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Meeting

Evaluation of the potential approaches to mixture risk assessment for future UK REACH assessments

TOX/2022/20

Last updated: 17 March 2022

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This is a paper for discussion.

This does not represent the views of the Committee and should not be cited.

1.             In September 2020 the UK Chemicals Delivery Board agreed that the Environment Agency should prepare a report on whether a mixture assessment factor (MAF) is a useful approach to address the potential risks arising from unintentional mixtures of chemicals under the UK REACH Regulation. This approach is also being considered by the European Union under EU REACH. Following that meeting, the UK Health Security Agency (UKHSA) agreed that they would work with the Environment Agency to prepare a joint report. Environmental aspects would be covered by the Environment Agency, and human health aspects by UKHSA.

2.             The report is now in draft form attached at Annex A and has been provided to members of COT for their review and to comment on the human health aspects prior to finalisation of the report.

3.             This paper is also being presented to the Hazardous Substances Advisory Committee (HSAC) to comment on the environmental aspects. The questions it has been asked are:

  • Comment on the identified benefits and disadvantages of a MAF.
  • Consider the evidence base and the suggested value of a potential MAF for the environment.
  • Provide any comment they may have on whether a MAF should be applied to the hazard assessment (when deriving the PNEC/DNEL) or during exposure assessment (when calculating the RCR) (Section 5.1.2).
  • Comment on whether the MAF be applied just to the aquatic compartment, or sediment and soil as well (Section 5.1.2).

 

Questions on which the views of the Committee are sought

4.             Members are invited to comment on the information provided in the report in Annex A and in particular:

  1. Comment on the identified benefits and disadvantages of a MAF.
  2. Consider the evidence base and whether the Committee agrees with the conclusion that a MAF is not considered appropriate for human health risk assessment.
  3. Provide any comment they may have on whether a MAF should be applied to the hazard assessment (when deriving the PNEC/DNEL) or during exposure assessment (when calculating the RCR) (Section 5.1.2).

Secretariat

March 2022