HomeSafetyNitrites, nitrates and nitrosamines, EFSA reviews the risk analysis

Nitrites, nitrates and nitrosamines, EFSA reviews the risk analysis

The safety of nitrites and nitrates - still used as preservative additives in some meat products - is called into question in the most recent risk analysis on nitrosamines conducted by EFSA.

The scientific opinion of the European Food Safety Authority confirms what is already evident in the scientific literature. And it is therefore that the European Commission must favor the use of alternative ingredients to preserve cured meats.

1) Nitrosamines. Premise

Nitrosamines (N-nitrosamines) are chemicals, organic compounds that are part of the nitrogen cycle. They can form in foods and drugs, (1) as a result of handling and transformation processes.

In the toxicological field, the formation of nitrosamines is a serious problem to be addressed since some of them are classified as genotoxic (ie capable of damaging DNA), as well as carcinogenic.

2) Nitrosamines, nitrites and nitrates

Nitrosamines they are formed by reaction of nitrites with secondary amines (e.g. le
meat proteins). Human exposure is associated with them (in primis) the consumption of foods that contain nitrate and nitrite salts.

IARC (International Agency for the Research on Cancer) classified nitrites and nitrates as'probable human carcinogens'(Group 2A) already in 2010. And returned to nitrosamines in 2018. (2)

3) Nitrites and nitrates, the limits of use in the EU

The reg. CE 1333/08 established the maximum doses of nitrites and nitrates that can be added as food additives during manufacturing, as well as the maximum residual doses in the final products.

Scientific opinion requested to EFSA by the European Commission is part of a process of revision of the conditions of use of the preservatives in question, in the wake of Denmark. (3)

4) EFSA, previous risk assessment

The previous evaluation risk assessment conducted by EFSA in 2017 set an Acceptable Daily Intake (ADI) of 0,07 mg nitrite ions per kg of body weight. Noting its overcoming in infants, young children, moderately exposed children and the most exposed people of all ages. (4)

5) EFSA, current scientific opinion

The most recent opinion scientific report of EFSA, subject to public consultation until 22.11.22, (5) updates the analysis of the risks of exposure to nitrosamines in the European population.

A systematic review considers both the incidence of liver tumors in rodents and the carcinogenicity of the more dangerous nitrosamine (N-nitrosodiethylamine).

The conclusions show dietary exposure to nitrosamines above the level at which health concerns may exist.

6) Nitrites, nitrates and cancer risk

The correlation between the intake of nitrates and nitrites and the risk of developing tumors was recently investigated in the French cohort study NutriNet-Santé (Chazelas et al., 2022).

Researchers examined the eating habits of 101.056 adults - from 2009 to the present, with a follow-up average of 6,7 years - tracing the composition and trade name of the products they consume.

Positive correlations high consumption of potassium nitrate and breast cancer, sodium nitrite and prostate cancer have been identified (6,7).

7) Provisional conclusions

The evolution of food technologies made it possible to guarantee the safety of meat products against microbiological risks (eg botulinum, listeria) without the need to use preservative additives that contain nitrites and nitrates. Italy, among other things, as we have seen, is at the forefront in the offer of cured meats'without nitrites and without nitrates'. (8)

Public health risks associated with the use of the aforementioned preservatives do not justify keeping them in the list of authorized additives. All the more so as the technical necessity can come 'satisfied by other economically and technologically feasible means'. (9) The way forward is therefore the French one, progressive elimination. (10)

Dario Dongo and Ylenia Desiree Patti Giammello


(1) European Medicines Agency (EMA). Nitrosamine impurities

(2) IARC (2018). Ingested Nitrate and Nitrite, and Cyanobacterial Peptide Toxins. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 94. ISBN 978-92-832-1294-2.

(3) Dario Dongo, Andrea Adelmo Della Penna. Reduction of nitrites in cured meats, work in progress in Brussels. The ABC. GIFT (Great Italian Food Trade). 1.10.21

(4) EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). Re-evaluation of potassium nitrite (E 249) and sodium nitrite (E 250) as food additives. EFSA Journal 2017; 15 (6): 4786.

(5) EFSA (2022). Draft Scientific Opinion on the human health risks related to the presence of N-nitrosamines (N-NAs) in food. Public consultation

(6) Eloi Chazelas, Fabrice Pierre, Nathalie Druesne-Pecollo, Younes Esseddik, Fabien Szabo de Edelenyi, Cédric Agaesse, Alexandre De Sa, Rebecca Lutchia, Stéphane Gigandet, Bernard Srour, Charlotte Debras, Inge Huybrechts, Chantal Julia, Emmanuelle Kesse- Guyot, Benjamin Allès, Pilar Galan, Serge Hercberg, Mélanie Deschasaux-Tanguy, Mathilde Touvier, Nitrites and nitrates from food additives and natural sources and cancer risk: results from the NutriNet-Santé cohort. International Journal of Epidemiology, Volume 51, Issue 4, August 2022, Pages 1106–1119,

(7) Martha Strinati. Nitrites and nitrates in cured meats. Market study and analysis. GIFT (Great Italian Food Trade). 30.4.22

(8) Dario Dongo. Natural preservatives in meatGIFT (Great Italian Food Trade). 6.11.17

(9) EC Reg. 1333/08, article 6 (General conditions for the inclusion of food additives in Community lists and for their use), paragraph 1, letter 'b'

(10) Dario Dongo. Hams and cured meats without nitrites by law, the French revolution of charcuterie. GIFT (Great Italian Food Trade). 7.2.22

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Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.

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Laboratory technician, passionate about the production and distribution of food products, consumer information and culinary art.

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