Heather Richie, writer, fisherman and mariner.
Heather Richie is a writer, fisherman, and mariner. Through Fisher & Farmer and its charitable arm, she promotes food sovereignty, education, and recreational fishing access. She studies EU and US fisheries and maritime law, and lives on Killary Harbour and in Charleston, South Carolina.
Abstract:
In Mowi Poland v European Commission (T‑354/24), the General Court annulled part of a Commission delegated regulation governing how fishery products may be chilled and held before processing, on the ground that the Commission imposed a binding ninety‑six‑hour limit without first consulting the European Food Safety Authority (‘EFSA’), as Article 13 of Regulation 853/2004 requires. This case note examines the judgment’s central holding — that where a delegated measure turns on scientific assessment, the parent regulation’s requirement to consult EFSA is a condition of the Commission’s authority to act, not a discretionary courtesy — and situates it within the architecture of EU food‑safety governance and the precautionary principle. Drawing a comparative line to the Irish courts’ duty‑to‑give‑reasons jurisprudence, it argues that Mowi Poland strengthens the procedural discipline on expert administrative action, and that skipping a consultation required by the governing regulation can be enough to render a measure unlawful.
Introduction
To slice smoked salmon cleanly, producers firm the fillets by chilling them to between roughly −7°C and −14°C.[1] Held briefly, this ‘stiffening’ is a step in processing; held long enough, it shades into freezing — and a product frozen in all but name may, in the Commission’s view, still reach the consumer labelled as fresh. It was to police that line that the Commission, by delegated regulation, capped the permitted cold-hold at ninety-six hours. In Mowi Poland v European Commission, the General Court of the European Union annulled part of a Commission regulation governing processing practices in the fishery products sector on grounds of procedural illegality. The judgment is notable for its reaffirmation of the obligation to base EU food law measures on appropriate scientific consultation and for its strict approach to the characterisation of allegedly “clarificatory” amendments. Although the dispute concerned a highly technical processing method, the Court’s reasoning has broader implications for EU administrative law, particularly the duty to ground food-safety measures in scientific consultation and the limits on presenting new obligations as mere clarifications. This note examines the Court’s reasoning, with particular attention to the procedural threshold for EFSA consultation under Article 13 of Regulation No 853/2004 and the implications of the ruling for consumer information in the fishery products sector.
Legal Framework
EU food law rests on a constitutional commitment to a high level of human health protection. Article 168(1) TFEU requires that health protection be ensured in the definition and implementation of all Union policies and activities..[2]This objective is given effect by Regulation (EC) No 178/2002 (the General Food Law Regulation), which establishes the general principles of EU food law.[3] The Regulation formalises the separation between risk assessment and risk management and entrusts the European Food Safety Authority (‘EFSA’), under Articles 22 and 29, with providing independent scientific advice on matters affecting food safety.[4]
Where proposed regulatory measures are liable to affect public health and depend upon scientific evaluation, consultation with EFSA constitutes an essential procedural requirement; the obligation to consult arises under Article 13 of Regulation No 853/2004. The failure to observe such requirements may justify annulment under Article 263 TFEU, irrespective of the substantive merits of the measure.[5]
Facts and Regulatory Background
The case was brought as an action for annulment under Article 263 TFEU, the Treaty provision which permits, among others, natural and legal persons to challenge the legality of EU acts before the General Court. Where the Court finds that an act was adopted in breach of an essential procedural requirement, or on other grounds including infringement of the Treaties or misuse of powers, it may declare the act void.
The case arose from a Commission amendment to Regulation (EC) No 853/2004 by means of Delegated Regulation (EU) 2024/1141 of 14 December 2023,[6] which introduced a binding 96‑hour maximum duration for “limited periods outside temperature control” in the processing of fishery products The amendment directly affected the stiffening technique used in the processing of smoked salmon, whereby fillets are cooled to between −7°C and −14°C to facilitate slicing.
