Turck Dominique, Bohn Torsten, Castenmiller Jacqueline, De Henauw Stefaan, Hirsch-Ernst Karen Ildico, Knutsen Helle Katrine, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pentieva Kristina, Thies Frank, Tsabouri Sophia, Vinceti Marco, Bresson Jean-Louis, Fiolet Thibault, Siani Alfonso
EFSA J. 2023 Jul 26;21(7):e08115. doi: 10.2903/j.efsa.2023.8115. eCollection 2023 Jul.
Following an application from Procter & Gamble BV pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the 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 choline and contribution to normal liver function of the foetus and exclusively breastfed infant. The scope of the application was proposed to fall under a health claim referring to children's development and health. The Panel considers that choline is sufficiently characterised. The claimed effect proposed by the applicant is contribution 'to normal foetal and infant development, especially liver'. The proposed target population is 'unborn fetuses and breastfed infants'. Choline is involved in the structure of cell membranes, cell signalling, metabolism and transport of lipids and cholesterol and neurotransmitter synthesis. Although choline can be synthesised de novo by the human body, depletion-repletion studies in humans show that low choline intake leads to liver dysfunction and muscle damage, which are reverted by the administration of dietary choline. For these functions, de novo synthesis of choline by the human body is insufficient and choline must be obtained from dietary sources. No human studies have addressed the effect of low maternal dietary choline intake on liver function in the fetus or exclusively breastfed infants. However, the Panel considers that the biological role of choline in normal liver function and dietary choline being essential for the function applies to all ages, including fetus and infants. The Panel concludes that a cause and effect relationship has been established between the intake of choline by pregnant and lactating women and contribution to normal liver function of the fetus and exclusively breastfed infants.
应宝洁公司荷兰分公司依据欧盟第1924/2006号法规第14条规定通过比利时主管当局提交的申请,营养、新型食品及食品过敏原专家委员会(NDA)被要求就一项与胆碱及对胎儿和纯母乳喂养婴儿正常肝功能的贡献相关的健康声明的科学依据发表意见。该申请的范围拟归入一项涉及儿童发育和健康的健康声明。专家委员会认为胆碱具有充分的特征描述。申请人提出的声称效果是“对胎儿和婴儿的正常发育,尤其是肝脏发育”有贡献。拟议的目标人群是“未出生胎儿和母乳喂养婴儿”。胆碱参与细胞膜结构、细胞信号传导、脂质和胆固醇的代谢与运输以及神经递质的合成。虽然人体能够从头合成胆碱,但人体的耗竭 - 补充研究表明,胆碱摄入量低会导致肝功能障碍和肌肉损伤,而通过膳食补充胆碱可逆转这些情况。由于这些功能,人体从头合成胆碱是不足的,胆碱必须从膳食来源获取。尚无人体研究探讨孕妇膳食胆碱摄入量低对胎儿或纯母乳喂养婴儿肝功能的影响。然而,专家委员会认为胆碱在正常肝功能中的生物学作用以及膳食胆碱对该功能的必要性适用于所有年龄段,包括胎儿和婴儿。专家委员会得出结论,已确定孕妇和哺乳期妇女摄入胆碱与对胎儿和纯母乳喂养婴儿正常肝功能的贡献之间存在因果关系。