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Step 3: Introductions that are automatically categorised as reported

Certain chemical introductions are considered to be ‘low risk’ to human health and the environment and are therefore automatically categorised as reported introductions. Compliance obligations apply including reporting and record-keeping.

Low-risk flavour or fragrance blend introductions

Flavour blends are mixtures of chemicals that are formulated to impart a taste. Fragrance blends are mixtures of chemicals that are formulated to impart a scent or cover a malodour. Your introduction is automatically categorised as reported if it meets these requirements:

  • your chemical is part of a flavour or a fragrance blend and the blend is introduced either on its own, or with other chemicals
  • the concentration of your chemical when it is introduced is 1% or less
  • the concentration of your chemical in end-use products is 1% or less
  • your chemical must not have an end use in a personal vaporiser, such as e-cigarettes
  • your chemical does not have any of the hazard characteristics in the highest human health and the environment hazard bands
  • your chemical must either be on the IFRA Transparency List at the time that your pre-introduction report is submitted, or certain information about its introduction must be given to us before you introduce the chemical, including:
    • the proper name of your chemical and its CAS number (if assigned)
    • information on known hazard characteristics
    • the maximum concentration of the chemical in the blend at introduction and end use
    • the name you use to refer to the blend

Learn more about categorisation of flavour or fragrance blend introductions

Chemicals that are only used for research and development

Your introduction is automatically categorised as reported if all of the following apply:

  • you only use your chemical for research and development, or make it available to another person who only uses it in research and development
  • you don’t make your chemical available to the public in any form (whether on its own, in combination with other industrial chemicals or as part of an article)
  • you use control measures to eliminate or minimise any risks to the environment and any risks to the people involved in using the chemical for research and development

and point 1 or 2 or 3 applies:

  1. you will introduce more than 250 kg of your chemical in a registration year, use of your chemical will be subject to your (the introducer’s) control and you can demonstrate that your chemical is not introduced as a solid or in a dispersion. To prove that your chemical is not introduced as a solid or in a dispersion, you might have an SDS or product information sheet that indicates the appearance (for example, in liquid form).
     
  2. you will introduce more than 250 kg of your chemical in a registration year, use of your chemical will be subject to your (the introducer’s) control and you can demonstrate that your chemical does not 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 particle size range of 1 to 100 nm. To prove that your chemical does not 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 particle size range of 1 to 100 nm, you might have a study report about the particle size distribution of your chemical.
     
  3. you will introduce more than 10 kg, but not more than 100 kg of your chemical in a registration year
If your chemical meets our criteria for a chemical at the nanoscale, then your introduction is not point 1 or 2.

Read our extra guidance on categorisation of chemicals introduced for research and development

Your obligations for introducing chemicals in the reported category

You can introduce a chemical that’s automatically categorised as reported into Australia, as long as you:

If your introduction is not covered on this page, go to step 4 and then step 5 to work out your introduction's indicative risk to human health and the environment. Your introduction's category could be exempted or reported or assessed depending on the outcome of steps 4 and 5.

Next – Step 4: Work out your introduction's risk to human health

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