Record keeping for exempted introductions - research and development

Before you read this page’s content, make sure you’ve already read and understood:

• why you must keep records
• written undertakings as records (if you’ve relied on information held by another person — such as a supplier or manufacturer — to categorise your introduction)

Go to our record-keeping overview page for this information.

Records you must keep

The type of records you must keep depends on whether you know the CAS number or the proper name (CAS, IUPAC or INCI for plant extracts under certain criteria) for your chemical. Work through the information on this page to understand your record-keeping obligations for this type of introduction.

Chemical identity

If the total volume of the chemical you introduce in a registration year is less than or equal to 10kg

• A​​​ record of the number of chemicals you introduce at volumes of less than or equal to 10kg that meet the ‘solely for use in research and development’ criteria described in subsection 26(3) of the General Rules.

If the total volume of the chemical you introduce in a registration year is greater than 10kg

• If you know the CAS number – a written or electronic record of the CAS number and either the CAS name or INCI name for the chemical.
• If you don't know the CAS number - you must have either A or B:
  
  A. Written or electronic record of the CAS name or IUPAC name. An INCI name can only be used if the chemical and its name meet all 4 criteria:
  
  i. the chemical does not have a CAS or IUPAC name 
  
  ii. the chemical is a plant extract – examples are extracts of flowers, seeds, or leaves of trees, shrubs, herbs, grasses, ferns, and mosses
  
  iii. the name of the plant extract is an INCI name based on a proper botanical name – for example, 'Helianthus Annus Leaf/Stem Extract' is acceptable but 'Sunflower extract' is not acceptable
  
  iv. the plant extract cannot be chemically modified – for example, the chemical cannot be hydrolysed, acetylated or hydrogenated
  
  B. Written or electronic record of the names you use to refer to your chemical and a written undertaking from the supplier or manufacturer that they will give us the proper name (CAS or IUPAC) and CAS number (if assigned) if we ask for them.

Introduction, use and exposure

• Records to prove one of the following: 
  • That the total volume introduced in a registration year does not exceed 10kg. This applies if any of the chemical you introduced in a registration year is a solid, or is in a dispersion, at the time of introduction and consists of particles, in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale) or it was not determined at the time of introduction whether the chemical meets this description. We’ll accept shipping documents to prove the introduction volume.
  • Otherwise, that the total volume introduced in a registration year does not exceed 250kg. We’ll accept shipping documents to prove the introduction volume.
• Records to prove your chemical will be used in research and development with control measures in place. The information that we’ll accept depends on the nature of your business and the number of chemicals that you’re introducing solely for research and development.
   

Introduction requirements

You will need all the following items. If you don’t know the proper name, you will need a written undertaking from the supplier or manufacturer confirming each of the following items. They must provide records to prove each of the following items if we ask for them.

• Records to prove your chemical meets our definition and is solely for use in research and development and not available to the general public. 
  
  We’ll accept a signed and dated declaration.

See our definition of research and development.

• Records to prove your chemical:
  • isn’t listed in Annex III of the Rotterdam Convention or Part 1 of Annex A, B or C of the Stockholm Convention on POPs (unless it is introduced solely for use in research or analysis and the amount that you introduce in a registration year does not exceed 100kg)
  • isn’t listed on the Inventory with conditions of introduction or use that will be contravened.
     
    We’ll accept a signed and dated declaration that these checks took place.
• If you’re introducing greater than 10kg but not more than 250kg of your chemical in a registration year – records to prove one of the following.
  Note: If you are not able to prove the following, or you had not determined this at the time of introducing your chemical, the total volume you can introduce in a registration year can’t exceed 10kg.
  • it’s not introduced as a solid or in a dispersion (if applicable). We’ll accept an SDS or product information sheet that indicates the appearance.
  • it doesn’t consist of particles in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale. The information we’ll accept depends on the particle size range of the solid or dispersion:
    • If it’s greater than 1µm in all dimensions, we’ll accept: 
      • an SDS or technical data sheet for the chemical or the product that it’s introduced in that indicates it will be introduced as granules, pellets or a wax; or
      • a study result from a particle size distribution study on your chemical or the product that you will introduce into Australia (conducted according to OECD TG 110) 
         
    • If it’s greater than 200nm and less than or equal to 1µm in all dimensions, we’ll accept:
      • a study result from a particle size distribution study on your chemical or the product that you will introduce into Australia (conducted according to OECD TG 110). This can be used to measure particle size and distribution to support that a chemical is not at the nanoscale for particles and fibres with sizes above 250 nm.
      • draft OECD TG on particle size and particle size distribution on nanomaterials. This is currently in development and is expected to be finalised in 2022. 
      • If the chemical is in a dispersion, the spectroscopy- and microscopy-based methods such as scanning electron microscopy (SEM) and transmission electron microscopy (TEM) are more appropriate. 
        
        Note: For particle size distributions in this range, information only from an SDS/technical data sheet or similar is not enough. 
         
    • If it’s less than or equal to 200nm, we’ll accept: 
      • a study result from a particle size distribution study on your chemical or the product that you will introduce into Australia. A draft OECD TG on particle size and particle size distribution on nanomaterials. is currently under progress and expected to be finalised in 2022.
      • If the chemical is in a dispersion, the spectroscopy- and microscopy-based methods such as scanning electron microscopy (SEM) and transmission electron microscopy (TEM) are more appropriate. 
        
        Note: For particle size distributions in this range, information only from an SDS/technical data sheet or similar is not enough.