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

Human health hazard band C hazard characteristics

This page accompanies step 4.4 Work out your human health hazard characteristics.

Do not start this page unless you have read Step 4.4 Work out your human health hazard characteristics

Human health hazard characteristics are split into hazard bands. Hazard characteristics of most concern are in hazard band C, while those of lower concern are in hazard band A. 

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

  • carcinogenicity
  • reproductive toxicity
  • developmental toxicity
  • adverse effects mediated by an endocrine mode of action 
  • genetic toxicity

Instructions

You must always start at hazard band C. Step 4.4 tells you when you can stop working through your chemical's human health hazard characteristics and when you need to check each of them - ie C, B and A.

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 human health hazard band is C. Move on to the next step - step 4.5 Work out your human health 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 human health hazard band is C. Move onto the next step – step 4.5 Work out your human health 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 human health hazard band B. This depends on the exposure band of your introduction. 

If your introduction is in human health exposure band 1 or 2, stop here - you don’t need to consider any other hazard characteristics. Next go to step 4.5 to work out your human health risk for categorisation.

If your introduction is in human health exposure band 3 you can choose to stop (and go to step 4.5 to work out your human health risk for categorisation), or to continue to human health hazard band B and then A. 

If your introduction is in human health exposure band 4, continue to human health hazard band B

 


Carcinogenicity

Carcinogenicity means that any of the following apply to the industrial chemical: 

  • the chemical is a known, presumed or suspected human carcinogen, as described in chapter 3.6 of the GHS, with the chemical classified as carcinogenicity (category 1 or 2), 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 carcinogenicity, or
  • an in vivo study on the chemical conducted following an acceptable test guideline for carcinogenicity, chronic toxicity, subchronic oral toxicity, subchronic dermal toxicity or subchronic inhalation toxicity results in the induction of cancer, or an increase in the incidence of cancer. 

Information required to demonstrate the absence of the hazard characteristic, carcinogenicity  

  • 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 carcinogenicity.
  • In addition, if the human health exposure band for the introduction is 4 and the chemical is a UV filter, information is required to justify why the chemical would not cause carcinogenicity mediated by exposure to UV light. This may include one or more of the following:
    • the chemical has a molar extinction/absorption coefficient of less than 1,000Lmol-1cm-1 at wavelengths between 290 and 700nm (based on the results of a study following OECD test guideline 101), or 
    • results from in vitro phototoxicity studies, or 
    • results from in vivo carcinogenicity studies where the methods have been modified to include photoactivation. 
 

Reproductive toxicity

Reproductive toxicity means that any of the following apply to the industrial chemical: 

  • the chemical is known, presumed or suspected to produce adverse effects on sexual function and fertility, as described in chapter 3.7 of the GHS, with the chemical classified as toxic to reproduction (category 1 or 2), 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 reproductive toxicity, or 
  • an in vivo study on the chemical conducted following an acceptable test guideline for reproductive toxicity, carcinogenicity, chronic toxicity, subchronic oral toxicity, subchronic dermal toxicity or subchronic inhalation toxicity results in adverse effects on sexual function and fertility, as described in chapter 3.7 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, reproductive toxicity  

  • If the chemical is a polyhalogenated organic chemical and the human health exposure band for the introduction is 4
    • an in vivo test result on the chemical or suitable read across information conducted following an acceptable test guideline for reproductive toxicity, which results in none of the adverse effects on sexual function or fertility described in chapter 3.7 of the GHS;
  • Otherwise – 
    • 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 reproductive toxicity.
 

Developmental toxicity

Developmental toxicity means that any of the following apply to the industrial chemical:

  • the chemical is known, presumed or suspected to produce adverse effects on the development of the offspring or effects on the offspring via lactation, as described in chapter 3.7 of the GHS, with the chemical classified as follows: 
    • toxic to reproduction (category 1 or 2), or 
    • effects on or via lactation, 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 developmental toxicity, or
    • an in vivo study on the chemical conducted following an acceptable test guideline for developmental toxicity or reproductive toxicity results in adverse effects on the development of the offspring or effects on the offspring via lactation, as described in chapter 3.7 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, developmental toxicity

  • If the chemical is a polyhalogenated organic chemical and the human health exposure band for the introduction is 4 – 
    • an in vivo test result on the chemical or suitable read across information conducted following an acceptable test guideline for developmental toxicity or reproductive toxicity which results in none of the adverse effects on the development of the offspring or effects on the offspring via lactation, as described in chapter 3.7 of the GHS
  • Otherwise – 
    • 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 developmental toxicity.
 

