FOSIE : The Project
A multidisciplinary European network was set up to critically assess the current knowledge in Risk Assessment and to examine the science base for new qualitative and quantitative methodologies used in assessing risks from chemical substances in the food chain. A gap analysis was conducted to identify research needs in the area.
The project was addressed by “Individual Theme Groups” (ITGs) comprising collaborators with specialised expertise in the theme areas of Hazard Identification and Characterisation, Intake Assessment and Epidemiology, and Risk Characterisation. The ITGs reviewed current methods, reliability and limitations, identified knowledge gaps and defined research needs. ITG assessments in hazard identification, characterization and exposure were integrated into a holistic assessment of the scientific base for risk assessment. The ITG assessments in these areas were a) published, and b) integrated into an overall holistic assessment of the scientific basis of Risk Assessment and potential scientific innovations, and of the requirements within, and interactions between, the theme areas.
The aim was to provide a measure of consensus of the ways in which Risk Assessment should be conducted in various situations and of the research needed to improve the process. The document focused on principles and guidelines.
Background
The traditional approach of “risk assessment” to ensure the toxicological safety of our food supply relies principally on the application of large uncertainty factors to the maximum no adverse effect dose determined from (long-term) animal studies. This traditional approach can be considered as a form of hazard characterisation but not a risk assessment as it does not quantify the actual risk of an adverse effect occurring at a certain exposure.
The objectives of a quantitative risk assessment are to derive a mathematical statement, based on the probability of certain events, of the chance of adverse health consequences resulting from exposure to an agent capable of causing harm (FAO/WHO Expert Consultation, 1995). However, it is not well defined how risk assessment should be performed in practice and there is no agreement on requirements of each stage in the risk assessment process or how some components of the overall database should be applied.
In practice this leads to a different assessment of risks for the same compounds in different countries, even when using the same database of information. Furthermore, it is questionable if the classical test methods and risk assessment procedures used for industrial chemicals are applicable for food ingredients. Improved risk assessment of the probability of adverse effects occurring following consumption of food components must be based on a well-founded scientific process.
In this context an EC Concerted Action on Food Safety in Europe (FOSIE): Risk Assessment of Chemicals in Food and Diet was funded via the EU 5th Framework programme. The aim of this project was to establish a multidisciplinary European network to critically examine and further develop qualitative and quantitative methodologies to assess risks from food-borne hazards. Such methodologies may derive from existing knowledge or through the identification of gaps in knowledge where further research is needed to refine and improve the methodology.
The following Individual Theme Groups (ITG) were established to address all steps involved in risk assessment and seek to integrate them in the most relevant manner for assessing risk.
Hazard Identification
- ITG A: Application and potential of in vitro toxicology
- ITG B: Animal-based methodology
Hazard Characterisation
- ITG C: Mathematical modelling
- ITG D: Biologically based methodology
Exposure Assessment
- ITG E: Assessment of intake from the diet
- ITG F: Epidemiological techniques relating exposure to outcome
Subsequently, the output of the ITG A—F will be integrated in a holistic appraisal of characterisation and quantification of risk.
Risk Characterisation
- ITG G: Characterisation and quantification of risk
The titles of the ITGs are only general headlines and do not express the full scope of issues that were addressed.
The following categories of "compounds" have to be considered:
- Low-molecular chemicals: additives, contaminants, natural toxins, processing aids, packaging migrants
- Micronutrients, food supplements and fortified foods
- Macronutrients, whole foods
- Novel Foods (except genetically modified foods)[1]
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[1] Novel foods were defined as separate category in accordance with the EC legislation. However it has to be noted that a novel food can fall into one of the other categories and can be evaluated accordingly.