The European Commission – as announced some time ago (1) – has reduced the limits on the use of nitrite and nitrate preservative additives on products of animal origin. Regulation (EU) No 2023/2108 modifies the conditions of use of the aforementioned additives in meat products, meat and fish preparations, cheeses. In addition to defining more stringent limits on heavy metal contamination of these additives. (2)
1) Nitrites and nitrates, pros and cons
The salting it is a meat and fish preservation technique consolidated in Europe starting from the ancient Roman Empire. Nitrite and nitrate salts are traditionally included in salting mixtures to inhibit the growth of pathogenic bacteria, preserve the colors of the meat and develop characteristic aromas. (3). The role of these salts is still fundamental in inactivating the dangerous pathogen Clostridium botulinum. (4)
Numerous studies scientific studies (ie Crowe et al., 2022) have however correlated the amounts of nitrites and nitrates added in processed meats with the onset of colorectal cancers. (5) EFSA in turn has estimated an excessive average level of exposure of European citizens to nitrosamines, carcinogenic and genotoxic substances which are formed from nitrites and nitrates (5,6).
2) Positive experiences of reducing additives
Denmark it is the first Member State to have introduced, already in 2015, nitrite limits lower than those established in the EU on meat products sold in its territory. Thanks also to the positive experiences of its industries in mitigating food safety risks thanks to the use of ‘food cultures’ (i.e. lactic ferments and others). (7)
Lower levels of nitrite and nitrate additives are moreover used in organic products, where the greater commitment in terms of good hygiene practices and monitoring of the risks of microbiological contamination, during self-control, have nevertheless made it possible to guarantee food safety.
4) Nitrites and nitrates, new limits on products of animal origin
Regulation (EU) No 2023/2108, in reform of the Food Additives Regulation (EC) No 1333/08, reduces the limits of nitrites and nitrates on products of animal origin to a significant extent. The new thresholds – which vary in relation to categories and types of products, as set out in the following paragraphs – apply starting from 9 October 2025. Without prejudice to the application of the transitional rules referred to in the following paragraph 5.
4.1) Cheeses and other dairy products
(a) Maximum dose that can be added during manufacturing (expressed in NO3 ions)
(b) If the residual dose from all sources on the finished product over the entire shelf-life period exceeds 35 mg/kg expressed as NO3 ions, food business operators shall investigate the reason for this exceedance
4.2) Meat products not subjected to heat treatment
4.3 Traditional meat products obtained by immersion salting
4.4) Traditional meat products obtained by dry salting
(XA) Maximum dose that can be added during manufacturing (expressed in NO3 ions)
(XC) Maximum dose that can be added during manufacturing (in NO2 ions)
(XD) The maximum residual dose from all sources in the final product, for the entire duration of its shelf life, must not exceed 45 mg/kg expressed as NO2 ions.
(XE) In case the residual dose from all sources for the product ready for marketing, for the entire duration of its shelf life, exceeds 90 mg/kg expressed as NO3 ions, food business operators shall investigate on the reason for this overcoming
(XF) Same cs, in case of exceeding 110 mg/kg expressed in NO3 ions
(XH) Maximum residual dose from all sources for the final product, over the entire duration of its shelf life, in NO2 ions
(XI) Maximum residual dose from each source on the finished product, over the entire shelf-life, in NO3 ions
(XJ) The maximum residual dose from all sources on the finished product, over the entire shelf-life, must not exceed 50 mg/kg in NO2 ions.
(XK) Case in which the residual dose from each source on the finished product, over the entire shelf-life, exceeds 95 mg/kg expressed in NO3 ions.
5) Transitional periods
Transitional rules are envisaged to facilitate the progressive reduction of the food additives under consideration by SMEs (Small and Medium Enterprises), in a gradual transition logic.
5.1) Foods that do not comply with the new limits
Non-compliant foods to the provisions of Annex I to the regulation. EU 2023/2108 that have been legally placed on the market before its application date can be and marketed until the end of their shelf-life. Retailers will thus be able to exhaust their stocks.
5.2) Heavy metal contamination limits
Food additives legally placed on the market before 29 October 2023 not compliant with the new maximum limits for heavy metal contamination (lead, mercury and arsenic) established in Annex II reg. EU 2023/2108 can be used in foods – as long as they comply with the limits set out in Annexes II and III of the regulation. (EC) 1333/2008 – until 29 April 2024. Foods containing these additives can be placed on the market until 29 April 2024 and marketed until their ‘date marking’.
6) Concluding reflections
The reform under examination intervenes on the methods and conditions (limits) of use of nitrite and nitrate additives. However, without dwelling on some fundamental needs, such as:
– the improvement of the levels of application of good hygiene practices (PRPs, Pre-Requisites Programs) in the livestock supply chain and the processing industries of products of animal origin, which have a fundamental role in the prevention and mitigation of the risks of microbiological contamination,
– the greater attention required, in self-control and official public controls, on the prevention and monitoring of microbiological contamination (e.g. Listeria, STEC), (8)
– the crucial role of ferments, enzymes and microbiological cultures (‘food cultures’) as natural and effective solutions, with a long and positive history of use, to improve the microbiological and organoleptic stability of products of animal origin and Ready-to -Eat (RTE) foods. (9)
Dario Dongo and Gabriele Sapienza
Footnotes
(1) Dario Dongo, Andrea Adelmo Della Penna. Reduction of nitrites in cured meats, work in progress in Brussels. The ABC. GIFT (Great Italian Food Trade). 1.10.20
(2) Commission Regulation (EU) 2023/2108 of 6 October 2023 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards food additives nitrites (E 249-250) and nitrates (E 251-252) https://tinyurl.com/bdf4ayb2
(3) Sindelar JJ, Milkowski AL. Human safety controversies surrounding nitrate and nitrite in the diet. Nitric Oxide. 2012 May 15;26(4):259-66. doi: 10.1016/j.niox.2012.03.011
(4) Dario Dongo, Silvia Bonardi. Botox, a dangerous bacterium to keep away. GIFT (Great Italian Food Trade). 19.7.18
(5) Marta Strinati. Nitrites in processed meats and colorectal cancer risk, new evidence. GIFT (Great Italian Food Trade). 4.1.23
(6) Marta Strinati. EFSA opinion on nitrosamines in food. The population is at risk. GIFT (Great Italian Food Trade). 30.3.23
(7) National provisions notified by Denmark concerning the addition of nitrites to certain meat products, decree 4.9.2015 n. 1044 https://tinyurl.com/4n5fmbha
(8) Dario Dongo. Listeria, a dangerous pathogen out of control. GIFT (Great Italian Food Trade). 19.8.23
(9) Dario Dongo. Natural preservatives at risk of legal barriers, short circuit in the EU. GIFT (Great Italian Food Trade). 20.10.23
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Graduated in Agronomy, with experience in sustainable agriculture and permaculture, laboratory and ecological monitoring.
