Endocrine Disruption
RSA provides specialist consultancy services, helping clients navigate the increasingly complex requirements for the regulatory assessment of endocrine disruption (ED) potential. Our scientific expertise, combined with extensive regulatory experience, enables us to support clients throughout every stage of the ED assessment process from early data review and vulnerability assessment, through to the design of testing strategies, CLP classification and regulatory submission.
Endocrine disrupting chemicals are subject to increased regulatory scrutiny; the assessment of ED potential has been required under biocides and pesticides legislation for a number of years. More recently, hazard classification classes have been introduced for endocrine disruption in the CLP Regulation, and ED information requirements are likely to be introduced under REACH.
Our Endocrine Disruption Services
Endocrine Disruption Vulnerability Assessments
We are provide initial endocrine disruption vulnerability assessments using proprietary datasets, published literature, high-throughput screening (HTS) data and (Q)SAR model predictions. This assessment can identify potential regulatory concerns at an early stage, enabling clients to develop compliance strategies.
Regulatory Advice & Testing Strategies
RSA advises clients on data completeness and testing strategies for endocrine disruption under REACH, Plant Protection Products (PPP) and Biocidal Products Regulations (BPR), as well as classification and labelling under the CLP Regulation. Our consultants help determine the most appropriate scientific approach, and ensure compliance with current regulatory guidance.
Study Design & Monitoring
Where additional data are required, our specialists have extensive experience monitoring all standard study types required for endocrine disruption assessment, including Extended One Generation Reproductive Toxicity Studies (EOGRTS). We also work closely with trusted CROs to design, conduct and interpret non-standard investigative and mechanistic studies.
Mechanistic Studies & Human Relevance
RSA has particular expertise in designing mechanistic studies that provide greater understanding of endocrine modes of action (MoAs) and the human relevance of observed endocrine effects. These studies can provide valuable supporting evidence during regulatory submissions and scientific discussions.
Endocrine Disruption Regulatory Assessments
We support clients throughout the regulatory process by preparing comprehensive endocrine disruption assessments, including Appendix E and Appendix I documentation. We also undertake Mode of Action (MoA) analyses and prepare scientifically robust regulatory submissions.
Classification & Labelling (CLP)
Our consultants have extensive experience in Classification, Labelling and Packaging (CLP) Regulation and can assess existing datasets against the new endocrine disruption hazard classes. We assist clients in understanding their classification obligations and preparing supporting documentation.
Literature Reviews & Evidence Assessment
RSA undertakes comprehensive literature reviews focused on endocrine disruption, including:
- Literature searching
- Abstract screening
- Relevance assessments
- Reliability assessments in accordance with EFSA guidance
This ensures regulatory decisions are supported by transparent and scientifically defensible evidence.
Endocrine Disruption Specialists
Regulatory Representation
We provide support throughout the regulatory review process, including representation during consultation and commenting periods. Our consultants work alongside clients to address regulatory questions and facilitate constructive engagement with authorities. Our multidisciplinary team has extensive expertise in the assessment of endocrine disruption, and is able to support clients across the agrochemical, biocide and chemicals sectors. Contact RSA today to discuss how our endocrine disruption specialists can help you meet current and future regulatory requirements with confidence.
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RSA’s Dick Lewis Contributes to Scientific Paper on Developmental Neurotoxicity Testing
Regulatory Science Associates: Helping Clients Navigate the Complexities of Regulatory Science
Reviewing the thoroughness of human safety testing for succinate dehydrogenase inhibitors: fluopyram as a case study
Understanding how to navigate Endocrine Disruption Assessment under EU Legislation
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 as part of the ongoing REACH revision.
RSA specialists have considerable experience and expertise in the science of endocrine disruption and have presented extensively in this area. 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).
RSA has 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 the 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 2024 symposium on the testing, assessment and classification of thyroid hormone disruptors. Please follow this link to view the symposium speaker slides.
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 literature and high-throughput screening (HTS) and (Q)SAR.
RSA can provide support throughout the regulatory process, including preparation of full ED assessments (Appendix E and I), Mode of Action (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 mechanistic studies, providing expert input into study design and interpretation.
Yes, RSA has particular expertise in mechanistic studies, enabling an understanding of the human relevance of ED effects. Our experts maintain awareness of new methodology relevant to ED assessment.
Yes, RSA can provide a targeted literature search for ED effects, including abstract screening and a relevance and reliability assessment according to EFSA guidance.
RSA consultants have extensive experience in classification and labelling under CLP, and can support clients in assessing their datasets for vulnerability or classification for the new ED hazard categories.
Please contact info@regulatoryscience.com for an initial discussion on RSA’s endocrine disruption experience and expertise