Pre-Introduction Report: internationally-assessed for human health and the environment

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This guide helps you complete the pre-introduction report online form in AICIS Business Services for the type of reported introduction called ‘internationally assessed for human health and the environment’.

 

Before you start your PIR: internationally-assessed human health and the environment

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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.

Do not submit a PIR for internationally-assessed for human health and the environment if the report you are relying on is not from our list of trusted international bodies. You will need to return to our Guide to categorising your chemical introduction or manufacture and continue to work out your introduction category.

Introducer checklist

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

REACH registration dossiers

  • 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 both human health and the environment.

Trusted international assessment bodies

  • You are using a report from one of these trusted overseas bodies below. The introduction must have been assessed for its risks to both human health and the environment:
    • 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.
  • The overseas report you are relying on — or any other information from the overseas jurisdiction where the chemical was assessed — does not state that the chemical cannot 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 tabled
  • You can tell us the human health and environmental hazard classifications that apply to your introduction that you know about. 
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Internationally-assessed human health and the environment - report type

Guide to completing the ‘Report type’ section of the pre-introduction report for ‘internationally-assessed for both human health and the environment’ in AICIS Business Services.

Under report type select 'internationally-assessed for both human health and the environment'.

Do you know the proper name of the industrial chemical?

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

Select No if someone else – such as your supplier or manufacturer – the chemical's CAS name, 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

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Internationally-assessed human health and the environment - chemical identity

Guide to completing the ‘Chemical identity’ section of the pre-introduction report for ‘internationally assessed for both human health and the environment’ in AICIS Business Services.

What is the proper name of the industrial chemical?

You, or someone else, must provide a CAS name, or 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.

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 and
  •  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 proper name, do not enter a trade name or marketing name for the industrial chemical.

Example:

1,2,3-Propanetriol
Glycerin

Do you know the Chemical Abstracts Service (CAS) registry number for the industrial chemical?

Select ‘Yes’ if know the CAS registry number for your chemical. You must enter a valid CAS number, either with or without the hyphens, otherwise the following error message will appear “CAS registry number must be a valid CAS Number. E.g. 12-34-0 or 12340”.

Select ‘No’ if you do not know the CAS registry number.

What is the name (or synonym) you use to refer to the industrial chemical?

Enter the names that you use to refer to the chemical.

Are you applying for protection of chemical name?

We consider internationally assessed reported introductions to potentially be of higher risk and therefore may decide to publish certain information on our website after you submit your pre-introduction report, including the proper name of the chemical you are introducing. 

If you do not want the proper chemical name to be published on our website, select 'yes and I understand that I need to apply for confidential business information in the AICIS Business Portal since the PIR is not deemed complete until I apply for CBI' in the PIR if you wish to apply.

You will need to separately apply for CBI and pay an additional fee. For more information on how to do this, see our page on applying for protection of CBI for an internationally-assessed reported introduction

If there are no concerns with publishing your chemical's proper name on our website, select 'No'. 

Learn more about what information we publish about internationally-assessed introductions.

Next: Related to introduction

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Internationally assessed human health and the environment - related to introduction

Guide to completing the ‘Related to introduction’ section of the pre-introduction report for ‘internationally-assessed for both human health and 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)?

Check that the volume range you select is consistent with the information you provide for the human health and environment exposure band sections

Select the range that is 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) of your chemical 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: If you are introducing a chemical for an end use in cosmetics, the picklist option you need to select “Personal care products not covered by other end uses”, unless your chemical will only be used in products with limited environmental release (for example, nail polish).

 

 

List of end uses - product descriptions and examples

Adhesive and sealant products means an end use to fasten other materials together or stop the passage of liquid or gas. Examples include:

  • glues 
  • binders
  • adhesives
  • pastes
  • sealants
  • fillers
  • putties
  • solder and caulking compounds
  • spray foam insulation 

Apparel and footwear care products means an end use to care for apparel and footwear products intended for consumer and commercial use. Examples include:

  • footwear polishes
  • waxes and stains to waterproof and improve appearance and other desirable properties
  • apparel surface treatment products for water, stain or flame resistance

Arts, crafts and hobby products means an end use in arts, crafts or hobbies. Examples include:

  • crafting paints
  • crafting glue
  • adhesives (e.g. solder and hot-melt adhesives)
  • fixatives
  • finishing spray coatings and modelling clay

Explosive products means an end use for producing a sudden expansion, usually accompanied by production of heat and large changes in pressure. Examples include:

  • pyrotechnics
  • high explosives and propellants
  • igniters
  • primers
  • initiatory
  • illuminants
  • smoke and decoy flares
  • incendiaries

Fuel, oil, fuel oil additives and related products means an end use as:

  • liquid fuel in containers used for cooking, heating or for power in vehicles or appliances, or
  • a fuel additive to inhibit corrosion, provide lubrication, increase efficiency of use, or decrease production of undesirable by-products.

