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World climate, environmental and other global changes would have wide-ranging and, mostly, adverse consequences for human health. These changes are a significant and emerging threat to public health, including the growing season, variability of crop yields and water demands. In this chapter, the Risk Assessment of Chemicals in food as a part of risk analysis process have been addressed.
World climate, environmental and other global changes would have wide-ranging and, mostly, adverse consequences for human health. These changes are a significant and emerging threat to public health, including the growing season, variability of crop yields and water demands. In this chapter, the Risk Assessment of Chemicals in food as a part of risk analysis process have been addressed.
World climate, environmental and other global changes would have wide-ranging and, mostly, adverse consequences for human health. These changes are a significant and emerging threat to public health, including the growing season, variability of crop yields and water demands. In this chapter, the Risk Assessment of Chemicals in food as a part of risk analysis process have been addressed.
), Understanding and Managing Threats to the Environment in South
Eastern Europe, NATO Science for Peace and Security Series C: Environmental Security, DOI 10.1007/978-94-007-0611-8_16, Springer Science+Business Media B.V. 2011 Abstract World climate, environmental and other global changes would have wide-ranging and, mostly, adverse consequences for human health. These changes are a significant and emerging threat to public health, including the growing season, variability of crop yields and water demands. Above mentioned factors have been influenced in areas of food security and food safety and moreover the food indus- try struggle for profits. These factors control the conditions and affect the use of chemicals in the agriculture and food industry. In this chapter, the risk assessment of chemicals in food as a part of risk analysis process have been addressed. We would like to point out the importance of this process in the area of public health and consumer protection. Through food and nutrition products and most often misleading advertisements, people are exposed to different hazards that could have severe harmful consequences. Among the consumer groups, children are mostly vulnerable because of their adult dependencies, age and body weight. In this chap- ter, an example of risk assessment of exposure to food additives among preschool children in Slovenia is evaluated. E. Miovi (*) Faculty of Criminal Justice and Security, University of Maribor, Kotnikova 8, 1000 Ljubljana, Slovenia e-mail: elizabeta.micovic@gmail.com M. Gorenjak Faculty of Medicine, University of Maribor, Maribor, Slovenia and Faculty of Agriculture and Life sciences, University of Maribor, Maribor, Slovenia G. Meko Faculty of Criminal Justice and Security, Institute of Security Strategies, University of Maribor, Kotnikova 8, 1000 Ljubljana, Slovenia e-mail: gorazd.mesko@fvv.uni-mb.si A. Cenci Faculty of Agriculture and Life sciences, University of Maribor, Maribor, Slovenia and Faculty of Medicine, University of Maribor, Maribor, Slovenia Chapter 16 Risk Assessment of Chemicals in Food for Public Health Protection Elizabeta Miovi, Mario Gorenjak, Gorazd Meko, and Avrelija Cenci 294 E. Miovi et al. 16.1 Introduction Living in a risk society as a parallel to the rapid changes witnessed in all spheres of life indicates the growth of various threats. Constantly changing circumstances in a society are increasing the number of hazards. As humans convert more land, water, and ecosystem services for their own use, the environmental changes resulting from these activities are combining to magnify several serious public health threats including exposure to infectious disease, food scarcity, water scarcity, air pollution, natural disasters, and population displacement. Taken together, these represent the greatest public health challenge of the twenty-first century. One of them is climate change, which threatens human health in numerous and profound ways. Large segments of the population will experience more heat waves, altered exposure to infectious disease and more frequent natural disasters. Climatic disruption threatens health for large populations around the globe: sufficient food and nutrition, safe water for drinking and sanitation, fresh air to breathe, and secure homes to live in. Such a society with such a lifestyle would certainly have to adjust the responsiveness of a good organization coordinated team of experts in various fields, in addition to a strategic consideration (thinking), should agree measures of the ability to realize them operational (Heines et al. 2000). Although altered exposure to infectious disease receives much of our attention, the most important impacts of global change on human health are likely to result