In a paper published on March 25, 2020, the Swedish and Dutch governments have proposed the introduction of a mixture assessment factor (MAF) into the EU REACH regulation to consider combined exposures from unintended mixtures during risk assessment and management activities. This was reported in an article published by regulatory news provider Chemical Watch. The paper was scheduled for discussion and feedback from other EU member states during a meeting of the Competent Authorities for REACH and CLP (CARACAL) on March 31, 2020.
The paper explains that on March 5-6, 2020, the Swedish and Dutch authorities held a workshop with policymakers and risk assessors from 12 European countries in addition to European Commission agencies with the aim to “build a common understanding of possible pragmatic approaches to address the risk from combined exposure to unintentional mixtures of substances.” The participants used REACH as a framework to investigate the impacts of applying an MAF of 10 for a group of 24 randomly selected registered substances. Application of the factor identified that “more risk management measures or testing would be needed for some of the substances.” The European Chemicals Agency (ECHA) is set to further study potential impacts on registration dossiers.
Outcomes from the workshop include:
- Participants agreed that exposure to multiple substances each below their defined safe exposure limits may pose a risk;
- Participants agreed that the EU Green Deal, Zero-Pollution Ambition, and Sustainable Chemicals Strategy need a “pragmatic approach to consider exposure to unintentional mixtures”;
- Participants expressed general support for the principle of applying an MAF;
- No other approaches were identified for addressing combined exposure to unintentional mixtures;
- Different views existed on exactly where to apply an MAF in the risk assessment process.
The paper asks CARACAL members: (i) if they generally support the outcomes of the workshop and think a pragmatic approach for addressing risk of combined exposures is urgently needed, (ii) if they consider the application of an MAF under REACH as a feasible and efficient method, (iii) which procedure should be used to determine an approach for introducing an MAF, and (iv) which procedure should be used to determine the magnitude of the MAF. CARACAL members and observers are invited to submit comments on the paper and these discussion points by May 8, 2020.
Andrew Turley (April 2, 2020). “EU member states consider REACH mixtures assessment factor.” Chemical Watch
Andrew Turley (May 21, 2020). “All petroleum REACH registrations could be affected by mixtures proposal.” Chemical Watch
Andrew Turley (July 2, 2020). “Feature: What are the challenges of introducing a REACH mixtures assessment factor?” Chemical Watch
CARACAL (March 25, 2020). “Paper by the Dutch and Swedish Competent Authorities outlining a practical approach that can be applied to manage the risks of exposure to unintended combinations of chemicals in the EU.” (pdf)