ID 711 -
Phosphatidylserine
PL:
EN: Phosphatidylserine
Pdf: phosphatidyl serine
1. Charakterystyka żywności / składnika
The food constituent that is the subject of this opinion is phosphatidyl serine related to the following claimed effects: “memory and cognitive functioning in the elderly”, “mental health/cognitive function” and “stress reduction and enhanced memory function”. Phosphatidyl serine is a phospholipid present in large quantities in the brains of animals. Dietary phosphatidyl serine supplements, however, can be derived from either animal or plant sources. The bovine brain cortex phosphatidyl serine is extracted from bovine cerebral tissue and purified (Calderini et al., 1985). The soy-based phosphatidyl serine is derived from soy lecithin that has been treated with serine and an enzyme to convert the phospholipids contained in soy to phosphatidyl serine (Sakai et al., 1996). The resulting phosphatidyl serine molecule comprises serine and two fatty acids. The animal and plant sourced phosphatidyl serine differ in fatty acid composition. For example, the phosphatidyl serine from soy contains 7 % alpha-linolenic acid (n-3) and 47 % linoleic acid (n-6), while the phosphatidyl serine derived from bovine brain cortex contains mostly saturated and monounsaturated fatty acids besides 8 % docosahexaenoic acid (n-3) and 2 % arachidonic acid (n-6) (FDA, 2003).
Bovine brain cortex- and soy-based phosphatidyl serine are different substances and might, therefore, have different biological activities. Thus, there is considerable uncertainty in generalising results from studies done with bovine brain cortex phosphatidyl serine as the test substance to soy-based phosphatidyl serine, and vice versa (FDA, 2003).
The references provided do not allow the Panel to characterise the food constituent, phosphatidyl serine, that is the subject of the health claims. The Panel notes that the source of phosphatidyl serine has not been defined in the conditions of use for IDs 711, 734. In ID 552 and ID 1632, the Panel notes that the phosphatidyl serine in the conditions of use is given as a soy phosphatidyl serine extract which is part of a food bar containing other substances including vitamins. In ID 1632, the Panel notes that although the phosphatidyl serine source is identified as soy, it is in the form of a combination of phospholipids. In ID 1937, the Panel notes that the phosphatidyl serine is derived from a milk protein concentrate as part of a product containing other substances, including other phospholipids.
The Panel considers that the food constituent, phosphatidyl serine, which is the subject of this opinion is not sufficiently characterised in relation to the claimed effects considered in this opinion.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of phosphatidyl serine and the claimed effects considered in this opinion.
Warunki i możliwe ograniczenia stosowania oświadczenia
The product should contain at least 15% of the minimum effective dose, which is 300 mg/day. Thus, products containing =45 mg phosphatidyl-serine per 100 g or 100 mL would qualify to carry the proposed claims.
Studies demonstrating efficacy ranged in duration from 6 weeks to 6 months. While, in some studies, efficacy, improvements were noted after 3 weeks, the majority of studies reported improvement after 6 weeks; thus, an intake of 300 mg/day phosphatidyl-serine for a minimum of 6 weeks is recommended.
No adverse effects are associated with phosphatidyl-serine
