ID 32 - Ryboflawina

PL: Ryboflawina
EN: Riboflavin
Pdf: various food(s)/food constituent(s) that are referring to children’s development

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is riboflavin (vitamin B2), which is a well recognised nutrient and is measurable in foods by established methods.
Riboflavin occurs naturally in foods and 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 riboflavin naturally present in foods and those forms authorised for addition to foods (Annex II of the Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC).
The Panel considers that the food constituent, riboflavin, which is the subject of the health claims, is sufficiently characterised.

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.

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).

3.4. 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.

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).

Warunki i możliwe ograniczenia stosowania oświadczenia

Must at least be a source of vitamin/s as per annex to regulation 1924/2006