Services

Endocrine Disruptors

According to the 2002 World Health Organization definition, “an Endocrine Disruptor (ED) is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations.” A wide range of substances, both natural and man-made, may be classified as endocrine disruptors.

In Europe, hazard-based criteria for identifying endocrine disruptors in Plant Protection Products (Reg. (EU) 2018/605) and Biocidal Products (Reg. (EU) 2017/2100) have applied since 2018. Since April 2023, the EU has also introduced dedicated endocrine disruptor hazard classes under the CLP Regulation (Reg. (EU) 1272/2008) through Commission Delegated Regulation (EU) 2023/707, allowing substances and mixtures to be classified as endocrine disruptors for human health (ED HH) or the environment (ED ENV) in Category 1 (known or presumed) or Category 2 (suspected). These classifications carry new EUH statements—EUH380/381 for human health and EUH430/431 for the environment—reflecting identified or suspected endocrine‑disrupting properties. Mandatory application dates are 1 May 2025 for substances and 1 May 2026 for mixtures, with transitional periods extending to 1 November 2026 and 1 May 2028, respectively. ECHA’s updated CLP Guidance, published in November 2024, provides practical criteria and detailed case handling for applying the new ED hazard classes.

Under REACH (Regulation (EC) 1907/2006), endocrine disruptors may be identified as substances of very high concern (SVHCs) under Article 57(f). The European Commission has announced a REACH revision for Q4 2025.

In North America, the US Environmental Protection Agency (EPA) uses a risk-based approach to screen pesticides, chemicals, and environmental contaminants for their potential effect on estrogen, androgen, thyroid and steroidogenesis (EATS) pathways under the Endocrine Disruptor Screening Program (EDSP).

Our staff in both Europe and North America have considerable practical and regulatory experience in conducting ED assessments under both EU and US legislation, including the provision of advice on assessment strategies, the design, conduct and interpretation of studies to support ED evaluations and the analysis of evidence.

Experienced Support For:

  • CLP ED classification support — assembling weight‑of‑evidence for ED HH/ED ENV (Cat 1/2), deriving EUH phrases, and advising on SDS/label and C&L notification implications.
  • PPP/BPR ED assessments — strategies aligned to EFSA/ECHA 2018 Guidance and EFSA’s 2025 technical learnings on recurring ED issues.
  • REACH & portfolio monitoring — SVHC identification (Art. 57(f)), horizon scanning (ED Lists portal), and monitoring REACH revision (Q4 2025).
  • Agency/Member State liaison — structured engagement with RMS/EFSA/ECHA.
  • Study design, placement & monitoring — GLP/OECD‑aligned ED studies.
  • Evidence assembly — integrating guideline studies, literature and NAMs into regulatory WoE.
  • Literature & database searching (systematic review) — EFSA/ECHA‑compliant, reliability appraisal, evidence grading.
  • QSAR/read‑across & in vitro bioassays — aligned to OECD CF/GD 150; EPA CompTox used as supporting evidence.
  • EATS and beyond — AOP‑anchored analysis across estrogen, androgen, thyroid and steroidogenesis pathways.

Development of ED Assessment Strategies & Advice on Testing Options

  • Development of tailored ED assessment strategies to support EU/UK PPP, BPR, REACH, and CLP (ED HH/ED ENV) regulatory requirements, including the 2023 introduction of CLP endocrine disruptor hazard classes (Reg. (EU) 2023/707).
  • Advice on data requirements and testing options for evaluating potential ED effects in humans, mammals, and non‑target organisms in accordance with the OECD Conceptual Framework and OECD Guidance Document 150, including updated approaches for EATS and non‑EATS pathways.
  • Identification of optimal testing pathways using a weight‑of‑evidence approach, integrating guideline studies, mechanistic data, and relevant new approach methodologies (NAMs).
  • Regulatory liaison with EU/UK Member State competent authorities to define the appropriate scientific and regulatory approach for ED‑related evaluations.

Study Design, Placement & Monitoring

  • Design, placement, and monitoring of ED‑relevant studies conducted under GLP and following OECD Test Guidelines, including endocrine‑specific in vitro and in vivo studies.
  • Advice on validated versus non-validated testing options.
  • Troubleshooting of study design challenges (e.g., sensitivity, biological variability, solubility/stability issues highlighted by recent EFSA assessments) to ensure robust ED endpoints.
  • Independent interpretation and scientific review of ED study results.

