Provisional text
JUDGMENT OF THE GENERAL COURT (Sixth Chamber)
24 September 2025 (*)
( Public health – Specific hygiene rules for food of animal origin – Regulation (EC) No 853/2004 – Point 3(e) of the Annex to Delegated Regulation (EU) 2024/1141 – Action for annulment – Locus standi – Interest in bringing proceedings – Admissibility – Concept of ‘frozen product’ – Lack of consultation with EFSA – Article 13 of Regulation No 853/2004 )
In Case T‑354/24,
Mowi Poland S.A., established in Ustka (Poland), represented by Z. Kiedacz and K. Puchalska, lawyers,
applicant,
v
European Commission, represented by M. Owsiany-Hornung, acting as Agent,
defendant,
supported by
French Republic, represented by B. Fodda, B. Travard and P. Chansou, acting as Agents,
intervener,
THE GENERAL COURT (Sixth Chamber),
composed, at the time of the deliberations, of M.J. Costeira (Rapporteur), President, U. Öberg and P. Zilgalvis, Judges,
Registrar: V. Di Bucci,
having regard to the written part of the procedure,
having regard to the fact that no request for a hearing was submitted by the parties within three weeks after service of notification of the close of the written part of the procedure, and having decided to rule on the action without an oral part of the procedure, pursuant to Article 106(3) of the Rules of Procedure of the General Court,
gives the following
Judgment
1        By its action under Article 263 TFEU, the applicant, Mowi Poland S.A., seeks, in essence, the annulment of point 3(e) of the Annex to 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 (OJ L 2024/1141) (‘the contested provision’).
Background to the dispute
2        The applicant is a company registered under Polish law specialising, in particular, in the processing of smoked salmon.
3        To slice the smoked salmon, the applicant uses the ‘stiffening’ technique, which consists of cutting smoked salmon fillets by lowering their initial temperature to a level between –7° C and –14 °C.
4        On 14 December 2023, the European Commission adopted Delegated Regulation 2024/1141, which includes the contested provision. That provision adds the following point to Chapter VII of Section VIII of Annex III to 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 (OJ 2004 L 139, p. 55):
‘4.      Where fresh fishery products, thawed unprocessed fishery products, or processed fishery products need to be at a temperature lower than that of melting ice to permit the use of machines that slice or cut fishery products, they may be maintained at such technologically required temperature for a period of time as short as possible and in any case not exceeding 96 hours. Storage and transport at that temperature shall not be allowed.
Where frozen fishery products need to be at a temperature higher than – 18 °C to permit the use of machines that slice or cut fishery products, they may be maintained at such technologically required temperature for a period of time as short as possible and in any case not exceeding 96 hours. Storage and transport at that temperature shall not be allowed.’
Forms of order sought
5        The applicant claims, in essence, that the Court should:
–        annul the contested provision;
–        order the Commission to pay the costs.
6        The Commission contends that the Court should:
–        dismiss the action;
–        order the applicant to pay the costs.
7        The French Republic contends that the Court should dismiss the action.
Law
Preliminary considerations on hygiene rules applicable to fishery products
8        Food safety is governed by a set of regulations which aims to harmonise health rules at EU level.
9        In particular, Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1) lays down, under Article 1(2) thereof, the general principles governing food and feed in general.
10      Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ 2004 L 139, p. 1) lays down, under Article 1(1) thereof, general rules on the hygiene of foodstuffs.
11      Regulation No 853/2004 provides, in accordance with Article 1(1) thereof, specific rules on the hygiene of food of animal origin.
12      With regard to those rules, it follows from Article 3(1) of Regulation No 853/2004 that food business operators must comply with the relevant provisions of Annexes II and III to that regulation.
13      Annex III to Regulation No 853/2004 lays down specific requirements for different food sectors. The fishery products sector is governed by Section VIII of that annex.
