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From 24 April 2024 there will be changes to categorisation, reporting & record keeping requirements - see announcements on changes to the General Rules & changes to the Categorisation Guidelines.

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

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