Scientific Opinion on the substantiation of health claims related to
magnesium and electrolyte balance (ID 238), energy-yielding metabolism
(ID 240, 247, 248), neurotransmission and muscle contraction including
heart muscle (ID 241, 242), cell division (ID 365), maintenance of bone
(ID 239), maintenance of teeth (ID 239), blood coagulation (ID 357) and
protein synthesis (ID 364) 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:
Magnesium
blood coagulation
bone
cell division
electrolyte balance
energy-yielding metabolism
health claims
heart
minerals
muscle
neurotransmission
protein synthesis
teeth
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 1925/20064 and Annex I of Directive 2002/46/EC5). 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. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Równowaga elektrolitowa (ID 238)
The claimed effect is “electrolyte balance”. The Panel assumes that the target population is the general population.
The Panel considers that electrolyte balance is beneficial to human health.
2.2. Metabolizm energetyczny (ID 240, 247, 248)
The claimed effects are “energy metabolism/normal cellular energy supply”, “magnesium is an essential cofactor for more than 300 enzymes involved in biosynthetic processes and energy metabolism”, “normal energy metabolism”. The Panel assumes that the target population is the general population.
The Panel considers that normal energy-yielding metabolism is beneficial to human health.
2.3. Przewodnictwo nerwowe i skurcze mięśni, w tym mięśnia sercowego (ID 241, 242)
The claimed effects are “normal muscle contraction including normal heartbeat” and “nerve transmission/function”. The Panel assumes that the target population is the general population.
The Panel considers that normal neurotransmission and muscle contraction including heart muscle are beneficial to human health.
2.4. Podziały komórek (ID 365)
The claimed effect is “cell division”. The Panel assumes that the target population is the general population.
The Panel notes that cell division is a crucial process for tissue growth and development and for tissue maintenance through cell turnover.
The Panel considers that normal cell division is beneficial to human health.
2.5. Utrzymanie prawidłowego stanu kości (ID 239)
The claimed effect is “bone and teeth structure”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal bone is beneficial to human health.
2.6. Utrzymanie prawidłowego stanu zębów (ID 239)
The claimed effect is “bone and teeth structure”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal teeth is beneficial to human health.
2.7. Krzepnięcie krwi (ID 357)
The claimed effect is “normal blood clotting”. The Panel assumes that the target population is the general population.
The Panel considers that normal blood coagulation is beneficial to human health.
2.8. Synteza białek (ID 364)
The claimed effect is “protein synthesis”. The Panel assumes that the target population is the general population.
The Panel considers that normal protein synthesis is beneficial to human health.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
Magnesium is an essential nutrient and serves as a cofactor for over 300 enzymes involved in biosynthetic processes. It is part of the Mg-ATP complex, is essential for oxidative phosphorylation and 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.
3.1. Równowaga elektrolitowa (ID 238)
The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that there is good consensus on the role of magnesium in electrolyte balance (IoM, 1997; EVM, 2003; Rude and Shils, 2006).
Soft tissue magnesium functions as a cofactor of many enzymes involved in the maintenance of the electrical potential of nerve tissue and cell membranes. Magnesium deficiency always includes secondary electrolyte disturbances. Hypomagnesaemia is often associated with hypocalcaemia and
calcium homeostasis is controlled in part by a Mg-requiring mechanism which releases parathyroid hormone.
The Panel concludes that a cause and effect relationship has been established between the dietary intake of magnesium and electrolyte balance.
3.2. Metabolizm energetyczny (ID 240, 247, 248)
The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that there is good consensus on the role of magnesium in energy-yielding metabolism (SCF, 2001; IoM, 1997)
The Panel concludes that a cause and effect relationship has been established between the dietary intake of magnesium and normal energy-yielding metabolism.
3.3. Przewodnictwo nerwowe i skurcze mięśni, w tym mięśnia sercowego (ID 241, 242)
The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that there is good consensus on the role of magnesium in nerve transmission and muscle contraction, including heart muscle contraction (IoM, 1997; FAO/WHO, 2004; EVM, 2002; DoH, 1991).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of magnesium and normal neurotransmission and muscle contraction including heart muscle.
3.4. Podziały komórek (ID 365)
Magnesium is able to form complexes with nucleic acids. The negatively charged ribose phosphate structure of nucleic acids has a high affinity for magnesium. The resulting stabilisation of numerous ribonucleotides and deoxyribonucleotides induces physicochemical changes that affect DNA maintenance, duplication and transcription (Rude and Shils, 2006).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of magnesium and cell division.
3.5. Utrzymanie prawidłowego stanu kości (ID 239)
Some 50 to 60% of the total body magnesium content of approximately 25 g in the normal adult resides in bones and teeth. One-third of skeletal magnesium is exchangeable, and it is this fraction that may serve as a reservoir for maintaining a normal extracellular magnesium concentration. The magnesium in bones and tooth enamel and dentin is not an integral part of the hydroxyapatite crystal structure (like calcium and phosphorus); rather, it is adsorbed on the surface of the crystal. Magnesium deficiency in animals results in decreased bone strength and volume and impaired bone and tooth development. Magnesium deficiency in humans causes hypocalcaemia and vitamin D abnormalities (Volpe, 2006).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of magnesium and maintenance of normal bone.
3.6. Utrzymanie prawidłowego stanu zębów (ID 239)
Some 50 to 60% of the total body magnesium content of approximately 25 g in the normal adult resides in bones and teeth. One-third of skeletal magnesium is exchangeable, and it is this fraction that may serve as a reservoir for maintaining a normal extracellular magnesium concentration. The magnesium in bones and tooth enamel and dentin is not an integral part of the hydroxyapatite crystal structure (like calcium and phosphorus); rather, it is adsorbed on the surface of the crystal. Magnesium deficiency in animals results in decreased bone strength and volume and impaired bone
and tooth development. Magnesium deficiency in humans causes hypocalcaemia and vitamin D abnormalities.
