Step 1: Is there an overseas assessment of your chemical?
This section relates to introductions that are internationally assessed for human health only. These must meet all of the criteria described in each step to be considered a 'low risk' introduction under AICIS.
If an overseas body has assessed your chemical, consider the following aspects of the assessment.
Step 1.1: Did a trusted overseas body perform the assessment?
A trusted overseas body listed in section 6 of the General Rules must have assessed or evaluated your introduction for its risks to human health, and published a report of the assessment or evaluation that describes the outcomes.
The trusted bodies are:
- 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). REACH registration dossiers are not accepted.
- 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.
You may know that there is a report of the assessment or evaluation because:
- it is publicly available on the website of the trusted overseas body
- an alternative source is available – for example, you know that your overseas parent company has had the chemical assessed in Canada
If one of the trusted overseas bodies assessed or evaluated your chemical and completed a report for it, continue to Step 1.2 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.
If one of the trusted overseas bodies has not assessed or evaluated your chemical, or there is no report for it, you do not meet our criteria for an introduction that has been internationally assessed for human health.
Step 1.2: Can I use the overseas assessment report?
The following factors determine whether you can use an overseas report.
1. The complete report must be available.
It’s important to note that:
- you must provide the complete report, not just a summary of it
- you must have permission to use the report and any information it contains for the purpose of introducing your chemical into Australia
- if the overseas report is publicly available and your company was not the applicant for the overseas assessment, you must ensure you have the applicant’s permission to use the assessment report
2. You must give us the report, if we ask for it.
This could mean:
- you give it to us directly, or tell us where we can find it (for example, if it’s publicly available on a website) or
- arrangements can be made for another party to give us the report
If the overseas report is available and you can provide it for these purposes, continue to Step 2 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.
If the overseas report is not available or you can’t provide it for these purposes, you do not meet our criteria for an introduction that has been internationally assessed for human health.
If you are using a Canadian report
If you want to use a Canadian report in an application, it must have been completed by Environment and Climate Change Canada (ECCC) / Health Canada (HC). We do not accept other Canadian reports.
The Canadian notifier must authorise ECCC to share the reports about your chemical with us.
- The Canadian notifier must fill in the relevant sections of the authority to release assessment report to AICIS using their own letterhead.
- The Canadian notifier must send the completed letter to ECCC.
We recommend that you do this at least 60 calendar days before you submit your application to us.
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