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

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:


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).

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