Step 5: Work out your introduction's risk to the environment

To be able to finish your categorisation you need to work out the risks of your introduction to the environment. To work this out start at 5.1 and continue as far as you need to through each step.

Once you have your answer for the risk of your introduction to the environment – medium to high, low or very low – go to Step 6. In Step 6 you'll combine the human health risk and the environment risk for the final category of your introduction.

By now you know the human health risk of your introduction – medium to high, low or very low – which you completed in step 4.

Step 5.1: Introductions that are always medium to high risk for the environment

You are at Step 5.1 because you've ruled out Steps 0, 1, 2 and 3 and have completed step 4 of the categorisation process.

Some introductions are always medium to high risk to the environment. This means they will be in the assessed introduction category and you need to apply for an assessment certificate.

Instructions

Go through A, B, C, D and E to work out if you are, or are not, introducing any of these types of chemicals. You must keep records of study reports and other information that you used to answer each question. 

A. Is your chemical a certain gas?

B. Is your chemical a certain organotin chemical?.

*C. Is your chemical a designated fluorinated chemical (including per- and poly-fluorinated alkyl substances, known as PFAS)?.

*D. Is your chemical a certain polyhalogenated organic chemical?.

*E. Is your chemical a certain chemical at the nanoscale?.

*Note, these last 3 types of chemical introductions we describe on this page are the same as the ones that we describe in step 4.1 for human health. This means that they are medium to high indicative risk to the environment and to human health. So, if you are introducing one of these types of chemicals, you should have already worked out that your introduction category is assessed because of its indicative human health risk being medium to high. Also, you now know that it’s also assessed because of its indicative environment risk being medium to high.


A. Is your chemical a certain gas?

Your chemical is a gas if it is in the gaseous phase at 20 oC and 101.3kPa (ambient conditions).

All introductions of chemicals that are a gas and are persistent in the environment are a specified class of introduction.

No I am not introducing this type of chemical

You must be able prove this. For example, you might have a SDS or product information sheet that indicates the appearance. You also need to be able to provide the information if we ask for it.

Next step: Go to 'B. Is your chemical a certain organotin chemical?'

Yes I am introducing this type of chemical

If you are introducing a gas, you must consider which of the following circumstances apply to your introduction.

1. Introduced at volumes less than 100kg 

Next step: Go to 'B. Is your chemical a certain organotin chemical?'

2. Introduced at volumes higher than 100kg each year

You need to have information about the persistence of your gas. To prove that your gas is not persistent, we’ll accept information that shows your gas has a half-life in air of less than 2 days. This could be: 

  • an in silico prediction using EPI Suite AOPWIN or
  • studies that use methods that are well established in published peer-reviewed scientific literature

Next step: If you do have the in silico predictions or studies to prove that your gas is not persistent, go to 'B. Is your chemical a certain organotin chemical?'. 

or

If you do not have the required in silico predictions or studies described above, then you cannot prove that your gas is not persistent.

Outcome: Your introduction is medium to high indicative risk to the environment. This means your introduction is in the assessed category and called an 'assessed introduction'.


B. Is your chemical an organotin chemical?

Organotin chemicals are chemicals that contain at least 1 tin atom that is covalently bound to at least one carbon atom. They are widely used as polyvinyl chloride (PVC) stabilisers, biocides, and in antifouling paints.

No I am not introducing this type of chemical

You must be able prove this. You (or the chemical identity holder) need information about the identity of the chemical as proof you are not introducing this type of chemical. You also need to be able to provide the information if we ask for it.

Next step: Go to 'C. Designated fluorinated chemicals (including per- and polyfluoroalkyl substances, known as PFAS)'.

Yes I am introducing this type of chemical

If you are introducing an organotin chemical, you must consider which of the below circumstances apply to your introduction.

1. Introduced at volumes less than or equal to 10 kg per year

Next step: Go to 'C. Is your chemical a designated fluorinated carbon (including per- and polyfluoroalkyl substances, known as PFAS)?'

2. Introduced at volumes greater than 10 kg per year

Outcome: If this applies to your introduction, it is in the assessed introduction category and is called an 'assessed introduction'. Before you can introduce the chemical, you must apply for an assessment certificate and select 'Environment' focus as the application type or apply for a commercial evaluation authorisation (if you meet the strict criteria).


C. Is your chemical a designated fluorinated chemical (including per- and polyfluoroalkyl substances, known as PFAS)?

Fluorinated chemicals contain fluorine atoms and include per- and polyfluoroalkyl substances (PFAS). These are commonly used in products to add resistance to heat, other chemicals, and abrasion. They also act as dispersion, wetting or surface treatment agents. We have an increased level of concern for introductions of designated fluorinated chemicals (including PFAS) because these chemicals, or their degradation products, may be persistent in the environment, bioaccumulate and be highly toxic. 

No I am not introducing this type of chemical

You must have information about your chemical's identity as proof that you're not introducing this type of chemical. You (or the chemical identity holder) need to provide the information if we ask for it.

Next step: Go to 'D. Is your chemical a certain polyhalogenated organic chemical?' below.

Yes I am introducing this type of chemical

We have extra guidance on categorising fluorinated chemicals

Outcome: Your introduction has a medium to high indicative risk to both human health and the environment. This means your introduction is in the assessed category and called an 'assessed introduction'.


D. Is your chemical a polyhalogenated organic chemical?

Polyhalogenated organic chemicals are carbon-based chemicals that contain more than 1 covalently bonded halogen atom, such as bromine, chlorine, fluorine, or iodine. Polyhalogenated organic chemicals are commonly used as flame retardants in plastics, textiles, and electronic circuitry. They may have long-term effects on human health and the environment. We have an increased level of concern for introductions of chemicals that are polyhalogenated organic chemicals because these chemicals, or their degradation products, may be persistent in the environment, bioaccumulate and be highly toxic. 

No I am not introducing this type of chemical

You must have information about your chemical's identity as proof that you're not introducing this type of chemical. You (or the chemical identity holder) need to provide the information if we ask for it.

Next step: Go to 'E. Is your chemical a certain chemical at the nanoscale?' below.

Yes I am introducing this type of chemical

All introductions of polyhalogenated chemicals are a  specified class of introduction.

If the chemical identity information that you (or the chemical identity holder) have confirms you are introducing this type of chemical, you must consider which of the following circumstances apply to your introduction.

1. Polyhalogenated organic chemicals introduced at volumes less than or equal to 100 kg each year

Next step: Go to 'E. Is your chemical a certain chemical at the nanoscale?' below.

2. Polyhalogenated organic chemicals introduced at volumes higher than 100 kg each year

You need to have test results about the persistence of your chemical and any of its known environmental degradation products.

  • Known environmental degradation products refer to the expected breakdown products of the chemical under environmentally relevant conditions. These breakdown products are ones that have been found in studies or reported in scientific literature.
  • A persistent chemical remains intact in the environment for long periods of time. A chemical is persistent if its degradation half-life (T1/2) is greater than or equal to: 
    • 2 days in air or 
    • 2 months in water or 
    • 6 months in soil or 
    • 6 months in sediment.

To prove that your chemical and any of its known environmental degradation products are not persistent, we accept study results in option 1 or 2.

Option 1

A study conducted following an acceptable test guideline for ready biodegradability that results in the pass levels being reached within one of the following time periods:

  • specified time period – such that the chemical is considered to be readily biodegradable or
  • duration of the test – but not within the specified time period for the chemical to be considered readily biodegradable, provided biodegradation has started within the specified time period

If you have this study showing these results, then move on to 'E. Is your chemical a certain chemical at the nanoscale?' below.

Option 2

A study conducted following an acceptable test guideline for Aerobic and Anaerobic Transformation in Aquatic Sediment Systems that results in both a degradation half-life of less than 2 months in water and 6 months in sediment.

If you have this study showing these results, then move on to 'E. Is your chemical a certain chemical at the nanoscale?' below.

If you do not have either of the study results described in option 1 or 2

Outcome: Your introduction is medium to high indicative risk to human health and the environment because you cannot prove that your chemical (and any of its known environmental degradation products) are not persistent. Your introduction is medium to high indicative risk to human health and the environment. This means your introduction is in the assessed category and called an 'assessed introduction'.


E. Is your chemical a certain chemical at the nanoscale?

Introductions of chemicals that meet all 4 criteria below are medium to high indicative risk to both human health and the environment. We refer to these introductions as 'certain chemicals at the nanoscale'. We have an increased level of concern for chemicals at the nanoscale, 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. 

  1. It is introduced as a solid or is in a dispersion.
  2. It consists of solid particles in an unbound state or as an aggregate or agglomerate. At least 50% (by number size distribution) of the particles have at least one external dimension in the particle size range of 1 nm to 100 nm (ie. the nanoscale). Note that 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.
  3. It is not soluble. This means the solubility of the chemical in water is less than 33.3 g/L measured following an acceptable test guideline for water solubility; or the dissolution rate of the chemical is not more than 70%.
  4. The introduction of the nanoscale portion of the chemical (the part that has a particle size range of 1 nm to 100 nm) is not incidental to the introduction of the non-nanoscale portion. This is the case if any of the following apply: 
    1. the manufacture of the chemical (in Australia or overseas) at the nanoscale is the result of a deliberate manufacturing decision 
    2. the manufacture of the chemical (in Australia or overseas) at the nanoscale is necessary for the manufacture of the non-nanoscale portion of the chemical. This means that to make the non-nanoscale chemical, part of the chemical has to be at the nanoscale
    3. the chemical at the nanoscale has specific technical characteristics that are the intended result of changes in the manufacturing process. For example, if the process of manufacturing the chemical changes in order to change the particle size of the chemical, or its properties at the nanoscale. This could happen by:
      • mechanical actions like milling, grinding, shearing, sieving or sonication
      • chemicals reactions like electrochemical exfoliation, or catalysts
      • other changes such as changes to pressure or temperature or pH or solvent

Yes I am introducing this type of chemical

We have extra guidance on categorising chemicals at the nanoscale

This means that your introduction meets all 4 criteria above and is a 'certain chemical at the nanoscale'.

