Pre-introduction report: internationally-assessed for human health only

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If your introduction meets the criteria for the reported category – internationally assessed, then you must submit a pre-introduction report (PIR) before you import or manufacture the chemical into Australia.

Introducer checklist

Go through the following checklist to see if you have all the information you need to submit your pre-introduction report for this type of reported introduction. 

• You are not using a REACH registration dossier. We do not accept REACH registration dossiers. 
• You have followed our Guide to categorising internationally-assessed introductions and you have confirmed your introduction meets the criteria for internationally-assessed for human health but not the environment.
• You have permission to use information that you relied on to categorise your introduction and you can demonstrate the absence of hazard characteristics. If we ask for it, you can provide this information to us, including full study reports. You can see a list of the study reports we accept in our Guide to categorising your chemical importation and manufacture (Categorisation Guide). 
• You are using a report from one of these trusted overseas bodies below. The introduction must have been assessed for its risks to human health:
  • Opinions from the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) or its equivalent former committees — the Scientific Committee on Consumer Products (SCCP) and the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP). We’ll accept these opinions as long as they have been finalised and adopted by the committee; the terms of reference include a question about the safety of your chemical in a cosmetic product; and the opinion concludes that it’s safe.
  • Opinions from the European Chemicals Agency (ECHA) Committee for Risk Assessment and the ECHA Committee for Socio-Economic Analysis. We’ll accept these opinions as long as they’ve formed the basis for the EC's decision to include or update a restriction in Annex XVII of the REACH regulation (REACH restrictions). Opinions from the European Food Safety Authority (EFSA) on materials and articles intended to come into contact with food.
  • European risk assessments that have formed the basis for the EC approving active biocidal substances. The ECHA or an authority of a member state of the European Union must have conducted these risk assessments, and the ECHA Biocidal Products Committee must have reviewed the risk assessment.
  • Risk assessments from Health Canada. We'll accept risk assessments that used Schedule 5, 6, 9, 10 or 11 from the current Canadian regulations (31 October 2005 onwards). We'll also accept risk assessments that used Schedule II, III, VI, VII or VIII from the old Canadian regulations (before 31 October 2005).
  • International parallel process assessments where Australia was involved as a secondary jurisdiction; and Health Canada OR the United States Environmental Protection Agency (US EPA) performed the risk assessment.
    
    The list of international assessment bodies can also be found in section 6 of the General Rules).
• You know the reference number and the year of the report.
• You have permission to use the report and you can provide the report to us if we ask for it.
• There is no information from the overseas jurisdiction where the chemical was assessed, indicating that the chemical can't be used or is prohibited.
• You know the maximum total volume you will introduce during the registration year.
• You know the end use for your chemical.
• You know the parameters of the international assessment or evaluation including any restrictions.
• You can tell us the human health and environmental hazard classifications that apply to your introduction that you know about. 

Next: Report type

Guide to completing the ‘Report type’ section of the pre-introduction report for ‘internationally-assessed for human health but not the environment’ in AICIS Business Services.

Under report type select 'internationally-assessed for human health but not the environment'.

Do you know the proper name of the industrial chemical?

You, or someone else, must provide the chemical's CAS name or IUPAC name or an eligible INCI plant extract name.

Important! Eligible INCI plant extract name

The INCI name for an industrial chemical is an eligible INCI plant extract name if:

the industrial chemical is a plant extract that has not intentionally undergone any chemical processes, or treatments, to change its chemical structure

 the INCI name is based on a botanical name for the relevant plant.

Examples of plant extracts 

Extracts of flowers, seeds or leaves of trees, shrubs, herbs, grasses, ferns and mosses.  

Examples of changes to the chemical structure: definition not met 

Where the chemical has been intentionally:

• hydrolysed 
• acetylated  
• hydrogenated. 

For the proper name, select Yes if you can provide the chemical's CAS name or IUPAC name, or an eligible INCI plant extract name.

For the proper name, select No if someone else – such as your supplier or manufacturer – is going to provide the CAS name or IUPAC name, or an eligible INCI plant extract name. Click Business look up and enter the AICIS business ID of your chemical data provider (starting with NIC) followed by the first and last name of your chemical data provider’s contact person. We will then email the contact person and ask them to provide this information directly to us.

If you don’t know the contact person’s name or AICIS business ID details, you must contact your chemical data provider as we cannot give you this information.

Next: Chemical identity

Guide to completing the ‘Chemical identity’ section of the pre-introduction report for ‘internationally assessed for human health but not the environment’ in AICIS Business Services.

What is the proper name of the industrial chemical?

You, or someone else, must provide a CAS name, IUPAC name or eligible INCI plant extract name for your chemical. The chemical identity should be available in the international assessment or evaluation you are relying on for your introduction.

Guide to completing the ‘Related to introduction’ section of the pre-introduction report for ‘internationally-assessed for human health but not the environment’ in AICIS Business Services.

Will the chemical be imported into Australia or manufactured in Australia?

