Guide to categorising your chemical importation and manufacture

Explore our categorisation tool for help on this subject

Are you introducing a chemical with an end use in TATTOO INKS or PERSONAL VAPORISERS? If you are, your introduction is automatically in exposure band 4 for human health — go to Step 4.4: Work out your human health hazard characteristics.

Use this guidance to calculate your introduction's human health categorisation volume.

Instructions

• We've included the equations to use and the options you have to choose from, dependent on the scenarios of your introduction.
• You can adopt a simple method or a more detailed method (which can result in a lower introduction volume than the simpler method).
• Once you have worked out your human health categorisation volume, you can complete step 4.3.

When you need to work out a HHCV for your chemical

You need to do this if you want to use an exposure band scenario in step 4.3 that includes HHCV as part of the criteria. This could be if you introduce and use the chemical at relatively high concentrations (> 1%).

When you do not need to work out a HHCV for your chemical

You don’t need to work out a HHCV if:

• you want to use an exposure band scenario in step 4.3 that does not include HHCV as part of the criteria. This could be if the concentration of your chemical when it’s introduced and during its end use is low (concentrations ≤1% or concentrations <0.1%, depending on the exposure band scenario that applies)
• it has an end use in tattoo inks or personal vaporisers

Methods you can use to work out a HHCV for your chemical

There are 2 ways to work out the human health categorisation volume.

Method 1: Simplest approach

Use this method if you want an easy way to work out your human health exposure band.

HHCV calculation for this approach

The HHCV is your chemical’s total introduction volume in a registration year for all end uses.

Method 2: More detailed approach

Use this method if you want a more refined human health categorisation volume. Using this method could result in an HHCV that is lower than the total introduction volume in a year. This could mean that your introduction ends up being in a lower human health exposure band than if the total introduction volume (method 1) had been used.

The calculation of the HHCV using method 2 is different depending on whether your chemical introduction has only 1 end use or more than 1 end use.

If your introduction has 1 end use

For a chemical with only 1 end use, calculate the HHCV by multiplying the introduction volume (IV) by the exposure reduction factor (ERF) for your chemical’s end use scenario:

Equation (1): HHCV = IV x ERF

The introduction volume you should use in your calculation is the total introduction volume in a registration year. Use the exposure reduction factor that applies to your end use scenario (see Table for ERFs for different end uses).

The ERF values range between 0 and 1. A low exposure reduction factor indicates that only a small portion of the introduction volume is likely to contribute to human exposure. A higher exposure reduction factor indicates that a higher proportion of the introduction volume could contribute to human exposure.

Exposure reduction factors (ERFs) for different end use scenarios

Note *Specified consumer products means any of the following products:

• cosmetics
• nasal sprays
• ear sprays
• intimate lubricants
• massage oils and gels
• products applied to the nails to harden, or deter the biting of, nails

Specified consumer products do not include tattoo inks and personal vaporisers. If your chemical has an end use in tattoo inks or personal vaporisers, its introduction will be in human health exposure band 4 and you do not need to calculate a HHCV for it.

If your introduction has more than 1 end use

You can choose from 2 options to calculate the HHCV where your chemical has more than one end use

Option 1: Simplest approach

Use this option if:

• you do not know the annual introduction volume of your chemical for each end use
• you want to simplify the process of working out your human health exposure band but still want a more refined human health categorisation volume

HHCV calculation for this approach

Allocate the total introduction volume to the end use scenario that has the highest exposure reduction factor (from the table), and use Equation (1) to calculate the HHCV. Note: do not just use the volume for one of the end uses.

Option 2: More detailed approach

Use option 2 if:

• you know the annual introduction volume of your chemical for each end use
• you are willing to keep track of any changes to your introduction volume for each end use. This is needed to make sure that the indicative human health risk of your introduction does not increase.

HHCV calculation for this approach

Calculate a separate human health categorisation volume for each of your end uses. Use the exposure reduction factor for the end use (from the table), and the volume that you will be introducing for that end use. Do this for all of your end uses and then add them up to get your total human health categorisation volume (use equation (2) below).

HHCV = (IV1 x ERF1) + (IV2 x ERF2) +… + (IVn x ERFn)

Note: IVn = the introduction volume for end use ‘n’

ERFn = the exposure reduction factor (ERF) for end use ‘n’.

Go back to step 4.3

Human health hazard characteristics are split into hazard bands. Hazard characteristics of most concern are in hazard band C, while those of lower concern are in hazard band A. 

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

• carcinogenicity
• reproductive toxicity
• developmental toxicity
• adverse effects mediated by an endocrine mode of action 
• genetic toxicity

Instructions

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 human health hazard band is C. Move on to the next step - step 4.5 Work out your human health 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 human health hazard band is C. Move onto the next step – step 4.5 Work out your human health 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 human health hazard band B. This depends on the exposure band of your introduction. 

If your introduction is in human health exposure band 1 or 2, stop here - you don’t need to consider any other hazard characteristics. Next go to step 4.5 to work out your human health risk for categorisation.

If your introduction is in human health exposure band 3 you can choose to stop (and go to step 4.5 to work out your human health risk for categorisation), or to continue to human health hazard band B and then A. 

