Re-evaluation of sodium nitrate (E 251) and potassium nitrate (E 252) as food additives (2024)

Mortensen, A., Aguilar, F., Crebelli, R., Di Domenico, A., Dusemund, B., Frutos, M. J., Galtier, P., Gott, D., Gundert-Remy, U., Lambre, C., Leblanc, J.-C., Lindtner, O., Moldeus, P., Mosesso, P., Oskarsson, A., Parent-Massin, D., Stankovic, I., Waalkens-Berendsen, I., Woutersen, R. A., ... EFSA Panel Food Additives (2017). Re-evaluation of sodium nitrate (E 251) and potassium nitrate (E 252) as food additives. Efsa journal, 15(6), Article e04787. https://doi.org/10.2903/j.efsa.2017.4787

Mortensen, Alicja ; Aguilar, Fernando ; Crebelli, Riccardo et al. / Re-evaluation of sodium nitrate (E 251) and potassium nitrate (E 252) as food additives. In: Efsa journal. 2017 ; Vol. 15, No. 6.

@article{68b89826feef4c728355f1e83adf8203,

title = "Re-evaluation of sodium nitrate (E 251) and potassium nitrate (E 252) as food additives",

abstract = "The Panel on Food Additives and Nutrient Sources added to Food (ANS) provided a scientific opinion re-evaluating the safety of sodium nitrate (E 251) and potassium nitrate (E 252) when used as food additives. The current acceptable daily intakes (ADIs) for nitrate of 3.7 mg/kg body weight (bw) per day were established by the SCF (1997) and JECFA (2002). The available data did not indicate genotoxic potential for sodium and potassium nitrate. The carcinogenicity studies in mice and rats were negative. The Panel considered the derivation of an ADI for nitrate based on the formation of methaemoglobin, following the conversion of nitrate, excreted in the saliva, to nitrite. However, there were large variations in the data on the nitrate-to-nitrite conversion in the saliva in humans. Therefore, the Panel considered that it was not possible to derive a single value of the ADI from the available data. The Panel noticed that even using the highest nitrate-to-nitrite conversion factor the methaemoglobin levels produced due to nitrite obtained from this conversion would not be clinically significant and would result to a theoretically estimated endogenous N-nitroso compounds (ENOC) production at levels which would be of low concern. Hence, and despite the uncertainty associated with the ADI established by the SCF, the Panel concluded that currently there was insufficient evidence to withdraw this ADI. The exposure to nitrate solely from its use as a food additive was estimated to be less than 5% of the overall exposure to nitrate in food based on a refined estimated exposure scenario. This exposure did not exceed the current ADI (SCF, 1997). However, if all sources of exposure to dietary nitrate are considered (food additive, natural presence and contamination), the ADI would be exceeded for all age groups at the mean and the highest exposure. (C) 2017 European Food Safety Authority.",

keywords = "sodium nitrate, potassium nitrate, E 251, E 252, food additive, CAS Registry number 7757-79-1, CAS Registry number 7631-99-4, N-NITROSO COMPOUNDS, NON-HODGKIN-LYMPHOMA, GASTRIC-CANCER RISK, NIH-AARP DIET, MUNICIPAL DRINKING-WATER, LARGE PROSPECTIVE COHORT, SHANGHAI WOMENS HEALTH, THYROID-GLAND ACTIVITY, MEAT-RELATED COMPOUNDS, RENAL-CELL CARCINOMA",

author = "Alicja Mortensen and Fernando Aguilar and Riccardo Crebelli and {Di Domenico}, Alessandro and Birgit Dusemund and Frutos, {Maria Jose} and Pierre Galtier and David Gott and Ursula Gundert-Remy and Claude Lambre and Jean-Charles Leblanc and Oliver Lindtner and Peter Moldeus and Pasquale Mosesso and Agneta Oskarsson and Dominique Parent-Massin and Ivan Stankovic and Ine Waalkens-Berendsen and Woutersen, {Rudolf Antonius} and Matthew Wright and {van den Brandt}, Piet and Cristina Fortes and Leonardo Merino and Fidel Toldra and Davide Arcella and Anna Christodoulidou and Federica Barrucci and Ana Garcia and Fabiola Pizzo and Dario Battacchi and Maged Younes and {EFSA Panel Food Additives}",

year = "2017",

month = jun,

doi = "10.2903/j.efsa.2017.4787",

language = "English",

volume = "15",

journal = "Efsa journal",

issn = "1831-4732",

publisher = "European Food Safety Authority-EFSA",

number = "6",

}

Mortensen, A, Aguilar, F, Crebelli, R, Di Domenico, A, Dusemund, B, Frutos, MJ, Galtier, P, Gott, D, Gundert-Remy, U, Lambre, C, Leblanc, J-C, Lindtner, O, Moldeus, P, Mosesso, P, Oskarsson, A, Parent-Massin, D, Stankovic, I, Waalkens-Berendsen, I, Woutersen, RA, Wright, M, van den Brandt, P, Fortes, C, Merino, L, Toldra, F, Arcella, D, Christodoulidou, A, Barrucci, F, Garcia, A, Pizzo, F, Battacchi, D, Younes, M & EFSA Panel Food Additives 2017, 'Re-evaluation of sodium nitrate (E 251) and potassium nitrate (E 252) as food additives', Efsa journal, vol. 15, no. 6, e04787. https://doi.org/10.2903/j.efsa.2017.4787

Re-evaluation of sodium nitrate (E 251) and potassium nitrate (E 252) as food additives. / Mortensen, Alicja; Aguilar, Fernando; Crebelli, Riccardo et al.
In: Efsa journal, Vol. 15, No. 6, e04787, 06.2017.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Re-evaluation of sodium nitrate (E 251) and potassium nitrate (E 252) as food additives

