Before a pesticide is approved, the risk to non-target organisms has to 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 eg vertebrate mortalities. The information provided 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.
Sections included on this page:
- Ecotoxicology guidance list
- Links to pages giving Information about specific groups of organisms
- UK Guidance for products
- Classification and labelling
- Research Reports
Ecotoxicology guidance list (list items are also included on pages referring to specific organisms where appropriate)
Current EU 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 in the context of Directive 91/414/EEC (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))
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)
Links to further pages giving 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”
- Ecotox - Don't forget! - a checklist of common problems with applications for product authorisations.
Formulation Studies in Ecotoxicology
This guidance provides advice on the need for Ecotox. formulation studies and their use in risk assessment. Formal sections of the Dir. 91/414/EEC (Annex III requirements) and existing SANCO guidance documents are presented together with additional CRD guidance. Applicants are advised to read this document before deciding on a formulation testing strategy.
From 1st April 2012, CRD will expect all product applications for products with multiple active substances to contain the appropriate aquatic and /or combined bird and mammal risk assessments. For the majority of applications CRD do not require new data - a reasoned case is sufficient. See guidance for further information.
Classification and labelling
CRD Guidance on Environmental Hazard Classification and Labelling under the ‘CLP Regulation’
This brief CRD guidance covers CLP environmental hazard classification and labelling for active substances and ‘mixtures’ (ie formulated products). The guidance is not intended to be definitive and more comprehensive guidance is included on ECHA’s website at http://echa.europa.eu/regulations/clp/classification
CRD Guidance on Environmental Safety Precautions and Risk Mitigation for Plant Protection Products in the UK
This CRD guidance provides 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 (EU) 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.
Key research reports useful for ecotox risk assessment.