Preparation of ED Assessments in Accordance with 2018 EFSA/ECHA Guidance

  • Preparation of ED assessments for EU active substance approvals/renewals and co‑formulant assessments under PPP and BPR frameworks, following the EFSA/ECHA 2018 ED identification criteria.
  • Conduct of systematic literature reviews compliant with EFSA/ECHA principles, including transparent search strategies, reliability appraisal, and evidence integration.
  • Evaluation of non‑test data (e.g., (Q)SAR, read‑across) and in vitro bioassays, incorporating resources such as EPA CompTox as supporting evidence within an IATA framework.
  • Assembly and evaluation of all evidence streams, including mechanistic and apical endpoints, and assessment of EATS‑mediated and non‑EATS mode‑of‑action pathways.
  • Preparation of ED assessment review reports and expert statements that clearly demonstrate adverse effect, endocrine activity, and the biologically plausible link required under EU ED criteria.

Endocrine Disruptors Experts

Endocrine Disruptors

Melanie Anderson

Senior Consultant

United Kingdom

Endocrine Disruptors

Michaela Benton

Principal Consultant

United Kingdom

Endocrine Disruptors

Cliff Habig

Senior Science Fellow

Maryland/Maine

Contact Us To Start Your Next Project
Scroll to Top
Linkedin

Melanie Anderson
Senior Consultant

Expertise: Ecotoxicology – Pesticides and Biocides

Melanie has over 17 years in lab-based testing roles and consultancy. Melanie has consultancy experience working mainly with plant protection products and, in the biocide and REACH sectors. She has been involved in study design, monitoring, data interpretation, risk assessments, and dossier writing. She has also acted as an endocrine disruption (ED) specialist, conducting evaluations for industry clients. At CSI, she is a member of the Regulatory Consulting team with a focus on ecotoxicology.

Melanie also previously worked as a Study Director in aquatic ecotoxicology for Smithers Viscient on a wide range of studies, particularly chronic pharma. She started her career at OPUS Plus Ltd. working on offshore chemical testing and hatchery facility management.

EDUCATION
BSc (Hons) Zoology, University of Aberdeen.

Linkedin

Michaela Benton
Principal Consultant

Expertise: Pesticide & Biocide Toxicology

Michaela specialises in pesticide and biocide toxicology.

Michaela has over 15 years’ experience in regulatory toxicology. She previously worked for the UK Chemicals Regulation Division (CRD) of the Health and Safety Executive evaluating pesticide and biocide active substance and product dossiers for UK and EU regulatory regimes, including input into classification dossiers and attendance at EU expert meetings.  She also has previous consultancy experience at Battelle, providing mammalian toxicology expertise for the preparation of pesticide dossiers for EU submissions including non-dietary exposure risk assessment, endocrine disruption, study monitoring, and (Q)SAR and read-across assessments of metabolites and impurities. 

EDUCATION
MSc Toxicology, University of Surrey.
BSc (Hons) Biochemistry (Toxicology), University of Surrey.

Linkedin

Cliff Habig
Senior Science Fellow

Expertise: Environmental Risk Assessment, Ecotoxicology,
Environmental Fate & Residue Chemistry

Cliff provides consulting expertise for environmental risk assessments and dietary risk assessments, including overseeing GLP studies in ecotoxicology, environmental fate, and residue chemistry. Cliff also provides expertise on endocrine disruptor (EDSP) issues.
 
Cliff has over 30 years of experience in overseeing testing in ecotoxicology, environmental fate, and residue chemistry, providing analysis and strategic support to US and international clients to determine appropriate studies to support and register their products with US, California, and international regulatory agencies. This work includes conducting regulatory agency modeling, particularly EPA modeling, modeling for standard environmental risk assessments, dietary risk assessments, and proposing tolerances or tolerance exemptions for conventional chemical pesticides, biopesticides, microbial pesticides, and non-pesticide products. Cliff also conducts higher-tier and probabilistic risk evaluations to support clients’ products. Cliff previously worked at Jellinik, Schwartz, and Connolly (JSC), Novigen, and Exponent. Cliff has numerous publications and presentations at professional conferences, participates in chemical industry workshops, and serves on expert panels.
 

EDUCATION
Ph.D., Environmental Toxicology, Duke University.
M.S., Biology, University of Georgia.
B.S., Biology, University of Southern Maine.

Compliance Services International
Powered by  GDPR Cookie Compliance (opens in a new tab)
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.