from reduced access to food and safe water. As the human population expands, world agricultural production will roughly double over the next 50 years to keep up with projected demand (Myers and Patz 2009). Food production is already facing significant ecological constraints including limits to arable land, water scarcity, soil nutrient depletion, and biological limits to increasing crop yields. Climate change will further challenge food production through myriad mechanisms and is expected to reduce yields significantly in many regions of the world particularly those where food scarcity is already endemic (McMichael et al. 1996; Heines et al. 2000; Gregory et al. 2005; WMO 2007). One of the results of all these new conditions in food production is also using chemi- cals with the aim to achieve sufficient quantities of food (food security), which has to be of good quality and safe (food quality and food safety) (FAO/WHO 2002; Unnevehr 2003). Worrying risk factors, such as chemicals that are in the food are invisible, just as their effects are not immediately visible. These risks are set out as acceptable risks, especially given the fact that it has not developed adequate methods of determining the exact exposure to these risk factors and their impact on health (Beck 2001). It is urgent to reduce ecological disruption while simultaneously strengthening the resilience of populations to withstand the impacts of unavoidable environmental change (Vanderlinden et al. 2005). Therefore, it is important to develop a strong tool to analyse risk, special hazards and effects on health of consumers. In response to some unwanted and unexpected incidents of non-food, safety system is a risk analysis developed to be a tool for early detection of risks, facilitating the prompt effective action. Risk analysis is based on a database of research results to scientific and sociological sciences. Results of risk analysis contribute to trust all those 295 16 Risk Assessment of Chemicals in Food for Public Health Protection involved in the system and to ensure safe food (Kleter and Marvin 2009). Management risk analysis involves combining activities related to risk assessment, risk management and risk communication, and is used to guide the adoption of administrative decisions at the national and international level, including in the areas of trade (Buchanan et al. 2004). Risk assessment is a scientific process that usually begins in order to define the reasons for the request, risk assessment and efficiency of implementation. Risk assessors are responsible for scientific evaluation whether a formal risk assessment is necessary or not (Benford 2001; Mack et al. 2006). The challenge of risk is that these risks represent a potent political charge, and potential political challenge. Identifying the risks, risk assessment and risk manage- ment can lead to a reorganization of power and responsibilities in the society. Therefore, the development of the risk of conflict developed between those who seek to risk and those who profit from them. It is important to have sufficient information to enable it to research potential risks carefully investigated and can be regarded as acceptable or unacceptable (Teuschler and Hertzberg 1995; Beck 2001; Newburn 2007). It is very important to change way we protect the vulnerable populations. Children are one of the most vulnerable populations as they are more heavily exposed to environmental toxins than adults. In this chapter, an example study among preschool childrens exposure to food additives in food they consumed and risk assessment of such exposure have been addressed. Food intake of preservatives, polyphosphates, sweeteners and colours was observed with aim to find out if such exposure is an acceptable or unacceptable risk for children included in this study. 16.2 Consumer as Possible Victim of Invisible Threats Consumers by definition, include us all. They are the largest economic group, affecting and affected by almost every public and private economic decision. Furthermore, consumers are the only important group whose views are often not heard (Kennedy 1962). A consumer is a person who buys goods or services for personal needs and not for resale or use in the production of other goods for resale (Zakon o varstvu potronikov [ZVPot-UPB2] 2004). Routine Activity Theory (RAT) is one of the main theories of environmental criminology. Criminologists Lawrence Cohen and Marcus Felson have worked for a number of years on crime prevention theory. RAT states that for a crime to occur, three elements must be present at the same time and in the same place: a suitable target is available, there is the lack of a suitable guardian to prevent the crime from happening and likely a motivated offender is present (Cohen and Felson 1979). All three elements from the theory in the area of food safety are recognized the motivated offender as the food industry, the suitable targets as consumers and the lack of a suitable guardian as insufficient official control. It is also important that opportunity for the commission of misleading, abuse or even crime occur. Opportunity is crucial in many deviant activities and can be related to a potential victim (a consumer), routines (practices) or places (interactions). 