Record keeping for reported 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 for chemicals that are only for use in research and development depends on whether you know the Chemical Abstracts Service Registry Number (CAS number) or the proper name (CAS or IUPAC) for your chemical.

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:
  1. 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:
     • the chemical does not have a CAS or IUPAC name
     • the chemical is a plant extracts - examples are extract of flowers, seeds or leaves of trees, shrubs, herbs, grasses, ferns and mosses.
     • 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.
     • the plant extract cannot be chemically modified – for example, the chemical cannot be hydrolysed, acetylated or hydrogenated.
  2. The names you use to refer to your chemical – written or electronic record of the names including the names given in your pre-introduction report.

Introduction, use and exposure

• Records to prove one of the following:
  1. That the total volume introduced in a registration year does not exceed 100kg. 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
  2. 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.
• If you’re introducing greater than 250kg of your chemical in a registration year – records to prove the use of your chemical is subject to your control. We’ll accept copies of correspondence between you and the users of your chemical.

Introduction requirements

You will need all the following records, or a written undertaking from the supplier or manufacturer confirming your introduction doesn’t meet the criteria for medium to high risk and that they will provide the required information if we ask for it.

• 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 100kg of your chemical in a registration year – records to prove either A or B:
  Note: If you’re not able to prove any of 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 must not exceed 100kg.
  1. 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.
  2. 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:
     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)
     
     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.
     
     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.
     
     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.