JUDGMENT OF THE GENERAL COURT (Fourth Chamber)

11 November 2026 (*)

( Public health – Foods – Regulation (EC) No 2065/2003 – Smoke flavourings – Non-renewal of authorisations of certain products as smoke flavouring primary products – EFSA’s evaluation procedure – Principle of non-discrimination – Plea of illegality – Manifest error of assessment – Error of law – Right to be heard – Obligation to state reasons )

In Case T‑523/24,

Kerry Inc., established in Beloit, Wisconsin (United States),

Kerry Ingredients (UK) Ltd, established in Bristol (United Kingdom),

represented by E. Righini, M. Meulenbelt and A. Robert, lawyers,

applicants,

European Commission, represented by I. Galindo Martín, B. Rous Demiri and A. Dawes, acting as Agents,

defendant,

supported by

European Parliament, represented by W. Kuzmienko and C. Burgos, acting as Agents,

and by

Council of the European Union, represented by A. Jaume and B. Contzen, acting as Agents,

interveners,

THE GENERAL COURT (Fourth Chamber),

composed of G. De Baere (Rapporteur), President, J. Svenningsen and C. Mac Eochaidh, Judges,

Registrar: A. Audras-Hidelot, Administrator,

having regard to the written part of the procedure,

further to the hearing on 18 March 2026,

gives the following

Judgment

1 By their action under Article 263 TFEU, the applicants, Kerry Inc. and Kerry Ingredients (UK) Ltd, seek, on the one hand, the annulment of (i) Commission Implementing Decision (EU) 2024/2066 of 31 July 2024 refusing the renewal of the authorisation of Zesti Smoke Code 10 (SF‑002) as a smoke flavouring primary product (OJ L, 2024/2066), (ii) Commission Implementing Decision (EU) 2024/2078 of 31 July 2024 refusing the renewal of the authorisation of SmokEz Enviro-23 (SF‑006) as a smoke flavouring primary product (OJ L, 2024/2078) and (iii) Commission Implementing Decision (EU) 2024/2079 of 31 July 2024 refusing the renewal of the authorisation of SmokEz C‑10 (SF‑005) as a smoke flavouring primary product (OJ L, 2024/2079); and, on the other hand, the partial annulment of Commission Implementing Regulation (EU) 2024/2067 of 31 July 2024 amending Implementing Regulation (EU) No 1321/2013 as regards the deletion of entries SF‑001 to SF‑010 from the Union list of authorised smoke flavouring primary products (OJ L, 2024/2067), in so far as it concerns the applicants (together, ‘the contested acts’).

Legal context

2 Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods (OJ 2003 L 309, p. 1) establishes a procedure for the authorisation of smoke flavourings at EU level.

3 Article 1(1) of Regulation No 2065/2003 provides that ‘the purpose of this Regulation is to ensure the effective functioning of the internal market in relation to smoke flavourings used or intended for use in or on foods, whilst providing the basis for securing a high level of protection for human health and the interests of consumers’.

4 To that end, according to Article 1(2) of Regulation No 2065/2003, the latter lays down procedures at EU level, first, for the evaluation and authorisation of smoke flavouring primary products (‘SFPPs’) for use as such in or on foods or in the production of derived smoke flavourings for use in or on foods, and, second, for the establishment of a list of SFPPs authorised in the European Union and their conditions of use in or on foods.

5 According to Article 2 of Regulation No 2065/2003, the latter applies to smoke flavourings used or intended for use in or on foods, to source materials for the production of smoke flavourings, to the conditions under which smoke flavourings are prepared, and to foods in or on which smoke flavourings are present.

6 The second paragraph of Article 3 of Regulation No 2065/2003 contains the following definitions:

‘1. “primary smoke condensate” shall refer to the purified water-based part of condensed smoke and shall fall within the definition of “smoke flavourings”;

2. “primary tar fraction” shall refer to the purified fraction of the water-insoluble high-density tar phase of condensed smoke and shall fall within the definition of “smoke flavourings”;

3. “primary products” shall refer to primary smoke condensates and primary tar fractions;

4. “derived smoke flavourings” shall refer to flavourings produced as a result of the further processing of primary products and which are used or intended to be used in or on foods in order to impart smoke flavour to those foods.’

7 Article 4 of Regulation No 2065/2003 provides:

‘1. The use of smoke flavourings in or on foods shall only be authorised if it is sufficiently demonstrated that

– it does not present risks to human health,

– it does not mislead consumers.

Each authorisation may be subject to specific conditions of use.

2. No person shall place on the market a smoke flavouring or any food in or on which such a smoke flavouring is present if the smoke flavouring is not a primary product authorised in accordance with Article 6, or if is not derived therefrom, and if the conditions of use laid down in the authorisation in accordance with this Regulation are not adhered to.’

8 Article 6(1) of Regulation No 2065/2003 provides that a list of the primary products authorised to the exclusion of all others in the European Union for use as such in or on foods or for the production of derived smoke flavourings is to be established in accordance with the procedure referred to in Article 19(2) of that regulation.

9 Articles 7 to 9 of Regulation No 2065/2003 describe the authorisation procedure prior to the placing on the market of smoke flavourings. Pursuant to Article 12(3) of that regulation, Articles 7 to 9 are applicable to the procedure for the renewal of authorisations.

10 Pursuant to Article 8 of Regulation No 2065/2003, within six months of receipt of an application for renewal of an authorisation, the European Food Safety Authority (EFSA) is to give an opinion on whether the SFPP and its intended use comply with Article 4(1) of that regulation.

11 Article 9(1) of Regulation No 2065/2003 provides that, within three months of receiving the opinion of EFSA, the European Commission is to prepare a draft of the measure to be taken in respect of the application for inclusion of a product in the list referred to in Article 6(1), taking into account the requirements of Article 4(1) of that regulation, EU law and other legitimate factors relevant to the matter under consideration. Where the draft measure is not in accordance with the opinion of EFSA, the Commission is to provide an explanation for the reasons for those differences.

12 According to Article 12(1) of Regulation No 2065/2003, authorisations are to be renewable for 10-year periods on application to the Commission by the authorisation holder, at the latest 18 months before the expiry date of the authorisation. Article 12(2) of Regulation No 2065/2003 provides that the application for renewal is to be accompanied by a reference to the original authorisation, by any available information necessary for the scientific evaluation of primary products listed in Annex II to that regulation, supplementing the information already provided to EFSA and updated in the light of the most recent scientific and technical developments, and by a reasoned statement affirming that the product complies with the first indent of Article 4(1) of that regulation.

Background to the dispute

13 Kerry is an undertaking in the agri-food sector which sells smoke flavourings and products containing smoke flavourings, such as seasonings.

14 Kerry holds the rights over three smoke flavouring primary products, namely Zesti Smoke Code 10 (SF‑002), SmokEz C‑10 (SF‑005) and SmokEz Enviro-23 (SF‑006) (together, ‘the products at issue’).

15 By Commission Implementing Regulation (EU) No 1321/2013 of 10 December 2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings (OJ 2013 L 333, p. 54), the products at issue were included in the list of SFPPs authorised in the European Union. Those authorisations were valid for ten years from 1 January 2014.

16 On 30 June 2022, Kerry applied for the renewal of the authorisations of the products at issue in accordance with Article 12 of Regulation No 2065/2003. Kerry attached technical dossiers to its applications and, on 10 and 27 February 2023, provided additional data at EFSA’s request.

17 On 28 September 2023, EFSA adopted the ‘Scientific opinion on the renewal of the authorisation of Zesti Smoke Code 10 (SF‑002) as a [SFPP]’, the ‘Scientific opinion on the renewal of the authorisation of SmokEz C‑10 (SF‑005) as a [SFPP]’ and the ‘Scientific opinion on the renewal of the authorisation of SmokEz Enviro-23 (SF‑006) as a [SFPP]’ (together, ‘EFSA’s opinions’). Those opinions were published on 16 November 2023.

18 In its opinions, EFSA concluded that it had identified a potential concern for genotoxicity for four components of SF‑002 and of SF‑006 and for five components of SF‑005 and for the unidentified fraction of the mixture. EFSA stated that, more importantly, the products at issue contained furan-2(5H)-one and benzene-1,2-diol, two substances known to be genotoxic in vivo when administered orally. Taking the view that the exposure estimates for those two components were above the threshold of toxicological concern (‘the TTC’) of 0.0025 micrograms per kilogram (μg/kg) of body weight (bw) per day for deoxyribonucleic acid (DNA)-reactive mutagens or carcinogens (‘the reference TTC’), EFSA concluded that the products at issue raised concerns for genotoxicity.

19 By letters of 16 November 2023, the Commission informed Kerry of its intention to reject the applications for renewal of the authorisations of the products at issue. Kerry, by way of letters, submitted observations to the Commission and attended meetings with the Commission’s services.

20 On 31 July 2024, the Commission adopted the contested acts.

21 In recital 6 of Implementing Decisions 2024/2066, 2024/2078 and 2024/2079, the Commission stated that EFSA, in its opinions, had noted that the products at issue contained the substances furan-2(5H)-one and benzene-1,2-diol and had concluded that the genotoxicity risk of those substances had been identified in vivo upon oral administration. In accordance with its statement on the genotoxicity assessment of chemical mixtures published on 17 January 2019 and given that the exposure estimates for those two components were above the reference TTC, EFSA concluded that the products at issue raised concerns for genotoxicity. The Commission added that EFSA had also concluded that four components of SF‑002 and of SF‑006 and five components of SF‑005 and the unidentified part of the products at issue raised a potential concern for genotoxicity.

