2. Znaczenie oświadczenia dla zdrowia człowieka

2.1. Udział w prawidłowym pozyskiwaniu energii w procesach metabolicznych (ID 29, 35, 36, 42)

The claimed effects are “energy metabolism”, “riboflavin participates in oxidation-reduction reactions in numerous metabolic pathways and in energy production via respiratory chain”, “macronutrient metabolism” and “release of energy from food”. 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 relate to energy- yielding metabolism.
The Panel considers that contribution to normal energy-yielding metabolism is a beneficial physiological effect.

2.2. Udział w prawidłowym metabolizmie żelaza (ID 30, 37)

The claimed effects are “transport and metabolism of iron” and “healthy iron status”. The Panel assumes that the target population is the general population.
The Panel considers that contribution to normal metabolism of iron is a beneficial physiological effect.
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2.3. Utrzymanie prawidłowego stanu skóry i błon śluzowych (ID 31, 33)

The claimed effects are “structure and function of the skin and mucous membranes (such as in the lung, intestines, nose, eyes and female reproductive tract)” and “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 skin and mucous membranes is a beneficial physiological effect.

2.4. Udział w prawidłowym przebiegu funkcji psychicznych (psychologicznych) (ID 32)

The claimed effect is “mental performance (where mental performance stands for those aspects of brain and nerve functions which determine aspects like concentration, learning, memory and reasoning, as well as resistance to stress)”. The Panel assumes that the target population is the general population.
The Panel considers that contribution to normal psychological functions, which encompass cognitive and affective domains, is a beneficial physiological effect.

2.5. Utrzymanie prawidłowego stanu kości (ID 33)

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.

2.6. Utrzymanie prawidłowego stanu zębów (ID 33)

2.7. Utrzymanie prawidłowego stanu włosów (ID 33)

2.8. Utrzymanie prawidłowego stanu paznokci (ID 33)

2.9. Utrzymanie prawidłowego wzroku (ID 39)

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

2.10. Utrzymanie prawidłowej budowy erytrocytów (czerwonych krwinek) (ID 40)

The claimed effect is “red blood cells”. 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 relates to the maintenance of normal red blood cells.
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The Panel considers that maintenance of normal red blood cells is a beneficial physiological effect.

2.11. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 207)

The claimed effect is “antioxidant properties”. 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 damage DNA, proteins and lipids if they are not intercepted by the antioxidant network which includes free radical scavengers such as antioxidant nutrients.
The Panel considers that the protection of DNA, proteins and lipids from oxidative damage may be a beneficial physiological effect.

2.12. Zmniejszenie zmęczenia (ID 41)

The claimed effect is “vitamin/mineral supplementation to reduce fatigue and tiredness in situations of inadequate micronutrient status”. The Panel assumes that the target population is the general population.
The Panel considers that the reduction of tiredness and fatigue is a beneficial physiological effect.

2.13. Utrzymanie prawidłowego funkcjonowania układu nerwowego (ID 213)

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

3. Naukowe uzasadnienia wpływu na zdrowie człowieka -

Riboflavin (vitamin B2) is a water-soluble, yellow, fluorescent compound, chemically specified as a 7,8-dimethyl-10-(1'-D-ribityl)-isoalloxazine. The vitamin is a precursor of certain essential coenzymes such as flavin mononucleotide (FMN) and flavin-adenine dinucleotide (FAD). In these coenzyme forms riboflavin functions as a catalyst for oxidation and reduction reactions and electron transport. Riboflavin is thus involved in a wide variety of metabolic pathways, including the biosynthesis and catabolism of amino acids, fatty acids and carbohydrates (IoM, 1998; SCF, 2000; Powers, 2003).
Riboflavin deficiency usually occurs in conjunction with other nutritional deficiencies. Early signs of riboflavin deficiency are soreness and burning of the lips, mouth, and tongue; burning and itching of the eyes; photophobia; and a loss of visual acuity. The most common signs are pallor and maceration of the mucosa at the angles of the mouth (angular stomatitis) and vermilion surfaces of the lips (cheilosis), eventually replaced by superficial linear fissures. The fissures can become infected with Candida albicans, causing grayish white lesions (perlèche). The tongue may appear magenta. Seborrheic dermatitis develops, usually affecting the nasolabial folds, ears, eyelids, and scrotum or labia majora. These areas become red, scaly, and greasy. Rarely, neovascularisation and keratitis of the cornea can also occur, causing lacrimation and photophobia (Bates, 2005; Bender, 2002). Deficiency symptoms also include normochromic, normocytic anaemia associated with pure erythrocyte cytoplasia of the bone marrow (IoM, 1998).