Outcome: Your introduction has a medium to high indicative risk to both human health and the environment. This means your introduction is in the assessed category and called an ‘assessed introduction’. 

No I am not introducing this type of chemical

This means that you have information or studies to prove that your chemical does not meet any of the 4 criteria, or it only meets some of the 4 criteria. Answering the questions below will help you prove this. As you go through the questions, we'll tell you the next steps you should take.

For example, information on appearance could be recorded on an SDS or technical data sheet of the chemical or product that will be introduced into Australia.

Note: 

  • If your information indicates that it’s a powder, flakes, granules, pellets, or wax, select ‘yes’.
  • If your information indicates that it’s a liquid, select ‘no’.

Yes 

Go to question 2. 

I don't know

Go to question 2. Alternatively, contact your chemical supplier and return to this page when you have further information.

No 

This means that your introduction is not of a ‘certain chemical at the nanoscale’.

The criteria for ‘certain chemicals at the nanoscale’ are not met for your introduction.

Next step: Go to 'Step 5.2 Introductions that can be low risk for the environment' and continue to categorise your introduction.

 

For example, there is information on the chemical or product’s appearance on an SDS or technical data sheet.

No - the chemical will not be introduced as granules, pellets or a wax.

Go to question 3.

Yes - the chemical will be introduced as granules, pellets or a wax.

Note: you must keep a record of this information.

This means that your introduction is not of a ‘certain chemical at the nanoscale’.

Next step: Go to 'Step 5.2 Introductions that can be low risk for the environment' and continue to categorise your introduction.

 

Examples of when you should answer 'yes'

  • Your chemical is imported in an end use product such as laundry or dishwashing powder and it is not known to be an insoluble component of the product. For the product to work the way it should, the chemical must be soluble in water.
  • You have a study result from a water solubility study on your chemical that was carried out following the test guideline OECD TG 105.
  • You will introduce a polymer and have information on solution/extraction behaviour of the polymer in water (OECD TG 120).
  • You have information on the dissolution rate (OECD WPMN Guidance document for the testing of dissolution and dispersion stability of nanomaterials and the use of the data for further environmental testing and assessment strategies; July 2021).

No or don't know - my information does not indicate that the chemical is soluble in water or has a high dissolution rate or I don't have access to information about this

Go to question 4.

Yes - I have access to information that indicates that the chemical is soluble in water or has a high dissolution rate

This means that your introduction is not a 'certain chemical at the nanoscale'. You must keep a record of information you have available. If the information includes a study result and another person holds the study, you must be able to provide the study to us, if we ask for it.

Learn more about your record keeping obligations 

If you have information that shows the chemical 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 (1-100 nm), the introduction will be a specified class of introduction. Extra reporting obligations apply.

Next step: Go to 'Step 5.2 Introductions that can be low risk for the environment' and continue to categorise your introduction.

For example: 

  • Information on appearance and mean particle size could be recorded on an SDS or technical data sheet of the chemical or product that will be introduced into Australia.
  • You have 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).

I don't have access to any information about the mean particle size (all dimensions) or I don't know the answer to this question

Go to question 7.

The information I have access to indicates the mean particle size is less than or equal to 1000 nm in one or more dimensions 

Go to question 5.

Yes - information I have access to indicates the mean particle size is greater than 1000 nm in all dimensions

This means that your introduction is not of a ‘certain chemical at the nanoscale’.

Next step: Go to 'Step 5.2 Introductions that can be low risk for the environment' and continue to categorise your introduction.

Note: you must keep a record of the information you have available. 

For example: you have 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).

Note the following:

  1. For particle size distributions in this range, information only from an SDS/technical data sheet or similar is not enough.
  2. OECD TG 110 on Particle Size Distribution/ Fibre Length and Diameter Distributions for insoluble chemicals 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. 
  3. OECD TG 125 on Nanomaterial Particle Size and Size Distribution of Nanomaterials 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 100 nm. 
  4. 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.

No - I don't have access to any study results that indicate this / I don't know

Go to question 6.

Yes - I do have access to study results that indicate the mean particle size is greater than 200 nm in all dimensions

This means that your introduction is not of a ‘certain chemical at the nanoscale’.

Next step: Go to 'Step 5.2 Introductions that can be low risk to the environment' and continue to categorise your introduction. 

Note: you must keep a record of the information you have available. If another person holds the study, you must be able to give it to us, if we ask for it.

Learn more about your record keeping obligations 

For example - you have 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).

Note the following:

  1. For particle size distributions in this range, information only from an SDS/technical data sheet or similar is not enough.
  2. 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.
  3. 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.
  4. 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.

No - I don't have access to study results that indicate this / I don't know

Go to question 7.

Yes - I have access to study results that indicate the mean particle size is less than or equal to 200 nm in one or more dimensions and the chemical 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 (1-100 nm)

Go to question 7 - note the introduction will be a specified class of introduction and extra reporting obligations will apply.

Yes - I have access to study results that indicate the mean particle size is less than or equal to 200 nm in one or more dimensions and the 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 nanoscale (1-100 nm):

This means that your introduction is not of a ‘certain chemical at the nanoscale’.

Next step: Go to 'Step 5.2 Introductions that can be low risk for the environment' and continue to categorise your introduction.  

Note: you must keep a record of the information you have available. If the study is held by another person, you must be able to provide it to us, if we ask for it. 

Learn more about your record keeping obligations 

For example, you could have a combination of 1 and 2:

  1. A declaration from the chemical manufacturer indicating all of the below:
    1. the manufacture of any chemical at the nanoscale is not the result of a deliberate manufacturing decision; and
    2. the manufacture of any chemical at the nanoscale is not necessary for the manufacture of the non-nanoscale portion of the chemical; and
    3. any chemical at the nanoscale does not have specific technical characteristics that are the intended result of changes in the manufacturing process.
  2. Information to show that the presence of any nanoscale particles in the chemical is not providing a commercial advantage to the non-nanoscale chemical, such as the absence of claims related to the presence of the nanoscale particles in technical data sheets and commercial product labels on the chemical/introduced product. 

Note: in general, the declaration must be from the manufacturer of the chemical in its solid/dispersion form. The declaration must also be held in conjunction with other supporting information.

No - I do not have access to this information / I don't know

You do not have enough information to demonstrate that your introduction is not a ‘certain chemical at the nanoscale’. In the absence of more information from the manufacturer or supplier of your chemical, your introduction has a medium to high indicative risk to both human health and the environment. This means your introduction is in the assessed category and called an 'assessed introduction'.

Yes - I do have access to this information that indicates this

This means that your introduction is not of a ‘certain chemical at the nanoscale’.

Next step: Go to 'Step 5.2 Introductions that can be low risk for the environment' and continue to categorise your introduction. 

Note: you must keep a record of the information you have available. 

Content final

Definition - specified class of introduction

A ‘specified class of introduction’ are introductions that have an increased level of concern to human health or the environment. The reason is due to greater potential for certain hazards or high level of human or environmental exposure. Additional, or different, requirements relating to hazard information, reporting or record keeping apply to introductions that are a specified class of introduction. These vary depending on whether you have categorised your introduction as exempted, reported or assessed. 

If you've followed the guidance on this page and can prove that your introduction is not any of these, continue to step 5.2.

Next - Step 5.2 Introductions that can be low risk to the environment

Step 5.2 Introductions that can be low risk for the environment

This step relates to introductions that are internationally assessed for the environment. These must meet all of the following criteria to be considered ‘low indicative risk’ for the environment.

Skip this step if you are not using an internationally assessed chemical.

Note: Your introduction might still be low indicative risk for the environment but you will need to complete steps 5.3, 5.4 and 5.5 to work this out.

Step 5.2.1

Refer to our Guide to categorising internationally assessed introductions. It has extra information for introducers using international assessments and covers scenarios and outcomes for chemicals that are internationally assessed for:

  • human health only
  • the environment only
  • both human health and the environment

It also lists the trusted overseas bodies we accept assessments from.

The relevant section to refer to in the guide to help you complete step 5.2 is Internationally assessed for the environment only.

Step 5.2.2

Once you’ve read the guide to categorising internationally assessed introductions, you'll be able to work out whether your introduction either:

  • meets our criteria for internationally assessed for the environment 
  • does not meet our criteria for internationally assessed for the environment

Your introduction meets our criteria for internationally assessed for the environment

Option 1

  • Keep the outcome you already have — your introduction is low risk for the environment; and
  • Go to step 6 to complete your categorisation.

Option 2

Check to see if your introduction can be very low risk for the environment by completing the rest of step 5:

Once you’ve done this, go to step 6 to complete your categorisation.

