In a landmark judgment delivered on 24 September 2025, the General Court of the European Union annulled key rules of EU food hygiene legislation concerning the processing of smoked salmon. The Court ruled that the European Commission unlawfully failed to consult the European Food Safety Authority (EFSA) before introducing new temperature and time restrictions on fishery product processing. This decision has significant implications for EU food safety legislation, procedural requirements, and the salmon processing industry across Europe.
Background: the ‘stiffening’ technique and EU food hygiene rules
Mowi Poland S.A., a Polish company specialising in smoked salmon processing, challenged new hygiene requirements introduced by the European Commission. The company employs a technique known as ‘stiffening‘ to slice smoked salmon, which involves temporarily lowering the temperature of smoked salmon fillets to between –7°C and –14°C to facilitate precise cutting (General Court of the European Union, 2025).
The dispute arose when the Commission adopted Delegated Regulation (EU) 2024/1141 on 14 December 2023, amending Regulation (EC) No 853/2004, which establishes specific hygiene rules for food of animal origin. The contested provision added new requirements to Chapter VII of Section VIII of Annex III, introducing specific rules for the stiffening process.
The annulled provision
The General Court annulled point 3(e) of the Annex to Commission Delegated Regulation (EU) 2024/1141, which had added comprehensive requirements to EU food hygiene law governing the temperature control and time limits for fishery product slicing operations.
For fresh and processed fishery products, the provision specified that products requiring temperatures lower than melting ice for machine slicing may be maintained at such temperatures for a maximum time limit of 96 hours, with the period kept as short as possible, whilst prohibiting storage and transport at these temperatures.
For frozen fishery products, the regulation stated that products requiring temperatures higher than –18°C for machine slicing may be maintained at such technologically required temperatures for a maximum of 96 hours, again with the period minimised and storage or transport at these temperatures prohibited.
The Commission argued this provision merely ‘clarified’ existing requirements. However, the General Court fundamentally disagreed with this characterisation.
Legal standing
The Commission initially contested whether Mowi Poland had legal standing to challenge the regulation. However, the General Court ruled the action admissible, finding that Delegated Regulation (EU) 2024/1141 constituted a regulatory act within the meaning of Article 263 TFEU, as it was not adopted through the legislative procedure. The provision directly affected Mowi Poland’s legal situation by imposing new obligations and required no further implementing measures. The Court determined that annulment would provide a tangible advantage by removing compliance obligations.
Critically, the Court determined that before the contested provision’s adoption, ‘no legally binding obligation governing the use of stiffening as a stage of production’ existed (General Court of the European Union, 2025, para. 34). Previous guidance documents, including the European Salmon Smokers Association’s guide and the Codex Alimentarius, were indeed voluntary and non-binding.
The Court’s analysis
Undefined concepts in pre-existing legislation
The General Court identified fundamental ambiguities in the regulatory framework that existed before the contested provision. Neither Regulation (EC) No 853/2004 nor related regulations (Nos 178/2002 and 852/2004) defined ‘storage‘. The Court noted: ‘it is not apparent from the provisions in force before the adoption of the contested provision from what point a fishery product should be considered to be stored’ (General Court of the European Union, 2025, para. 40).
Similarly, no definition existed for ‘frozen product‘. The Commission’s interpretation that products at stiffening temperatures (–7°C to –14°C) constituted frozen products requiring storage at –18°C lacked regulatory support. The Court observed that throughout Regulation (EC) No 853/2004, the concept of frozen product consistently associated with temperatures not exceeding –18°C (General Court of the European Union, 2025, para. 48).
The 96-hour time limit
The Court rejected the Commission’s argument that the 96-hour limit ‘was already known previously as being the maximum authorised period’. Such a time limit represented a new obligation imposed on operators, regardless of its appearance in non-binding guidance documents (General Court of the European Union, 2025, para. 44).
Before the contested provision, operators working with ‘stiffened’ smoked salmon were subject only to point 5 of Chapter IX of Annex II to Regulation (EC) No 852/2004, which permitted ‘limited periods outside temperature control’ without specifying a time limit (General Court of the European Union, 2025, para. 52).
