Turck Dominique, Bresson Jean-Louis, Burlingame Barbara, Dean Tara, Fairweather-Tait Susan, Heinonen Marina, Hirsch-Ernst Karen Ildico, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Neuhäuser-Berthold Monika, Nowicka Grażyna, Pentieva Kristina, Sanz Yolanda, Sjödin Anders, Stern Martin, Tomé Daniel, Van Loveren Henk, Vinceti Marco, Willatts Peter, Martin Ambroise, Strain Sean J J, Siani Alfonso
EFSA J. 2018 Jul 25;16(7):e05364. doi: 10.2903/j.efsa.2018.5364. eCollection 2018 Jul.
Following an application from Han-Biotech GmbH, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Symbiosal, lowering of blood pressure and reduced risk of hypertension. The Panel considers that the food, Symbiosal, which is the subject of the health claim, and the food, table salt, which Symbiosal should replace, are sufficiently characterised. Lowering of blood pressure is a beneficial physiological effect. Increased blood pressure is a risk factor for hypertension. In weighing the evidence, the Panel took into account that one human study with some methodological limitations showed an effect of Symbiosal on blood pressure in the context of a self-selected diet with a maximum of 3 g/day added salt. The Panel also took into account that no other human studies in which these results have been replicated were provided, that the animal studies did not support the results of the human study, that no evidence was provided in support of a mechanism by which Symbiosal could induce a decrease in blood pressure upon oral consumption as compared to table salt in humans, and the low biological plausibility of the effect observed in the human intervention study. The Panel concludes that a cause and effect relationship has not been established between the consumption of Symbiosal and lowering of blood pressure.
Han-Biotech GmbH依据欧盟第1924/2006号法规第14条，通过德国主管当局提交了一份关于健康声称授权的申请。欧洲食品安全局（EFSA）的营养产品、营养和过敏专家组（NDA）被要求就一项与Symbiosal有关的健康声称的科学依据发表意见，该声称涉及降低血压和降低患高血压的风险。专家组认为，作为健康声称主题的食品Symbiosal以及Symbiosal应替代的食品食盐，均已得到充分描述。降低血压是一种有益的生理效应。血压升高是高血压的一个风险因素。在权衡证据时，专家组考虑到一项存在一些方法学局限性的人体研究表明，在自行选择的每日添加盐量最多为3克的饮食背景下，Symbiosal对血压有影响。专家组还考虑到，没有提供其他重复这些结果的人体研究，动物研究不支持人体研究的结果，没有提供证据支持Symbiosal在口服时与食盐相比能诱导人体血压下降的机制，以及人体干预研究中观察到的效应的生物学合理性较低。专家组得出结论，在食用Symbiosal与降低血压之间尚未建立因果关系。
