Scientific Opinion on the substantiation of health claims related to betaine and contribution to normal homocysteine metabolism (ID 4325) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

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 in relation to betaine and contribution to normal homocysteine metabolism. 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 claim is betaine. The Panel considers that betaine is sufficiently characterised. The claimed effect is \u201cheart health and vascular system\u201d. 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 relates 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 betaine can act as a methyl donor in the remethylation of homocysteine in the liver by the enzyme betaine-homocysteine methyltransferase, and that human intervention studies consistently show a significant decrease in plasma concentrations of homocysteine following betaine administration. The Panel concludes that a cause and effect relationship has been established between the consumption of betaine and contribution to normal homocysteine metabolism. The Panel considers that in order to obtain the claimed effect, 1.5 g of betaine should be consumed daily. The target population is the general population. The Panel notes that daily doses of betaine 4 g may significantly increase total and LDL-cholesterol concentrations in the blood