Skip to main content

Open for public comment: proposed amendments to the General Rules – closes 17 September 2021.

Decision tool – Hazard characteristics for human health exposure band 4

This decision tool is related to step 4.4 and 4.5 of the process to categorise your chemical introduction.

Optional: If you’d like to save or print your completed decision tool for your own records, click on ‘Chemical identity’ before Question 1 and enter your chemical’s name or CAS number. Note that a copy of a completed decision tool is not sufficient to meet your record-keeping obligations. To save as a PDF, select the print option in your browser and choose ‘Save as PDF’ or ‘Microsoft Print to PDF’. For Safari users, click 'File' and 'Export to PDF'.

Who should use this?

This decision tool only applies for introductions with a human health exposure band of 4. If your introduction is in human health exposure band 4, you can use this decision tool to help you work out:

  • if your chemical has certain human health hazard characteristics
  • your introduction's indicative human health risk

If you're working out if your introduction's indicative human health risk is low, you'll have to answer 1-25 questions depending on your circumstances.

If you're working out if your introduction's indicative human health risk is very low, you'll have to answer 1-38 questions depending on your circumstances.

This tool refers to the Industrial Chemicals Categorisation Guidelines.

See the full list of decision tools to help you categorise your introduction

Help us improve these tools by giving us your feedback.

Information about the following for your chemical:

  • carcinogenicity 
  • reproductive toxicity
  • developmental toxicity
  • adverse effects mediated by an endocrine mode of action 
  • genetic toxicity 
  • very low indicative human health risk
  • high molecular weight polymer that is water absorbing
  • respiratory sensitisation 
  • corrosive to the respiratory tract
  • specific target organ toxicity after a single exposure (significant toxicity)
  • skin corrosion
  • eye damage
  • skin sensitisation
  • acute toxicity (fatal or toxic)
  • specific target organ toxicity after repeated exposure
  • high molecular weight polymer that has lung overloading potential
  • aspiration hazard
  • specific target organ toxicity after a single exposure (harmful or transient effects)
  • skin irritation
  • eye irritation
  • acute toxicity (harmful)
  • is it on the list of chemicals with high hazards for categorisation
  • human health categorisation volume (HHCV)

Chemical identity (optional)

Question 1

Is your chemical:

Please note that that this tool doesn't cover the additional requirements for these specified classes. For the extra guidance and requirements for these chemicals please refer to

  • UV Filters: Carcinogenicity (Part 6.3.2 of the Categorisation Guidelines); Genetic toxicity (Part 6.7.2 of the Categorisation Guidelines); Skin sensitisation (Part 6.14.2 of the Categorisation Guidelines)
  • Tattoo inks: Skin Sensitisation (Part 6.14.2 of the Categorisation Guidelines); Skin irritation (Part 6.20.2 of the Categorisation Guidelines
  • Personal vaporisers: Acute toxicity (fatal or toxic) (part 6.15.2 of the Categorisation Guidelines); Specific target organ toxicity after repeated exposure (part 6.16.2 of the Categorisation Guidelines); Acute toxicity (harmful) (Part 6.22.2 of the Categorisation Guidelines)
  • Polyhalogenated organic chemicals: Reproductive toxicity (Part 6.4.2 of the Categorisation Guidelines); Developmental toxicity (Part 6.5.2 of the Categorisation Guidelines)
  • End use in an article with food contact: Specific target organ toxicity after repeated exposure (Part 6.16.2 of the Categorisation Guidelines)
  • End use in an article that is a children’s toy or children’s care product that can be placed in the mouth (guidance coming soon): Specific target organ toxicity after repeated exposure (Part 6.16.2 of the Categorisation Guidelines)

Question 2

Is your chemical on the list of chemicals with high hazards for categorisation based on any of the following hazard characteristics? If your chemical's an ester or salt, there are extra requirements when you check the list.

