TY - GEN
T1 - 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
AU - Younes, Maged
AU - Aquilina, Gabriele
AU - Castle, Laurence
AU - Engel, Karl-Heinz
AU - Fowler, Paul
AU - Frutos Fernandez, Maria Jose
AU - Fürst, Peter
AU - Gürtler, Rainer
AU - Husøy, Trine
AU - Mennes, Wim
AU - Moldeus, Peter
AU - Oskarsson, Agneta
AU - Shah, Romina
AU - Waalkens-Berendsen, Ine
AU - Wölfle, Detlef
AU - Aggett, Peter
AU - Cupisti, Adamasco
AU - Fortes, Cristina
AU - Kuhnle, Gunter
AU - Lillegaard, Inger Therese
AU - Scotter, Michael
AU - Giarola, Alessandra
AU - Rincon, Ana
AU - Tard, Alexandra
AU - Gundert-Remy, Ursula
AU - EFSA Panel on Food Additives and Flavourings (FAF)
N1 - Acknowledgements: The Panel wishes to thank Dominique Turck, Agnes de Sesmaisons-Lecarr e and Valeriu Curtui for the support provided to this scientific output. The ANS Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.
PY - 2019/6
Y1 - 2019/6
N2 - 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 80–90considered 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.
AB - 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 80–90considered 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.
KW - phosphates
KW - phosphorus
KW - food additive
KW - acceptable daily intake
KW - risk assessment
KW - safety
U2 - 10.2903/j.efsa.2019.5674
DO - 10.2903/j.efsa.2019.5674
M3 - Article
C2 - 32626329
SN - 1831-4732
VL - 17
SP - e05674
JO - EFSA Journal
JF - EFSA Journal
ER -