Record keeping for exempted introductions – chemicals resulting from non-functionalised surface treatment of listed chemicals

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 you know the CAS number – 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) for the industrial chemical, substrate chemical and all other chemicals involved in the reaction at the surface of the substrate chemical if we ask for them..

Introduction requirements

You will also need all of the following records or 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.

• A record of the CAS numbers and CAS names for the substrate chemical and all other chemicals involved in the reaction at the surface of the substrate chemical.
  
  If you don’t have this information, you must have a written undertaking from the supplier or manufacturer. 
• 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.
• Records to prove one of the following:
  • it’s not introduced as a solid or in 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 1000 nm 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 200 nm and less than or equal to 1000 nm 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 or 125).

      • 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 200 nm in at least one dimension, 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 125).

      • 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 you don’t have this information, you must have a written undertaking from the supplier or manufacturer.

  You can use OECD TG 110 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. 

  OECD TG 125 on Nanomaterial Particle Size and Size Distribution of Nanomaterials measures particles and fibres with a diameter of 1 to 1000 nm and fibres with a length up to 20 µm. 

• Records to prove your chemical doesn’t have any reactive functional groups that weren’t present on the substrate chemical. The information that we’ll accept depends on the type of reaction that has occurred at the surface of the substrate chemical.
  
  If you don’t have this information, you must have a written undertaking from the supplier or manufacturer.

How to print the checklist

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