MANY WAYS
Endocrine disruptors: exploring present challenges and future developments (in memory of Alfonso Lostia)
Currently, at EU level, scientific criteria for the identification of Endocrine Disruptors (EDs) are implemented only for pesticides and biocides. As highlighted by the Fitness Check of legislation on EDs, there is a need for a more horizontal approach to identifying EDs across different sectorial legislation, supported by strengthened information requirements. For EDs, screening of chemicals and decision-making is dominated by use of vertebrate data in general and, mammalian data, in particular. The session aims at giving emphasis to advancements in the field of EDs. It should serve as a platform for an open dialogue between regulatory and non-regulatory scientists to explore future possibilities to move to more integrated assessments. These would incorporate data generated by new technologies to reach better and faster decisions for more chemicals on a cross-sector basis, in line with the ‘one substance-one assessment’ ambitions within the Chemicals Strategy for Sustainability. Overall, the session outcome should help preparing for future challenges by putting shape on future directions and possible collaborations.
Vision
The session aims to explore advancements in the field of Endocrine Disruptors (EDs) with the scope of moving to a more integrated interdisciplinary approach for testing and assessment for the identification of EDs. Such approaches should enable a deeper understanding of the different mechanisms disrupting the endocrine system leading to an adverse effect at individual and population level. Improved mechanistic understanding supports (i) development of alternatives to vertebrate test methods, (ii) extrapolation across species, (iii) identification of key targets associated with Adverse Outcome Pathways (AOPs). In the context of the European Green Deal, these integrated approaches can be used to pioneer the way forward for simplifying and consolidating EU regulatory frameworks and the implementation of the ‘one substance-one assessment’ concept with the ultimate goal of a toxic free environment.
Background – Challenges and opportunities
Currently, at EU level, scientific criteria for the identification of Endocrine Disruptors (EDs) are implemented only for pesticides and biocides. As highlighted by the Fitness Check of legislation on EDs, a more horizontal approach is needed to identify EDs across different sectorial legislation, supported by strengthened information requirements. Additionally, while at EU level, a hazard-based approach built on the World Health Organization definition for adversity is applied, a risk-assessment based approach is followed in other global regions. One of the challenges for the future of ED assessments is the harmonisation across jurisdictions.
For EDs, screening of chemicals and decision-making is dominated by the use of vertebrate data in general and, mammalian data, in particular. Methods for non-mammalian species are comparatively scarce and they include only a few endpoints that may be considered ED specific. In any case, reliance on animal testing is not a practical approach for effective screening, and new approaches are needed to fill the gap between the number of chemicals in use and the number of chemicals assessed to date. The development of new methodologies as valid alternatives to in vivo data is a key step. Improvements in our mechanistic understanding would also allow for a more reliable extrapolation between vertebrate species since it is well known that the vertebrate endocrine system is conserved across species.
Given the complexity of ED assessments at sectorial level and across legislation, constant engagement with stakeholders, Member State competent authorities, sister agencies and the public is essential for knowledge sharing and for consistency in assessments across legislation.
The session will provide an opportunity to engage with all stakeholders to explore future possibilities to move to more integrated assessments incorporating data generated by new technologies to reach better decisions, faster and for more chemicals on a cross-sector basis, in line with the ‘one substance-one assessment’ ambitions within the Chemicals Strategy for Sustainability.
Scope and objectives
The session aims at addressing identified gaps by soliciting contributions on:
- Current status (e.g. regulatory requirements, available scientific knowledge and testing methodologies) and challenges;
- New testing methodologies and strategies, including extended test protocols, application of New Approach Methodologies (NAMs), use of computational methods in predicting adverse outcomes, AOPs, AOP networks, Integrated Approaches to Testing and Assessment (IATA), extrapolation across species , approaches for prioritisation;
- Redefining ED identification on the basis of new approach methodologies;
- Approaches for grouping of similar substances and cumulative assessments.
| Time | Duration | Talk |
|---|---|---|
| 14:00 | 10 |
Opening and welcome Martin Wilks, University of Basel | Manuela Tiramani, European Food Safety Authority (EFSA) |
Part I - Present and future
| Time | Duration | Talk |
|---|---|---|
| 14:10 | 20 |
Endocrine disruption across taxa: support for a One Health perspective Andreas Kortenkamp, Brunel University London |
| 14:30 | 5 |
Q&A
|
| 14:35 | 5 |
Poster pitch 1 - Identifying endocrine disruptors – thoughts and recommendations for implementation in the EU) Donna Macmillan, Humane Society International |
| 14:40 | 5 |
Poster pitch 2 - Evaluation of an adverse outcome pathway network for thyroid hormone system disruption across taxonomic groups Lucia Vergauwen, University of Antwerp |
| 14:45 | 5 |
Poster pitch 3 - Developing a quantitative AOP for liver-mediated thyroid modulation after prenatal exposure to a xenobiotic compound in rats Aldert Piersma, National Institute for Public Health and the Environment (RIVM) |
| 14:50 | 5 |
Poster pitch 4 - Refining EDC hazard assessment by integrating an in vitro testing battery for endocrine disruptor (ED)-induced developmental neurotoxicity (DNT) Kevin Schlüppmann, Leibniz Research Institute for Environmental Medicine (IUF) |
| 14:55 | 30 |
Coffee break |
Part II - Stakeholder views
| Time | Duration | Talk |
|---|---|---|
| 15:25 | 45 |
Flash report | What works well and what needs improvement in ED assessments: a stakeholder view Henrik Holbech, University of Southern Denmark | Daniel Pickford, Syngenta | Sander Van der Linden, European Chemicals Agency (ECHA) | Emily Mcvey, Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) | Ninja Reineke, CHEM Trust | Karin Nienstedt, European Commission | Jordane Wodli, European Commission |
Part III - Moderated panel discussion
| Time | Duration | Talk |
|---|---|---|
| 16:10 | 70 |
Panel discussion moderated by Andreas Kortenkamp and Sharon Munn Daniel Pickford, Syngenta | Karin Nienstedt, European Commission | Jordane Wodli, European Commission | Henrik Holbech, University of Southern Denmark | Emily Mcvey, Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) | Ninja Reineke, CHEM Trust | Sander Van der Linden, European Chemicals Agency (ECHA) |
| 17:20 | 10 |
Wrap up and concluding remarks Manuela Tiramani, European Food Safety Authority (EFSA) | Andrea Terron, European Food Safety Authority (EFSA) | Francesca Pellizzato, European Chemicals Agency (ECHA) |