22 In recital 7 of Implementing Decisions 2024/2066, 2024/2078 and 2024/2079, the Commission stated that, pursuant to Article 4 of Regulation No 2065/2003, only smoke flavourings that do not present risks to human health may be authorised and placed on the market.

23 Consequently, by Article 1 of Implementing Decisions 2024/2066, 2024/2078 and 2024/2079, the Commission refused the renewal of the authorisations of the products at issue as SFPPs.

24 By Article 2 of Implementing Decisions 2024/2066, 2024/2078 and 2024/2079, the Commission decided that the products at issue could continue to be placed on the market until 1 July 2029.

25 Article 3 of Implementing Decisions 2024/2066, 2024/2078 and 2024/2079 states that Kerry is the addressee of each decision.

26 In Implementing Regulation 2024/2067, the Commission noted that, of the ten SFPPs, namely SF‑001 to SF‑010, no application had been submitted for the renewal of authorisation of two of them and that authorisation had expired on 1 January 2024, and that, by implementing decisions, it had refused the renewal of the authorisation of the other eight SFPPs.

27 Consequently, Article 1 of Implementing Regulation 2024/2067 provides that the entries relating to those ten products are deleted from the EU list set out in the Annex to Implementing Regulation No 1321/2013.

28 Article 2 of Implementing Regulation 2024/2067 provides:

‘1. Foods containing [the eight SFPPs for which the renewal of authorisation was refused] that comply with the provisions laid down for those [SFPPs] in the Union list before 21 August 2024 may continue to be placed on the market and remain on the market until their date of minimum durability or use by date if they are placed on the market until the following dates:

(a) 1 July 2029 for food categories 1.7. (Cheese and cheese products), 8. (Meat), 9.2. (Processed fish and fishery products including crustaceans and molluscs), 9.3. (Fish roe) and their corresponding sub-categories;

(b) 1 July 2026 for all other food categories.

2. Preparations containing [the eight SFPPs for which the renewal of authorisation was refused] and not intended to be consumed as such may be placed on the market until 1 July 2029 for use in the food categories listed in paragraph 1, point (a), and until 1 July 2026 for all other food categories.

…’

Forms of order sought

29 The applicants claim that the Court should:

– annul Implementing Decisions 2024/2066, 2024/2078 and 2024/2079;

– annul in part Implementing Regulation 2024/2067, in so far as it concerns the products at issue;

– order the Commission to pay the costs.

30 The Commission, supported by the European Parliament and the Council of the European Union, contends that the Court should:

– dismiss the action;

– order the applicants to pay the costs.

Law

31 The applicants put forward seven pleas in law in support of their action. The first plea alleges that the Commission and EFSA erred in law by failing to examine whether the products at issue presented risks to human health. The second plea alleges that the Commission and EFSA made manifest errors of assessment in their assessment of the risks presented by the products at issue. The third plea alleges that the Commission infringed Article 9(1) of Regulation No 2065/2003 by failing to carry out a full risk-management assessment. The fourth plea alleges that the Commission acted in breach of the principle of proportionality. The fifth plea alleges, first, a plea of illegality in respect of Regulation No 2065/2003, on the basis of Article 277 TFEU, in so far as that regulation is in breach of the principle of non-discrimination and, second, that the contested acts are in breach of that principle. The sixth plea alleges that the Commission and EFSA infringed the applicants’ right to be heard. The seventh plea alleges that the Commission infringed the obligation to state reasons and the right to good administration.

32 The Court considers it appropriate to examine, first of all, the fifth plea in so far as the applicants raise a plea of illegality in respect of Regulation No 2065/2003, then the second and third pleas and, lastly, the first, fourth, sixth and seventh pleas.

The fifth plea in law, alleging breach of the principle of non-discrimination

33 The applicants, first, raise a plea of illegality in respect of Regulation No 2065/2003 in so far as it is in breach of the principle of non-discrimination and, second, claim, in the alternative, that the contested acts are in breach of that principle.

The first part, alleging that Regulation No 2065/2003 is unlawful in so far as it is in breach of the principle of non-discrimination

34 The applicants, on the basis of Article 277 TFEU, raise a plea of illegality in respect of Regulation No 2065/2003. They submit that that regulation must be declared inapplicable in that it is in breach of the principle of non-discrimination enshrined in Article 21(1) of the Charter of Fundamental Rights of the European Union (‘the Charter’).

35 The applicants claim that Regulation No 2065/2003 results in an unjustified difference in treatment between comparable products, in that it makes SFPPs subject to a requirement of prior marketing authorisation, whereas traditionally smoked products are subject only to maximum contaminant levels. They submit that traditionally smoked products should be subject to rules similar to those applicable to SFPPs. In that regard, they consider that the traditional smoking process poses increased risks to health and, in accordance with Article 168 TFEU, should have been the subject of legislation similar to that of SFPPs, providing for a prior marketing authorisation procedure, and that Article 114 TFEU could constitute the legal basis for such legislation.

36 At the hearing, in response to a question put by the Court, the applicants stated that they did not claim that Regulation No 2065/2003 was in breach of the principle of non-discrimination in so far as its scope was limited to SFPPs whereas it should also apply to traditionally smoked products. In their view, the alleged discrimination results from the fact that traditionally smoked products are not subject to a prior authorisation procedure equivalent to that applicable to SFPPs.

37 As a preliminary point, it should be recalled that, under Article 277 TFEU, any party may, in proceedings in which an act of general application adopted by an institution, body, office or agency of the European Union is at issue, plead the grounds specified in the second paragraph of Article 263 TFEU in order to invoke before the Court of Justice of the European Union the inapplicability of that act.

38 According to settled case-law, Article 277 TFEU gives expression to a general principle conferring upon any party to proceedings the right to challenge, for the purpose of obtaining the annulment of an EU act on the basis of Article 263 TFEU, the validity of previous acts of the institutions which form the legal basis of the act which is being challenged, if that party was not entitled under Article 263 TFEU to bring a direct action challenging those acts by which it was thus affected without having been in a position to ask that they be declared void (see judgment of 16 March 2023, Commission v Jiangsu Seraphim Solar System and Council v Jiangsu Seraphim Solar System and Commission, C‑439/20 P and C‑441/20 P, EU:C:2023:211, paragraph 78 and the case-law cited).

39 The principle of equal treatment, enshrined in Article 20 of the Charter, is a general principle of EU law; the principle of non-discrimination laid down in Article 21(1) of the Charter is a special manifestation of that principle of equal treatment.

40 According to settled case-law of the Court of Justice, that principle requires that comparable situations must not be treated differently and that different situations must not be treated in the same way unless such treatment is objectively justified (see judgment of 26 February 2026, Cargolux Airlines v Commission, C‑401/22 P, EU:C:2026:132, paragraph 232 and the case-law cited).

41 The requirement that situations must be comparable, for the purpose of determining whether there is a breach of the principle of equal treatment, must be assessed in the light of all the elements that characterise them and, in particular, in the light of the subject matter and purpose of the act that makes the distinction in question, while the principles and objectives of the field to which the act relates must also be taken into account. In so far as the situations are not comparable, a difference in treatment of the situations concerned does not infringe equality before the law as enshrined in Article 20 of the Charter (see judgments of 6 June 2023, O.G. (European arrest warrant issued against a third-country national), C‑700/21, EU:C:2023:444, paragraph 43 and the case-law cited, and of 25 June 2025, RWE Supply & Trading v ACER, T‑95/23, EU:T:2025:632, paragraph 54 and the case-law cited).

42 In the present case, it must be noted, as the Commission has submitted, that the applicants criticise, in essence, the EU legislation on food products in general and not Regulation No 2065/2003 in particular.

43 It should also be noted that SFPPs and traditionally smoked products are subject to different regulatory frameworks. As the Commission states, the scope of Regulation No 2065/2003 is limited to SFPPs and does not exclude the existence of rules covering traditionally smoked products.

44 First, SFPPs are a specific category of flavourings covered by the general rules deriving from Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ 2008 L 354, p. 34).

45 The purpose of Regulation No 2065/2003 is to establish a procedure for the evaluation and authorisation, at EU level, of SFPPs used in or on foods. Recital 4 of Regulation No 2065/2003 states that, in order to protect human health, smoke flavourings should undergo a safety assessment through a procedure at EU level before being placed on the market or used in or on foods within the European Union. Regulation No 2065/2003 provides for the establishment of a list of SFPPs the use of which is authorised to the exclusion of all others.

46 Second, traditionally smoked products fall within the scope of EU legislation on contaminants in food resulting from Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (OJ 1993 L 37, p. 1).

47 On the basis of Regulation No 315/93, the Commission adopted Regulation (EU) 2023/915 of 25 April 2023 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006 (OJ 2023 L 119, p. 103). Article 2(1) of Regulation 2023/915 provides that ‘the food listed in Annex I shall not be placed on the market and shall not be used as a raw material in food or as an ingredient in food where it contains a contaminant at a level which exceeds the maximum level set out in Annex I’. As regards contaminants linked to processing, Annex I to that regulation lays down maximum levels of polycyclic aromatic hydrocarbons (PAHs) for smoked food products. Article 7(3) and (4) of Regulation 2023/915 contains derogations from Article 2, allowing certain Member States to authorise, under certain conditions, the placing on their respective market for the final consumer of certain traditionally smoked meat and meat products and certain traditionally smoked fish and fishery products, smoked in their territory, with PAH levels higher than those set out in Annex I.