Select from:

• Import
• Manufacture
• Both import and manufacture

Note 'both import and manufacture' does not include the scenario where a chemical is imported then reformulated/used in Australia to make a mixture or product. In this scenario select ‘import’.

What is the maximum total volume of the chemical introduced in Australia during a registration year (1 September to 31 August?)

Select the range that represents the maximum total volume of the chemical that you will introduce into Australia during a registration year:

• ≤ 25 kg (less than or equal to 25 kg)
• > 25 kg to ≤ 100 kg (more than 25 kg and less than, or equal to 100 kg)
• > 100 kg to ≤ 1,000 kg (more than 100 kg and less than, or equal to 1,000 kg)
• > 1,000 kg to ≤ 10,000 kg (more than 1,000 kg and less than, or equal to 10,000 kg)
• > 10,000 kg (more than 10,000 kg)

What is the end use of the chemical?

Select all the end use(s) for your chemical introduction from a picklist in the form. This is the same list of options that you may have used to calculate the environment categorisation volume (Step 5.3 from Categorisation Guide) and is also shown below.

Example: Company ABC wants to introduce a chemical with an end use in cosmetics. The picklist option they select is “Personal care products not covered by other end uses”.

Example: Company XYZ wants to introduce a chemical for use in laundry detergent, shampoo and hand soap. The picklist options they select are both “Personal care products not covered by other end uses” and “Laundry and dishwashing products”.

Guide to completing the ‘International body’ section of the pre-introduction report for 'internationally-assessed for human health but not environment' in AICIS Business Services. 

The international assessment body that assessed or evaluated your chemical 

Select from the list which overseas body(ies) you used as the basis of your categorisation: 

• Canada - both Health Canada and Environment and Climate Change Canada 
• European Chemicals Agency (ECHA)- for active biocidal substances reviewed by ECHA and approved by the European Commission (EC) 
• European Commission (EC) Scientific Committee on Consumer Safety (SCCS) 
• Scientific Committee on Consumer Products (SCCP) 
• Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) 
• European Scientific Committee on Consumer Safety 
• United States Environmental Protection Agency - international parallel process assessments only 
• European Food Safety Authority (EFSA) 
• An authority of a member state of the European Union - for biocidal substances reviewed by ECHA and approved by the EC 
• ECHA Committee for Risk Assessment AND ECHA Committee for Socio Economic Analysis - REACH restrictions only 
• Environment and Climate Change Canada 
• Health Canada 

Once you’ve selected the overseas assessor, enter the following information: 

• The reference number/however described of the international assessment or evaluation.  
• The name of the chemical identified in the international assessment or evaluation.  
• The year the international assessment or evaluation was completed. 

Did the overseas jurisdiction impose any conditions to manage risks to human health or the environment? 

Check the report you are using for any restrictions or conditions. This includes any restrictions on the production or use of the chemical: 

• on its own 
• in a mixture  
• in an article. 

Answer 'no' if the overseas jurisdiction has not imposed conditions.   

Answer ‘yes’ if the overseas jurisdiction has imposed conditions. 

If you answered 'yes', describe the condition imposed by the jurisdiction that assessed or evaluated your chemical 

You can enter ‘not applicable’ as your answer if both of the following apply to your introduction: 

Where overseas assessments or evaluations are for chemicals that are restricted under Annex XVII of the REACH regulation 

1. Your chemical is a substance that is in Annex XVII to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations in the European Union. 
2. You have a copy of the opinion from the European Chemicals Agency (ECHA) Committee for Risk Assessment and Committee for Socio-economic analysis for your chemical. 

Otherwise, you must enter the conditions or restrictions that apply in the jurisdiction where the chemical was assessed.  

Example - describing the condition imposed

Cosmetic ingredient for use as an emulsifier in topical personal care and cosmetic products (e.g. hair conditioning, skin conditioning) up to 10%.

If you answered 'yes', how will you comply with those conditions in Australia? 

You must tell us how you plan to comply with these conditions in Australia.

Example - acceptable response to describe how you will comply with the conditions in Australia
 
My hair dye products only contain the chemical at 0.25% without the presence of any nitrosating products and a maximum 20µ/kg nitrosamine content. I can provide a SDS and technical data sheets to support this.

You can enter ‘not applicable’ as your answer if both of the following apply to your introduction: 

Where overseas assessments or evaluations are for chemicals that are restricted under Annex XVII of the REACH regulation 

1. Your chemical is a substance that is in Annex XVII to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations in the European Union. 
2. You have a copy of the opinion from the European Chemicals Agency (ECHA) Committee for Risk Assessment and Committee for Socio-economic analysis for your chemical. 

Describe parameters (if any) in the international assessments or evaluations that relate to end use, introduction volume and maximum concentration at the end use 

Examples

An opinion on health and safety risks detailed by the SCCS considers Chemical ABC to be safe when used in personal hand wash up to a maximum concentration of 0.5% (w/v).

A Canadian assessment detailed conditions of use based on a maximum import volume that should not exceed 10,000 kg per annum.  

Next: Hazard and exposure

Guide to completing the ‘Hazard and exposure’ section of the pre-introduction report for ‘internationally-assessed for human health but not environment’ in AICIS Business Services.

