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

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

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

Instructions

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

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

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

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

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

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

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

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

Hazard characteristics and required information

Contains arsenic, cadmium, lead or mercury

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

• arsenic
• cadmium
• lead or
• mercury

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

Ozone depleting chemical

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

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

Synthetic greenhouse gas

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

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

Adverse effects mediated by an endocrine mode of action

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

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

or 

• the chemical (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).