48 Thus, because of their difference in category, SFPPs and traditionally smoked products are covered by two separate sector-specific sets of legislation, with SFPPs falling under the legislation on flavourings and traditionally smoked products falling under the legislation on foods containing contaminants. It follows that the difference in legislation applicable to SFPPs and to traditionally smoked products does not follow from the adoption of Regulation No 2065/2003.

49 In addition, it must be noted that the applicants’ line of argument amounts, in essence, to taking the view that it is not possible to regulate the placing on the market of SFPPs for such time as traditionally smoked products are not also subject to a prior authorisation procedure, which cannot be accepted.

50 Therefore, since it is not Regulation No 2065/2003 that establishes the distinction between SFPPs and traditionally smoked products, the applicants cannot validly claim that it is in breach of the principle of non-discrimination.

51 In any event, it must be held, as the Commission, the Parliament and the Council have submitted, that SFPPs and traditionally smoked products are not comparable products and that, therefore, different treatment, on the basis of different rules, cannot constitute a breach of the principle of equal treatment, in accordance with the case-law cited in paragraph 41 above.

52 First, SFPPs are flavourings, namely industrially manufactured products which are intentionally added to food. By contrast, the traditional smoking process concerns the processing of food, which has the unintended effect of causing there to be contaminants in that food.

53 In that regard, on the one hand, it must be noted that, contrary to what the applicants submit, the Commission, the Parliament and the Council have not claimed that additional chemical components were added to the SFPPs during their manufacture. They have merely stated that the SFPPs were chemical industry products which were added to food.

54 On the other hand, as the Parliament states, the intentional addition of SFPPs to food by industry justifies the scientific assessment of those SFPPs in order to ensure a high level of protection of human health, even if their production process poses, a priori, less health problems than the traditional method of processing foods the flavour of which they are supposed to reproduce.

55 Second, the addition of SFPPs to food and the traditional smoking process have different purposes. On the one hand, the primary objective of the traditional smoking process is to preserve food, in particular fish and meat. On the other hand, SFPPs fall within the category of flavourings and have the main objective of making food taste or smell of smoke.

56 Similarly, the uses of SFPPs and the uses of a traditional smoking process are not the same. Thus, as stated in recital 6 of Regulation No 2065/2003, ‘the possibility of wider applications of smoke flavourings in comparison to conventional smoking has to be taken into account in safety assessments’. SFPPs are added to a whole range of foods for which a traditional smoking process is not used, for example sauces, soups, confectionery or snacks, such as crisps.

57 Third, by analogy with the EU legislation on tobacco products and referring to the judgments of 14 December 2004, Swedish Match (C‑210/03, EU:C:2004:802, paragraph 71), and of 30 January 2019, Planta Tabak (C‑220/17, EU:C:2019:76), the Parliament and the Council rightly point out that, even though some products are not fundamentally different in their composition or intended use, they are not in a comparable situation because some are new to the market and the others are the result of a long tradition.

58 In that regard, SFPPs are industrial products aimed at reproducing the taste of smoke in food which, even though the applicants submit they have been used since the end of the 19th century, cannot be regarded as deriving from a traditional method of processing foods, unlike the process whereby food is smoked.

59 It follows from all of the foregoing that the first part must be rejected.

The second part, alleging that the contested acts are in breach of the principle of non-discrimination

60 In the alternative, the applicants submit that, even if Regulation No 2065/2003 constitutes a valid legal basis, the contested acts are in breach of the principle of non-discrimination in that they refuse the renewal of the authorisations of the products at issue, whereas traditionally smoked products may continue to be sold, even though they do not have a marketing authorisation. Those products of a comparable nature are, the applicants argue, treated differently under the contested acts.

61 It must be noted that the applicants do not claim that the Commission applied in a discriminatory manner the conditions, as regards the adoption of the marketing authorisations for SFPPs, that are laid down in Regulation No 2065/2003.

62 The applicants have not put forward any argument to establish that their applications for renewal of the authorisations of the products at issue were treated differently by the Commission in the light of comparable situations, namely other applications for authorisation or for renewal of authorisation of SFPPs.

63 Accordingly, the applicants have not established that the Commission, by adopting the contested acts, acted in breach of the principle of non-discrimination.

64 Moreover, the applicants’ line of argument amounts to considering that the Commission could not refuse to renew the authorisations of the products at issue without acting in breach of the principle of non-discrimination in so far as traditionally smoked products are not subject to authorisation. As the Commission submits, that line of argument would have the effect of rendering meaningless the conditions for authorisation that are laid down in Regulation No 2065/2003.

65 It follows that the second part must be rejected, as must, therefore, the first plea in its entirety.

The second plea in law, alleging that the Commission and EFSA made manifest errors of assessment in their assessment of the risks presented by the products at issue

66 The applicants submit that EFSA’s opinions are vitiated by manifest errors of assessment and that, therefore, the contested acts, which reproduce the conclusions in those opinions, are also vitiated by manifest errors of assessment. The applicants claim, by the first part, that the methodology used by EFSA to assess the genotoxicity of the products at issue contradicts its own guidance and, by the second part, that that assessment is contrary to the principle of scientific excellence.

67 At the hearing, the applicants withdrew the third part, which had alleged that the EFSA guidance was incompatible with the legal requirements applicable to the scientific risk assessment, formal note of which was taken in the minutes of the hearing.

Preliminary observations

68 The procedure established by Regulation No 2065/2003 is characterised by the essential role assigned to a scientific assessment by EFSA as to whether the SFPP, the authorisation or renewal of which is sought, and its intended use, do not present any risk to human health. Since the Commission is not in a position to carry out scientific assessments regarding the identification of the potential harmful effects of SFPPs on health, the aim of the mandatory consultation of EFSA is to provide the Commission with the evidence of scientific assessment which is essential for it to be able to determine, in full knowledge of the facts, the appropriate measures to ensure a high level of public health protection (see, by analogy, judgments of 13 November 2024, Aloe Vera of Europe v Commission, T‑189/21, under appeal, EU:T:2024:802, paragraph 49, and of 13 November 2024, Aboca and Others v Commission, T‑302/21, under appeal, EU:T:2024:808, paragraph 73).

69 However, the Commission is not bound by EFSA’s opinions when it adopts a decision on an application for renewal of the authorisation of an SFPP. Although it is true that the Commission adopts its decision on whether or not to include a SFPP in the EU list of authorised primary products after obtaining the opinion of EFSA, it must be stated that there is nothing in Regulation No 2065/2003 to suggest that the Commission is obliged to comply with EFSA’s opinions in substantive terms and therefore has no discretion (see, by analogy, judgments of 9 September 2011, Dow AgroSciences and Others v Commission, T‑475/07, EU:T:2011:445, paragraph 87 and the case-law cited, and of 15 December 2016, TestBioTech and Others v Commission, T‑177/13, not published, EU:T:2016:736, paragraph 103). In that regard, Article 9(1) of Regulation No 2065/2003 expressly provides that it is possible that the decision on the application for renewal that is adopted by the Commission may not be in accordance with EFSA’s opinion.

70 In order to be able to pursue effectively the objectives assigned to it by Regulation No 2065/2003, and in view of the complex technical assessments which it must carry out, the Commission must be granted a broad discretion. That applies, in particular, to the risk management decisions which the Commission has to take pursuant to that regulation (see, by analogy, judgments of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 143, and of 9 February 2022, Taminco and Arysta LifeScience Great Britain v Commission, T‑740/18, EU:T:2022:61, paragraph 52).

– The scope of the Court’s review

71 According to settled case-law, where the EU authorities have a broad discretion, in particular as regards highly complex scientific and technical facts in order to determine the nature and scope of the measures which they adopt in that context, review by the EU judicature is limited to verifying whether there has been a manifest error of assessment or a misuse of powers, or whether those authorities have manifestly exceeded the limits of their discretion. In such a context, the EU judicature cannot substitute its assessment of scientific and technical facts for that of those institutions on which alone the FEU Treaty has placed that task (see judgments of 9 March 2023, PlasticsEurope v ECHA, C‑119/21 P, EU:C:2023:180, paragraph 46 and the case-law cited; of 1 August 2025, France and Commission v CWS Powder Coatings and Others, C‑71/23 P and C‑82/23 P, EU:C:2025:601, paragraph 106 and the case-law cited, and of 24 September 2025, Sanofi v Commission, T‑483/22, EU:T:2025:912, paragraph 76 and the case-law cited).

72 The broad discretion of the EU authorities, which implies limited judicial review of its exercise, applies not only to the nature and scope of the measures to be taken but also, to some extent, to the finding of the basic facts. However, even though such judicial review is of limited scope, it requires that the EU authorities which have adopted the act in question must be able to show before the EU judicature that in adopting the act they actually exercised their discretion, which presupposes the taking into consideration of all the relevant factors and circumstances of the situation the act was intended to regulate (see judgments of 9 March 2023, PlasticsEurope v ECHA, C‑119/21 P, EU:C:2023:180, paragraph 47 and the case-law cited; of 1 August 2025, France and Commission v CWS Powder Coatings and Others, C‑71/23 P and C‑82/23 P, EU:C:2025:601, paragraph 107 and the case-law cited, and of 24 September 2025, Sanofi v Commission, T‑483/22, EU:T:2025:912, paragraph 77 and the case-law cited).

