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 Jj, Siani Alfonso
EFSA J. 2018 Mar 13;16(3):e05192. doi: 10.2903/j.efsa.2018.5192. eCollection 2018 Mar.
Following an application from TA-XAN AG, submitted for authorisation of a health claim pursuant to Article 13(5) 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 xanthohumol in XERME , a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage. 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 xanthohumol in XERME , a xanthohumol-enriched roasted malt extract. The Panel considers that xanthohumol in XERME , a xanthohumol-enriched roasted malt extract, is sufficiently characterised. The claimed effect proposed by the applicant is 'helps to maintain the integrity of DNA and protects against oxidative damage in the cells of the body'. The Panel considers that protection of DNA from oxidative damage is a beneficial physiological effect. The only human study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of xanthohumol in XERME on the protection of DNA from oxidative damage. In the absence of evidence for an effect of xanthohumol in XERME on the protection of DNA from oxidative damage, the studies provided by the applicant on the proposed mechanisms by which the food/constituent could exert the claimed effect were not considered by the Panel for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of xanthohumol in XERME , a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage.
TA-XAN AG依据欧盟法规（EC）No 1924/2006第13(5)条，通过德国主管当局提交了一份关于健康声明授权的申请，欧洲食品安全局（EFSA）的营养产品、营养与过敏专家组（NDA）被要求就XERME（一种富含黄腐酚的烘焙麦芽提取物）中黄腐酚与保护DNA免受氧化损伤相关的健康声明的科学依据发表意见。该申请的范围被提议归入基于新的科学证据的健康声明。申请人提议作为健康声明主题的食品是XERME中的黄腐酚（一种富含黄腐酚的烘焙麦芽提取物）。专家组认为XERME中的黄腐酚（一种富含黄腐酚的烘焙麦芽提取物）具有充分的特征描述。申请人声称的效果是“有助于维持DNA的完整性并保护身体细胞免受氧化损伤”。专家组认为保护DNA免受氧化损伤是一种有益的生理效应。唯一一项可为该声明的科学依据得出结论的人体研究并未显示XERME中的黄腐酚对保护DNA免受氧化损伤有作用。由于缺乏XERME中的黄腐酚对保护DNA免受氧化损伤有作用的证据，专家组在对该声明进行科学论证时未考虑申请人提供的关于该食品/成分可能发挥声称效果的拟议机制的研究。专家组得出结论，在食用XERME（一种富含黄腐酚的烘焙麦芽提取物）中的黄腐酚与保护DNA免受氧化损伤之间尚未建立因果关系。