3.1. Udział w prawidłowym pozyskiwaniu energii w procesach metabolicznych (ID 29, 35, 36, 42)

The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that there is consensus on the role of riboflavin in energy-yielding metabolism (JHCI, 2003; Bates, 2005; SCF, 2000; IoM, 1998; EVM, 2002).
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Riboflavin has an important role as a coenzyme in energy-yielding metabolism acting as an electron carrier in a wide variety of oxidation and reduction reactions that are central to many metabolic processes, including the mitochondrial electron transport chain, fatty acid and amino acid oxidation, and the citric acid cycle (Bender, 2002; Rivlin, 2006).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of riboflavin and the contribution to normal energy-yielding metabolism.

3.2. Udział w prawidłowym metabolizmie żelaza (ID 30, 37)

The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that there is consensus on the role of riboflavin in the metabolism of iron (JHCI, 2003; Bates, 2005; SCF, 2000; IoM, 1998; Bender, 2002).
Iron metabolism is impaired in riboflavin deficiency. The utilisation of iron reserves from the intracellular protein, ferritin, requires riboflavin. Animal studies show that riboflavin deficiency increases the rate of gastrointestinal iron loss (Powers, 2003). Riboflavin is required for haemoglobin synthesis (Bates, 2005).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of riboflavin and contribution to normal metabolism of iron.

3.3. Utrzymanie prawidłowego stanu skóry i błon śluzowych (ID 31, 33)

The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that there is consensus on the role of riboflavin in the structure and function of skin and mucous membranes (JHCI, 2003; Bates, 2005; EVM, 2002; IoM, 1998).
This evidence comes mainly from the observation of symptoms of riboflavin deficiency. Mucocutaneous lesions are present in both acute and chronic riboflavin deficiency. The distribution of the lesions varies with the age and sex of the patient. Lesions of acute riboflavin deficiency are similar to those observed in protein-energy malnutrition of the kwashiorkor type. In chronic riboflavin deficiency the cutaneous lesions resemble monilial intertrigo and the mucous membrane lesions include a characteristic glossitis. Mucosal and skin symptoms disappear after administration of riboflavin in adequate doses (Roe, 1991).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of riboflavin and maintenance of normal skin and mucous membranes.

