Calcium sulphate (gypsum, CaSO4) exists in an anhydrous form and as a dihydrate. It is only slightly soluble in water. It is permitted as a food additive in most foods with no other restriction other than good manufacturing practice. It is intended to be used in food supplements as an alternative source of calcium and the petitioner estimates that the daily dose is unlikely to exceed 800 mg calcium (equivalent to 2.7 g calcium sulphate/day), which is the Recommended Daily Allowance defined in Directive 90/496/EEC on nutritional labelling. A single feeding study in rats indicated no difference in calcium bioavailability from a diet with added calcium sulphate or calcium from other sources. Human studies indicate that the bioavailability of calcium from calcium sulphate in mineral waters is comparable to that from milk and that the sulphate anion does not affect the urinary excretion of calcium. Although human studies were not available for food, the AFC Panel concluded in 2004 that the bioavailability of calcium from calcium sulphate in other foods is not expected to differ from that of already permitted calcium sources in foods for particular nutritional uses. If calcium sulphate as a “worst case” scenario would be assumed to be consumed up to the tolerable upper intake level of 2500 mg calcium per day this would correspond to an intake of 8.5 g calcium sulphate (anhydrous) per day. This would amount to a daily intake of 6 g sulphate ion. JECFA states that the few available studies in experimental animals do not raise concern about the toxicity of the sulphate ion in sodium sulphate. Sodium sulphate is used clinically as a laxative. In clinical trials using 2-4 oral doses of up to 4.5 g sodium sulphate decahydrate per person (9 – 18 g per person) only occasional loose stools were reported. These doses correspond to 2.7 – 5.4 g sulphate ion. Because of the low solubility of calcium sulphate compared with sodium sulphate it can be expected that the sulphate ion would not be present as a bolus dose after ingestion of calcium sulphate, but would rather dissociate at a lower rate. On the basis of available studies the ANS Panel considers that the bioavailability of calcium from calcium sulphate is comparable to other inorganic calcium salts and that the use of calcium sulphate as a source of calcium in food supplements is of no safety concern assuming the total dietary exposure to calcium remains within the defined tolerable upper intake level and that the commercially available calcium sulphate will comply to the existing specifications as laid down in Directive 2000/63/EC.

Calcium sulphate for use as a source of calcium in food supplements

GRILLI, SANDRO;
2008

Abstract

Calcium sulphate (gypsum, CaSO4) exists in an anhydrous form and as a dihydrate. It is only slightly soluble in water. It is permitted as a food additive in most foods with no other restriction other than good manufacturing practice. It is intended to be used in food supplements as an alternative source of calcium and the petitioner estimates that the daily dose is unlikely to exceed 800 mg calcium (equivalent to 2.7 g calcium sulphate/day), which is the Recommended Daily Allowance defined in Directive 90/496/EEC on nutritional labelling. A single feeding study in rats indicated no difference in calcium bioavailability from a diet with added calcium sulphate or calcium from other sources. Human studies indicate that the bioavailability of calcium from calcium sulphate in mineral waters is comparable to that from milk and that the sulphate anion does not affect the urinary excretion of calcium. Although human studies were not available for food, the AFC Panel concluded in 2004 that the bioavailability of calcium from calcium sulphate in other foods is not expected to differ from that of already permitted calcium sources in foods for particular nutritional uses. If calcium sulphate as a “worst case” scenario would be assumed to be consumed up to the tolerable upper intake level of 2500 mg calcium per day this would correspond to an intake of 8.5 g calcium sulphate (anhydrous) per day. This would amount to a daily intake of 6 g sulphate ion. JECFA states that the few available studies in experimental animals do not raise concern about the toxicity of the sulphate ion in sodium sulphate. Sodium sulphate is used clinically as a laxative. In clinical trials using 2-4 oral doses of up to 4.5 g sodium sulphate decahydrate per person (9 – 18 g per person) only occasional loose stools were reported. These doses correspond to 2.7 – 5.4 g sulphate ion. Because of the low solubility of calcium sulphate compared with sodium sulphate it can be expected that the sulphate ion would not be present as a bolus dose after ingestion of calcium sulphate, but would rather dissociate at a lower rate. On the basis of available studies the ANS Panel considers that the bioavailability of calcium from calcium sulphate is comparable to other inorganic calcium salts and that the use of calcium sulphate as a source of calcium in food supplements is of no safety concern assuming the total dietary exposure to calcium remains within the defined tolerable upper intake level and that the commercially available calcium sulphate will comply to the existing specifications as laid down in Directive 2000/63/EC.
F. Aguilar; U. Charrondiere; B. Dusemund; P. Galtier; J. Gilbert; D.M. Gott; S. Grilli; Guertler; G.E.N. Kass; J. Koenig; C. Lambré; J-C. Larsen; J-C. Leblanc; A. Mortensen; Parent-Massin; I. Pratt; I. Rietjens; I. Stankovic; P. Tobback; T. Verguieva; R. Woutersen.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/101808
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