Turck Dominique, Castenmiller Jacqueline, De Henauw Stefaan, Hirsch-Ernst Karen Ildico, Kearney John, Knutsen Helle Katrine, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pelaez Carmen, Pentieva Kristina, Thies Frank, Tsabouri Sophia, Vinceti Marco, Bresson Jean-Louis, Siani Alfonso
EFSA J. 2021 Jul 2;19(7):e06660. doi: 10.2903/j.efsa.2021.6669. eCollection 2021 Jul.
Following an application from Pharmactive Biotech Products, S.L. submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to affron and contributes to maintain a healthy mood. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is affron, an aqueous saffron extract with a content of the sum of crocins and safranal typically between 3.5% and 3.9%. The Panel notes that affron is sufficiently characterised. The claimed effect proposed by the applicant is 'contributes to maintain a healthy mood'. The Panel notes that increase in positive mood is a beneficial physiological effect for individuals with low mood or anxiety. One human intervention study showed that consumption of affron at a dose of 28 mg/day for 4 weeks improves mood in a population of adults with low mood. However, the results have not been replicated in other studies. The information supplied by the applicant did not provide evidence for a plausible mechanism by which affron could exert the claimed effect. The Panel concludes that the evidence is insufficient to establish a cause and effect relationship between the consumption of affron and increase in positive mood.
根据Pharmactive Biotech Products, S.L. 的申请,其通过西班牙主管当局依据欧盟第1924/2006号法规第13(5)条提交了一项健康声称授权申请,欧洲食品安全局营养、新型食品和食品过敏原专家小组(NDA)被要求就一项与藏红花相关且有助于维持健康情绪的健康声称的科学依据发表意见。该申请的范围被提议属于基于新科学证据的健康声称。申请人提议作为健康声称主题的食品是藏红花,一种藏红花水提取物,其中藏花素和藏红花醛的总含量通常在3.5%至3.9%之间。专家小组指出藏红花具有充分的特征描述。申请人声称的效果是“有助于维持健康情绪”。专家小组指出,积极情绪的增加对情绪低落或焦虑的个体来说是一种有益的生理效应。一项人体干预研究表明,每天服用28毫克藏红花,持续4周,可改善情绪低落的成年人群体的情绪。然而,其他研究并未重复这一结果。申请人提供的信息未提供藏红花能够发挥声称效果的合理作用机制的证据。专家小组得出结论,证据不足以确立食用藏红花与积极情绪增加之间的因果关系。