296 E. Miovi et al. Consumers also expect a wide range of competitively priced, highly processed and convenient food products of consistently high quality. They expect it to be fresh, good looking, nutritious, wholesome, tasty and it must be primarily and absolutely safe. On the other hand, consumers have no direct means for the verifica- tion of their expectancies and have to rely completely on the food legislators and enforcement agencies (Anklam and Battaglia 2001). Consumers could be victims of food poisoning, food adulteration and food frauds, misleading food content (labelling), misleading indications, misleading descriptions, misleading pictures, and food packaging (Jin and Kato 2004; Gibson and Taylor 2005; Tombs 2008; Croall 2009). In todays technological age, a reactive response to the consumer fraud is neither efficient nor effective (Holtfreter et al. 2005). A guideline for consumer protection provides eight basic consumer rights inter- preted from the food safety point of view (Harland 1987; Hogarth and English 2002): The Right to Safety to be protected against threats that are hazardous to health or life. The Right to Information to be protected against fraudulent, deceitful or grossly misleading information, advertising, labelling, or other practices and to be given the facts s/he needs to make an informed choice. The Right to Choose to be assured, wherever possible, access to a variety of products and services at competitive prices: and in those industries where com- petition is not workable and Government regulation is substituted, an assurance of satisfactory quality and service at fair prices. The Right to be heard to be assured that consumer interests will receive full and sympathetic consideration in the formulation of Government policy, and fair and expeditious treatment in its administrative tribunals. Consumers are privileged to have human rights. However, they come with certain responsibilities too to seek, to evaluate and to use available information on products and services in order to make healthier and better decisions. In case of exposure to different chemicals in food, consumers know that food products consist of addi- tives, but they do not know the quantity. Total intake is unknown, so how could consumers be sure that the consumed food is safe? It is very important to consider different sensitivities of populations, especially among infants and children. 16.3 Food Safety The main challenge in the area of agriculture is to provide sufficient quantities of food, which have to be of good quality and safe. Food production and food consumption are the primary aspects of our lives and are therefore subject to our care. To achieve these goals the agriculture and food industry has to use in their production different chemi- cals such as pesticides and food additives. Without the use of chemicals the yields of fields will reduce, food production and the earnings will be considerably smaller. With using chemicals, the benefits are visible, but the risks are often invisible. Chemicals can have negative effects on us and make us vulnerable (Beck 2001). 297 16 Risk Assessment of Chemicals in Food for Public Health Protection Safe food is food that is free not only from toxins, pesticides, chemical and physical contaminants, but also from microbiological pathogens such as bacteria and viruses that can cause illness (Golob and Jamnik 2004). There are main concerns regarding food safety. Consuming food is a daily routine activity throughout lifetime. It is very important that such food does not cause health risks to consumers. Possible hazards in food are microorganisms, viruses, contaminants (toxins, heavy metals), pesticides and other chemicals. Consumer could be concerned and afraid of such hazards, but in many cases one does not know the exact quantity of exposure and exact effect on his health. Therefore, it is very important to be aware of possibility of invisible threats in food, especially because of the fact that all three elements from RAT in the food safety area have been recognized. The food industry has a strong motive to make profit and many opportunities to manage it. The food operators try to convince consumers that they need their products. The food industry uses all sorts of food additives, ingredients and advertising tactics to achieve better sales (Cheftel 2005). The food industry can also be involved in corporate crimes committed directly against the consumers. Examples include the sale of unfit goods, the provision of unfit services, false/illegal labelling or information, selling unsafe food, poisonings, etc. (Jin and Kato 2004; Gibson and Taylor 2005; Tombs 