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

Carcinogenicity

Carcinogenicity means that any of the following apply to the industrial chemical: 

• the chemical is a known, presumed or suspected human carcinogen, as described in chapter 3.6 of the GHS, with the chemical classified as carcinogenicity (category 1 or 2), or 
• the chemical (or the chemical of which it is an ester or salt) is on the list of chemicals with high hazards for categorisation based on its carcinogenicity, or
• an in vivo study on the chemical conducted following an acceptable test guideline for carcinogenicity, chronic toxicity, subchronic oral toxicity, subchronic dermal toxicity or subchronic inhalation toxicity results in the induction of cancer, or an increase in the incidence of cancer. 

Information required to demonstrate the absence of the hazard characteristic, carcinogenicity  

• Confirmation that the chemical (or the chemical of which it is an ester or salt) is not on the list of chemicals with high hazards for categorisation, based on its carcinogenicity.
• In addition, if the human health exposure band for the introduction is 4 and the chemical is a UV filter, information is required to justify why the chemical would not cause carcinogenicity mediated by exposure to UV light. This may include one or more of the following:
  • the chemical has a molar extinction/absorption coefficient of less than 1,000Lmol-1cm-1 at wavelengths between 290 and 700nm (based on the results of a study following OECD test guideline 101), or 
  • results from in vitro phototoxicity studies, or 
  • results from in vivo carcinogenicity studies where the methods have been modified to include photoactivation. 

Human health hazard characteristics are split into hazard bands. Hazard characteristics of most concern are in hazard band C, while those of lower concern are in hazard band A. You must always start at hazard band C. Step 4.4 tells you when you can stop working through your chemical's human health hazard characteristics and when you need to check each of them - ie C, B and A.

Hazard band B has 9 hazard characteristics you need to consider:

• High molecular weight polymer that is water absorbing
• Respiratory sensitisation
• Corrosive to the respiratory tract
• Specific target organ toxicity and a single exposure (significant toxicity)
• Skin corrosion
• Eye damage
• Skin sensitisation
• Acute toxicity (fatal or toxic)
• Specific target organ toxicity after repeated exposure

Instructions

You must always start at hazard band C. 

You only need to work through the hazard characteristics on this page if your introduction is in: 

• human health exposure band 3, and you are trying to get to an outcome of very low indicative human health risk or 
• human health exposure band 4, and you are trying to get to an outcome of low or very low indicative human health 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 human health hazard band is B. Move on to the next step - step 4.5 Work out your human health 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 human health hazard band is B. Move onto the next step – step 4.5 Work out your human health 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 human health hazard band A This depends on the exposure band of your introduction. 

If your introduction is in human health exposure band 3, continue to human health hazard band A. 

If your introduction is in human health exposure band 4, you can choose to stop (and go to step 4.5 to work out your human health risk for categorisation), or continue to human health hazard band A.

High molecular weight polymer that is water absorbing

High molecular weight polymer that is water absorbing means that all of the following apply to the industrial chemical: 

• it is a high molecular weight polymer, and 
• it has a number average molecular weight that is greater than or equal to 10,000 g/mol, and 
• it is capable of absorbing its own weight, or more, in water, and 
• it contains particles with a particle size less than 10 micrometres (microns).

Information required to demonstrate the absence of the hazard characteristic, high molecular weight polymer that is water absorbing 

If the chemical is a high molecular weight polymer, the information required to demonstrate that it does not have the hazard characteristic, high molecular weight polymer that is water absorbing, is at least one of: 

• molecular weight information that demonstrates the number average molecular weight (NAMW) is less than 10,000 g/mol, or 
• information that demonstrates that the polymer is not introduced in a particulate form, or 
• particle size information that demonstrates that the particle size is greater than or equal to 10 micrometres (microns), or
• information that demonstrates that the polymer does not absorb its own weight or more in water, such as experiments that show that it does not form a gel in water, or that if it does, the gel dissolves upon addition of more water.

Respiratory sensitisation

Respiratory sensitisation means that any of the following apply to the industrial chemical: 

• the chemical is known or presumed to produce hypersensitivity of the airways in humans, as described in chapter 3.4 of the GHS, with the chemical classified as respiratory sensitisation (category 1), or 
• the chemical is named: 
  • on the EU SVHC Candidate list for authorisation, based on respiratory sensitising properties (https://echa.europa.eu/candidate-list-table), or 
  • in the Danish EPA (Q)SAR Database as a predicted respiratory sensitiser (http://qsar.food.dtu.dk/), or 
  • the chemical is an enzyme, or 
  • the chemical is a polymer that contains one or more free isocyanate groups, or 
  • an in vivo study on the chemical indicates hypersensitivity of the airways, as discussed in chapter 3.4 of the GHS, or 
  • an in vitro study on the chemical: 
    • indicates hypersensitivity of the airways, as discussed in chapter 3.4 of the GHS, and 
    • the result of the study has not been negated by in vivo studies conducted on the chemical for hypersensitivity of the airways.

Information required to demonstrate the absence of the hazard characteristic, respiratory sensitisation  

There are no information requirements to demonstrate the absence of the hazard characteristic, respiratory sensitisation. If you do not have any information that demonstrates that the chemical has this hazard characteristic then you can assume it does not for the purposes of categorisation.

