Scientific Opinion on the substantiation of health claims related to calcium
and maintenance of normal bone and teeth (ID 2731, 3155, 4311, 4312,
4703), maintenance of normal hair and nails (ID 399, 3155), maintenance of
normal blood LDL-cholesterol concentrations (ID 349, 1893), maintenance
of normal blood HDL-cholesterol concentrations (ID 349, 1893), reduction
in the severity of symptoms related to the premenstrual syndrome (ID 348,
1892), “cell membrane permeability” (ID 363), reduction of tiredness and
fatigue (ID 232), contribution to normal psychological functions (ID 233),
contribution to the maintenance or achievement of a normal body weight
(ID 228, 229) and regulation of normal cell division and differentiation
(ID 237) 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:
Calcium
HDL-cholesterol
LDL-cholesterol
body weight
bone
cell differentiation
cell division
cell membrane permeability
fatigue
hair
health claims
nails
premenstrual syndrome
psychological functions
teeth
tiredness
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. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Utrzymanie prawidłowego stanu kości i zębów (ID 2731, 3155, 4311, 4312, 4703)
The claimed effects are “bone health-mineralisation”, “bone health”, “essential for proper structure and development of bones, teeth and nails” and “calcium is essential for growth”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effects refer to the maintenance of normal bone and teeth.
A claim on calcium and maintenance of normal bone and teeth has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009).
2.2. Utrzymanie prawidłowego stanu włosów i paznokci (ID 399, 3155)
The claimed effects are “significant effect on building of hair and nails” and “essential for proper structure and development of bones, teeth and nails”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effects refer to the maintenance of normal hair and nails.
The Panel considers that maintenance of normal hair and nails is a beneficial physiological effect.
2.3. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 349, 1893)
The claimed effect is “cholesterol: calcium reduces LDL-cholesterol and increases HDL-cholesterol. calcium participates to the control of cholesterol”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effect refers to the maintenance of normal blood LDL-cholesterol concentrations.
Low-density lipoproteins (LDL) carry cholesterol from the liver to peripheral tissues, including the arteries. Elevated LDL-cholesterol, by convention >160 mg/dL (>4.14 mmol/L), may compromise the normal structure and function of the arteries.
The Panel considers that maintenance of normal blood LDL-cholesterol concentrations is a beneficial physiological effect.
2.4. Utrzymanie prawidłowego stężenia cholesterolu HDL we krwi (ID 349, 1893)
The claimed effect is “cholesterol: calcium reduces LDL-cholesterol and increases-HDL cholesterol. Calcium participates to the control of cholesterol”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effect refers to the maintenance of normal blood HDL-cholesterol concentrations.
High-density lipoproteins (HDL) act as cholesterol scavengers and are involved in the reverse transport of cholesterol in the body (from peripheral tissues back to the liver). Conversely, low- density lipoproteins (LDL) carry cholesterol from the liver to peripheral tissues, including the arteries.
The Panel considers that maintenance of normal blood HDL-cholesterol concentrations (without increasing LDL-cholesterol concentrations) may be a beneficial physiological effect.
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.
2.6. Przepuszczalność błon komórkowych (ID 363)
The claimed effect is “cell functioning”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effect refers to “cell membrane permeability”.
The Panel considers that the claimed effect “cell membrane permeability” is not sufficiently defined for a scientific evaluation.
The Panel considers that the claimed effect is general and non-specific and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
2.7. Zmniejszenie zmęczenia (ID 232)
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 reduction of tiredness and fatigue is a beneficial physiological effect.
2.8. Udział w prawidłowym przebiegu funkcji psychicznych (psychologicznych) (ID 233)
The claimed effect is “the role of vitamins and minerals in mental performance (where mental performance stands for those aspects of brain and nerve functions which determine aspects like concentration, learning, memory and reasoning)”. The Panel assumes that the target population is the general population.
The Panel considers that contribution to normal psychological functions, which encompass cognitive and affective domains, is a beneficial physiological effect.
2.9. Udział w utrzymaniu lub osiągnięciu prawidłowej masy ciała (ID 228, 229)
The claimed effect is “weight management”. The Panel assumes that the target group is the general population.
Weight management can be interpreted as the contribution to the maintenance of a normal body weight. In this context weight loss in overweight subjects without achieving a normal body weight is considered to be a beneficial physiological effect.
The Panel considers that contribution to the maintenance or achievement of a normal body weight is a beneficial physiological effect.
2.10. Regulacja prawidłowych podziałów komórkowych i różnicowania komórek (ID 237)
The claimed effect is “colorectal cell protection”. The Panel assumes that the target population is the general population.
From the proposed wordings the Panel notes that the claimed effect refers to the regulation of division and differentiation of colorectal cells. However, the Panel considers that the functional role of calcium in the regulation of normal cell division and differentiation is not limited to colorectal cells.
