Background and Regulatory Context
Chemicals with the potential to cause endocrine disruption (ED) continue to be a focus of global chemical regulations, not least in the EU. Chemicals registered under EU pesticide and biocide legislation have been assessed for ED potential for several years. The Chemicals Strategy for Sustainability (CSS) is a key part of the EU’s Green Deal, and includes a strong focus on ED chemicals due to concerns over effects on human health and the environment. The REACH and CLP regulations are seen as key measures of enforcing the CSS, with the recent introduction of new hazard classes under CLP and new ED information requirements proposed for the ongoing REACH revision.
RSA Experience and Expertise
RSA specialists have extensive experience and expertise in the science of endocrine disruption. Our consultants have been involved in the development and drafting of OECD Guidance Document 150 on Standardized Test Guidelines for Evaluating Chemicals for Endocrine Disruption. RSA consultants have also participated in ED test method validation projects, been representatives on various OECD ED Task Forces and Management Groups as well as the ECHA ED Expert Group (EDEG).
We have considerable experience in performing ED assessments for pesticide and biocide active substances according to the 2018 ECHA/EFSA Guidance, and can use this experience to assist clients in facing new challenges of ED assessment under CLP and REACH.
We continue to promote engagement between industry and regulatory authorities, and were co-organisers with ECETOC of a recent symposium on the testing, assessment and classification of thyroid hormone disruptors. Please follow this link to view the symposium speaker slides.
How We Can Help
RSA can provide advice to clients on data completeness and testing strategies for ED under REACH, pesticides and biocides regulations, including an initial ED vulnerability assessment based on existing proprietary and published data, HTS and (Q)SAR. We can provide support throughout the regulatory process, including preparation of full ED assessments (Appendix E and I), MoA analysis for regulatory submission, client representation and support during commenting or consultation periods.
If new data are required, RSA specialists have significant experience in monitoring all study types required to provide a sufficient ED dataset including EOGRTS. We also have close contact with CROs offering non-standard studies, providing expert input into study design and interpretation. We have particular expertise in the design of mechanistic studies, enabling an understanding of the human relevance of ED effects
RSA can provide a literature search for ED effects, including abstract screening and a relevance and reliability assessment according to EFSA guidance.
Furthermore, our consultants have extensive experience in classification and labelling under CLP, and can support clients in assessing their datasets for classification for the new ED hazard categories.
Please contact info@regulatoryscience.com for an initial discussion on how RSA can support you in meeting the regulatory requirements for ED.