Corrosive to the respiratory tract

Corrosive to the respiratory tract means that any of the following apply to the industrial chemical: 

• the chemical is known to cause destruction of the respiratory tract tissue, as described in chapter 3.1 of the GHS, with the chemical classified as corrosive to the respiratory tract (AUH071 - non-GHS hazard statement), or 
• an in vivo study on the chemical conducted following an acceptable test guideline for acute inhalation toxicity, subacute inhalation toxicity or subchronic inhalation toxicity results in destruction of the respiratory tract, as described in chapter 3.1 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, corrosive to the respiratory tract  

There are no information requirements to demonstrate the absence of the hazard characteristic, corrosive to the respiratory tract. If you do not have any information that demonstrates that the chemical has this hazard characteristic, then you can assume it does not for the purposes of categorisation.

Specific target organ toxicity after a single exposure (significant toxicity)

Specific target organ toxicity after a single exposure (significant toxicity) means that any of the following apply to the industrial chemical: 

• the chemical is known or presumed to produce significant toxicity in humans, as described in chapter 3.8 of the GHS, with the chemical classified as specific target organ toxicity – single exposure (category 1), or 
• an in vivo study on the chemical: 
  • conducted following an acceptable test guideline for acute oral toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at less than or equal to 300 mg/kg bw, or 
  • conducted following an acceptable test guideline for acute dermal toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at less than or equal to 1,000 mg/kg bw, or
  • conducted following an acceptable test guideline for acute inhalation toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS:
    • gases - less than or equal to 2,500 ppmV/4h, or 
    • vapours -  less than or equal to mg/L/4h, or 
    • for dusts/mists/fumes - less than or equal to 1 mg/L/4h.

Information required to demonstrate the absence of the hazard characteristic, specific target organ toxicity after a single exposure (significant toxicity) 

There are no information requirements to demonstrate the absence of the hazard characteristic, specific target organ toxicity after a single exposure (significant toxicity). If you do not have any information that demonstrates that the chemical has this hazard characteristic, then you can assume it does not for the purposes of categorisation.
 

Skin corrosion

Skin corrosion means that any of the following apply to the industrial chemical: 

• the chemical is known to produce irreversible damage to the skin, as described in chapter 3.2 of the GHS, with the chemical classified as skin corrosion (category 1), or 
• an in vitro study on the chemical conducted following an acceptable test guideline for skin corrosion results in the prediction of skin corrosion effects, or 
• an in vivo study on the chemical conducted following an acceptable test guideline for skin irritation results in destruction of skin tissue, as described for skin corrosion in chapter 3.2 of the GHS, or 
• the chemical is a pyrophoric liquid or a pyrophoric solid, as described in chapters 2.9 and 2.10 of the GHS respectively. 

Information required to demonstrate the absence of the hazard characteristic, skin corrosion  

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

• information that demonstrates that the chemical is a high molecular weight polymer that does not contain any of the following reactive functional groups: 
  • anhydride, or
  • epoxide, or 
  • sulfonic acid, or 
  • amine, or 
• information that demonstrates that the chemical is a high molecular weight polymer that contains any of the following reactive functional groups and the polymer has a combined functional group equivalent weight of greater than or equal to 1,000 g/mol: 
  • anhydride, or 
  • epoxide, or 
  • sulfonic acid, or 
  • amine, or 
• if the human health exposure band for the introduction is 3 - a suitable in silico prediction indicating that the chemical is not irritating to skin or has no alerting groups for skin irritation, or 
• 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, or 
• 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, or 
• 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.

Eye damage

Eye damage means that any of the following apply to the industrial chemical: 

• the chemical is known to produce serious eye damage, as described in chapter 3.3 of the GHS, with the chemical classified as eye damage (category 1), or 
• an in vitro study on the chemical conducted following an acceptable test guideline for eye damage results in the prediction of serious eye damage effects, or 
• an in vivo study on the chemical conducted following an acceptable test guideline for eye irritation results in effects on the eye, as described for serious eye damage in chapter 3.3 of the GHS, or 
• the chemical is a pyrophoric liquid or a pyrophoric solid, as described in chapters 2.9 and 2.10 of the GHS, respectively. 

Information required to demonstrate the absence of the hazard characteristic, eye damage 

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

• information that demonstrates that the chemical is a high molecular weight polymer that does not contain any of the following reactive functional groups: 
  • anhydride, or 
  • epoxide, or 
  • sulfonic acid, or 
  • amine, or
• information that demonstrates that 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, or 
  • epoxide, or 
  • sulfonic acid, or 
  • amine, or 
• if the human health exposure band for the introduction is 3 - a suitable in silico prediction indicating that the chemical is not irritating to the eye, or 
• 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, which predicts 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.

