2. Znaczenie oświadczenia dla zdrowia człowieka

2.1. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 160, 162, 1947)

The claimed effects are “protection of body cells from oxidative damage by being a free radical scavenger”, “antioxidants and aging”, and “antioxidant”. The Panel assumes that the target population is the general population.
Reactive oxygen species (ROS) including several kinds of radicals are generated in biochemical processes (e.g. respiratory chain) and as a consequence of exposure to exogenous factors (e.g. radiation, pollutants). These reactive intermediates can damage molecules such as DNA, proteins and lipids if they are not intercepted by the antioxidant network, which includes free radical scavengers such as antioxidant nutrients.
No definition has been provided of what constitutes “aging”, and therefore the Panel cannot evaluate the “anti-aging effects” implied in claim ID 162. Also, it should be noted that there is a difference between the ageing process itself and the increasing risk for specific age-related diseases where oxidative and/or free radical-mediated damage may play a role.
The Panel considers that protection of DNA, proteins and lipids from oxidative damage may be a beneficial physiological effect.

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.

2.3. Utrzymanie prawidłowego stanu kości (ID 164)

The claimed effect is “bone/teeth/hair/skin and nails health”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal bone is a beneficial physiological effect.

2.4. Utrzymanie prawidłowego stanu zębów (ID 164)

2.5. Utrzymanie prawidłowego stanu włosów (ID 164)

2.6. Utrzymanie prawidłowego stanu skóry (ID 164)

2.7. Utrzymanie prawidłowego stanu paznokci (ID 164)

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.

2.9. Utrzymanie prawidłowego wzroku poprzez ochronę soczewki oka (ID 167)

The claimed effect is “eye health; vitamin E, C are found in the lens of the eye; acts jointly with vitamin C”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to the protection of the lens of the eye.
The Panel considers that maintenance of normal vision by protection of the lens of the eye is a beneficial physiological effect.

2.10. Udział w prawidłowym przebiegu procesów poznawczych (ID 182, 183)

The claimed effects are “antioxidant activity and cognitive function”, and “mental state and performance”. The Panel assumes that the target population is the general population.
Cognitive function includes memory, attention (concentration), learning, intelligence and problem solving. These are well defined constructs and can be measured by validated psychometric cognitive tests.
The Panel considers that contribution to normal cognitive function is a beneficial physiological effect.

2.11. Regeneracja zredukowanej formy witaminy C (ID 203)

The claimed effect is “regeneration of vitamin C, vitamin C and vitamin E have synergistic effects”. The Panel assumes that the target population is the general population.
The Panel considers that regeneration of the reduced form of vitamin C is a beneficial physiological effect.

2.12. Utrzymanie prawidłowego krążenia krwi (ID 216)

The claimed effect is “blood circulation”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal blood circulation is a beneficial physiological effect.

2.13. Utrzymanie prawidłowego stanu skóry głowy (ID 2873)

The claimed effect is “health of the scalp”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of a normal scalp 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).

3.1. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 160, 162, 1947)

Vitamin E functions physiologically as a chain-breaking antioxidant that prevents the propagation of lipid peroxidation (Shils et al., 2006; IoM 2000). Vitamin E is part of the antioxidant defence system, which is a complex network including both endogenous and dietary antioxidants, antioxidant enzymes and repair mechanisms, with mutual interactions and synergetic effects among the various components.
The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin E and protection of DNA, proteins and lipids from oxidative damage.

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.

3.3. Utrzymanie prawidłowego stanu kości (ID 164)

A total of 29 references were cited to substantiate the claimed effect. Some of these references were textbooks or opinions from scientific bodies in which the claimed effect was not stated or addressed. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of normal bone.

3.4. Utrzymanie prawidłowego stanu zębów (ID 164)

A total of 29 references were cited to substantiate the claimed effect. None of the references addressed the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of normal teeth.

3.5. Utrzymanie prawidłowego stanu włosów (ID 164)

3.6. Utrzymanie prawidłowego stanu skóry (ID 164)

A total of 29 references were cited to substantiate the claimed effect. Some of these references were textbooks or opinions from scientific bodies in which the claimed effect was not stated. The Panel notes that only one reference (Weber et al., 2003) was provided in relation to skin health. This study involved the use of benzoyl peroxide, which is a common drug for the treatment of acne vulgaris and topical supplementation of alpha-tocotrienol. The aim of this study was to show that antioxidant supplementation may mitigate the benzoyl peroxide-induced stratum corneum changes. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of normal skin.

3.7. Utrzymanie prawidłowego stanu paznokci (ID 164)

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.

3.9. Utrzymanie prawidłowego wzroku poprzez ochronę soczewki oka (ID 167)

The references provided included one textbook and four articles which reported on human epidemiological studies.
Two studies, Jacques et al. (2001) and Taylor et al. (2002), found no significant correlation between supplement intake of vitamin E and the incidence of lens opacity and reduced prevalence of cataract, respectively. The remaining two studies (Kuzniarz et al., 2001; Mares-Perlman et al., 2000), considered the use of vitamin supplements in general and cannot be used to substantiate a claim on vitamin E alone. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of normal vision by protection of the lens of the eye.