Examples of liquid fuels include:

  • gasoline
  • diesel fuels
  • kerosene
  • lamp oils

Examples of fuel oil additives include:

  • stabilisers
  • anti-knock agents
  • corrosion inhibitors
  • detergents
  • fuel dyes
  • oxygenates
  • antioxidants
  • odour agents

Lubricant and grease products means an end use in a liquid, paste or spray to reduce friction, heat generation and wear between solid surfaces. Examples include:

  • engine oils
  • transmission, brake and hydraulic fluids
  • gear oils
  • calcium, sodium, lithium, and silicone-based greases

Personal care products – limited environmental release means an end use in solid or hardening personal care products (including cosmetics) that are primarily disposed of to landfill. Examples include:

  • baby wipes
  • facial tissues
  • nail care products including nail polish and remover

Tattoo ink products means an end use in a combination of industrial chemicals that contains one or more colouring agents and is applied to the dermal layer of the skin for the purposes of colouring the skin. Examples include:

  • pigments
  • dyes
  • resins

Paint and coating products means an end use to paint or coat substrates intended for consumer or commercial use. Examples include: 

  • decorative coatings 
  • automotive coatings
  • transportation coatings
  • wood finishes
  • powder coatings
  • coil coatings
  • packaging finishes
  • general industrial coatings
  • automotive refinish
  • industrial maintenance and protective coatings
  • marine coatings
  • thinners
  • removers

Plastic and polymer products means an end use in production of plastics or polymers. Examples include:

  • monomers
  • initiators
  • additives

Construction products not covered by other end uses means an end use in construction materials, except where another scenario covers the end use. Examples include:

  • additives in cements and dry mortar
  • additives to bitumen for road repair
  • internal release agents for thermo-set laminating resins
  • resins in particle board manufacture
  • wood substitutes used to make mouldings
  • resins used in the production of composite materials

Fabric, textile and leather products not covered by other end uses means an end use to impart colour and other desirable properties onto fabric, textiles, and leather products that are intended for consumer or commercial use.

These properties include:

  • water/soil/stain repellence
  • wrinkle resistance
  • flame resistance

Examples of this type of product include:

  • textile dyes
  • textile finishing agents
  • leather tanning products
  • leather dyes
  • leather finishing agents, leather conditioner and surface treatment products

Electronic products means an end use in the production of electronic components. Examples include:

  • chemicals in vapour deposition
  • electroless plating
  • electroplating
  • etching
  • high vacuum evaporation/sputtering
  • laminate processing
  • soldering
  • photolithography

Ink, toner and colourant products means an end use for:

  • writing
  • printing
  • creating an image on paper and other substrates
  • applying to substrates to change their colour or hide images

Examples of this type of product include:

  • pigmented liquid
  • toners or powders used in copy machines and toner/printer cartridges
  • inks used in writing equipment
  • inks for stamps and correction fluids and tapes

This category does not include pigments and colourants added to paints and coatings.

Air care products means an end use to odorise or deodorise indoor air in homes, offices, motor vehicles, and enclosed spaces and intended for consumer or commercial use. Examples include:

  • aerosol sprays
  • liquid/solid/gel diffusers
  • air fresheners
  • scented candles
  • incense

Anti-freeze and de-icing products means an end use:

  • as an additive to fluids, especially water, to reduce the freezing point of the mixture, or
  • applied to surfaces to melt or prevent build-up of ice

Examples of this type of product include:

  • anti-freeze liquids
  • de-icing liquids (windshield de-icers, aircraft de-icers)
  • de-icing solids (ice melting crystals)
  • lock de-icers

Automotive care products means an end use (intended for consumer or commercial use) to clean and care for exterior and interior surfaces of automotive vehicles. Examples include:

  • car waxes
  • polishes
  • waterproofing products for windshield or automotive window glass
  • cleaners
  • sealers
  • car wash solutions
  • vinyl/rubber/plastic protectants
  • automotive carpet and upholstery cleaners
  • wheel and tyre care products
  • exterior trim protectants
  • touch-up paint products

Cleaning and furniture care products means an end use (intended for consumer or commercial use) to:

  • remove dirt, grease, stains, and foreign matter from furniture and furnishings
  • cleanse, sanitise, bleach, scour, polish, protect, or improve the appearance of surfaces

Examples include:

