Kroes R, Müller D, Lambe J, Löwik M R H, van Klaveren J, Kleiner J, Massey R, Mayer S, Urieta I, Verger P, Visconti A
Utrecht University, Institute for Risk Assessment Sciences (IRAS), Faculty of Veterinary Medicine, Yalelaan 2, PO Box 80176, NL-3508 TD, Utrecht, The Netherlands.
Food Chem Toxicol. 2002 Feb-Mar;40(2-3):327-85. doi: 10.1016/s0278-6915(01)00113-2.
Exposure assessment is one of the key parts of the risk assessment process. Only intake of toxicologically significant amounts can lead to adverse health effects even for a relatively toxic substance. In the case of chemicals in foods this is based on three major aspects: (i) how to determine quantitatively the presence of a chemical in individual foods and diets, including its fate during the processes within the food production chain; (ii) how to determine the consumption patterns of the individual foods containing the relevant chemicals; (iii) how to integrate both the likelihood of consumers eating large amounts of the given foods and of the relevant chemical being present in these foods at high levels. The techniques used for the evaluation of these three aspects have been critically reviewed in this paper to determine those areas where the current approaches provide a solid basis for assessments and those areas where improvements are needed or desirable. For those latter areas, options for improvements are being suggested, including, for example, the development of a pan-European food composition database, activities to understand better effects of processing on individual food chemicals, harmonisation of food consumption survey methods with the option of a regular pan-European survey, evaluation of probabilistic models and the development of models to assess exposure to food allergens. In all three areas, the limitations of the approaches currently used lead to uncertainties which can either cause an over- or underestimation of real intakes and thus risks. Given these imprecisions, risk assessors tend to build in additional uncertainty factors to avoid health-relevant underestimates. This is partly done by using screening methods designed to look for "worst case" situations. Such worse case assumptions lead to intake estimates that are higher than reality. These screening methods are used to screen all those chemicals with a safe intake distribution. For chemicals with a potential risk, more information is needed to allow more refined screening or even the most accurate estimation. More information and more refined methods however, require more resources. The ultimate aims are: (1) to obtain appropriate estimations for the presence and quantity of a given chemical in a food and in the diet in general; (2) to assess the consumption patterns for the foods containing these substances, including especially those parts of the population with high consumption and thus potentially high intakes; and (3) to develop and apply tools to predict reliably the likelihood of high end consumption with the presence of high levels of the relevant substances. It has thus been demonstrated that a tiered approach at all three steps can be helpful to optimise the use of the available resources: if relatively crude tools - designed to provide a "worst case" estimate - do not suggest a toxicologically significant exposure (or a relevant deficit of a particular nutrient) it may not be necessary to use more sophisticated tools. These will be needed if initially high intakes are indicated for at least parts of the population. Existing pragmatic approaches are a first crude step to model food chemical intake. It is recommended to extend, refine and validate this approach in the near future. This has to result in a cost-effective exposure assessment system to be used for existing and potential categories of chemicals. This system of knowledge (with information on sensitivities, accuracy, etc.) will guide future data collection.
暴露评估是风险评估过程的关键部分之一。即使是相对有毒的物质,只有摄入毒理学上具有显著意义的量才会导致健康不良影响。就食品中的化学物质而言,这基于三个主要方面:(i)如何定量确定单个食品和饮食中化学物质的存在,包括其在食品生产链过程中的变化;(ii)如何确定含有相关化学物质的单个食品的消费模式;(iii)如何综合考虑消费者大量食用特定食品的可能性以及这些食品中高水平存在相关化学物质的可能性。本文对用于评估这三个方面的技术进行了批判性审查,以确定当前方法为评估提供坚实基础的领域以及需要改进或期望改进的领域。对于后一类领域,提出了改进方案,例如,开发泛欧食品成分数据库、更好地了解加工对单个食品化学物质影响的活动、统一食品消费调查方法并定期进行泛欧调查、评估概率模型以及开发评估食品过敏原暴露的模型。在所有这三个领域中,当前使用的方法的局限性导致了不确定性,这可能会导致对实际摄入量以及因此产生的风险的高估或低估。鉴于这些不精确性,风险评估人员倾向于纳入额外的不确定性因素以避免与健康相关的低估。部分原因是使用旨在寻找“最坏情况”的筛选方法。这种更坏情况的假设导致摄入量估计高于实际情况。这些筛选方法用于筛选所有具有安全摄入量分布的化学物质。对于具有潜在风险的化学物质,需要更多信息以进行更精细的筛选甚至最准确的估计。然而,更多信息和更精细的方法需要更多资源。最终目标是:(1)对食品和总体饮食中给定化学物质的存在和数量进行适当估计;(2)评估含有这些物质的食品的消费模式,特别是那些高消费人群以及因此可能高摄入量的人群的消费模式;(3)开发并应用工具来可靠地预测在存在高水平相关物质的情况下高端消费的可能性。因此已经证明,在所有三个步骤中采用分层方法有助于优化可用资源的使用:如果旨在提供“最坏情况”估计的相对粗略的工具未表明存在毒理学上显著的暴露(或特定营养素的相关缺乏),则可能无需使用更复杂的工具。如果最初表明至少部分人群摄入量高,则将需要这些工具。现有的实用方法是对食品化学物质摄入量进行建模的第一步粗略尝试。建议在不久的将来扩展、完善并验证这种方法。这必须产生一个具有成本效益的暴露评估系统,用于现有和潜在的化学物质类别。这个知识体系(包含关于敏感性、准确性等的信息)将指导未来的数据收集。