14      Before the adoption of the contested provision, Chapter VII of Section VIII of Annex III to Regulation No 853/2004, concerning the storage of fishery products, provided as follows:
‘Food business operators storing fishery products must ensure compliance with the following requirements:
1.      Fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and molluscs, must be maintained at a temperature approaching that of melting ice [;]
2.      Frozen fishery products must be kept at a temperature of not more than –18 °C in all parts of the product; however, whole frozen fish in brine intended for the manufacture of canned food may be kept at a temperature of not more than –9 °C;
…’
15      As stated in paragraph 4 above, the contested provision modifies that chapter by adding the following point:
‘4.      Where fresh fishery products, thawed unprocessed fishery products, or processed fishery products need to be at a temperature lower than that of melting ice to permit the use of machines that slice or cut fishery products, they may be maintained at such technologically required temperature for a period of time as short as possible and in any case not exceeding 96 hours. Storage and transport at that temperature shall not be allowed.
Where frozen fishery products need to be at a temperature higher than – 18 °C to permit the use of machines that slice or cut fishery products, they may be maintained at such technologically required temperature for a period of time as short as possible and in any case not exceeding 96 hours. Storage and transport at that temperature shall not be allowed.’
Whether the action is admissible
16      Without formally raising an objection of inadmissibility by separate document on the basis of Article 130(1) of the Rules of Procedure of the General Court, the Commission, supported by the French Republic, disputes the admissibility of the action on the grounds, in essence, that the applicant, first, does not have standing to bring proceedings and, second, has no interest in bringing proceedings.
The applicant’s standing to bring proceedings
17      The Commission, supported by the French Republic, argues that the contested provision is not of direct concern to the applicant within the meaning of the fourth paragraph of Article 263 TFEU. That provision does not affect its legal situation since, before the adoption of that provision, EU law did not allow smoked salmon to be stored at the temperature used for its stiffening. In particular, before the adoption of the contested provision, Chapter VII, point 2, of Section VIII of Annex III to Regulation No 853/2004 was applicable to smoked salmon. First, while the concept of ‘storage’ is not defined under Regulation No 853/2004, it is appropriate to refer to the ‘generally accepted meaning’ and to that arising from the context of Regulation No 853/2004. Secondly, the products resulting from stiffening are ‘frozen products’ within the meaning of that point 2. Therefore, before the adoption of the contested provision, the use of the temperature employed
for stiffening should have taken place in the production process and for a period of time as short as possible and in any case not exceeding 96 hours. The lack of reference to the period of 96 hours in the applicable provisions did not have the effect of authorising the applicant to apply the temperature used for stiffening for a longer period. Furthermore, the reference to 96 hours provided for in the contested provision does not adversely affect the legal situation of the applicant since that limit was ‘already known previously as being the maximum authorised period’ and appeared in various documents. Thus, the contested provision confirms the possibility of using stiffening and merely provides greater clarity and readability to the existing provisions.
18      The applicant maintains, in essence, that it has standing to bring proceedings. It argues that Delegated Regulation 2024/1141 is a regulatory act and that the contested provision is of direct concern to it and does not entail implementing measures.
19      In that regard, it should be borne in mind that the admissibility of an action brought by natural or legal persons against an act which is not addressed to them, in accordance with the fourth paragraph of Article 263 TFEU, is subject to the condition that they be accorded standing to bring proceedings, which arises in two situations. First, such proceedings may be instituted if the act is of direct and individual concern to those persons. Second, such persons may bring proceedings against a regulatory act not entailing implementing measures if that act is of direct concern to them (see judgment of 30 June 2022, Danske Slagtermestre v Commission, C‑99/21 P, EU:C:2022:510, paragraph 41 and the case-law cited).
20      Therefore, it is necessary to determine whether, as the applicant claims, it has standing to bring proceedings on the grounds that the contested provision is a regulatory act which does not entail implementing measures and which is of direct concern to the applicant.
21      In the first place, it should be stated that, as the applicant maintains, first, Delegated Regulation 2024/1141 was not adopted in accordance with the legislative procedure. Accordingly, it is not a legislative act within the meaning of Article 289(3) TFEU. Secondly, that regulation is of general application inasmuch as it applies to objectively determined situations and produces legal effects with respect to categories of persons envisaged in general and in the abstract, that is to say food business operators. It follows that Delegated Regulation 2024/1141 is a regulatory act within the third limb of the fourth paragraph of Article 263 TFEU.
