ID 348 - Wapń

PL: Wapń
EN: Calcium
Pdf: calcium

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is calcium, which is a well recognised nutrient and is measurable in foods by established methods. Calcium occurs naturally in foods in many forms which are generally well utilised by the body. Different forms of calcium are authorised for addition to foods and for use in food supplements (Annex II of the Regulation (EC) No 1925/20066 and Annex II of Directive 2002/46/EC7). This evaluation applies to calcium naturally present in foods and those forms authorised for addition to foods and for use in food supplements (Annex II of the Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC).
The Panel considers that the food constituent, calcium, which is the subject of the health claims, is sufficiently characterised.

2.5. Zmniejszenie nasilenia objawów związanych z zespołem napięcia przedmiesiączkowego (ID 348, 1892)

The claimed effect is “premenstrual health: calcium alleviates premenstrual syndromes”. The Panel assumes that the target population is women with premenstrual syndrome.
In the context of the proposed wordings, clarifications provided by Member States and references cited for the substantiation of this claim, the Panel assumes that the claimed effect refers to a reduction in the severity of symptoms related to the premenstrual syndrome. Severity of symptoms related to the premenstrual syndrome can be assessed using validated questionnaires.
The Panel considers that reduction in the severity of symptoms related to the premenstrual syndrome is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - 

More than 99 % of the total calcium in the body is located in bones and teeth and contributes to their mass, structure and strength. Besides this structural role, calcium acts as an intracellular messenger and as a cofactor for extracellular enzymes and proteins. Overt, symptomatic calcium deficiencies are almost nonexistent given the large skeletal reserves, although inadequate calcium intakes have been associated with a higher risk of bone fractures (IoM, 1997, Weaver and Heaney, 2006).

3.4. Zmniejszenie nasilenia objawów związanych z zespołem napięcia przedmiesiączkowego (ID 348, 1892)

Two references were cited for the substantiation of this claim. One was a narrative review on the protein components of the shell matrix of molluscs. The Panel considers that no conclusions can be drawn for the scientific substantiation of the claimed effect.
The second (Thys-Jacobs et al., 1989) reports on a double-blind, randomised, placebo controlled, cross-over intervention in pre-menopausal women selected on the basis of a history of recurrent pre- menstrual symptoms (PMS) and on the results of a prospective assessment of daily symptom scores. Only women with symptom scores during the latter half of the luteal phase at least 50 % greater than those during the early inter-menstrual phase (days following the menstrual period) and with symptoms recorded as moderate or severe in the latter half of the menstrual cycle were recruited (n=60 out of 78 initially screened). Women were asked to consume either 1 g per day of calcium or placebo for three months each in a random order. The 14 symptoms evaluated were nervousness, irritability, crying, mood swings, depression, fatigue, violent tendencies, abdominal bloating, headache, breast fullness, increased appetite, abdominal cramps, back pain, and craving for sweets by using a validated questionnaire. Each symptom was rated daily from zero to three by the study participants. Out of the 60 women randomised, 27 dropped out before cross-over and only 33 entered the (per protocol) data analysis, 22 of which reported a compliance of at least 90 %. A significant decrease in the total mean symptom score was observed for the calcium treatment compared to placebo during both the luteal and menstrual phases (3.33 vs 5.34, p=0.011; 4.71 vs 6.02, p=0.032, respectively). The repeated measures analysis showed no significant carryover effects or cycle effects on symptoms. In order to evaluate the specific symptoms, a factor analysis was performed by clustering the 14 symptoms in four groups as follows: factor 1 included nervousness, irritability, crying, mood swings, depression, and violent tendencies (“negative affect group”); factor 2 included fatigue, abdominal bloating, headache, and breast fullness (“water retention group”); factor 3 included increased appetite, craving for sweets; and factor 4 included abdominal cramps and back pain (“pain goup”). Mean scores for all these factors except for factor 3 significantly decreased during the luteal phase and factor 4 significantly decreased during the menstrual phase on calcium treatment as compared to placebo. The Panel notes the high number of drop outs in the study and that only per protocol data analyses were performed, which limits the conclusions that can be drawn from this study for the scientific substantiation of the claim.
No evidence was provided for a biologically plausible mechanism by which calcium could exert the claimed effect.
In weighing the evidence, the Panel took into account that only one small intervention study in humans was provided from which limited conclusions can be drawn in relation to the claimed effect, and that no evidence for a biologically plausible mechanism by which calcium could exert the claimed effect has been provided.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of calcium and a reduction in the severity of symptoms related to the premenstrual syndrome.

Warunki i możliwe ograniczenia stosowania oświadczenia

Poudre 1g de carbonate de calcium/jour