July 24, 2020 by Olivia Tran


Olivia Tran recently completed an ECHA training course on ‘analysis of alternatives’ (AoA) for hazardous substances. AoA is required to support applications for substance Restriction and Authorisation under REACH but can also be useful to support the research and development of “safer by design” materials and products. It is anticipated that AoA will play a greater role in chemicals management and stewardship activities in Europe as the new EU Chemicals Strategy for Sustainability (due to be finalised in Q3 2020) will introduce additional policies to protect citizens and the environment against hazardous chemicals and encourage innovation for the development of safe and sustainable alternatives1. Importantly, hazardous substances in materials and products need to be replaced to support the transition to the Circular Economy. AoA is a fundamental part of ECHA’s Substitution Strategy introduced in 20182 and is identified as an area for further development over the next 2 years in a recently published report3.

The training course covered assessment scoping, identification of alternatives, hazard and intrinsic exposure assessment, cost and technical performance assessment, decision frameworks and approaches to dealing with data uncertainties and trade-offs in safety and performance. Although most AoAs share these common aspects, it was apparent from the course that there are many ways to conduct AoAs, with varying depth of analysis and different tools and assessment approaches available depending on the specific objectives and resources available. The course also provided an extensive list of resources and tools to support AoA and shared experience and tips from both EU and US practitioners.

wca has worked with both industry and regulators to prepare AoAs to support Restriction and Authorisation activities under REACH and the Biocidal Products Regulation and much of our experience can be applied at the R&D stage for materials and products as well. We have conducted hazard assessments and intrinsic exposure assessments for a wide range of industrial chemicals and are experienced in the use of non-testing approaches to generate data (e.g. read-across, QSARs, screening criteria). We also have extensive experience in stakeholder engagement to inform the market analysis for cost and performance assessment to add business realism to the assessment. From our experience, scoping the AoA (to define stakeholder engagement, assessment goals, decision criteria and assessment methods) is key to a successful evaluation that will achieve the intended objectives within the available time and budget resources. Whether to fulfil regulatory obligations or to inform R&D activities, wca can help in the preparation of AoAs. Please contact us to discuss how we can help.

References

1 European Commission. May 2020. Chemicals – strategy for sustainability (toxic-free EU environment). Accessed on 16 July 2020.

2 European Chemicals Agency. January 2018. Strategy to promote substitution to safer chemicals through innovation. Accessed on 16 July 2020.

3 European Chemicals Agency. July 2020. Report on substitution-supporting activities in 2018-2019 and focus in 2020-21: Implementation of the Substitution Strategy. Accessed on 16 July 2020.