73 In order to establish that an institution made a manifest error in assessing complex facts such as to justify the annulment of an act, the evidence adduced by the applicant must be sufficient to make the factual assessments used in the act implausible. Subject to that review of plausibility, it is not the Court’s role to substitute its assessment of complex facts for that made by the institution which adopted the decision. Consequently, a plea alleging the existence of a manifest error must be rejected if, despite the evidence adduced by the applicant, the contested assessment may still be accepted as true or valid (see judgments of 18 October 2023, TestBioTech v Commission, T‑605/21, not published, EU:T:2023:648, paragraph 20 and the case-law cited, and of 29 October 2025, ClientEarth and Collectif Nourrir v Commission, T‑399/23, not published, EU:T:2025:1002, paragraph 19 and the case-law cited).

74 The limits on the review by the EU judicature do not, however, affect its duty to establish whether the evidence relied on is factually accurate, reliable and consistent, whether that evidence contains all the information which must be taken into account in order to assess a complex situation, and whether it is capable of substantiating the conclusions drawn from it (see judgments of 9 September 2011, Dow AgroSciences and Others v Commission, T‑475/07, EU:T:2011:445, paragraph 153 and the case-law cited, and of 9 July 2025, LAT Nitrogen Piesteritz and Cornerstone v ECHA (Melamine), T‑167/23, EU:T:2025:689, paragraph 140 (not published) and the case-law cited).

75 Furthermore, the review by the EU judicature of the assessment of the facts made by the Commission, the author of the contested measure, is also carried out indirectly on the assessment made by EFSA where, as in the present case, the Commission relies on EFSA’s assessment for the purposes of determining the existence of a risk (see, by analogy, judgment of 4 October 2023, Ascenza Agro and Industrias Afrasa v Commission, T‑77/20, EU:T:2023:602, paragraph 415).

76 Since the Commission relied, in the present case, on the risk assessment carried out by EFSA, the Court’s review of that assessment must also be limited to manifest errors of assessment (see, by analogy, judgment of 4 October 2023, Ascenza Agro and Industrias Afrasa v Commission, T‑77/20, EU:T:2023:602, paragraph 438).

77 Furthermore, the applicants rely, on several occasions, on the judgment of 18 October 2023, TestBioTech v Commission (T‑606/21, not published, EU:T:2023:649, paragraph 58), in order to argue that, for it to be demonstrated that there is a manifest error of assessment, it is sufficient that information ‘seriously casts doubt on EFSA’s opinions’.

78 However, it must be noted, as the Commission has submitted, that that assessment in the judgment of 18 October 2023, TestBioTech v Commission (T‑606/21, not published, EU:T:2023:649), concerned the evidence that had to be adduced before the Commission in support of a request for internal review of a decision authorising the placing of a product on the market and is therefore irrelevant to the present case.

79 Nevertheless, in accordance with the case-law cited in paragraph 73 above, the evidence adduced by the applicant before the General Court seeking to establish that the Commission made a manifest error in assessing complex facts such as to justify the annulment of the contested acts must be sufficient to make the assessment carried out by EFSA in its opinions implausible and not merely raise serious doubts about that assessment.

– The burden of proof

80 As is apparent from Article 4(1) of Regulation No 2065/2003, the two fundamental safety rules set out in that provision must be observed before smoke flavourings can be the subject of an authorisation valid throughout the European Union. Their use in or on foods can be authorised only if it has been demonstrated that there are no risks to human health. In addition, authorisation is granted only if the use of those substances does not mislead consumers (judgment of 6 December 2005, United Kingdom v Parliament and Council, C‑66/04, EU:C:2005:743, paragraph 55).

81 Pursuant to Article 7(3) of Regulation No 2065/2003, an application for authorisation or for the renewal of authorisation of an SFPP is to contain, inter alia, the information necessary for the scientific evaluation of the primary products – that information being set out in Annex II to that regulation – and a reasoned statement affirming that the product complies with the first indent of Article 4(1) of that regulation.

82 Thus, it follows from the wording and the scheme of the relevant provisions of Regulation No 2065/2003 that it is for the applicant to prove that the product for which an authorisation is sought does not present risks to human health.

83 In that regard, it is apparent from the scientific guidance for the preparation of applications on SFPPs, adopted by the EFSA Panel on Food Additives and Flavourings on 26 January 2021 and published on 2 March 2021 (‘the 2021 Guidance’), that the main purpose of applications for authorisation of new SFPPs and for the renewal and amendment of existing authorisations is to demonstrate that, in the light of current knowledge, the SFPPs do not present risks to human health or the environment, under the conditions of use, in accordance with Article 4 of Regulation No 2065/2003 and Article 1 of Regulation No 1334/2008.

84 Furthermore, in accordance with the principle that it is for the party relying on a legal provision to prove that the conditions for its application are met, it follows from those formulations that it is the applicant who must prove that the conditions for approval are met, in order to obtain approval, and not the Commission which must prove that the conditions for approval are not met in order to be able to refuse it (see, by analogy, judgments of 28 May 2020, Agrochem-Maks v Commission, T‑574/18, EU:T:2020:226, paragraph 67 and the case-law cited, and of 9 February 2022, Taminco and Arysta LifeScience Great Britain v Commission, T‑740/18, EU:T:2022:61, paragraph 57 and the case-law cited).

85 It must be noted that, on several occasions, the applicants reverse the burden of proof by arguing that a refusal to authorise or renew the authorisation of an SFPP presupposes that EFSA and the Commission have sufficiently demonstrated that that product presents risks to human health.

The first part, alleging that the methodology followed by EFSA contradicts its own guidance

86 The applicants claim that EFSA, in its opinions, made manifest errors of assessment in that its assessment of the genotoxicity of the products at issue does not comply with the methodologies established in the 2021 Guidance and in the cross-sectional guidance documents to which the 2021 Guidance refers. They submit, in essence, that EFSA misapplied the 2021 Guidance and the cross-sectional guidance documents by adopting an approach structured around the components of the mixture and ignoring the data relating to the whole mixture.

87 The first part is divided, in essence, into three complaints. By the first two complaints, the applicants state that EFSA failed to take into account the data relating to the whole mixtures (i) by following a component-based approach that did not comply with its guidance, and (ii) by confining itself to following the ‘TTC’ approach (‘the TTC approach’) in order to assess the genotoxicity of the products at issue. By the third complaint, they submit that EFSA carried out an incomplete risk assessment.

– The scope of the 2021 Guidance and of the EFSA cross-sectional guidance documents

88 As regards the methodology followed in EFSA’s opinions, EFSA stated that the safety assessment of the products at issue had been carried out by its Panel on Food Additives and Flavourings in accordance with the requirements laid down in Regulation No 2065/2003 and in accordance with the principles contained in the 2021 Guidance.

89 The 2021 Guidance was drawn up by EFSA, at the request of the Commission, to assist applicants in preparing applications for authorisations of SFPPs, and describes the scientific data to be included, inter alia, in applications for renewal of authorisation of SFPPs that are submitted under Article 12 of Regulation No 2065/2003.

90 The 2021 Guidance constitutes an update and compilation of various documents taking into account the following cross-sectional guidance documents of the EFSA Scientific Committee:

– the 2011 scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment (‘the opinion on testing strategy’);

– the 2017 opinion on the clarification of some aspects related to genotoxicity assessment (‘the opinion on genotoxicity clarification’);

– the 2019 statement on the genotoxicity assessment of chemical mixtures (‘the statement on mixtures’);

– the 2019 harmonised methodologies for human and animal health and ecological risk assessment of combined exposure to multiple chemicals (‘the guidance on combined exposure’);

– the 2019 guidance on the use of the [TTC approach] in food safety assessment (‘the TTC Guidance’).

91 In addition, it should be noted that Regulation No 2065/2003 does not require EFSA to apply precise assessment rules when issuing its opinion on whether a SFPP and its intended use comply with Article 4(1) of that regulation. Thus, EFSA has a broad discretion in the choice of assessment rules which it applies.

92 According to the case-law, the guidelines form rules of practice from which the administration may not depart in an individual case without giving reasons that are compatible with the principle of equal treatment. In adopting such rules of conduct and announcing by publishing them that they will henceforth apply to the cases to which they relate, the institution in question imposes a limit on the exercise of its discretion (see, to that effect, judgment of 28 June 2005, Dansk Rørindustri and Others v Commission, C‑189/02 P, C‑202/02 P, C‑205/02 P to C‑208/02 P and C‑213/02 P, EU:C:2005:408, paragraphs 209 to 211). That case-law is intended to apply only to the author of those rules of conduct (judgment of 4 October 2023, Ascenza Agro and Industrias Afrasa v Commission, T‑77/20, EU:T:2023:602, paragraph 478).

93 In addition, the guidance documents are in the form of non-binding scientific opinions from one of EFSA’s scientific groups or scientific committee. Those documents are thus in no way binding on the Commission in its decision as to whether to grant or refuse an authorisation or renewal of authorisation of a SFPP under Regulation No 2065/2003 (see, by analogy, judgment of 15 December 2016, TestBioTech and Others v Commission, T‑177/13, not published, EU:T:2016:736, paragraph 114).

94 In the present case, the Commission based the statement of reasons for Implementing Decisions 2024/2066, 2024/2078 and 2024/2079 on EFSA’s findings that the products at issue raised concerns for genotoxicity. Therefore, any manifest misapplication by EFSA of the guidance that it adopted for the purposes of assessing the genotoxicity of the SFPPs would have an impact on the legality of the grounds for the contested acts.

