Choose from 5 options:
Highest indicative risk is low risk – hazard and exposure
Guide to completing the ‘Hazard and exposure’ section of the pre-introduction report for ‘highest indicative risk is low risk and the other types do not apply’ in AICIS Business Services.
When working out the indicative human health and environment risk for your introduction, you must check the definitions of each human health and environment hazard characteristic. Note that our hazard characteristic definitions are broader than the definitions or classification criteria under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
What you need to know about human health hazard characteristics
The human health hazard characteristics you need to consider vary and depend on your introduction’s human health exposure band.
It is not enough to determine the indicative human health risk based on the hazard characteristics that you know about your chemical. For example, you can't just rely on information in a Safety Data Sheet.
Most of the time, to categorise correctly, you need to prove that your chemical does not have certain hazard characteristics.
You must make sure you check the human health hazard characteristic definitions and how you can prove your chemical does not have the hazard characteristics in Step 4.4 of our Categorisation Guide.
If the human health exposure band for your introduction is:
- 2 or 3, you need to be able to prove that your chemical does not have any of the hazard characteristics in human health hazard band C
- 4, you need to be able to prove that your chemical does not have any of the hazard characteristics in human health hazard bands C and B.
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 specified in the Categorisation Guide. Therefore, you need to make sure you have access to this information and are able to provide it to us.
Does your chemical have a human health hazard characteristic?
You need to tell us whether or not your chemical has any human health hazard characteristics that are known to you. If you don’t know, you’ll have to indicate that as well.
Make sure that the hazard characteristics you select are consistent with characteristics permitted for a reported introduction in your exposure band.
For example, if the human health exposure band for your introduction is 4, then you shouldn’t be selecting hazard characteristics in human health hazard bands B or C – if the chemical is known to have these characteristics, the introduction should be categorised as assessed (not reported) and you need to apply for an assessment certificate to introduce the chemical.
If you answer yes, you need to select what these are from a picklist (can be more than one):
Human health hazard band A
- Acute toxicity (harmful)
- Skin irritation
- Eye irritation
- Specific target organ toxicity after a single exposure (harmful or transient effects)
- Aspiration hazard
- High molecular weight polymer that has lung overloading potential
Human health hazard band B
- Specific target organ toxicity after repeated exposure
- Acute toxicity (fatal or toxic)
- Skin sensitisation
- Skin corrosion
- Eye damage
- Specific target organ toxicity after a single exposure (significant toxicity)
- Corrosive to the respiratory tract
- Respiratory sensitisation
- High molecular weight polymer that is water absorbing
Human health hazard band C
- Genetic toxicity
- Adverse effects mediated by an endocrine mode of action
- Reproductive toxicity
- Developmental toxicity
- Carcinogenicity
- Is an inorganic arsenic compound; or contains beryllium, cadmium, chromium (VI), lead or nickel
What you need to know about environment hazard characteristics
The environment hazard characteristics you need to consider vary and depend on your introduction’s environment exposure band. For more help, take a look at Step 5.4 (Work out your environment hazard characteristics) of our Categorisation Guide.
It is not enough to determine the indicative environment risk based on the hazard characteristics that you know about your chemical. For example, you can’t just rely on information in a Safety Data Sheet.
Most of the time, to categorise correctly, you need to prove that your chemical does not have certain hazard characteristics. You must make sure you check the environment hazard characteristic definitions in step 5.4 of the Categorisation Guide. This step of the Categorisation Guide also explains how you can prove your chemical does not have a hazard characteristic.
If the environment exposure band for your introduction is:
- 1 or 2, you need to be able to prove that your chemical does not have any of the hazard characteristics in environment hazard band D
- 3, you need to be able to prove that your chemical does not have any of the hazard characteristics in environment hazard bands D and C
- 4, you need to be able to prove that your chemical does not have any of the hazard characteristics in environment hazard bands D, C and B.
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 specified in the Categorisation Guide. Therefore, you need to make sure you have access to this information and are able to provide it to us.
Does your chemical have an environment hazard characteristic?
You’ll need to tell us whether or not your chemical has any environment hazard characteristics that are known to you. If you don’t know, you’ll have to indicate that as well.
If you answer yes, you need to select what these are from a picklist (can be more than one):
Environment hazard band A
- Harmful to any aquatic life
- Industrial chemical (other than a polymer) that does not meet the criteria for ready biodegradability
- Bioaccumulation potential
- Polymer that is not stable
- Polymer that does not have a low cationic density
- Contains aluminium, chromium, copper, nickel, selenium, silver or zinc
Environment hazard band B
- Toxic to any aquatic life
Environment hazard band C
- Persistent and bioaccumulative
- Very toxic to any aquatic life
Environment hazard band D
- Persistent, bioaccumulative and toxic
- Adverse effects mediated by an endocrine mode of action
- Synthetic greenhouse gas
- Ozone depleting chemical
- Contains arsenic, cadmium, lead or mercury
What is the human health exposure band for the introduction?
