ID 33 - Ryboflawina

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

Oświadczenie (4)

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.

2.3. 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.

2.5. 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)

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 teeth is a beneficial physiological effect.

2.7. Utrzymanie prawidłowego stanu włosów (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 hair is a beneficial physiological effect.

2.8. Utrzymanie prawidłowego stanu paznokci (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 nails 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).

3.3. 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.

3.5. 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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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”.

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 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.