ID 166 - Witamina E

PL: Witamina E
EN: Vitamin E
Pdf:

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is vitamin E, which is a well recognised nutrient and is measurable in foods by established methods.
Vitamin E is authorised for addition to foods (Annex I of the Regulation (EC) No 1925/20066 and Annex I of Directive 2002/46/EC7). This evaluation applies to vitamin E naturally present in foods and those forms authorised for addition to foods (Annex II of Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC).
The Panel considers that the food constituent, vitamin E, which is the subject of the health claims, is sufficiently characterised.

2.8. Utrzymanie prawidłowego funkcjonowania serca (ID 166)

The claimed effect is “can neutralise free radicals and help maintain a healthy heart”. The Panel assumes that the target population is the general population. The Panel assumes that the claimed effect refers to the maintenance of normal cardiac function.
The Panel considers that maintenance of normal cardiac function is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka

The evidence provided by opinions/reports from authoritative bodies and reviews shows that there is good consensus on the role of vitamin E in the body (Berdanier et al., 2002; EVM, 2002; Gibney et al., 2002; IoM, 2000; NNR, 2004; Sadler et al., 1999; SCF, 2003; Shils et al., 2006). Vitamin E is fat-soluble and is transported in plasma lipoproteins and partitions into membranes and fat-storage sites where it has the unique role of protecting polyunsaturated fatty acids from peroxidation. Plasma
-tocopherol is regulated by the liver -tocopherol transfer protein ( -TTP). In humans, a genetic
defect in -TTP results in severe vitamin E deficiency (Shils et al., 2006).
A major vitamin E deficiency symptom in humans is peripheral neuropathy characterised by the degeneration of the large calibre axons in the sensory neurons (IoM, 2000). Vitamin E deficiency as a result of inadequate intake of vitamin E is uncommon. Vitamin E deficiency can occur as a result of
genetic abnormalities in -TTP and as a result of various fat malabsorption syndromes. Vitamin E supplementation halts the progression of the neurological abnormalities caused by inadequate nerve
tissue -tocopherol and, in some cases, has reversed these abnormalities. Other vitamin E deficiency symptoms observed in humans include spinocerebellar ataxia, skeleton myopathy, pigmented retinopathy (IoM, 2000), loss of deep tendon reflexes, unsteady gait, restriction of upward gaze and visual field loss (Sadler et al., 1999).

3.8. Utrzymanie prawidłowego funkcjonowania serca (ID 166)

The literature provided in the consolidated list in relation to vitamin E and cardiac function in humans consisted of 18 references, of which three were textbooks and four were reports from authoritative bodies. Two of the references were not pertinent to the claimed effect as one study was confounded by vitamin C (Jaxa-Chamiec et al., 2005), and the other study did not address relevant endpoints (Kraemer et al., 2004). Eight of the remaining references reported on observational studies (either cross-sectional or prospective cohort studies) which reported associations between dietary vitamin E intake or plasma concentrations of vitamin E and coronary heart disease endpoints or various indicators of atherosclerosis or LDL (Low-Density Lipoprotein) oxidation (Cherubini et al., 2001; Gale et al. 2001; Knekt et al., 1994; Kushi et al., 1996; McQuillan et al., 2001; Rimm et al., 1993; Simon et al., 2001; Stampfer et al. 1993).
A meta-analysis of randomised controlled trials of vitamin E supplementation of different population groups, including seven studies on patients at risk of or with coronary heart disease, showed a statistically significant dose-dependent relationship between vitamin E supplementation and all-cause mortality (Miller et al., 2005). The Panel considers that no conclusions can be drawn from this meta- analysis for the scientific substantiation of the claimed effect as no relevant endpoint for the claimed effect has been included in the analysis.
Four published, large-scale, randomised, double-blind clinical intervention studies have tested the ability of vitamin E to prevent myocardial infarction. One of these, a secondary prevention trial (CHAOS), was associated with a statistically significant decrease in the occurrence of non-fatal and total myocardial infarctions and a non-statistically significant increase in fatal myocardial infarctions, while the other three, one carried out in a group of high risk cigarette smokers (ATBC Cancer Prevention Study) and the other two in high-risk cardiovascular patients (GISSI Prevenzione trial; HOPE Study), were neutral (IoM, 2000).
The Panel notes that the results of intervention studies with vitamin E do not support the majority of the findings from the epidemiological studies that vitamin E might be important in maintaining normal cardiac function.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of normal cardiac function.

5. Warunki i możliwe ograniczenia stosowania oświadczenia

The Panel considers that in order to bear the claim a food should be at least a source of Vitamin E as per Annex to Regulation (EC) No 1924/2006. Such amounts can be easily consumed as part of a balanced diet. The target population is the general population. Tolerable Upper Intake Levels (UL) have been established for vitamin E in children, adolescents and adults (SCF, 2003).

Warunki i możliwe ograniczenia stosowania oświadczenia

Must meet minimum requirements for use of the claim "source of [name of vitamin/s] and/or [name of mineral/s}" as per Annex to Regulation 1924/2006.