– The first complaint, relating to EFSA’s application of a component-based approach

95 The applicants complain that EFSA did not follow its own guidance given that it relied on a component-based approach, rather than an approach based on the whole mixture, in order to assess the genotoxicity of the products at issue.

96 As regards the methodology applicable to the assessment of the genotoxicity of the SFPPs, the parties agree that the 2021 Guidance introduced a new component-based approach for the identified part of the mixture. That guidance provides for two approaches, namely a component-based approach for the chemically identified components of the mixture and a whole mixture approach for the unidentified fraction of the mixture.

97 It must be noted that the applicants wrongly refer to the Guidance on submission of a dossier on a SFPP for evaluation by EFSA, published on 27 April 2005, which indicates that the assessment of the genotoxicity of SFPPs should be carried out by applying the whole mixture approach. It is sufficient to note that that guidance is irrelevant since it was replaced by the 2021 Guidance.

98 In section 1.2.4.3 of the 2021 Guidance, concerning the identification and quantification of the various components, it is stated, inter alia, that since the previous assessments of the currently authorised SFPPs listed in Implementing Regulation No 1321/2013, there has been considerable analytical progress, allowing improved qualitative and quantitative analyses of both volatile and non-volatile target compounds. That offers applicants the opportunity and the obligation to minimise the unidentiﬁed fraction of SFPPs. Consequently, the components of the primary products should be characterised as fully as possible. That information is particularly required as the basis for the component-based approach employed in the course of the genotoxicity assessment of primary products (see section 3.2).

99 In section 3.1 of the 2021 Guidance, concerning general considerations on safety data, EFSA states the following:

‘For the genotoxicity assessment of mixtures containing a substantial fraction of unidentiﬁed components, the [statement on mixtures] requires a combination of a component-based and a whole mixture approach, since genotoxicity of individual components may not be detected in a whole mixture testing approach, e.g. as a result of dilution. According to the [opinion on testing strategy], clear evidence of genotoxicity in somatic cells in vivo has to be considered as an adverse effect per se.’

100 More specifically, in section 3.2 of the 2021 Guidance, which relates to genotoxicity, EFSA explains:

‘[SFPPs] are complex mixtures that may contain a substantial fraction of unidentiﬁed components. The recommended approach for the genotoxicity assessment of such type of mixtures is described by the [statement on mixtures].

In line with this statement, an evaluation scheme describing the recommended approach for the genotoxicity assessment of [SFPPs] is also reported in Appendix C. This evaluation scheme is equally applicable to renewal applications as to applications for the authorisation of new [SFPPs].

As a ﬁrst step, the mixture should be chemically characterised as fully as possible. Concentrations of the identiﬁed components in the primary product should be provided …

The genotoxic potential of the chemically identiﬁed components in a [SFPP] should be assessed individually, using all available data. Genotoxicity data should be collected and evaluated based on the Scientiﬁc Committee guidance on genotoxicity … Conclusions on genotoxicity are required for all identiﬁed components.

…

If a primary product contains one or more components that have been assessed (i.e. they are already known) to be genotoxic in vivo via a relevant route of administration (i.e. after oral exposure), then the primary product raises a concern for genotoxicity and the risk to human health related to this identiﬁed hazard needs to be taken into account in the risk assessment …

If none of the identiﬁed chemical substances in a primary product raises a concern for genotoxicity …, as a following step, the Scientiﬁc Committee recommends evaluating the genotoxic potential of the unidentiﬁed fraction of the mixture. Experimental testing of the fraction of unidentiﬁed components should be considered as a ﬁrst option … or, if this is not feasible and a scientiﬁc justiﬁcation can be provided, the whole mixture should be tested …’

101 In addition, the statement on mixtures, to which the 2021 Guidance refers, provides, in section 2.3 thereof, entitled ‘Genotoxicity assessment of mixtures containing a substantial fraction of unidentiﬁed components’:

‘If a mixture contains, besides chemically identiﬁed substances, a substantial fraction of chemical substances that have not been chemically characterised, the Scientiﬁc Committee recommends that ﬁrst the chemically deﬁned substances be assessed individually for their potential genotoxicity, using all available information … This means that for regulated products, a conclusion on genotoxicity will be required for all identiﬁed components or at least for representative chemical substances for mixtures containing structurally related substances. As described in Section 2.2, if the mixture contains one or more chemical substances that are evaluated to be genotoxic in vivo via a relevant route of administration, the whole mixture raises concern about genotoxicity.

As already mentioned in Section 2.2, for mixtures that contain individual components that may indicate a potential concern for genotoxicity but for which the data available are not sufﬁcient to conclude on genotoxicity, e.g. positive results in in vitro genotoxicity tests of an individual component, additional data would be needed to complete an assessment …

If none of the identiﬁed chemical substances in a mixture raises concern for genotoxicity, the genotoxic potential of the unidentiﬁed fraction should also be evaluated to complete the assessment of the mixture. Experimental testing of the unidentiﬁed fraction should be considered as the ﬁrst option or, if this is not feasible and a scientiﬁc justiﬁcation is provided, testing of the whole mixture should be undertaken …’

102 Accordingly, it is apparent both from the 2021 Guidance and from the statement on mixtures that, where the SFPP includes chemically identified components, their genotoxicity must first be assessed individually.

103 In addition, according to section 3.2 of the 2021 Guidance, cited in paragraph 100 above, the use of a whole mixture approach requires several conditions to be met, namely that none of the components present in the product have been considered to raise concerns for genotoxicity, that it is impossible to carry out tests on the unidentified fraction of the mixture and that scientific justification has been provided. It is also apparent from section 2.3 of the statement on mixtures, cited in paragraph 101 above, that the assessment of the unidentified fraction of the mixture presupposes that none of the chemical substances identified in a primary product raises a genotoxicity concern.

104 It should be noted that, in its applications for renewal, Kerry partially determined the chemical composition of the products at issue, and that data were available regarding the genotoxicity or potential genotoxicity of several of their components.

105 In that regard, in its opinions, EFSA considered that, on the basis of the analysis of the available information on the genotoxicity of the identified individual components of the products at issue, concerns for genotoxicity were identified for two components, namely furan-2(5H)-one and benzene-1,2-diol, and that potential concerns for genotoxicity were identified for four components of SF‑002 and of SF‑006 and five components of SF‑005.

106 EFSA noted that, as regards furan-2(5H)-one and benzene-1,2-diol, the available data raised concerns for genotoxicity. It considered that, as stated in Appendix B to its opinions, furan-2(5H)-one had genotoxic activity in vivo, observed during a test of comet assay in the liver and during a micronucleus test in the liver. As regards benzene-1,2-diol, EFSA examined the assessment of the Risk Assessment Committee of the European Chemicals Agency (ECHA) and agreed that, on the basis of in vitro and in vivo experimental data (including studies in which animals had been exposed orally), concerns for genotoxicity in vivo had been identified.

107 The applicants have not raised any arguments concerning the validity, relevance or results of the tests on which EFSA relied in its opinions and which establish the in vivo genotoxicity of furan-2(5H)-one and benzene-1,2-diol. Nor have they disputed the findings of the tests on the potential genotoxicity of the other identified components of the products at issue.

108 For the first time, in the reply, the applicants submit that the studies on which EFSA relied to conclude that benzene-1,2-diol raised concerns for genotoxicity were not particularly reliable.

109 It is sufficient to note that that argument, even if it were admissible, is not substantiated and must, therefore, in any event, be rejected.

110 It follows that, given that the products at issue contained identified substances raising concerns for genotoxicity, the applicants cannot validly claim that EFSA’s component-based approach did not comply with the 2021 Guidance. The conditions for the use of a whole mixture approach, laid down in the 2021 Guidance and cited in paragraph 103 above, were not satisfied.

111 That conclusion is not called into question by the extracts from the Combined Exposure Guidance that are cited in paragraph 86 of the application and which, according to the applicants, establish that the most appropriate approach for carrying out a genotoxicity assessment is based on the whole mixture. In paragraph 64 of the reply, they also cite an extract from the 2021 Guidance which, they argue, confirms that.

112 It is sufficient to note that those extracts from the Combined Exposure Guidance and from the 2021 Guidance do not specifically concern the assessment of genotoxicity, but rather that of toxicity in general, and they are therefore irrelevant. As the Court of Justice has stated, the assessment of toxicity and that of genotoxicity, and the results deriving from them, should not be confused and are not substitutable (judgment of 18 December 2025, PAN Europe v Commission, C‑316/24 P, EU:C:2025:992, paragraph 125).

113 Accordingly, the first complaint must be rejected.

– The second complaint, relating to EFSA’s application of the TTC approach

114 The applicants claim that EFSA made a manifest error of assessment by limiting the assessment of the genotoxicity of the products at issue to the application of the TTC approach and by ignoring the data produced by Kerry relating to the products at issue and to the whole mixtures. They submit that, according to EFSA’s interpretation of the 2021 Guidance, if the reference TTC is exceeded for one of the identified components of the mixture, the genotoxicity analysis stops at that stage and there is no way of excluding the potential genotoxicity problem identified, even if the data specific to the chemicals are available and the studies on those data demonstrate the absence of any genotoxicity concern. That approach is, they argue, contrary to the various EFSA guidance documents.