Skin sensitisation 

Skin sensitisation means that any of the following apply to the industrial chemical: 

• the chemical is known to cause an allergic response following skin contact, as described in chapter 3.4 of the GHS, with the chemical classified as skin sensitisation (category 1), or 
• human testing or epidemiological studies on the chemical result in evidence of an allergic response, as described in chapter 3.4 of the GHS, or 
• an in vitro study on the chemical: 
  • conducted following an acceptable test guideline for skin sensitisation, results in the prediction of skin sensitisation effects, and 
  • the results of the study have not been negated by in vivo studies conducted on the chemical for skin sensitisation, or 
• an in chemico study on the chemical: 
  • conducted following an acceptable test guideline for skin sensitisation, results in the prediction of skin sensitisation effects, and 
  • the results of the study have not been negated by in vivo studies conducted on the chemical for skin sensitisation, or 
• an in vivo study on the chemical conducted following an acceptable test guideline for skin sensitisation, results in the induction of an allergic response, as described in chapter 3.4 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, skin sensitisation  

• There are no information requirements to demonstrate the absence of the hazard characteristic, skin sensitisation, if the chemical is corrosive to the skin (GHS category 1) as the in vivo tests cannot be conducted 
• otherwise, the information required to demonstrate that a chemical does not have the hazard characteristic, skin sensitisation, is at least one of the following:  
  • information that demonstrates that the chemical is a high molecular weight polymer for which at least one of the following: 
    • contains only low concern reactive functional groups, or 
    • contains only low concern reactive functional groups and unsubstituted positions ortho and para to phenolic hydroxyl groups, or  
    • contains only reactive functional groups it contains are unsubstituted positions ortho and para to phenolic hydroxyl groups, or 
    • contains only low and moderate concern reactive functional groups , with a combined functional group equivalent weight of greater than or equal to 1000 g/mol, or 
    • it contains only moderate concern reactive functional groups, with a combined functional group equivalent weight of greater than or equal to 1000 g/mol, or 
    • has 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, and 
      • less than 5% by mass of molecules with molecular weight that is less than 1,000 g/mol, or 
  • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V, of the REACH Regulation, or 
  • if the human health exposure band is 3 - all of the following: 
    • suitable in silico prediction indicating that the chemical and its metabolites (if any) do not cause skin sensitisation, and 
    • 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, and 
    • 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, or 
  • all of the following: 
    • 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, and 
    • 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, and 
    • 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 
• in addition, if the human health exposure band for the introduction is 4 and the chemical is a UV filter or is introduced for an end use in a tattoo ink, information is required to justify why the chemical would not cause skin sensitisation mediated by UV light. This may include one or more of the following : 
  • the chemical has a molar extinction coefficient/absorption coefficient of less than or equal to 1,000Lmol-¹cm-¹ at wavelengths between 290 and 700nm (based on the results of a study following OECD test guideline 101), or 
  • results from in vitro phototoxicity studies, or 
  • results from in vitro or in vivo skin sensitisation studies where the methods have been modified to include photoactivation.

Low concern reactive functional groups - see our polymer of low concern criteria page.

Moderate concern reactive functional groups - see our polymer of low concern criteria page. 

Acute toxicity (fatal or toxic) 

Acute toxicity (fatal or toxic) means that any of the following apply to the industrial chemical: 

• the chemical is known to exhibit acute toxicity effects, as described in chapter 3.1 of the GHS, with the chemical classified as acute toxicity (category 1 or 2 or 3), or
• an in vitro study on the chemical: 
  • conducted following an acceptable test guideline for acute oral toxicity, results in a predicted acute oral toxicity LD50 value of less than or equal to 300 mg/kg bw, and 
  • the results of the study have not been negated by in vivo studies conducted on the chemical for acute toxicity, or 
• an in vivo study on the chemical: 
  • conducted following an acceptable test guideline for acute oral toxicity results in an acute oral LD50 value of less than or equal to 300 mg/kg bw, or 
  • conducted following an acceptable test guideline for acute dermal toxicity results in an acute dermal LD50 value of less than or equal to 1,000 mg/kg bw, or 
  • conducted following an acceptable test guideline for acute inhalation toxicity results in an acute inhalation LC50 value of:
    • for gases - less than or equal to 2,500 ppmV/4h, or 
    • for vapours - less than or equal to 10 mg/L/4h, or 
    • for dusts/mists/fumes - less than equal to 1 mg/L/4h , or 
• evidence in humans of systemic toxicity after eye contact, with the chemical classified with the non-GHS hazard statement – AUH070, or 
• an in vivo study, conducted following an acceptable test guideline for eye irritation, results in overt signs of systemic toxicity or mortality, which is likely to be attributed to absorption of the chemical through the mucous membranes of the eye, with the chemical classified with the non-GHS hazard statement – AUH070.

Information required to demonstrate the absence of the hazard characteristic, acute toxicity (fatal or toxic) 

• there are no information requirements to demonstrate the absence of the hazard characteristic, acute toxicity (fatal or toxic), if 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 2.0) or base (pH greater than or equal to 11.5), and has high buffering capacity (if relevant)), as the in vivo tests cannot be conducted
• if the chemical is for end use in a personal vaporiser - the information required to demonstrate that the chemical does not have the hazard characteristic, acute toxicity (fatal or toxic), is a test result from at least one in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for acute inhalation toxicity with an LC50: 
  • for gases -  greater than 2,500 ppmV/4h, or 
  • for vapours - greater than 10 mg/L/4h, or 
  • for dusts/mists/fumes - greater than 1 mg/L/4h, or 
• otherwise, the information required to demonstrate that a chemical does not have the hazard characteristic, acute toxicity (fatal or toxic), is at least one of the following: 
  • if the human health exposure band for the introduction is 3 - both of the following: 
    • a suitable in silico prediction for acute toxicity (LD50) of the chemical of greater than 2,000 mg/kg bw/day, and 
    • test results from an in vitro study on the chemical or from suitable read across information for acute toxicity (LD50), conducted following an acceptable test guideline for acute oral toxicity, of greater than 300 mg/kg bw,  or 
  • 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, or 
  • inclusion of the chemical in the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
  • the chemical has been notified to the US FDA GRAS notification program and FDA had no questions about the notifier’s conclusion of GRAS status, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
  • 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, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
  • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or 
  • a test result from at least one 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, or
      • for vapours - greater than 10 mg/L/4h, or 
      • for dusts/mists/fumes - greater than 1 mg/L/4h, or 
  • 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.

