Sodium nitrite

What this is

Sodium nitrite is regulated because it has both a real food-safety role and a real toxicology boundary. FDA and USDA allow it only in specified foods and curing contexts, with finished-product limits; Codex lists INS 250 in the nitrites group with specific processed-meat residual limits; and EU E 250 remains authorized but was updated under Regulation (EU) 2023/2108. EFSA derived an acceptable daily intake of 0.07 mg nitrite ion/kg body weight/day based on methemoglobin effects and found additive-only exposure generally below that level, except slight exceedance in high-percentile children. The main concern is that nitrite can participate in formation of N-nitroso compounds; IARC classifies ingested nitrate or nitrite under endogenous nitrosation conditions as probably carcinogenic to humans. A recent UK review describes mixed, non-conclusive human evidence, with highest concern in very high processed-meat diets. Separately, some U.S. states restrict high-purity consumer sales because of acute poisoning risk; those laws do not broadly ban regulated food uses.

Safety Review

The critical endpoints experts review in safety assessments. This is not a prediction of harm.

EFSA's ADI is based on methemoglobin effects, and concentrated sodium nitrite ingestion can cause severe poisoning and death. In food, concern also comes from nitrosamine chemistry: nitrite can participate in formation of N-nitroso compounds, with greatest concern in high processed-meat dietary patterns and high-exposure children.