ID 161 - 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.

2.2. Utrzymanie prawidłowego funkcjonowania układu odpornościowego (ID 161, 163)

The claimed effects are “normal immune system function” and “is important for the immune system”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of the normal function of the immune system 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).

3.2. Utrzymanie prawidłowego funkcjonowania układu odpornościowego (ID 161, 163)

Eighty-three references were provided in the consolidated list in relation to vitamin E and the immune system which included textbooks, systematic reviews, human studies, animal studies and in vitro studies.
Some randomised, double-blind, placebo-controlled clinical trials investigated the efficacy of supplementation of vitamin E and stimulation of delayed-type-hypersensitivity skin response (Meydani et al., 1990, 1997; Pallast et al., 1999). The Panel notes that this endpoint is not appropriate to draw a conclusion on the role of vitamin E and the function of the immune system.
Only one observational study reported a relationship between low plasma concentrations of vitamin E and an increased number of infections (Chavance et al., 1989), but randomised, double-blind, placebo-controlled clinical trials failed to show effects of vitamin E on the incidence of infections (Meydani et al., 2004), or even noted adverse effects of vitamin E on illness severity of respiratory infections (Graat et al., 2002).
In weighing the evidence, the Panel took into account that the studies presented did not demonstrate immune defects in vitamin E deficient individuals, and that a restoration of a depressed immune system by vitamin E has not been shown.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of the normal function of the immune system.

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 at least be a source of vitamin/s as per annex to regulation 1924/2006 Applicable to both adults and children