  • Carcinogenicity
  • Reproductive toxicity
  • Developmental toxicity
  • Adverse effects mediated by an endocrine mode of action
  • Genetic toxicity

Question 3

Does the definition of carcinogenicity apply to your chemical? You can refer to Part 6.3.1 of the Categorisation Guidelines.

Question 4

Does the definition of reproductive toxicity apply to your chemical? You can refer to Part 6.4.1 of the Categorisation Guidelines.

Question 5

Does the definition of developmental toxicity apply to your chemical. You can refer to Part 6.5.1 of the Categorisation Guidelines.

Question 6

Does the definition of adverse effects mediated by an endocrine mode of action apply to your chemical. You can refer to Part 6.6.1 of the Categorisation Guidelines.

Question 7

Does the definition of genetic toxicity apply to your chemical? You can refer to Part 6.7.1 of the Categorisation Guidelines.

Question 8

This question relates to the genetic toxicity hazard characteristic in hazard band C. Does at least one of the following apply to your chemical? You can refer to Part 6.7.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be medium-high.

Note: If you check the list and can answer ‘yes’, you will have shown that your chemical doesn’t have the genetic toxicity hazard characteristic in hazard band C.

Both of the following apply. 

  • The chemical is included in the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion.
  • The human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

Both of the following apply.

  • The chemical has been notified to the US FDA GRAS notification program and the FDA had no questions about the notifier’s conclusion of GRAS status.
  • The human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

Information demonstrating the chemical's a substance covered by Entry 9 of Annex V of the REACH Regulation.


The chemical is a high molecular weight polymer.


Information demonstrating the absence of mutagenic or genotoxic effects from both:

  • a study on the chemical or from suitable read across information (conducted following an acceptable test guideline for gene mutation) and
  • a study on the chemical or from suitable read across information (conducted following an acceptable test guideline for chromosomal abnormalities)

Question 9

This question relates to hazard band B. Does the definition of ‘high molecular weight polymer that is water absorbing’ apply to your chemical? You can refer to Part 6.8.1 of the Categorisation Guidelines.

Question 10

This question relates to the ‘high molecular weight polymer that is water absorbing’ hazard characteristic in hazard band B. Do any of the following apply to your chemical? You can refer to Part 6.8.2 of the Categorisation Guidelines. 

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be medium-high.

Note: If you check the list and can answer ‘yes’, you will have shown that your chemical doesn’t have the ‘high molecular weight polymer that is water absorbing’ hazard characteristic in hazard band B.

The chemical is not a polymer.


Molecular weight information for the polymer that demonstrates the number average molecular weight (NAMW) is less than 10,000 g/mol.


Information demonstrating the polymer isn't introduced in a particulate form.


Particle size information for the polymer demonstrating the particle size is greater than or equal to 10 micrometres (microns).


Information demonstrating that the polymer doesn’t absorb its own weight or more in water. This could be from an experiment showing either:

  • the polymer does not form a gel in water or
  • if a gel is formed in water, it dissolves if more water is added.

Question 11

This question relates to hazard band B. Does the definition of respiratory sensitisation apply to your chemical? You can refer to Part 6.9.1 of the Categorisation Guidelines.

Question 12

This question refers to hazard band B. Does the definition of ‘corrosive to the respiratory tract’ apply to your chemical? You can refer to Part 6.10.1 of the Categorisation Guidelines.

Question 13

This question refers to hazard band B. Does the definition of ‘specific target organ toxicity after a single exposure (significant toxicity)’ apply to your chemical? You can refer to Part 6.11.1 of the Categorisation Guidelines.

Question 14

This question refers to hazard band B. Does the definition of ‘skin corrosion’ apply to your chemical? You can refer to Part 6.12.1 of the Categorisation Guidelines.

Question 15

This question refers to the ‘skin corrosion’ hazard characteristic in hazard band B. Does at least one of the following apply to your chemical? You can refer to Part 6.12.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be medium to high.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘skin corrosion’ hazard characteristic in hazard band B.

