[2,3,4,5,6-pentabromo- (decabromodiphenylethane or DBDPE; CAS number 84852-53-9) and 
Benzene, 1,1'-oxybis-, pentabromo derivative (pentabromodiphenyl ether; CAS number 32534-81-9)

Important:

  • Steps 1 and 2 of the 6-step categorisation process would still apply to the introduction. For example, the chemical cannot be listed on the Rotterdam or Stockholm Conventions.
  • The criteria are similar to criteria (and/or guidance) that applied for introductions of chemicals under the NICNAS exemptions. Instead, there would be objective criteria that ensure that known high concern chemicals will not be able to be categorised as reported using this new circumstance. 
  • The criteria do not limit the end uses or concentrations of chemical introductions that would be authorised using this proposal. 
  • If the criteria aren’t met, or the introducer can’t meet the reporting or record-keeping requirements for the introduction, then the introduction cannot be categorised as reported using step 3 of the categorisation process. The appropriate categorisation outcome for the introduction (and subsequent regulatory obligations) must be worked out in steps 4-6 of the categorisation process.
  • If an introducer works out that their introduction is reported using this proposed new circumstance, they can still choose to go through steps 4-6 – for example, to work out if the introduction is categorised as exempted.

Pre-introduction report requirements

Schedule 1, Clause 4 of the Exposure Draft 

All introducers who import or manufacture chemicals that are authorised under the reported category must submit a pre-introduction report, before they start introducing the chemicals. The information an introducer must submit depends on the type of reported introduction and is prescribed by the Rules. 

The information provided in pre-introduction reports is monitored by AICIS to understand the types of chemicals being introduced into Australia, their use categories and identified hazards. Information provided can also lead to targeted audits of introductions or introducers, and evaluations of chemicals or classes of chemicals.  

This section sets out proposed pre-introduction report requirements for the proposed reported introduction circumstance.

What changes are we proposing?

The Rules are proposed to be amended so that introducers would need to submit the following information in their pre-introduction report.

If the CAS number for the chemical is known to the introducer

  • the CAS number; and
  • CAS name or IUPAC name or INCI name; and
  • any other names by which the chemical is known to the introducer

If a CAS number for the chemical is not assigned, or is not known, but the CAS name or IUPAC name for the chemical is known to the introducer

  • the CAS name or IUPAC name; and
  • any other names by which the chemical is known to the introducer

If a CAS number for the chemical is not assigned, or is not known, and neither the CAS name nor IUPAC name for the chemical is known to the introducer, but they know the INCI name:

  • the INCI name 

If a CAS number for the chemical is not assigned, or is not known, and neither the CAS name, IUPAC name, nor INCI name for the chemical is known to the introducer:

  • the names by which the chemical is known to the introducer; and 
  • the details of who they believe, on reasonable grounds would, provide the CAS number (if assigned) and CAS, IUPAC or INCI name of the chemical to the Executive Director, if requested
If it would be reasonably practicable for the introducer to find out the CAS number (if assigned), and the CAS, IUPAC or INCI name of the chemical, then the introducer is taken to have known it. This ensures that an introducer would actively try to find this information. If unsuccessful, details of who they believe, on reasonable grounds would supply the CAS number (if assigned) and the CAS, IUPAC or INCI name would be inputted as free text into the pre-introduction report in AICIS Business Services. The details can be of a business or a specific person. This would not require the introducer to have the NIC ID of the person who holds the information. The information would need to be provided to the Executive Director on request, rather than as part of the pre-introduction report. 
  • whether the chemical will be introduced as a solid or in a dispersion, neither, or that this information is unknown
  • the end use for the chemical 
  • any hazard classification for the chemical that is known to the introducer
  • a declaration that the introducer has met the requirements for the introduction

Important

  • Introducers would need to submit less information in their pre-introduction report than is currently required for other reported introductions (which apply to all introduction volumes) - this is appropriate and proportionate to the risk of these lower volume chemical introductions.
  • Introducers would be able to submit their pre-introduction report based on information that they already know or should be able to easily access.
  • An INCI name would be able to be provided in the report if the CAS number is not assigned or not known to the introducer, and the CAS or IUPAC name isn’t known. This is currently not an option in pre-introduction reports and would only apply if the total volume of chemical, across all products that an introducer imports and manufactures containing the chemical, does not exceed 10 kg in a registration year. The use of INCI names more broadly to meet chemical identity requirements under AICIS will be considered at a later stage. 
  • AICIS will know more about these introductions than we did for chemicals introduced under NICNAS exemptions, and in all cases prior to introduction.  