The Panel considers that regulation of normal cell division and differentiation 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).
3.1. Utrzymanie prawidłowego stanu włosów i paznokci (ID 399, 3155)
Two references were cited for the substantiation of this claim. One reference was not accessible to the Panel despite every reasonable effort to retrieve it. The second reference was an opinion of a scientific body which did not mention the role of calcium in the maintenance of normal hair and nails. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of calcium and the maintenance of normal hair and nails.
3.2. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 349, 1893)
Two references were cited for the substantiation of this claim. One was a review on the composition and mineralisation of mollusc shell proteins. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect. The second was a narrative review on the effects of calcium intake on blood lipids (Reid, 2004), which refers to a series of small- scale and short-term randomised, placebo controlled trials on the effects of calcium supplementation in various forms (carbonate, citrate, phosphate) on LDL-cholesterol concentrations. The Panel has also identified a number of studies which were published after 2004 and were not included in the review.
Three small-scale and short-term randomised, placebo control trials (RCTs) have observed a statistically significant reduction of LDL-cholesterol (4-11 %) concentrations following the administration of 1 to 2 g per day of calcium compared to placebo (Groot et al., 1980; Bell et al., 1992; Denke et al., 1993). However, four other small-scale and short-term RCTs have shown no effect (Ditscheid et al., 2005; Bostick et al., 2000; Karandish et al., 2009; Karanja et al., 1987). A large RCT originally designed to assess the effects of calcium supplementation on bone health also addressed the effect of calcium supplementation on LDL-cholesterol concentrations. A total of 223 postmenopausal women were randomly assigned to consume either calcium citrate (1 g/d, n = 111) or placebo (n = 112) for one year (Reid et al., 2002). Changes in LDL-cholesterol concentrations were not significantly different between the intervention and placebo groups.
In a recently published RCT on the effects of calcium supplementation on blood lipids (primary outcome) a total of 323 healthy men were randomly assigned to consume either calcium (600 mg/d, n=108 or 1200 mg/d, n=108) or placebo (n=107) for two years (Reid et al., 2010). No significant differences between the calcium and placebo groups were observed with respect to changes in total
cholesterol, LDL- and HDL-cholesterol, and triglyceride concentrations or in the HDL to LDL- cholesterol ratio during the study.
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 six out of nine RCTs, including two large RCTs, showed no effect of calcium intake on LDL-cholesterol concentrations, and that no evidence was provided for a biologically plausible mechanism by which calcium could exert the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of calcium and maintenance of normal blood LDL-cholesterol concentrations.
3.3. Utrzymanie prawidłowego stężenia cholesterolu HDL we krwi (ID 349, 1893)
Two references were cited for the substantiation of this claim. One was a review on the composition and mineralisation of mollusc shell proteins. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect. The second was a narrative review on the effects of calcium intake on blood lipids (Reid, 2004), which refers to a series of small- scale and short-term randomised, placebo controlled trials on the effects of calcium supplementation in various forms (carbonate, citrate, phosphate) on HDL-cholesterol concentrations. The Panel has also identified a number of studies which were published after 2004 and were not included in the review, including two large RCTs. Of the smaller studies, one observed a statistically significant increase in HDL-cholesterol concentrations following the administration of 1 to 2 g per day of calcium compared to placebo (Bell et al., 1992), whereas six others showed no effect in adults with normal or elevated blood cholesterol concentrations (Groot et al., 1980; Denke et al., 1993; Ditscheid et al., 2005; Bostick et al., 2000; Karandish et al., 2009; Karanja et al., 1987).
A large RCT originally designed to assess the effects of calcium supplementation on bone health also assessed the effect of calcium supplementation on HDL-cholesterol concentrations. A total of 223 postmenopausal women were randomly assigned to consume either calcium citrate (1 g/d, n=111) or placebo (n=112) for one year (Reid et al., 2002). HDL-cholesterol concentrations and the HDL to LDL-cholesterol ratio significantly increased in the intervention group (by 0.09 mmol/L; 95 % CI=0.02-0.17, and by 0.05; 95 % CI=0.02-0.08; respectively) compared to placebo during the study.
In a recently published RCT on the effects of calcium supplementation on blood lipids (primary outcome) a total of 323 healthy men were randomly assigned to consume either calcium (600 mg/d, n=108 or 1200 mg/d, n=108) or placebo (n=107) for two years (Reid et al., 2010). No significant differences between the calcium and placebo groups were observed with respect to changes in total cholesterol, LDL- and HDL-cholesterol, and triglyceride concentrations or in the HDL to LDL ratio during the study.
