Review of ways to assess sufficiency of environmental endocrine disruptor databases for regulatory purposes

Descriptions

"According to Article 60 of the UK REACH legislation, authorisation of a chemical determined to be a Substance of Very High Concern (SVHC) as a result of environmental endocrine disruption (ED) can be granted in two ways: based on environmental emissions below an acceptable concentration or due to socio-economic need. To date, authorisations granted under EU REACH for SVHCs due to environmental ED have only been on socio-economic grounds. A SETAC Pellston workshop on Ecotoxicological Hazard and Risk Assessment Approaches for Endocrine-Active Substances held in 2016 concluded that a predicted no effect concentration (PNEC) can be determined for ED provided that sufficient data are available, and therefore a risk assessment can be performed. To inform our future work on UK REACH authorisations, we would like a contractor to explore how "sufficient data" might be assessed or managed in relation to new Applications for Authorisation (AfAs) for substances concluded to be SVHC due to environmental ED. This will also be useful for restriction work. The Environment Agency expects AfAs for nonylphenol ethoxylates (NPEO) and octylphenol ethoxylates (OPEO) to be received by the UK Chemicals Agency in the future. Due to this, there is a related need to have up to date environmental ED datasets for these substances to allow the Environment Agency to assess the applications and set any conditions if the AfA is granted. "