FOOD AND CHEMICAL TOXICOLOGY
Food safety has been topic of some recent policy changes increased awareness among the public, and various incidents. These developments indicate that there is a need for a system that can identify food safety hazards in an early stage so that these hazards can be tackled in time, before developing into real risks. With regard to food safety hazards that are known as such, measures can be taken towards the prevention and mitigation of these hazards based on their characteristics, behavior and point of entry into the food chain. For example, good practices for agriculture and manufacturing, as well as the hazard analysis critical control points (HACPP) approach to assess risks and control them, are now commonplace in many jurisdictions. Yet it can be envisioned that for a number of risks, such measures may not be applicable given that these risks are yet unknown or unanticipated.
The overall aim of the SAFE FOODS project, which is primarily sponsored by the European Commission Directorate for Research’s Sixth Framework Program, is to further develop risk analysis of food based on inputs from advanced research in both the natural and social sciences. Among other things, this is also likely to contribute to the confidence of stakeholder in the European Union’s food safety governance. SAFE FOODS is composed of various Work Packages that more or less act as subprojects on different topics, including the use of advanced analytical methodologies to study potential effects of agricultural practices on crop composition, emerging risks in food safety, assesment of consumer exposure to food safety hazards by the use of advanced statistical techniques, confidence of consumers and other stakeholders in risk management in food safety, and instutional arrangements for food safety governance. The findings of all these Work Packages are integrated into a new model on risk analysis, which will be refined with inputs solicited from stakeholders.
The early identification of emerging hazards to food safety is also a major topic of the activities of SAFE FOODS Work Package 2. Previously, Work Package 2 has made a number of accomplishments on this topic, including the establishment of an expet database, description of a framework for timely identification of emerging hazards, reports describing systems for timely identification of emerging hazards to food safety or to hazards of another nature that can be exemplary for food safety as well, an analysis of conspicuous trends in European Union (EU) food safety alerts, and reports reviewing the background and characteristics of a seleted range of hazards to food safety caused by microorganisme, mycotoxins, biochemical and chemical agents.
Various terms with specific meanings are used throughout this report, which therefore would merit from further clarification. Where appropriate, the definitions used are in line with internationally accepted definitions published by the food and agiculture organization (FAO) and the world healt organization (WHO).
A hazard is an agent that has the potential to exert a negative effect on health. An example of a hazard in food is the presence of Salmonella bacteria that may cause gastroenteritis. The risk is defined as the negative effect of the hazard if it really occurs, which depends on the likehood of the occurence – and severity of the negative effect. (FAO, 1995, 1997)
The internationally harmonized model for scientific risk assessment is composed of four phases, namely hazard identification, hazard characterization, that is, the characteristics of specific negative health effects and the dose – response relationships between hazard and effects, exposure assessment, in which the exposure of consumers ingesting the food containing the hazard is estimated, and risk characterization, in which the outcomes of the three preceding phases are combined into an assessment and in which also uncertaintiesv are taken into account (FAO, 1995). To illustrate this with an example the hazard characterization may describe the minimum infectious dose of Salmonella, while subsequently the exposure assessment may help estimating the real dose to which consumers are exposed, so that the risk characterization can conclude on the likelihood of gastroeteritis caused by Salmonella.
Besides risk assessment, which is the scientific process assessing risks, also two other activitites, that is, risk management and risk communication, are considered to be part of the internationally acknowledged risk analysis model for food safety. During risk management, policy alternatives are weighted based upon the outcomes of the risk assessment process, and measures to control and mitigate the risks are subsequently defined, Risk communication is the process of exchange of information and opinion among the risk managers and risk assessors, managers, but also between risk profesionals, such as assessors, managers, and communicators, and other parties involved. Although preferably these activities are strictly separated from each other, some overlap cannot be avoided in practice. For example, risk managers have to formulate the policy for risk assessment such as the risk to which consideration will be given and the issues that have priority.(e.g FAO, 1997)
With regard to emerging hazards, which are the topic of this report, the emerging characteristics of these hazards may have various causes. For instance, the hazard can be new and has not occurred before. For example, certain synthetic man made substances may not occur in nature and are therefore new. In case substances are hazardous and also enter the food supply, these substances would turn into emerging food safety hazards. The same may also hold true for hazards that have only occurred in the non food area, but that also start entering the food domain. Alternatitively, hazards that once have disappeared from the food domain may enter it again, for example due to changes in practice or the termination of certain risk – eliminating measures. In addition, hazards that have previously occurred in food, but that have only recently been discovered, can be regarded emerging hazards as well.
The definition of an indicator is taken from the guide on handling indicators and signals that has been published as Annex 4 to the report of the EMRISK project, which had been carried out under auspices of EFSA. This project has carried out various activities on emerging food safety risks, including retrospective case studies on food safety incidents, and has recommended a working procedure for early identification of emerging food risks. (EFSA, 2006a).
An indicator is considered by EMRISK as an entity that indicates the posibility that a risk may occur, due to its direct or indirect relationship with the risk. A signal is defined as a substantial change in the indicator. Signals can thus be used to flag the possible occurrence of risks. The EMRISK guide also provides a number of criteria to select appropriate indicators, which will be discussed in more details in the section on EMRISK below.