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 six of the seven small RCTs showed no effect of calcium intake on HDL-cholesterol concentrations, that one large RCT not designed to address the effects of calcium intake on blood lipids showed a significant increase in HDL-cholesterol concentrations, that results from the largest RCT available which was specifically designed to address the effects of calcium intake on blood lipids showed no effect of calcium supplementation on HDL- cholesterol concentrations, and that no evidence was provided for a biologically plausible mechanism by which calcium could exert the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of calcium and the maintenance of normal blood HDL-cholesterol concentrations.
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.
3.5. Zmniejszenie zmęczenia (ID 232)
One book chapter and one consensus opinion on the health effects of calcium were provided for the substantiation of this claim. None referred to a role of calcium in the reduction of fatigue and/or tiredness. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of calcium and reduction of tiredness and fatigue.
3.6. Udział w prawidłowym przebiegu funkcji psychicznych (psychologicznych) (ID 233)
Three book chapters and one consensus opinion on the health effects of calcium were provided for the substantiation of the claim. No role of calcium in psychological functions was mentioned in any of these. In addition, an intervention study on the effects of an oral multivitamin and mineral supplementation on psychological outcomes was cited (Carroll et al., 2000). The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of calcium and contribution to normal psychological functions.
3.7. Udział w utrzymaniu lub osiągnięciu prawidłowej masy ciała (ID 228, 229)
The literature provided includes mechanistic studies, opinions from authoritative bodies, (systematic) reviews, original research papers of observational epidemiological studies, and randomised clinical trials (RCT) on the effects of calcium intake on body weight control.
In addition, the Panel has identified five other references pertinent to the claimed effect (Winzenberg et al., 2007; Lorenzen et al., 2006; van Loan, et al. 2009; Bortolotti, et al 2008; Christensen et al., 2009).
Most of the individual studies presented have been included in two systematic reviews of randomised controlled trials (RCT) which investigated the effects of calcium intake on body weight (Winzenberg et al., 2007; Trowman et al., 2006). Four of the most recent RCTs presented were not included in these reviews (Lorenzen et al., 2006; Thompson et al., 2005; Bowen et al., 2005; Gunther et al., 2005)
A systematic review and subsequent meta-analysis of 13 RCT on the effects of calcium supplementation on body weight (including papers published up to 2004 mostly on adult females) concluded that calcium supplementation has no statistically significant association with a reduction in body weight (Trowman et al., 2006). Another systematic review of 19 RCT on the effects of calcium supplementation in healthy children concluded that calcium supplements do not affect weight gain, height or body composition (Winzenberg et al., 2007). Some recently published randomised clinical trials on the effect of calcium on body weight also show no beneficial effects of calcium intake on body weight control, either following calcium supplementation (Lorenzen et al., 2006) or by increasing calcium intake from dairy products (Thompson et al., 2005; Bowen et al., 2005; Gunther et al., 2005).
A recent review (van Loan, 2009) suggests that human observational retrospective, cross-sectional and prospective studies support the idea that dietary calcium is associated with body weight control. However, a causal relationship cannot be inferred from these studies as the observed relationships in human observational studies between dietary calcium and body weight control may be confounded by other dietary components and/or by life style factors related to calcium intake.
The suggested mechanisms for an effect of calcium intake on body weight control are an increase in fat oxidation, inhibition of lipogenesis, and/or an increased fat excretion (Astrup, 2008). However, in a well controlled study by Bortolotti et al. (2008) dairy calcium supplementation in overweight subjects with habitual low calcium intakes failed to alter fat metabolism. In addition, a recently published meta-analysis of 13 RCT on the effects of additional calcium intake from dairy and dietary supplements on faecal fat excretion concluded that increasing dietary calcium by 800-6000 mg per day increases fat excretion by about 2 g per day, with no evidence of a dose-response relationship.
However, the relevance of such an effect for the daily energy balance and body-weight regulation is unknown (Christensen et al., 2009).
In weighing the evidence, the Panel took into account that, although epidemiological studies generally observe an inverse relationship between calcium intake and body weight, evidence from a large number of RCTs does not support this hypothesis, and that the evidence for possible mechanisms by which calcium intake could exert an effect on body weight control is not convincing.
The Panel concludes that a cause and effect relationship has not been established between the intake of calcium and the contribution to the maintenance or achievement of a normal body weight.
3.8. Regulacja prawidłowych podziałów komórkowych i różnicowania komórek (ID 237)
The evidence available from consensus opinions/reports from authoritative bodies and reviews shows that there is consensus on the role of calcium in the normal regulation of cell division and differentiation (SCF, 1993; IoM, 1997; Weaver and Heaney, 2006).
Calcium is a cofactor for extracellular enzymes and proteins and also functions as intracellular messenger. Calcium messenger systems include trigger proteins in excitable cells and sustained responses in both excitable and non-excitable cells (Weaver and Heaney, 2006). Calcium activates phospholipases and mitogen-activated protein kinase, inhibits adenylate cyclase (among other enzymes) and has an important regulatory role in diverse cellular processes, including cell proliferation and differentiation (SCF, 1993; IoM, 1997; Weaver and Heaney, 2006).