22      In the second place, it should be noted, as it was by the applicant, that it is apparent from the wording of the contested provision that it provides for specific requirements regarding the stiffening technique without further measures being necessary. It follows that the contested provision does not entail implementing measures vis-à-vis the applicant within the meaning of the third limb of the fourth paragraph of Article 263 TFEU.
23      In the third place, it should be recalled that, according to the Court’s settled case-law, in order to satisfy the requirement that the decision forming the subject matter of the proceedings must be of direct concern to a natural or legal person, two cumulative criteria must be met, namely, first, the contested measure must directly affect the legal situation of an applicant and, second, it must leave no discretion to its addressees, who are entrusted with the task of implementing it, such implementation being purely automatic and resulting from the contested legislation without the application of other intermediate rules (judgments of 5 May 1998, Dreyfus v Commission, C‑386/96 P, EU:C:1998:193, paragraph 43, and of 10 September 2009, Commission v Ente per le Ville Vesuviane and Ente per le Ville Vesuviane v Commission, C‑445/07 P and C‑455/07 P, EU:C:2009:529, paragraph 45).
24      With regard to the first criterion, it should be noted that, in accordance with the case-law, a provision directly affects the legal position of individuals by restricting their rights or by imposing obligations on them (judgment of 7 July 2015, Federcoopesca and Others v Commission, T‑312/14, EU:T:2015:472, paragraph 36).
25      It is therefore appropriate to examine whether the contested provision restricts the applicant’s rights or imposes obligations on that applicant.
26      In that regard, it should be noted that, as follows from paragraph 15 above, the contested provision, first, expressly provides for the possibility of using stiffening as a stage of production, specifying that maintaining fishery products at the temperature required for
that technique must be limited to ‘a period of time as short as possible and in any case not exceeding 96 hours’ and, second, provides that storage
and transport at that temperature are not allowed.
27      As regards the possibility of using stiffening as a stage of
production, it should be noted, as it was by the applicant, that, before the adoption of the contested provision, no provision of Regulations Nos 178/2002, 852/2004 or 853/2004 referred to that technique.
28      As the Commission maintains, before the adoption of that provision, stiffening was described in Annex III of the ‘European Guide to Good Practice for Smoked and/or Salted and/or Marinated Fish’ of the European Salmon Smokers Association (‘ESSA’).
29      That guide constitutes an EU guide to good practice for hygiene and the application of the hazard analysis and critical control point (‘HACCP’) principles within the meaning of Article 9 of Regulation No 852/2004.
30      As is apparent from the second paragraph of Article 7 of Regulation No 852/2004, while the use of EU guides is encouraged, food business operators may use those guides on a voluntary basis.
31      Pursuant to that provision, the same applies to national guides to good practice within the meaning of Article 8 of Regulation No 852/2004.
32      Furthermore, as the Commission submits, Section 14.1.13 of the Code of Practice for Fish and Fishery Products (Codex Alimentarius), established by the Food and Agriculture Organization of the United Nations (‘FAO’) and the World Health Organization (‘WHO’), adopted in 2003 and most recently amended in 2016, also provides technical guidance for slicing smoked salmon using the stiffening technique and it follows from recital 15 of Regulation No 852/2004 that the HACCP requirements should take account of the principles contained in the Codex Alimentarius.
33      However, it must be noted that it is apparent from the introductory part of that code that it ‘offer[s] general advice on the production, storage and handling of fish and fishery products on board fishing vessels and on shore.’
34      It follows that, before the adoption of the contested provision, there was no legally binding obligation governing the use of stiffening as a stage of production.
35      As regards the requirements relating to storage, it is appropriate to check, as the Commission, supported by the French Republic, in essence argues, whether,
before the adoption of the contested provision, the provisions in force already provided for a prohibition on keeping smoked salmon at stiffening-required temperature for a period exceeding 96 hours.
