Science Department, University College Roosevelt, Lange Noordstraat 1, 4331 CB Middelburg, the Netherlands.
Benef Microbes. 2013 Sep;4(3):223-30. doi: 10.3920/BM2013.0019.
Probiotics are microorganisms that have a beneficial effect on the health of the host. However, before these effects can be referred to as beneficial to human health, such claims need to be evaluated by regulatory institutes such as the European Food Safety Authority (EFSA). The EFSA Panel on Dietetic Products, Nutrition and allergies (NDA) has published their opinions regarding health claims including probiotics, most of which were rejected in the past years. Using the EFSA database, the NDA dossiers published between 2005 and 2013 were analysed to provide an overview on what grounds certain health effects were accepted as beneficial and others not. The NDA Panel distinguishes between claims that are definitely beneficial, possibly beneficial or non-beneficial to human health. Overall, 78% of all analysed health claims are considered by the NDA Panel as (possibly) beneficial to human health, in particular the gut health effects. Since, in many cases, the scientific substantiation of a particular health claim was deemed insufficient, most applications were turned down. For future health claim applications concerning probiotics to be successful, they should include specific statements on what exactly the microorganism affects, and the scientific substantiation of the particular health claim should be based on the targeted (general) population.
益生菌是对宿主健康具有有益影响的微生物。然而,在这些影响可以被称为对人类健康有益之前,需要由监管机构(如欧洲食品安全局)进行评估。欧洲食品安全局(EFSA)饮食产品、营养和过敏专家组(NDA)发布了他们对包括益生菌在内的健康声称的意见,这些意见在过去几年中大多被否决。该专家组使用 EFSA 数据库,对 2005 年至 2013 年间发布的 NDA 档案进行了分析,以概述某些健康影响被认为有益而其他则不然的依据。NDA 专家组区分了对人类健康绝对有益、可能有益或无益的声称。总体而言,NDA 专家组认为,所有分析的健康声称中有 78%(可能)对人类健康有益,特别是对肠道健康的影响。由于在许多情况下,特定健康声称的科学依据被认为不足,因此大多数申请被拒绝。为了使未来与益生菌有关的健康声称申请获得成功,它们应该包括关于微生物具体影响的具体声明,并且特定健康声称的科学依据应该基于目标(一般)人群。