关键词: RBA benefit–risk food safety risk ranking risk–benefit risk–benefit assessment risk–benefit communication

来  源:   DOI:10.2903/j.efsa.2024.8875   PDF(Pubmed)

Abstract:
The EFSA Scientific Committee has updated its 2010 Guidance on risk-benefit assessment (RBA) of foods. The update addresses methodological developments and regulatory needs. While it retains the stepwise RBA approach, it provides additional methods for complex assessments, such as multiple chemical hazards and all relevant health effects impacting different population subgroups. The updated guidance includes approaches for systematic identification, prioritisation and selection of hazardous and beneficial food components. It also offers updates relevant to characterising adverse and beneficial effects, such as measures of effect size and dose-response modelling. The guidance expands options for characterising risks and benefits, incorporating variability, uncertainty, severity categorisation and ranking of different (beneficial or adverse) effects. The impact of different types of health effects is assessed qualitatively or quantitatively, depending on the problem formulation, scope of the RBA question and data availability. The integration of risks and benefits often involves value-based judgements and should ideally be performed with the risk-benefit manager. Metrics such as Disability-Adjusted Life Years (DALYs) and Quality-Adjusted Life Years (QALYs) can be used. Additional approaches are presented, such as probability of all relevant effects and/or effects of given severities and their integration using severity weight functions. The update includes practical guidance on reporting results, interpreting outcomes and communicating the outcome of an RBA, considering consumer perspectives and responses to advice.
摘要:
EFSA科学委员会更新了其2010年食品风险效益评估指南(RBA)。更新解决了方法发展和监管需求。虽然它保留了逐步的RBA方法,它为复杂的评估提供了额外的方法,例如多种化学危害和影响不同人群亚组的所有相关健康影响。更新的指南包括系统识别的方法,对有害和有益食品成分的优先排序和选择。它还提供与表征不利和有益影响相关的更新,如效应大小和剂量反应模型的测量。该指南扩展了表征风险和收益的选项,结合可变性,不确定性,不同(有益或不利)影响的严重程度分类和排名。定性或定量评估不同类型的健康影响的影响,根据问题的表述,澳洲联储问题的范围和数据可用性。风险和收益的整合通常涉及基于价值的判断,理想情况下应该与风险收益经理一起执行。可以使用诸如残疾调整寿命年(DALYs)和质量调整寿命年(QALYs)之类的指标。提出了其他方法,例如所有相关影响和/或给定严重性的影响的概率及其使用严重性权重函数的整合。最新情况包括报告结果的实际指导,解释结果并传达澳洲联储的结果,考虑消费者的观点和对建议的回应。
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