Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface waters

pesticides, formulations, metabolites, ecotoxicology, aquatic organisms, specific protection goals, regulatory acceptable concentrations
First published in the EFSA Journal
18 Julio 2013
20 Junio 2013
Last Updated
5 Agosto 2013. This version replaces the previous one/s.


EFSA’s Panel on Plant Protection Products and their Residues (PPR) was tasked to revise the Guidance Document (GD) on Aquatic Ecotoxicology under Council Directive 91/414/EEC (SANCO/3268/2001 rev.4 (final), 17 October 2002). This Guidance of the PPR Panel is the first of three requested deliverables within this mandate. It has its focus on tiered acute and chronic effect assessment schemes with detailed guidance on tier 1 and higher tier effect assessments for aquatic organisms in edge-of-field surface waters and on proposals regarding how to link effects to exposure estimates. The exposure assessment methodology was not reviewed and it is assumed that the current FOCUS surface water exposure assessment methodology will continue to be used for exposure assessment at EU level. The current GD is intended to be used for authorisation of active substances at EU level as well as for plant protection products at Member State level. The effect assessment schemes in this GD allow for the derivation of regulatory acceptable concentrations (RACs) on the basis of two options: (1) the ecological threshold option (ETO), accepting negligible population effects only, and (2) the ecological recovery option (ERO), accepting some population-level effects if ecological recovery takes place within an acceptable time period. In the tiered effect assessment schemes, in principle, all tiers (1, 2 and 3) are able to address the ETO, while the model ecosystem approach (tier 3), under certain conditions, is able to also address the ERO. The GD provides the scientific background for the risk assessment to aquatic organisms in edge-of-field surface waters and is structured to give detailed guidance on all assessment steps. An executive summary joining all parts of the guidance and decision schemes in a concise way is provided and is intended to help applicants and regulatory authorities in day-to-day use.

Panel members at the time of adoption

Alf Aagaard, Theo Brock, Ettore Capri, Sabine Duquesne, Metka Filipic, Antonio F. Hernandez-Jerez, Karen I. Hirsch-Ernst, Susanne Hougaard Bennekou, Michael Klein, Thomas Kuhl, Ryszard Laskowski, Matthias Liess, Alberto Mantovani, Colin Ockleford, Bernadette Ossendorp, Daniel Pickford, Robert Smith, Paulo Sousa, Ingvar Sundh, Aaldrik Tiktak, Ton Van Der Linden
Panel on Plant Protection Products and their Residues
pesticides.ppr [at]
EFSA Journal 2013;11(7):3290
Question Number
On request from