Display options
Cite
, Younes M, Aquilina G, et al. Re-evaluation of phosphoric acid-phosphates - di-, tri- and polyphosphates (E 338-341, E 343, E 450-452) as food additives and the safety of proposed extension of use. EFSA J. 2019;17(6):e05674doi: 10.2903/j.efsa.2019.5674.
, Younes, M., Aquilina, G., Castle, L., Engel, K. H., Fowler, P., Frutos Fernandez, M. J., Fürst, P., Gürtler, R., Husøy, T., Mennes, W., Moldeus, P., Oskarsson, A., Shah, R., Waalkens-Berendsen, I., Wölfle, D., Aggett, P., Cupisti, A., Fortes, C., Kuhnle, G., Lillegaard, I. T., Scotter, M., Giarola, A., Rincon, A., Tard, A., & Gundert-Remy, U. (2019). Re-evaluation of phosphoric acid-phosphates - di-, tri- and polyphosphates (E 338-341, E 343, E 450-452) as food additives and the safety of proposed extension of use. EFSA journal. European Food Safety Authority, 17(6), e05674. https://doi.org/10.2903/j.efsa.2019.5674
, et al. "Re-evaluation of phosphoric acid-phosphates - di-, tri- and polyphosphates (E 338-341, E 343, E 450-452) as food additives and the safety of proposed extension of use." EFSA journal. European Food Safety Authority vol. 17,6 (2019): e05674. doi: https://doi.org/10.2903/j.efsa.2019.5674
, Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gürtler R, Husøy T, Mennes W, Moldeus P, Oskarsson A, Shah R, Waalkens-Berendsen I, Wölfle D, Aggett P, Cupisti A, Fortes C, Kuhnle G, Lillegaard IT, Scotter M, Giarola A, Rincon A, Tard A, Gundert-Remy U. Re-evaluation of phosphoric acid-phosphates - di-, tri- and polyphosphates (E 338-341, E 343, E 450-452) as food additives and the safety of proposed extension of use. EFSA J. 2019 Jun 12;17(6):e05674. doi: 10.2903/j.efsa.2019.5674. eCollection 2019 Jun. PMID: 32626329; PMCID: PMC7009158.
Copy Download .nbib Format: NLM
Share it on

EFSA J. 2019 Jun 12;17(6):e05674. doi: 10.2903/j.efsa.2019.5674. eCollection 2019 Jun.

Re-evaluation of phosphoric acid-phosphates - di-, tri- and polyphosphates (E 338-341, E 343, E 450-452) as food additives and the safety of proposed extension of use.

EFSA journal. European Food Safety Authority

Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Rainer Gürtler, Trine Husøy, Wim Mennes, Peter Moldeus, Agneta Oskarsson, Romina Shah, Ine Waalkens-Berendsen, Detlef Wölfle, Peter Aggett, Adamasco Cupisti, Cristina Fortes, Gunter Kuhnle, Inger Therese Lillegaard, Michael Scotter, Alessandra Giarola, Ana Rincon, Alexandra Tard, Ursula Gundert-Remy

PMID: 32626329 PMCID: PMC7009158 DOI: 10.2903/j.efsa.2019.5674

Abstract

The Panel on Food Additives and Flavourings added to Food (FAF) provided a scientific opinion re-evaluating the safety of phosphates (E 338-341, E 343, E 450-452) as food additives. The Panel considered that adequate exposure and toxicity data were available. Phosphates are authorised food additives in the EU in accordance with Annex II and III to Regulation (EC) No 1333/2008. Exposure to phosphates from the whole diet was estimated using mainly analytical data. The values ranged from 251 mg P/person per day in infants to 1,625 mg P/person per day for adults, and the high exposure (95th percentile) from 331 mg P/person per day in infants to 2,728 mg P/person per day for adults. Phosphate is essential for all living organisms, is absorbed at 80-90% as free orthophosphate excreted via the kidney. The Panel considered phosphates to be of low acute oral toxicity and there is no concern with respect to genotoxicity and carcinogenicity. No effects were reported in developmental toxicity studies. The Panel derived a group acceptable daily intake (ADI) for phosphates expressed as phosphorus of 40 mg/kg body weight (bw) per day and concluded that this ADI is protective for the human population. The Panel noted that in the estimated exposure scenario based on analytical data exposure estimates exceeded the proposed ADI for infants, toddlers and other children at the mean level, and for infants, toddlers, children and adolescents at the 95th percentile. The Panel also noted that phosphates exposure by food supplements exceeds the proposed ADI. The Panel concluded that the available data did not give rise to safety concerns in infants below 16 weeks of age consuming formula and food for medical purposes.

© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Keywords: acceptable daily intake; food additive; phosphates; phosphorus; risk assessment; safety

References

  1. Neth J Med. 2008 Nov;66(10):438-41 - PubMed
  2. Arzneimittelforschung. 1959 Aug;9:501-3 - PubMed
  3. J Nutr. 1977 May;107(5):834-9 - PubMed
  4. J Clin Endocrinol Metab. 2006 Aug;91(8):3144-9 - PubMed
  5. Bone Miner. 1989 Sep;7(2):159-69 - PubMed
  6. Can J Physiol Pharmacol. 1979 Jan;57(1):92-7 - PubMed
  7. J Clin Endocrinol Metab. 1988 Apr;66(4):823-9 - PubMed
  8. J Clin Invest. 1987 Oct;80(4):1147-54 - PubMed
  9. Ren Fail. 2012;34(4):499-501 - PubMed
  10. Pediatr Nephrol. 1994 Jun;8(3):394-5 - PubMed
  11. J Nutr Biochem. 2006 Jul;17(7):479-84 - PubMed
  12. Crit Rev Food Sci Nutr. 1980;13(4):297-335 - PubMed
  13. Arch Intern Med. 1975 Apr;135(4):563-7 - PubMed
  14. Clin J Am Soc Nephrol. 2018 Jul 6;13(7):1002-1012 - PubMed
  15. Adv Exp Med Biol. 2012;728:84-91 - PubMed
  16. Am J Epidemiol. 2009 Jan 1;169(1):67-77 - PubMed
  17. Arzneimittelforschung. 1957 Jul;7(7):445-6 - PubMed
  18. Am J Clin Nutr. 2015 Aug;102(2):444-53 - PubMed
  19. Kidney Int. 2009 Jan;75(1):41-51 - PubMed
  20. Presse Med. 1984 May 12;13(20):1257-60 - PubMed
  21. Arterioscler Thromb Vasc Biol. 2010 Nov;30(11):2289-96 - PubMed
  22. Invest Urol. 1980 Jan;17(4):273-6 - PubMed
  23. Clin J Am Soc Nephrol. 2013 May;8(5):781-6 - PubMed
  24. Clin J Am Soc Nephrol. 2018 Jul 6;13(7):973-974 - PubMed
  25. Dis Colon Rectum. 1997 Apr;40(4):497-9 - PubMed
  26. Calcif Tissue Int. 1992 Oct;51(4):276-81 - PubMed
  27. FAO Nutr Meet Rep Ser. 1974;(53A):1-520 - PubMed
  28. Am J Clin Nutr. 2014 Sep;100(3):756-64 - PubMed
  29. J Exp Med. 1935 Feb 28;61(3):319-34 - PubMed
  30. Nephrol Dial Transplant. 2007 Mar;22(3):920-2 - PubMed
  31. Clin J Am Soc Nephrol. 2011 Feb;6(2):257-64 - PubMed
  32. Rev Invest Clin. 1998 May-Jun;50(3):185-9 - PubMed
  33. Environ Mutagen. 1983;5 Suppl 1:1-142 - PubMed
  34. J Toxicol Sci. 2010 Aug;35(4):555-62 - PubMed
  35. Hum Pathol. 2004 Jun;35(6):675-84 - PubMed
  36. Arzneimittelforschung. 1958 May;8(5):286-9 - PubMed
  37. Br J Nutr. 2006 Sep;96(3):545-52 - PubMed
  38. J Pharmacol Toxicol Methods. 2007 Nov-Dec;56(3):277-89 - PubMed
  39. Am J Clin Nutr. 2006 Oct;84(4):936-42 - PubMed
  40. Arch Dis Child. 1986 Jul;61(7):677-81 - PubMed
  41. Nephrol Dial Transplant. 2016 Jul;31(7):1088-99 - PubMed
  42. Adv Chronic Kidney Dis. 2011 Mar;18(2):85-90 - PubMed
  43. J Clin Invest. 1970 Nov;49(11):2146-9 - PubMed
  44. Physiology (Bethesda). 2009 Feb;24:17-25 - PubMed
  45. Arch Intern Med. 1968 Aug;122(2):128-33 - PubMed
  46. Talanta. 2011 Mar 15;84(1):199-203 - PubMed
  47. J AOAC Int. 2016 Apr 8;: - PubMed
  48. Kidney Int. 2009 Nov;76(10):1027-34 - PubMed
  49. Arch Intern Med. 2007 May 14;167(9):879-85 - PubMed