115 As a preliminary point, it must be noted that, at the hearing, in response to a question put by the Court, the applicants stated that, by their arguments raised in the application, they were not claiming that EFSA had used the methodology set out in the TTC Guidance, and in particular the ‘TTC decision tree’, to assess the genotoxicity of the components of the products at issue. They explained that, in criticising EFSA for having used the TTC approach, they were challenging only the fact that it had used the exceeding of the reference TTC as the final stage of its assessment.

116 In any event, it should be noted that, in its opinions, EFSA did not apply the TTC methodology, as defined in the TTC Guidance, in order to assess the genotoxicity of the components of the products at issue.

117 The TTC Guidance states:

‘The TTC approach should not be used for substances for which the [EU] food/feed legislation requires the submission of toxicity data. Furthermore, when sufﬁcient data are available for a risk assessment, these data should be used and not the TTC approach.’

118 Therefore, as the Commission submits, the TTC approach was not applicable in so far as, first, pursuant to point 6 of Annex II to Regulation No 2065/2003, an application for authorisation of a SFPP must include toxicological data and, second, data were available that established the genotoxicity of certain components of the products at issue.

119 In its opinions, EFSA examined whether the concern for genotoxicity in respect of furan-2(5H)-one and benzene-1,2-diol and the potential concerns for genotoxicity in respect of four components of SF‑002 and of SF‑006 and five components of SF‑005 could be ruled out by applying the TTC approach for DNA-reactive mutagens and carcinogens. The exposure estimates obtained were compared with the reference TTC. EFSA noted that, for five substances of SF‑002, for the seven substances of SF‑005 and for the six substances of SF‑006, the exposure estimates were significantly higher than the reference TTC and that, consequently, the application of the TTC approach would not rule out the concerns and potential concerns for the genotoxicity of those components.

120 EFSA examined whether refined exposure estimates for the primary product, in accordance with the principles described in the 2021 Guidance, could mitigate the concerns and potential concerns for the genotoxicity of each of those components. However, taking into account, on the one hand, the magnitude of the calculated ratios between the exposure estimates and the reference TTC and, on the other hand, the uses of the primary product and the nature of the restrictions or exceptions indicated by the applicant for the different food categories, EFSA considered that a more refined exposure assessment would not reduce the exposure estimates for those components to such an extent that they would be below the reference TTC.

121 EFSA also stated that the primary products (the whole mixture) had been tested in in vitro and in vivo genotoxicity studies to investigate the genotoxicity of the unidentified fraction of the primary products, in accordance with the statement on mixtures. EFSA considered that those in vivo studies were of limited relevance and were therefore not sufficiently robust to rule out the concerns for genotoxicity, in respect of the whole mixture, that were raised by the observation of chromosomal aberrations in in vitro tests.

122 EFSA found that, in the present case, the concerns for genotoxicity for the primary products could not be ruled out by an additional in vivo comet assay test performed on the whole mixture, since the exposure estimate for the two genotoxic components, furan-2(5H)-one and benzene-1,2-diol, exceeded the reference TTC. It noted that, as set out in the statement on mixtures, ‘if the mixture contains one or more chemical substances that are evaluated to be genotoxic in vivo via a relevant route of administration, the whole mixture raises concern about genotoxicity’.

123 EFSA noted that, for the same reason, filling of the data gaps for the other components that raised potential concerns for genotoxicity would not remove the safety concern in respect of the primary products.

124 In conclusion, EFSA stated that it had identified potential concerns for genotoxicity for four components of SF‑002 and of SF‑006 and five components of SF‑005 as well as for the unidentified fraction of the mixture. It noted that, more importantly, the primary products contained furan-2(5H)-one and benzene-1,2-diol, which were two substances known to be genotoxic in vivo when administered orally. Given that the exposure estimates for furan-2(5H)-one and benzene-1,2-diol were above the reference TTC, EFSA concluded that the products at issue raised concerns for genotoxicity.

125 As regards the assessment of the genotoxicity of a product, section 3.2 of the 2021 Guidance, relating to genotoxicity, states:

‘If a component of a primary product is evaluated to be genotoxic in vivo via a relevant route of administration and no relevant carcinogenicity data are available, it might be possible to apply the [TTC] concept … This would be applicable when the estimated exposure to the identiﬁed genotoxic component(s) is very low, i.e. below the [reference TTC], and if the(se) component(s) is/are unavoidably resulting from the production process of the primary product. In such circumstances, it can be concluded that there is a low probability of adverse health effects … On the other hand, if the estimated exposure of such component(s) is higher than the [reference TTC] for DNA-reactive mutagens and/or carcinogens, the primary product raises a concern for genotoxicity …’

126 In addition, it must be noted that the statement on mixtures, referred to in paragraph 101 above, provides that ‘if the mixture contains one or more chemical substances that are evaluated to be genotoxic in vivo via a relevant route of administration, the whole mixture raises concern about genotoxicity’.

127 First of all, it should be noted that EFSA explained that the concerns for the genotoxicity of the two components identified as genotoxic in vivo, contained in the products at issue, could not be ruled out by the application of the TTC approach set out in the TTC Guidance, given the extent to which the reference TTC was exceeded. It made the same finding for the other substances contained in the products at issue raising potential concerns for genotoxicity.

128 In that regard, it should be noted that, in the application, the applicants stated that ‘Kerry was aware that two components of [its] SFPPs identified as known genotoxic concern exceeded the [reference] TTC’. The applicants have not put forward any arguments to the effect that EFSA made a manifest error in its assessment of the extent to which the reference TTC was exceeded for those two components.

129 Next, as the Commission submits, EFSA, in its opinions, carried out an assessment of the whole mixture in order to determine the genotoxicity of the unidentified fraction of the products at issue.

130 Lastly, EFSA considered that, in view of the extent to which the reference TTC was exceeded for the two components raising concerns for genotoxicity, the products at issue raised concerns for genotoxicity which could not be called into question by additional tests relating to the whole mixture.

131 With regard to the taking into account of data on the whole mixture, it must be noted that, in section 3.4.2 of its opinions, in respect of the genotoxicity of the products at issue (whole mixture), EFSA took into account, on the one hand, the studies submitted by Kerry which had already been evaluated in 2009 (section 3.4.2.1) and, on the other hand, new in vitro and in vivo genotoxicity studies (section 3.4.2.2).

132 The applicants cannot therefore validly maintain that EFSA ignored the data produced by Kerry relating to the products at issue and the whole mixtures.

133 It should also be noted, as the Commission has submitted, that the applicants do not dispute EFSA’s assessment, in its opinions, concerning the in vitro and in vivo genotoxicity studies carried out on the whole mixture and, in particular, its conclusion, referred to in paragraph 121 above, that the in vitro tests established concerns for genotoxicity for the whole mixture which could not be called into question by the in vivo studies given the limited relevance of the latter studies.

134 Therefore, the applicants have not established to what extent the taking into account of the data relating to the whole mixture is such as to call into question EFSA’s findings that the products at issue raised concerns for genotoxicity.

135 Accordingly, it is apparent from the 2021 Guidance and from the statement on mixtures, cited in paragraphs 125 and 126 above, that EFSA could infer the genotoxicity of the products at issue from the fact that they contained substances identified as genotoxic at an exposure level above the reference TTC.

136 It follows that the applicants have not established that, in its opinions, EFSA used a methodology that did not comply with the 2021 Guidance and with the applicable cross-sectional guidance documents.

137 That conclusion is not called into question by the extracts from the cross-sectional guidance documents cited by the applicants, which, they argue, provide for the possibility of calling into question the concerns for genotoxicity thus identified, through the taking into account of the data relating to the whole mixture.

138 In paragraphs 87 to 89 of the application, the applicants quote extracts from the opinion on genotoxicity clarification, from the opinion on testing strategy and from the TTC Guidance to argue that the weight-of-evidence approach is the primary standard for a genotoxicity assessment and that EFSA failed to apply that approach to determine whether the specific component was genotoxic at the levels present in the SFPP and whether the results of the TTC approach could be overruled. In paragraph 91 of the application, the applicants also refer to an extract from the TTC Guidance, concerning the ‘TTC decision tree’, according to which a ‘non-TTC approach’ based on product-specific data should be followed in order to examine whether the results of the TTC approach could be overruled.

139 It should be noted that the applicants rely on an extract from section 3.3.2 of the opinion on genotoxicity clarification, entitled ‘Drawing conclusions on the genotoxic potential of substances’, which concerns testing and tests for assessing the genotoxicity of a substance. Contrary to what the applicants state, the term ‘substance’ used in the cited extract refers to the components of a product, but does not concern the whole mixture.

140 Similarly, the extracts from the opinion on testing strategy and from the TTC Guidance that are cited by the applicants relate to the assessment of the genotoxicity of a substance and not of a product.

141 It should be borne in mind, first, that the TTC Guidance is not applicable to regulated products such as SFPPs and, second, as stated in paragraph 115 above, that the applicants acknowledged at the hearing that EFSA had not applied the methodology set out in the TTC Guidance to assess the genotoxicity of the components of the products at issue.

142 It follows from paragraphs 105 to 107 above that the in vivo genotoxicity of furan-2(5H)-one and of benzene-1,2-diol and the potential genotoxicity of the other identified components of the products at issue were established on the basis of the available data and not by using the ‘TTC decision tree’.

143 Therefore, the applicants have not explained how a weight-of-evidence approach or a ‘non-TTC approach’ applied to the assessment of the genotoxicity of a substance would be relevant for the purposes of calling into question EFSA’s findings regarding the genotoxicity of the identified components of the products at issue.

