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

Do not start this page unless you have read Step 5.4: Work out your environment hazard characteristics

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 

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: 

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.

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