Record-keeping requirements

Schedule 1, Clause 9 of the Exposure Draft  

Records must be kept for reported introductions. The information that is needed for each type of reported introduction is different and is prescribed in the Rules. The records: 

  • help introducers to know that their chemical introductions are authorised; and
  • must be provided to the Executive Director, if requested. For example, if we ask for the information as part of our compliance monitoring. 

This section sets out the proposed record-keeping requirements for the proposed reported introduction circumstance.

What changes are we proposing?

Introducers must keep the following information as records:

  • the names by which the chemical is known to the introducer (must include the name in the pre-introduction report for the chemical)
  • the names of any products containing the chemical that the introducer imports into Australia
  • records to show that the criteria have been met for this type of reported introduction.

Important

  • Introducers would need to keep less information about their introductions than is currently required for other reported introductions (which apply to all introduction volumes) - this is appropriate and proportionate to the risk of these lower volume chemical introductions.
  • The record-keeping requirements complement the information about the introductions provided as part of the pre-introduction report. AICIS will know more about these introductions than we did under NICNAS. 
  • If the CAS number, or the CAS or IUPAC name of the chemical is not known to the introducer, they would not need to keep a written undertaking from the chemical supplier or person who knows that information. Instead, they could have information that is proportionate to the risk, such as the INCI name as a record.
  • Introducers would need to keep information that they should have or should be able to easily access. Information about introductions would be provided to us, if requested, as part of our compliance monitoring of chemical introductions.

Reported introduction examples

These are examples only to illustrate changes we are proposing under this consultation.
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Company ABC know the following information about chemical:

  • the INCI name (but not CAS number or CAS name)

  • the volume is 9 kg per year

  • it is imported in liquid hand soap (4 kg) and body wash (5 kg)

  • product information sheet indicates no CMR ingredients; no ingredients prohibited or restricted in EU or USA

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They work out the chemical: 

  • is not listed on Inventory 

  • is not listed on Rotterdam or Stockholm Convention

  • has not had a certificate cancelled or been removed from Inventory

  • does not contain fluorine

  • is not a PBT chemical

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After reading steps 1 and 2 of the categorisation guide, they work out the chemical introduction:

  • does not meet criteria for introductions that cannot be exempted or reported (step 1)

  • does not meet criteria for an exempted introduction (step 2)

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After reading step 3 of categorisation guide, they work out:

  • introduction meets criteria for chemical introductions at 10 kg or less

  • the introduction can be categorised as a reported introduction

  • they don’t need to use steps 4-6

  • they can meet their reporting and record-keeping obligations

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Company ABC must then:

  • submit a pre-introduction report (PIR)

  • introduce the chemical according to PIR terms

  • keep records about the introduction

  • vary the PIR or re-categorise the introduction (if needed)

  • give information to AICIS to prove the introduction is authorised (if asked to)

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Company XYZ know the following information about the chemical:

  • the CAS number and CAS name 
  • it is not listed on the Inventory
  • it is imported as an additive in coatings
  • the volume imported is 5 kg per year
  • the SDS indicates it is classified as a carcinogen
  • it is not listed on Rotterdam or Stockholm Convention
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After reading steps 1 and 2 of the categorisation guide, they work out the chemical introduction:

  • does not meet criteria for introductions that cannot be exempted or reported (step 1)
  • does not meet criteria for an exempted introduction (step 2)
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After reading step 3 of the categorisation guide, they work out:

  • the introduction doesn’t meet the criteria for chemical introductions at 10 kg or less. The chemical is a carcinogen. 
  • the introduction cannot be categorised as a reported introduction
  • they need to continue to steps 4-6 of the categorisation process to work out the appropriate introduction category and regulatory obligations applicable to that category
     

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