- 15/05/2026
- Posted by: Marta
- Category: Questions and answers
Dear Dongo lawyer,
Our meat processing industry is about to implement a tartare of beef to be marketed frozen. A large-scale retail customer raised concerns about the use of preservatives (sodium nitrite, in this case) given that the product is frozen.
I ask you for advice on this matter.
Thank you very much, [signed letter]
The lawyer Dario Dongo, Ph.D. in Agri-Food Systems, answers
- food additives are governed by Regulation (EC) No. 1333/2008 (1) which defines the authorised substances, the food categories in which they can be used and the related conditions of use.
Regulation (EC) No 853/2004 (2), so-called 'Hygiene 2', contains specific provisions on the hygiene and safety of food products of animal origin. This regulation distinguishes products derived from meat into two categories: (3)
- meat preparations: fresh meat, including meat reduced to fragments, which has undergone the addition of food products, seasonings or additives or treatments not sufficient to modify the internal muscle-fibrous structure of the meat and therefore eliminate the characteristics of fresh meat;
- meat products: processed products resulting from the processing of meat or from the further processing of such processed products, in such a way that the cut surface allows the disappearance of the characteristics of fresh meat to be seen. (4)
- frozen foods are regulated at European level by Directive 89/108/EEC (5), implemented in Italy by Legislative Decree no. 110/1992 (6). They are defined by art. 1.2 of the directive as food products that meet two conditions:
- have been subjected to a special freezing process, called 'freezing', which allows the maximum crystallization zone of the product to be exceeded as quickly as necessary (depending on the nature of the product) and to ensure that the temperature of the product in all its points - after thermal stabilization - is continuously maintained at values equal to or lower than -18 °C;
- are marketed in such a way as to distinguish their physical state ('frozen').
Preservative food additives
Il sodium nitrite (E 250) is a food additive belonging to the 5th group of additives listed in Part C of Annex II of Regulation (EC) No. 1333/2008, which establishes the list of food additives authorised in the EU. It is indicated as E 249-250: nitrites.
The use of a food additive requires its inclusion in Part E of Annex II, where the conditions of use are indicated for the food categories in which that additive is authorised.
Meat preparations, as defined in Regulation (EC) No 853/2004, fall under category 08.2. Meat products not subjected to heat treatment (7) are instead included in category 08.3.1.
Commission Regulation (EU) 2023/2108 (8) amended the maximum levels of nitrites and nitrates to be used as food additives, starting from 9 October 2025. The limits are set as follows:
- 08.2 – Meat preparations as defined in Regulation (EC) No 853/2004: up to 80 mg/kg (9). The restrictions determine the applicability to specific products, such as beef tartare (danie tatarskie); (10)
- 08.3.1 – Non-heat-treated meat products: up to 80 mg/kg (11). There are no restrictions on food products to which nitrites and nitrates may be added.
Provisions on frozen products
National implementation of Directive 89/108/EEC on frozen products, carried out in Italy with Legislative Decree no. 110/1992, introduced in Article 3 some restrictions relating to the use of food additives in raw materials to be used for the production of frozen products.