144 The extracts from the cross-sectional guidance documents referred to in paragraph 138 above, concerning only the evaluation of a substance, are therefore irrelevant and are not, in any event, capable of rebutting EFSA’s conclusion as to the genotoxicity of the products at issue.

145 The second complaint must therefore be rejected.

– The third complaint, relating to the incomplete risk assessment

146 In the reply, first, the applicants submit that EFSA, by concluding that the products at issue were not safe for their intended use, on the ground that some of their components were identified as potentially genotoxic, limited its risk assessment to the first stage of that assessment, namely hazard identification.

147 Article 3(11) of 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) defines risk assessment as ‘a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation’.

148 First of all, it must be noted that EFSA examined the chemical composition of the products at issue on the basis of the data provided by Kerry. It found that the genotoxicity of two components of the products at issue, namely furan-2(5H)-one and benzene-1,2-diol, had been established by in vivo tests, which corresponds to the first stage of the risk assessment, namely hazard identification.

149 In that regard, contrary to what the applicants submit, EFSA did not rely on the existence of only potential concerns for the genotoxicity of the components of the products at issue.

150 Next, in accordance with section 3.2 of the 2021 Guidance and section 2.3 of the statement on mixtures, cited respectively in paragraphs 100 and 101 above, EFSA found that the products at issue raised concerns for genotoxicity in so far as they contained those two components. EFSA did not have to determine a dose above which the hazard was characterised. Thus, the second stage of the risk assessment, namely hazard characterisation, which is a quantitative process, was not applicable to genotoxicity.

151 Lastly, EFSA examined whether the concern for genotoxicity for furan-2(5H)-one and benzene-1,2-diol and the potential concern for genotoxicity for four or five other components of the products at issue could be ruled out by applying the TTC approach to DNA-reactive mutagens and carcinogens. It explained that, for that purpose, it had calculated the exposure to each of those components by multiplying the estimated exposure to the products at issue by the average content of those components in the products at issue and that the exposure estimates obtained had been compared with the reference TTC. EFSA stated that all the exposure estimates obtained were a factor of at least 10 400 for SF‑002, 64 for SF‑005 and 3 800 for SF‑006 above the reference TTC and that, consequently, the application of the TTC approach could not rule out the concerns and potential concerns for genotoxicity for those components.

152 It follows that EFSA carried out the third stage of the risk assessment, namely exposure assessment, for the components of the products at issue raising concerns for genotoxicity.

153 In finding that the exposure to components which raised concerns for genotoxicity and which were present in the products at issue caused the reference TTC to be exceeded, EFSA identified the nature of the hazard and the intensity of exposure, which corresponds to the fourth stage of the risk assessment, namely risk characterisation.

154 Furthermore, the applicants, in order to maintain that EFSA limited its risk assessment to the first stage relating to hazard identification, rely on an extract from the 2021 Guidance, cited in paragraph 100 above, according to which, if a primary product contains one or more components that are already known to be genotoxic in vivo via oral exposure, then that primary product raises concerns for genotoxicity and the risk to human health related to that identiﬁed hazard must be taken into account in the risk assessment.

155 In that regard, it should be noted that it follows from the extract from the 2021 Guidance, cited in paragraph 125 above, that there is a low probability of adverse effects on health if the estimated exposure to the components identified as genotoxic is very low, that is, below the reference TTC, but that that is not the case if that exposure is higher than the reference TTC.

156 In its opinions, EFSA did not limit its risk assessment to the genotoxicity hazard of the components of the products at issue. It took account of the fact that exposure to the components raising concerns for genotoxicity greatly exceeded the reference TTC in order to conclude that the products at issue raised concerns for genotoxicity and thus established that the risk to human health could not be regarded as low.

157 Accordingly, the applicants cannot validly claim that EFSA’s conclusion that the products at issue raised concerns for genotoxicity was not based on a full risk assessment.

158 Second, the applicants submit that ignoring the data on the whole mixture in the subsequent stages of the risk assessment is contrary to the 2021 Guidance and to the cross-sectional guidance documents.

159 It must be noted that the applicants refer to the same extracts from the 2021 Guidance and from the cross-sectional guidance documents as those mentioned in paragraphs 87 to 89 of the application, referred to in paragraph 138 above.

160 Thus, for the reasons set out in paragraphs 139 to 144 above, those extracts concerning only the assessment of the genotoxicity of a substance are irrelevant.

161 It follows that the conclusion that a SFPP presents a risk to human health may be based on the presence, in that SFPP, of a component identified in vivo as raising concerns for genotoxicity, the exposure of which is higher than the reference TTC. Contrary to what the applicants claim, the 2021 Guidance does not provide that that conclusion may be called into question by an assessment of the whole mixture.

162 It follows from all of the foregoing that, since the applicants have not established that the methodology used by EFSA to assess the genotoxicity of the products at issue did not comply with the 2021 Guidance and with the applicable cross-sectional guidance documents, EFSA did not make a manifest error of assessment.

163 Accordingly, the third complaint must be rejected and, therefore, the first part must be rejected in its entirety.

The second part, alleging that the genotoxicity assessment in EFSA’s opinions is contrary to the principle of scientific excellence

164 The applicants claim that the approach followed by EFSA and the conclusions submitted by Kerry in its applications for renewal cast serious doubt on EFSA’s opinions. They submit that, by failing to examine the results of studies conducted on the basis of the best and most recent available methodology, which systematically demonstrate that the products at issue do not present any risk to human health, EFSA acted in breach of the principle of scientific excellence, lacked scientific objectivity, relied on a scientific risk assessment which is not as exhaustive as possible and identified purely hypothetical and not actual concerns. In the applicants’ view, EFSA therefore made a manifest error of assessment.

165 According to the case-law, a scientific risk assessment carried out as thoroughly as possible on the basis of scientific advice founded on the principles of excellence, transparency and independence is an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures (see judgments of 17 March 2021, FMC v Commission, T‑719/17, EU:T:2021:143, paragraph 95 and the case-law cited, and of 9 February 2022, Taminco and Arysta LifeScience Great Britain v Commission, T‑740/18, EU:T:2022:61, paragraph 56 and the case-law cited).

166 It also follows from the case-law that, according to Article 95(3) EC, which was in force at the time and on which Regulation No 2065/2003 is, inter alia, based, the Commission, in its proposals in the fields of health, safety, environmental protection and consumer protection that are made in the context of the approximation of laws having as their object the establishment and functioning of the internal market, takes as a base a high level of protection, taking into account, in particular, any new development based on scientific facts. Furthermore, it has been held that that protection, in particular of public health and the environment, took precedence over economic considerations, with the result that it could justify adverse economic consequences, even those which are substantial, for certain traders. It follows from those principles, which constitute the basis of the general protection objective of that regulation, that, unless otherwise specified, the decisions which the Commission is required to take in the context of that regulation must always take account of the latest scientific and technical knowledge (see, by analogy, judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 289 and the case-law cited; see also, to that effect and by analogy, judgments of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraphs 66 to 69 and 88, and of 4 October 2024, UPL Europe and Indofil Industries (Netherlands) v Commission, C‑262/23 P, not published, EU:C:2024:862, paragraph 179).

167 Moreover, as regards the risk assessment, since that assessment must be, in particular, independent and objective, it is imperative to take into account relevant evidence other than the tests, analyses and studies submitted by the applicant for renewal which might contradict the latter. With that in mind, it is necessary not only to take account of the most reliable scientific data available and the most recent results of international research, but also not to give in all cases preponderant weight to the studies submitted by the applicant for renewal (judgments of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraphs 93 and 94, and of 4 October 2023, Ascenza Agro and Industrias Afrasa v Commission, T‑77/20, EU:T:2023:602, paragraph 382).

168 It should be noted that EFSA has a broad discretion and that, under the case-law cited in paragraph 73 above, the applicants’ arguments must make the assessment of the products at issue set out in its opinions implausible. In that regard, it follows from paragraphs 77 to 79 above that, contrary to what the applicants claim, it is not sufficient that the evidence submitted in the application casts serious doubt on EFSA’s opinions.

169 In the first place, the applicants refer to articles and scientific opinions from which, they argue, it is apparent that the methodology used by EFSA in its opinions did not correspond to the most recent scientific knowledge. First, they submit that, according to the scientific literature on the toxicological assessment of mixtures and to documents of international agencies, the most practical and scientifically sound approach to risk assessment of complex chemical mixtures is to use all available data, with a preference for data relating to whole mixtures. Second, the applicants refer to scientific articles in which toxicologists recommend moving away from the binary method, consisting of assessing whether or not a chemical product is genotoxic, in favour of an approach that is more compatible with other toxicological parameters, taking into account the dose at which a product presents a risk to human health.

170 It must be noted that the applicants have merely cited references to scientific articles, without producing them as an annex to the application and without specifying which passages of those articles are relevant in the present case.

171 According to settled case-law, while the body of the application may be supported and supplemented on specific points by references to extracts from documents annexed thereto, a general reference to other documents, even those annexed to the application, cannot make up for the absence of the essential element in law, which, in accordance with Article 21 of the Statute of the Court of Justice of the European Union and Article 76 of the Rules of Procedure of the General Court, must appear in the application (see judgments of 12 December 2024, Euranimi v Commission, C‑772/23 P, not published, EU:C:2024:1025, paragraph 71 and the case-law cited, and of 31 January 2024, Symphony Environmental Technologies and Symphony Environmental v Parliament and Others, T‑745/20, EU:T:2024:45, paragraph 163 and the case-law cited). That is all the more so where reference is made to documents which are not annexed to the application.

