ID 1502 - Cholina

PL: Cholina
EN: Choline
Pdf: choline

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.

2.4. Utrzymanie prawidłowego funkcjonowania układu nerwowego (ID 1502)

The claimed effect is “cognitive, memory functioning; neurological functioning”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal neurological function is a beneficial physiological effect.

2.5. Udział w prawidłowym przebiegu procesów poznawczych (ID 1502)

The claimed effect is “cognitive, memory functioning; neurological functioning”. The Panel assumes that the target population is the general population.
Cognitive function includes memory, attention (concentration), learning, intelligence and problem solving. These are well defined constructs and can be measured by validated psychometric cognitive tests.
The Panel considers that contribution to normal cognitive 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.

3.4. Utrzymanie prawidłowego funkcjonowania układu nerwowego (ID 1502)

The references provided included narrative reviews and textbooks which did not provide any original data for the scientific substantiation of the claimed effect, and conference abstracts which did not provide sufficient detail for a scientific evaluation. A number of the remaining references did not address relevant endpoints (e.g. choline metabolism, memory and attention) or did not evaluate choline (e.g. citicoline and phosphatidylserine). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The Panel notes that no human studies have been provided from which conclusions can be drawn for the scientific substantiation of the claimed effect.
Ten animal studies provided primary data to substantiate the claimed effect. These studies evaluated the effects of choline supplementation and deprivation on choline plasma concentrations, acetylcholine synthesis and release, and nicotinic receptor regulation. The Panel considers that while effects shown in animal studies may be used as supportive evidence, human studies are required for
the substantiation of a claim, and that evidence provided in animal studies alone is not sufficient to predict the occurrence of an effect of choline consumption on the maintenance of normal neurological function in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of choline and the maintenance of normal neurological function.

3.5. Udział w prawidłowym przebiegu procesów poznawczych (ID 1502)

The references provided included narrative reviews which did not provide any original data, and conference abstracts which did not provide sufficient detail for a scientific evaluation. A number of the remaining references did not report on relevant endpoints (e.g. choline metabolism and functions, choline uptake into the brain, and deficiency symptoms unrelated to cognition) or did not evaluate choline (e.g. citicoline and phosphatidylserine). Some of the human intervention studies provided used lecithin preparations. The Panel notes that these interventions did not control for dietary compounds other than choline (e.g. phospholipids and fatty acids) which could contribute to the claimed effect. The Panel notes that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The study by Sitaram et al. (1978) evaluated the effect of a single dose of choline chloride (10 g) against placebo (not defined but matched for colour and taste) given in random order on two separate days on a serial learning test and a selective reminding test in 10 healthy male and female volunteers. The Panel notes that the dose of choline which was used in the study was much greater than the minimum dose of 20 mg, the indicated “therapeutic” dose of 300 mg, or the “excess” consumption of 3.5 g per day given in the conditions of use. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
The study by Buchman et al. (2001) was a pilot study in patients (n=11) receiving long-term parenteral nutrition (more than 80 % of their nutritional needs). The effect of choline supplementation on verbal and visual memory was evaluated after 24 weeks of parenteral nutrition regimen supplemented with 2 g of choline chloride (n=5) vs. no supplementation (n=6). The Panel notes that 24 endpoints were tested in this pilot study and that no correction was made for multiple testing. The Panel considers that no conclusions can be drawn from this small pilot study for the scientific substantiation of the claimed effect.
Nine of the animal studies provided evaluated the effect of choline supplementation on various memory tests in rats. The Panel considers that evidence provided in animal studies is not sufficient to predict the occurrence of an effect of choline consumption on contribution to normal cognitive function in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of choline and contribution to normal cognitive 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