Abstract
The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the safety of potassium sulphate and sodium sulphate as sources of potassium and sodium, respectively, and on their bioavailabilities from these sources. The safety of potassium and sodium in terms of the amounts that may be consumed is outside the remit of the Panel. Based on the available data and the fact that potassium sulphate and sodium sulphate are water‐soluble, the Panel concluded that potassium and sodium from these sources are bioavailable. The petitioner indicates that potassium sulphate and sodium sulphate will be used in food supplements to provide maximum amounts of 100 mg potassium/day and 200 mg sodium/day for adults. The Panel calculated that these dose levels result in a supply of 0.123 g sulphate ion/day (equivalent to 2.1 mg sulphate ion/kg bw/day for a 60 kg person) from potassium sulphate and of 0.417 g sulphate ion/day (equivalent to 7 mg sulphate ion/kg bw/day) from sodium sulphate. This will result in a combined intake of 0.540 g sulphate ion/day (equivalent to 9.0 mg sulphate/kg bw/day for a 60 kg person). Previously the Panel concluded that a daily intake of sulphate ion up to 6 g/day (100 mg sulphate ion/kg bw/day) does not give rise to concern. The Panel noted that this intake of 100 mg potassium/day amounts to 2 to 4% of the average intake level of potassium from the diet and that the proposed level of sodium to be supplied via food supplements of 200 mg sodium/day would represent between 4‐7% of the mean intake level of sodium from the diet. Therefore, the Panel concluded that the proposed use and use levels of potassium sulphate and sodium sulphate as sources of potassium and sodium are not of safety concern.
Keywords: Sulphuric acid, dipotassium salt, CAS No. 7778‐80‐5, bisodium sulphate anhydrous, CAS No. 7757‐82‐6, dibasic sodium sulphate, disodium monosulphate, disodium sulphate decahydrate, CAS No. 7727‐73‐3, Glauber's salt
EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) ; Scientific Opinion on the use of potassium sulphate and sodium sulphate as sources of respectively potassium and sodium added for nutritional purposes to food supplements. EFSA Journal 2010;8(12):1940 [12 pp.]. doi: 10.2903/j.efsa.2010.1940.
Panel members: F. Aguilar, B. Dusemund, P. Galtier, J. Gilbert, D.M. Gott, S. Grilli, R. Gürtler, J. König, C. Lambré, J‐C. Larsen, J‐C. Leblanc, A. Mortensen, D. Parent‐Massin, I. Pratt, I.M.C.M. Rietjens, I. Stankovic, P. Tobback, T. Verguieva, R.A. Woutersen
Correspondence: ans@efsa.europa.eu
Acknowledgement: The Panel wishes to thank the members of the Working Group B on Food Additives and Nutrient Sources added to Food: M. Bakker, D. Boskou, B. Dusemund, D. Gott, T. Hallas‐Møller, A. Hearty, J. König, D. Marzin, D. Parent‐Massin, I.M.C.M. Rietjens, G.J.A. Speijers, P. Tobback, T. Verguieva, R.A. Woutersen for the preparatory work on this scientific opinion.
Adoption date: 8 December 2010
Published date: 22 December 2010
Question number: EFSA‐Q‐2010‐00818
On request from: European Commission
References
- EFSA , 2005a. Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to the Tolerable Upper Intake level of Potassium, February 2005. The EFSA Journal (2005) 193, 1–19. Available at: www.efsa.europa.eu/en/scdocs/scdoc/193.htm. [Google Scholar]
- EFSA , 2005b. Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to the Tolerable Upper Intake level of Sodium. Available at: www.efsa.europa.eu/en/scdocs/scdoc/209.htm.
- EFSA , 2008. Calcium sulphate for use as a source of calcium in food supplements Scientific Panel on Food Additives and Nutrient Sources added to food. The EFSA Journal, 814, 1–9. Available at: www.efsa.europa.eu/en/scdocs/doc/814.pdf. [Google Scholar]
- EVM (Expert Group on Vitamins and Minerals) , 2003. Report on safe upper levels for vitamins and minerals. London. May 2003. Available at: www.foodstandards.gov.uk/multimedia/pdfs/vitmin2003.pdf.
- JECFA (Joint FAO/WHO Expert Committee on Food Additives) , 1986. Evaluation of certain food additives and contaminants. Twenty‐ninth report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series, No. 733, 1986, and corrigendum.
- JECFA (Joint FAO/WHO Expert Committee on Food Additives) , 2000. Forty‐third report of the Joint FAO/WHO Expert Committee on Food Additives. Evaluation of certain food additives and contaminants. World Health Organization. Technical Report Series, No 896. Available from: whqlibdoc.who.int/trs/WHO_TRS_896.pdf. [Google Scholar]
- JECFA (Joint FAO/WHO Expert Committee on Food Additives) , 2002. Evaluation of certain food additives and contaminants. Fifty‐seventh report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series, No. 909.
- SCF (Scientific Committee for Food) , 1990. First series of food additives of various technological functions. Reports of the Scientific Committee for Food (25th series). Opinion expressed on May 18, 1990. Directorate‐General Internal Market and Industrial Affairs, 1991. Available at: ec.europa.eu/food/fs/sc/scf/reports/scf_reports_25.pdf.
- SCF (Scientific Committee on Food) , 1993. Reports of the Scientific Committee on Food (31st series). Commission of the European Community, Luxembourg, pp. 177–189. Available at: ec.europa.eu/food/fs/sc/scf/reports/scf_reports_31.pdf. [Google Scholar]
- TemaNord , 2002. Food additives in Europe 2000 ‐Status of safety assessments of food additives presently permitted in the EU. TemaNord; 560. [Google Scholar]