Information demonstrating the chemical is a high molecular weight polymer that does not contain any of the following reactive functional groups:

  • anhydride
  • epoxide
  • sulfonic acid
  • amine

Information demonstrating the chemical is a high molecular weight polymer that contains any of the following reactive functional groups and it has a combined functional group equivalent weight of greater than or equal to 1,000 g/mol:

  • anhydride
  • epoxide
  • sulfonic acid
  • amine

Test results from an in vitro study on the chemical or from suitable read across information (conducted following an acceptable test guideline for skin corrosion) with a non-corrosive prediction.


Test results from an in vitro study on the chemical or from suitable read across information (conducted following an acceptable test guideline for skin irritation) with a non-irritant prediction.


Test results from an in vivo study on the chemical or from suitable read across information (conducted following an acceptable test guideline for skin irritation) which does not result in destruction of skin tissue (as described for skin corrosion in chapter 3.2 of the GHS).

Question 16

This question refers to hazard band B. Does the definition of ‘eye damage’ apply to your chemical? You can refer to Part 6.13.1 of the Categorisation Guidelines.

Question 17

This question refers to the ‘eye damage’ hazard characteristic in hazard band B. Does at least one of the following apply to your chemical? You can refer to Part 6.13.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be medium to high.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘eye damage’ hazard characteristic in hazard band B.

Information demonstrating the chemical is a high molecular weight polymer that does not contain any of the following reactive functional groups:

  • anhydride
  • epoxide
  • sulfonic acid
  • amine

Information demonstrating the chemical is a high molecular weight polymer that contains any of the following reactive functional groups with a combined functional group equivalent weight of greater than or equal to 1,000 g/mol:

  • anhydride
  • epoxide
  • sulfonic acid
  • amine

Test results from an in vitro study on the chemical or from suitable read across information (conducted following an acceptable test guideline for eye damage) predicting the chemical would not induce serious eye damage.


Test results from an in vivo study on the chemical or from suitable read across information (conducted following an acceptable test guideline for eye irritation) which does not result in effects on the eye (as described for eye damage in chapter 3.3 of the GHS).

Question 18

This question refers to hazard band B. Does the definition of ‘skin sensitisation’ apply to your chemical? You can refer to Part 6.14.1 of the Categorisation Guidelines.

Question 19

This question refers to the ‘skin sensitisation’ hazard characteristic in hazard band B. Does at least one of the following apply to your chemical? You can refer to Part 6.14.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be medium to high.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘skin sensitisation’ hazard characteristic in hazard band B.

The chemical is corrosive to the skin (GHS category 1).


Information demonstrating the chemical is a high molecular weight polymer with only low concern reactive functional groups.


Information demonstrating the chemical is a high molecular weight polymer with only: 


Information demonstrating the chemical is a high molecular weight polymer, where the only reactive functional groups it contains are unsubstituted positions ortho and para to phenolic hydroxyl groups.


Information demonstrating the chemical is a high molecular weight polymer with:


Information demonstrating the chemical is a high molecular weight polymer with:


Information demonstrating the chemical is a high molecular weight polymer with a number average molecular weight that is greater than or equal to 10,000 g/mol and both: 

  • less than 2% by mass of molecules with molecular weight that is less than 500 g/mol
  • less than 5% by mass of molecules with molecular weight that is less than 1,000 g/mol

Information demonstrating the chemical is a substance covered by Entry 9 of Annex V, of the REACH Regulation.


All of the following apply:

  • Test results from an in chemico test on the chemical or from suitable read-across information (conducted following an acceptable test guideline for the 1st key event in skin sensitisation) with a non-sensitising prediction.
  • Test results from an in vitro study on the chemical or from suitable read across information (conducted following an acceptable test guideline for the 2nd key event in skin sensitisation) with a non-sensitising prediction.
  • Test results from an in vitro study on the chemical or from suitable read across information (conducted following an acceptable test guideline for the 3rd key event in skin sensitisation) with a non-sensitising prediction.

