Scientific Opinion on the substantiation of health claims related to manganese and protection of DNA, proteins and lipids from oxidative
damage (ID 309), maintenance of bone (ID 310), energy-yielding metabolism (ID 311), and cognitive function (ID 340) pursuant to Article
13(1) of Regulation (EC) No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
Manganese
bone
cognitive function
energy-yielding metabolism
health claims
oxidative damage
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claim 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 1925/20064 and Annex I of Directive 2002/46/EC5). 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 claim, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 309)
The claimed effects are “protection of body tissues and cells from oxidative damage” and “antioxidant activity”. 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 agents (e.g. radiation, pollutants). These reactive intermediates can cause oxidative damage to biologically important molecules such as DNA, proteins and lipids if they are not intercepted by the antioxidant defence system which includes free radical scavengers like antioxidant nutrients.
The Panel considers that the protection of DNA, proteins and lipids from oxidative damage is beneficial to human health.
2.2. Utrzymanie prawidłowego stanu kości (ID 310)
The claimed effect is “bone formation”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel notes that the claimed effect relates to the maintenance of normal bone.
The Panel considers that the maintenance of normal bone is beneficial to human health.
2.3. Metabolizm energetyczny (ID 311)
The claimed effect is “energy metabolism”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel notes that the claimed effect relates to the conversion of energy from foods into energy in the form of ATP which may be readily used by the body.
The Panel considers that normal energy-yielding metabolism is beneficial to human health.
2.4. Funkcje poznawcze (ID 340)
The claimed effect is “mental state and performance”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect relates to cognitive function.
The Panel considers that normal cognitive function is beneficial to human health.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka
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, glutamine synthetase, hydrolases, kinases and transferases, such us glycosyltranferases. 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).
3.1. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 309)
SOD catalyzes the dismutation of superoxide into oxygen and hydrogen peroxide, and, as such, it is an important antioxidant defence in nearly all cells exposed to oxygen. SOD2 (Mn-SOD) is the isoenzyme of SOD present in mitochondria. Its synthesis is regulated by manganese by a mechanism of gene activation and reduced activity of the enzyme has been shown in manganese deficiency in mice. Mice lacking SOD2 die a few days after birth owing to massive oxidative stress. Tissue Mn- SOD activity increases after exposure to environmental factors inducing an increase of free radicals in animal cells (JHCI, 2003; Buchman, 2006).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of manganese and the protection of DNA, proteins and lipids from oxidative damage. However, the evidence provided does not establish that inadequate intake of manganese leading to impaired protection of DNA, proteins and lipids from oxidative damage occurs in the general EU population.
3.2. Utrzymanie prawidłowego stanu kości (ID 310)
Glycosyltranferases and xylosyltransferases are important for proteoglycan synthesis and thus bone formation and are sensitive to manganese intake and status in animals (JHCI, 2003; IoM, 2001; 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). The very few cases reported of manganese deficiency in humans (induced in experimental conditions) also point towards an impairment of growth and development of bone. However, manganese deficiency has not been well documented in humans (Buchman, 2006).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of manganese and the maintenance normal bone. However, the evidence provided does not establish that intake of manganese inadequate for the maintenance of normal bone occurs in the general EU population.
3.3. Metabolizm energetyczny (ID 311)
Manganese is a cofactor of many enzymes involved in amino acid, carbohydrate and cholesterol metabolism. Deficiency signs of manganese in animals and in humans include alterations in carbohydrate and lipid metabolism (JHCI, 2003), albeit clinical manifestations of manganese deficiency regarding macronutrient metabolism in humans have not been well documented (Buchman, 2006).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of manganese and normal energy-yielding metabolism. However, the evidence provided does not establish that inadequate intake of manganese leading to impaired energy-yielding metabolism occurs in the general EU population.
3.4. Funkcje poznawcze (ID 340)
A total of six references were provided in the consolidated list to support this claim (Takeda, 2003 and 2004; Bourre, 2004; Wedler, 1993; Shils et al., 1994; Buchman, 2006; Mason, 2001).
Glutamine synthetase, which catalyzes the conversion of glutamate to glutamine, is a manganese metalloprotein and accounts for approximately 80% of total manganese in the brain. Manganese- deficient rats are more susceptible to seizures induced by electroshock than control rats fed a manganese-adequate diet and ataxia has been reported in offspring from manganese-deprived rats (Takeda, 2003). Manganese deficiency has not been well documented and does not occur readily in humans. An impairment in neurological function is not among the signs and symptoms of manganese deficiency described in humans (Buchman, 2006). Although lower plasma concentrations of manganese have been found in sub-groups of patients with psychiatric diseases as compared to healthy controls (Takeda, 2003), it has not been shown that these conditions respond to increased manganese intake. No data have been provided on the effects of manganese supplementation on cognitive function or mental performance.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of manganese and normal cognitive function. However, the evidence provided does not establish that inadequate intake of manganese leading to impaired cognitive function occurs in the general EU population.
4. Uwagi do zaproponowanego brzmienia oświadczenia
4.1. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 309)
The Panel considers that the following wording reflects the scientific evidence: “Manganese contributes to the protection of cell constituents from oxidative damage”.
4.2. Utrzymanie prawidłowego stanu kości (ID 310)
The Panel considers that the following wording reflects the scientific evidence: “Manganese contributes to the maintenance of normal bone”.
4.3. Metabolizm energetyczny (ID 311)
The Panel considers that the following wording reflects the scientific evidence: "Manganese contributes to normal energy-yielding metabolism".
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 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, that is the subject of the health claims, is sufficiently characterised.
Protection of DNA, proteins and lipids from oxidative damage (ID 309)
The claimed effect is “protection of body tissues and cells from oxidative damage” and “antioxidant activity”. The target population is assumed to be the general population. Protection of DNA, proteins and lipids from oxidative damage is beneficial to human health.
A cause and effect relationship has been established between the dietary intake of manganese and the protection of DNA, proteins and lipids from oxidative damage.
The evidence provided does not establish that inadequate intake of manganese leading to impaired protection of DNA, proteins and lipids from oxidative damage occurs in the general EU population.
The following wording reflects the scientific evidence: “Manganese contributes to the protection of body cells from oxidative damage”.
Maintenance of normal of bone (ID 310)
The claimed effect is “bone formation”. The target population is assumed to be the general population. Maintenance of normal bone is beneficial to human health.
A cause and effect relationship has been established between the dietary intake of manganese and the maintenance of normal bone.
The evidence provided does not establish that intake of manganese inadequate for the maintenance of normal bone occurs in the general EU population.
The following wording reflects the scientific evidence: “Manganese contributes to the maintenance of normal bone”.
Energy-yielding metabolism (ID 311)
The claimed effect is “energy metabolism”. The target population is assumed to be the general population. Normal energy-yielding metabolism is beneficial to human health.
A cause and effect relationship has been established between the dietary intake of manganese and normal energy-yielding metabolism.
The evidence provided does not establish that inadequate intake of manganese leading to impaired energy-yielding metabolism occurs in the general EU population.
The following wording reflects the scientific evidence: "Manganese contributes to normal energy-yielding metabolism".
Cognitive function (ID 340)
The claimed effect is “mental state and performance”. The target population is assumed to be the general population. Normal cognitive function is beneficial to human health.
A cause and effect relationship has not been established between the dietary intake of manganese and normal cognitive function.
Conditions and possible restrictions of use
In order to bear the claims 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.
