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Draft AICIS Cost Recovery Implementation Statement (CRIS) 2021-22 – read the CRIS and have your say. Comments close on 14 May 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 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.


Very toxic to any aquatic life

Very 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 1), 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 1), 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 it being very toxic to aquatic life, 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 less than or equal to 1mg/L, or
      • conducted following an acceptable test guideline for acute toxicity to invertebrates results in a 48h EC50 less than or equal to 1mg/L, or 
      • conducted following an acceptable test guideline for acute toxicity to algae or other aquatic plants results in a 72 or 96h ErC50 less than or equal to 1mg/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 less than equal to 0.1mg/L (for chemicals that are not readily biodegradable), or 
      • NOEC or EC10 less than or equal to 0.01mg/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 less than or equal to 1mg/L, or 
      • for invertebrates - 48h EC50 less than or equal to 1mg/L, or 
      • for algae or other aquatic plants - 72 or 96h ErC50 less than or equal to 1mg/L

              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, very toxic to any aquatic life  

The information required to demonstrate that a chemical does not have the hazard characteristic, very toxic to any aquatic life, is: 

  • if the exposure band for the introduction is 1 - 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 very toxic to any aquatic life
  • if the environment exposure band for the introduction is 2, 3, or 4, -  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 1 mg/L (LC50 (fish), or EC50 (invertebrates) or ErC50 (algae)), or 
      • chronic aquatic toxicity NOEC or EC10 greater than 0.1mg/L (for chemicals that are not readily biodegradable), or 
      • chronic aquatic toxicity NOEC or EC10 greater than 0.01mg/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 0.1mg/L (for chemicals that are not readily biodegradable), or 
      • NOEC or EC10 greater than 0.01mg/L (for chemicals that are readily biodegradable).
 

Persistent and bioaccumulative 

Persistent and bioaccumulative means that 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 and bioaccumulative, or 
  • both of the following apply: 
    • the chemical is persistent, and 
    • the chemical is bioaccumulative.

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 BCF or BAF 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 the absence of the hazard characteristic, persistent and bioaccumulative  

The information required to demonstrate that a chemical does not have the hazard characteristic, persistent and bioaccumulative, 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 it being persistent and bioaccumulative. 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 and bioaccumulative, is at least one of the following: 

  • information that demonstrates that the chemical is an inorganic chemical, or 
  • 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 
  • 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 
  • 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 4.2, 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 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 
  • 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 is 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 is less than 2,000. 

*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 very toxic to any aquatic life hazard characteristic – only in vivo chronic aquatic toxicity studies, as described in the next dot point, are acceptable.

 

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