  50. Am J Clin Nutr. 2014 Feb;99(2):320-7 - PubMed
  51. World Health Organ Tech Rep Ser. 1964;281:1-189 - PubMed
  52. Cancer. 1950 Nov;3(6):1003-9 - PubMed
  53. J Am Coll Nutr. 2002 Jun;21(3):239-44 - PubMed
  54. Mutat Res. 1987 Nov;189(3):263-9 - PubMed
  55. Environ Toxicol Pharmacol. 2010 Mar;29(2):111-6 - PubMed
  56. Teratog Carcinog Mutagen. 1986;6(4):275-87 - PubMed
  57. World Health Organ Tech Rep Ser. 1986;733:1-59 - PubMed
  58. PLoS One. 2016 Mar 18;11(3):e0151007 - PubMed
  59. Am J Physiol Renal Physiol. 2005 Mar;288(3):F587-96 - PubMed
  60. Annu Rev Nutr. 2017 Aug 21;37:321-346 - PubMed
  61. Arterioscler Thromb Vasc Biol. 2010 Feb;30(2):333-9 - PubMed
  62. Mol Nutr Food Res. 2009 Sep;53 Suppl 2:S330-75 - PubMed
  63. J Clin Endocrinol Metab. 1976 Sep;43(3):523-32 - PubMed
  64. Early Hum Dev. 2015 Nov;91(11):623-8 - PubMed
  65. J Bone Miner Res. 1986 Aug;1(4):383-8 - PubMed
  66. Atherosclerosis. 2014 Apr;233(2):331-337 - PubMed
  67. Atherosclerosis. 2014 Nov;237(1):53-9 - PubMed
  68. Eur J Nutr. 2006 Sep;45(6):349-54 - PubMed
  69. J Bone Miner Res. 1996 Dec;11(12):1905-12 - PubMed
  70. Lab Anim. 1991 Apr;25(2):126-32 - PubMed
  71. Eur J Heart Fail. 2010 Aug;12(8):812-8 - PubMed
  72. Drug Metab Pharmacokinet. 2006 Jun;21(3):217-21 - PubMed
  73. Am J Med. 1976 Oct;61(4):478-84 - PubMed
  74. Kidney Int. 2009 May;75(10):1079-87 - PubMed
  75. Am Heart J. 2008 Sep;156(3):556-63 - PubMed
  76. Public Health Nutr. 2017 Jul;20(10):1713-1717 - PubMed
  77. Am J Nephrol. 1999;19(1):60-3 - PubMed
  78. J Nutr. 1977 Jan;107(1):42-50 - PubMed
  79. J Ren Nutr. 2012 May;22(3):344-9 - PubMed
  80. Am J Clin Nutr. 2014 Nov;100(5):1392-7 - PubMed
  81. J Food Sci. 2009 Jun;74(5):C375-9 - PubMed
  82. Meat Sci. 2011 Dec;89(4):372-6 - PubMed
  83. Kidney Int. 2013 Apr;83(4):707-14 - PubMed
  84. J Ren Nutr. 2011 Jul;21(4):303-8 - PubMed
  85. Ren Fail. 2013 Jul;35(6):875-8 - PubMed
  86. Food Chem Toxicol. 1984 Aug;22(8):623-36 - PubMed
  87. Biosci Biotechnol Biochem. 2001 Apr;65(4):928-34 - PubMed
  88. Lancet. 1970 Sep 26;2(7674):628-30 - PubMed
  89. J R Soc Interface. 2016 Oct;13(123): - PubMed
  90. J Clin Endocrinol Metab. 1980 Nov;51(5):998-1001 - PubMed
  91. Atherosclerosis. 2008 Aug;199(2):424-31 - PubMed
  92. Food Chem. 2012 Sep 15;134(2):712-6 - PubMed
  93. J Am Soc Nephrol. 2018 Aug;29(8):2089-2098 - PubMed
  94. Pediatr Nephrol. 2012 Nov;27(11):2039-2048 - PubMed
  95. Nutrition. 2011 Jan;27(1):86-91 - PubMed
  96. Clin Sci (Lond). 1979 May;56(5):407-12 - PubMed
  97. Nutr J. 2013 Jul 10;12:94 - PubMed
  98. J Am Soc Nephrol. 2009 Feb;20(2):397-404 - PubMed
  99. Calcif Tissue Int. 1988 Jun;42(6):345-50 - PubMed
  100. Eur J Nutr. 2013 Apr;52(3):991-6 - PubMed
  101. BMJ. 2009 Jul 21;339:b2535 - PubMed
  102. Lancet. 1966 Nov 19;2(7473):1105-7 - PubMed
  103. PLoS One. 2017 Nov 8;12(11):e0184774 - PubMed