36      As a preliminary point, it should be noted that, contrary to what the applicant claims, before the adoption of the contested provision, Section VIII of Annex III to Regulation No 853/2004 was applicable to smoked salmon. In that regard, it should be noted that the parties rightly agree that smoked salmon is a ‘processed fishery product’ within the meaning of point 7.4 of Annex I to Regulation No 853/2004. As stated by the French Republic, Article 1(1) of Regulation No 853/2004 lays down specific rules which are to apply to unprocessed and processed products of animal origin. Furthermore, as the Commission notes, Section VIII of Annex III to Regulation No 853/2004 lays down provisions which apply to processed products. This is particularly the case of Chapter IV of that section which lays down requirements which apply to some processed fishery products.
37      Although the third subparagraph of point 1 of Section VIII of Annex III to Regulation No 853/2004 provides that ‘[this] Section shall apply
to thawed unprocessed fishery products and fresh fishery products to which food additives have been added in accordance with the appropriate Union legislation’, it must be noted, as it was by the Commission, that that provision was added by Commission Regulation No 558/2010 of 24 June 2010 amending Annex III to Regulation No 853/2004 (OJ 2010 L 159, p. 18), recital 11 of which provides that ‘for consistency of Union legislation, the same requirements as for fresh fishery products should apply to
those products’. Thus, it must be found that the third subparagraph of point 1 of Section VIII of Annex III to Regulation No 853/2004 merely states that that section also applies to thawed unprocessed fishery products and to fresh fishery products to which food additives have been added in accordance with EU legislation.
38      With regard, in particular, to the provisions relating to the storage of fishery products in force before the adoption of the contested provision, it should be noted that, first, as is apparent from paragraph 14 above, the requirements laid down in Chapter VII of Section VIII of Annex III to Regulation No 853/2004 apply to food business operators storing fishery products.
39      However, it must be stated that neither Regulation No 853/2004 nor Regulations Nos 178/2002 and 852/2004 to which Regulation No 853/2004 refers define the concept of ‘storage’. The Commission furthermore accepts as such in its written submissions.
40      Thus, 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.
41      That finding is reinforced by the fact that the context section of the explanatory memorandum to Delegated Regulation 2024/1141 states that it is appropriate ‘in order to avoid any ambiguity’
to ‘clarify’ the requirements as regards ‘the operation to slightly decrease the temperature for slicing fresh or processed fishery products or to increase the temperature of frozen fishery products and the prohibition to store or transport fishery products at that temporarily technologically required temperature’.
42      Furthermore, in response to the applicant’s second plea in law, the Commission maintains that the contested provision ‘clarifies the delimitation between what may be considered to be necessary in the context of the stiffening stage of production, on the one hand, and storage, on the other hand’.
43      The interpretation of the concept of ‘storage’ proposed by the Commission in the light of the ‘generally accepted meaning’, namely ‘the action of keeping or preserving something in a specific place for a certain time for its subsequent use’ or the protection of something ‘against any alteration, destruction, disappearance, etc., by placing it in appropriate conditions’, does not provide any further clarification on the question of ascertaining
from what point a fishery product should be considered to be stored.
44      As regards the contextual interpretation of that concept proposed by the Commission, namely that ‘storage for the purposes of [Chapter VII], point 2, [of Section VIII of Annex III to Regulation No 853/2004] occurs when a product is kept in a specific place pending its subsequent use, as opposed to the situation in which it would be placed in a specific state due to a necessity inherent in the production process (as in the case of the use of “stiffening” for the purpose of slicing)’, and the argument that stiffening, as a stage of production, was permitted only ‘in the context of salmon processing and for a period of time as short as possible’, with the result that, after that period had passed, it constituted storage, it must be noted that the contested provision introduces a time limit of 96 hours. Such a time limit constitutes an obligation imposed on the applicant in accordance with the case-law referred to in paragraph 24 above, regardless of whether, as the Commission maintains, it ‘was already known previously as being the maximum authorised period’ and appeared in various documents which, moreover, for the reasons set out in paragraphs 28 to 34 above, do not have binding force.
45      Secondly, it should be noted that the parties rightly agree that, before the adoption of the contested provision, smoked salmon, as a processed fishery product, did not fall within the scope of Chapter VII, point 1, of Section VIII of Annex III to Regulation No 853/2004.