2008; Croall 2009). On the market, companies make money by providing goods to consumers, and consumers pay for goods received. Consumers have the legal right to be protected (Xu and Yuan 2009). The long-term health of consumers is also jeopardised by the use of foods and other consumer products of a vast range of chemicals and other substances that, while associated with long- term health risks, do not result in imme- diate harm. While there is a growing public concern about the number of foods and consumer issues, these facts have a lower political and governmental profile than the occupational health and safety or the safety of the environment (Croall 2009). The main authority concerns, regarding food safety, are to protect interests of public health, interests of food producers (economic view) and the consumer interests and their rights. It is not easy to make the right decision and to achieve all that goals in practice at the same time. Recognizing possible invisible threats could assure better consumer protection. Furthermore, knowing all the risks of invisible threats in the food area help us to make corrective measures on time. These measures could make the system for food safety more effective and give consumers better protection. The big challenge in the area of food safety for consumer health is recognition of possible invisible threats on time. This can help us to set up effective response regarding those threats and risk assessment. Identifying all potential hazards that have to be assessed, eliminating or reducing them to acceptable levels, are the most important activities for achieving consumer protection, specially their basic right to safety. 16.3.1 Risk Analysis Public health decisions on the plausible risks of chemical exposures can include several possible outcomes. The ultimate goal is to implement a risk management action that will produce the desired reduction of risk. A risk analysis paradigm is a formal 298 E. Miovi et al. representation of a process that distinguishes the scientific bases from the risk management objectives and generally contains a component where the probability of harm is estimated. The overall risk analysis process includes risk assessment, risk manage- ment and risk communication, and involves political, social economic and technical considerations. Moreover, there is consensus among scientists that risk assessment should be an independent scientific process, distinct from measures taken to control and manage the risk. Risk assessors are responsible for scientific evaluation whether a formal risk assessment is necessary or not (Benford 2001). As a probability calculation, a risk assessment will include both a statement of the objective under consideration (harm) and the basis for the assertion that the harm may occur (probability). Risk man- agement is the decision-making process involving the consideration of political, social, economic and technical factors with relevant risk assessment information relating to a hazard so as to develop, analyse, select and implement appropriate risk mitigation options. Risk management is comprised of three elements: risk evaluation, emission and exposure control and risk monitoring (WHO 2004). Risk management strategies may be regulatory, advisory or technological and take into account factors such as the size of the exposed population, resources required and available, costs of implementation and the scientific quality and cer- tainty of the risk assessment. Risk managers are responsible for judgements con- cerning the acceptability of risk; they have to weigh risk against other factors including costs, benefit and social values, so called risk benefit approach. Risk communication should include interactive exchange of information and opinions among risk assessors, risk managers, consumers and all other interested parties, often called stakeholders (Benford 2001). 16.3.1.1 Risk Assessment Exposure to the Chemicals in the Food Risk is defined as the chance or probability of an adverse health effect occurring and severity of that effect (Benford 2001). Risk assessment is a scientific process, conducted by scientific experts, who may begin with a statement of purpose intended to define the reasons that the risk assessment is required and support the aims of the subsequent stages of risk management. Chemical risk assessment often does not have a formal statement of purpose (Benford 2001). Generally, formal risk assessments are preceeded by preliminary risk assessments. These are usually sub- jective and informal and could be initiated from inside or outside the risk assess- ment and scientific communities. A key consideration of these preliminary risk assessments is whether a formal risk assessment is necessary or not (WHO 2004). However, risk assessment could be defined implicitly in a generic form, as in the terms of reference of an expert committee, such as Joint FAO/WHO or JECFA. In this context, it concerns