Test results from an in vivo study on the chemical or from suitable read-across information (conducted following an acceptable test guideline for skin sensitisation) which does not result in induction of an allergic response (as described in chapter 3.4 of the GHS).

Question 20

This question refers to hazard band B. Does the definition of ‘acute toxicity (fatal or toxic)’ apply to your chemical? You can refer to Part 6.15.1 of the Categorisation Guidelines.

Question 21

This question refers to the ‘acute toxicity (fatal or toxic)’ hazard characteristic in hazard band B. Do any of the following apply to your chemical? You can refer to part 6.15.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be medium to high.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘acute toxicity (fatal or toxic)’ hazard characteristic in hazard band B.

The chemical is corrosive to the skin (GHS Category 1), or likely to be corrosive to the skin. That is, the chemical is a strong acid (pH less than or equal to 2) or base (pH greater than or equal to 11.5), and has high buffering capacity (if relevant).


Information that demonstrates that the chemical is a high molecular weight polymer that has:

  • less than 5% by mass of molecules with molecular weight less than 1,000 g/mol and
  • less than 2% by mass of molecules with molecular weight less than 500 g/mol

Both of the following apply:

  • The chemical is included in the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion.
  • The human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

Both of the following apply:

  • The chemical has been notified to the US FDA GRAS notification program and the FDA had no questions about the notifier’s conclusion of GRAS status.
  • The human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

Both of the following apply:

  • The chemical is permitted to be used as a food additive according to Schedule 15 of the Australia New Zealand Food Standards Code - Standard 1.3.1 - Food Additives.
  • The human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

Information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation.


A test result from at least 1 in vivo study on the chemical or from suitable read across information (as detailed below) with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available):

  • conducted following an acceptable test guideline for acute oral toxicity with an LD50 greater than 300 mg/kg bw or
  • conducted following an acceptable test guideline for acute dermal toxicity with an LD50 greater than 1,000 mg/kg bw or
  • conducted following an acceptable test guideline for acute inhalation toxicity, with an LC50:
    • for gases - greater than 2,500 ppmV/4h 
    • for vapours - greater than 10 mg/L/4h 
    • for dusts/mists/fumes - greater than 1 mg/L/4h

Test results from an in vivo study via the oral route on the chemical or from suitable read across information (conducted following an acceptable test guideline for subacute oral toxicity) with a NOAEL greater than or equal to 1,000 mg/kg bw/day.

Question 22

This question refers to hazard band B. Does the definition of ‘specific target organ toxicity after repeated exposure’ apply to your chemical? You can refer to Part 6.16.1 of the Categorisation Guidelines.

Question 23

This question refers to the ‘specific target organ toxicity after repeated exposure’ hazard characteristic in hazard band B. What is the human health categorisation volume (HHCV) of your introduction?

Question 24

This question refers to the ‘specific target organ toxicity after repeated exposure’ hazard characteristic in hazard band B. Do any of the following apply to your chemical? You can also refer to part 6.16.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be medium to high.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘specific target organ toxicity after repeated exposure’ hazard characteristic in hazard band B.

Both of the following apply:

  • The chemical is included in the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion.
  • The human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

Both of the following apply:

  • The chemical has been notified to the US FDA GRAS notification program and the FDA had no questions about the notifier’s conclusion of GRAS status.
  • The human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

Both of the following apply:

  • The chemical is permitted to be used as a food additive according to Schedule 15 of the Australia New Zealand Food Standards Code - Standard 1.3.1 - Food Additives.
  • The human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

Information demonstrating that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation.


Information demonstrating the chemical is a high molecular weight polymer that does not have the skin corrosion hazard characteristic.


