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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 band B hazard characteristics

This page accompanies step 5.4 Work out 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 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).

 

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