3.4. Udział w prawidłowym przebiegu funkcji psychicznych (psychologicznych) (ID 32)

A total of 22 references, 14 of which were textbooks, were provided for the substantiation of the claimed effect.
Four studies were randomised clinical trials of the effects of multivitamin supplementation in normal healthy adults (Benton et al, 1995a; Carroll et al., 2000; Heseker et al., 1995). The Panel considers that no conclusions can be drawn from studies on fixed combinations for the substantiation of the claim on riboflavin alone.
One article was a review of the nutritional effects of oral contraceptive use in women (Webb, 1980), another was a short report from a meeting on malnutrition (Buzina et al, 1989), and a third was on dietary reference intakes. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
Two articles were narrative reviews of the influence of micronutrients and vitamins on cognitive function and performance (Huskisson et al, 2007a) and the role of vitamins and minerals in energy metabolism and well-being (Huskisson et al, 2007b). The Panel notes that neither focused on the
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specific role of riboflavin, but rather considered the benefits of multivitamin and micronutrient supplementation in vitamin and micronutrient deficiencies.
One observational study found an association between severe riboflavin deficiency and clinical signs of behavioural disturbance in psychiatric patients (Carney et al., 1982), and suggested that affective changes are characteristic of riboflavin and pyridoxine deficiencies. This study did not investigate relevant endpoints of cognitive outcomes. The Panel notes that no evidence was presented to indicate that findings from an observational study on affective changes in psychiatric patients could be extrapolated to the general population and, moreover, no conclusions on a causal relationship between the dietary intake of riboflavin and contribution to normal psychological function can be drawn from this study because residual confounding by other dietary and lifestyle factors inherent to the observational study design cannot be excluded.
The Panel notes that none of the references provided addressed the relationship between the intake of riboflavin and psychological functions.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of riboflavin and contribution to normal psychological functions.

3.5. Utrzymanie prawidłowego stanu kości (ID 33)

Four consensus references were provided for the substantiation of the claimed effect (SCF, 1993; IoM, 1998; SCF, 2000; EVM, 2003). None mentioned a specific relationship between riboflavin intake and the maintenance of normal bone. 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 riboflavin and maintenance of normal bones.

3.6. Utrzymanie prawidłowego stanu zębów (ID 33)

Four consensus references were provided for the substantiation of the claimed effect (SCF, 1993; IoM, 1998; SCF, 2000; EVM, 2003). None mentioned a specific relationship between riboflavin intake and maintenance of normal teeth. 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 riboflavin and maintenance of normal teeth.

3.7. Utrzymanie prawidłowego stanu włosów (ID 33)

Four consensus references were provided for the substantiation of the claimed effect (SCF, 1993; IoM, 1998; SCF, 2000; EVM, 2003). None mentioned a specific relationship between riboflavin intake and maintenance of normal hair. 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 riboflavin and maintenance of normal hair.

3.8. Utrzymanie prawidłowego stanu paznokci (ID 33)

Four consensus references were provided for the substantiation of the claimed effect (SCF, 1993; IoM, 1998; SCF, 2000; EVM, 2003). None mentioned a specific relationship between riboflavin intake and maintenance of normal nails. 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 riboflavin and maintenance of normal nails.
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3.9. Utrzymanie prawidłowego wzroku (ID 39)

Riboflavin deficiency can cause conjunctivitis with vascularisation of the cornea and opacity of the lens – the only lesion of araboflavinosis for which the biochemical basis is known. Glutathione is important in maintaining the normal clarity of crystallins in the lens and glutathione reductase is a flavoprotein that is particularly sensitive to riboflavin depletion (Gibney et al., 2002).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of riboflavin and maintenance of normal vision.

3.10. Utrzymanie prawidłowej budowy erytrocytów (czerwonych krwinek) (ID 40)

Riboflavin deficiency induces normocytic and normochromic anaemia characterised by an increase in the number of reticulocytes, immature precursors of red blood cells, which are virtually absent from normal blood. Symptoms are corrected by treatment with riboflavin. (Bates, 2005; Powers, 2003).
The Panel considers that a cause and effect relationship has been established between the dietary intake of riboflavin and maintenance of normal red blood cells.

3.11. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 207)

It is well established that riboflavin participates in a diversity of redox reactions, through the cofactors FMN and FAD, which act as electron carriers (Powers, 2003; Rivlin, 2007). A protective role of riboflavin against lipid peroxidation is provided mainly by the glutathione redox cycle (Sadler et al., 1999). Glutathione peroxidase requires reduced glutathione, which in turn is generated by glutathione reductase. The glutathione reductase enzyme requires the riboflavin co-enzyme FAD and this enzyme is particularly sensitive to riboflavin deficiency making glutathione reductase enzyme measures most suitable for assessing riboflavin status (Hoey et al, 2009). Riboflavin deficiency is associated with increased lipid peroxidation, a process that can be inhibited by riboflavin (Bates, 2005; Dutta et al., 1995; Miyazawa et al., 1983; Taniguchi et al., 1983).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of riboflavin and protection of DNA, proteins and lipids from oxidative damage.

