Federal Institute for Risk Assessment, Thielallee 88-92, 14198, Berlin, Germany.
Eur J Nutr. 2009 Dec;48 Suppl 1:S15-22. doi: 10.1007/s00394-009-0077-z.
Within the framework of Codex Alimentarius, attempts are being made at international level to establish guidelines for use of nutrition and health claims. An important issue that has to be addressed is the process of scientific substantiating of claims on foods.
To provide an insight into the current step procedure of the proposed draft recommendations on the scientific basis of health claims. These Codex recommendations are intended to facilitate governments' own evaluation of health claims made by the industry.
Review of comments of governments, observers and non-governmental organizations (NGOs) and relevant references to the proposed draft recommendations of the last sessions of the Codex Committee on Nutrition and Food for Special Dietary Uses (CCNFSDU). A literature search was performed using the PubMed database.
RESULTS/CONCLUSIONS: Several proposed draft recommendations on the scientific substantiation of health claims have been considered and amended by the CCNFSDU in recent years but the work is not yet complete. The current work draws on the work of FUFOSE and PASSCLAIM and also on that of WHO and FDA. Given the important role of Codex in food safety, the draft recommendations emphasize circumstances where additional evaluation of safety or nutritional safety needs to be considered. High quality human intervention studies are the prime evidence needed to substantiate claims but there is recognition that, in some cases, only observational studies may be available. Animal and in vitro studies will also be evaluated as part of the totality of the evidence. It has been suggested that the recommendations should include re-evaluation of claims after a certain time period, or if new evidence calls into question the scientific validity underpinning the claims. Setting out a common approach for the substantiation of health claims is an important step in the use of health claims around the world. There is a need to reflect emerging as well as consensus science. The substantiating evidence should be proportionate to the claim. Further progress in the elaboration of this relevant Codex text is needed to reach consensus.
在食品法典框架内，国际上正在努力制定营养和健康声称使用准则。需要解决的一个重要问题是对食品声称进行科学证实的过程。
深入了解健康声称科学依据建议草案的现行步骤程序。这些食品法典建议旨在为各国政府自行评估行业提出的健康声称提供便利。
审查各国政府、观察员和非政府组织（NGO）的评论意见以及对食品法典营养和特殊膳食用途食品委员会（CCNFSDU）前几届会议健康声称建议草案的相关参考文献。使用 PubMed 数据库进行文献检索。
结果/结论：近年来，CCNFSDU 审议并修订了若干关于健康声称科学依据的建议草案，但工作尚未完成。目前的工作借鉴了 FUFOSE 和 PASSCLAIM 的工作，以及世界卫生组织（WHO）和美国食品药品监督管理局（FDA）的工作。鉴于食品法典在食品安全方面的重要作用，建议草案强调需要考虑额外评估安全性或营养安全性的情况。高质量的人体干预研究是证实声称所需的主要证据，但也认识到在某些情况下，可能只有观察性研究可用。动物和体外研究也将作为证据总体的一部分进行评估。有人建议，建议应包括在一定时间后重新评估声称，或者如果新证据质疑支持声称的科学有效性。为健康声称的证实制定共同方法是在全球范围内使用健康声称的重要步骤。需要反映新兴科学和共识科学。证实证据应与声称相称。需要进一步详细阐述这一相关食品法典案文以达成共识。
