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Ecotoxicology: Overview

Before a pesticide is approved, the risk to non-target organisms must be assessed. This assessment is to ensure that there are no significant long-term changes to the population nor to the function of the ecosystem. Certain other effects may also be unacceptable such as vertebrate mortalities.

The information you provide must be sufficient to allow an assessment of the impact on non-target organisms likely to be at risk from exposure to the active substance and appropriate metabolites.

This guidance covers:

Ecotoxicology guidance

(items are also included on pages referring to specific organisms where appropriate)

Current Guidance Documents

Previous EU Guidance Documents

Information about specific groups of organisms

UK guidance for products

Formulation Studies in Ecotoxicology

For guidance on the need for ecotoxicology formulation studies and their use in risk assessment, along with how to consider the combined risk for relevant groups, use the link below.

Formulation studies and combined risk assessment in ecotoxicology [23]

Classification and labelling

Environmental Hazard Classification and Labelling under CLP Regulation

This is a brief guide to CLP environmental hazard classification and labelling (PDF) [24] for active substances and 'mixtures' (formulated products).

Environmental Safety Precautions and Risk Mitigation for Plant Protection Products in the UK

Advice regarding the wording on product labels of 'safety precautions' (PDF) [25] previously required under Annex V to Directive 91/414 and now required under Commission Regulation (EC) No 547/2011. It details the various risk mitigation measures that may be needed, including a more detailed consideration of UK product labelling and risk management strategies for terrestrial (crop dwelling) non-target arthropods.

Research reports

There is a list of research reports useful for ecotoxicology risk assessment[26].

Link URLs in this page

  1. a list of ecotoxicology guidancehttps://www.hse.gov.uk/pesticides/data-requirements-handbook/ecotoxicology.htm#Ecotox-guide-list
  2. information about specific groups of organismshttps://www.hse.gov.uk/pesticides/data-requirements-handbook/ecotoxicology.htm#Specific-organisms
  3. UK guidance for productshttps://www.hse.gov.uk/pesticides/data-requirements-handbook/ecotoxicology.htm#Product-guidance
  4. classification and labellinghttps://www.hse.gov.uk/pesticides/data-requirements-handbook/ecotoxicology.htm#Classification-and-labelling
  5. research reportshttps://www.hse.gov.uk/pesticides/data-requirements-handbook/ecotoxicology.htm#Research-Reports
  6. EFSA Guidance document for Risk Assessment for Birds and Mammalshttps://www.efsa.europa.eu/en/efsajournal/pub/1438
  7. Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface watershttps://www.efsa.europa.eu/en/efsajournal/pub/3290
  8. Guidance document on Terrestrial Ecotoxicologyhttps://ec.europa.eu/food/system/files/2016-10/pesticides_ppp_app-proc_guide_ecotox_terrestrial.pdf
  9. Guidance Document on Relevant Metaboliteshttps://ec.europa.eu/food/system/files/2016-10/pesticides_ppp_app-proc_guide_fate_metabolites-groundwtr.pdf
  10. Environmental Safety Evaluation of Microbial Biocontrol Agents https://www.hse.gov.uk/pesticides/data-requirements-handbook/env-safety-micro-biocon.htm
  11. Guidance document on the assessment of the equivalence of technical materials of substances regulated under Regulation (EC) No 1107/2009https://ec.europa.eu/food/system/files/2017-01/pesticides_ppp_app-proc_guide_phys-chem-ana_subst-tech_201207.doc
  12. Guidance document on Aquatic Ecotoxicology in the frame of the Directive 91/414/EEChttps://www.hse.gov.uk/pesticides/assets/docs/Aquatic_Ecotox_3268_rev4_final.pdf
  13. Guidance Document on Risk Assessment for Birds and Mammals under Council Directive 91/414/EEChttps://www.efsa.europa.eu/en/efsajournal/pub/734
  14. List of associated referenceshttps://www.hse.gov.uk/pesticides/data-requirements-handbook/env-safety-micro-biocon.htm
  15. Birds and mammalshttps://www.hse.gov.uk/pesticides/data-requirements-handbook/birds.htm
  16. Aquatic organismshttps://www.hse.gov.uk/pesticides/data-requirements-handbook/aquatic-ecotoxicology.htm
  17. Bees and non-target arthropods (NTA)https://www.hse.gov.uk/pesticides/data-requirements-handbook/bees-and-non-target-art.htm
  18. Soil organismshttps://www.hse.gov.uk/pesticides/data-requirements-handbook/soil-organisms.htm
  19. Other areas (non-target plants and sewage treatment)https://www.hse.gov.uk/pesticides/data-requirements-handbook/other-areas.htm
  20. Amateur/home garden products: UK risk assessment schemehttps://www.hse.gov.uk/pesticides/data-requirements-handbook/ecotox-home-garden.htm
  21. Crops grown under permanent protectionhttps://www.hse.gov.uk/pesticides/data-requirements-handbook/crop-qual-per-protectio.htm
  22. Ecotoxicology - Don't forget!https://www.hse.gov.uk/pesticides/data-requirements-handbook/ecotoxicology-dont-forget.htm
  23. Formulation studies and combined risk assessment in ecotoxicology https://www.hse.gov.uk/pesticides/data-requirements-handbook/ecotoxicology/index.htm
  24. CLP environmental hazard classification and labellinghttps://www.hse.gov.uk/pesticides/assets/docs/CLP-Hazard-Classification-and-Labelling-Guidance-Note-September-2014.pdf
  25. wording on product labels of 'safety precautions'https://www.hse.gov.uk/pesticides/assets/docs/Ecotox_risk_mitigation_labelling-2015.pdf
  26. research reports useful for ecotoxicology risk assessmenthttps://www.hse.gov.uk/pesticides/data-requirements-handbook/ecotox-research-reports.htm
  27. Codes of Practicehttps://www.hse.gov.uk/pesticides/using-pesticides/codes-of-practice/index.htm
  28. Pesticide/Plant Protection Product Databaseshttps://www.hse.gov.uk/pesticides/databases/index.htm
  29. Application formshttps://www.hse.gov.uk/pesticides/applicant-guide/what-to-include-in-an-application.htm#application-form

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Updated 2025-01-08