Consultant to the European Commission, Töpchiner Weg 163, D-12309 Berlin, Germany.
Regul Toxicol Pharmacol. 2011 Jun;60(1):161-4. doi: 10.1016/j.yrtph.2011.02.011. Epub 2011 Mar 5.
The Codex Alimentarius provides the food standards and guidelines recognized by the World Trade Organization as the primary authority for use in settlement of related trade disputes. Codex bases its decisions primarily on scientific principles and evidence, although other legitimate factors such as economic and societal values may be considered. Codex has two primary aims: to protect consumers' health and assure fair practices in food trade. Codex documents may provide templates for individual nations but are not binding for domestic policies. Despite many advances over the last couple of decades, misunderstandings and controversies have interfered with important aspects of progress which Codex needs to accomplish, especially in the areas of claims of benefits related to food or nutrient consumption and the establishment of the safety of these items. Claims for health benefits should be based on the totality of available scientific evidence, including observational data collected from large populations as well as the results from randomized clinical trials. Safety should be evaluated by risk assessment on high quality experimental data, with anecdotal information having a lesser role. Regulatory policy would be improved if "history of safe use" were to be better defined and described.
《食品法典》为世界贸易组织所认可的食品标准和准则提供了依据,被视为解决相关贸易争端的主要权威。《食品法典》的决策主要基于科学原则和证据,但也可能考虑其他合法因素,如经济和社会价值。《食品法典》有两个主要目标:保护消费者健康和确保食品贸易中的公平做法。《食品法典》文件可为各国提供模板,但对国内政策不具有约束力。尽管在过去几十年取得了许多进展,但误解和争议干扰了《食品法典》需要完成的重要方面的进展,特别是在与食品或营养素消费相关的益处声称以及这些物品的安全性方面。健康益处的声称应基于现有科学证据的总体情况,包括从大人群中收集的观察性数据以及随机临床试验的结果。安全性应通过高质量实验数据的风险评估来评估,轶事信息的作用较小。如果能够更好地定义和描述“安全使用历史”,则监管政策将会得到改善。