The Italian Council of State has definitively ruled that the Ministry of Health lacks competence to reclassify lysozyme from a preservative to a technological aid in the production of Grana Padano PDO. The decision, issued on 4 November 2025 (No. 8575/2025), upholds the earlier judgment of the TAR Lazio and clarifies a crucial point in EU food law: only the European institutions, through the procedures established by Regulation (EC) No 1333/2008, can modify the lists of authorised food additives.
Different dairy systems and the use of lysozyme
The ruling recalls that Parmigiano Reggiano and Grana Padano – although both long-aged hard cheeses with PDO status – derive from different production methods and cattle-feeding systems. As the judges note,
‘the Parmigiano Reggiano specification requires the exclusive use of milk from cows fed with alfalfa, hay and vegetable feeds, while the Grana Padano specification allows milk from cows fed with silage, consequently requiring the use of lysozyme… to counteract the possible presence of Clostridium tyrobutyricum spores’.
The court explains that the acidic environment of silos used to store silage favours clostridial fermentation, potentially damaging the cheese during ripening and causing late butyric swelling. Hence, the use of lysozyme in Grana Padano – up to 2.5 g per 100 kg of milk – is technically justified to ensure stability during maturation.
Lysozyme’s technological role and its classification
Lysozyme, identified by the EU additive code E1105, is an enzymatic protein extracted from egg white with bacteriolytic properties against Clostridium butyricum. It is included in Annex II of Regulation (EC) No 1333/2008, within the list of ‘food additives other than colours and sweeteners’, authorised in ripened cheeses under the quantum satis principle.
The Grana Padano Consortium had requested to the Italian Ministry of Health, in 2017, that lysozyme be reclassified as a ‘technological processing aid’, arguing that after nine months of ageing it no longer performs a preservative function. The Ministry of Health, having accepted the favourable opinion of the Higher Health Council (CSS), had approved the request. However, the Parmigiano Reggiano Consortium appealed the decision, claiming a lack of ministerial competence and a violation of EU rules.
The Council of State agreed, observing that:
‘the classification of lysozyme as a food additive with code E1105 in ripened cheeses… is a binding EU datum that imposes itself imperatively on any divergent deduction until it is validly modified according to the uniform procedure provided for in Article 10(3) of Regulation (EC) No 1333/2008’.
The function of lysozyme as a preservative
The judges rejected the Ministry’s thesis that lysozyme acts as a technological aid in Grana Padano, pointing out that empirical evidence contradicts this claim. According to the court,
‘it cannot in any way be affirmed that the finished product contains only residues of the substance or its derivatives: in this case, all empirical evidence supports the opposite – namely that lysozyme persists in the finished product in significant, even concentrated, amounts’.
This persistence demonstrates that lysozyme continues to perform a technological (preservative) effect in the final cheese, thus meeting the definition of a food additive, not that of a technological aid, which must leave only unintentional and functionally inert residues.
Lack of ministerial competence
The ruling firmly establishes that the Italian Ministry of Health cannot unilaterally alter or reinterpret EU additive classifications:
‘the Ministry cannot adopt determinations that modify, even indirectly, the EU list of food additives (Annex II to Regulation 1333/2008), since any substantial amendment or interpretative decision is reserved to the Union authorities’.
Allowing national deviations, the judges added, would ‘undermine the integrity of the single list and the uniform authorisation procedure, with an evident risk to food safety within the internal market’.
Implications for the dairy sector
The decision safeguards the distinctive positioning of Parmigiano Reggiano, the closest Italian hard cheese (together with Trentingrana) authorised to bear the claim ‘without additives or preservatives’. It also confirms that Grana Padano DOP must continue to declare lysozyme (E1105) on its label as a preservative of egg origin, in line with Regulation (EU) No 1169/2011 on food information to consumers.
Beyond the specific case, the ruling reasserts the exclusive competence of the European Union in food additive authorisation and classification, reaffirming that national authorities cannot reinterpret scientific evidence to modify the legal status of substances governed by harmonised EU law.
Conclusions
By rejecting the appeals of both the Ministry of Health and the Grana Padano Consortium, the Italian Council of State reinforces the primacy of EU food law and the need for uniform safety standards across the single market. The decision also highlights the technological and regulatory differences between two of Italy’s most emblematic PDO cheeses, whose production systems – based on contrasting feed practices – determine the technological necessity and legal status of lysozyme.
Ultimately, the court clarifies that only the European Commission, through the EFSA-supported procedure of Regulation 1333/2008, may review or amend the classification of lysozyme or similar substances.
Dario Dongo
References
- Consiglio di Stato. (2025, November 4). Sentenza n. 8575/2025 – Ministero della Salute v. Consorzio del Formaggio Parmigiano Reggiano & Consorzio Grana Padano. Retrieved from mdp.giustizia-amministrativa.it
- Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. Consolidated text: 31/07/2025 http://data.europa.eu/eli/reg/2008/1333/2025-07-31
- Regulation (EU) No 1129/2011 of the Commission of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008. Consolidated text: 21/11/2013 http://data.europa.eu/eli/reg/2011/1129/2013-11-21
- Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers. Consolidated text: 01/04/2025 http://data.europa.eu/eli/reg/2011/1169/2025-04-01
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