46      With regard to Chapter VII, point 2, of Section VIII of Annex III to Regulation No 853/2004, it must be stated that neither Regulation No 853/2004 nor Regulations Nos 178/2002 and 852/2004 to which Regulation No 853/2004
refers define the concept of ‘frozen product’.
47      The Commission’s interpretation of that concept is based on a technical document from the FAO, on the part relating to chilled
and sub 0 °C chilling products of ESSA’s ‘European Guide to Good Practice for Smoked and/or Salted and/or Marinated Fish’ or on an illustration which appears on the website of the French Agricultural Research Centre for International Development (CIRAD) and is not supported by any reference to the regulations referred to in paragraph 46 above.
48      Furthermore, as maintained by the applicant, in Section VIII, Chapter
VII, point 2, of Annex III to Regulation No 853/2004, as in other provisions of that annex, such as Section I, relating to meat of domestic ungulates, Chapter VII, point 4, Section V, relating to minced meat, meat preparations and mechanically separated meat, Chapter III, point 2(c)(ii), or Section VIII, relating to fishery products,
Chapter I, Part I, C, point 1, the concept of ‘frozen product’ is associated with a temperature not exceeding –18 °C.
49      Thus, it is not apparent from the provisions in force before the adoption of the contested provision that smoked salmon, placed at a temperature used for stiffening, which varies, as far as the applicant’s practice is concerned, between –7 °C and –14 °C, should be considered to be a ‘frozen product’ within the meaning of Chapter VII, point 2, of Section VIII of Annex III to Regulation No 853/2004.
50      That finding is corroborated by the fact that, under the terms of Annex III of the ESSA ‘European Guide to Good Practice for Smoked and/or Salted and/or Marinated Fish’, to which the Commission itself refers, ‘stiffened’ products are classified in the category of Never Frozen Products.
51      It follows that, before the adoption of the contested provision, operators of ‘stiffened’ smoked salmon were subject to the requirements laid down in point 5 of Chapter IX of Annex II to Regulation No 852/2004, to which the Commission refers in its written submissions and which states:
‘Raw materials, ingredients, intermediate products and finished products likely to support the reproduction of pathogenic micro-organisms or the formation of toxins are not to be kept at temperatures that might result in a risk to health. The cold chain is not to be interrupted. However, limited periods outside temperature control are permitted, to accommodate the practicalities of handling during preparation, transport, storage, display and service of food, provided that it does not result in a risk to health. Food businesses manufacturing, handling and wrapping processed foodstuffs are to have suitable rooms, large enough for the separate storage of raw materials from processed material and sufficient separate refrigerated storage.’
52      It should be noted that that provision refers to the possibility of removing products from temperatures at which there is no health risk for ‘limited periods’, without indicating a time limit.
53      Therefore, contrary to what the Commission, supported by the French Republic, in essence argues, before the adoption of the contested provision it was not clear from the provisions in force that it was prohibited to keep smoked salmon at stiffening-required temperature for a period exceeding 96 hours.
54      Therefore, it must be found that the contested provision imposes obligations on the applicant and that the first criterion of direct concern is met.
55      With regard to the second criterion, it must be stated that the implementation of the contested provision is purely automatic and arises from the contested legislation
without requiring the application of other intermediate rules. It follows that the second criterion of direct concern is also met.
56      The applicant must therefore be regarded as directly concerned by the contested provision.
57      In light of the foregoing, it must be found that the applicant has standing to bring proceedings.
The applicant’s interest in bringing proceedings
58      According to settled case-law, an action for annulment brought by a natural or legal person is admissible only in so far as that person has an interest in having the contested act annulled. Such an interest requires that the annulment of that act must be capable, in itself, of having legal consequences and that the action may therefore, through its outcome, procure an advantage to the party which brought it (see judgment of 17 September 2015, Mory and Others v Commission, C‑33/14 P, EU:C:2015:609, paragraph 55 and the case-law cited).
59      In the present case, it is sufficient to note that the possible annulment of the contested provision is likely to procure an advantage to the applicant, namely that of not having to comply with the requirements imposed by that provision under Article 3(1) of Regulation No 853/2004.