Food safety has been topic of some recent policy changes increased awareness among the public, and various incidents. These developments indicate that there is a need for a system that can identify food safety hazards in an early stage so that these hazards can be tackled in time, before developing into real risks. With regard to food safety hazards that are known as such, measures can be taken towards the prevention and mitigation of these hazards based on their characteristics, behavior and point of entry into the food chain. For example, good practices for agriculture and manufacturing, as well as the hazard analysis critical control points (HACPP) approach to assess risks and control them, are now commonplace in many jurisdictions. Yet it can be envisioned that for a number of risks, such measures may not be applicable given that these risks are yet unknown or unanticipated.
The overall aim of the SAFE FOODS project, which is primarily sponsored by the European Commission Directorate for Research’s Sixth Framework Program, is to further develop risk analysis of food based on inputs from advanced research in both the natural and social sciences. Among other things, this is also likely to contribute to the confidence of stakeholder in the European Union’s food safety governance. SAFE FOODS is composed of various Work Packages that more or less act as subprojects on different topics, including the use of advanced analytical methodologies to study potential effects of agricultural practices on crop composition, emerging risks in food safety, assesment of consumer exposure to food safety hazards by the use of advanced statistical techniques, confidence of consumers and other stakeholders in risk management in food safety, and instutional arrangements for food safety governance. The findings of all these Work Packages are integrated into a new model on risk analysis, which will be refined with inputs solicited from stakeholders.
The early identification of emerging hazards to food safety is also a major topic of the activities of SAFE FOODS Work Package 2. Previously, Work Package 2 has made a number of accomplishments on this topic, including the establishment of an expet database, description of a framework for timely identification of emerging hazards, reports describing systems for timely identification of emerging hazards to food safety or to hazards of another nature that can be exemplary for food safety as well, an analysis of conspicuous trends in European Union (EU) food safety alerts, and reports reviewing the background and characteristics of a seleted range of hazards to food safety caused by microorganisme, mycotoxins, biochemical and chemical agents.
Various terms with specific meanings are used throughout this report, which therefore would merit from further clarification. Where appropriate, the definitions used are in line with internationally accepted definitions published by the food and agiculture organization (FAO) and the world healt organization (WHO).
A hazard is an agent that has the potential to exert a negative effect on health. An example of a hazard in food is the presence of Salmonella bacteria that may cause gastroenteritis. The risk is defined as the negative effect of the hazard if it really occurs, which depends on the likehood of the occurence – and severity of the negative effect. (FAO, 1995, 1997)
The internationally harmonized model for scientific risk assessment is composed of four phases, namely hazard identification, hazard characterization, that is, the characteristics of specific negative health effects and the dose – response relationships between hazard and effects, exposure assessment, in which the exposure of consumers ingesting the food containing the hazard is estimated, and risk characterization, in which the outcomes of the three preceding phases are combined into an assessment and in which also uncertaintiesv are taken into account (FAO, 1995). To illustrate this with an example the hazard characterization may describe the minimum infectious dose of Salmonella, while subsequently the exposure assessment may help estimating the real dose to which consumers are exposed, so that the risk characterization can conclude on the likelihood of gastroeteritis caused by Salmonella.
Besides risk assessment, which is the scientific process assessing risks, also two other activitites, that is, risk management and risk communication, are considered to be part of the internationally acknowledged risk analysis model for food safety. During risk management, policy alternatives are weighted based upon the outcomes of the risk assessment process, and measures to control and mitigate the risks are subsequently defined, Risk communication is the process of exchange of information and opinion among the risk managers and risk assessors, managers, but also between risk profesionals, such as assessors, managers, and communicators, and other parties involved. Although preferably these activities are strictly separated from each other, some overlap cannot be avoided in practice. For example, risk managers have to formulate the policy for risk assessment such as the risk to which consideration will be given and the issues that have priority.(e.g FAO, 1997)
With regard to emerging hazards, which are the topic of this report, the emerging characteristics of these hazards may have various causes. For instance, the hazard can be new and has not occurred before. For example, certain synthetic man made substances may not occur in nature and are therefore new. In case substances are hazardous and also enter the food supply, these substances would turn into emerging food safety hazards. The same may also hold true for hazards that have only occurred in the non food area, but that also start entering the food domain. Alternatitively, hazards that once have disappeared from the food domain may enter it again, for example due to changes in practice or the termination of certain risk – eliminating measures. In addition, hazards that have previously occurred in food, but that have only recently been discovered, can be regarded emerging hazards as well.
The definition of an indicator is taken from the guide on handling indicators and signals that has been published as Annex 4 to the report of the EMRISK project, which had been carried out under auspices of EFSA. This project has carried out various activities on emerging food safety risks, including retrospective case studies on food safety incidents, and has recommended a working procedure for early identification of emerging food risks. (EFSA, 2006a).
An indicator is considered by EMRISK as an entity that indicates the posibility that a risk may occur, due to its direct or indirect relationship with the risk. A signal is defined as a substantial change in the indicator. Signals can thus be used to flag the possible occurrence of risks. The EMRISK guide also provides a number of criteria to select appropriate indicators, which will be discussed in more details in the section on EMRISK below.
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