Turck Dominique, Bohn Torsten, Cámara Montaña, Castenmiller Jacqueline, de Henauw Stefaan, Hirsch-Ernst Karen-Ildico, Jos Angeles, Maciuk Alexandre, Mangelsdorf Inge, McNulty Breige, Naska Androniki, Pentieva Kristina, Thies Frank, Craciun Ionut, Fiolet Thibault, Siani Alfonso
EFSA J. 2025 Apr 2;23(4):e9319. doi: 10.2903/j.efsa.2025.9319. eCollection 2025 Apr.
Following an application from Givaudan, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Italy, 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 Pacran® and defence against bacterial pathogens in the lower urinary tract. The Panel considers that the food Pacran®, a powder obtained from cranberries, is sufficiently characterised. Defence against bacterial pathogens in the lower urinary tract is a beneficial physiological effect. The applicant identified two human intervention studies which investigated the effect of Pacran® on the incidence of urinary tract infections (UTI) as being pertinent to the claim. In weighing the evidence, the Panel took into account that one human intervention study showed a beneficial effect of Pacran® consumed daily at doses of 500 mg for 6 months on the incidence of symptomatic, culture-confirmed UTI in women with a history of recurrent UTI, whereas such an effect was not consistently observed in another study under similar conditions. The Panel also took into account that limited evidence has been provided for a mechanism by which Pacran® could exert the claimed effect. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of Pacran® and the defence against bacterial pathogens in the lower urinary tract.
吉万特公司依据欧盟法规（EC）No 1924/2006第13(5)条，通过意大利主管当局提交了一份关于健康声称授权的申请。欧洲食品安全局营养、新型食品及食品过敏原专家委员会（NDA）被要求就一项与Pacran®以及下尿路细菌病原体防御相关的健康声称的科学依据发表意见。专家委员会认为，Pacran®这种从蔓越莓中提取的粉末状食品具有充分的特征描述。下尿路细菌病原体防御是一种有益的生理效应。申请人确定了两项人体干预研究，认为这两项研究调查了Pacran®对尿路感染（UTI）发病率的影响，与该声称相关。在权衡证据时，专家委员会考虑到一项人体干预研究表明，对于有复发性UTI病史的女性，每天服用500毫克Pacran®，持续6个月，对有症状的、经培养确诊的UTI发病率有有益影响，而在另一项类似条件下的研究中并未始终观察到这种效果。专家委员会还考虑到，关于Pacran®发挥声称效果的机制，所提供的证据有限。专家委员会得出结论，所提供的证据不足以确立食用Pacran®与下尿路细菌病原体防御之间的因果关系。