60      The applicant therefore has an interest in bringing proceedings.
61      In the light of all the foregoing considerations, the action is admissible.
The merits
62      In support of its action, the applicant formally puts forward four pleas in law, alleging:
–        first, infringement of Article 290 TFEU, in that the contested provision concerns an essential element of Regulation No 853/2004;
–        second, a breach of the principle of proportionality enshrined in Article 5(4) TEU;
–        third, infringement of Article 10(1) of Regulation No 853/2004, in that the contested provision does not fall within the achievement of the objectives pursued by that regulation;
–        fourth, infringement of Article 13 of that regulation, in that the Commission did not consult the European Food Safety Authority (EFSA) during the procedure for drafting the contested provision.
63      The Court considers it appropriate to examine the fourth plea in law first.
64      In the fourth plea, the applicant submits, in essence, that, by failing to consult EFSA in the procedure for drafting the contested provision, the Commission infringed Article 13 of Regulation No 853/2004.
65      Furthermore, through the arguments relied on in the first, second and third pleas in law, the applicant argues, in essence, that (i) the time limit of 96 hours imposed by the contested provision is not based on any scientific data; (ii) the Commission has not provided any justification for that time limit; and (iii) that institution should have consulted EFSA on the time limit to be taken into account.
66      The Commission, supported by the French Republic, contends that the contested provision does not concern a matter that could have a significant impact on public health within the meaning of Article 13 of Regulation No 853/2004. That article limits the consultation of EFSA to some cases only, namely when the modifications made are of a sufficiently significant scale. In the present case, since the contested provision does not make any modification to the provisions in force before its adoption, no significant impact on health can be observed. That interpretation is also confirmed by a letter of 12 June 2024 from the Executive Director of EFSA to the President of the European Parliament. Furthermore, the contested provision clarifies the legal situation and does not concern scientific matters. Furthermore, there is no scientific evidence that the applicant’s practices have a positive impact on the health of consumers.
67      In the rejoinder, in response to the applicant’s arguments raised in the first, second and third pleas in law, the Commission, supported by the French Republic, notes, in the
defence, that it relied on studies demonstrating that the temperature and time for freezing smoked salmon have a significant impact on its quality. Furthermore, the period of 96 hours takes into account the maximum time required to complete the slicing. Thus, that time limit takes into consideration the objective of consumer protection in the area of food safety and the needs of the sector.
68      Article 13 of Regulation No 853/2004 provides that the Commission is to consult EFSA on any matter falling within the scope of that regulation that could have a significant impact on public health.
69      In the present case, it is common ground between the parties that the Commission did not consult EFSA prior to the adoption of the contested provision.
70      Contrary to what the Commission, supported by the French Republic, maintains, as is apparent from paragraphs 26 to 54 above, the contested provision introduces new obligations vis-à-vis the applicant.
71      The fact relied on by the Commission that, in his letter to the President of the Parliament, the Executive Director of EFSA stated that ‘the reduction of risks of microbiological hazards is already covered by established legislation which has defined the conditions of storage of fish products’, that ‘Regulation …
No 853/2004 prescribes temperatures around
0 °C (melting ice) for fresh products and –18 °C for frozen products’ and that ‘the Codex Alimentarius prescribes that fresh fishery products must be kept at melting ice temperatures and frozen fishery products at –18° C’ has no bearing on such an interpretation.
72      Apart from the fact that, under Article 22(2) of Regulation No 178/2002, EFSA’s mission is to provide scientific advice, such an assessment does not provide any clarification on any provisions in force before the adoption of the contested provision which defined the concepts of ‘storage’ or ‘frozen product’, which indicated from what point a fishery product was to
be considered to be stored or which specified the temperature at which such a product was to
be considered to be a frozen product.
73      It is therefore appropriate to ascertain whether the Commission was required to consult EFSA before adopting the contested provision under Article 13 of Regulation No 853/2004.
74      In that regard, it should be noted that the parties rightly agree that the issue to which the contested provision relates falls within the scope of Regulation No 853/2004.