3.10. Udział w prawidłowym przebiegu procesów poznawczych (ID 182, 183)

A total of seven references were provided to substantiate the claimed effect. Three references did not address relevant endpoints (cardiovascular efficacy, safety of high vitamin E intake). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect. The narrative review provided discussed the use of antioxidants, including vitamin E, in prevention and treatment of Alzheimer disease. This reference did not contain any primary data that could be used to substantiate the claimed effect.
Three articles reported on observational human studies.
One of these, a large (n=3,385) longitudinal cohort study of healthy men aged 71-90 years, investigated associations between the use of both vitamin E and vitamin C supplements and cognitive performance assessed two years later using the Cognitive Abilities Screening Instrument (Masaki et al., 2000). The Panel notes that findings from this study cannot be used for the scientific substantiation of the claimed effect as the study investigated the association of two vitamins rather than vitamin E alone.
The two other studies were a prospective cohort study, which evaluated the association between dietary intake of antioxidants (including vitamin E) and risk of Alzheimer disease (Engelhart et al., 2002) and a cross-sectional study, which examined associations between dietary intake of nutrients (including vitamin E) and cognitive performance in 260 elderly people, aged 65-90 years, who were free of significant cognitive impairment (Ortega et al., 1997). The Panel notes that no conclusions on a causal relationship between the dietary intake of vitamin E and cognitive function can be drawn from these studies because confounding by other dietary and lifestyle factors inherent to the observational study design cannot be excluded.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of vitamin E and contribution to normal cognitive function.

3.11. Regeneracja zredukowanej formy witaminy C (ID 203)

Two references were cited to substantiate the claimed effect. One was a textbook (Berman, 1991) and the other was a report on the antioxidant activity of vitamin E and vitamin C (Janisch et al., 2005). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of vitamin E and regeneration of the reduced form of vitamin C.

3.12. Utrzymanie prawidłowego krążenia krwi (ID 216)

One study was provided in the consolidated list in relation to vitamin E and blood circulation (Bursell et al., 1999). This study was a randomised, double-blind, placebo-controlled cross-over trial in type 1 diabetic subjects. The aim of this study was to measure retinal blood flow and renal function. The Panel considers that the evidence provided does not establish that patients with diabetes are representative of the general population with regard to retinal blood flow and renal function, or that results obtained in studies on subjects with diabetes can be extrapolated to the general population with regard to retinal blood flow and renal function owing to the abnormal eye and kidney functions of diabetic subjects.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of normal blood circulation.

3.13. Utrzymanie prawidłowego stanu skóry głowy (ID 2873)

Two studies (one human and one in vitro study) were provided in the consolidated list which did not address the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of a normal scalp.

4. Uwagi do zaproponowanego brzmienia oświadczenia

4.1. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 160, 162, 1947)

The Panel considers that the following wording reflects the scientific evidence: “Vitamin E contributes to the protection of cell constituents from oxidative damage”.

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).

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, vitamin E, which is the subject of the health claims, is sufficiently characterised.
Protection of DNA, proteins and lipids from oxidative damage (ID 160, 162, 1947)
The claimed effects are “protection of body cells from oxidative damage by being a free radical scavenger” and “antioxidants and aging”. The target population is assumed to be the general population. Protection of DNA, protein and lipids from oxidative damage may be a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of vitamin E and protection of DNA, protein and lipids from oxidative damage.
The following wording reflects the scientific evidence: “Vitamin E contributes to the protection of cell constituents from oxidative damage”.
Maintenance of the normal function of the immune system (ID 161, 163)
The claimed effects are “normal immune system function” and “is important for the immune system”. The target population is assumed to be the general population. Maintenance of the normal function of the immune system is a beneficial physiological effect.
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.
Maintenance of normal bone (ID 164)
The claimed effect is “bone/teeth/hair/skin and nails health”. The target population is assumed to be the general population. Maintenance of normal bone is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of normal bone.
Maintenance of normal teeth (ID 164)
The claimed effect is “bone/teeth/hair/skin and nails health”. The target population is assumed to be the general population. Maintenance of normal teeth is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of normal teeth.
Maintenance of normal hair (ID 164)
The claimed effect is “bone/teeth/hair/skin and nails health”. The target population is assumed to be the general population. Maintenance of normal hair is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of normal hair.
Maintenance of normal skin (ID 164)
The claimed effect is “bone/teeth/hair/skin and nails health”. The target population is assumed to be the general population. Maintenance of normal skin is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of normal skin.
Maintenance of normal nails (ID 164)
The claimed effect is “bone/teeth/hair/skin and nails health”. The target population is assumed to be the general population. Maintenance of normal nails is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of normal nails.
Maintenance of normal cardiac function (ID 166)
The claimed effect is “can neutralize free radicals and help maintain a healthy heart”. The target population is assumed to be the general population. Maintenance of normal cardiac function is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of normal cardiac function.
Maintenance of normal vision by protection of the lens of the eye (ID 167)
The claimed effect is “eye health; vitamin E, C are found in the lens of the eye; acts jointly with vitamin C”. The target population is assumed to be the general population.
Maintenance of normal vision by protection of the lens of the eye is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of normal vision by protection of the lens of the eye.
Contribution to normal cognitive function (ID 182, 183)
The claimed effects are “antioxidant activity and cognitive function”, and “mental state and performance”. The target population is assumed to be the general population. Contribution to normal cognitive function is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of vitamin E and contribution to normal cognitive function.
Regeneration of the reduced form of vitamin C (ID 203)
The claimed effect is “regeneration of vitamin C, vitamin C and vitamin E have synergistic effects”. The target population is assumed to be the general population. Regeneration of the reduced form of vitamin C is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of vitamin E and regeneration of the reduced form of vitamin C.
Maintenance of normal blood circulation (ID 216)
The claimed effect is “blood circulation”. The target population is assumed to be the general population. Maintenance of normal blood circulation is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of normal blood circulation.
Maintenance of a normal scalp (ID 2873)
The claimed effect is “health of the scalp”. The target population is assumed to be the general population. Maintenance of a normal scalp is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of vitamin E and maintenance of a normal scalp.
Conditions and possible restrictions of use
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.

Oświadczenia zdrowotne

1816.pdf

1. Charakterystyka żywności / składnika