Prior to the amendment, the use of stiffening was governed only by non‑binding guidance documents, which imposed no specific temporal limitation.[7] The Commission maintained that the 96‑hour threshold merely clarified an already recognised maximum duration reflected in technical materials.[8] Mowi Poland challenged the measure, arguing that it introduced a new binding obligation without scientific justification and without prior consultation with EFSA.[9]
Arguments of the Parties
Mowi Poland contended that the imposition of a binding time limit constituted a substantive regulatory change and that the Commission was therefore obliged to obtain EFSA’s scientific advice. The applicant emphasised that the Commission had neither demonstrated the scientific basis for the 96‑hour limit nor explained why EFSA consultation was unnecessary.[10]
The Commission argued that the amendment was merely clarificatory and did not concern a matter capable of having a significant impact on public health.[11] It further relied on concerns relating to consumer deception and product quality, alleging that some producers had abused the absence of a clear temporal limit to market products subjected to extended stiffening or freezing as having never been frozen, thereby misleading consumers as to the nature and quality of the product.[12] However, the Commission also acknowledged that prolonged maintenance at stiffening temperatures could affect consumer health.[13]
Judgment of the General Court
The case was heard by the Sixth Chamber of the General Court, which handed down judgment on 24 September 2025. Mowi Poland advanced four pleas in law: infringement of Article 290 TFEU on the ground that the contested provision concerned an essential element of Regulation No 853/2004; breach of the principle of proportionality under Article 5(4) TEU; infringement of Article 10(1) of Regulation No 853/2004; and infringement of Article 13 of that regulation, relating to the failure to consult EFSA.[14] The Court considered it appropriate to examine the fourth plea first, and ultimately annulled the contested provision on that ground alone, without reaching the remaining pleas.[15]
Before turning to the merits, the Court addressed admissibility, which the Commission and the French Republic had disputed. The Court confirmed that Delegated Regulation (EU) 2024/1141, not having been adopted through the legislative procedure, constituted a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU;[16]that the contested provision did not entail implementing measures;[17] and, most substantively, that the measure directly affected the applicant’s legal situation by imposing new obligations.[18] That finding, that the provision imposed new obligations, necessarily bore on the merits, since it undercut the Commission’s characterisation of the measure as merely clarificatory.
On the central question of whether the measure engaged Article 13 of Regulation No 853/2004 — which requires the Commission to consult EFSA on any matter within the scope of the regulation “that could have a significant impact on public health” — the Court rejected the Commission’s threshold argument that the contested provision concerned no such matter. It held that the introduction of a time limit during which operators are authorised to maintain fishery products at the stiffening-required temperature requires analysing and taking into account the period during which such products do not pose a health risk — a question, it observed, that “involves scientific assessments.”[19]
The Court turned the Commission’s own submissions against it. The Commission had argued, in defending the substantive rationale for the measure, that some producers had abused the tolerance of EU legislation “to the detriment of consumers,”[20] that fillets kept at stiffening temperature were of poorer quality, and that Mowi Poland’s reading of the earlier framework would render certain products “manifestly dangerous for the health of consumers.”[21] It had also relied on scientific studies showing that the temperature and duration of freezing significantly affect product quality and that freezing performed incorrectly can cause significant tissue damage. The Court concluded that “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.”[22] The Commission had itself described the alternative scenario as “manifestly dangerous,” which the Court treated as evidence that the public-health impact was significant.[23]
Having found that the matter fell within Article 13, the Court confirmed that the Commission had not consulted EFSA before adopting the regulation, and that the scientific basis for the 96-hour threshold was nowhere apparent from the instrument or its explanatory memorandum. Indeed, the Commission had defended the figure as reflecting a “consensus among producers” and a “reasonable and sufficient period” for slicing — a justification rooted in industry practice rather than scientific evaluation.[24] The Court further noted that although the President of the European Parliament had requested a scientific opinion from EFSA by letter of 14 May 2024, to which EFSA’s Executive Director replied on 12 June 2024, that exchange post-dated the adoption of the regulation in December 2023 and was therefore immaterial to its legality.[25]
The Court reinforced its conclusion by reference to recital 27 of Regulation No 853/2004, from which it drew the principle that scientific advice should underpin EU legislation on food hygiene.[26] The fourth plea was upheld and point 3(e) of the Annex to Delegated Regulation (EU) 2024/1141 annulled in its entirety, with the Commission ordered to bear its own costs and those of the applicant, and the French Republic, as intervener, ordered to bear its own.[27]
Comment
The judgment is doctrinally significant for its strict approach to procedural legality in EU administrative action.[28] It reinforces the principle that binding regulatory measures cannot evade procedural safeguards by being framed as clarifications of existing practice and reaffirms EFSA’s role in supplying the scientific basis for food-safety regulation.
The case also shows how a procedural failure can defeat a sound regulatory aim. A central concern articulated by the Commission related not to food safety in a narrow sense, but to consumer information and labelling.[29] That labelling concern falls squarely within the scope of Regulation (EU) No 1169/2011 on the provision of food information to consumers, which seeks to ensure that food labelling is accurate, clear, and not misleading.[30] The Court did not reach the consumer information question; the observation here concerns the scope of the Regulation, not a judicial finding.
