Categorisation of chemicals at the nanoscale

Who should read this?

Importers and manufacturers of industrial chemicals (and products that are designed to release industrial chemicals) who are working out which category applies to their chemical importation/manufacture (introduction):

• listed
• exempted
• reported
• assessed

You must read this page in conjunction with our categorisation guide.

What is a chemical at the nanoscale?

Nanoscale means the particle size range of 1 to 100 nm. Your introduction is a ‘specified class of introduction’ if it is of a chemical that is both of the following:

• is introduced as a solid or is in a dispersion
• consists of solid 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

We have an increased level of concern for specified classes of introductions, due to a greater potential for particular hazards or high levels of human or environmental exposure. For this reason, there may be additional or different requirements when working out your category of introduction as well as additional record keeping obligations.

Our increased level of concern for chemicals at the nanoscale, is because of uncertainty about the risks of some of these chemicals due to their potentially different properties, such as chemical reactivity, relative to the non-nanoscale forms of the chemicals. This uncertainty requires either assessment by us, or increased reporting or record-keeping requirements. The additional or different requirements arising from these concerns are outlined below.

Is this type of introduction listed, exempted, reported or assessed?

There are different criteria for each category and you must work out which one applies to your introduction by going through our categorisation guide, starting at 'Step 0: introductions that are in the listed category'. If your introduction does not meet the criteria for the listed or exempted or reported category, it will be an assessed introduction (unless you meet the criteria for a commercial evaluation authorisation.

The additional or different requirements to be aware of when working out your category of introduction are at:

• Step 2: Introductions that are categorised as exempted (chemicals for use in research and development only)
• Step 3: Introductions that are categorised as reported (chemicals for use in research and development only)
• Step 4.1: Introductions that are always medium to high risk for human health
• Step 4.4 Work out your human health hazard characteristics
• Step 4.5: Your human health risk for categorisation
• Step 5.1: Introductions that are always medium to high risk for environment
• Step 5.4 Work out your environment hazard characteristics
• Step 5.5 Your environment risk for categorisation

If your introduction is categorised as assessed, when submitting your application for an assessment certificate, you need to:

• identify that your introduction is a specified class of introduction
• provide any additional information that is required based on your chemical being at the nanoscale

If your introduction is categorised as reported, when submitting your pre-introduction report, you need to identify that your introduction is a specified class of introduction and select that it 'is a solid, or is in a dispersion, at the time of introduction; and consists of solid 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'.

If your introduction is categorised as exempted, because you worked out that the highest indicative risk for your introduction is very low risk, you need to keep a record that your introduction is a specified class of introduction, i.e. that 'is a solid, or is in a dispersion, at the time of introduction; and consists of solid 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'.

Introductions of chemicals for use in research and development

If your introduction is of a chemical that will only be used in research and development, it may be categorised as exempted or reported (steps 2 and 3 of the categorisation guidance), if it meets our criteria.

Read - categorisation of chemicals introduced for research and development

Volume restrictions apply if your chemical is both 1 and 2:

1. is introduced as a solid or is in a dispersion
2. consists of solid 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

Unless you can demonstrate that one (or both) of these criteria don’t apply to your introduction, then the volume of your chemical that you can introduce in a registration year is limited to 10kg (exempted introductions) or 100 kg (reported introductions). See our categorisation guide for how you can demonstrate that these criteria don’t apply.

Introductions categorised using steps 4-6 of the categorisation guide

The indicative human health risk and indicative environment risk for your introduction is medium to high risk if all of the following applies. We refer to these introductions as 'certain chemicals at the nanoscale'.

1. your chemical is introduced as a solid or is in a dispersion
2. your chemical consists of solid 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
3. your chemical meets our definition of 'not soluble'
4. the introduction of the nanoscale portion of your chemical is not incidental to the introduction of the non-nanoscale portion of your chemical

Note: If you meet criteria 1 and 2, and regardless of whether you meet criteria 3 and 4, your introduction is a 'specified class of introduction'.

