Endocrine Disruption

Expert advice and assessment for endocrine disruption assessment

Enviresearch can deliver expert advice and assessment to meet your requirements for endocrine disruption (ED) assessment, both for active substances and co-formulants. We have considerable expertise in endocrine disruption and our scientists have supported several governmental programmes contributing to advancing the science in this developing area. We perform evaluations for European regulations and developing GB legislation, including literature searches, monitoring studies to meet new data requirements and higher-tier population modelling to address issues of population relevance.

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Active substance assessments (plant protection products and biocides)

For a substance to be considered as having ED properties, all three of the following criteria must be demonstrated:

  1. The substance shows an adverse effect. For non-target organisms, these adverse effects need to be relevant at the population level.
  2. The substance has an endocrine mode of action (alters the function of the endocrine system).
  3. The adverse effect needs to be a consequence of the mode of action.

For plant protection products and biocides at the active substance level, these assessments follow the ECHA EFSA 2018 guidance, using a weight-of-evidence approach, assimilating all the relevant (and reliable) data available and identifying where new studies are necessary. Enviresearch will apply expert judgement and experience to navigate this system on your behalf, keeping abreast of new developments in the area (e.g., Xenopus embryonic thyroid signalling assay (XETA) and the Rapid Androgen Disruption Activity Reporter (RADAR) assay) and issues in certain regulatory studies (e.g., LAGDA and MEOGRT) to ensure assessments remain current. In addition to the standard ED evaluations, we can also challenge the default assumption that adverse effects in non-target organisms are relevant at the population level.

Co-formulant assessments (biocides)

Non-active substances in biocidal products need to be systematically checked to determine those identified as EDs or (potential EDs), drawing on REACH, EU priority lists and other internationally recognised databases. We have experience in working through this system and conducting the necessary literature searches to satisfy the requirements for your product.

Evolving requirements

Regulations on endocrine disruption are still rapidly evolving, with new developments in Europe driven by the EU Chemicals Strategy for Sustainability, which is leading to changes in REACH and CLP regarding a new category for ‘suspected’ endocrine disruption. We actively monitor ongoing developments, contributing to feedback and researching new tools to aid the evaluations.

As new approaches become established in the EU, we are closely monitoring how these developments are being translated into GB pesticides law and how they will affect forthcoming pesticide active substance approvals and product authorisations in the UK

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Our services

  • Weight-of-evidence reviews of ED properties for active substances in agrochemicals and biocides
  • Review of available data for co-formulants in biocidal products
  • Data searches (as per Appendix F of the ECHA/EFSA guidance)
  • Gathering of available studies (DAR/RAR/CAR, other relevant studies)
  • Data/study relevance and reliability evaluation
  • Assessment of the preliminary evidence of ED properties
  • Estrogen, androgen, thyroid and steroidogenic (EATS) mediated adversity evaluation by setting specific scenarios
  • Mode of action (MoA) analysis
  • Data gap identification
  • Development of testing strategies and study monitoring
  • Dossier preparation

Other expertise

Regulatory Affairs
Effects Modelling
Ecotoxicology
Environmental Fate
Aged Sorption
Efficacy
Human Health Risk Assessment
Analytical Chemistry
Residues Chemistry
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Enviresearch is part of the RSK group of companies

The RSK group is a leading integrated environmental, engineering and technical services business offering bespoke end-to-end solutions to a variety of sectors. Headquartered in the UK but with an established presence throughout Europe, Africa, the Middle East, Asia and Australia, RSK helps organisations around the world achieve their business aspirations in a sustainable and efficient manner.

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