Your introduction does not meet our criteria for internationally assessed for the environment

Continue with step 5 to work out your introduction's risk for the environment.

Next:

Once you’ve done this, go to step 6 to complete your categorisation.

If you've established your introduction is not medium to high risk for the environment (Step 5.1), now see if your introduction can be low risk for the environment. 

Step 5.3 Work out your environment exposure band

Why you need to work out your introduction's exposure band

It is part of the process to identify the indicative environment risk of your introduction. In step 4, you also had to work out your introduction's human health exposure band.

What does an environment exposure band identify about your introduction?

It identifies the likelihood and extent of environmental exposure to the chemical.  This likelihood and extent of exposure increases with each band. Exposure band 1 is the lowest exposure band, and exposure band 4 the highest. Introductions in environment exposure band 1 will have the lowest level of environmental exposure, and exposure band 4, the highest.

Information used to assign a chemical to its correct exposure band

Environment categorisation volume

Use this guidance to help you calculate this.

If your chemical has a designated kind of release into the environment

We define 'designated kind of release into the environment' (which we refer to throughout this page) to be where the chemical is intentionally released during use to land, biota, natural waterways, municipal water supplies or air (unless its only for domestic or personal use, or end use in an air freshener). It also includes any releases to the environment from firefighting end uses and releases into the ocean.

See also:


There are 4 environment exposure bands - exposure band 1 has the lowest level of environmental exposure and exposure band 4 the highest level. Follow steps on this page to work out your environment exposure band.

What's your environment exposure band?

Start with Exposure Band 1 and work down the page.

Introductions with a designated kind of release into the environmentif you're introducing one of these you are automatically in exposure band 4 for the environment. If this is your introduction type, go to Step 5.4: Work out your environment hazard characteristics.

Exposure band 1 criteria

If the environment categorisation volume for your chemical does not exceed 25kg, then your introduction is in environment exposure band 1. Next, work out the environment hazard characteristics of your introduction (Step 5.4)

If your introduction does not meet this criteria, go to exposure band 2 criteria.

Exposure band 2 criteria

If the environment categorisation volume for your chemical is greater than 25kg, but no more than 1,000kg, then your introduction is in environment exposure band 2. Next, work out the environment hazard characteristics of your introduction (Step 5.4)

If your introduction does not meet this criteria, go to exposure band 3 criteria.

Exposure band 3 criteria

If the environment categorisation volume for your chemical is greater than 1,000kg, but no more than 10,000kg, then your introduction is in environment exposure band 3. Next, work out the environment hazard characteristics of your introduction (Step 5.4).

If you are not in exposure bands 1-3 for the environment, go to exposure band 4 criteria.

Exposure band 4 criteria

Introductions with a designated kind of release into the environment: if you're introducing one of these you are in exposure band 4 for the environment. Next, go to Step 5.4: Work out your environment hazard characteristics.

The environment categorisation volume of your introduction is greater than 10,000kg. Go to Step 5.4: Work out your environment hazard characteristics.

Decorative image of a table summarising the information on the page

Step 5.4 Work out your environment hazard characteristics

Important! Your starting point is always hazard band D (the highest hazard band)  Then work your way down the hazard bands as far as you need to get to your outcome (that is, D, then C, then B, then A). Our guidance on this page steps you through this. Links on this page take you to hazard characteristics for each hazard band.

You must have permission to use information that you relied on to demonstrate the absence of hazard characteristics. If we ask you for the information that you relied on to categorise your introduction, you need to provide us with the detailed information, including full study reports, of the kind we specify in this step to demonstrate the absence of the hazard characteristics. 

Hazard characteristics in environment hazard bands

A chemical has an environment hazard characteristic if the chemical can cause damage, harm or adverse effects to the environment. For example, a chemical that has the 'toxic to any aquatic life' hazard characteristic can cause toxic injury to an organism following short term aquatic exposure.

Environment hazard characteristics are split up into hazard bands. Hazard characteristics of most concern are in hazard band D, while those of lower concern are in hazard band A. 

See links below to each of the hazard bands:  D, C, B and A.

Our pages for environment hazard bands D, C, B and A describe hazard characteristics (eg toxic to any aquatic life and so on) in each hazard band and the information you need to have to prove your chemical does not have a particular hazard characteristic.

Information you need and hazard characteristics you need to consider

This varies depending on your introduction’s environment exposure band.

If your introduction is in a lower exposure band

Generally, in the lower exposure bands, where the level of exposure to the environment is relatively low, as a minimum you have to consider only a few hazard characteristics and you don’t need much information on them. 

If your introduction is in a higher exposure band

In comparison, in higher exposure bands, where the level of exposure to the environment is higher, generally you’ll need to consider more hazard characteristics and need more information on them.

Information you need for lower indicative risk

You will need more hazard information to be able to get to lower indicative risk outcomes. Generally, within any given environment exposure band you need:

  • less hazard information to get to medium to high risk
  • more hazard information to get to low risk
  • the most hazard information to get to very low risk

See Step 5.5 for more information about indicative environment risk outcomes

Where to start and when you can stop considering your chemical's hazard characteristics

Starting point — is always hazard band D

Always start in the highest hazard band (hazard band D) and work your way down the hazard bands as far as you need to get to your outcome (that is, D, C then B then A).

You must consider each hazard characteristic in the hazard band you are in (unless there is a reason for you to stop sooner) - does your chemical have that hazard characteristic or not?

When you might not need to consider all of the hazard bands

  • Because your introduction’s environment exposure band (which you worked out in step 5.3) doesn’t require it. For example, if your introduction’s environment exposure band is 2, you only need to consider the hazards in hazard band D to get to an indicative environment risk of either medium to high or low.
  • Because the outcome for indicative environment risk that you are trying to get to doesn’t require it. For example, if your introduction’s environment exposure band is 3 and you want to get to an indicative environment risk of low, you only need to consider the hazard characteristics in environment hazard bands D and C.

In many cases, you’ll only need to consider hazard band D. But in other cases you might need to consider D, C, B and A because your introduction is in exposure band 3 or 4 and you are trying to get to very low indicative environment risk.

See step 5.5 for more about indicative environment risk outcomes

When you can stop working through your chemical’s environment hazard characteristics

Stop if you:

  • determine that your chemical has a hazard characteristic in the hazard band (e.g. persistent, bioaccumulative and toxic - you are in hazard band D) or
  • cannot demonstrate that your chemical does not have a certain hazard characteristic in that hazard band . This means that we consider your chemical to have this hazard characteristic or
  • get to an indicative environment risk outcome and don’t want to go any further - see step 5.5 for more information about environment risk outcomes or
  • have demonstrated that your chemical does not have any hazard characteristics in hazard bands D, C, B and A . This would only be needed for environment exposure bands 3 and 4. It means that the indicative environment risk of your introduction is very low

After you stop, you don’t need to consider the remaining hazard characteristics in the hazard band where you stopped, or any of the hazard characteristics in lower hazard bands. Take note of where and why you stopped and move on to step 5.5.

Example: Rosemary's introduction is in environment exposure band 4. She considers all of the hazard characteristics in environment hazard band D and can demonstrate that her chemical does not have any of these hazards. Rosemary then moves on to hazard band C. She works through the hazard characteristics in this hazard band in the order that they are shown in the table. When Rosemary comes to 'very toxic to any aquatic life', she finds that her chemical has this hazard characteristic. This means Rosemary can stop there. The indicative environment risk of Rosemary's introduction is medium to high. She does not need to continue further to see if her chemical has the other hazard characteristic in hazard band C (persistent and bio-accumulative). Also Rosemary doesn't need to consider if her chemical has any of the hazard characteristics in hazard bands B or A.

How to consider each hazard characteristic

Look at whether your chemical meets the hazard characteristic definition based on the information that you have.

If it does meet the hazard characteristic definition, stop there and move to step 5.5.

If it does not meet the hazard characteristic definition, you’ll need to try and prove that your chemical does not have this hazard characteristic.

Our pages on hazard bands D, C, B and A describe hazard characteristics and the ways to prove that your chemical does not have a hazard characteristic.

How to prove that your chemical does not have a hazard characteristic

You can read about your options to prove that your chemical does not have a particular hazard characteristic on each environment hazard band page. These options include:

  • checking if your chemical is on the list of chemicals with high hazards for categorisation
  • in silico predictions 
  • in vitro test results 
  • in vivo test results 
  • suitable read-across information in place of information on the chemical itself
  • other information about your chemical that means that testing and in silico predictions are not necessary (that is, information waivers)

If you have access to existing information on the chemical or suitable read-across information, you should consider these first. If you need to generate new data to prove the absence of a hazard characteristic, you should choose non-animal test data when possible. You should only generate new animal test data as a last resort.

See our section on use of animal test data

If you can prove that your chemical does not have the hazard characteristic, move on to the next hazard characteristic in that hazard band, or from the next hazard band down.

If you cannot prove that your chemical does not have the hazard characteristic, stop there – your chemical is considered to have this hazard characteristic.

Take note of the hazard band that this hazard characteristic is in. If your chemical is one of these:

there may be different requirements for you to prove that your chemical does not have certain hazard characteristics. 

 

Resources to help you with this step

We refer to the following throughout this step:

To work out the environment characteristics your chemical does and does not have, you must know your environment exposure band (Step 5.3). The information you need to consider hazard characteristics varies depending on your introduction’s exposure band.

