ID 3187 - 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.

2.1. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 709, 1308, 1630, 1961, 3138, 3187, 4687)

The claimed effects are “cholesterol/heart health”, “control of cholesterol”, “rate cholesterol stabilisation”, “helps to keep normal cholesterol level”, “cardiovascular system”, and “helps heart health and to maintain a balanced level of cholesterol and lipids in the body”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to maintenance of normal blood cholesterol concentrations.
Low-density lipoproteins (LDL) carry cholesterol from the liver to peripheral tissues, including the arteries. Elevated LDL-cholesterol, by convention >160 mg/dL (>4.14 mmol/L), may compromise the normal structure and function of the arteries. High-density lipoproteins (HDL) act as cholesterol scavengers and are involved in the reverse transport of cholesterol in the body (from peripheral tissues back to the liver).
The Panel considers that maintenance of normal blood cholesterol concentrations is a beneficial physiological effect.

3.1. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 709, 1308, 1630, 1961, 3138, 3187, 4687)

Among the references cited in the list, a review of human intervention studies (Knuiman et al., 1989) and eight individual intervention studies investigated the effects of soy lecithin on blood lipids. Three of the intervention studies were already included in the review (Simons et al., 1977; Tompkins and Parkin, 1980; Kesäniemi and Grundy, 1986) and five were not (Galli et al., 1985; Sirtori et al., 1985; Wojcicki et al., 1995; Kirsten et al., 1989; Kirsten et al., 1994).
The effects of consumption of soy lecithin preparations or of pure soy phosphatidyl choline on serum lipids have been studied in small clinical trials since 1943. Knuiman et al. (1989) reviewed 24 intervention studies in humans which investigated the effects of supplementary soy lecithin at doses of 1 to 54 g per day on blood cholesterol concentrations. Most of the studies were small (using less than nine subjects per group), were not properly controlled or did not take into account the fatty acid composition of soy lecithin. Knuiman et al. (1989) found that only four studies tried to control for the fatty acid composition of soy lecithin preparations or of pure soy phosphatidyl choline when assessing their effects on blood lipids (Greten et al., 1980; Childs et al., 1981; Prack et al., 1983; Kesäniemi and Grundy, 1986). Soybean oil (Greten et al., 1980), corn oil (Childs et al., 1981), sunflower oil (Prack et al., 1983) and safflower oil (Kesäniemi and Grundy, 1986) were used as the control in these studies. LA is quantitatively the most abundant fatty acid in all these oils. The anticipated differences between the intervention and control groups on blood cholesterol concentrations calculated using the formula by Keys et al. (1965) were minimal (<0.04 mmol/L), suggesting that the cholesterolaemic effects that could be expected form the fatty acid composition of soy lecithin were almost completely controlled for (Knuiman et al., 1989). None of these trials showed significant effects of soy lecithin (Greten et al., 1980; Childs et al., 1981; Kesäniemi and Grundy, 1986) or of pure soy phosphatidyl choline (Prack et al., 1983) consumption on blood cholesterol concentrations compared to the control oil. The studies by Simons et al. (1977), Tompkins and Parkin (1980), Galli et al. (1985), Sirtori et al. (1985), and Wojcicki et al. (1995) were small, open label, single-arm, uncontrolled studies on the effects of soy lecithin preparations on blood lipids. The Panel considers that no conclusions can be drawn from these uncontrolled studies for the scientific substantiation of the claimed effect.
In a randomised, placebo-controlled trial (RCT), Kirsten et al. (1989) investigated the effects of 3-sn-polyenyl-phosphatidylcholine (2.7 g per day) given for six weeks on blood lipids in patients with renal failure on chronic haemodialysis (10 patients per group). The same phospholipid and the same daily dose were studied by the same research group with a similar design in 30 patients with type 2 diabetes (Kirsten et al., 1994). The Panel notes that, in these studies with small sample sizes, the
background diet was not monitored and the composition of the placebo was not reported, and that therefore it is unclear whether the fatty acid composition of 3-sn-polyenyl-phosphatidylcholine was accounted for in the placebo group.
In weighing the evidence, the Panel took into account that the only four studies presented which tried to control for the fatty acid composition of soy lecithin preparations or pure soy phosphatidyl choline found no effect of the food component on blood lipids.
The Panel concludes that a cause and effect relationship has not been established between the consumption of soy phosphatidyl choline and maintenance of normal blood cholesterol concentrations beyond the hypocholesterolaemic effects that could be expected from its fatty acid composition (e.g. primarily from its content of LA).

Warunki i możliwe ograniczenia stosowania oświadczenia

1,5 g/d