Our hazard characteristic definitions are broader than the definitions or classification criteria under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Does your chemical have a human health and/or environment hazard classification?

Select your answer

• no
• yes
• I don’t know.

If you selected 'yes', you will be asked to select the hazard classification for your chemical in the dropdown box. For example, GHS, HCIS. 

The types of hazards could include:

• very toxic to aquatic life (H400)
• may cause long lasting harmful effects to aquatic life (H413)

What you need to know about environment hazard characteristics

The environment hazard characteristics you need to consider vary and depend on your introduction’s environment exposure band. For more help, take a look at Step 5.4 of the Categorisation Guide: Work out your environment hazard characteristics

Most of the time, to categorise correctly, you need to prove that your chemical does not have certain hazard characteristics. You must make sure you check the environment hazard characteristic definitions in the Categorisation Guide. We also tell you in the Categorisation Guide how you can prove your chemical does not have the hazard characteristics.

If the environment exposure band for your introduction is:

• 1 or 2, you need to be able to prove that your chemical does not have any of the hazard characteristics in environment hazard band D
• 3, you need to be able to prove that your chemical does not have any of the hazard characteristics in environment hazard bands D and C
• 4, you need to be able to prove that your chemical does not have any of the hazard characteristics in environment hazard bands D, C and B.

Does your chemical have an environment hazard characteristic?

These are any environment hazard characteristics that you have already identified at step 5.4 of the Categorisation Guide. The environment hazard characteristic could be separate from the environment hazard classification.

Environment hazard band A

• Harmful to any aquatic life 
• Industrial chemical (other than a polymer) that does not meet the criteria for ready biodegradability
• Bioaccumulation potential
• Polymer that is not stable
• Polymer that does not have a low cationic density
• Contains aluminium, chromium, copper, nickel, selenium, silver or zinc

Environment hazard band B

• Toxic to any aquatic life

Environment hazard band C

• Persistent and bioaccumulative
• Very toxic to any aquatic life

Environment hazard band D

• Persistent, bioaccumulative and toxic 
• Adverse effects mediated by an endocrine mode of action
• Synthetic greenhouse gas 
• Ozone depleting chemical
• Contains arsenic, cadmium, lead or mercury

What is the environment exposure band for the introduction?

Select your answer: environment exposure band 1, 2, 3, 4 or 5. 

Tip! If your introduction involves a designated kind of release into the environment, it is automatically in exposure band 4 for the environment. 

We define 'designated kind of release into the environment' to be where the chemical is intentionally released during use to land, biota, natural waterways, municipal water supplies or air (unless its only for domestic or personal use, or end use in an air freshener). It also includes any releases to the environment from firefighting end uses and releases into the ocean.

What criteria did you use to determine the environment exposure band?

Select your answer: item number 1, 2, 3, 4 or 5 for your introduction. See below for the description of each item number as set out in Schedule 1, Part 2, Clause 3(1) of the Industrial Chemicals (General) Rules 2019.

Next: Declaration

Guide to completing the ‘Declaration’ section of the pre-introduction report for ‘internationally assessed for human health but not environment’ in AICIS Business Services.

Are you flagging any other information as confidential?

If any other information in your submission (apart from chemical name and end use) is commercially sensitive, then select 'yes'. If you select 'yes' to this question, specify the information that you are flagging for protection. By selecting 'yes' you are not formally applying for confidential business information (CBI), rather you are indicating to us that you would like this information to be treated confidentially. There is no fee to flag information as confidential.

'By selecting 'yes', you’re also acknowledging that if we ever decide to publish your flagged information, we will send you a ‘section 113 notice’ and you will need to apply for CBI in AICIS Business Services (fee applies). 

*Please note: You cannot apply for CBI of the name of the international assessment body that assessed your introduction. We will always publish this on our website.

Declaration

Before you can submit you must declare the following:

• The complete international assessment or evaluation report for the industrial chemical is available and you will provide it to AICIS if we ask for it.
• The introduction of the industrial chemical is not prohibited (however described) in the overseas jurisdiction.
• The risk to the human health from the introduction and use of the industrial chemical in Australia is no higher than in the overseas jurisdiction, as determined in accordance with the Industrial Chemicals Categorisation Guidelines.
• None of the following information became available to you after the completion of the international assessment or evaluation: 
  • a hazard to human health from the industrial chemical that is not identified in the international assessment or evaluation
  • or an increase in the severity of a hazard to human health from the industrial chemical that is identified in the international assessment or evaluation.
• You have had regard to such information as is known to you that demonstrates that the industrial chemical has hazard characteristics that are relevant for determining the highest indicative risk for the introduction.
• You have had regard to the information detailed in the Industrial Chemicals Categorisation Guidelines to demonstrate the absence of certain hazard characteristics, as required for introductions where the highest indicative risk is determined (in whole or in part) on the basis of the absence of certain hazard characteristics.
• The information you have given is true, correct and complete. Giving false or misleading information is a serious offence.