Directorate-General for Health and Food Safety
In line with its procedures for stakeholder dialogue, published on 15 September 2007, the European Commission is launching a public consultation on the above-mentioned preliminary opinion. The Stakeholder Dialogue Procedure is now implemented in the Rules of Procedure (Annex IV) of the Scientific Committees set up by Commission Decision 2008/721/EC of 5 September 2008.
The Inter-Committee Coordination Group of the non-food Scientific Committees serving the European Commission established a joint Working Group for 1) reviewing risk assessment procedures and new challenges for risk assessment taking into account both fundamental and practical considerations (sampling, instrumentation, cost, analysis, etc.), and to provide a scientific discussion paper on the issue. The motivation for this review has been the perception that as a consequence of advances in scientific knowledge as well as in modelling and measuring techniques, the procedures currently used for human and environmental risk assessment are required and anticipated to change substantially over the next few decades.
The main challenge for ecological risk assessment is to develop tools that take account of the complexity of the potentially exposed ecosystems and enable assessment of site-specific effects. The exposure considerations involve: verification and harmonization of physico-chemical data; new and improved models for polar and ionized chemicals and metals; methods for characterization the exposure to nanomaterials; criteria and protocols for obtaining and comparing monitoring data. In terms of effects considerations, the identified priorities for improvements are: assessment of the effects of variable exposure due to space and time variability of chemical concentrations; development of improved models to examine the vulnerability of aquatic and terrestrial ecosystems to different kinds of stressors, particularly for site-specific risk assessment; improvement of knowledge on the interactions of toxicants with other environmental factors in natural ecosystems; improvement of the application of trait-based ecological risk assessment; development of ecological models capable to describe and predict direct and indirect effects of stress factors on structure and functions of ecosystems; etc.
As regards human-health risk assessment, there is a trend/need to change the basis of risk assessment from the one based on standard tests to one that is centred on modes of action. A paradigm shift is likely from a hazard-driven process to one that is exposure driven. Achieving this will require major improvements in the assessment of exposure to individual chemicals and groups of chemicals. Major changes are also expected in the identification and characterisation of hazards to humans. The development of alternatives to using laboratory animals for the identification and characterisation of hazardous properties of chemicals is a priority because of the political, ethical, and other pressures to reduce the use of laboratory animals for testing purposes. In investigations using laboratory animals, increasing importance should be directed to characterising the mode of action with less emphasis to endpoints based on histopathological criteria, body and organ weight, and blood chemistry.
Please note that this discussion paper has been approved for public consultation in view of receiving feedback from stakeholders for its further development.
Submission of comments
The preliminary opinion can be found at:
All interested parties are invited to submit their comments and proposals on the preliminary opinion to the following website:
The deadline for submission of comments is 30 November 2012.
1. In line with the transparency principle outlined in the Rules of Procedure of the Scientific Committees set up by Commission Decision 2008/721/EC of 5 September 2008, all submissions and the names of the submitters in response to this public consultation may be made available to the general public via SANCO's website.
2. Only comments submitted in accordance with the Rules of Procedure(Annex IV) will be taken into account.