The fatal flaw: failure to consult EFSA
Article 13 of Regulation No 853/2004
Article 13 mandates: ‘The Commission is to consult [EFSA] on any matter falling within the scope of [Regulation EC No 853/2004] that could have a significant impact on public health‘. The parties agreed the Commission did not consult EFSA before adopting the contested provision. The central question became whether consultation was mandatory in this case.
Significant impact on public health
The Court concluded the matter could have a significant impact on public health based on several factors. Introducing a time limit for maintaining fishery products at stiffening temperatures ‘requires analysing and taking into account the time during which it can be considered that those products, maintained at such a temperature, do not pose a health risk‘ (General Court of the European Union, 2025, para. 75). This inherently involves scientific assessments.
Ironically, the Commission’s own submissions undermined its position. The Commission argued that some producers had ‘abused the tolerance’ of EU legislation regarding stiffening ‘to the detriment of consumers’, that fillets stored at stiffening temperature are of poorer quality, and that accepting Mowi Poland’s interpretation would create a situation ‘manifestly dangerous for the health of consumers’.
The Court noted: ‘it is apparent, in essence, from the Commission’s own arguments that maintaining smoked salmon at stiffening-required temperature for a long period could have an impact on the health of consumers’ (General Court of the European Union, 2025, para. 84).
The Commission referenced several scientific studies in its defence, including a 2021 study on freezing damage in cod, showing that ‘freezing of fish is an important processing method that can extend the shelf life of the product but can also lead to significant damage to the tissue if performed incorrectly’ (Gudjónsdóttir et al., 2021, as cited in General Court of the European Union, 2025, para. 79).
A 2018 study also demonstrated that ‘storage time and temperature are major factors affecting quality loss and the shelf life of fish’ and that oxidation reduces ‘fish nutritional, texture, and colour quality’ (Hammad et al., 2018, as cited in General Court of the European Union, 2025, para. 79).
Lack of scientific basis
The Court observed that ‘the scientific basis taken into account by the Commission for the purposes of drafting the contested provision is not apparent from Delegated Regulation (EU) 2024/1141 or from its explanatory memorandum’ (General Court of the European Union, 2025, para. 88).
Furthermore, the Commission admitted the 96-hour maximum period resulted from ‘a ‘consensus among producers in the sector‘ rather than scientific assessment (General Court of the European Union, 2025, para. 90). This admission highlighted that the time limit was based on industry practice rather than evidence-based scientific evaluation of health risks.
Post-adoption consultation insufficient
After adoption, the European Parliament requested EFSA’s opinion in May 2024. EFSA’s Executive Director responded in June 2024, stating he could not ‘identify any open issue relating to food safety or risks to human health in the storage conditions described in the request’.
However, the Court ruled this exchange ‘is subsequent to the adoption of Delegated Regulation (EU) 2024/1141, which took place on 14 December 2023, and that, therefore, it is, in any event, without impact on the legality of that regulation’ (General Court of the European Union, 2025, para. 92).
Retrospective consultation cannot cure procedural defects that existed at the time of adoption.
The case for EFSA consultation
Procedural requirements are substantive
The Court’s ruling emphasises that procedural requirements, such as EFSA consultation, are not mere formalities. They constitute essential safeguards ensuring EU legislation rests on sound scientific foundations. As the Court noted, ‘it is apparent from recital 27 of Regulation EC No 853/2004 that scientific advice should underpin EU legislation on food hygiene‘ (General Court of the European Union, 2025, para. 87).
The precautionary principle
The judgment implicitly reinforces the precautionary principle in EU food safety law. Before imposing new restrictions affecting public health, the Commission must obtain expert scientific assessment. This principle ensures that regulatory measures protect consumers without being arbitrary or based solely on industry consensus.
Transparency and evidence-based policy
The Court’s criticism of the lack of scientific basis and reliance on ‘consensus among producers’ highlights expectations for evidence-based, transparent policymaking in the EU. Regulations affecting public health must demonstrate scientific justification, not merely reflect commercial convenience or industry preferences.