  104. Nutr J. 2016 Jan 19;15:7 - PubMed
  105. Arch Pathol Lab Med. 2006 Jan;130(1):101-6 - PubMed
  106. Crit Rev Toxicol. 2017 Oct;47(9):729-749 - PubMed
  107. PLoS One. 2013 Sep 10;8(9):e74996 - PubMed
  108. Cell Metab. 2015 Dec 1;22(6):1020-32 - PubMed
  109. J Ren Nutr. 2006 Jan;16(1):79-81 - PubMed
  110. J Am Coll Cardiol. 2011 Jul 12;58(3):291-7 - PubMed
  111. Toxicol Ind Health. 2014 Nov;30(10):926-37 - PubMed
  112. Am J Clin Nutr. 1978 Jan;31(1):117-21 - PubMed
  113. Food Chem Toxicol. 2001 Aug;39(8):759-86 - PubMed
  114. Am J Clin Nutr. 2013 Jul;98(1):6-15 - PubMed
  115. Clin J Am Soc Nephrol. 2010 Mar;5(3):519-30 - PubMed
  116. Osteoporos Int. 1991 Jun;1(3):171-6 - PubMed
  117. Naunyn Schmiedebergs Arch Exp Pathol Pharmakol. 1955;227(3):199-209 - PubMed
  118. Arterioscler Thromb Vasc Biol. 2014 Aug;34(8):1763-9 - PubMed
  119. J Clin Invest. 2011 Nov;121(11):4393-408 - PubMed
  120. Nefrologia. 2010;30(6):702-4 - PubMed
  121. Am J Med. 1976 Aug;61(2):200-6 - PubMed
  122. Annu Rev Nutr. 2005;25:197-214 - PubMed
  123. J Clin Endocrinol Metab. 1990 May;70(5):1334-40 - PubMed
  124. J Ren Nutr. 2012 Nov;22(6):533-40 - PubMed
  125. Clin J Am Soc Nephrol. 2009 Mar;4(3):609-15 - PubMed
  126. J Bone Miner Res. 2017 Jun;32(6):1182-1193 - PubMed
  127. Urol Res. 1993;21(5):309-12 - PubMed
  128. Kidney Int. 2003 Dec;64(6):2272-9 - PubMed
  129. J Clin Biochem Nutr. 2014 Jul;55(1):62-6 - PubMed
  130. Curr Osteoporos Rep. 2017 Oct;15(5):473-482 - PubMed
  131. Am J Clin Nutr. 2017 Jan;105(1):159-168 - PubMed
  132. Annu Rev Physiol. 2013;75:535-50 - PubMed
  133. Clin J Am Soc Nephrol. 2013 Jul;8(7):1202-10 - PubMed
  134. J Clin Invest. 1971 Dec;50(12):2506-18 - PubMed
  135. J Nutr. 1959 Dec;69(4):419-28 - PubMed
  136. Diabetes Metab Syndr. 2017 Nov;11 Suppl 1:S65-S71 - PubMed
  137. Am J Clin Nutr. 1988 Jun;47(6):1025-9 - PubMed
  138. Nutrients. 2018 Feb 02;10(2): - PubMed
  139. Clin Sci. 1964 Jun;26:479-86 - PubMed
  140. Am J Cardiol. 2013 Mar 15;111(6):857-62 - PubMed
  141. Am J Kidney Dis. 1997 Jan;29(1):103-5 - PubMed
  142. Eur J Clin Nutr. 1998 Jan;52(1):29-33 - PubMed
  143. Exp Pathol. 1981;19(1):53-65 - PubMed
  144. J Am Soc Nephrol. 2014 Dec;25(12):2730-9 - PubMed
  145. Chem Commun (Camb). 2011 Jul 28;47(28):8118-20 - PubMed
  146. Adv Chronic Kidney Dis. 2011 Mar;18(2):63-76 - PubMed
  147. Am J Kidney Dis. 2009 Mar;53(3):399-407 - PubMed
  148. Environ Health Toxicol. 2011;26:e2011014 - PubMed
  149. Front Endocrinol (Lausanne). 2018 Jun 27;9:351 - PubMed
  150. J Nutr. 1989 Oct;119(10):1423-31 - PubMed
  151. J Nutr Metab. 2014;2014:575932 - PubMed
  152. Hypertension. 2010 Mar;55(3):776-84 - PubMed
  153. Kidney Int. 2008 Jul;74(2):148-57 - PubMed
  154. Miner Electrolyte Metab. 1986;12(3):199-203 - PubMed
  155. Eur Heart J. 2012 Nov;33(22):2873-81 - PubMed

Publication Types