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NOAEL of 0.2 mg kgbw 1 day 1 calculated for rats; MoEs of 200 and 50 were calculated for mean and high-level consumers. JECFA calculated MoEs of 2000 and 500 for mean and high-level consumers for reproductive, developmental, and non-neoplastic effects. Based on these MoEs, it was concluded that adverse neurological, reproductive, and developmental effects are unlikely for the average consumer, but that morphological changes in nerves cannot be excluded for individuals with very high intake of acrylamide. To date, a number of epidemiology studies have investigated possible associations between dietary intake of acrylamide and the incidence of several types of cancer in humans (96 100). The majority of these studies have failed to show an association; however, a recent study in Dutch women showed an increase in ovarian cancer incidence that reached statistical signi cance (101). Many of the negative studies lack suf cient power to detect effects on cancer incidence, partly due to the relatively small difference between high- and lowlevel intake. The uncertainty surrounding dietary estimates of acrylamide, due to the large variability between individual foods, is a further limitation in these studies. A recent epidemiology study in postmenopausal women (102) used hemoglobin adducts in blood taken when the women joined the study. The use of hemoglobin adducts as a biomarker of total exposure to acrylamide removes the uncertainty associated with dietary intake estimations, but only represents a limited snapshot of exposure, which may not re ect the whole duration of cancer development. This study appears to show an increase in incidence of breast cancer associated with acrylamide exposure, although required complex adjustment for cigarette smoking, which is an additional source of acrylamide exposure. Clearly, further work is required. A number of epidemiology studies are ongoing. The US FDA and associated agencies are carrying out a suite of studies on acrylamide and glycidamide as part of the FDA Action Plan for Acrylamide. Several short-term studies have been completed (80, 103 107); however, the results of long-term studies that will give a clearer picture of the situation are not expected until 2008.
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The issue of acrylamide in food is a developing area. Owing to the lack of understanding concerning the mechanisms of formation of acrylamide and the mechanism of toxicological effect, regulators have not opted to set maximum levels for acrylamide in foods. Instead, many government organizations/ authorities have opted to focus on effective mitigation strategies and monitoring activities, often working with industry toward solving the problem. In Europe, regulators have worked with researchers and manufacturers to develop the Acrylamide Toolbox (43) and a series of brochures (108) that describe current strategies for reducing acrylamide concentrations in a variety of foods and beverages. In 2002, the US FDA published its Draft Action Plan
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for Acrylamide in Food (12). This plan outlined how the US FDA planned to tackle the issue of acrylamide in food; it has been updated, with the latest version published in 2004 (109). Other countries have conducted research in order to inform risk assessment and risk management measures. The European Union and its member states have compiled an online database containing information on those research projects being undertaken in the European Union (110). A similar database is also maintained by the Joint Institute for Food Safety and Applied Nutrition (111). Recently, the European Commission issued European member states with a recommendation to monitor acrylamide in a variety of foods known to contain high levels, with the aim of obtaining a clear picture of the current levels of acrylamide across Europe (112). The US FDA has undertaken annual acrylamide monitoring, using the Total Diet Study format. Exposure estimates have also been calculated on a regular basis, although no apparent changes in acrylamide intake over time have been observed (75). 2.1.8.1 HEATOX Project
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The European Commission funded the HEATOX Project, a large multidisciplinary project, from 2003 to 2007. The project involved 24 partners from 14 countries and aimed to estimate the health risks associated with hazardous compounds found in heat-treated foods and to establish cooking/processing methods that could minimize the occurrence of these compounds in foods. The project focused mostly on acrylamide, but other heat-generated toxicants such as furan and hydroxymethylfurfural (HMF) were also studied. The project produced outputs in the areas of formation, analysis, hazard characterization, risk assessment, and risk characterization. Some advice was also issued from the project board to European industry and governments. Further details of the HEATOX project are available at www.heatox.org. 2.1.8.2 CIAA Acrylamide Toolbox
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The latest version of the CIAA Acrylamide Toolbox (see Section 2.1.5) was published in November 2007 (43). The toolbox was developed over several years and re ects the results of industry cooperation. The document describes a number of mitigation strategies that can be employed to reduce acrylamide levels in a variety of different foods. Primarily aimed to assist individual manufacturers with technical knowledge but limited research and development capability, the Toolbox describes parameters that can be manipulated to control acrylamide levels; these parameters are divided into four groups: agronomy, recipe, processing, and nal preparation. Information for the toolbox was taken from a variety of research papers and presentations from various international meetings, as well as some activities coordinated by various trade associations. CIAA states that the Toolbox is a living document, which should be treated as a catalogue of tried and tested
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