A test result from at least 1 in vivo study on the chemical or from suitable read across information (as detailed below) with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available):

  • Conducted following an acceptable test guideline for subacute oral toxicity, in which the NOAEL (oral) is greater than or equal to 300 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced.
  • Conducted following an acceptable test guideline for subchronic oral toxicity, in which the NOAEL (oral) is greater than or equal to 100 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced.
  • Conducted following an acceptable test guideline for subacute dermal toxicity, in which the NOAEL (dermal) is greater than or equal to 600 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced.
  • Conducted following an acceptable test guideline for subchronic dermal toxicity, in which the NOAEL (dermal) is greater than or equal to 200 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced.
  • Conducted following an acceptable test guideline for subacute inhalation toxicity, in which there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or the NOAEC (inhalation) is:
    • for gases - greater than or equal to 750 ppmV/6 h/day
    • for vapours - greater than or equal to 3 mg/L/6 h/day
    • for dusts/mists/fumes - greater than or equal to 0.6 mg/L/6 h/day
  • Conducted following an acceptable test guideline for subchronic inhalation toxicity, in which there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or the NOAEC (inhalation) is: 
    • for gases - greater than or equal to 250 ppmV/6 h/day
    • for vapours - greater than or equal to 1 mg/L/6 h/day
    • for dusts/mists/fumes - greater than or equal to 0.2 mg/L/6 h/day.

Question 25

Do you want to find out if your introduction could have a very low indicative human health risk?

Question 26

Question 25

This question relates to the genetic toxicity hazard characteristic in hazard band C. Is your chemical a high molecular weight polymer, and do you have:

  • test results from an in vitro study on the polymer or from suitable read across information (conducted following an acceptable test guideline for gene mutation) demonstrating the absence of mutagenic effects?

Question 27

Question 27

Question 26

Question 26

This question refers to hazard band A. Does the definition of ‘high molecular weight polymer that has lung overloading potential’ apply to your chemical? You can refer to Part 6.17.1 of the Categorisation Guidelines.

Question 28

Question 28

Question 27

Question 27

This question relates to the ‘high molecular weight polymer that has lung overloading potential’ hazard characteristic in hazard band A. Do any of the following apply to your chemical? You can also refer to Part 6.17.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be low.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘high molecular weight polymer that has lung overloading potential’ hazard characteristic in hazard band A.

The chemical is not a polymer.


Molecular weight information demonstrating the number average molecular weight of the polymer is less than or equal to 70,000 g/mol.


Information demonstrating the polymer has a solubility in water greater than or equal to 0.1 mg/L measured following an acceptable test guideline for water solubility.


Information demonstrating the polymer does not become aerosolised during end use.

Question 29

Question 28

This question refers to hazard band A. Does the definition of ‘aspiration hazard’ apply to your chemical? You can also refer to Part 6.18.1 of the Categorisation Guidelines.

Question 30

Question 30

Question 29

Question 29

This question refers to hazard band A. Is the chemical a hydrocarbon?

Question 31

Question 30

Do you have test results that measured the kinematic viscosity of the chemical to be greater than 20.5mm2/s at 40 degrees celsius?

Question 32

Question 31

Question 31

Question 30

This question refers to hazard band A. Does the definition of ‘specific target organ toxicity after a single exposure (harmful or transient effects)’ apply to your chemical? You can refer to Part 6.19.1 of the Categorisation Guidelines.

Question 33

Question 33

Question 32

Question 32

Question 31

Question 31

Question 32

Question 32

This question refers to hazard band A. Does the definition of ‘skin irritation’ apply to your chemical? You can refer to Part 6.20.1 of the Categorisation Guidelines.

Question 34

Question 34

Question 33

Question 33

Question 33

Question 33

Question 32

Question 32

This question refers to the ‘skin irritation’ hazard characteristic in hazard band A. Do any of the following apply to your chemical? 

You can also refer to Part 6.20.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be low.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘skin irritation’ hazard characteristic in hazard band A.

Test results from an in vitro study on the chemical or from suitable read across information (conducted following an acceptable test guideline for skin irritation) with a non-irritant prediction. 


Test results from an in vivo study on the chemical or from suitable read across information (conducted following an acceptable test guideline for skin irritation) which does not result in skin reactions (as described for skin irritation in chapter 3.2 of the GHS).