Human health hazard characteristics are split into hazard bands. Hazard characteristics of most concern are in hazard band C, while those of lower concern are in hazard band A. 

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

• 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)

Instructions

You must always start at hazard band C. You only need to work through the hazard characteristics on this page if your introduction is in: 

• human health exposure band 3, and you are trying to get to an outcome of very low indicative human health risk or 
• human health exposure band 4, and you are trying to get to an outcome of very low indicative human health 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 human health hazard band is A.

Move on to the next step - step 4.5 Work out your human health 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 human health hazard band is A.

Move onto the next step – step 4.5 Work out your human health 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 4.5 to work out your human health risk for categorisation).

High molecular weight polymer that has lung overloading potential

High molecular weight polymer that has lung overloading potential means that all of the following apply to the industrial chemical: 

• it is a polymer, and 
• it has a number average molecular weight that is greater than 70,000 g/mol, and 
• it has a solubility in water of less than 0.1 mg/L, and 
• it becomes aerosolised during end use.

Information required to demonstrate the absence of the hazard characteristic, high molecular weight polymer that has lung overloading potential  

If the chemical is a polymer, the information required to demonstrate that a chemical does not have the hazard characteristic, high molecular weight polymer that has lung overloading potential, is at least one of the following: 

• molecular weight information that demonstrates that the number average molecular weight is less than or equal to 70,000 g/mol, or 
• information that demonstrates that the polymer has a solubility in water that is greater than or equal to 0.1 mg/L measured following an acceptable test guideline for water solubility, or 
• information that demonstrates that the polymer does not become aerosolised during end use

Aspiration hazard

Aspiration hazard means that any of the following apply to the industrial chemical:

• the chemical is known or presumed to cause aspiration toxicity, as described in chapter 3.10 of the GHS, with the chemical classified as may be fatal if swallowed and enters airways (category 1), or 
• the chemical is a hydrocarbon that has a kinematic viscosity less than or equal to 20.5 mm2/s, measured at 40°C.

Information required to demonstrate the absence of the hazard characteristic, aspiration hazard  

• If the chemical is a hydrocarbon, the information required to demonstrate the absence of the hazard characteristic, aspiration hazard, is a measured kinematic viscosity greater than a20.5 mm2/s, at 40°C 
• Otherwise, there are no information requirements to demonstrate the absence of the hazard characteristic, aspiration hazard. If you do not have any information that demonstrates that the chemical has this hazard characteristic, then you can assume it does not for the purposes of categorisation.

Specific target organ toxicity after a single exposure (harmful or transient effects)

Specific target organ toxicity after a single exposure (harmful or transient effects) means that any of the following apply to the industrial chemical: 

• the chemical is known or presumed to be harmful to humans or to cause transient target organ effects, as described in chapter 3.8 of the GHS, with the chemical classified as specific target organ toxicity-single exposure (category 2 or 3), or 
• an in vivo study on the chemical: 
  • conducted following an acceptable test guideline for acute oral toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at greater than 300 but less than or equal to 2,000 mg/kg bw, or 
  • conducted following an acceptable test guideline for acute dermal toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at greater than 1,000 but less than or equal to 2,000 mg/kg bw, or 
  • conducted following an acceptable test guideline for acute inhalation toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at: 
    • for gases -  greater than 2,500 but less than or equal to 20,000 ppmV/4h, or 
    • for vapours -  greater than 10 but less than or equal to 20 mg/L/4h, or 
    • for dusts/mists/fumes -  greater than 1 but less than or equal to 5 mg/L/4h.

Information required to demonstrate the absence of the hazard characteristic, specific target organ toxicity after a single exposure (harmful or transient effects)  

There are no information requirements to demonstrate the absence of the hazard characteristic, specific target organ toxicity after a single exposure (harmful or transient effects). If you do not have any information that demonstrates that the chemical has this hazard characteristic, then you can assume it does not for the purposes of categorisation. 

Skin irritation 

Skin irritation means that any of the following apply to the industrial chemical: 

• the chemical is known to produce reversible damage to the skin, as described in chapter 3.2 of the GHS, with the chemical classified as skin irritation (category 2), or 
• an in vitro study on the chemical conducted following an acceptable test guideline for skin irritation results in the prediction of skin irritation effects, or 
• an in vivo study on the chemical conducted following an acceptable test guideline for skin irritation results in skin reactions, as described for skin irritation (category 2) in chapter 3.2 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, skin irritation  

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

• if the human health exposure band for the introduction is 3 - a suitable in silico prediction indicating that the chemical is not irritating to the skin, or 
• 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, or 
• 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, or 
• 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.

