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:
- a list of ecotoxicology guidance
- information about specific groups of organisms
- UK guidance for products
- classification and labelling
- research reports
(items are also included on pages referring to specific organisms where appropriate)
Current Guidance Documents
- EFSA Guidance document for Risk Assessment for Birds and Mammals (EFSA-Q-2009-00223).
- Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface waters (EFSA Journal 2013; 11(7):3290)
- Guidance document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev.2, final) (pdf)
- Guidance Document on Relevant Metabolites (SANCO/221/2000 rev10 25 Feb 2003) (pdf)
- Environmental Safety Evaluation of Microbial Biocontrol Agents (SANCO/12117/2012 –rev. 0 (September 2012))
- Guidance document on the assessment of the equivalence of technical materials of substances regulated under Regulation (EC) No 1107/2009 (SANCO/10597/2003 –rev. 10.1, 13 July 2012)
Previous EU Guidance Documents
- Guidance document on Aquatic Ecotoxicology in the frame of the Directive 91/414/EEC (SANCO/3268/2001 rev.4, final, 17 October 2002)
- Guidance Document on Risk Assessment for Birds and Mammals under Council Directive 91/414/EEC (SANCO/4145/2000, Sept 2002) (pdf) (List of associated references)
Information about specific groups of organisms
- Birds and mammals
- Aquatic organisms
- Bees and non-target arthropods (NTA)
- Soil organisms
- Other areas (non-target plants and sewage treatment)
UK guidance for products
- Crops grown under permanent protection – explanation of the crop qualifier 'Permanent protection with full enclosure'
- Ecotoxicology - Don't forget!- a checklist of common problems with applications for product authorisations.
Formulation Studies in Ecotoxicology
For applications considered under Regulation 1107/2009 (as it applies in Great Britain and Northern Ireland) the formal requirements for Ecotoxicology formulation testing are laid out in Part A, Section 10, Annex to the Regulation 284/2013. UK specific formulation guidance is also available as outlined in the HSE formulation guidance. This HSE guidance provides advice on the need for ecotoxicology formulation studies and their use in risk assessment, along with how to consider the combined risk for relevant groups. Formal sections of the data requirements and existing guidance documents are presented together with additional guidance. Applicants are advised to read this document before deciding on a formulation testing strategy.
All product applications for products with multiple active substances should contain the appropriate aquatic and /or combined bird and mammal risk assessments. For the majority of applications HSE does not require new data - a reasoned case is sufficient. See guidance (.docx) - Microsoft Word document for further information.
Classification and labelling
Environmental Hazard Classification and Labelling under CLP Regulation
This is a brief guide to CLP environmental hazard classification and labelling 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' 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.
There is a list of research reports useful for ecotoxicology risk assessment.