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Top tags: AOP guideline  Endocrine disruptors guideline  Endocrine disruptors initiative 

EU Initiative: Towards a more comprehensive EU framework on endocrine disruptors

Posted By Maria Teresa P. Fagundes, Thursday, September 20, 2018
Updated: Tuesday, September 11, 2018

Roadmap as an example of stakeholder participation in EU initiatives

"Roadmaps aim to inform citizens and stakeholders about the Commission's work in order to allow them to provide feedback and to participate effectively in future consultation activities. Citizens and stakeholders are in particular invited to provide views on the Commission's understanding of the problem and possible solutions and to make available any relevant information that they may have."
For this particular initiative the feedback pariod has recently closed.

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OECD guidance on AOP development and use

Posted By Maria Teresa P. Fagundes, Tuesday, September 11, 2018

Revised Guidance Document on Developing and Assessing Adverse Outcome Pathways (No. 184)

"This guidance document provides an introduction to the development and assessment of AOPs, and the framework for consistent information gathering and organisation, including definitions for AOP-specific terminology. In this context, an AOP is a conceptual construct that portrays existing knowledge concerning the pathway of causal linkages between a molecular initiating event (MIE) and a final adverse outcome (AO) at a biological level of organisation that is relevant to a regulatory decision (Ankley et al., 2010)."

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Developments in the EU guideline for ED identification

Posted By Maria Teresa P. Fagundes, Tuesday, September 11, 2018

Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009

This document "provides guidance to applicants and assessors of competent regulatory authorities on how to identify endocrine disruptors in accordance with the ED criteria laid down in Commission Delegated Regulation (EU) No 2017/21003 and Commission Regulation (EU) No2018/6054 for biocidal products (BP) and plant protection products (PPP), respectively. The guidance document describes how to gather, evaluate and consider all relevant information for the assessment,conduct a mode of action (MoA) analysis, and apply a weight of evidence (WoE) approach, in order to establish whether the ED criteria are fulfilled."

https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5311

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Risk assessment procedures for endocrine disrupters

Posted By Peter Matthiessen, Saturday, October 27, 2012

Having helped to organise this week's SETAC-Europe Special Science Symposium on Endocrine Disrupter Testing and Evaluation, it became obvious to me that regulatory authorities have not yet thought in depth about how the special properties of EDCs could be taken into account in environmental risk assessments. Although the European Union appears to have turned its back on risk assessment for this group of substances, in my view a retrograde step, other authorities (e.g. the US and Japan) have indicated that they consider risk assessment of EDCs to be feasible. For that reason, I think a major and urgent task of this new SETAC Advisory Group will be to develop new risk assessment methods for EDCs which explicitly deal with such phenomena as low dose effects, non-monotonic dose-responses, and delayed appearance of adverse effects. I would like to hear people's comments on this issue.

Peter Matthiessen

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