Environment hazard bands - what are the hazard characteristics in each hazard band?

The following pages describe the hazard characteristics in each hazard band and the information you need to have to prove your chemical does not have a particular hazard characteristic. Follow instructions on each of these pages. Always start with hazard band D.

Environment hazard band D hazard characteristics

Do not start this page unless you have read Step 5.4: Work out your environment hazard characteristics

Environment hazard characteristics are split into hazard bands. Hazard characteristics of most concern are in hazard band D, while those of lower concern are in hazard band A.

Hazard band D has 5 hazard characteristics you need to consider:

  • Contains arsenic, cadmium, lead or mercury
  • Ozone depleting chemical
  • Synthetic greenhouse gas
  • Adverse effects mediated by an endocrine mode of action
  • Persistent, bioaccumulative and toxic

Instructions

You must always start at hazard band D. Step 5.4 tells you when you can stop working through your chemical's environment hazard characteristics and when you need to check each of them - ie D, C, B and A.

Work your way through hazard characteristic on this page. Look at whether your chemical meets the hazard characteristic definition based on the information that you have.

If it does meet the hazard characteristic definition, stop there - your introduction's environment hazard band is D. Move on to the next step - step 5.5 Work out your environment risk for categorisation.

If it does not meet the hazard characteristic definition, you’ll need to try and prove that your chemical does not have this hazard characteristic. The information that you need to prove this for each hazard characteristic is shown below. If you do not have this information, stop there - your introduction’s environment hazard band is D. Move onto the next step – step 5.5 Work out your environment risk for categorisation.

If you do have this information (so you can prove that the chemical does not have the hazard characteristic), move onto the next hazard characteristic on this page. 

After you have considered all the hazard characteristics on this page and have proven that the chemical does not have any of them, decide whether you can stop there or continue to environment hazard band C. This depends on the exposure band of your introduction. 

If your introduction is in environment exposure band 1 or 2, you can choose to stop (and go to step 5.5 to work out your environment risk for categorisation), or to continue to environment hazard band C.

If your introduction is in environment exposure band 3 or 4, continue to environment hazard band C.


Hazard characteristics and required information

Contains arsenic, cadmium, lead or mercury

Contains arsenic, cadmium, lead or mercury means that the industrial chemical contains one or more of the following:

  • arsenic
  • cadmium
  • lead or
  • mercury

There are no extra information requirements to prove that the chemical does not have this hazard characteristic.


Ozone depleting chemical

Ozone depleting chemical means that any of the following apply to the industrial chemical: 

  • the chemical is controlled under the Ozone Protection and Synthetic Greenhouse Gas Management Act 1989, or 
  • the chemical is controlled under the Montreal Protocol on Substances that Deplete the Ozone Layer.

Synthetic greenhouse gas

Synthetic greenhouse gas means that any of the following apply to the industrial chemical: 

  • the chemical is controlled under the Ozone Protection and Synthetic Greenhouse Gas Management Act 1989, or
  • the chemical is listed on the Kyoto Protocol, Synthetic Greenhouse Gases under Annex A, or
  • the chemical is controlled under the Montreal Protocol on Substances that Deplete the Ozone Layer.

Adverse effects mediated by an endocrine mode of action

Adverse effects mediated by an endocrine mode of action means that any of the following apply to the industrial chemical:

  • the chemical meets all of the following:
    • it shows an adverse effect in an intact organism or its progeny, which is a change in the morphology, physiology, growth, development, reproduction or lifespan of an organism, system or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in the susceptibility to other influences, and 
    • it has an endocrine activity, which is the capacity to alter the function(s) of the endocrine system, and 
    • the adverse effect is a consequence of the endocrine activity

or 

  • the chemical is on the list of chemicals with high hazards for categorisation, based on its adverse effects mediated by an endocrine mode of action, or 
  • the chemical is an ester or a salt of a chemical that is listed in the table below, which are on the list of chemicals with high hazards for categorisation based on adverse effects mediated by an endocrine mode of action unless an exception, as identified in the table below, is met for that chemical, 

or

  • the chemical meets all of the following: 
    • information is available that is relevant to determining whether the chemical has the hazard characteristic, adverse effects mediated by an endocrine mode of action, and 
    • the information has been considered in a weight of evidence analysis based on the following guidance documents: 
      • the EU guidance for identifying endocrine disruptors*, and 
      • the guidance provided in OECD GD 150**; and 
    • the weight of evidence analysis concludes that the chemical has the hazard characteristic, adverse effects mediated by an endocrine mode of action. 

Information required to demonstrate the absence of the hazard characteristic, adverse effects mediated by an endocrine mode of action 

  • If the chemical has existing information relevant to determining whether it has the hazard characteristic, adverse effects mediated by an endocrine mode of action, information is required to demonstrate that the chemical does not have this hazard characteristic:
    • this must involve a documented weight of evidence analysis based on the EU guidance for identifying endocrine disruptors* and the guidance in OECD Revised Guidance Document 150, and 
    • the analysis must conclude that the chemical does not have the hazard characteristic, adverse effects mediated by an endocrine mode of action. 
  • Otherwise, the information required to demonstrate that a chemical does not have the hazard characteristic, adverse effects mediated by an endocrine mode of action, is confirmation that the chemical is not on the list of chemicals with high hazards for categorisation, based on its adverse effects mediated by an endocrine mode of action and
  • Confirmation that the chemical is not an ester or salt of the specified chemicals shown in the table below, which are on the list of chemicals with high hazards for categorisation, based on adverse effects mediated by an endocrine mode of action.

Adverse effects mediated by an endocrine mode of action - exception criteria

Check the following table - an ester or salt of the chemical has the adverse effects mediated by an endocrine mode of action hazard characteristic, unless one or more of the following exception criteria apply. 

CAS numberChemical nameAn ester or salt of the chemical has the adverse effects mediated by an endocrine mode of action hazard characteristic, unless one or more of the below exception criteria apply
80-05-7Phenol, 4,4'-(1-methylethylidene)bis- (Bisphenol A)
  • the salt/ester is a high molecular weight polymer, with low levels of low molecular weight species
  • the molecular weight of the salt/ester is greater than or equal to 1,000 g/mol.
80-09-1Phenol, 4,4'-sulfonylbis- (Bisphenol S)
  • the salt/ester is a high molecular weight polymer, with low levels of low molecular weight species
  • the molecular weight of the salt/ester is greater than or equal to 1,000 g/mol.
98-54-4Phenol, 4-(1,1-dimethylethyl)-
  • the salt/ester is a high molecular weight polymer that is not an ethoxylate polymer and has low levels of low molecular weight species
  • the molecular weight of the salt/ester is greater than or equal to 1,000 g/mol.
80-46-6Phenol, 4-(1,1-dimethylpropyl)-
  • the salt/ester is a high molecular weight polymer that is not an ethoxylate polymer and has low levels of low molecular weight species
  • the molecular weight of the salt/ester is greater than or equal to 1,000 g/mol. 
VariousHeptylphenols on the list of chemicals with high hazards for categorisation – includes linear and branched isomers
  • the salt/ester is a high molecular weight polymer that is not an ethoxylate polymer and has low levels of low molecular weight species
  • the molecular weight of the salt/ester is greater than or equal to 1,000 g/mol.
VariousOctylphenols on the list of chemicals with high hazards for categorisation – includes linear and branched isomers
  • the salt/ester is a high molecular weight polymer that is not an ethoxylate polymer and has low levels of low molecular weight species
  • the molecular weight of the salt/ester is greater than or equal to 1,000 g/mol.
VariousNonylphenols on the list of chemicals with high hazards for categorisation – includes linear and branched isomers
  • the salt/ester is a high molecular weight polymer that is not an ethoxylate polymer and has low levels of low molecular weight species
  • the molecular weight of the salt/ester is greater than or equal to 1,000 g/mol.
VariousDodecylphenols on the list of chemicals with high hazards for categorisation – includes linear and branched isomers
  • the salt/ester is a high molecular weight polymer that is not an ethoxylate polymer and has low levels of low molecular weight species
  • the molecular weight of the salt/ester is greater than or equal to 1,000 g/mol.
Various Octyl and Nonylphenol ethoxylates on the list of chemicals with high hazards for categorisationNo exceptions

Note – Low levels of low molecular weight species (in relation to a polymer) means less than 10% (by mass) of molecules with a molecular weight that is less than 500 g/mol and less than 25% (by mass) of molecules with a molecular weight that is less than 1,000 g/mol.

*Guidance for the identification of endocrine disruptors in the context of 39 Regulations (EU) No 528/2012 and (EC) No 1107/2009, 2018 

**‘OECD Series on Testing and Assessment, No. 150 - Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption.’  OECD, OECD Series on Testing and Assessment, No. 150, 2018
 


Persistent, bioaccumulative and toxic 

Your introduction is in environment hazard band D if any of the following apply to the industrial chemical: 

For the purposes of this hazard characteristic, bioaccumulative means any of the following apply to the chemical:

  • it has a bioaccumulation factor (BAF) greater than or equal to 2000 for the aquatic compartment, or
  • it has a bioconcentration factor (BCF) greater than or equal to 2000 for the aquatic compartment, or
  • it has a measured log Kow greater than or equal to 4.2 for the aquatic compartment (unless a measured BAF or BCF is less than 2000), or
  • it has a log Koa greater than 6 and log Kow greater than or equal to 2 for the terrestrial compartment, or
  • it has a biomagnification factor (BMF) greater than 1.