Adverse effects mediated by an endocrine mode of action

Adverse effects of 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 150**, 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.

*Guidance for the identification of endocrine disruptors in the context of 39 Regulations (EU) No 528/2012 and (EC) No 1107/2009, currently a 2017 consultation draft. 

**ENV/JM/MONO(2012)22, OECD Series on Testing and Assessment, No. 150 - Guidance document on standardised test guidelines for evaluating chemicals for endocrine disruption.

 

Genetic toxicity

Genetic toxicity means that any of the following apply to the industrial chemical: 

  • the chemical is known to induce or may induce mutations in the germ cells of humans, as described in chapter 3.5 of the GHS, with the chemical classified as germ cell mutagenicity (category 1 or 2), 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 genetic toxicity, or 
  • an in vitro study on the chemical:
    • conducted following an acceptable test guideline for gene mutation or chromosomal abnormalities results in the prediction of mutagenic or genotoxic effects, as described in chapter 3.5 of the GHS, and 
    • the results of the study have not been negated by in vivo studies conducted on the chemical for gene mutation, chromosomal abnormalities or heritable germ cell mutagenicity, or 
    • an in vivo study on the chemical conducted following an acceptable test guideline for gene mutation, chromosomal abnormalities or heritable germ cell mutagenicity results in mutagenic or genotoxic effects, as described by chapter 3.5 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, genetic toxicity

The information required to demonstrate that a chemical does not have the hazard characteristic, genetic toxicity, is: 

  • if the human health exposure band for the introduction is 4 - at least one of the following: 
    • information to demonstrate that the chemical is included on the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion, and that the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
    • information to demonstrate that the chemical has been notified to the US FDA GRAS notification program and FDA had no questions about the notifier’s conclusion of GRAS status, and that the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
    • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or 
    • information to demonstrate that the chemical is a high molecular weight polymer, and if you are seeking to demonstrate that the introduction meets the criteria for very low risk and is not one of the 'special cases' mentioned in step 4.5 - test results from an in vitro study on the polymer or from suitable read across information conducted following an acceptable test guideline for gene mutation, which demonstrates the absence of mutagenic effects, or 
    • test results that demonstrate the absence of mutagenic or genotoxic effects from both: 
      • study on the chemical or from suitable read across information conducted following an acceptable test guideline for gene mutation, and 
      • study on the chemical or from suitable read across information conducted following an acceptable test guideline for chromosomal abnormalities. 
    • if the human health exposure band for the introduction is 3, and you are seeking to demonstrate that the introduction meets the criteria for very low risk and is not one of the 'special cases' mentioned in step 4.5 - at least one of the following: 
      • inclusion of the chemical in the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
      • the chemical has been notified to the US FDA GRAS notification program and FDA had no questions about the notifier’s conclusion of GRAS status, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
      • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or
      • if the polymer is a high molecular weight polymer, test results from an in vitro study on the polymer or from suitable read across information conducted following an acceptable test guideline for gene mutations, which demonstrates the absence of mutagenic effects, or 
      • information that demonstrates the absence of mutagenic or genotoxic effects from both: 
        • information on the chemical or from suitable read across information that addresses gene mutations - this could be: 
          • a suitable in silico prediction, both with and without metabolic activation, or 
          • test results from a study conducted following an acceptable test guideline for gene mutations; and
        • test results from a study on the chemical or from suitable read across information conducted following an acceptable test guideline for chromosomal abnormalities.
  • otherwise, the information required to demonstrate that a chemical does not have the hazard characteristic, genetic toxicity, 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 genetic toxicity. 
  • in addition, if the human health exposure band for the introduction is 4 and the chemical is a UV filter, information is required to justify why the chemical would not cause genetic toxicity mediated by UV light. This may include one or more of the following: 
    • the chemical has a molar extinction coefficient/absorption coefficient of less than 1,000Lmol-1cm-1 at wavelengths between 290 and 700nm (based on the results of a study following OECD test guideline 101), or 
    • results from in vitro phototoxicity studies, or 
    • results from in vitro or in vivo genetic toxicity studies where the methods have been modified to include photoactivation.
       

 

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