the definition of acceptable or tolerable levels of intake for a chemical in food that may require review and revision in the light of new informa- tion. It is a very important fact that risk assessment may need to be quantified dif- ferently for persons with different degrees of susceptibility. Risk assessment for chemical agents requires consideration of the factors mentioned before and these 299 16 Risk Assessment of Chemicals in Food for Public Health Protection are generally encompassed within the stages of the overall risk assessment process, defined as hazard identification, hazard characterisation, exposure assessment risk- characterisation (Benford 2001). Hazard identification is the process of identifying of the type and nature of adverse health effects [human studies-epidemiology, animal based toxicology studies, in-vitro toxicology studies, structure-activity studies (cell cultures, tissue slices)]. Hazard characterization involves the derivation of a level of exposure at or below which there would be no appreciable risk to health if the chemicals were to be consumed daily throughout life. Exposure assessment is evaluation of concentra- tion or amount of a particular agent that reaches a target population: magnitude, frequency, duration, route, extent. Risk characterization is the stage of risk assess- ment that integrates information from exposure assessment and risk characteriza- tion into advice suitable for use in decision-making (Benford 2001). The fact is that people could be exposed to different chemicals that pass from environment to food such as contaminants, food additives, pesticides, heavy metals, toxins, detergents etc. (De Muelenaer 2006). They could represent a threat to humans, especially, because they are invisible. The vast majority of toxicity studies and risk evaluations deal with single chemicals. In reality, people are exposed to large numbers of chemicals via multiple routes (Feron and Groten 2002). So far, possible effects of a mixture of all chemicals and interactions between them, so called cocktail effect, have not been understood fully. Food additives are typically used in combination within processed foods and therefore collectively may have some adverse effects at the cellular level, even if their individual concentrations are below the recommended acceptable daily intake (ADI) value (Lau et al. 2005). The basic concept underlying any chemical risk assessment is the dose-response relationship. As described by Paracelsus nearly 500 years ago, All substances are poisons; there is none which is not a poison. The right dose differentiates a poison and a remedy (Winter and Francis 1997). This means that any chemical substance is likely to produce some form(s) of harmful effect, if taken in sufficient quantity. Experts refer to a potential harmful effect as a hazard associated with that sub- stance. The definition of hazard is a biological, chemical or physical agent with the potential to cause an adverse health effect (Unnevehr 2003; Raspor 2004; Armstrong 2009). While this may be appropriate with respect to pathogenic organ- isms, chemical substances may be associated with a number of different adverse health effects, not all of which would necessarily be expressed in a specific expo- sure scenario. Therefore, experts dealing with chemical substances prefer to define the potential health effects as individual hazards, which need to be considered sepa- rately during the evaluation. The likelihood or risk of that hazard actually occurring in humans is dependent upon the quantity of chemical encountered or taken into the body, i.e. the exposure. The hazard is an inherent property of a chemical substance, but if there is no exposure, then there is no risk that anyone will suffer because of that hazard. Risk assessment is the process of determining whether a particular hazard will be expressed at a given exposure level, duration and timing within the life cycle, and if so the magnitude of any risk is estimated (Benford 2001). Among the first 300 E. Miovi et al. objectives of a risk assessment is the determination of the presence or absence of a cause-effect relationship. If there is sufficient plausibility for the presence of such a relationship, then dose-response modelling (DRM) information is needed. The procedures used to estimate exposure to chemical contaminants in food are essentially the same as those used for food additives (DiNovi and Kuznesof 2006). Exposure assessment should cover the general population, as well as critical groups that are vulnerable or are expected to have exposures that are significantly different from those of the general population, for example infants, children, pregnant women, or the elderly (WHO 2005). 16.3.1.2 Acceptable Daily Intake and Estimated Daily Intake of Food Additives The concept of the ADI is internationally accepted today as the basis for estimation of safety of food additives and pesticides, for evaluation of contaminants and by this, for legislation in the area of food and drinking water. The ADI (Tables 16.116.3) is Table 16.1 Acceptance daily intake of preservatives and polyphosphates Preservatives E number ADI (mg/kg bw/day) Sorbic acid E 200 025 (JECFA a , 1973) Bensoic acid E 210 05 (JECFA, 2002) Nitrate E 251 03.7 (SCF b ; JECFA 2002) Nitrite E 250 00.07 (JECFA, 2002) Sulphur dioxide E 220 00.7 (JECFA, 1973) Polyphosphates (E 450-452) 070 (JECFA, 19822001) a,
