ID 1596 - Lecytyna

PL: Lecytyna
EN: Lecithin
Pdf: various food(s)/food constituent(s)

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is lecithin/phospatidyl choline.
Lecithin is a common name for phosphatidyl cholines. However, this term has also been used to designate commercial preparations from different sources in which the most abundant phospholipid is phosphatidyl choline. For the purpose of this opinion, the term phosphatidyl choline will be used to denote glycerol molecules esterified with two fatty acids and one phosphocholine molecule, whereas the term “lecithin” will only be used in reference to commercially available lecithin preparations.
The fatty acid composition of phosphatidyl cholines varies depending on the source. Phosphatidyl cholines are the main phospholipid in commercially available lecithin preparations, but also phosphatidyl serine, phosphatidyl inositol and phosphatidyl ethanolamine, among others, may be present. Although phosphatidyl cholines were originally isolated from egg yolk, the most common source in commercially available lecithin preparations is soybeans, albeit rapeseed and safflower lecithin preparations are also available.
The majority of the human intervention studies provided for the scientific substantiation of the health claims considered in this opinion used either commercial lecithin preparations from soy or phosphatidyl cholines from unspecified sources. The Panel notes that, for the latter, the fatty acid composition is generally not reported in the publications, and therefore phosphatidyl cholines from unspecified sources would not be sufficiently characterised in relation to the claimed effects. The Panel also notes that both the type and amount of phospholipids (phosphatidyl choline, phosphatidyl serine, phosphatidyl inositol, phosphatidyl ethanolamine, etc.) present in the commercial soy lecithin preparations could have an impact on the claimed effects related to neurological and cognitive functions. Therefore, the Panel assumes that the food that is the subject of the health claim is phosphatidyl choline from soy, which is the most abundant phospholipid in soy lecithin preparations.
Linoleic acid (LA) is the most common fatty acid in soy lecithin, representing about 60-65 % by weight (Knuiman et al., 1989). For the claimed effects on blood cholesterol and lipid metabolism, the fatty acid profile of soy lecithin preparations (rather than the phospholipid profile) appears to be
relevant. A claim on LA related to the maintenance of normal cholesterol concentrations in the context of article 13 claims under Regulation (EC) 1924/2006 has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009). The Panel concluded that a cause and effect relationship was established between the consumption of LA and the maintenance of normal blood cholesterol concentrations. Therefore the Panel will address in the present opinion whether consumption of soy lecithin preparations (in which phosphatidyl cholines are the most abundant phospholipid) has an effect on blood cholesterol concentrations beyond what could be expected from their content of LA.
The Panel considers that, whereas lecithin preparations or phosphatidyl choline from unspecified sources are not sufficiently characterised, the food constituent, soy phosphatidyl choline, which the Panel assumes to be the subject of the health claims, is sufficiently characterised.

2.6. Udział w prawidłowym przebiegu procesów poznawczych (ID 710, 1596, 1631, 1983)

The claimed effects are “cognitive function”, “for metabolism of nervous system” and “memory and concentration”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effect “for metabolism of nervous system” refers to normal cognitive function.
Cognitive function includes memory, attention (concentration), learning, intelligence and problem solving, which are well defined constructs and can be measured by validated psychometric cognitive tests.
The Panel concludes that contribution to normal cognitive function is a beneficial physiological effect.

2.7. Utrzymanie prawidłowego funkcjonowania układu nerwowego (ID 1596)

The claimed effect is “for metabolism of nervous system”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effect refers to the maintenance of normal neurological function.
The Panel concludes that maintenance of normal neurological function is a beneficial physiological effect.

3.5. Udział w prawidłowym przebiegu procesów poznawczych (ID 710, 1596, 1631, 1983)

A total of 104 references were cited to substantiate the claimed effect. Fourteen of these were textbook references, five were opinions of an authoritative body, 13 were narrative reviews, one was a systematic review, 41 reported on studies in humans, 24 reported on animal studies and four reported in vitro studies. There were also an unpublished study and a letter to the editor.
The studies undertaken in humans could be classified further into those which investigated patients with Alzheimer's disease (diagnosed or suspected) or other forms of dementia and one systematic review on the effect of lecithin preparations on dementia and cognitive impairment. One study involved subjects with mild or moderate closed head injury, one study concerned subjects with brain organic psychosyndrome, and there was one case-study of post-traumatic amnesia. The Panel notes that no evidence was presented that findings from patients with various forms of dementia or subjects with mild or moderate closed head injury, brain organic psychosyndrome or post-traumatic amnesia could be extrapolated to the general population with regard to cognitive function. Furthermore, one study on thiamin rather than soy phosphatidyl choline and three studies which did not address relevant endpoints were also considered not to be pertinent for the substantiation of the claim.
In the studies in older subjects with cognitive deficits but without dementia, two used phosphatidyl serine, one used cytidine-5-diphosphate choline, one used choline, and two used citicholine. Five of the ten human studies cited in healthy subjects in the general population used choline. The Panel notes that studies on choline, choline donors or phosphatidyl serine cannot be used to substantiate a claim on soy phosphatidyl choline.
The remaining five studies in healthy subjects included three studies on commercial products of lecithin where the source or composition and amounts of phospholipids were not given (Drachman et al., 1982; Sorgatz, 1986, 1988) and one study which used high single doses (20 g per day) of phosphatidyl choline of unspecified source and purity (Harris et al., 1983). The Panel notes that the sources of phosphatidyl choline tested were not sufficiently characterised for a claim on cognitive function. The remaining study (Ladd et al., 1993) investigated the effects of high single doses of 18.2 or 45.5 g of a soy lecithin preparation (containing 55 % phosphatidyl choline, 30 % phosphatidylethanolamine, 3 % phosphatidyl inositol, 8 % other phosphatides, and 4 % tryglycerides neutral oil) against placebo on explicit memory in 80 college students in a double- blind mixed design. The Panel notes that the lecithin preparation used contained other components that could potentially affect the claimed effect and confound the results with respect to the effects of soy phosphatidyl choline.
The animal studies and in vitro studies provided were unrelated to the claimed effect or undertaken with choline or phosphatidyl choline from egg in combination with vitamin B12, and therefore not of relevance for a claim on soy phosphatidyl choline. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
The Panel notes that no evidence was provided in which soy phosphatidyl choline was administered in the target population from which conclusions could be drawn for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of soy phosphatidyl choline and contribution to normal cognitive function.

3.6. Utrzymanie prawidłowego funkcjonowania układu nerwowego (ID 1596)

A total of six references were provided to substantiate the claimed effect, including two textbook references which were not accessible to the Panel; one meta-analysis on the effect of lecithin from
various sources and purity on dementia and cognitive impairment; two narrative reviews on choline and one human study. The human study evaluated the effect on memory of a commercial product of lecithin, where the composition and amounts of phospholipids were not given (Sorgatz, 1986). The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of soy phosphatidyl choline and the maintenance of normal neurological function.

Warunki i możliwe ograniczenia stosowania oświadczenia

50-120 mg