Information required to demonstrate that a chemical does not have the hazard characteristic, persistent, bioaccumulative and toxic

Confirmation that the chemical is not on the list of chemicals with high hazards for categorisation based on it being persistent, bioaccumulative and toxic. In addition, if the environment exposure band for the introduction is 2 (and you are seeking to demonstrate that the introduction meets the criteria for very low risk and it is not the 'special cases' mentioned in step 5.5), or 3, or 4, the information required to demonstrate that a chemical does not have the hazard characteristic, persistent, bioaccumulative and toxic, is at least one of the following: 

  • information that demonstrates that the chemical is an inorganic chemical, or 
  • information to demonstrate that the chemical is a biological chemical, or 
  • information that demonstrates that the chemical has a molecular weight that is greater than 1,000 g/mol, or 
  • information that demonstrates that the chemical is a high molecular weight polymer with: 
    • less than 25% low molecular weight oligomeric species less than 1,000g/mol, and 
    • less than 10% low molecular weight oligomeric species less than 500g/mol, or 
  • information that demonstrates that the chemical has a solubility in water that is greater than 5g/L, measured following an acceptable test guideline for water solubility, or 
  • information that demonstrates that the chemical is a gas that is not expected to partition to the aquatic compartment, or 
  • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or 
  • a suitable in silico prediction for partition coefficient of the chemical itself of log Kow less than 4.2 (that is not negated by a measured log Kow), or 
  • measured value from a study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for partition coefficient, for which log Kow less than 4.2, or 
  • if the chemical is not a highly branched organic chemical*  – a test result from a study on the chemical or from suitable read across information, conducted following an acceptable test guideline for ready biodegradability, which meets at least one of the following degradation pass levels during the period specified in the test method: 
    • tests based on dissolved organic carbon (DOC) - greater than or equal to 70% DOC removal, or 
    • tests based on carbon dioxide generation - greater than or equal to 60% theoretical carbon dioxide, or 
    • tests based on oxygen depletion - greater than or equal to 60% theoretical oxygen demand, or 
  • a test result from a study on the chemical, conducted following an acceptable test guideline for ready biodegradability, which meets at least one of the following degradation pass levels during the period specified in the test method:
    • tests based on dissolved organic carbon (DOC) - greater than or equal to 70% DOC removal, or
    • tests based on carbon dioxide generation - greater than or equal to 60% theoretical carbon dioxide, or 
    • tests based on oxygen depletion - greater than or equal to 60% theoretical oxygen demand, or 
  • if the chemical is not a highly branched organic chemical*  – a test result from a study on the chemical or from suitable read across information, conducted following an acceptable test guideline for transformation in aquatic sediment systems, results in both: 
    • a degradation half-life in water of less than 2 months, and 
    • a degradation half-life in sediment of less than 6 months, or 
  • a test result from a study on the chemical, conducted following an acceptable test guideline for transformation in aquatic sediment systems, results in both: 
    • a degradation half-life in water of less than 2 months, and 
    • a degradation half-life in sediment of less than 6 months, or 
  • if the chemical is not a biocidal active and not a persistent, highly branched organic chemical**  – information on aquatic toxicity for all 3 trophic levels (fish, invertebrates and algae), from suitable in silico predictions on the chemical or in vivo studies on the chemical or from suitable read-across information conducted following acceptable test guidelines for aquatic toxicity, with at least one of the following results for all 3 trophic levels: 
    • acute aquatic toxicity greater than 1 mg/L (96h LC50 (fish), or 48h EC50 (invertebrates) or 72 or 96h ErC50 (algae)), or 
    • chronic aquatic toxicity NOEC or EC10 greater than 0.1mg/L (for chemicals that are not readily biodegradable), or 
    • chronic aquatic toxicity NOEC or EC10 > 0.01 mg/L (for chemicals that are readily biodegradable), or
  • test results for all 3 trophic levels (fish, invertebrates and algae) from in vivo studies on the chemical or from suitable read-across information, conducted following acceptable test guidelines for chronic aquatic toxicity with a NOEC or EC10 greater than 0.1mg/L for all 3 trophic levels, or 
  • a test result from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for bioconcentration, for which the BCF less than 2,000, or  
  • a test result from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for bioaccumulation, for which the BAF less than 2,000. 

*If the chemical is a highly branched organic chemical, in silico predictions and read across information cannot be used to demonstrate that the chemical does not have the persistence aspect of the persistent, bioaccumulative and toxic hazard characteristic – only studies on the chemical itself, as described in the next dot point, are acceptable

**If the chemical is a biocidal active or a persistent, highly branched organic chemical, in silico predictions cannot be used to demonstrate that the chemical does not have the toxicity aspect of the persistent, bioaccumulative and toxic hazard characteristic – only in vivo chronic aquatic toxicity studies, as described in the next dot point, are acceptable.

Environment hazard band C hazard characteristics

Environment hazard characteristics are split into hazard bands. Hazard characteristics of most concern are in hazard band D, while those of lower concern are in hazard band A.

Hazard band C has 2 hazard characteristics you need to consider:

  • very toxic to any aquatic life
  • persistent and bioaccumlative - environment hazard band C

Instructions

You must always start at hazard band D. Step 5.4 tells you when you can stop working through your chemical's environment hazard characteristics and when you need to check each of them - ie D, C, B and A.. You only need to work through the hazard characteristics on this page is your introduction is in:

  • Environment exposure band 1 or 2 and you are trying to get to an outcome of very low indicative environment risk or
  • Environment exposure band 3 or 4

Work your way through each hazard characteristic on this page. Look at whether your chemical meets the hazard characteristic definition based on the information that you have.

If it does meet the hazard characteristic definition, stop there - your introduction's environment hazard band is C. Move on to the next step - step 5.5 Work out your environment risk for categorisation.

If it does not meet the hazard characteristic definition, you’ll need to try and prove that your chemical does not have this hazard characteristic. The information that you need to prove this for each hazard characteristic is shown below. If you do not have this information, stop there - your introduction’s environment hazard band is C. Move onto the next step – step 5.5 Work out your environment risk for categorisation.

If you do have this information (so you can prove that the chemical does not have the hazard characteristic), move onto the next hazard characteristic on this page.

After you have considered all the hazard characteristics on this page and have proven that the chemical does not have any of them, decide whether you can stop there or continue to environment hazard band B. This depends on the exposure band of your introduction.

If your introduction is in environment exposure band 1, stop here – you don’t need to consider any other hazard characteristics. Next go to step 5.5 to work out your environment risk for categorisation.

If your introduction is in environment exposure band 2, continue to environment hazard band B.

If your introduction is in environment exposure band 3, you can choose to stop here (and go to step 5.5 to work out your environment risk for categorisation, or to continue to environment hazard band B.

If your introduction is in environment exposure band 4, continue to environment hazard band B.


Very toxic to any aquatic life

Very toxic to any aquatic life means that any of the following apply to the industrial chemical: 

  • the chemical is known to cause: 
    • toxic injury to an organism following short term aquatic exposure as described in chapter 4.1 of the GHS, with the chemical classified as acute aquatic toxicity (category 1), or 
    • adverse effects to an organism during aquatic exposures determined in relation to the life-cycle of the organism, as described in chapter 4.1 of the GHS, with the chemical classified as chronic aquatic toxicity (category 1), or 
    • the chemical is on the list of chemicals with high hazards for categorisation based on it being very toxic to any aquatic life, or 
    • an in vivo acute study on the chemical: 
      • conducted following an acceptable test guideline for acute toxicity to fish results in a 96h LC50 less than or equal to 1 mg/L, or
      • conducted following an acceptable test guideline for acute toxicity to invertebrates results in a 48h EC50 less than or equal to 1 mg/L, or 
      • conducted following an acceptable test guideline for acute toxicity to algae or other aquatic plants results in a 72 or 96h ErC50 less than or equal to 1 mg/L, or
    • an in vivo chronic study on the chemical conducted following an acceptable test guideline for chronic toxicity to fish, chronic toxicity to invertebrates, or chronic toxicity to algae or other aquatic plants results in a: 
      • NOEC or EC10 less than equal to 0.1 mg/L (for chemicals that are not readily biodegradable), or 
      • NOEC or EC10 less than or equal to 0.01 mg/L (for chemicals that are readily biodegradable), or
    • a suitable in silico prediction for acute aquatic toxicity results in a prediction of:  
      • for fish - 96h LC50 less than or equal to 1 mg/L, or 
      • for invertebrates - 48h EC50 less than or equal to 1 mg/L, or 
      • for algae or other aquatic plants - 72 or 96h ErC50 less than or equal to 1 mg/L

              and the predictions have not been negated by in vivo studies conducted on the chemical for aquatic toxicity.

