National Institute for Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA Bilthoven, The Netherlands.
Food Chem Toxicol. 2012 Jan;50(1):5-25. doi: 10.1016/j.fct.2011.06.010. Epub 2011 Jun 12.
Benefit-risk assessment in food and nutrition is relatively new. It weighs the beneficial and adverse effects that a food (component) may have, in order to facilitate more informed management decisions regarding public health issues. It is rooted in the recognition that good food and nutrition can improve health and that some risk may be acceptable if benefit is expected to outweigh it. This paper presents an overview of current concepts and practices in benefit-risk analysis for food and nutrition. It aims to facilitate scientists and policy makers in performing, interpreting and evaluating benefit-risk assessments. Historically, the assessments of risks and benefits have been separate processes. Risk assessment is mainly addressed by toxicology, as demanded by regulation. It traditionally assumes that a maximum safe dose can be determined from experimental studies (usually in animals) and that applying appropriate uncertainty factors then defines the 'safe' intake for human populations. There is a minor role for other research traditions in risk assessment, such as epidemiology, which quantifies associations between determinants and health effects in humans. These effects can be both adverse and beneficial. Benefit assessment is newly developing in regulatory terms, but has been the subject of research for a long time within nutrition and epidemiology. The exact scope is yet to be defined. Reductions in risk can be termed benefits, but also states rising above 'the average health' are explored as benefits. In nutrition, current interest is in 'optimal' intake; from a population perspective, but also from a more individualised perspective. In current approaches to combine benefit and risk assessment, benefit assessment mirrors the traditional risk assessment paradigm of hazard identification, hazard characterization, exposure assessment and risk characterization. Benefit-risk comparison can be qualitative and quantitative. In a quantitative comparison, benefits and risks are expressed in a common currency, for which the input may be deterministic or (increasingly more) probabilistic. A tiered approach is advocated, as this allows for transparency, an early stop in the analysis and interim interaction with the decision-maker. A general problem in the disciplines underlying benefit-risk assessment is that good dose-response data, i.e. at relevant intake levels and suitable for the target population, are scarce. It is concluded that, provided it is clearly explained, benefit-risk assessment is a valuable approach to systematically show current knowledge and its gaps and to transparently provide the best possible science-based answer to complicated questions with a large potential impact on public health.
食品和营养的受益-风险评估相对较新。它权衡了一种食品（成分）可能产生的有益和有害影响，以便更明智地管理公共卫生问题。它的基础是认识到良好的食品和营养可以改善健康，并且如果预期受益大于风险，那么一些风险可能是可以接受的。本文概述了食品和营养受益-风险分析的当前概念和实践。它旨在为科学家和决策者进行、解释和评估受益-风险评估提供便利。从历史上看，风险和收益的评估是分开进行的。风险评估主要由毒理学来完成，这是法规的要求。它传统上假设可以从实验研究（通常在动物中）中确定最大安全剂量，并且应用适当的不确定性因素然后定义人类群体的“安全”摄入量。风险评估中还有其他研究传统的次要作用，例如流行病学，它量化了人类中决定因素与健康影响之间的关联。这些影响既可以是不利的，也可以是有益的。受益评估在监管方面是新发展的，但在营养和流行病学方面已经是长期的研究课题。确切的范围尚未确定。降低风险可以称为收益，但也探索了超越“平均健康”的状态作为收益。在营养方面，当前的兴趣在于“最佳”摄入量；从人群的角度来看，但也从更个体化的角度来看。在当前结合受益和风险评估的方法中，受益评估反映了传统的风险评估范式，即危害识别、危害特征描述、暴露评估和风险特征描述。受益-风险比较可以是定性的，也可以是定量的。在定量比较中，收益和风险用共同的货币表示，其输入可以是确定性的，也可以是（越来越多）概率性的。提倡采用分层方法，因为这允许透明度、在分析中尽早停止以及与决策者进行临时交互。受益风险评估所依据的学科中的一个普遍问题是，缺乏良好的剂量-反应数据，即在相关摄入水平下适用于目标人群的数据。结论是，只要解释清楚，受益风险评估就是一种有价值的方法，可以系统地展示当前知识及其差距，并以对公共卫生有重大潜在影响的复杂问题提供最有可能基于科学的答案。