  • cleaners used on glass, floors, tub and tile, ovens and drains
  • scouring powders
  • dusting products
  • waxes
  • polishes
  • stain repellent sprays

Laundry and dishwashing products means an end use in liquid, granular, gel or unit dose packets/tablets to:

  • remove food residue from dishes
  • remove dirt from textiles
  • enhance properties of textiles
  • remove stains from textiles

Examples include:

  • dishwashing detergents and laundry detergents
  • stain removers and fabric enhancers
  • bleach
  • rinse aids
  • lime and rust removers
  • dry cleaning products used in non-aqueous cleaning processes

Extractive products not covered by other end uses means an end use in:

  • mining
  • onshore drilling
  • related activities such as extraction, cementing, hydraulic fracturing, refining

These scenarios do not include end use in offshore drilling. This end use is a designated kind of release into the environment (for which you do not calculate an ECV).

Paper products means an end use in paper production. Examples include:

  • effluent treatment chemicals
  • maintenance chemicals
  • deposit and cleaning agents
  • defoamers
  • surfactants
  • polymeric retention aids
  • coagulants
  • clay
  • resins

Personal care products not covered by other end uses means an end use for cosmetic use, except those covered under the “personal care products - limited environmental release end use” scenario. Examples include:

  • bath and shower products
  • make-up products
  • hair, oral and skin care products
  • secondary sunscreen products
  • deodorants
  • perfumes

Photographic products means an end use (for consumer or commercial use) to take photographic images, develop and process film, and make photographic prints. Examples include:

  • processing solutions (for developing, stopping, and fixing photos)
  • chemicals used in the manufacture or processing of film or photographic paper

Water treatment products means an end use to treat water in cooling and heating systems (including industrial heat-exchanger systems) and potable water supplies. Examples include:

  • chemicals used in pH buffers
  • scale and corrosion inhibitors
  • flocculating agents
  • ion exchange resins

This scenario does not include end uses to treat municipal water supplies or other large-scale water supplies for human or animal consumption or irrigation. These end uses involve a designated kind of release into the environment.

Personal vaporiser products means an end use in a device that is intended to produce a vapour or aerosol that is delivered into a person’s body when the person inhales through the device. Examples include:

  • e-cigarettes
  • e-cigars
  • e-hookah pens
  • e-pens
  • e-pipes
  • vape pens

Specify the end use of the chemical

You must specify the end use of the chemical for each product type(s) that you selected in the question above.

Example: Company XYZ wants to introduce a chemical for use in laundry detergent, shampoo and hand soap. In their pre-introduction report, they select both “Personal care products not covered by other end uses” and “Laundry and dishwashing products” from the end uses picklist. For this question they specify that the chemical will have end uses in “laundry detergent, shampoo and hand soap”.

Are you claiming protection of the specific end use?

We consider internationally assessed reported introductions to potentially be of higher risk and therefore may decide to publish certain information on our website after you submit your pre-introduction report, including the specific end use of the chemical you are introducing. 

If you do not want the specific end use to be published on our website, select 'yes and I understand that I need to apply for confidential business information in the AICIS Business Portal since the PIR is not deemed complete until I apply for CBI' in the PIR if you wish to apply.

You will need to separately apply for confidential business information and pay an additional fee. For more information on how to do this, see our page on applying for protection of CBI for an internationally-assessed reported introduction.

If there are no concerns with publishing your chemical's end use on our website, select 'No'.

Learn more about information we may publish about an internationally-assessed introduction.

Next: International body

 

Internationally-assessed human health and the environment - international body

Guide to completing the ‘International body’ section of the pre-introduction report for 'internationally-assessed for both human health and the environment' in AICIS Business Services

 

We do not accept REACH registration dossiers. The only REACH assessment that we will accept are opinions about REACH restrictions.
You must be able to provide a complete report from a trusted international assessment body and have permission to use it.  

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 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 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.


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

Internationally-assessed human health and the environment - hazard and exposure

Guide to completing the ‘Hazard and exposure’ section of the pre-introduction report for ‘internationally-assessed for both human health and the environment’ in AICIS Business Services.

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:

  • serious eye damage (H318)
  • very toxic to aquatic life (H400)

If you selected 'no' or 'I don't know', go to your declaration.

Next: Declaration

Internationally-assessed human health and the environment - declaration

Guide to completing the ‘Declaration’ section of the pre-introduction report for ‘internationally assessed for both human health and the 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.

You must flag information as confidential at the same time as you give us the information in the pre-introduction report form. Flagging is invalid if you do it after you have already submitted your pre-introduction report.

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 and the environment 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 or the environment 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 or the environment 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.