b Acceptable daily intakes have been derived from toxicological studies by the former EU Scientific Committee on Food (SCF) and by the WHO/ FAO Joint Expert Committee on Food Additives and Contaminants Table 16.2 Acceptable daily intake of colours Colours E number ADI (mg/kg bw/day) Tartrazine E 102 07.5 (EFSA a , 2009) Quinolyne yellow E 104 00.5 (EFSA, 2009) Sunset yellow FCF E 110 01.0 temporary (EFSA, 2009) Azorubine E 122 04 (EFSA, 2009) Amaranth E 123 00.5 (JECFA, 1975) Ponceau red 4R E 124 00.7 (EFSA, 2009) Erythrosine E 127 00.1 (JECFA) Allura red AC E 129 07 (EFSA, 2009) Patent blue V E 131 01 (JECFA, 1969) Brilliant Indigotine E 132 05 (JECFA, 1974) Blue FCF E 133 012.5 (JECFA, 1969) Brilliant black PN E 151 01 (JECFA, 1981) a European Food Safety Authority 301 16 Risk Assessment of Chemicals in Food for Public Health Protection an estimate of the amount of a food additive, expressed on a body weight basis that can be ingested daily over a lifetime without appreciable health risk (WHO 1987). Although ADI is derived from the safety assessment of each food additive, their combined adverse effects are unclear and have not been widely studied. Food additives are typically used in combination within processed foods and therefore, collectively may have some adverse effects at the cellular level, even if their individual concentrations are below the recommended ADI value (Lau et al. 2005). Dose response modelling (DRM), used as quantitative risk assessment tool for public health recommendations about chemical exposures, can be described as a six-step process. The first four steps-data selection, model selection, statistical analyses, and parameter estimation-constitute doseresponse analysis. The fifth step involves the integration of the results of the doseresponse analysis with esti- mates of human exposure. The final step involves an assessment of the quality of the doseresponse analysis and the sensitivity of model predictions to the assump- tions used in the analysis. Extrapolation is a fundamental problem in the quantitative health risk assessment of exposure to chemicals that are toxic to human in experimental systems. Adverse health effects of chemicals are, in the absence of human data, typically evaluated in laboratory animals at significantly higher doses than the levels to which humans may be exposed. Moreover, the data obtained in animals are very often misleading, as the animals used usually do not respond to the toxic compounds in the same way as humans (WHO 2004). The acceptable daily intake (ADI) is used widely to describe safe levels of intake; other terms that are used are the reference dose (RfD) and tolerable intakes that are expressed on either a daily (TDI or tolerable daily intake) or weekly basis. The weekly designation is used to stress the importance of limiting intake over a period of time for such substances (Herman and Younes 1999). In order to calculate an ADI using the data from toxicity studies, the lowest dose should ideally result in no effects under the conditions of the particular study. That dose may be termed as the No Observed Effect Level (NOEL). Observed effects are referred to because assumptions cannot be made about effects not detectable by the methods used. Some effects observed in toxicity studies may represent adaptive responses with no implications for the health status of the animal and would generally not be used as the basis for establishing an ADI. Effects that are considered to result in harm to the animal are referred to as adverse, and therefore some expert com- mittees use the expression No Observed Adverse Effect Level (NOAEL) (Benford 2001). When using this approach no-observed-adverse-effect levels (NOAELs) are Table 16.3 Acceptable daily intake of sweeteners Sweeteners E number ADI (mg/kg bw/day) Saccharin E 954 05 (JECFA, 1993) Cyclamate E 952 011 (JECFA, 1982) Acesulfame K E 950 015 (JECFA, 1990) Aspartame E 951 040 (JECFA, 1981) 302 E. Miovi et al. identified in the critical studies, to which appropriate safety or uncertainty factors are applied. Although the value of safety factors varies depending upon a number of factors, 100 is most often used, which is designed to account for interspecies and interspecies variations (Herman and Younes 1999). ADI = NOAEL/100 Estimated daily intake (EDI) is value of chemical exposure, which can be deter- mined by combining food consumption data with data on the concentration of addi- tives in food. The resulting dietary exposure estimate is afterwards compared with the relevant toxicological or nutritional reference value for the food additive concern, for example acceptable daily intake (ADI) or tolerable daily intake (TDI) (WHO 2005). Usually EDI is expressed as percentage of value of ADI for each food additive. If EDI is lower or the same as ADI, there is no concern regarding such exposure and we can assume that food additive intake among the observed population repre- sent no risk. If EDI is higher or the same as ADI, than exact risk assessment should be done on a case-by-case base, and risk managers should decide and take effective measurements. 