We were recently invited by the Luxembourg Environment Agency to undertake a short project to investigate the potential of candidate methods to translate conventional risk assessment outputs into metrics that could be more readily “valued” as part of a socioeconomic assessment during the REACH Restriction process. The project built on work previously undertaken by wca on socioeconomic assessment under REACH.
REACH Restriction Process
A Member State or the European Chemicals Agency (ECHA) can identify a chemical for potential Restriction under REACH. The restriction procedure is as follows:
- The Member State or ECHA submits a Restriction Dossier to ECHA according to Annex XV of REACH.
- Two ECHA committees – those for risk assessment (RAC) and for socioeconomic analysis (SEAC) – form an opinion on the proposal in parallel, but with communication over cross-cutting issues.
RAC must form an opinion on the measure’s adequacy at reducing the risk while SEAC must form an opinion about the appropriateness and proportionality of a proposed risk reduction measure after undertaking a socioeconomic analysis. Unfortunately, the outputs from conventional chemical risk assessments (such as those performed under the ESR or during REACH registration) are not the same as the information required to undertake a robust socioeconomic analysis, so the two committees are using two different “currencies” when forming their opinions. This makes it difficult to develop co-ordinated and coherent opinions about Restrictions. Similar translation challenges are also to be expected under the Authorisation process of REACH.
The project objectives were:
- To use a wide range of substances likely to be subject to Restriction or Authorisation to test the utility of relatively simple and “rapid approaches” when translating ERA outputs to impact assessments to be used in SEA. These approaches include:
- Life-cycle Assessment (LCA) using industry-standard software.
- Use of Species Sensitivity Distributions (SSDs)
- Exposure-based “proxies” of effect such as changes in volumes of affected media, as generated by probabilistic EUSES modelling.
- Read-across from similar substances for which there is more information.
- To take a smaller subset of these substances to test the utility of more “complex approaches” such as use of the ecosystem services concept.
- To consider uncertainty explicitly when developing examples for each substance.
- To run a focused one-day workshop with relevant stakeholders at which the project outputs are presented and discussed.
The project report (Refinement of Environmental Risk Assessment Outputs for use in Socioeconomic Assessment under REACH) can be downloaded as a pdf document by clicking here.
We also presented a poster on the project at SETAC Europe Milan (Approaches for Translating the Results of Environmental Risk Assessment for use in Socioeconomic Impact Assessment under REACH) which can also be downloaded by clicking here.
The main project conclusions were:
- At the present time, LCIA and Ecosystem Services are limited in their applicability and ability to support SEA much beyond more conventional methods of risk assessment. Primarily this is because of data limitations. Should sufficient additional data be made available, particularly for LCIA, then these methodologies should be reappraised.
- Application of probabilistic methods in combination with species sensitivity distributions (use of dose-response curves from individual tests for those substances with low amounts of test data) to calculate the notional fraction of species affected in the environment, or amounts of media affected for a particular emission level could potentially be beneficial in SEA, as long as these measures were not misinterpreted.
- Additional consideration of “non-threshold” chemicals (i.e. PBT and vPvB chemicals) under the REACH authorisation regime, and their appraisal within SEA is required.