Some of the references provided relate to intervention trials which investigated the effects of calcium on colon cancer risk. The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of an effect of calcium on the regulation of cell division and differentiation.
The Panel concludes that a cause and effect relationship has been established between calcium and the regulation of normal cell division and differentiation.
4. Uwagi do zaproponowanego brzmienia oświadczenia
4.1. Regulacja prawidłowych podziałów komórkowych i różnicowania komórek (ID 237)
The Panel considers that the following wording reflects the scientific evidence: “Calcium contributes to normal cell division and differentiation”.
5. Warunki i możliwe ograniczenia stosowania oświadczenia
5.1. Regulacja prawidłowych podziałów komórkowych i różnicowania komórek (ID 237)
The Panel considers that in order to bear the claim a food should be at least a source of calcium 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 calcium in children and adolescents; the UL for calcium in adults is 2500 mg/day (SCF, 2003).
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, calcium, which is the subject of the health claims is sufficiently characterised.
Maintenance of normal bone and teeth (ID 2731, 3155, 4311, 4312, 4703)
The claimed effects are “bone health-mineralisation”, “bone health”, “essential for proper structure and development of bones, teeth and nails” and “calcium is essential for growth”. The target population is assumed to be the general population.
A claim on calcium and maintenance of normal bone and teeth has already been assessed with a favourable outcome.
Maintenance of normal hair and nails (ID 399, 3155)
The claimed effects are “significant effect on building of hair and nails”, and “essential for proper structure and development of bones, teeth and nails”. The target population is assumed to be the general population. Maintenance of normal hair and nails is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of calcium and maintenance of normal hair and nails.
Maintenance of normal blood LDL-cholesterol concentrations (ID 349, 1893)
The claimed effect is “cholesterol: calcium reduces LDL-cholesterol and increases HDL- cholesterol. Calcium participates to the control of cholesterol”. The target population is assumed to be the general population. Maintenance of normal blood LDL-cholesterol concentrations is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of calcium and maintenance of normal blood LDL-cholesterol concentrations.
Maintenance of normal blood HDL-cholesterol concentrations (ID 349, 1893)
The claimed effect is “cholesterol: calcium reduces LDL-cholesterol and increases HDL- cholesterol. Calcium participates to the control of cholesterol”. The target population is assumed to be the general population. Maintenance of normal blood HDL-cholesterol concentrations (without increasing LDL-cholesterol concentrations) may be a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of calcium and maintenance of normal blood HDL-cholesterol concentrations.
Reduction in the severity of symptoms related to the premenstrual syndrome (ID 348, 1892)
The claimed effect is “premenstrual health: calcium alleviates premenstrual syndromes”. The target population is assumed to be women with premenstrual syndrome. Reduction in the severity of symptoms related to the premenstrual syndrome is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of calcium and reduction in the severity of symptoms related to the premenstrual syndrome.
“Cell membrane permeability” (ID 363)
The claimed effect is “cell functioning”. The target population is assumed to be the general population. In the context of the proposed wordings and clarifications provided by Member States, it is assumed that the claimed effect refers to “cell membrane permeability”. The claimed effect “cell membrane permeability” is not sufficiently defined for a scientific evaluation.
The Panel considers that the claimed effect is general and non-specific and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
Reduction of tiredness and fatigue (ID 232)
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 calcium and reduction of tiredness and fatigue.
Contribution to normal psychological functions (ID 233)
The claimed effect is “the role of vitamins and minerals in mental performance (where mental performance stands for those aspects of brain and nerve functions which determine aspects like concentration, learning, memory and reasoning)”. The target population is assumed to be the general population. Contribution to normal psychological functions, which encompass cognitive and affective domains, is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of calcium and contribution to normal psychological functions.
Contribution to the maintenance or achievement of a normal body weight (ID 228, 229)
The claimed effect is “weight management”. The target population is assumed to be the general population. Contribution to the maintenance or achievement of a normal body weight is a beneficial physiological effect.
A cause and effect relationship has not been established between the intake of calcium and contribution to the maintenance or achievement of a normal body weight.
Regulation of normal cell division and differentiation (ID 237)
The claimed effect is “colorectal cell protection”. The target population is assumed to be the general population. The functional role of calcium on the regulation of cell division and differentiation is not limited to colorectal cells. Regulation of normal cell division and differentiation is a beneficial physiological effect.
A cause and effect relationship has been established between calcium and regulation of normal cell division and differentiation.
The following wording reflects the scientific evidence: “Calcium contributes to normal cell division and differentiation”.
Conditions and possible restrictions of use
In order to bear the claim a food should be at least a source of calcium 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.
