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Europe approves important health claims for Calcium

Jul 25, 2014

The European Food Safety Authority accepts a health claim for the mineral Calcium along with Vitamin D for supporting bone health and the reduction in the risk of bone fractures

The following is an approved health claim in European Union member countries.

The European Food Safety Authority has been busily reviewing submitted data in relation to health claims for nutritional supplements. The following has been
taken verbatim from their journal; EFSA Journal 2010; 8(5):1609

Scientific Opinion in relation to the authorization procedure for health claims on calcium and vitamin D and the reduction of the risk of osteoporotic fractures by reducing bone loss pursuant to Article 14 of Regulation (EC) No 1924/2006

The target population for the claim was women 50 years and older. However, because there is no difference between dietary and supplemental calcium and vitamin D intakes with respect to slowing the reduction in BMD in the target population, the scientific evaluation of the health claim applied to all forms of calcium and vitamin D. This implies that appropriate conditions of use for a claim on calcium and vitamin D and the reduction of the risk of bone loss in women 50 years and older should be established for total calcium and vitamin D intakes rather than for the supplemental calcium and vitamin D proposed by the applicant.

A cause and effect relationship was established between the intake of calcium, either alone or in combination with vitamin D, and reducing the loss of BMD (bone mineral density), which may contribute to a reduction in the risk of bone fracture. This relationship implies that the critical nutrient in relation to the claimed effect is calcium.

The daily vitamin D intake needed for 97.5 % of women aged greater than 64 years to maintain a serum concentration of 25(OH)D above 50 nmol/L during winter is about 876 I.U. (21.9 µg).

In the context of low habitual calcium intakes (about 300 mg/day), 500 mg/day of supplemental calcium appear to reduce the risk of osteoporotic fractures by reducing the loss of BMD in post-menopausal women. Additional benefits in terms of preventing loss of BMD and facture risk reduction have been observed with habitual calcium intakes ranging from 700 mg/day to about 1100 mg/day with the addition of supplemental calcium intakes of 500 mg/day to 1200 mg/day. The Institute of Medicine set an adequate intake of calcium at 1200 mg/day for adults >50 years of age based on calcium retention from balance studies, factorial estimates of requirements, and data on changes in BMD and bone mineral content.

The Panel proposes that at least 1200 mg of calcium from all sources or at least 1200 mg of calcium and 800 I.U. of vitamin D from all sources to be consumed daily should be considered for the purpose of setting conditions of use for a risk reduction claim on the loss of BMD, which may contribute to a reduction in the risk of bone fracture. The target population is women 50 years and older.
Tolerable Upper Intake Levels (UL) have been established for calcium and vitamin D in adults.

Note from our Scientific Director, Jerry Hickey R Ph; the EFSA accepts the claim for calcium and vitamin D in the prevention of brittle bone fractures in older women but have not established a set dosage for supplementation because it varies according to diet and this establishes the individuals level of supplementation required for healthy bone maintenance.

Here is information taken verbatim from the Food and Drug Administration (FDA) in America website;

§101.72 Health claims: calcium, vitamin D, and osteoporosis.

(a) Relationship between calcium, vitamin D, and osteoporosis. An inadequate intake of calcium or calcium and vitamin D contributes to low peak bone mass, which has been identified as one of many risk factors in the development of osteoporosis. Peak bone mass is the total quantity of bone present at maturity, and experts believe that it has the greatest bearing on whether a person will be at risk of developing osteoporosis and related bone fractures later in life. Another factor that influences total bone mass and susceptibility to osteoporosis is the rate of bone loss after skeletal maturity. …………………………………………………….
All persons lose bone with age. Hence, those with higher bone mass at maturity take longer to reach the critically reduced mass at which bones can fracture easily. The rate of bone loss after skeletal maturity also influences the amount of bone present at old age and can influence an individual's risk of developing osteoporosis.
Maintenance of adequate intakes of calcium and vitamin D later in life is thought to be important in reducing the rate of bone loss particularly in the elderly and in women during the first decade following menopause, but a significant protective effect is also seen among men and younger women.

Here are the actual American Health Claims;

e) Model health claims. The following model health claims may be used in food labeling to describe the relationship between calcium and osteoporosis:

Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.

Adequate calcium as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life.

(f) Model additional health claims for calcium and vitamin D. The following model health claims may be used in food labeling to describe the relationship between calcium, vitamin D, and osteoporosis:

Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.

Adequate calcium and vitamin D as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life.

Here are additional health claims for calcium in the USA;

Claim Statement for Colon/Rectal Cancer

Some evidence suggests that calcium supplements may reduce the risk of colon/rectal cancer, however, FDA has determined that this evidence is limited and not conclusive.

Claim Statement for Recurrent Colon Polyps

Very limited and preliminary evidence suggests that calcium supplements may reduce the risk of colon/rectal polyps. FDA concludes that there is little scientific evidence to support this claim.

Eligible foods

Dietary supplements containing calcium

Claim Statement for Calcium & Hypertension

  1. Some scientific evidence suggests that calcium supplements may reduce the risk of hypertension. However, FDA has determined that the evidence is inconsistent and not conclusive.

Eligible foods
Dietary supplements containing calcium