Test results from an in vivo study on the chemical or from suitable read across information (conducted following an acceptable test guideline for acute dermal toxicity) that when tested at 2,000 mg/kg bw/day is not irritating to the skin.

Question 35

Question 34

Question 34

Question 33

This question refers to hazard band A. Does the definition of ‘eye irritation’ apply to your chemical? You can refer to Part 6.21.1 of the Categorisation Guidelines.

Question 36

Question 36

Question 35

Question 35

Question 35

Question 35

Question 34

Question 34

This question refers to the ‘eye irritation’ hazard characteristic in hazard band A. Do any of the following apply to your chemical? 

You can also refer to Part 6.21.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be low.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘eye irritation’ hazard characteristic in hazard band A.

Test results from an in vitro study on the chemical or from suitable read across information (conducted following an acceptable test guideline for eye damage or eye irritation) with a non-irritant prediction.


Test results from an in vivo study on the chemical or from suitable read across information (conducted following an acceptable test guideline for eye irritation) which does not result in changes in the eyes (as described for eye irritation [category 2] in chapter 3.3 of the GHS).

Question 37

Question 36

Question 36

Question 35

This question refers to hazard band A. Does the definition of ‘acute toxicity (harmful)’ apply to your chemical? You can refer to Part 6.22.1 of the Categorisation Guidelines.

Question 38

Question 38

Question 37

Question 37

Question 37

Question 37

Question 36

Question 36

This question refers to the ‘acute toxicity (harmful)’ hazard characteristic in hazard band A. Do any of the following apply to your chemical?

You can refer to Part 6.22.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be low.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘acute toxicity (harmful)’ hazard characteristic in hazard band A.

Information demonstrating the chemical is a high molecular weight polymer that has:

  • less than 5% by mass of molecules with molecular weight less than 1,000 g/mol, and
  • less than 2% by mass of molecules with molecular weight less than 500 g/mol 

Both of the following apply:

  • The chemical is included in the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion.
  • The human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

Both of the following apply:

  • The chemical has been notified to the US FDA GRAS notification program and the FDA had no questions about the notifier’s conclusion of GRAS status.
  • The human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

Both of the following apply:

  • The chemical is permitted to be used as a food additive according to Schedule 15 of the Australia New Zealand Food Standards Code - Standard 1.3.1 - Food Additives.
  • The human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

Information demonstrating the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation.


A test result from at least 1 in vivo study on the chemical or from suitable read across information (as detailed below) with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available):

  • conducted following an acceptable test guideline for acute oral toxicity with an LD50 greater than 2,000 mg/kg bw or
  • conducted following an acceptable test guideline for acute dermal toxicity with an LD50 greater than 2,000 mg/kg bw or
  • conducted following an acceptable test guideline for acute inhalation toxicity with an LC50:
    • for gases - greater than 20,000 ppmV/4h or 
    • for vapours - greater than 20 mg/L/4h or 
    • for dusts/mists/fumes - greater than 5 mg/L/4h

Test results from an in vivo study on the chemical or from suitable read across information (conducted following an acceptable test guideline for subacute oral toxicity) with a NOAEL greater than or equal to 1,000 mg/kg bw/day.

Your introduction's indicative human health risk is medium to high and is in the assessed category. This means that you must apply for an assessment certificate before you can introduce your chemical. To work out which type of certificate you need to apply for, you must continue and work out your introduction's indicative risk to the environment.

Go to Decision tool – Work out your environment exposure band.

Your introduction's indicative human health risk is low. Make a note of this outcome.

Go to Decision tool – Work out your environment exposure band.

Your introduction’s indicative human health risk is very low. Make a note of this outcome.

Go to Decision tool – Work out your environment exposure band.

Was this page helpful?
For broken links or technical issues, please provide as much detail as possible. Do not include your name, email address and other personal or commercially sensitive information.

Keep informed with updates