16.4 Example of Risk Assessment Among Preschool Children in Slovenia The purpose of research was to assess if food additives intake could be a possible threat to the health of preschool children. It is assumed that intake of each food additive separately could not be so high or greater than ADI. However, the total intake of all food additives per day is unknown. It is assumed that higher exposure to food additives is in relation to appearance with possible harm reactions among observed children. In the first place, it is necessary to find out the exact exposure to food intake and consumed food additives: preservatives, polyphosphates, sweet- eners and colours as they shown in Figs. 16.1 and 16.2. 16.4.1 Methodology 16.4.1.1 Observed Population Among randomly selected regions in Slovenia, we selected kindergartens and all children aged 26 years. Initially, the study included 250 children, representing all children of one section of selected kindergartens. Due to incomplete data, 60 cases were excluded from analysis. Therefore, the total number of children used in this study were 190, 98 boys and 92 girls. Anthropometric measurements of experimen- tal children groups were conducted as for example data regarding their age and gender, weight and height. In the selected group, boys and girls were divided into two groups regarding their age: 23.9 years and 3.96 years. 303 16 Risk Assessment of Chemicals in Food for Public Health Protection 16.4.1.2 Food Consumption Data The dietary intake is generally based on the 3-day-weighed record method in the kindergartens and food diary at homes. In the kindergartens subject to the research, we have weighed quantities of individual foods and dishes, randomly chosen and Fig. 16.1 Food intake among observed children Fig. 16.2 Intake of food additives: preservatives, polyphosphates, colours and sweeteners 304 E. Miovi et al. offered to the observed children. Data were calculated by average day and body weight of each child included into research. Food intake (g) = food offered (g) waste food on the plate (g) From these data, we have obtained the exact amount of food eaten by each child in three days. Specific types of food it has divided regarding to their characteristics in the following categories as shown Table 16.4. It was considered those food cat- egories in a particular food or otherwise adds any additives, which are the subject of our research. These are mainly processed industrially prepared food. 16.4.1.3 Estimated Daily Intake of Food Additives Food additives set in Tables 16.116.3 are included in the research. These are pre- servatives: sorbic acid (E 200), benzoic acid (E 210), nitrate (E 251), nitrite (E 250), sulphur dioxide (E 220); emulsifiers: polyphosphates (E 450-452); sweeteners: cyclamate (E 952), saccharin (E 954), aspartame (E 951), acesulfame K (E 950) and colours: tartrazine (E 102), quinoline yellow (E 104), sunset yellow FCF (E 110), azorubine (E 122), amaranth (E 123), ponceau red 4R (E 124), erythrosine (E 127), allura red AC (E 129), patent blue V (E 131), brilliant indigotyne (E 132), brilliant blue FCF (E 133), brilliant black PN (E 151). To estimate the daily intake of food additives we had to combine food consump- tion data with data on the concentration of additives in food. Calculation of the average daily consumption of specific groups of food per body weight for each child was made. The data from databases obtained from the official control and monitoring on food additives content in different food categories were used. EDI = food additive concentration x food consumption per body weight To calculate how much of each additive, the children daily ingested per kg body weight, food additives were added together, equal and shared with the childs body weight expressed in kg and thus received the additive value in mg/kg body weight. Table 16.4 Food categories Food category Food product Non-alcoholic beverages Coca-cola, ice-tea Fat spreads Margarine, butter Bakery products Bread, cookies, pastry Fruit products Dried fruits, jams, candied fruits Confectionary products Chocolate like products, cream cakes, milk cakes Meat products Salami, pate, hot-dogs Snacks Salty snacks 305 16 Risk Assessment of Chemicals in Food for Public Health Protection 16.4.1.4 Comparison Between ADI and EDI To assess safety of food additives exposure, we