3.12. Zmniejszenie zmęczenia (ID 41)

The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that there is consensus that the symptoms of riboflavin deficiency include weakness and fatigue (Rivlin, 2006).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of riboflavin and a reduction of tiredness and fatigue.

3.13. Utrzymanie prawidłowego funkcjonowania układu nerwowego (ID 213)

The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that there is consensus on the role of riboflavin in maintaining normal function of the nervous system (Powers, 2003).
Riboflavin deficiency causes degenerative changes in peripheral nerves found in experimental conditions in several species of animals, which are characterised by demyelination with hypertrophy of Schwann cells, marked lipid accumulation, paranodal tomacula and fibroblastic onion bulbs. The presence of lipid depositions in Schwann cells and the formation of paranodal redundant loops of normal myelin suggest a disturbance of lipid metabolism and control of myelin membrane formation in the myelinating Schwann cell. Spinal cord and brain are unaffected (Cai et al., 2009). Some case reports are available in humans showing the presence of peripheral polyneuropathy in riboflavin depleted subjects (Powers, 2003; Bates, 2005).
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The Panel concludes that a cause and effect relationship has been established between the dietary intake of riboflavin and maintenance of the normal function of the nervous system.

4. Uwagi do zaproponowanego brzmienia oświadczenia

4.1. Udział w prawidłowym pozyskiwaniu energii w procesach metabolicznych (ID 29, 35, 36, 42)

The Panel considers that the following wording reflects the scientific evidence: “Riboflavin contributes to normal energy-yielding metabolism”.

4.2. Udział w prawidłowym metabolizmie żelaza (ID 30, 37)

The Panel considers that the following wording reflects the scientific evidence: “Riboflavin contributes to the normal metabolism of iron in the body”.

4.3. Utrzymanie prawidłowego stanu skóry i błon śluzowych (ID 31, 33)

The Panel considers that the following wording reflects the scientific evidence: “Riboflavin contributes to the maintenance of normal skin and mucous membranes”.

4.4. Utrzymanie prawidłowej budowy erytrocytów (czerwonych krwinek) (ID 40)

The Panel considers that the following wording reflects the scientific evidence: “Riboflavin contributes to the maintenance of normal red blood cells”.

4.5. Utrzymanie prawidłowego wzroku (ID 39)

The following wording reflects the scientific evidence: “Riboflavin contributes to the maintenance of normal vision”.

4.6. Ochrona DNA, białek i tłuszczów przed uszkodzeniem oksydacyjnym (ID 207)

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

4.7. Zmniejszenie zmęczenia (ID 41)

The Panel considers that the following wording reflects the scientific evidence: “Riboflavin can contribute to the reduction of tiredness and fatigue”.

4.8. Utrzymanie prawidłowego funkcjonowania układu nerwowego (ID 213)

The Panel considers that the following wording reflects the scientific evidence: “Riboflavin contributes to the maintenance of the normal function of the nervous system”.

5. Warunki i możliwe ograniczenia stosowania oświadczenia

The Panel considers that in order to bear the claims a food should be at least a source of riboflavin as per Annex to Regulation (EC) No 1924/2006. Such amounts can be easily consumed as part of a balanced diet. Tolerable Upper Intake Levels (UL) have not been established for riboflavin in children, adolescents and adults (SCF, 2000).

