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Welcome to the website of the Australian Industrial Chemicals Introduction Scheme (AICIS). We started on 1 July 2020. Read about us.

Guide for defined scope of assessment

This guide explains what you need to tell us when you apply for an assessment certificate so we can set a defined scope of assessment, and explains your options for protecting your confidential business information.

Learn about defined scope of assessment

When we assess a chemical introduction and issue an assessment certificate, we include a ‘defined scope of assessment’ as one of the terms of the assessment certificate. It is a legal obligation for certificate holders to introduce a chemical within the defined scope of assessment. The defined scope of assessment is published in the assessment statement that is available on our website when our assessment is complete.

When the chemical is listed on the Inventory 5 years after the issue of the certificate (or earlier if an early listing application is made), then the defined scope of assessment becomes a term of the Inventory listing for that chemical.

How is the defined scope of assessment determined?

We set a defined scope of assessment based on the information you give us and on the outcome of our risk assessment.  

When we are working out a defined scope of assessment we look at the information you tell us

  • about the chemical’s use, including end use
  • importation or manufacture volume/quantity and concentration in products
  • exposure scenarios
  • about the chemical’s hazard characteristics

as well as

  • our risk assessment conclusions and risk management recommendations
  • any uncertainties we have about the risk
  • if the chemical is a specified class of introduction

Is your information commercially sensitive? 

Because we publish the defined scope of assessment on our website, we ask you to identify information which may be commercially sensitive and that you don’t want published. In the assessment certificate application, you will be asked questions about whether you want to protect information as confidential business information or flag information as confidential.

Your chemical’s end use in your introduction 

As we may often publish this information, you can apply for protection of end use as confidential business information (CBI). This is a formal application with a separate fee and you must meet a statutory test. If we approve your application, we won’t publish the specific end use but will publish generalised information about the type of use. 

 Find out how to apply for protection of specific end use as CBI 

Flagging volumes, concentrations and purity as CBI  

When applying, to help us set a defined scope of assessment, you must provide suggested information for publication about your chemical’s purity (%), volume (tonnes of chemical introduced each year), concentration (%) and end use concentration (%). This could be the same as the exact information in the Chemical Dossier of your application or generalised information if you are flagging the exact information as CBI. There is no fee to flag information as CBI.

Learn more about flagging information as CBI

We’ll use the suggested information for publication as the basis of our risk assessment. However, if this generalised information  results in a different conclusion on the risks of your introduction compared with exact information, we may have reason to publish the specific data.

In this situation, because you’ve flagged the information as confidential, we must notify you of our intention to publish. At this point, you’ll have the opportunity to apply for the information to be protected as CBI. You will have to provide evidence and reasons to meet our statutory test for protection of CBI.  If we approve your application, we will not publish the specific information.

Examples: defined scope of assessments

Information provided 

Use and end use information

  • chemical imported at up to 15 tonnes/annum for use as a surfactant in rinse-off cosmetic products and household/commercial dishwashing/laundry products
  • maximum concentration in end use products 4%
  • maximum concentration at introduction 50%

Hazard characteristics 

  • chemical meets the GHS criteria for classification as category 1 eye damage 
  • data were available to demonstrate that eye irritation effects are reduced at low concentrations, but with some irritation at concentration of 4% 
  • chemical meets GHS criteria for classification for acute aquatic toxicity category 2 

Our risk assessment conclusions and risk management recommendations 

  • recommendation for classification for eye damage 
  • advice to industry on controls based on classification 
  • no recommendation for inclusion on the Poison Standard. The risks to the public can be managed based on
    • the maximum concentration specified in the scope of assessment 
    • proposed use in rinse off cosmetic products 
  • the risks to the environment can be managed based on the risk quotient (PEC/PNEC)
  • summary of environmental hazard 
    • classification for acute aquatic toxicity
    • Persistent (P) 
    • Not Bioaccumulative (Not B) 
    • Not Toxic (Not T) 

 
Uncertainties in assessments 

  • the extent of eye damage or irritation effects at concentrations greater than 4 % cannot be identified based on available data 
  • information on inhalation effects was not available. Proposed uses would not be expected to result in inhalation exposure e.g. no spray application 

Based on the information available, the defined scope of assessment may be determined as:
 
The chemical has been assessed 

  • as imported up to 15 tonnes/annum as a finished use product or for reformulation in Australia 
  • for use as a component of rinse-off cosmetic products and household/commercial dishwashing/laundry products (non-spray) at a maximum concentration of 4% 

In this case, you  

  • can import the chemical as a finished product or for reformulation in Australia 
  • can import at any concentration for reformulation 
  • can use the chemical in the mentioned end use products for any function as the function of the chemical is not defined in the scope 
  • cannot include the chemical in end use products above 4 
  • cannot use the chemical in leave on or oral care cosmetics or other categories of household products including spray applications
  • cannot use the chemical for other purposes such as coatings as the activity is not within the scope

Information provided 

 Use and end use information 

  • the chemical will be manufactured in end use products at maximum of 10 tonnes/year 
  • the chemical will be used in an industrial/commercial lubricant and grease 
  • the maximum use concentration of the chemical requested is 10% 

Hazard characteristics 

  • chemical meets the GHS criteria for classification as a skin sensitiser (category 1B) 
  • ecotoxicological data were not provided

Our risk assessment conclusions and risk management recommendations 

  • recommendation for classification for skin sensitisation 
  • advice to industry on controls based on classification 
  • no recommendation for inclusion on the Poison Standard. Risks to the public were not identified based on the proposed use in non-consumer products
  • our assessment confirmed environment categorisation as low risk 

Uncertainties in assessments 

  • we did not conduct an environmental risk assessment as part of the assessment 

The defined scope of assessment may be generated as:
 
This chemical has been assessed 

  •  as introduced up to 10 tonnes/annum as a finished use product or for reformulation in Australia 
  • for use as a component of industrial/commercial lubricants and greases

In this case, you 

  • can import the chemical as a finished product or for reformulation in Australia 
  • can import at any concentration for reformulation 
  • can manufacture the chemical in Australia 
  • can include the chemical in end use products at any concentration 
  • cannot include the chemical in end use products available to the public 
  • cannot use the chemical for purposes other than commercial lubricants and greases 

Information provided 

Use and end use information

  • the chemical is manufactured at 30 tonnes/annum for end use as a stabiliser in automotive coatings at 30% concentration 

Hazard characteristics 

  • the chemical is a polymer of low concern 
  • the chemical is a high molecular weight polymer with lung overloading potential 

Our risk assessment conclusions and risk management recommendations  

  • the manufacture and reformulation processes minimised potential for inhalation exposure 
  • control measures were recommended to minimise inhalation to aerosols during end use 

The defined scope of assessment may be generated as: 
  
This chemical has been assessed

  • as a polymer that meets the criteria as a polymer of low concern  
  • as introduced in non-powder form 
  • for all end uses where the chemical does not become aerosolised and for spray applications of the end use products conducted under recommended control measures (see Recommendations sectio

In this case, you

  • can introduce the chemical if it meets the polymer of low concern criteria and is in non-powder form 
  • can use the chemical in any end use where it does not become aerosolised 
  • can use the chemical in uses with spray application where recommended control measures can be applied 

Note: If a chemical is confirmed as a PLC with no health and environmental concerns at all under normal conditions after the assessment, the defined scope of assessment may be generated as:
 
This chemical has been assessed as a polymer that meets the criteria as a polymer of low concern that is not a high molecular weight polymer with lung overloading potential as defined in the Categorisation Guidelines
 

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