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Nitrate and nitrite occur naturally in food, especially in vegetables, but are also used as food additives (E 249–252) in certain products to inhibit bacterial growth. Nitrate is permitted for use, for example, in some types of cheese, meat, and fish, while nitrite is permitted in certain processed meat products. Both nitrate and nitrite may also occur as contaminants, including in drinking water.
Nitrate can be converted to nitrite, and nitrite can react with naturally occurring amines to form nitrosamines, several of which are carcinogenic. Conversion of nitrate and nitrite can occur both in food and in the body (endogenous formation). VKM has assessed whether nitrate, nitrite, and nitrosamines exposure may pose a health risk to the Norwegian population. The assessment includes ten nitrosamines that have been detected in food and classified as carcinogenic. VKM estimated both the dietary intake of these substances and the contributing exposure from the formation of nitrite and nitrosamines in the body.
Exposure estimates are based on national dietary surveys and data on the occurrence of these substances in food. VKM used three intake levels: typical (median), average, and high intake (95th percentile). A typical intake reflects what is common in the population, while a high intake represents the top 5% of consumers.
Storage and processing can influence the conversion of nitrate to nitrite and nitrite to nitrosamines in food. Since most available occurrence data were from raw foods, VKM developed a model to estimate concentrations in ready-to-eat foods. The purpose was to provide a more realistic estimate of exposure than from estimates based on raw foods alone.
To estimate the total exposure to nitrite and nitrosamines, both from food and endogenous formation, VKM further developed mathematical models for endogenous formation. Since nitrate is converted to nitrite, which is responsible for the critical health effect, and this conversion was included in the total nitrite exposure, VKM did not perform a separate risk characterisation for nitrate.
VKM compared exposure levels with reference values established by the European Food Safety Authority (EFSA):
• For nitrite, EFSA has set an acceptable daily intake (ADI) of 0.07 mg/kg body weight per day, including a safety margin of 100, to protect against increased levels of methemoglobin in the blood, which can reduce oxygen transport. This condition is rare, it can be reversible but is potentially serious. The ADI is an estimate of the amount of a substance that can be consumed daily over a lifetime without appreciable health risk. For carcinogenic substances such as the nitrosamines in this risk assessment, health risk is assessed using the Margin of Exposure (MOE). This is defined as the ratio between the dose causing increased cancer risk in animal studies and the estimated human exposure. An MOE above 10,000 indicates low health concern.
Regarding exposure to nitrite and nitrosamines, VKM found the following:
• Typical and average dietary exposure to nitrite was below ADI for all age groups. High intake (P95) exceeded the ADI for 1- and 4-year-olds and adults, while it was below for 2-, 9-, and 13-year-olds.
• When endogenous formation was included, the total nitrite exposure in all age groups and intake levels exceeded the ADI (except typical intake in adults).
• The estimated nitrite exposure is at similar level to those of EFSA when endogenous production is included.
• MOE values for nitrosamines were below 10,000 for all intake levels and age groups.
• Nitrosamine exposure in Norway is similar to that observed in other European countries.
• The main source of exposure to nitrate was vegetables, while meat and meat products were the main sources of nitrite and nitrosamines. A major limitation of this assessment was the lack of data on nitrosamine levels in several food groups that are important contributors to nitrite exposure, particularly vegetables. This makes it difficult to assess whether, and to what extent, these food groups contribute to nitrosamine exposure.
To investigate how compliance with the Norwegian dietary guidelines may affect exposure to nitrites and nitrosamines, VKM developed two scenarios based on recommended intake levels. Scenario 1 represented the lower guidance intake (e.g. 500 g fruits and vegetables per day and no red meat), while Scenario 2 represented the upper guidance intake (e.g. 800 g fruits and vegetables and up to 50 g unprocessed red meat per day). Since these scenarios cover only part of the total diet, actual exposure may be higher or lower depending on other foods consumed. The exposure estimates were adjusted for energy intake to enable comparison with average intake in adults, as calculated from the national dietary survey Norkost 4.
Regarding how compliance with the dietary guidelines may affect exposure to nitrite and nitrosamines, VKM found the following:
• Both scenarios resulted in higher nitrate and nitrite intake compared to the intake in Norkost 4, mainly due to increased vegetable consumption.
• Nitrosamine exposure was lower in Scenario 1 and similar in Scenario 2. For the food groups included in the dietary guidelines, occurrence data were available for meat and cheese only.
VKM concludes the following regarding the risk from nitrite exposure:
• Total exposure, i.e. dietary and endogenous formation, exceeded the ADI at average and high (P95) intake levels in adults, and may therefore imply an increased risk of adverse health effects (methemoglobinemia).
• Typical and average exposure to nitrite from food alone was below the ADI for all age groups. The same applies to high intake (P95) for 2-, 9- and 13-year-olds. This indicates negligible risk of adverse health effects at these exposure levels. High intake (P95) among 1- and 4-year-olds as well as adults exceeded the ADI and may therefore imply an increased risk of adverse health effects (methemoglobinemia) in these groups.
• In adults, the endogenous synthesis of nitrite from nitrate was up to five-fold higher than the estimated nitrite exposure from food (external exposure). Total exposure was not estimated for other age groups than adults, however, by assuming that endogenous formation is of the same order of magnitude across age groups, it cannot be excluded that total exposure at typical, average, and high (P95) intake levels also exceeds the ADI in these age groups. This may indicate an increased risk of adverse health effects (methemoglobinemia) across more exposure levels and age groups. There is greater uncertainty associated with total exposure than with exposure from food alone.
VKM concludes the following regarding the risk from nitrosamine exposure:
• MOE values were below 10,000 for all age groups at typical, average, and high intake levels. This implies that VKM cannot exclude an increased risk of cancer resulting from dietary exposure to nitrosamines in the Norwegian population.