Apparent conflict of rules
Il apparent conflict of rules between Regulation (EC) No. 1333/08 and Legislative Decree No. 110 of 27 January 1992 – in the part relating to the use of food additives in frozen products – must be resolved by disapplying the national legislation, in light of three distinct general principles of the legal system, which operate in a logically graduated order:
- first of all, and with an absorbing character with respect to the other criteria, the principle of hierarchy of sources of law (lex superior derogat legi inferiori): Regulation (EC) No. 1333/2008 of the European Parliament and of the Council constitutes a source of European Union law directly applicable in the legal systems of the Member States pursuant to Article 288 TFEU, and therefore prevails over provisions of national legislative rank by virtue of the primacy of European law (primauté du droit de l'Union), principle affirmed since the ruling Costa v. ENEL (Court of Justice, 15 July 1964, case 6/64) and constantly reiterated in subsequent jurisprudence;
- secondly, and in a complementary way, the application is principle of specialty (lex specialis derogat general laws): where Regulation (EC) No. 1333/2008 specifically and comprehensively regulates the use of additives in specific categories of foods - including frozen products - the special European regulation exhausts the regulatory scope of the matter, excluding the application of the more general national regulation. The criterion of speciality therefore operates on a level distinct from the hierarchy of sources: it does not concern the normative force of the provisions, but rather their respective scope of application (ratio legis e ambitus);
- thirdly, and as a further systematic confirmation, the principle of temporal succession of norms (lex posterior derogat legi priori): Regulation (EC) No. 1333/2008, adopted on 16 December 2008 and entered into force on 20 January 2009, is chronologically subsequent to Legislative Decree No. 110/1992. Even if we ignore the hierarchical and specialty criteria - which in themselves determine the non-application of the national provision - the new regulation replaces the previous one to the extent that the two regulations regulate the same material (eadem materia), resulting in tacit abrogation of incompatible national provisions.
It follows that any assessment of the legality of the use of food additives in frozen products must be conducted exclusively in light of Regulation (EC) No. 1333/2008 and its subsequent amendments, as well as Regulation (EU) No. 231/2012 which establishes the technical specifications, without leaving any room for the application of the previous national provisions referred to in Legislative Decree No. 110/1992.
Conclusions
The use of sodium nitrite (E 250) in a tartare frozen is legitimate – regardless of the physical characteristics of the product, which determine its qualification as a 'meat preparation' (see beef tartare danie tatarskie) or 'non-heat-treated meat product' – the attribution of which is the responsibility of the food business operator (FBO) placing the product on the market. In both cases, the new maximum limits are 80 mg/kg (or 80 ppm) of product.
The provisions of Legislative Decree no. 110/1992, regarding food additives, are no longer applicable to frozen products, as these provisions have been superseded by Regulation (EC) no. 1333/2008, which prevails by virtue of the hierarchy of sources.
Dario Dongo
Credit cover Yang Hao
Note
(1) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. http://data.europa.eu/eli/reg/2008/1333/oj (latest consolidated version: http://data.europa.eu/eli/reg/2008/1333/2026-02-18)
(2) Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin. http://data.europa.eu/eli/reg/2004/853/oj (latest consolidated version: http://data.europa.eu/eli/reg/2004/853/2026-01-27)
(3) See points 1.15 and 7.1 of Annex I to Regulation (EC) No 853/2004
(4) According to the Commission guidance on food categories of Regulation (EC) No 1333/2008, 'processing' means any operation which substantially changes the initial product, including heating, smoking, salting, maturing, drying, marinating, extraction, extrusion or a combination of these processes.
(5) Council Directive 89/108/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to quick-frozen foods intended for human consumption. http://data.europa.eu/eli/dir/1989/108/oj (latest consolidated version: http://data.europa.eu/eli/dir/1989/108/2013-07-01)
(6) Legislative Decree 27 January 1992, n. 110. Implementation of Directive n. 89/108/EEC on frozen foods intended for human consumption. https://www.normattiva.it/eli/id/1992/02/17/092G0147/CONSOLIDATED
(7) The term 'heat treatment' means an operation carried out through the administration of heat, such as pasteurisation or sterilisation
(8) 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 the food additives nitrites (E 249-250) and nitrates (E 251-252). http://data.europa.eu/eli/reg/2023/2108/oj
(9) The maximum dose that can be added during manufacturing (expressed in NO ions2). The maximum residual dose from all sources for the product ready for marketing, for the entire duration of its shelf life, must not exceed 45 mg/kg expressed as NO ions.2
(10) Polish meat preparations intended for consumption without heat treatment, obtained from finely minced beef with the addition of water, seasonings, spices and additives; packaged in barrier packaging.
(11) See note 9.
