Before you start your PIR: 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. 

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