The Panel concludes that a cause and effect relationship has been established between the dietary intake of magnesium and maintenance of teeth.
3.7. Krzepnięcie krwi (ID 357)
The normal mechanism for blood coagulation is a complex series of events involving the interaction of the injured blood vessel, platelets, and a number of various coagulation factors circulating in the blood.
The only reference provided does not refer to the role of magnesium on blood coagulation. The magnesium cation might act indirectly on this function through its effects on calcium. However, impaired blood coagulation is not an established symptom of magnesium deficiency.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of magnesium and normal blood coagulation.
3.8. Synteza białek (ID 364)
Magnesium is an essential cofactor of enzymes involved in protein synthesis (SCF, 2001; FAO/WHO, 2004). Protein synthesis is reported to be sensitive to magnesium depletion (IoM, 1997).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of magnesium and normal protein synthesis.
4. Uwagi do zaproponowanego brzmienia oświadczenia
4.1. Równowaga elektrolitowa (ID 238)
The Panel considers that the following wording reflects the scientific evidence: “Magnesium contributes to electrolyte balance”.
4.2. Metabolizm energetyczny (ID 240, 247, 248)
The Panel considers that the following wording reflects the scientific evidence: “Magnesium contributes to normal energy-yielding metabolism”.
4.3. Przewodnictwo nerwowe i skurcze mięśni, w tym mięśnia sercowego (ID 241, 242)
The Panel considers that the following wordings reflect the scientific evidence: “Magnesium contributes to normal muscle function including the heart muscle”, “magnesium contributes to normal nerve function”.
4.4. Podziały komórek (ID 365)
The Panel considers that the following wording reflects the scientific evidence: “Magnesium contributes to normal cell division”.
4.5. Utrzymanie prawidłowego stanu kości (ID 239)
The Panel considers that the following wording reflects the scientific evidence: “Magnesium contributes to the maintenance of normal bone”.
4.6. Utrzymanie prawidłowego stanu zębów (ID 239)
The Panel considers that the following wording reflects the scientific evidence: “Magnesium contributes to the maintenance of normal teeth”.
4.7. Synteza białek (ID 364)
The Panel considers that the following wording reflects the scientific evidence: “Magnesium contributes to normal protein synthesis”.
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 Levels (UL) have been established for magnesium normally present in food and beverages. An UL of 250 mg Mg/day for older children and adults has been established for readily dissociable magnesium salts and compounds like MgO in nutritional supplements, waters or added to food and beverages (SCF, 2001).
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, magnesium, which is the subject of the health claims is sufficiently characterised.
Electrolyte balance (ID 238)
The claimed effect is “electrolyte balance”. The target population is assumed to be the general population. Electrolyte balance is beneficial to human health.
A cause and effect relationship has been established between the dietary intake of magnesium and electrolyte balance.
The following wording reflects the scientific evidence: “magnesium contributes to electrolyte balance”.
Energy-yielding metabolism (ID 240, 247, 248)
The claimed effects are “energy metabolism/ normal cellular energy supply”, “magnesium is an essential cofactor for more than 300 enzymes involved in biosynthetic processes and energy metabolism”, “normal 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 magnesium and normal energy-yielding metabolism.
The following wording reflects the scientific evidence: “magnesium contributes to normal energy metabolism”.
Neurotransmission and muscle contraction including heart muscle (ID 241, 242)
The claimed effects are “normal muscle contraction including normal heartbeat” and “nerve transmission/function”. The target population is assumed to be the general population. Normal neurotransmission and muscle contraction including heart muscle are beneficial to human health.
A cause and effect relationship has been established between the dietary intake of magnesium and neurotransmission and muscle contraction including heart muscle.
The following wordings reflect the scientific evidence: “magnesium contributes to muscle function including the heart muscle”, “magnesium contributes to nerve function”.
Cell division (ID 365)
The claimed effect is “cell division”. The target population is assumed to be the general population. Normal cell division is beneficial to human health.
A cause and effect relationship has been established between the dietary intake of magnesium and cell division.
The following wording reflects the scientific evidence: “magnesium contributes to cell division”.
Maintenance of bone (ID 239)
The claimed effect is “bone and teeth structure”. 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 magnesium and maintenance of normal bone.
The following wording reflects the scientific evidence: “magnesium contributes to the maintenance of normal bone”.
Maintenance of teeth (ID 239)
The claimed effect is “bone and teeth structure”. The target population is assumed to be the general population. Maintenance of normal teeth is beneficial to human health.
A cause and effect relationship has been established between the dietary intake of magnesium and maintenance of normal teeth.
The following wording reflects the scientific evidence: “magnesium contributes to the maintenance of normal teeth”.
Blood coagulation (ID 357)
The claimed effect is “normal blood clotting”. The target population is assumed to be the general population. Normal blood coagulation is beneficial to human health.
A cause and effect relationship has not been established between the dietary intake of magnesium and normal blood coagulation.
Protein synthesis (ID 364)
The claimed effect is “protein synthesis”. The target population is assumed to be the general population. Normal protein synthesis is beneficial to human health.
A cause and effect relationship has been established between the dietary intake of magnesium and normal protein synthesis.
The following wording reflects the scientific evidence: “magnesium contributes to normal protein synthesis”.
Conditions and possible restrictions of use
In order to bear the claims 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.