Information required to demonstrate the absence of the hazard characteristic, very toxic to any aquatic life  

The information required to demonstrate that a chemical does not have the hazard characteristic, very toxic to any aquatic life, is: 

  • if the exposure band for the introduction is 1 - confirmation that the chemical is not on the list of chemicals with high hazards for categorisation based on it being very toxic to any aquatic life
  • if the environment exposure band for the introduction is 2, 3, or 4, -  at least one of the following: 
    • information that demonstrates that the chemical has a molecular weight greater than 1,000g/mol and has a low cationic density, or 
    • information that demonstrates that the chemical is a high molecular weight polymer that has a low cationic density, or 
    • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or 
    • if the chemical is not a biocidal active and not a persistent, highly branched organic chemical  – information on aquatic toxicity for all 3 trophic levels (fish, invertebrates and algae), from suitable in silico predictions on the chemical or in vivo studies on the chemical or from suitable read-across information conducted following acceptable test guidelines for aquatic toxicity, with one of the following results for each of the 3 trophic levels: 
      • acute aquatic toxicity greater than 1 mg/L (LC50 (fish), or EC50 (invertebrates) or ErC50 (algae)), or 
      • chronic aquatic toxicity NOEC or EC10 greater than 0.1 mg/L (for chemicals that are not readily biodegradable), or 
      • chronic aquatic toxicity NOEC or EC10 greater than 0.01 mg/L (for chemicals that are readily biodegradable), or 
    • test results for all 3 trophic levels (fish, invertebrates and algae) from in vivo studies on the chemical or from suitable read-across information, conducted following acceptable test guidelines for chronic aquatic toxicity with the following results for all 3 trophic levels: 
      • NOEC or EC10 greater than 0.1 mg/L (for chemicals that are not readily biodegradable), or 
      • NOEC or EC10 greater than 0.01 mg/L (for chemicals that are readily biodegradable).
 

Persistent and bioaccumulative 

Persistent and bioaccumulative means that any of the following apply to the industrial chemical: 

For the purposes of this hazard characteristic, bioaccumulative means any of the following apply to the chemical: 

  • it has a bioaccumulation factor (BAF) greater than OR equal to 2000 for the aquatic compartment, or 
  • it has a bioconcentration factor (BCF) greater than or equal to 2000 for the aquatic compartment, or 
  • it has a measured log Kow greater than or equal to 4.2 for the aquatic compartment (unless a measured BCF or BAF is less than 2000), or 
  • it has a log Koa greater than 6 and log Kow greater than or equal to 2 for the terrestrial compartment, or 
  • it has a biomagnification factor (BMF) greater than 1.

Information required to demonstrate the absence of the hazard characteristic, persistent and bioaccumulative  

The information required to demonstrate that a chemical does not have the hazard characteristic, persistent and bioaccumulative, is confirmation that the chemical is not on the list of chemicals with high hazards for categorisation based on it being persistent and bioaccumulative. In addition, if the environment exposure band for the introduction is 2 (and you are seeking to demonstrate that the introduction meets the criteria for very low risk and it is not the 'special cases' mentioned in step 5.5), or 3 or 4, the information required to demonstrate that a chemical does not have the hazard characteristic, persistent and bioaccumulative, is at least one of the following: 

  • information that demonstrates that the chemical is an inorganic chemical, or 
  • to demonstrate that the chemical is a biological chemical, or 
  • information that demonstrates that the chemical has a molecular weight that is greater than 1,000 g/mol, or 
  • information that demonstrates that the chemical is a high molecular weight polymer with: 
    • less than 25% low molecular weight oligomeric species less than 1,000g/mol, and 
    • less than 10% low molecular weight oligomeric species less than 500g/mol, or 
  • information that demonstrates that the chemical has a solubility in water that is greater than 5g/L, measured following an acceptable test guideline for water solubility, or 
  • information that demonstrates that the chemical is a gas that is not expected to partition to the aquatic compartment, or 
  • a suitable in silico prediction for partition coefficient of the chemical itself of log Kow less than 4.2 (that is not negated by a measured log Kow), or 
  • a measured value from a study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for partition coefficient, for which log Kow less than 4.2, or 
  • if the chemical is not a highly branched organic chemical*  – a test result from a study on the chemical or from suitable read across information, conducted following an acceptable test guideline for ready biodegradability, which meets at least one of the following degradation pass levels during the period specified in the test method: 
    • tests based on dissolved organic carbon (DOC) - greater than or equal to 70% DOC removal, or 
    • tests based on carbon dioxide generation - greater than or equal to 60% theoretical carbon dioxide, or 
    • tests based on oxygen depletion - greater than or equal to 60% theoretical oxygen demand, or 
  • a test result from a study on the chemical, conducted following an acceptable test guideline for ready biodegradability, which meets at least one of the following degradation pass levels during the period specified in the test method: 
    • tests based on dissolved organic carbon (DOC) - greater than or equal to 70% DOC removal, or 
    • tests based on carbon dioxide generation - greater than or equal to 60% theoretical carbon dioxide, or 
    • tests based on oxygen depletion - greater than or equal to 60% theoretical oxygen demand, or 
  • if the chemical is not a highly branched organic chemical*  – a test result from a study on the chemical or from suitable read across information, conducted following an acceptable test guideline for transformation in aquatic sediment systems, results in both: 
    • a degradation half-life in water of less than 2 months, and 
    • a degradation half-life in sediment of less than 6 months, or 
  • a test result from the chemical, conducted following an acceptable test guideline for transformation in aquatic sediment systems, results in both: 
    • a degradation half-life in water of less than 2 months, and 
    • a degradation half-life in sediment of less than 6 months, or 
  • a test result from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for bioconcentration, for which the BCF is less than 2,000, or  
  • a test result from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for bioaccumulation, for which the BAF is less than 2,000. 

*If the chemical is a biocidal active or a persistent, highly branched organic chemical, in silico predictions cannot be used to demonstrate that the chemical does not have the very toxic to any aquatic life hazard characteristic – only in vivo chronic aquatic toxicity studies, as described in the next dot point, are acceptable.

 

Environment hazard band B hazard characteristics

Environment hazard characteristics are split into hazard bands. Hazard characteristics of most concern are in hazard band D, while those of lower concern are in hazard band A. 

Hazard band B has 1 hazard characteristic you need to consider - toxic to any aquatic life.

Instructions

You must always start at hazard band D. Step 5.4 tells you when you can stop working through your chemical's environment hazard characteristics and when you need to check each of them - ie D, C, B and A. You only need to work through the hazard characteristics on this page is your introduction is in: 

  • Environment exposure band 2 or 3 and you are trying to get to an outcome of very low indicative environment risk or 
  • Environment exposure band 4

Work your way through each hazard characteristic on this page. Look at whether your chemical meets the hazard characteristic definition based on the information that you have. 

If it does meet the hazard characteristic definition, stop there - your introduction's environment hazard band is B. Move on to the next step - step 5.5 Work out your environment risk for categorisation

If it does not meet the hazard characteristic definition, you’ll need to try and prove that your chemical does not have this hazard characteristic. The information that you need to prove this for each hazard characteristic is shown below. If you do not have this information, stop there - your introduction’s environment hazard band is B.

Move onto the next step – step 5.5 Work out your environment risk for categorisation

If you do have this information (so you can prove that the chemical does not have the hazard characteristic), move onto the next hazard characteristic on this page. 

After you have considered all the hazard characteristics on this page and have proven that the chemical does not have any of them, decide whether you can stop there or continue to environment hazard band A. This depends on the exposure band of your introduction. 

If your introduction is in environment exposure band 2, stop here – you don’t need to consider any other hazard characteristics. Next go to step 5.5 to work out your environment risk for categorisation

If your introduction is in environment exposure band 3, continue to environment hazard band A

If your introduction is in environment exposure band 4, you can choose to stop here (and go to step 5.5 to work out your environment risk for categorisation, or to continue to environment hazard band A


Toxic to any aquatic life 

Toxic to any aquatic life means that any of the following apply to the industrial chemical:  

  • the chemical is known to cause: 
    • toxic injury to an organism following short term aquatic exposure as described in chapter 4.1 of the GHS, with the chemical classified as acute aquatic toxicity (category 2), or 
    • adverse effects to an organism during aquatic exposures determined in relation to the life-cycle of the organism, as described in chapter 4.1 of the GHS, with the chemical classified as chronic aquatic toxicity (category 2), or 
  • an in vivo acute study on the chemical: 
    • conducted following an acceptable test guideline for acute toxicity to fish results in a 96h LC50 greater than 1mg/L but less than or equal to 10mg/L, or 
    • conducted following an acceptable test guideline for acute toxicity to invertebrates results in a 48h EC50 greater than 1mg/L but less than or equal to 10mg/L, or 
    • conducted following an acceptable test guideline for acute toxicity to algae or other aquatic plants results in a 72 or 96h ErC50 greater than 1mg/L but less than or equal to 10mg/L, or 
  • an in vivo chronic study on the chemical conducted following an acceptable test guideline for chronic toxicity to fish, chronic toxicity to invertebrates, or chronic toxicity to algae or other aquatic plants results in a: 
    • NOEC or EC10 greater than 0.1mg/L but less than or equal to 1mg/L (for chemicals that are not readily biodegradable), or 
    • NOEC or EC10 greater than 0.01mg/L but less than or equal to 0.1mg/L (for chemicals that are readily biodegradable), or 
  • a suitable in silico prediction for acute aquatic toxicity results in a prediction of:  
    • for fish - 96h LC50 greater than 1mg/L but less than or equal to 10mg/L, or 
    • for invertebrates - 48h EC50 greater than 1mg/L but less than or equal to 10mg/L, or
    • for algae or other aquatic plants - 72 or 96h ErC50 greater than 1mg/L but less than or equal to 10mg/L, or

      and the predictions have not been negated by in vivo studies conducted on the chemical for aquatic toxicity.

