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益生菌在欧洲和世界其他地区的健康影响和健康声称的监管问题:祝福的升华。

The ascent of the blessed: regulatory issues on health effects and health claims for probiotics in Europe and the rest of the world.

机构信息

1 Science Department, University College Roosevelt, Lange Noordstraat 1, 4331 CB Middelburg, the Netherlands.

出版信息

Benef Microbes. 2018 Sep 18;9(5):717-723. doi: 10.3920/BM2017.0196. Epub 2018 May 25.

DOI:10.3920/BM2017.0196
PMID:29798707
Abstract

The outcome of the first series of health claim applications for probiotics in Europe as evaluated by the European Food Safety Authority (EFSA) has, up to 2013 almost completely yielded negative results. All recent applications also have been rejected, including the latest on prevention of mastitis in breastfeeding mothers. In other developed countries, such as Switzerland, Japan and Canada, the health effects of probiotics, for which scientific evidence has been provided, can be communicated to potential consumers. The number of clinical trials with probiotics over recent years shows a trend to level off or even decline. At the same time, clinical research into the role of (gut) microbiota in a wide variety of diseases and conditions is booming. Ultimately, this may offer new indications for gut microbiota management by probiotics, prebiotics or other food supplements.

摘要

截至 2013 年,欧洲食品安全局 (EFSA) 评估的第一批益生菌健康声称申请的结果几乎完全为否定。所有最近的申请也都被拒绝了,包括最新的预防哺乳期母亲乳腺炎的申请。在其他发达国家,如瑞士、日本和加拿大,对于已经提供科学证据的益生菌的健康效果,可以向潜在消费者进行宣传。近年来,益生菌临床试验的数量呈持平甚至下降的趋势。与此同时,针对(肠道)微生物群在各种疾病和病症中的作用的临床研究正在蓬勃发展。最终,这可能为通过益生菌、益生元或其他膳食补充剂来管理肠道微生物群提供新的适应症。

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