European Food Safety Authority (EFSA)

European Food Safety Authority (EFSA)

Opinion of the Scientific Panel on Plant protection products and their residues (PPR) related to the revision of Annexes II and III to Council Directive 91/414/EEC concerning the placing of plant protection products on the market - Ecotoxicological studies

Question number: EFSA-Q-2006-170

Adopted date: 07/03/2007

application/pdf Summary

application/pdf Opinion

The PPR Panel was asked to review the Commission Working Document SANCO/10483/2006 rev.6 on the proposed data requirements for the revision of Directive 96/12/EC (ecotoxicological studies) within the framework of a revision process involving Part A of Annexes II and III of Directive 91/414/EEC concerning the placing of plant protection products on the market. In particular, the PPR Panel was asked to verify that the proposed methodology and the approaches presented in the draft data requirements are in line with the state of the art and its extent of applicability with respect to the assessment of risks posed to the ecosystem from the residues of plant protection products, present in time and space following their application.
The PPR Panel concluded that this document makes a significant contribution towards improving and better defining the data requirements in line with current scientific advancement and the experience of applying the legislation for the evaluation of risks to the ecosystem, non-target organisms, humans and animals used in food production.
However, the PPR Panel proposes that the document should be revised, taking into consideration the issues identified by the Panel, to improve precision and clarity, avoid inconsistency and to provide justification for the proposed data requirements.
In view of the numerous recommendations and suggestions made, the PPR Panel would like to refer the reader to the list of conclusions and recommendations and the detailed explanations in the opinion.
Nevertheless, the PPR Panel makes the following main recommendations:
  • Data requirements should be drafted in a way that facilitates harmonisation and uptake of future scientific developments.
  • Field testing be improved in their (statistical) power to detect effects, including reporting their power to detect effects.
  • Currently proposed triggers based on the fate (e.g. DT90) or the use (e.g. number or rate of applications) of the substance should be replaced by detailed exposure considerations (e.g. including modelling).
  • Consideration should be given to requiring more detailed information to be recorded from existing studies, such as more frequent observations in the time course effects, to avoid any need for repeating studies.
  • Given the scientific limitations and welfare costs, the use of the avian short-term dietary study should be restricted as far as possible.
  • Food avoidance of birds should be assessed not by specialised avoidance tests but with an alternative approach that makes use of information from available toxicity studies.
  • A fish full life cycle test should be used rather than separate tests of different life stages.
  • Specific testing on endocrine endpoints should be included in the respective sections for both, fish and invertebrates.
  • Given the high diversity among invertebrates, toxicity data for another taxonomic group should be included in addition to Crustaceans.
  • The data on which the current risk assessment for non-target arthropods is based (ESCORT) be made available to regulatory authorities to allow transparent evaluation.
  • The risk assessment for the terrestrial environment should be approached in a more integrated way, and include tests on structural endpoints (different species).
  • Even if there is only acute exposure, long term toxicity studies (e.g. fish, aquatic invertebrates, earthworms) should still be provided unless it can be clearly demonstrated that no adverse delayed effects (of a short term exposure) are to be expected.
  • Ecotoxicity testing (including field tests of e.g. earthworms and non-target arthropods) should generally be carried out using a dose-response design rather than single dose tests.
  • An appropriate risk assessment approach for amphibians should be developed.
  • An holistic check of all six proposed revisions to the data requirements should be carried out before they are finalised to ensure that the data requirements in each individual area of risk assessment for plant protection products are consistent with those for the other areas.
In addition to these main recommendations, the PPR Panel makes specific comments and recommendations on various sections of the draft data requirements. These are documented and explained in the opinion.

Publication date: 30/03/2007
Last updated: 30/04/2007