Information required to demonstrate the absence of the hazard characteristic, toxic to any aquatic life

The information required to demonstrate that a chemical does not have the hazard characteristic, toxic to any aquatic life, is at least one of the following:  

  • information that demonstrates that the chemical has a molecular weight greater than 1,000 g/mol and has a low cationic density, or 
  • information that demonstrates that the chemical is a high molecular weight polymer that has a low cationic density, or 
  • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or 
  • if the chemical is not a biocidal active and not a persistent, highly branched organic chemical  – information on aquatic toxicity for all three trophic levels (fish, invertebrates and algae), from suitable in silico predictions on the chemical or in vivo studies on the chemical or from suitable read-across information conducted following acceptable test guidelines for aquatic toxicity, with the following results for all three trophic levels: 
    • acute aquatic toxicity greater than 10 mg/L (LC50 (fish), or EC50 (invertebrates) or ErC50 (algae)), or 
    • chronic aquatic toxicity NOEC or EC10 greater than 1mg/L (for chemicals that are not readily biodegradable), or 
    • chronic aquatic toxicity NOEC or EC10 greater than 0.1mg/L (for chemicals that are readily biodegradable), or 
  • test results for all three trophic levels (fish, invertebrates and algae) from in vivo studies on the chemical or from suitable read-across information, conducted following acceptable test guidelines for chronic aquatic toxicity with the following results for all three trophic levels: 
    • NOEC or EC10 greater than 1mg/L (for chemicals that are not readily biodegradable), or 
    • NOEC or EC10 greater than 0.1mg/L (for chemicals that are readily biodegradable).

 

Environment hazard band A hazard characteristics

Environment hazard characteristics are split into hazard bands. Hazard characteristics of most concern are in hazard band D, while those of lower concern are in hazard band A. 

Hazard band A has 6 hazard characteristics you need to consider:

  • Contains aluminium, chromium, copper, nickel, selenium, silver or zinc 
  • Polymer that does not have a low cationic density 
  • Polymer that is not stable
  • Bioaccumulation potential  
  • Industrial chemical (other than a polymer) that does not meet the criteria for ready biodegradability 
  • Harmful to any aquatic life 

Instructions

You must always start at hazard band D. Step 5.4 tells you when you can stop working through your chemical's environment hazard characteristics and when you need to check each of them - that is, D, C, B and A. You only need to work through the hazard characteristics on this page is your introduction is in: 

  • Environment exposure band 3 or 4 and you are trying to get to an outcome of very low indicative environment risk 

Work your way through each hazard characteristic on this page. Look at whether your chemical meets the hazard characteristic definition based on the information that you have.

If it does meet the hazard characteristic definition, stop there - your introduction's environment hazard band is A. Move on to the next step - step 5.5 Work out your environment risk for categorisation.

If it does not meet the hazard characteristic definition, you’ll need to try and prove that your chemical does not have this hazard characteristic. The information that you need to prove this for each hazard characteristic is shown below. If you do not have this information, stop there - your introduction’s environment hazard band is A. Move onto the next step – step 5.5 Work out your environment risk for categorisation.

If you do have this information (so you can prove that the chemical does not have the hazard characteristic), move onto the next hazard characteristic on this page.  

After you have considered all the hazard characteristics on this page and have proven that the chemical does not have any of them, go to step 5.5 to work out your environment risk for categorisation.

Links to resources to help you with the following:


Hazard characteristics and required information

Contains aluminium, chromium, copper, nickel, selenium, silver or zinc 

Contains aluminium, chromium, copper, nickel, selenium, silver or zinc means that the industrial chemical contains one or more of the following:

  • aluminium
  • chromium
  • copper
  • nickel
  • selenium
  • silver
  • zinc

There are no extra information requirements to prove that the chemical does not have this hazard characteristic.


Polymer that does not have a low cationic density 

Polymer that does not have a low cationic density means that the industrial chemical is a polymer that does not meet the definition of low cationic density.

There are no extra information requirements to prove that the chemical does not have this hazard characteristic.


Polymer that is not stable

Polymer that is not stable means that all of the following apply to the industrial chemical: 

  • the chemical is a polymer, and 
  • the polymer substantially degrades, decomposes or depolymerises during use; that is, the polymer is considerably, meaningfully or to a significantly large extent, changed into simpler, smaller molecular weight chemicals as the result of processes including, but not limited to: 
    • oxidation 
    • hydrolysis 
    • heat
    • sunlight 
    • attack by solvents

Information required to demonstrate the absence of the hazard characteristic, polymer that is not stable  

The information required to demonstrate that a chemical does not have the hazard characteristic, polymer that is not stable, is at least one of the following: 

  •  information that demonstrates that the polymer is protected from degradation by being encapsulated during use, or 
  • information that demonstrates that all of the following applies to the polymer: 
    • it is not designed to be pyrolysed or burnt, and 
    • it is not designed or reasonably anticipated to substantially photodegrade, and 
    • it is not designed or reasonably anticipated to substantially biodegrade, and 
    • it is not explosive, and 
    • it is hydrolytically stable (T½ greater than or equal to 12 hours), and 
    • it is not a biological polymer, and 
    • it is not a polysaccharide, and 
    • if it is a polymer that contains polyethylene glycol (PEG) functionalities and has a solubility in water of greater than 200 mg/L - measured data demonstrates that the polymer does not substantially biodegrade, and 
    • if it is a polymer that contains polypropylene glycol (PPG) functionalities and has a solubility in water of greater than 200 mg/L - measured data demonstrates that the polymer does not substantially biodegrade.

Industrial chemical (other than a polymer) that does not meet the criteria for ready biodegradability

Industrial chemical (other than a polymer) that does not meet the criteria for ready biodegradability, means that a study on the chemical, conducted following an acceptable test guideline for ready biodegradability, results in at least one of the following, as relevant to the test method used, and within the period specified in the test method: 

  • less than or equal to 70% dissolved organic carbon (DOC) removal, or 
  • less than or equal to 60% theoretical carbon dioxide, or 
  • less than or equal to 60% theoretical oxygen demand.

Information required to demonstrate the absence of the hazard characteristic, industrial chemical (other than a polymer) that does not meet the criteria for ready biodegradability  

The information required to demonstrate that a chemical does not have the hazard characteristic, industrial chemical (other than a polymer) that does not meet the criteria for ready biodegradability, is at least one of the following:

  • information that demonstrates that the chemical is highly volatile and it is expected to predominately partition to the air compartment, or
  • information that demonstrates that it is an inorganic chemical, or 
  • information that demonstrates that it is a biological chemical, or 
  • if the chemical is not a highly branched organic chemical*  – a test result from a study on the chemical or suitable read across information, conducted following an acceptable test guideline for ready biodegradability, which meets at least one of the following degradation pass levels during the period specified in the test method: 
    • tests based on dissolved organic carbon (DOC) - greater than or equal to 70% DOC removal, or 
    • tests based on carbon dioxide generation - greater than or equal to 60% theoretical carbon dioxide 
    • tests based on oxygen depletion - greater than or equal to 60% theoretical oxygen demand, or 
  • a test result from a study on the chemical, conducted following an acceptable test guideline for ready biodegradability, which meets at least one of the following degradation pass levels during the period specified in the test method: 
    • tests based on dissolved organic carbon (DOC) - greater than or equal to 70% DOC removal, or 
    • tests based on carbon dioxide generation - greater than or equal to 60% theoretical carbon dioxide, or 
    • tests based on oxygen depletion - greater than or equal to 60% theoretical oxygen demand.

*If the chemical is a highly branched organic chemical, in silico predictions and read across information cannot be used to demonstrate that the chemical does not have the hazard characteristic, industrial chemical (other than a polymer) that does not meet the criteria for ready biodegradability – only studies on the chemical itself, as described in the next dot point, are acceptable.


Harmful to any aquatic life

Harmful to any aquatic life means that any of the following apply to the industrial chemical: 

  • the chemical is known to cause: 
    • toxic injury to an organism following short term aquatic exposure , as described in chapter 4.1 of the GHS, with the chemical classified as acute aquatic toxicity (category 3), or
    • adverse effects to an organism during aquatic exposures determined in relation to the life-cycle of the organism, as described in chapter 4.1 of the GHS, with the chemical classified as chronic aquatic toxicity (category 3 or 4), or 
  • an in vivo acute study on the chemical: 
    • conducted following an acceptable test guideline for acute toxicity to fish results in a 96h LC50 greater than 10mg/L but less than or equal to 100mg/L, or 
    • conducted following an acceptable test guideline for acute toxicity to invertebrates results in a 48h EC50 greater than 10mg/L but less than or equal to 100mg/L, or 
    • conducted following an acceptable test guideline for acute toxicity to algae or other aquatic plants results in a 72 or 96h ErC50 greater than 10mg/L but less than or equal to 100mg/L, or 
  • an in vivo chronic study on the chemical conducted following an acceptable test guideline for chronic toxicity to fish, chronic toxicity to invertebrates, or chronic toxicity to algae or other aquatic plants results in a: 
    • NOEC or EC10 greater than 0.1mg/L but less than or equal to 1mg/L (for chemicals that are readily biodegradable), or 
  • a suitable in silico prediction for acute aquatic toxicity results in a prediction of:  
    • for fish - 96h LC50 greater than 10mg/L but less than or equal to 100mg/L, or 
    • for invertebrates - 48h EC50 greater than 10mg/L but less than or equal to 100mg/L, or 
    • for algae or other aquatic plants - 72 or 96h ErC50 greater than 10mg/L but less than or equal to100mg/L.

     and the predictions have not been negated by in vivo studies conducted on the chemical for aquatic toxicity. 

