ID 381 - Magnez

PL: Magnez
EN: Magnesium
Pdf: magnesium

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is magnesium, which is a well recognised nutrient and is measurable in foods by established methods.
Magnesium 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 magnesium naturally present in foods and to 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, magnesium, which is the subject of the health claims, is sufficiently characterised.

2.9. Odporność na stres (ID 375, 381)

The claimed effects are “système nerveux” and “magnésium et stress: magnesium is a mineral involved in stress and its reactions. On one hand, stress tends to reduce the magnesium status and, on the other hand, an exogenous or endogenous deficit in magnesium increases the stress response. It matters to maintain a suitable magnesium status in order to better react against stress”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and from the references provided, the Panel assumes that the claimed effects refer to resistance to mental stress. Resistance to mental stress can be measured by established methods.
The Panel considers that resistance to mental stress might be a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - 

Magnesium is an essential nutrient and serves as a cofactor for over 300 enzymes involved in biological processes. Magnesium is part of the Mg-ATPase complex and is essential for oxidative phosphorylation; it has roles in energy metabolism, mineral homeostasis, calcium metabolism, and neuromuscular and endocrine function (IoM, 1997; SCF, 2001; Volpe, 2006).
In the human body, 50 to 60 % of magnesium is located in the bone. Part of it is readily exchangeable with serum and therefore bone represents a magnesium store. The remaining magnesium is mainly intracellular; extracellular magnesium represents only 1 % of the total magnesium content of the body.
Because magnesium is mostly within cells or in bone, assessment of magnesium status is difficult (Rude and Shils, 2006).
Manifestations of magnesium deficiency include signs related to bone and mineral metabolism, neuromuscular and psychological manifestations (e.g. positive Chvostek and Trousseau signs, spontaneous carpal-pedal spasm, seizures, vertigo, ataxia, nystagmus, athetoid and choreiform movements, muscular weakness, tremor, fasciculation, wasting, depression, psychosis, hallucinations, confusion), symptoms related to potassium homeostasis, and cardiovascular manifestations (Rude and Shils, 2006; FAO/WHO, 2001; O'Brien, 1999). Most of the early symptoms of magnesium depletion are neurological or neuromuscular; thus, a decline in magnesium status produces loss of appetite, nausea, muscular weakness, vomiting, fatigue, lethargy, staggering and, if the deficit is prolonged, weight loss (FAO/WHO, 2001; Volpe, 2006). Progressively increasing with the severity and duration of deficiency are signs such as hyperirritability, hyperexcitability, muscular spasms and tetany, leading ultimately to convulsions (FAO/WHO, 2001).

3.8. Odporność na stres (ID 375, 381)

The references cited for the scientific substantiation of the claimed effect include textbooks or general publications, one consensus opinion from a national authoritative body (without any mention about mental stress) and one opinion of a European authoritative body. Many other provided references reported on outcomes not directly related to the claimed effect: physical exercise, extreme physical stress, alcohol and drug use by students before exams, delayed-type hypersensitivity and chronic fatigue syndrome, recommended dietary amounts, magnesium metabolism and deficiency, dietary intakes, sleep electroencephalogram and nocturnal hormonal secretion in the elderly, psychiatric disorders, depression, pregnancy-related outcomes, premenstrual symptoms, biorhythms, anxiety- depressive states in epilepsy, cardiovascular outcomes and atherosclerosis. The Panel considers that these endpoints are not relevant for the claimed effect and that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
One reference, reporting on changes in the concentration of non-esterified fatty acids and magnesium in emotional stress, was in Russian, and the English translation was not available to the Panel. In addition, the provided narrative reviews on stress reactions and those specifically on noise-induced stress, did not provide any primary data for the scientific substantiation of the claimed effect.
One reference (Hanus et al., 2004) reported on the effects of a combination of two plant extracts and magnesium on mild-to-moderate anxiety disorders. The Panel considers that no conclusions can be drawn from a study using a fixed combination for the scientific substantiation of the claimed effect on magnesium alone. Another reference (James et al., 1989) reported on the inhibition by intravenous magnesium sulphate of catecholamine release associated with tracheal intubation. The Panel considers that the evidence provided does not establish that results obtained in studies on patients with tracheal intubation can be extrapolated to oral consumption and to the general population.
One reference (Cernak et al., 2000) reported on plasma magnesium and oxidative status in young volunteers exposed to chronic stress (political intolerance, awareness of potential military attacks, permanent stand-by duty and reduced holidays for more than 10 years) or sub-chronic stress consisting of everyday mortal danger in military actions lasting more than three months. Porta et al. (1994) reported on the differential regulation of free and bound plasma magnesium in healthy volunteers exposed to various forms of stress, and patients screened for thyroid disorder. Another reference (Grases et al., 2006) reported on alterations of calcium and magnesium excretion in urine in relation to stress and anxiety in university science students, in basal conditions and during exams, using stress and anxiety questionnaires. The reference of Mocci et al. (2001) reported on urinary catecholamine excretion and serum concentration and urinary excretion of magnesium and other related electrolytes in relation to a short-term exposure to loud noise, in healthy volunteers. Joachims et al. (1987) reported on the correlation between noise-induced hearing loss and serum magnesium concentration in air force pilots. Takase et al. (2004) reported on the effects of chronic stress on endothelial function and intracellular magnesium concentrations in humans. The Panel notes that in the absence of intervention studies with magnesium, changes in blood, intracellular and urinary magnesium in response to stress cannot be used for the scientific substantiation of the claimed effect.
Seven references were animal studies which reported on the effects of various magnesium salts and combinations thereof on the development of stress ulcers and cardiac necroses, antidepressant and anxiolytic-like activity, prevention of stress-induced damage and noise-induced hypertension. The Panel considers that evidence provided in animal studies is not sufficient to predict the occurrence of an effect of the dietary intake of magnesium on resistance to mental stress in humans.
The Panel notes that no human data were provided from which conclusions could be drawn for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between dietary intake of magnesium and resistance to mental stress.

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 magnesium 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. No Tolerable Upper Intake Level (UL) has been established for magnesium normally present in food and beverages. An UL for older children and adults has been established for readily dissociable magnesium salts and compounds like magnesium oxide in nutritional supplements, waters or added to food and beverages (SCF, 2001).

Warunki i możliwe ograniczenia stosowania oświadczenia

120mg/j