ID 213 -
	
		
			Ryboflawina
		
		
		
	 
PL: Ryboflawina
EN: Riboflavin
Pdf: various food(s)/food constituent(s) that are referring to children’s development
	Oświadczenie (4)
	
		
			-  Ryboflawina przyczynia się do utrzymania prawidłowego funkcjonowania układu nerwowego
 
		
	
 
 
        
        
                
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.
                 
                 
	        
        
        
        
        
                
2.13. 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).
                 
                 
	        
        
        
        
                
3.13. 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.
                 
                 
	        
        
        
        
        
                
4.8. 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).
                 
                 
	        
        
Warunki i możliwe ograniczenia stosowania oświadczenia
yes