Information required to demonstrate that a chemical does not have the hazard characteristic, harmful to any aquatic life 

At least one of the following: 

  • information that demonstrates that the chemical has a molecular weight greater than 1,000g/mol and has a low cationic density, or 
  • information that demonstrates that the chemical is a high molecular weight polymer that has a low cationic density, or 
  • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or 
  • if the chemical is not a biocidal active and not a persistent, highly branched organic chemical  – information on aquatic toxicity for all three trophic levels (fish, invertebrates and algae), from suitable in silico predictions on the chemical or in vivo studies on the chemical or from suitable read-across information conducted following acceptable test guidelines for aquatic toxicity, with the following results for all three trophic levels: 
    • acute aquatic toxicity greater than 100 mg/L (LC50 (fish), or EC50 (invertebrates) or ErC50 (algae)), or 
    • chronic aquatic toxicity NOEC or EC10 greater than 1mg/L (for chemicals that are readily biodegradable), or 
  • test results for all three trophic levels (fish, invertebrates and algae) from in vivo studies on the chemical or from suitable read-across information, conducted following acceptable test guidelines for chronic aquatic toxicity with the following results for all three trophic levels: 
    • NOEC or EC10 greater than 1mg/L (for chemicals that are readily biodegradable).

Bioaccumulation potential

Bioaccumulation potential means that at least one of the following applies to the industrial chemical: 

  • it has a bioconcentration factor (BCF) greater than or equal to 500, or 
  • it has a bioaccumulation factor (BAF) greater than or equal to 500, or 
  • it has a partition coefficient (log Kow) greater than or equal to 4.0 (unless a measured BAF or BCF is <500).

Information required to demonstrate the absence of the hazard characteristic, bioaccumulation potential  

The information required to demonstrate that a chemical does not have the hazard characteristic, bioaccumulation potential, is at least one of the following: 

  • information that demonstrates that the chemical is an inorganic chemical, or 
  • information that demonstrates that the chemical has a high molecular weight, or
  • information that demonstrates that the chemical is a high molecular weight polymer with: 
    • less than 25% low molecular weight oligomeric species less than 1,000g/mol 
    • less than 10% low molecular weight oligomeric species less than 500g/mol, or 
  • information that demonstrates that the chemical has a solubility in water that is greater than 5g/L, measured following an acceptable test guideline for water solubility, or 
  • information that demonstrates that the chemical is a gas that is not expected to partition to the aquatic compartment, or 
  • a measured value from a study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for partition coefficient, for which log Kow less than 4.0, or 
  • a suitable in silico prediction for partition coefficient of the chemical using KOWWIN on the chemical for log Kow less than 4.0 (that is not negated by a measured log Kow), or 
  • a test result from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for bioconcentration, for which the BCF less than 500, or 
  • a test result from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for bioaccumulation, for which the BAF less than 500.

Step 5.5 Your environment risk for categorisation

Get help with this step — explore our categorisation decision tools

We explain the table in detail for each environment exposure band that your introduction could be in. This includes what your indicative environment risk outcome will be, depending on which hazard characteristics your chemical does or does not have. Your outcome will be that your introduction has an indicative environment risk of:

  • Medium to high
  • Low OR
  • Very low

Refer back to step 5.4 for information about how to consider the hazard characteristics and where to start and stop when considering hazard characteristics.

Environment risk table

Work out your indicative environment risk Environment exposure band
1 2 3 4
Environment hazard band D Medium to high risk Medium to high risk Medium to high risk Medium to high risk
C Low risk Low risk Medium to high risk Medium to high risk
B Very low risk Low risk Low risk Medium to high risk
A Very low risk Very low risk Low risk Low risk
Not A, B, C or D Very low risk Very low risk Very low risk Very low risk

If your introduction is environment exposure band 1

If your introduction is in environment exposure band 1, at a minimum, you will need to consider if your chemical has any of the hazard characteristics in environment hazard band D.

The indicative environment risk of your introduction will be:

  • Medium to high if your chemical has 1 or more of the hazard characteristics in environment hazard bands D OR
  • Low if your chemical does not have any of the hazard characteristics in environment hazard band D

You can choose to stop if you get to low indicative environment risk.

If you want to see if your introduction could have a very low indicative environment risk, you will also need to consider if it has any of the hazard characteristics in environment hazard band C.

The indicative environment risk of your introduction will be:

  • Low if your chemical has 1 or more of the hazard characteristics in environment hazard band C OR
  • Very low if your chemical does not have any of the hazard characteristics in environment hazard band C

If your introduction is environment exposure band 2

If your introduction is in environment exposure band 2, you will need to consider if your chemical has any of the hazard characteristics in environment hazard band D.

The indicative environment risk of your introduction will be:

  • Medium to high if your chemical has 1 or more of the hazard characteristics in environment hazard band D OR
  • Low if your chemical does not have any of the hazard characteristics in environment hazard band D

You can choose to stop if you get to low indicative environment risk.

If you want to see if your introduction could have a very low indicative environment risk, you will also need to consider if it has any of the hazard characteristics in environment hazard bands C and B.

The indicative environment risk of your introduction will be:

  • Low if your chemical has 1 or more of the hazard characteristics in environment hazard bands C or B OR
  • Very low if your chemical does not have any of the hazard characteristics in environment hazard bands C or B

If your introduction is environment exposure band 3

If your introduction is in environment exposure band 3, you will first need to consider if your chemical has any of the hazard characteristics in environment hazard band D. If it does not, then continue on to consider the hazard characteristics in environment hazard band C.

The indicative environment risk of your introduction will be:

  • Medium to high if your chemical has 1 or more of the hazard characteristics in environment hazard bands D or C OR
  • Low if your chemical does not have any of the hazard characteristics in environment hazard bands D or C

You can choose to stop if you get to low indicative environment risk.

If you want to see if your introduction could have a very low indicative environment risk, you will also need to consider if it has any of the hazard characteristics in environment hazard bands B and A.

The indicative environment risk of your introduction will be:

  • Low if your chemical has 1 or more of the hazard characteristics in environment hazard bands B or A OR
  • Very low if your chemical does not have any of the hazard characteristics in environment hazard bands B or A

If your introduction is environment exposure band 4

If your introduction is in environment exposure band 4, you will first need to consider if your chemical has any of the hazard characteristics in environment hazard band D. If it does not, then continue on to consider the hazard characteristics in environment hazard band C. If it does not, then continue on to consider the hazard characteristics in environment hazard band B.

The indicative environment risk of your introduction will be:

  • Medium to high if your chemical has 1 or more of the hazard characteristics in environment hazard bands D, C or B OR
  • Low if your chemical does not have any of the hazard characteristics in environment hazard bands D, C or B

You can choose to stop if you get to low indicative environment risk.

If you want to see if your introduction could have a very low indicative environment risk, you will also need to consider if it has any of the hazard characteristics in environment hazard band A.

The indicative environment risk of your introduction will be:

  • Low if your chemical has 1 or more of the hazard characteristics in environment hazard band A OR
  • Very low if your chemical does not have any of the hazard characteristics in environment hazard band A

'Special cases' - introductions that CANNOT have a very low indicative environment risk

Your introduction CANNOT have a very low indicative environment risk if it is a:

  • organotin chemical OR
  • polyhalogenated organic chemical OR
  • a chemical that has an end use as a biocidal active OR
  • a chemical that is introduced as a solid or a dispersion that is not soluble, that meets the nanoscale particle size criteria, and the introduction of the nanoscale portion of the chemical (the part that has a particle size range of 1nm to 100nm) is incidental to the introduction of the non-nanoscale portion OR
  • chemical that is introduced as a solid or a dispersion where there is no information available on its water solubility or its particle size, and the introduction of any nanoscale portion of the chemical (the part that has a particle size range of 1nm to 100nm) is incidental to the introduction of the non-nanoscale portion

If your introduction is 1 of these, and you got a very low risk outcome in this step, you need to CHANGE that outcome to LOW RISK.

This means if your consideration of step 5.5 got you to an outcome of very low risk, your final outcome needs to be changed to low risk.

Definitions of these 'special cases'

Organotin chemicals are chemicals that contain at least 1 tin atom that is covalently bound to at least one carbon atom.

Polyhalogenated organic chemicals are carbon-based chemicals that contain more than 1 covalently bonded halogen atom, such as bromine, chlorine, fluorine or iodine.

Biocidal active is a chemical that is intended to act by chemical means on or against a harmful organism by destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, the harmful organism.

Nanoscale particle size criteria means that the chemical consists of particles in an unbound state or as an aggregate or agglomerate. At least 50% (by number size distribution) of the particles must have at least 1 external dimension in the particle size range of 1nm to 100nm (i.e. the nanoscale).

Not soluble means the solubility of the chemical in water is less than 33.3 g/L measured following OECD test guidelines 105 or 120 for water solubility; or the dissolution rate of the chemical is not more than 70%.

Next – go to step 6 to complete your categorisation 

The table on this page shows how you can work out your indicative environment risk by using your environment exposure band (step 5.3) and the environment hazard characteristics (step 5.4) that your chemical does or does not have.