By failing to consult EFSA, the Commission deprived itself of the opportunity to embed this labelling concern within a scientifically grounded regulatory framework. The Court’s analysis therefore remained confined to procedural legality, and the substantive compatibility of the measure with EU consumer information law was never examined. The precautionary principle underpins much of EU food safety regulation.[31] But the Commission acted on precaution alone, without consulting EFSA, and that procedurally-flawed approach left the labelling concern scientifically ungrounded and undercut clear, non-misleading consumer information.
Irish administrative law approaches procedural failure in much the same way. The Supreme Court’s decision in Mallak v Minister for Justice[32] confirms that failures of procedure or reasoning may vitiate an administrative decision regardless of the apparent strength of the underlying policy objective. In Mallak, the Supreme Court held that the attainment of fairness requires decision-makers to give reasons for their decisions, both to enable the individual to challenge the decision on substantive grounds and to permit the courts to exercise supervisory jurisdiction.[33] As in the EU context, Irish courts frequently resolve disputes at the procedural level, with the effect that substantive policy aims remain judicially untested.[34]
As of this writing, the Commission has neither appealed the judgment nor initiated a fresh consultation with EFSA on the stiffening question. The regulatory status quo ante therefore prevails: operators remain subject to the general requirement of ‘limited periods outside temperature control’ under Regulation No 852/2004, without a specified time limit. Mowi Poland has, however, pursued related litigation, filing a further action against EFSA seeking access to documents under Regulation (EC) No 1049/2001 (Case T‑657/25), suggesting that the applicant regards the underlying scientific record as incomplete.[35]
Conclusion
Mowi Poland v European Commission confirms that a binding obligation cannot be passed off as a clarification, and that a food-hygiene measure resting on scientific assessment requires EFSA consultation before adoption. The sharper point is how the regulation fell: the Commission’s own submissions — that prolonged stiffening was “manifestly dangerous” and worked to the detriment of consumers — supplied the very public-health significance that triggered the Article 13 duty it had bypassed, so that the case for the measure became the case against its legality. If the Commission wants to reinstate a fixed limit it must now consult EFSA, secure an opinion, and legislate afresh on that footing; until then, the open-ended standard the provision sought to replace remains in force.
[1] Case T‑354/24 Mowi Poland v European Commission ECLI:EU:T:2025:913 (General Court, Sixth Chamber, 24 September 2025) para 3.
[2] Consolidated Version of the Treaty on the Functioning of the European Union [2016] OJ C202/47, art 168(1).
[3] Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law [2002] OJ L31/1.
[4] ibid arts 22, 29.
[5] See eg Case C‑269/90 Technische Universität München ECLI:EU:C:1991:438.
[6] 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 [2024] OJ L 2024/1141.
[7] Mowi Poland (n 1) paras 28–34.
[8] ibid paras 17, 41–42.
[9] ibid paras 64–65.
[10] ibid paras 64–65.
[11] ibid para 66.
[12] ibid paras 77–78.
[13] ibid paras 80–81.
[14] ibid para 62.
[15] ibid paras 63, 93.
[16] ibid para 21.
[17] ibid para 22.
[18] ibid paras 26, 54.
[19] ibid para 75.
[20] ibid para 78.
[21] ibid para 85.
[22] ibid para 84.
[23] ibid para 85.
[24] ibid para 90.
[25] ibid paras 91–92.
[26] ibid para 87.
[27] ibid operative part, points 1–3.
[28] See Bregt Raus, ‘Food Hygiene for Fish: EU General Court Requires Scientific Basis to “Clarify” the Law’ (ALTIUS, 9 October 2025). See also ‘Mowi Poland challenges EU food hygiene Regulation: official publication today’ (EU Law Live, 26 August 2024).
[29] Mowi Poland (n 1) paras 67, 78.
[30] Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers [2011] OJ L304/18.
[31] Regulation (EC) No 178/2002, art 7. See also Communication from the Commission on the Precautionary Principle COM(2000) 1 final.
[32] Mallak v Minister for Justice, Equality and Law Reform [2012] IESC 59.
[33] Mallak (n 30) [66] (Fennelly J). See also Suzanne Kingston, ‘“Mallak-Plus”: The Emergence of an Enhanced Duty to Give Reasons in Connelly v An Bord Pleanála’ (2019) SSRN 3349202.
[34] See eg Connelly v An Bord Pleanála [2018] IESC 31; Murphy v Ireland [2014] IESC 19.
[35] Action brought on 24 September 2025, Case T‑657/25 Mowi Poland v EFSA [2025] OJ C/2025/5863.
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