In addition, if the chemical is introduced for an end use in a tattoo ink, information is required to justify why the chemical would not cause skin irritation mediated by UV light. This may include one or more of the following: 

• the chemical has a molar extinction coefficient/absorption coefficient of less than 1,000Lmol^-1cm^-1 at wavelengths between 290 and 700nm (based on the results of a study following OECD test guideline 101), or 
• results from in vitro phototoxicity studies, or  
• results from in vitro or in vivo irritation studies where the methods have been modified to include photoactivation.

Eye irritation

Eye irritation means that any of the following apply to the industrial chemical: 

• the chemical is known to produce changes in the eye, as described in chapter 3.3 of the GHS, with the chemical classified as eye irritation (category 2), or 
• an in vitro study on the chemical conducted following an acceptable test guideline for eye irritation results in the prediction of eye irritation effects, or 
• an in vivo study on the chemical conducted following an acceptable test guideline for eye irritation results in changes in the eye, as described for eye irritation in chapter 3.3 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, eye irritation  

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

• if the human health exposure band for the introduction is 3 - a suitable in silico prediction indicating that the chemical is not irritating to the eyes, or 
• 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, or 
• 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. 

Acute toxicity (harmful) 

Acute toxicity (harmful) means that any of the following apply to the industrial chemical: 

• the chemical is known to exhibit acute toxicity effects, as described in chapter 3.1 of the GHS, with the chemical classified as acute toxicity (category 4), or 
• an in vitro study on the chemical: 
  • conducted following an acceptable test guideline for acute oral toxicity, results in a predicted acute toxicity LD50 value of greater than 300 but less than or equal to 2,000 mg/kg bw, and 
  • the results of the study have not been negated by in vivo studies conducted on the chemical for acute toxicity, or 
• an in vivo study on the chemical: 
  • conducted following an acceptable test guideline for acute oral toxicity results in an acute oral LD50 value of greater than 300 but less than or equal to 2,000 mg/kg bw, or 
  • conducted following an acceptable test guideline for acute dermal toxicity results in an acute dermal LD50 value of greater than 1,000 but less than or equal to 2,000 mg/kg bw, or 
  • conducted following an acceptable test guideline for acute inhalation toxicity results in an acute inhalation LC50 value of: 
    • for gases -  greater than 2500 but less than or equal to 20,000 ppmV/4h, or 
    • for vapours - greater than 10 but less than or equal to 20 mg/L/4h, or 
    • for dusts/mists/fumes - greater than 1 but less than or equal to 5 mg/L/4h.

Information required to demonstrate the absence of the hazard characteristic, acute toxicity (harmful)  

• if the chemical is for end use in a personal vaporiser - the information required to demonstrate that the chemical does not have the hazard characteristic, acute toxicity (harmful), is a test result from at least one in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for acute inhalation toxicity with an LC50 of: 
  • 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, or 
• otherwise, the information required to demonstrate that a chemical does not have the hazard characteristic, acute toxicity (harmful), is at least one of the following: 
  • if the human health exposure band for the introduction is 3 -  both of the following: 
    • a suitable in silico prediction for acute toxicity (LD50) of the chemical of greater than 2,000 mg/kg bw/day, and 
    • test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for acute oral toxicity, with a predicted LD50 of greater than 2,000 mg/kg bw, or 
  • information that demonstrates that the chemical is a high molecular weight polymer that has: 
    • less than 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 
  • inclusion of the chemical in the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
  • the chemical has been notified to the US FDA GRAS notification program and FDA had no questions about the notifier’s conclusion of GRAS status, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
  • 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, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
  • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or 
  • a test result from at least one 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, or
  • 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.

On this page:

• Instructions
• Methods you can use to work out an ECV for your chemical
• Table - release reduction factor (RRF) you need to work out ECV, depending on end use scenario
• Product definitions and examples from the RRF table

Explore our categorisation tool for help on this subject

Instructions

• Use this guidance to calculate your introduction's environment categorisation volume.
• We've included the equations to use and the options you have to choose from, dependent on the scenarios of your introduction.
• You can adopt a simple method or a more detailed method (which can result in a lower introduction volume than the simpler method).
• Once you have worked out your environment categorisation volume, you can complete step 5.3.

Methods you can use to work out an ECV for your chemical

There are 2 ways to work out the environment categorisation volume.

Method 1: Simplest approach

Use this method if you want an easy way to work out your environment exposure band.

ECV calculation for this approach

The ECV is your chemical’s total introduction volume in a registration year for all end uses.

Method 2: More detailed approach

Use this method if you want a more refined environment categorisation volume. Using this method could result in an ECV that is lower than the total introduction volume in a year. This could mean that your introduction ends up being in a lower environment exposure band than if the total introduction volume (method 1) had been used.

The calculation of the ECV using method 2 is different depending on whether your chemical introduction has 1 end use or more than 1 end use.

If your introduction has 1 end use

For a chemical with only 1 end use, calculate the ECV by multiplying the introduction volume (IV) by the release reduction factor (RRF) for your chemical’s end use scenario:

Equation (1): ECV = IV x RRF

The introduction volume you should use in your calculation is the total introduction volume in a registration year. Use the RRF that applies to your end use scenario (refer to our RRF table).

