ID 1501 - Cholina

PL: Cholina
EN: Choline
Pdf: choline

Oświadczenie (4)

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is choline.
Choline (2-hydroxyethyl-N,N,N-trimethylammonium chloride) is a quaternary ammonium cation generally present in foods either with a chloride counterion (chloride salt) or bound to an acetyl group (acetylcholine), to a cytidine diphosphate group (citicoline) or, mainly, to a phosphatidyl group (lecithin) as in milk, liver, eggs and peanuts. Choline is also synthesised in the body. In supplements, choline is mostly present as choline chloride or as phosphatidylcholine, isolated from soy or egg yolk.
Choline is measurable in foods by established methods. This evaluation applies to choline present in foods, and to those forms consumed as food supplements.
The Panel considers that the food constituent, choline, which is the subject of the health claims, is sufficiently characterised.

2.2. Utrzymanie prawidłowego funkcjonowania wątroby (ID 1501)

The claimed effect is “maintaining healthy liver functioning”. The Panel assumes that the target population is 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.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - 

Choline is a dietary component which is also formed endogenously in the body by methylation of phosphatidylethanolamine using S-adenosylmethionine as the methyl donor. Choline functions as a precursor of acetylcholine, phospholipids and betaine, and plays a role in the structural integrity of cell membranes, in methyl metabolism, in cholinergic neurotransmission, and in lipid and cholesterol transport and metabolism. Demand for dietary choline is dependent on the metabolic methyl-group exchange relationships between choline and methionine, folate and vitamin B12. With this type of
nutrient interdependence, the designation of the essential nature of a nutrient will depend on whether de novo synthesis rates are adequate to meet the demand when other nutrients are available in amounts sufficient to sustain normal growth and function. In men with adequate folate and vitamin B12 status fed a choline-deficient diet, endogenous synthesis of choline may not be sufficient to cover needs, whereas little information is available with respect to other population subgroups (e.g. women, children and elderly subjects). The primary criterion to estimate adequate intakes of choline in the United States is the prevention of liver damage, as assessed by measuring serum alanine aminotransferase activity in the blood (IoM, 1998).
No dietary reference values for choline have been established in the EU. There are no reliable intake data, and no indications of inadequate choline intakes, available in the EU.

3.2. Utrzymanie prawidłowego funkcjonowania wątroby (ID 1501)

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 pre- menopausal women) fed choline-deficient diets (Kohlmeier et al., 2005) or a choline-deficient diet with adequate amounts of methionine, folate and occasionally vitamin B12 (da Costa et al., 2005; Fischer et al., 2007; IoM, 1998; Zeisel, 2006). These effects can be reversed by the administration of dietary choline (Buchman et al., 1992; 1995; da Costa et al., 2005). The effect of choline-deficient diets on fat accretion in the liver appears to depend on genetic variations of, for example, the 5,10-methylenetetrahydrofolate dehydrogenase, the phosphatidylethanolamine N-methyltransferase,
and/or the choline dehydrogenase genes, as well as on oestrogen status (i.e. de novo choline synthesis of phosphatidylcholine is up-regulated by oestrogen) (da Costa et al., 2006; Kohlmeier et al., 2005).
Prevention of elevated serum alanine aminotransferase activities and/or fat accretion in the liver, assessed by appropriate imaging techniques (computed tomography, magnetic resonance imaging), have been proposed as the primary criterion to estimate adequate intakes for choline (IoM, 1998).
The Panel concludes that a cause and effect relationship has been established between the consumption of choline and maintenance of normal liver function.

4.2. Utrzymanie prawidłowego funkcjonowania wątroby (ID 1501)

The Panel considers that the following wording reflects the scientific evidence: “Choline contributes to the maintenance of normal liver function”.

5. Warunki i możliwe ograniczenia stosowania oświadczenia

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 (IoM, 1998). 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).

Warunki i możliwe ograniczenia stosowania oświadczenia

The product must contain at least 15% of the AI (AI for adult males and females varies is 550 and 425 mg/day, respectively). To also present a statement that excess choline consumption (=3.5 g/day), may be associated with hypotension and/or a fishy body odour