November 26, 2018 by Becky Brown
Last week (20th – 21st November) I attended the 9th International Fresenius Conference on Endocrine Disrupters in Cologne1, Germany. The conference was well timed as the:
- New criteria for biocides2 and plant protection products (PPPs)3 are now adopted;
- EFSA/ECHA guidance4 (June 2018) on identifying endocrine disrupter (ED) substances is available; and,
- OECD guidance document (GD) 1505 providing details of the relevant test methods was published in September.
Dr Karin Nienstedt of the European Commission (EC) gave an update on the ED criteria and the next steps to be taken in this area. The ED criteria apply to new and on-going applications. For PPPs she highlighted a new implementing regulation 2018/16596 published on 7th November 2018 which allows for companies to obtain and assess additional data for pending applications via a “stop the clock” process. Pending applications are those submitted before 10th November 2018 and where a committee has not already voted on a draft regulation concerning the substance. The “stop the clock” period for generating new data is not foreseen to exceed 30 months. The new data requirements for assessment of EDs are currently only given in the EFSA/ECHA guidance document, but these are expected to be incorporated into legislation in due course.
Karin also confirmed the intention to fund eight research projects on EDs via Horizon 2020 with the aim of developing new testing and screening methods to identify ED chemicals. It is hoped that new methods will be developed which can better link endocrine activity to an adverse effect. Several of these projects will focus on the thyroid modality. Finally, she highlighted a recent communication from the EC titled “Towards a comprehensive European Union framework on endocrine disruptors”7. The document summarises the ECs recent work on EDs and includes a commitment to a Fitness Check to assess whether the relevant EU legislation reduces exposure to ED substances and therefore delivers on its objective to improve human health and the environment. The fitness check will consider areas where there are currently no provisions for assessing EDs e.g. toys, food contact materials and cosmetics, and will include public consultation.
Niklas Andersson (ECHA) and Domenica Auteri (EFSA) gave a joint presentation on the ED guidance document, while Peter Matthiesson, the ecotoxicology expert who co-drafted OECD GD 150, provided feedback on how this document should be used.
There were also international perspectives on EDs, with a presentation from Taison Iguchi of the National Institute of Basic Biology, Japan. He outlined a retrospective risk assessment approach to evaluating EDs that is being taken in Japan, with substance evaluations being prioritised based on measured concentrations in the environment. Testing is tiered starting with in vitro assays (specific to wildlife species), in vivo screening assays, and finally a high tier assessment using the Medaka Extended One Generation Test (OECD 240). A presentation from Kamel Mansouri (Integrated Laboratory Systems, USA) discussed the US focus on in vitro testing for endocrine activity. For the estrogen and androgen receptors the US EPA ToxCast Dataset have been used to develop a consensus model for predicting activity of new substances8. The prediction models are expected to be incorporated into the US Environmental Protection Agencies (EPA) CompTox dashboard9.
Other presentations included Lisa Baumann of the University of Heidelberg who discussed some of the considerations for interpreting histopathological data from fish studies, Stephanie Melching-Kollmuss of BASF presented some initial thoughts on an alternative approach to Appendix A of the EFSA/ECHA guidance for differentiating the direct or indirect effects of thyroid toxicants, and Mark Lohmann of the Federal Institute for Risk Assessment (BfR) in Germany who discussed public perception of the risks of EDs.
The conference was an opportunity for industry to highlight concerns regarding the new EU regulation. Capacity was highlighted as a key concern. This applies not just to laboratory testing to generate new studies for meeting the new data requirements but also in obtaining the expertise to review the ED data, interpret the results and conduct the weight of evidence (WoE) assessments.
wca has experienced toxicologists and ecotoxicologists who have been conducting WoE assessments for EDs covering EU regulatory drivers for many years. We have updated our approaches to comply with the new guidance and already have experience of completing the Appendix 5 spreadsheet (ECHA/EFSA guidance 2018) summarising lines of evidence for ED substances. Please contact me if you would like more information on our services in this area or support in evaluating your substance to the new ED criteria.
- 9th International Fresenius Conference on Endocrine Disrupters https://www.akademie-fresenius.com/events/detail/p...
- Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012. https://eur-lex.europa.eu/eli/reg_del/2017/2100/oj
- Regulation (EU) 2018/605 of 19 April 2018 setting out scientific criteria for the determination of endocrine disrupting and amending Annex II to Regulation (EC) 1107/2009. http://data.europa.eu/eli/reg/2018/605/oj
- Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009; https://www.efsa.europa.eu/en/efsajournal/pub/5311
- OECD Guidance Document 150 http://www.oecd.org/publications/guidance-document...
- Implementing Regulation (EU) No 844/2012 in view of the scientific criteria for the determination of endocrine disrupting properties introduced by Regulation (EU) 2018/605 https://eur-lex.europa.eu/legal-content/EN/TXT/?ur...
- Communication from the Commission to the European Parliament, the Council, the European economic and social committee and the committee of the regions: “Towards a comprehensive European Union framework on endocrine disruptors” http://ec.europa.eu/transparency/regdoc/rep/1/2018...
- Collaborative Estrogen Receptor Activity Prediction Project (CERAPP) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4937869/
- US EPA CompTox Dashboard https://comptox.epa.gov/dashboard