75      As to whether that matter can have a significant impact on public health, it should be noted, first of all, that, contrary to what the Commission maintains, such a question involves scientific assessments. The introduction of a time limit during which operators of fishery products are authorised to maintain those products at the stiffening-required temperature 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.
76      With regard in particular to the assessment of the significant impact on public health, it should be noted that, while Delegated Regulation 2024/1141 does not contain any justification for the introduction of the stiffening requirements, it is, as specified in paragraph 41 above, apparent from the context section of the explanatory memorandum to that regulation that it is appropriate
‘in order to avoid any ambiguity’ to ‘clarify’ the requirements as regards ‘the operation to slightly decrease the temperature for slicing fresh or processed fishery products or to increase the temperature of frozen fishery products and the prohibition to store or transport fishery products at that temporarily technologically required temperature’.
77      Furthermore, it is apparent, in essence, from recital 13 of the initial version of the explanatory memorandum to Delegated Regulation 2024/1141 to which the applicant refers that, ‘to avoid abusive practices consisting in using such production requirements for storing fishery products at a temperature not in compliance with Chapter VII, point 2, of Section VIII of Annex III to [Regulation No 853/2004], the decreasing, or for already frozen products, the increasing, of temperature should be done as quickly as possible and the storage of fishery products at a temperature facilitating the cutting or slicing should be limited in time’.
78      It should also be noted that, in the context of the present action, although the Commission does not expressly rule on whether the issue to which the contested provision relates could
have a significant impact on public health, it maintains, in response to the applicant’s second plea in law, that some producers have abused the tolerance of EU legislation as regards the use of stiffening in the production process to the detriment of consumers, given that fillets stored at stiffening temperature are of poorer quality and that consumers are misled into believing that they are buying a product that has not been frozen.
79      The Commission notes that a number of scientific studies show that the temperature at which and duration for which smoked salmon is frozen have a significant impact on its quality. In that regard, it refers, first, to the study ‘Quantification and mapping of tissue damage from freezing in cod by magnetic resonance imaging – ScienceDirect’) (Food Control, volume 123, May 2021, 107734), which appears to show that the ‘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’ and that ‘the colder the freezing procedure, the less damage the process generally produced’. Secondly, it refers to the study entitled ‘Effect of Freezing on the Shelf Life of Salmon’ (International Journal of Food Science, August 2018, 1686121), which allegedly shows that ‘Storage time and temperature are major factors affecting quality loss and the shelf life of fish with the lipid fraction subject to mainly autoxidative and hydrolytic changes during frozen storage’ and that ‘fish lipids […] are highly susceptible to oxidation; thus oxidation reduces fish nutritional, texture, and colour quality’.
80      Furthermore, in its preliminary considerations on the legal framework, the Commission argues that smoked salmon, brought to a temperature below freezing, must be regarded as a frozen product and, as such, to the extent that it is stored, as a product subject to the provisions relating to the storage of frozen products, namely Chapter VII, point 2, of Section VIII of Annex III to Regulation No 853/2004. In that regard, it states that, due to the storage of smoked salmon at the temperature intended for slicing, there remains a certain percentage of water which, at that temperature, is not crystallized, which can, in some cases, lead to the development of bacterial flora in that water. The Commission further states that storing that product at stiffening temperature, in the event of temperature fluctuations, is likely to cause cell lysis, that is to say cell disintegration (when ice crystals damage the cell structure), which leads to increased health risks and affects the texture, taste and nutritional value of the finished product. It states that the documentation available on the FAO website shows that ‘fish proteins become permanently changed during freezing and cold storage’, that ‘the speed at which this denaturation occurs depends very largely upon temperature’, that ‘at temperatures not very far below freezing point, 28 °F [–2 °C]
for example, significant changes occur rapidly’ and that ‘even at 15 °F [–10 °C], the changes are so rapid that an initially good quality product can be spoilt within a few weeks’.