The RRF values range between 0 and 1. A low RRF indicates that only a small portion of the introduction volume is likely to contribute to environmental exposure. A higher RRF indicates that a higher proportion of the introduction volume could contribute to environmental exposure.

If your introduction has more than 1 end use

You can choose from 2 options to calculate the ECV where your chemical has more than 1 end use.

Option 1: Simplest approach

Use this option if:

• you do not know the annual introduction volume of your chemical for each end use
• you want to simplify the process of working out your environment exposure band but still want a more refined environment categorisation volume

ECV calculation for this approach

Allocate the total introduction volume to the end use scenario that has the highest RRF (refer to our RRF table, and use Equation (1) to calculate the ECV. Note: do not just use the volume for one of the end uses.

Option 2: More detailed approach

Use option 2 if:

• you know the annual introduction volume of your chemical for each end use
• you are willing to keep track of any changes to your introduction volume for each end use. This is needed to make sure that the indicative environment risk of your introduction does not increase

Calculate a separate environment categorisation volume for each of your end uses. Use the RRF for the end use (refer to our RRF table), and the volume that you will be introducing for that end use. Do this for all of your end uses and then add them up to get your total environment categorisation volume (use equation (2) below).

ECV = (IV1 x RRF1) + (IV2 x RRF2) +… + (IVn x RRFn)

Note: IVn = the introduction volume for end use ‘n’

RRFn = the release reduction factor (RRF) for end use ‘n’.

Table - Release reduction factor (RRF) you need to work out ECV, depending on end use scenario

Note, after this table, we've provided product definitions with examples.

Product definitions and examples from the RRF table

Adhesive and sealant products means an end use to fasten other materials together or stop the passage of liquid or gas. Examples include:

• glues 
• binders
• adhesives
• pastes
• sealants
• fillers
• putties
• solder and caulking compounds

Apparel and footwear care products means an end use to care for apparel and footwear products intended for consumer and commercial use. Examples include:

• footwear polishes
• waxes and stains to waterproof and improve appearance and other desirable properties
• apparel surface treatment products for water, stain or flame resistance

Arts, crafts and hobby products means an end use in arts, crafts or hobbies. Examples include:

• crafting paints
• crafting glue
• adhesives (e.g. solder and hot-melt adhesives)
• fixatives
• finishing spray coatings and modelling clay

Explosive products means an end use for producing a sudden expansion, usually accompanied by production of heat and large changes in pressure. Examples include:

• pyrotechnics
• high explosives and propellants
• igniters
• primers
• initiatory
• illuminants
• smoke and decoy flares
• incendiaries

Fuel, oil, fuel oil additives and related products means an end use as:

• liquid fuel in containers used for cooking, heating or for power in vehicles or appliances, or
• a fuel additive to inhibit corrosion, provide lubrication, increase efficiency of use, or decrease production of undesirable by-products.

Examples of liquid fuels include:

• gasoline
• diesel fuels
• kerosene
• lamp oils

Examples of fuel oil additives include:

• stabilisers
• anti-knock agents
• corrosion inhibitors
• detergents
• fuel dyes
• oxygenates
• antioxidants
• odour agents

Lubricant and grease products means an end use in a liquid, paste or spray to reduce friction, heat generation and wear between solid surfaces. Examples include:

• engine oils
• transmission, brake and hydraulic fluids
• gear oils
• calcium, sodium, lithium, and silicone-based greases

Personal care products – limited environmental release means an end use in solid or hardening personal care products (including cosmetics) that are primarily disposed of to landfill. Examples include:

• baby wipes
• facial tissues
• nail care products including nail polish and remover

Tattoo ink products means an end use in a combination of industrial chemicals that contains one or more colouring agents and is applied to the dermal layer of the skin for the purposes of colouring the skin. Examples include:

• pigments
• dyes
• resins

Paint and coating products means an end use to paint or coat substrates intended for consumer or commercial use. Examples include: 

• decorative coatings 
• automotive coatings
• transportation coatings
• wood finishes
• powder coatings
• coil coatings
• packaging finishes
• general industrial coatings
• automotive refinish
• industrial maintenance and protective coatings
• marine coatings
• thinners
• removers

Plastic and polymer products means an end use in production of plastics or polymers. Examples include:

• monomers
• initiators
• additives

Construction products not covered by other end uses means an end use in construction materials, except where another scenario covers the end use. Examples include:

• additives in cements and dry mortar
• additives to bitumen for road repair
• internal release agents for thermo-set laminating resins
• resins in particle board manufacture
• wood substitutes used to make mouldings
• resins used in the production of composite materials

Fabric, textile and leather products not covered by other end uses means an end use to impart colour and other desirable properties onto fabric, textiles, and leather products that are intended for consumer or commercial use.