compare acceptable daily intake (ADI) of each food additive with estimated daily intake (EDI). The estimated daily intake (EDI) of each additive is acceptable and safe if its value is lower or the same as ADI. To determine safety assessment among observed children EDI was com- pared with ADI, and expressed in percentage of ADI. 16.4.2 Results 16.4.2.1 Food Consumption Data Estimated dietary intake of food is the first important data for making successful assessment of exposure to any agent in the food (Fig. 16.1). The most eaten food categories among observed children are milk products and bakery products. Dietary intake of non-alcoholic beverages, meat products and confectionary products is not so high than consumption of milk and bakery products. 16.4.2.2 Estimated Daily Intake of Food Additives From results of analytical tests from official control, we can calculate how much exactly consumed food contains each food additive. All additives were divided into group of preservatives and polyphosphates, sweeteners and colours. The conclusion is that observed children eat more preservatives and polyphosphates than sweeteners and colours. As Fig. 16.2 shows, the higher intake of food additives expressed in mg/kg body weight, are among older children, 46 years old girls. 16.4.2.3 Results of Comparison Between EDI and ADI of Each Group of Food Additives Results of safety assessment regarding relation between EDI and ADI of food addi- tive show that intake of each group of additive is acceptable and safe. Figure 16.3 presents estimated daily intake of sweeteners EDI expressed as percentage of ADI. The average exposure to sweeteners does not achieve 1% of ADI. Average exposure to colours reaches very low values from 0 to 1,1% ADI. It is interesting that average exposure to preservatives and polyphosphates (EDI) achieves almost 30% of ADI. It is obvious that the higher exposure among food additives belongs to preservatives and polyphosphates. It could be concluded that basic food products that are eaten very often by children (few times a day) contain preservatives and polyphosphates. Such food products are bakery products, meat products and fruit products. 306 E. Miovi et al. Regarding exposure to different sweeteners as Fig. 16.3 shows, the highest intake is intake of cyclamate, intake of aspartame is the lowest. Neither one average exposure of sweetener exceeds 1% ADI. Exposure to sweeteners is very low and only cyclamate is consumed by almost all groups of children. Figure 16.4 presents EDIADI relationship of preservatives and polyphosphates. It is evident that average exposure to nitrites and sulphite dioxide is relatively high, Fig. 16.3 EDIADI relationship of sweeteners Fig. 16.4 EDIADI relationship of preservatives and polyphosphates 307 16 Risk Assessment of Chemicals in Food for Public Health Protection the highest among older children. Intake of benzoic acid, sorbic acid, nitrates and polyphosphates is not so high. In compare to sweeteners and colours, the highest level of exposure belongs to preservatives and polyphosphates. Figure 16.5 presents intakes of food colours expressed as EDIADI relationship. Exposure to colours among observed children are low. It is apparent that intake among older children is higher especially for erythrosine (E 127) and quinoline yellow (E 104). Such average exposure (around 1% of ADI) is very low and does not represent risk for observed children. 16.5 Conclusion The human health risk assessment of food constituents is an internationally agreed and well-established process, being an integral part of the risk analysis process, which also includes risk management and risk communication. These three elements are separate tasks, performed by different player, and are parts of an interactive process. The risk assessment of chemicals in food is a purely scientific process that requires expertise in toxicology, nutrition and exposure assessment. The risk man- agement includes an identification of the food safety problem, consideration of its magnitude, seriousness, and consequently the way of handling it. In this process, the risk manager may include cost-benefit considerations before deciding how to manage the case (ban the compound, introduce limitations, provide specific dietary advice or accept the status quo). Finally, the risk analysis has to include a clear and interactive risk communication with consumers, industry and other stakeholders. In this contribution an example of risk assessment is presented, special exposure assessment of food additives among preschool children. In research 190 children Fig. 16.5 EDIADI relationship of colours 308 E. Miovi et al. were included, 92 girls and 98 boys, aged 26 years. It is apparent that such exposure does not present any harm or threat to observed children, regarding comparison between estimated daily intake (EDI) and acceptable daily intake (ADI) of each food additive. 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