81      The Commission also maintains that, if the applicant’s interpretation were accepted as correct, that only products whose temperature has been reduced to
–18 °C can be considered to be frozen, this would mean that fishery products whose temperature has been reduced only to, for example, –17.5 °C would not be subject to the obligation to store at a temperature of –18 °C and could be sold to consumers as products which have never been frozen and that that situation would be ‘manifestly dangerous for the health of consumers’, given the risk to which they would be exposed due to the possibility that the same product had been thawed several times.
82      Thus, it can be inferred from the travaux préparatoires
for Delegated Regulation 2024/1141 and the Commission’s arguments put forward in the context of the present
action that the reason which led to the adoption of the contested provision is linked to the fact that there were ‘ambiguities’ in the previous legal framework regarding stiffening and the prohibition on storing and transporting fishery products at the temperature required by that technique, while
maintaining smoked salmon at that temperature for a long period would be likely to lead to health risks.
83      Such an issue must be categorised as a matter that could have a significant impact on public health.
84      In that regard, it is sufficient to note that, as stated in paragraph 82 above, 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 and, therefore, have an impact on public health.
85      Furthermore, as is also apparent from the Commission’s written submissions, such an impact on public health appears to be significant. The Commission states that accepting the interpretation adopted by the applicant with regard to Chapter VII, point 2, of Section VIII of Annex III to Regulation No 853/2004 would lead to a situation that is ‘manifestly dangerous for the health of consumers’.
86      Therefore, it must be found that the Commission was required to consult EFSA under Article 13 of Regulation No 853/2004 before adopting the contested provision.
87      That finding is borne out
by the fact that, as the Commission itself argues, it is apparent from recital 27 of Regulation No 853/2004 that scientific advice should underpin EU legislation on food hygiene.
88      It must be stated, as noted by the applicant, that the scientific basis
taken into account by the Commission for the purposes of drafting the contested provision is not apparent from Delegated Regulation 2024/1141 or from its explanatory memorandum.
89      Moreover, the Commission does not dispute the applicant’s arguments based on such lack of a scientific basis. In the rejoinder, the Commission merely states that, in the defence, it relied on studies demonstrating that the temperature and time for freezing smoked salmon have a significant impact on its quality, but does not discuss the lack of a scientific basis
for the contested provision in the context of the drafting of that provision.
90      The lack of a scientific basis for the contested provision in the context of the
drafting thereof can, moreover, be inferred from the Commission’s argument in response to the applicant’s second plea, according to which the maximum period of 96 hours results from a ‘consensus among producers in the sector’ as to the time required for slicing smoked salmon which has been stiffened and according to which it ‘is undoubtedly a reasonable and sufficient period to carry out the slicing process itself, taking into account the logistical and organisational needs of the sector at that stage of production’.
91      Admittedly, as the Commission argues, the President of the Parliament requested EFSA, under the second subparagraph of Article 29(1) of Regulation No 178/2002, by letter of 14 May 2024, to issue a scientific opinion on the impact of the stiffening and thawing procedures on the survival and development of biological hazards, to which the Executive Director of EFSA replied by letter of 12 June 2024, in which he stated that he was ‘not able to identify any open
issue relating to food safety or risks to human
health in
the storage conditions described in the request’.
92      However, it must be noted that such an exchange is subsequent to the adoption of Delegated Regulation 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.
93      Therefore, in light of all the foregoing considerations, the fourth plea must be upheld and the contested provision annulled, without there being any need to examine the other arguments and pleas put forward by the applicant.
Costs
94      Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the Commission has been unsuccessful, it must be ordered to bear its own costs and to pay those incurred by the applicant, in accordance with the form of order sought by the latter.
95      Under Article 138(1) of the Rules of Procedure, the Member States and institutions which have intervened in the proceedings are to bear their own costs. It follows that the French Republic must bear its own costs.
On those grounds,
THE GENERAL COURT (Sixth Chamber)
hereby:
1.      Annuls point 3(e) of the Annex to 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;
2.      Orders the European Commission to bear its own costs and to pay those incurred by Mowi Poland S.A.;
3.      Orders the French Republic to bear its own costs.
Costeira
Öberg
Zilgalvis
Delivered in open court in Luxembourg on 24 September 2025.
[Signatures]
*      Language of the case: Polish.