Scientific Opinion on the substantiation of health claims related to
manganese and reduction of tiredness and fatigue (ID 312), contribution to
normal formation of connective tissue (ID 404) and contribution to normal
energy-yielding metabolism (ID 405) pursuant to Article 13(1) of
Regulation (EC) No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
Manganese
connective tissue
energy-yielding metabolism
fatigue
health claims
tiredness
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is manganese, which is a well recognised nutrient and is measurable in foods by established methods.
Manganese occurs naturally in foods and is authorised for addition to foods (Annex I of Regulation (EC) No 1925/20066 and Annex I of Directive 2002/46/EC7). This evaluation applies to manganese naturally present in foods and those forms authorised for addition to foods (Annex II of Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC).
The Panel considers that the food constituent, manganese, which is the subject of the health claims, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Zmniejszenie zmęczenia (ID 312)
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.
2.2. Udział w prawidłowym tworzeniu tkanki łącznej (ID 404)
The claimed effect is “role of manganese within formation of tissue”. 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 normal formation of connective tissue, including connective tissue in cartilage and bone.
The Panel considers that contribution to normal formation of connective tissue is a beneficial physiological effect.
2.3. Udział w prawidłowym pozyskiwaniu energii w procesach metabolicznych (ID 405)
The claimed effect is “key function within metabolism (e.g. activation of enzymes)”. 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 energy- yielding metabolism.
A claim on manganese and energy-yielding metabolism has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009).
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
3.1. Zmniejszenie zmęczenia (ID 312)
Two references were provided for the scientific substantiation of this claim: one text book chapter on the role of minerals in sports nutrition (Driskell, 1999) and a consensus opinion on dietary reference intakes for several vitamins and minerals including manganese (IoM, 2000) in which the claimed effect was not mentioned. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
Tiredness and fatigue are not among the symptoms observed in the very few cases of manganese deficiency (all induced in experimental conditions) that have been reported in humans (Buchman, 2006).
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of manganese and reduction of tiredness and fatigue.
3.2. Udział w prawidłowym tworzeniu tkanki łącznej (ID 404)
Manganese is essential as a cofactor for the metalloenzymes superoxide dismutase (SOD), xanthine oxidase, arginase, galactosyltransferase and pyruvate carboxylase. Manganese also activates a number of other enzymes such as various decarboxylases, hydrolases, kinases and transferases, for example glycosyltranferases, and glutamine synthetase. Manganese is not essential for the activity of most of these enzyme systems, which can also be activated by other metals, with the exception of glycosyltransferases (JHCI, 2003; Buchman, 2006). Manganese deficiency interferes with normal skeletal development in various animal species (Combs et al., 1942; Leach and Muenster, 1962; Tsai and Everson, 1967).
Glycosyltranferases and xylosyltransferases are important for proteoglycan synthesis and thus formation of connective tissue, including connective tissue in bone and cartilage, and these enzymes are sensitive to manganese intake and status in animals (JHCI, 2003; IoM, 2000; Buchman, 2006). The very few cases of manganese deficiency in humans have been induced in experimental conditions (Buchman, 2006).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of manganese and contribution to normal formation of connective tissue. However, the
evidence provided does not establish that inadequate intake of manganese leading to impaired formation of connective tissue occurs in the general EU population.
4. Uwagi do zaproponowanego brzmienia oświadczenia
4.1. Udział w prawidłowym tworzeniu tkanki łącznej (ID 404)
The Panel considers that the following wording reflects the scientific evidence: “Manganese contributes to the normal formation of connective tissue”.
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 manganese 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. Although adverse health effects of excess intake of manganese have been reported, Tolerable Upper Intake Levels (UL) have not been established owing to lack of data on dose response (SCF, 2000).
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, manganese, which is the subject of the health claims, is sufficiently characterised.
Reduction of tiredness and fatigue (ID 312)
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 not been established between the dietary intake of manganese and reduction of tiredness and fatigue.
Contribution to normal formation of connective tissue (ID 404)
The claimed effect is “role of manganese within formation of tissue”. The target population is assumed to be the general population. In the context of the proposed wording, it is assumed that the claimed effect refers to the normal formation of connective tissue, including connective tissue in cartilage and bone. Contribution to the normal formation of connective tissue is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of manganese and contribution to normal formation of connective tissue.
The evidence provided does not establish that inadequate intake of manganese leading to impaired formation of connective tissue occurs in the general EU population.
The following wording reflects the scientific evidence: “Manganese contributes to the normal formation of connective tissue”.
Contribution to normal energy-yielding metabolism (ID 405)
The claimed effect is “key function within metabolism (e.g. activation of enzymes)”. The target population is assumed to be the general population. In the context of the proposed wording, it is assumed that the claimed effect refers to energy-yielding metabolism.
A claim on manganese and energy-yielding metabolism has already been assessed with a favourable outcome.
Conditions and possible restrictions of use
In order to bear the claim a food should be at least a source of manganese 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.