See step 4.1 or step 5.1 of our categorisation guide for how you can demonstrate that these criteria don’t apply.

Unless you can demonstrate that one (or more) of criteria 1-4 don’t apply to your introduction, then it will be categorised as assessed.

If you can demonstrate that one (or more) of criteria 1-3 don’t apply to your introduction, then your introduction may be categorised as exempted, reported or assessed, depending on the circumstances of your introduction.

If you can’t demonstrate that criteria 1-3 don’t apply to your introduction, but you can demonstrate that criterion 4 doesn’t apply (i.e. you can show that the introduction of the nanoscale portion is incidental to the introduction of the non-nanoscale portion of your chemical), then your introduction may be categorised as reported or assessed. It can’t be categorised as exempted. In this case, you also need to be aware that when demonstrating that human health and environment hazard characteristics do not apply to your chemical:

• you cannot use in silico predictions and
• you will need to ensure that you consider the appropriateness of any tests conducted, for example, if they’ve been conducted on a non-nanoform of your chemical

Summary – categorisation outcomes

We describe below the possible categorisation outcomes if your introduction is not a listed introduction and your chemical is introduced as a solid, or is in a dispersion  at the time of introduction and either:

• your chemical consists of solid 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
• you can’t prove your chemical doesn’t consist of solid 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

When your introduction category is assessed

1. If your chemical meets our definition of 'not soluble' and the introduction of the nanoscale portion of your chemical is not incidental to the introduction of the non-nanoscale portion of your chemical
   
   This applies unless your introduction is categorised as exempted or reported (Steps 2 and 3 of our categorisation guidance) or you are able to apply for a commercial evaluation authorisation for your introduction
    
2. If your chemical meets our definition of 'not soluble' and the introduction of the nanoscale portion of your chemical is incidental to the introduction of the non-nanoscale portion of your chemical and you work out that the human health indicative risk or environment indicative risk for your introduction is medium to high (steps 4-5 of our categorisation guidance)
   
   This applies unless your introduction is categorised as exempted or reported (Steps 2 and 3 of our categorisation guidance) or you are able to apply for a commercial evaluation authorisation for your introduction
    
3. If your chemical doesn’t meet our definition of 'not soluble' and you work out that the human health indicative risk or environment indicative risk for your introduction is medium to high (steps 4-5 of our categorisation guidance)
   
   This applies unless your introduction is categorised as exempted or reported (Steps 2 and 3 of our categorisation guidance) or you are able to apply for a commercial evaluation authorisation for your introduction

When your introduction category is reported

1. If your chemical meets our definition of 'not soluble' and the introduction of the nanoscale portion of your chemical is incidental to the introduction of the non-nanoscale portion of your chemical and you work out that the highest indicative risk for your introduction is low or very low (steps 4-6 of our categorisation guidance)
   
   This applies unless your introduction is categorised as exempted (Step 2 of our categorisation guidance)
    
2. If your chemical doesn’t meet our definition of 'not soluble' and you work out that the highest indicative risk for your introduction is low (steps 4-6 of our categorisation guidance)
   
   This applies unless your introduction is categorised as exempted (Step 2 of our categorisation guidance)
    
3. If your chemical will only be used in research and development and you will introduce more than 10 kg, but not more than 100 kg of your chemical in a registration year and the research and development reported criteria are met for your introduction
   
   This applies unless your chemical doesn’t meet our definition of 'not soluble' and you  work out that your introduction can be categorised as exempted using Steps 4-6 of our categorisation guidance

When your introduction is exempted

1. If your chemical doesn’t meet our definition of 'not soluble' and you work out that the highest indicative risk for your introduction is very low (steps 4-6 of our categorisation guide)
2. If your chemical will only be used in research and development and you will introduce no more than 10kg of your chemical in a registration year and the research and development exempted criteria are met for your introduction