Select your answer: human health exposure band 1, 2, 3 or 4. This is the human health exposure band that you determined as part of working out your introduction category.
What criteria did you use to determine the human health exposure band?
Select your answer: item number 1, 1A, 2, 3, 4, 5, 6 or 7 for your introduction. See below for the description of each item number as set out in Schedule 1, Part 1, Clause 1(1) of the Industrial Chemicals (General) Rules 2019.
Select item number ‘1' for this question if the human health exposure band for your introduction is 1 because all of the following apply:
- The introduction of your chemical does not involve a ‘designated kind of human exposure’ – this means you are not introducing a chemical with an end use in tattoo inks.
- The introduction of your chemical is not for any consumer end use.
- The concentration of your chemical at introduction and at all end uses is less than 0.1%.
Select item number ‘1A' for this question if the human health exposure band for your introduction is 1 because all of the following apply:
- The introduction of your chemical does not involve a ‘designated kind of human exposure’ – this means you are not introducing a chemical with an end use in tattoo inks.
- The introduction of your chemical is not for any consumer end use.
- The human health categorisation volume for your chemical does not exceed 25kg.
- During introduction and use of your chemical, either or both of the following control measures to eliminate or minimise exposure of persons to the industrial chemical are implemented:
- The industrial chemical is isolated from any person who could be exposed to it;
- Engineering controls (including a mechanical device or process).
- If, after implementing the control measures above, exposure of persons to your chemical could still occur, that potential exposure is minimised, so far as is reasonably practicable, by the implementation of additional suitable control measures, including the provision and use of suitable personal protective equipment.
- The industrial chemical is subject to your (the introducer’s) control.
Select item number ‘2' for this question if the human health exposure band for your introduction is 2 because all of the following apply:
- The introduction of your chemical does not involve a chemical with an end use in tattoo inks.
- The human health categorisation volume for your chemical does not exceed 25kg.
- Item number 1 does not apply to your introduction.
Select item number ‘3' for this question if the human health exposure band for your introduction is 2, because all of the following apply:
- The introduction of your chemical does not involve a chemical with an end use in tattoo inks.
- The introduction of your chemical is either for a consumer end use only or for multiple end uses, including a consumer end use.
- The concentration of your chemical at introduction and at all end uses is less than 0.1%.
Select item number ‘4' for this question if the human health exposure band for your introduction is 3, because all of the following apply:
- The introduction of your chemical does not involve a chemical with an end use in tattoo inks.
- The human health categorisation volume for your chemical does not exceed 100kg.
- Item numbers 1, 2 and 3 do not apply to your introduction.
Select item number ‘5' for this question if the human health exposure band for your introduction is 3, because all of the following apply:
- The introduction of your chemical does not involve a chemical with an end use in tattoo inks.
- The concentration of your chemical at introduction and at all end uses is 1% or less.
- Item numbers 1, 2 and 3 do not apply to your introduction.
Select item number ‘6' for this question if the human health exposure band for your introduction is 4, because all of the following apply:
- The introduction of your chemical does not involve a a chemical with an end use in tattoo inks.
- The human health categorisation volume for your chemical is greater than 100kg.
- Item numbers 1, 3 and 5 do not apply to your introduction.
Select item number ‘7' for this question if the human health exposure band for your introduction is 4 because the introduction of your chemical involves a chemical with an end use in tattoo inks.
What is the environment exposure band for the introduction?
Select your answer: environment exposure band 1, 2, 3, 4 or 5. This is the environment exposure band that you determined as part of working out your introduction category.
What criteria did you use to determine the environment exposure band?
Select your answer: item number 1, 2, 3, 4 or 5 for your introduction. See below for the description of each item number as set out in Schedule 1, Part 2, Clause 3(1) of the Industrial Chemicals (General) Rules 2019.
Select item number ‘1' for this question if the environment exposure band for your introduction is 1, because all of the following apply:
- The introduction of your chemical does not involve an end use in tattoo inks.
- The environment categorisation volume for your chemical does not exceed 25kg.
Select item number ‘2' for this question if the environment exposure band for your introduction is 2, because all of the following apply:
- The introduction of your chemical does not involve an end use in tattoo inks.
- The environment categorisation volume for your chemical is greater than 25kg but no more than 1,000kg
Select item number ‘3' for this question if the environment exposure band for your introduction is 3, because all of the following apply:
- The introduction of your chemical does not involve an end use in tattoo inks.
- The environment categorisation volume for your chemical is greater than 1,000kg but no more than 10,000kg.
Select item number ‘4' for this question if the environment exposure band for your introduction is 4, if the introduction of your chemical involves an end use in a tattoo ink.
Select item number ‘5' for this question if the environment exposure band for your introduction is 4, because the following applies:
- The environment categorisation volume for your chemical is greater than 10,000kg.