TY - JOUR
T1 - Re-evaluation of potassium nitrite (E 249) and sodium nitrite (E 250) 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 - Abrahantes, Jose Cortinas
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 potassium nitrite (E 249) and sodium nitrite (E 250) when used as food additives. The ADIs established by the SCF (1997) and by JECFA (2002) for nitrite were 0-0.06 and 0-0.07 mg/kg bw per day, respectively. The available information did not indicate in vivo genotoxic potential for sodium and potassium nitrite. Overall, an ADI for nitrite per se could be derived from the available repeated dose toxicity studies in animals, also considering the negative carcinogenicity results. The Panel concluded that an increased methaemoglobin level, observed in human and animals, was a relevant effect for the derivation of the ADI. The Panel, using a BMD approach, derived an ADI of 0.07 mg nitrite ion/kg bw per day. The exposure to nitrite resulting from its use as food additive did not exceed this ADI for the general population, except for a slight exceedance in children at the highest percentile. The Panel assessed the endogenous formation of nitrosamines from nitrites based on the theoretical calculation of the NDMA produced upon ingestion of nitrites at the ADI and estimated a MoE > 10,000. The Panel estimated the MoE to exogenous nitrosamines in meat products to be <10,000 in all age groups at high level exposure. Based on the results of a systematic review, it was not possible to clearly discern nitrosamines produced from the nitrite added at the authorised levels, from those found in the food matrix without addition of external nitrite. In epidemiological studies there was some evidence to link (i) dietary nitrite and gastric cancers and (ii) the combination of nitrite plus nitrate from processed meat and colorectal cancers. There was evidence to link preformed NDMA and colorectal cancers. (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 potassium nitrite (E 249) and sodium nitrite (E 250) when used as food additives. The ADIs established by the SCF (1997) and by JECFA (2002) for nitrite were 0-0.06 and 0-0.07 mg/kg bw per day, respectively. The available information did not indicate in vivo genotoxic potential for sodium and potassium nitrite. Overall, an ADI for nitrite per se could be derived from the available repeated dose toxicity studies in animals, also considering the negative carcinogenicity results. The Panel concluded that an increased methaemoglobin level, observed in human and animals, was a relevant effect for the derivation of the ADI. The Panel, using a BMD approach, derived an ADI of 0.07 mg nitrite ion/kg bw per day. The exposure to nitrite resulting from its use as food additive did not exceed this ADI for the general population, except for a slight exceedance in children at the highest percentile. The Panel assessed the endogenous formation of nitrosamines from nitrites based on the theoretical calculation of the NDMA produced upon ingestion of nitrites at the ADI and estimated a MoE > 10,000. The Panel estimated the MoE to exogenous nitrosamines in meat products to be <10,000 in all age groups at high level exposure. Based on the results of a systematic review, it was not possible to clearly discern nitrosamines produced from the nitrite added at the authorised levels, from those found in the food matrix without addition of external nitrite. In epidemiological studies there was some evidence to link (i) dietary nitrite and gastric cancers and (ii) the combination of nitrite plus nitrate from processed meat and colorectal cancers. There was evidence to link preformed NDMA and colorectal cancers. (C) 2017 European Food Safety Authority.
KW - potassium nitrite
KW - sodium nitrite
KW - E 249
KW - E 250
KW - food additive
KW - CAS Registry number 7632-00-0
KW - CAS Registry number 7758-09-0
KW - N-NITROSO COMPOUNDS
KW - NON-HODGKIN-LYMPHOMA
KW - NIH-AARP DIET
KW - PROCESSED MEAT-PRODUCTS
KW - PUBLIC WATER-SUPPLIES
KW - RAT FORESTOMACH CARCINOGENESIS
KW - LARGE PROSPECTIVE COHORT
KW - SHANGHAI WOMENS HEALTH
KW - COLORECTAL-CANCER RISK
KW - RENAL-CELL CARCINOMA
U2 - 10.2903/j.efsa.2017.4786
DO - 10.2903/j.efsa.2017.4786
M3 - Article
C2 - 32625504
SN - 1831-4732
VL - 15
JO - Efsa journal
JF - Efsa journal
IS - 6
M1 - e4786
ER -