Consequences of the annulment
Immediate legal effects
The annulment means that point 3(e) of the Annex to Delegated Regulation (EU) 2024/1141 is void. The previous legal framework applies, with the Commission ordered to bear its own costs and pay Mowi Poland’s costs. The French Republic, which intervened supporting the Commission, bears its own costs.
Practical implications for the salmon industry
Smoked salmon processors are no longer subject to the 96-hour time limit for stiffening. The previous, more flexible framework under point 5 of Chapter IX of Annex II to Regulation (EC) No 852/2004 applies, permitting ‘limited periods outside temperature control’ without specific time constraints. However, the judgment reveals significant regulatory uncertainty regarding when processing becomes ‘storage’, what temperatures constitute ‘frozen products’, and how long ‘limited periods’ may extend.
Implications for the European Commission
The Commission must ensure EFSA consultation before adopting food safety measures that could significantly impact public health, even when claiming merely to ‘clarify’ existing rules. The Commission may now consult EFSA and re-propose similar provisions with scientific backing, leave the current ambiguous framework in place, or propose more comprehensive amendments addressing the definitional gaps identified by the Court. Under Article 56 of the Statute of the Court of Justice, the Commission may appeal to the Court of Justice within two months and ten days, though appeals are limited to points of law.
Broader significance for EU food safety law
EFSA’s central role
This judgment reinforces EFSA’s gatekeeping function in EU food safety legislation. The Court confirmed that matters requiring scientific assessment to determine health impacts fall within the mandatory consultation requirement. EFSA’s role is not discretionary but mandatory when matters could significantly affect public health.
Definition of ‘significant impact’
The judgment provides guidance on interpreting ‘significant impact on public health’ under Article 13 of Regulation (EC) No 853/2004. The test includes whether scientific assessment is necessary, the Commission’s own characterisation of health risks, and the potential consequences of the measure. The Court’s approach suggests a relatively broad interpretation, encompassing matters affecting food quality, consumer protection, and potential health risks.
Regulatory acts and access to justice
The judgment also contributes to case law on standing requirements under Article 263 TFEU. The Court’s finding that the contested provision imposed new obligations, despite Commission arguments it merely clarified existing rules, demonstrates judicial willingness to examine substance over form. This approach facilitates access to justice for businesses affected by EU regulatory measures.
Jurisprudential Impact
This judgment may influence future challenges to Commission delegated acts lacking proper consultation, interpretation of mandatory consultation requirements across EU law, and standing requirements for food business operators challenging EU hygiene rules. The judgment establishes a clear precedent that procedural requirements cannot be bypassed through characterisation of measures as mere ‘clarifications’.
Conclusion
The General Court’s judgment in Mowi Poland v Commission represents a significant victory for procedural rigour in EU food safety legislation. By annulling the contested provision, the Court affirmed that:
- the Commission cannot bypass mandatory EFSA consultation;
- issues requiring scientific assessment of health impacts demand expert input;
- industry consensus can contribute but not replace scientific evaluation; and
- post-adoption consultation cannot remedy procedural defects occurred beforehand.
Dario Dongo
References
- Commission Delegated Regulation (EU) 2024/1141 of 14 December 2023 amending Annexes II and III to Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards specific hygiene requirements for certain meat, fishery products, dairy products and eggs. http://data.europa.eu/eli/reg_del/2024/1141/oj
- General Court of the European Union. (2025). Judgment of the General Court (Sixth Chamber) of 24 September 2025, Mowi Poland S.A. v European Commission. Case T-354/24. ECLI:EU:T:2025:913. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A62024TJ0354
- Gudjónsdóttir, M., Gunnlaugsson, V., & Arason, S. (2021). Quantification and mapping of tissue damage from freezing in cod by magnetic resonance imaging. Food Control, 123, 107734. https://doi.org/10.1016/j.foodcont.2020.107734
- Hammad, A. I., Hafez, E. E., Romeih, E., & Taher, M. A. (2018). Effect of freezing on the shelf life of salmon. International Journal of Food Science, 2018, 1686121. https://doi.org/10.1155/2018/1686121
- 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. Consolidated text: 09/11/2024 http://data.europa.eu/eli/reg/2004/853/2024-11-09
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