These properties include:

• water/soil/stain repellence
• wrinkle resistance
• flame resistance

Examples of this type of product include:

• textile dyes
• textile finishing agents
• leather tanning products
• leather dyes
• leather finishing agents, leather conditioner and surface treatment products

Electronic products means an end use in the production of electronic components. Examples include:

• chemicals in vapour deposition
• electroless plating
• electroplating
• etching
• high vacuum evaporation/sputtering
• laminate processing
• soldering
• photolithography

Ink, toner and colourant products means an end use for:

• writing
• printing
• creating an image on paper and other substrates
• applying to substrates to change their colour or hide images

Examples of this type of product include:

• pigmented liquid
• toners or powders used in copy machines and toner/printer cartridges
• inks used in writing equipment
• inks for stamps and correction fluids and tapes

This category does not include pigments and colourants added to paints and coatings.

Air care products means an end use to odorise or deodorise indoor air in homes, offices, motor vehicles, and enclosed spaces and intended for consumer or commercial use. Examples include:

• aerosol sprays
• liquid/solid/gel diffusers
• air fresheners
• scented candles
• incense

Anti-freeze and de-icing products means an end use:

• as an additive to fluids, especially water, to reduce the freezing point of the mixture, or
• applied to surfaces to melt or prevent build-up of ice

Examples of this type of product include:

• anti-freeze liquids
• de-icing liquids (windshield de-icers, aircraft de-icers)
• de-icing solids (ice melting crystals)
• lock de-icers

Automotive care products means an end use (intended for consumer or commercial use) to clean and care for exterior and interior surfaces of automotive vehicles. Examples include:

• car waxes
• polishes
• waterproofing products for windshield or automotive window glass
• cleaners
• sealers
• car wash solutions
• vinyl/rubber/plastic protectants
• automotive carpet and upholstery cleaners
• wheel and tyre care products
• exterior trim protectants
• touch-up paint products

Cleaning and furniture care products means an end use (intended for consumer or commercial use) to:

• remove dirt, grease, stains, and foreign matter from furniture and furnishings
• cleanse, sanitise, bleach, scour, polish, protect, or improve the appearance of surfaces

Examples include:

• cleaners used on glass, floors, tub and tile, ovens and drains
• scouring powders
• dusting products
• waxes
• polishes
• stain repellent sprays

Laundry and dishwashing products means an end use in liquid, granular, gel or unit dose packets/tablets to:

• remove food residue from dishes
• remove dirt from textiles
• enhance properties of textiles
• remove stains from textiles

Examples include:

• dishwashing detergents and laundry detergents
• stain removers and fabric enhancers
• bleach
• rinse aids
• lime and rust removers
• dry cleaning products used in non-aqueous cleaning processes

Extractive products not covered by other end uses means an end use in:

• mining
• onshore drilling
• related activities such as extraction, cementing, hydraulic fracturing, refining

These scenarios do not include end use in offshore drilling. This end use is a designated kind of release into the environment (for which you do not calculate an ECV).

Paper products means an end use in paper production. Examples include:

• effluent treatment chemicals
• maintenance chemicals
• deposit and cleaning agents
• defoamers
• surfactants
• polymeric retention aids
• coagulants
• clay
• resins

Personal care products not covered by other end uses means an end use for cosmetic use, except those covered under the “personal care products - limited environmental release end use” scenario. Examples include:

• bath and shower products
• make-up products
• hair, oral and skin care products
• secondary sunscreen products
• deodorants
• perfumes

Photographic products means an end use (for consumer or commercial use) to take photographic images, develop and process film, and make photographic prints. Examples include:

• processing solutions (for developing, stopping, and fixing photos)
• chemicals used in the manufacture or processing of film or photographic paper

Water treatment products means an end use to treat water in cooling and heating systems (including industrial heat-exchanger systems) and potable water supplies. Examples include:

• chemicals used in pH buffers
• scale and corrosion inhibitors
• flocculating agents
• ion exchange resins

This scenario does not include end uses to treat municipal water supplies or other large-scale water supplies for human or animal consumptions or irrigation. These end uses involve a designated kind of release into the environment (for which you do not calculate an environment categorisation volume).

Personal vaporiser products means an end use in a device that is intended to produce a vapour or aerosol that is delivered into a person’s body when the person inhales through the device. Examples include:

• e-cigarettes
• e-cigars
• e-hookah pens
• e-pens
• e-pipes
• vape pens

Go back to step 5.3

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 gas3>

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 (or the chemical of which it is an ester or salt) 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 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 GD 1503, 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 (or the chemical of which it is an ester or salt) is not on the list of chemicals with high hazards for categorisation, based on its adverse effects mediated by an endocrine mode of action.

Persistent, bioaccumulative and toxic 

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

• the chemical (or the chemical of which it is an ester or salt) is on the list of chemicals with high hazards for categorisation, based on it being persistent, bioaccumulative and toxic, or
• all of the following apply:
  • the chemical is persistent (see our glossary definition)
  • the chemical is bioaccumulative, and 
  • the chemical has the hazard characteristic, very toxic to any aquatic life

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 (or the chemical of which it is an ester or salt) 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 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 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 
• 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 a NOEC or EC10 greater than 0.1mg/L for all three 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 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.

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 1,000gt/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 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 - 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 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:

• Read-across information
• Acceptable test guidelines for categorisation
• In silico predictions for categorisation

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.

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 
• 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, 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 
• 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.

*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 bioaccumulation potential hazard characteristic – only studies on the chemical itself, as described in the next dot point, are acceptable.

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).