AU - Mortensen, Alicja

AU - Aguilar, Fernando

AU - Crebelli, Riccardo

AU - Di Domenico, Alessandro

AU - Dusemund, Birgit

AU - Frutos, Maria Jose

AU - Galtier, Pierre

AU - Gott, David

AU - Gundert-Remy, Ursula

AU - Lambre, Claude

AU - Leblanc, Jean-Charles

AU - Lindtner, Oliver

AU - Moldeus, Peter

AU - Mosesso, Pasquale

AU - Oskarsson, Agneta

AU - Parent-Massin, Dominique

AU - Stankovic, Ivan

AU - Waalkens-Berendsen, Ine

AU - Woutersen, Rudolf Antonius

AU - Wright, Matthew

AU - van den Brandt, Piet

AU - Fortes, Cristina

AU - Merino, Leonardo

AU - Toldra, Fidel

AU - Arcella, Davide

AU - Christodoulidou, Anna

AU - Barrucci, Federica

AU - Garcia, Ana

AU - Pizzo, Fabiola

AU - Battacchi, Dario

AU - Younes, Maged

AU - EFSA Panel Food Additives

PY - 2017/6

Y1 - 2017/6

N2 - The Panel on Food Additives and Nutrient Sources added to Food (ANS) provided a scientific opinion re-evaluating the safety of sodium nitrate (E 251) and potassium nitrate (E 252) when used as food additives. The current acceptable daily intakes (ADIs) for nitrate of 3.7 mg/kg body weight (bw) per day were established by the SCF (1997) and JECFA (2002). The available data did not indicate genotoxic potential for sodium and potassium nitrate. The carcinogenicity studies in mice and rats were negative. The Panel considered the derivation of an ADI for nitrate based on the formation of methaemoglobin, following the conversion of nitrate, excreted in the saliva, to nitrite. However, there were large variations in the data on the nitrate-to-nitrite conversion in the saliva in humans. Therefore, the Panel considered that it was not possible to derive a single value of the ADI from the available data. The Panel noticed that even using the highest nitrate-to-nitrite conversion factor the methaemoglobin levels produced due to nitrite obtained from this conversion would not be clinically significant and would result to a theoretically estimated endogenous N-nitroso compounds (ENOC) production at levels which would be of low concern. Hence, and despite the uncertainty associated with the ADI established by the SCF, the Panel concluded that currently there was insufficient evidence to withdraw this ADI. The exposure to nitrate solely from its use as a food additive was estimated to be less than 5% of the overall exposure to nitrate in food based on a refined estimated exposure scenario. This exposure did not exceed the current ADI (SCF, 1997). However, if all sources of exposure to dietary nitrate are considered (food additive, natural presence and contamination), the ADI would be exceeded for all age groups at the mean and the highest exposure. (C) 2017 European Food Safety Authority.

AB - The Panel on Food Additives and Nutrient Sources added to Food (ANS) provided a scientific opinion re-evaluating the safety of sodium nitrate (E 251) and potassium nitrate (E 252) when used as food additives. The current acceptable daily intakes (ADIs) for nitrate of 3.7 mg/kg body weight (bw) per day were established by the SCF (1997) and JECFA (2002). The available data did not indicate genotoxic potential for sodium and potassium nitrate. The carcinogenicity studies in mice and rats were negative. The Panel considered the derivation of an ADI for nitrate based on the formation of methaemoglobin, following the conversion of nitrate, excreted in the saliva, to nitrite. However, there were large variations in the data on the nitrate-to-nitrite conversion in the saliva in humans. Therefore, the Panel considered that it was not possible to derive a single value of the ADI from the available data. The Panel noticed that even using the highest nitrate-to-nitrite conversion factor the methaemoglobin levels produced due to nitrite obtained from this conversion would not be clinically significant and would result to a theoretically estimated endogenous N-nitroso compounds (ENOC) production at levels which would be of low concern. Hence, and despite the uncertainty associated with the ADI established by the SCF, the Panel concluded that currently there was insufficient evidence to withdraw this ADI. The exposure to nitrate solely from its use as a food additive was estimated to be less than 5% of the overall exposure to nitrate in food based on a refined estimated exposure scenario. This exposure did not exceed the current ADI (SCF, 1997). However, if all sources of exposure to dietary nitrate are considered (food additive, natural presence and contamination), the ADI would be exceeded for all age groups at the mean and the highest exposure. (C) 2017 European Food Safety Authority.

KW - sodium nitrate

KW - potassium nitrate

KW - E 251

KW - E 252

KW - food additive

KW - CAS Registry number 7757-79-1

KW - CAS Registry number 7631-99-4

KW - N-NITROSO COMPOUNDS

KW - NON-HODGKIN-LYMPHOMA

KW - GASTRIC-CANCER RISK

KW - NIH-AARP DIET

KW - MUNICIPAL DRINKING-WATER

KW - LARGE PROSPECTIVE COHORT

KW - SHANGHAI WOMENS HEALTH

KW - THYROID-GLAND ACTIVITY

KW - MEAT-RELATED COMPOUNDS

KW - RENAL-CELL CARCINOMA

U2 - 10.2903/j.efsa.2017.4787

DO - 10.2903/j.efsa.2017.4787

M3 - Article

C2 - 32625505

SN - 1831-4732

VL - 15

JO - Efsa journal

JF - Efsa journal

IS - 6

M1 - e04787

ER -

Mortensen A, Aguilar F, Crebelli R, Di Domenico A, Dusemund B, Frutos MJ et al. Re-evaluation of sodium nitrate (E 251) and potassium nitrate (E 252) as food additives. Efsa journal. 2017 Jun;15(6):e04787. doi: 10.2903/j.efsa.2017.4787