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, riboflavin, which is the subject of the health claims, is sufficiently characterised.
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Contribution to normal energy-yielding metabolism (ID 29, 35, 36, 42)
The claimed effects are “energy metabolism”, “riboflavin participates in oxidation-reduction reactions in numerous metabolic pathways and in energy production via respiratory chain”, “macronutrient metabolism” and “release of energy from food”. The target population is assumed to be the general population. Contribution to normal energy-yielding metabolism is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of riboflavin and contribution to normal energy-yielding metabolism.
The following wording reflects the scientific evidence: “Riboflavin contributes to normal energy-yielding metabolism”.
Contribution to normal metabolism of iron (ID 30, 37)
The claimed effects are “transport and metabolism of iron”, and “healthy iron status”. The target population is assumed to be the general population. Contribution to normal metabolism of iron is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of riboflavin and contribution to normal metabolism of iron.
The following wording reflects the scientific evidence: “Riboflavin contributes to normal metabolism of iron in the body”.
Maintenance of normal skin and mucous membranes (ID 31, 33)
The claimed effects are “structure and function of the skin and mucous membranes (such as in the lung, intestines, nose, eyes and female reproductive tract)” and “bone/teeth/hair/skin and nails health”. The target population is assumed to be the general population. Maintenance of normal skin and mucous membranes is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of riboflavin and maintenance of normal skin and mucous membranes.
The following wording reflects the scientific evidence: “Riboflavin contributes to the maintenance of normal skin and mucous membranes”.
Contribution to normal psychological functions (ID 32)
The claimed effect is “mental performance (where mental performance stands for those aspects of brain and nerve functions which determine aspects like concentration, learning, memory and reasoning, as well as resistance to stress)”. The target population is assumed to be the general population. Contribution to normal psychological functions, which encompass cognitive and affective domains, is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of riboflavin and contribution to normal psychological functions.
Maintenance of normal bone (ID 33)
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 riboflavin and maintenance of normal bone.
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Maintenance of normal teeth (ID 33)
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 riboflavin and maintenance of normal teeth.
Maintenance of normal hair (ID 33)
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 riboflavin and maintenance of normal hair.
Maintenance of normal nails (ID 33)
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 riboflavin and maintenance of normal nails.
Maintenance of normal vision (ID 39)
The claimed effect is “eyes”. The Panel target population is assumed to be the general population. Maintenance of normal vision is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of riboflavin and maintenance of normal vision.
The following wording reflects the scientific evidence: “Riboflavin contributes to the maintenance of normal vision”.
Maintenance of normal red blood cells (ID 40)
The claimed effect is “red blood cells”. The target population is assumed to be the general population. Maintenance of normal red blood cells is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of riboflavin and maintenance of normal red blood cells.
The following wording reflects the scientific evidence: “Riboflavin contributes to the maintenance of normal red blood cells”.
Protection of DNA, proteins and lipids from oxidative damage (ID 207)
The claimed effect is “antioxidant properties”. The target population is assumed to be the general population. Protection of DNA, proteins and lipids from oxidative damage may be a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of riboflavin and protection of DNA, proteins and lipids from oxidative damage.
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The following wording reflects the scientific evidence: “Riboflavin contributes to the protection of cell constituents from oxidative damage”.
Reduction of tiredness and fatigue (ID 41)
The claimed effect is “vitamin/mineral supplementation to reduce fatigue and tiredness in situations of inadequate micronutrient status”. The target population is assumed to be the general population. Reduction of tiredness and fatigue is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of riboflavin and a reduction of tiredness and fatigue.
The following wording reflects the scientific evidence “Riboflavin can contribute to the reduction of tiredness and fatigue”.
Maintenance of the normal function of the nervous system (ID 213)
The claimed effect is “nervous system”. The target population is assumed to be the general population. Maintenance of the normal function of the nervous system is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of riboflavin and maintenance of the normal function of the nervous system.
The following wording reflects the scientific evidence “Riboflavin contributes to the maintenance of the normal function of the nervous system”.
Conditions and possible restrictions of use
The Panel considers that in order to bear the claims a food should be at least a source of riboflavin 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

1814.pdf

1. Charakterystyka żywności / składnika