Scientific Opinion on the substantiation of health claims related to choline and contribution to normal lipid metabolism (ID 3186), maintenance of normal liver function (ID 1501), contribution to normal homocysteine metabolism (ID 3090), maintenance of normal neurological function (ID 1502), contribution to normal cognitive function (ID 1502), and brain and neurological development (ID 1503) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims related to choline and contribution to normal lipid metabolism, maintenance of normal liver function, contribution to normal homocysteine metabolism, maintenance of normal neurological function, contribution to normal cognitive function, and brain and neurological development. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claims is choline. The Panel considers that choline is sufficiently characterised. Contribution to normal lipid metabolism The claimed effect is choline is needed for lipids metabolism. The target population is assumed to be the general population. The Panel considers that contribution to normal lipid metabolism is a beneficial physiological effect. It is well established that choline functions as a precursor of phospholipids, and plays a role in the structural integrity of cell membranes. Phosphatidylcholine is the predominant phospholipid in cell membranes. It is also well established that choline plays a role in lipid and cholesterol transport and metabolism. The Panel concludes that a cause and effect relationship has been established between the consumption of choline and contribution to normal lipid metabolism. Maintenance of normal liver function The claimed effect is maintaining healthy liver functioning. The target population is assumed to be the general population. The Panel notes that the claimed effect refers to the maintenance of normal liver function. The Panel considers that maintenance of normal liver function is a beneficial physiological effect. It is well established that choline deficiency is associated with liver damage (elevated serum alanine aminotransferase activity) and the development of fatty liver (hepatosteatosis) in humans fed choline-free total parenteral nutrition solutions, as well as in men and post-menopausal women (but not in premenopausal women) fed choline-deficient diets or a choline-deficient diet with adequate amounts of methionine, folate and occasionally vitamin B12; these effects can be reversed by the administration of dietary choline. The Panel concludes that a cause and effect relationship has been established between the consumption of choline and maintenance of normal liver function. Contribution to normal homocysteine metabolism The claimed effect is reduction in homocysteine levels. The target population is assumed to be the general population. In the context of the proposed wordings and the references provided, the Panel assumes that the claimed effect refers to the maintenance of normal blood concentrations of homocysteine by contributing to normal homocysteine metabolism. The Panel considers that contribution to normal homocysteine metabolism is a beneficial physiological effect. In weighing the evidence, the Panel took into account that choline can be a precursor for the formation of betaine, that betaine can act as a methyl donor in the remethylation of homocysteine in the liver by the enzyme betaine-homocysteine methyltransferase, that choline depleted diets tend to increase plasma concentrations of homocysteine, that a human intervention study showed a significant decrease in plasma concentrations of homocysteine following choline administration, and that two observational studies supported the inverse association between dietary choline and blood concentrations of homocysteine. On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of choline and contribution to normal homocysteine metabolism. Maintenance of normal neurological function The claimed effect is cognitive, memory functioning; neurological functioning. The target population is assumed to be the general population. The Panel considers that maintenance of normal neurological function is a beneficial physiological effect. No references were provided from which conclusions could be drawn for the scientific substantiation of the claimed effect. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of choline and the maintenance of neurological function. Contribution to normal cognitive function The claimed effect is cognitive, memory functioning; neurological functioning. The target population is assumed to be the general population. The Panel considers that contribution to normal cognitive function is a beneficial physiological effect. No references were provided from which conclusions could be drawn for the scientific substantiation of the claimed effect. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of choline and contribution to normal cognitive function. Brain and neurological development The claimed effect is development. In the context of the proposed wordings and the clarifications provided by Member States, the Panel assumes that the claimed effect is related to brain and neurological development, which is interpreted by the Panel as children's development. The Panel notes that claims related to children's development and health are outside the scope of Article 13 of Regulation (EC) No 1924/2006. Conditions and possible restrictions of use The Panel notes that no dietary reference values for choline have been established in the EU. There are no reliable intake data and there are no indications of inadequate choline intakes available in the EU. The Panel also notes that dietary references values (adequate intakes) have been established outside the EU for different population subgroups. A nutrient content claim has been authorised in the United States based on the adequate intake for adult males (550 mg of choline per day).