Specific purity criteria on sodium and potassium nitrites are defined in Commission Regulation (EU) No 231/2012. Sodium and potassium salts of nitrite are commonly used in curing mixtures to develop and fix the colour of meat, to inhibit microbial growth and/or to develop characteristic flavours (IARC, 2010 Sindelar and Milkowski, 2012). Not all original studies on which previous evaluations were based were available for re-evaluation by the Panel. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations and reviews, additional literature that became available since then and the data provided following public calls for data. The acceptable daily intake (ADIs) for sodium and potassium nitrite (expressed as nitrite ion) established by the SCF ( 1997) and by JECFA ( 2002, 1996) were 0–0.06 and 0–0.07 mg/kg body weight (bw) per day, respectively. Sodium (E 250) and potassium (E 249) nitrites are authorised as food additives in the European Union (EU) according to Annex II to Regulation (EC) No 1333/2008 on food additives and they were previously evaluated by the EU Scientific Committee for Food (SCF), the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the European Food Safety Authority (EFSA). There was evidence to link preformed NDMA and colorectal cancers.įollowing a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to re-evaluate the safety of potassium nitrite (E 249) and sodium nitrite (E 250) when used as food additives.
AMYL NIGHT EXTREME FORMULA PLUS
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. 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. The Panel estimated the MoE to exogenous nitrosamines in meat products to be < 10,000 in all age groups at high level exposure. 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 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, using a BMD approach, derived an ADI of 0.07 mg nitrite ion/kg bw per day.
The Panel concluded that an increased methaemoglobin level, observed in human and animals, was a relevant effect for the derivation of the ADI. 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 available information did not indicate in vivo genotoxic potential for sodium and potassium nitrite. 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 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.
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