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Workshop on applications for authorisation for environmental endocrine disruptors

Introduction

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))1. 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[2] 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[3] 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.

[1] http://eur-lex.europa.eu/eli/reg/2017/999/oj

[2] https://ec.europa.eu/transparency/regdoc/rep/1/2016/EN/COM-2016-814-F1-EN-MAIN-PART-1.PDF

[3] RAC – ECHA’s scientific committee for risk assessment

 

Purpose

The purpose of the workshop is to have an open exchange of views between stakeholders and ECHA on the available scientific evidence relating to the hazard, risk and impact assessment of NPnEO and OPnEO. The workshop will address in particular whether it is possible to derive thresholds or dose-response relationships for these substances

 

Date and venue

The workshop is organised in European Commission premises on 22 August 2017. It is provisionally scheduled to start at 10:00 and end at 16:00 (exact timings will be confirmed once the programme has been finalised). The workshop will be web streamed, if the meeting room allows for this. 

 

Presentations

The presentations will be made available after the event.

 

Expenses

The seminar is free of charge. However, participants will need to cover meal, travel and accommodation expenses.

 

Registration

The participants to this technical workshop would comprise experts in ED substances for the aquatic environment from EU Member States, ECHA including some members of the Risk Assessment Committee, the Commission, industry, academia and non-governmental organisations. Should you be interested in participating in the workshop please complete the form via the link below by 2 August 2017. We will confirm your registration by 7 August 2017. The number of places being limited, priority will be given to potential applicants (one representative per company).

LINK: https://www.webropolsurveys.com/S/08BE53F790DF0165.par

 

Contact

For questions about the workshop, please contact: application-authorisation [at] echa.europa.eu.