Workshop on applications for authorisation for environmental endocrine disruptors
On 13 June 2017 two substances were added to the Authorisation list (Annex XIV) of the REACH Regulation on the basis of their endocrine disrupting properties (Article 57(f)) . These were:
- Entry 42: 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated [4-tert-octylphenol, ethoxylated; 4-tert-OPnEO]
- Entry 43: 4-nonylphenol, branched and linear, ethoxylated [4-NPnEO]
The Commission clarified in its Report to the European Parliament and the Council on 20 December 2016, in relation to applications for authorisation for endocrine disrupting substances, that “it remains the responsibility of applicants for authorisation to demonstrate that a threshold exists and to determine that threshold in accordance with Annex I to REACH.” and that “it is up to RAC to assess the validity of the assessment and ultimately decide on the possible existence or not of this threshold.”
There is scientific uncertainty surrounding whether or not thresholds can be derived for Endocrine Disrupting (ED) substances. This uncertainty was discussed in the ECHA seminar for potential applicants for authorisation (18-19 April 2017) where it was concluded that further clarity would be needed in relation to the expected applications for authorisation for these two substances. Therefore, ECHA will organise a workshop to discuss the ED properties of these two substances and explore potential ways forward in applications for authorisation.
 RAC – ECHA’s scientific committee for risk assessment
The purpose of the workshop was to have an open exchange of views between stakeholders and ECHA on the available scientific evidence relating to the hazard and risk assessment of NPnEO and OPnEO. In particular, the workshop discussed the uncertainties surrounding the derivation of thresholds and dose-response relationships for these substances as well as the challenges of estimating exposure in environmental compartments. Minimising exposure was also discussed.
- Programme [PDF]
- SEAC’s considerations after workshop [PDF]
- RAC’s considerations after workshop [PDF]
- Welcome and Introduction - Tim Bowmer, ECHA - Presentation | Recording
- Identification of OPnEO and NPnEO as SVHC; Workings of ED Expert Group - Conor Clenaghan, ECHA - Presentation | Recording
- REACH ED Review - Enrique Garcia-John, European Commission - Presentation | Recording
- Report of EU COM ED expert advisory group on thresholds for Endocrine Disrupters and related uncertainties - Frauke Stock, German Environment Agency - Presentation | Recording
- Ecotoxicological Hazard and Risk Assessment of Endocrine Active Substances - Annegaaike Leopold, Calidris Environment BV - Presentation | Recording
- Environmental Quality Standards (EQS) for NP and OP under the Water Framework Directive - Helen Clayton, European Commission - Presentation | Recording
- Summary of the RAC evaluation and opinion on the proposal for a restriction on the use of NPnEO in textiles - Peter Simpson, ECHA - Presentation | Recording
- Development of a rationale for a risk-based approach to Applications for Authorisation for OPnEO - Thomas Sendor, Martina Vosteen, Ramboll Environ - Presentation | Recording
- Summing up - Tim Bowmer, Peter Simpson, ECHA - Presentation | Recording
For questions about the workshop, please contact: application-authorisation [at] echa.europa.eu.