172 In accordance with the case-law, it is not for the Court to seek and identify, in the documents referred to in the application, the passages which might demonstrate the truth of the applicants’ assertions. By failing to specify the passages of those documents that are capable, in the applicants’ view, of supporting their claims, the applicants have in fact confined themselves to making a general reference which is not permitted pursuant to the case-law. Moreover, by substituting itself for the applicants in identifying passages of those documents which could support their claims, the Court could be led to neglect its duty of impartiality (see, to that effect, judgment of 5 February 2025, Ege İhracatçıları Birliği and Others v Commission, T‑122/23, not published, EU:T:2025:133, paragraph 165 and the case-law cited).

173 As regards the two scientific articles annexed to the application, it must be noted that, for one, the applicants have merely made a general reference and, for the other, the sentences taken from it and cited in the application concern the toxicity of mixtures and are therefore irrelevant.

174 As regards the alleged documents of international agencies to which the applicants refer, it is sufficient to note that they are three documents of two United States federal agencies. More specifically, the two documents of the United States Environmental Protection Agency are rather old (dating from 1986 and 2000) and the document of the Agency for Toxic Substances and Disease Registry concerns insecticides and is no longer accessible.

175 It follows that, by confining themselves to a general reference to scientific articles, the applicants have not established that those documents concerned the assessment of the genotoxicity of food products and have not demonstrated their relevance in the present case. The applicants have therefore not demonstrated that the methodology used by EFSA in its opinions was contradicted by scientific literature.

176 In the second place, the applicants submit that EFSA, in its risk assessment, did not apply the most recent scientific knowledge, because it confined itself to applying a methodology based on the TTC and ignored the data that were specific to the chemical products and provided by Kerry. In its applications for renewal, Kerry used the data specific to the chemical products and applied the Margin of Exposure approach (‘the MoE approach’), which, the applicants argue, is the most scientifically sound approach.

177 First, as the Commission submits, EFSA, in its cross-sectional guidance documents, and in particular in the statement on mixtures, acknowledges the existence of a scientific debate as to the use of the MoE approach.

178 In that regard, according to the statement on mixtures:

‘The Scientiﬁc Committee reiterates its earlier statement that chemical substances that are both genotoxic and carcinogenic should not be deliberately added to foods or used earlier in the food chain. In certain cases, i.e. unavoidable contaminants and impurities, it might be possible to conclude that human exposure is likely to be of low concern from a public health perspective. Such a conclusion may be reached based on a [MoE] approach … when respective carcinogenicity data are available, either for the genotoxicant itself or for a structurally closely related chemical substance. For details on the application of the [MoE] approach for mixtures, the reader is referred to the guidance document on combined exposure to multiple chemicals under development … The Scientiﬁc Committee notes that in the scientiﬁc community there is, as yet, no consensus on whether and how a [MoE] approach could be applied to genotoxicity data alone (in the absence of relevant carcinogenicity data).’

179 It must be noted that the existence of a scientific debate on the best methodology to be applied is not a sufficient ground to make the methodology used by EFSA in its opinions implausible. At no point have the applicants set out a sufficient scientific consensus establishing that the approach used in EFSA’s opinions should be abandoned in favour of the MoE approach.

180 Second, it should, first of all, be noted that EFSA did not use the TTC methodology in order to assess the genotoxicity of the components of the products at issue. Accordingly, the applicants’ arguments raised in the application seeking to compare the TTC methodology with the MoE methodology concerning the assessment of the genotoxicity of substances and the references to the TTC Guidance are irrelevant.

181 Next, it must be noted that, in the second part, the applicants have put forward arguments very similar to those already raised in the first part with regard to the methodology followed by EFSA in its opinions. They claim, in essence, that EFSA did not follow a scientifically objective and exhaustive methodology, in that it used the exceedance of the reference TTC as the final stage of its risk assessment and ignored the data, provided by Kerry, on whole mixtures.

182 It follows from the analysis of the first part that the methodology followed by EFSA is consistent with the 2021 Guidance and with the applicable cross-sectional guidance documents.

183 In that regard, it must be noted that the 2021 Guidance constitutes updated consolidated guidance for the submission of applications relating to SFPPs. EFSA drafted that guidance taking into account, inter alia, the most recent scientific and technical documents. It must therefore be held that EFSA, in relying on that guidance in its opinions, took into account the most recent scientific knowledge in the field of genotoxicity.

184 Lastly, it must be noted that, in its opinions, EFSA examined Kerry’s arguments concerning the application of the MoE approach to assess the risks associated with the products at issue and explained why that methodology did not apply in the present case.

185 In that regard, in section 3.4.1 of its opinions, EFSA stated:

‘For those components for which a concern for genotoxicity was identified by the applicant …, a risk-based analysis was subsequently applied by the applicant based on a [MoE] approach. According to the applicant, genotoxicity data can be amenable to dose-response modelling like other toxicological endpoints … and no observed adverse effect levels (NOAELs) were derived from the available in vivo genotoxicity studies conducted either with the individual components or with the Primary Product (whole mixture). [MoEs] for genotoxicity were then calculated for each of these constituents, by comparing the derived NOAELs with the DietEx exposure estimates to each of the constituents via the consumption of the Primary Product …

[EFSA] noted that the derivation of NOAELs for DNA-reactive genotoxic substances is considered to be inappropriate; this also applies to mixtures containing such substances. Therefore, [EFSA] did not follow the NOAEL approach suggested by the applicant. [EFSA] recognises ongoing developments to include dose-response modelling and derivation of benchmark dose levels in risk assessment strategies for such substances … However, the techniques, as applied by the applicant (e.g. for furan-2(5H)-one), have not yet been validated and are not generally accepted.’

186 Similarly, in section 4 of its opinions, after stating that furan-2(5H)-one displayed genotoxic activity in vivo observed during tests, EFSA noted the following:

‘From these EFSA opinions, no evidence is available to prove that furan-2(5H)-one induces chromosomal damage via a threshold-based mechanism. Therefore, [EFSA] considered that the derivation of reference points from the available genotoxicity studies and the calculation of a [MoE], as proposed by the applicant, is not appropriate.’

187 The applicants have not put forward any argument capable of establishing that that assessment by EFSA is not scientifically well founded. As the Commission submits, by their arguments, the applicants have merely set out a scientific opinion that differs from that of EFSA.

188 The mere fact that Kerry followed, in its applications for renewal, a methodology that differed from that followed by EFSA in its opinions is not sufficient to make EFSA’s assessment implausible.

189 It follows from the foregoing that the applicants have not established that the methodology followed by EFSA in its opinions did not correspond to the most recent scientific approaches and methodologies and that it was scientifically implausible.

190 The second part must therefore be rejected.

191 It follows from the overall analysis of the second plea that the applicants have not established that EFSA, in its opinions, and the Commission, in so far as it reproduces EFSA’s findings in the contested acts, made manifest errors of assessment.

192 The second plea must therefore be rejected in its entirety.

The third plea in law, alleging that the Commission infringed Article 9(1) of Regulation No 2065/2003 by failing to carry out a full risk management assessment

193 The applicants submit that the Commission infringed Article 9(1) of Regulation No 2065/2003 by relying solely on EFSA’s opinions and by failing to carry out a proper risk management assessment. That plea is divided into three complaints. First, the Commission failed to examine whether EFSA’s opinions were sufficient to determine whether the products at issue satisfied the requirements laid down in Article 4(1) of Regulation No 2065/2003. Second, it failed to take into account the direct repercussions of the contested acts on the public health objectives pursued by Regulation No 2065/2003 and general EU law. Third, it failed to take into account the other legitimate factors relevant to risk management.

The first complaint, alleging that the Commission failed to examine whether EFSA’s opinions were sufficient

194 The applicants submit that the Commission, as risk manager, must ensure that the products at issue do not present any risk to human health in accordance with Article 4(1) of Regulation No 2065/2003. They argue that the risk assessment carried out by EFSA was not sufficient to enable the Commission to satisfy itself that that criterion was met.

195 First of all, it should be noted that, under Article 4(1) of Regulation No 2065/2003, the use of SFPPs is authorised only if it is sufficiently demonstrated, inter alia, that they do not present risks to human health.

196 As follows from paragraphs 80 to 84 above, the applicants reverse the burden of proof by maintaining that EFSA and the Commission have not established that the products at issue present risks to human health. It is for the applicant for authorisation or renewal of authorisation to demonstrate that the product concerned does not present risks to human health.

197 First, the applicants submit that the risk assessment carried out by EFSA was not sufficient to enable the Commission to satisfy itself that the criterion laid down in Article 4(1) of Regulation No 2065/2003 was met. The Commission merely relied, they argue, on EFSA’s identification of concerns for genotoxicity at component level, without determining whether the products at issue presented risks to human health in the context of their intended use.

198 It follows from the analysis of the second plea, in particular from paragraphs 147 to 157 above, that EFSA carried out a full risk assessment and that, contrary to what the applicants claim, it did not identify only potential or hypothetical concerns for the genotoxicity of the products at issue.

199 It also follows from the analysis of the first part of the second plea that the applicants have not established that EFSA made a manifest error of assessment in considering that the fact that the products at issue contained components identified as genotoxic was sufficient to conclude that those products raised concerns for genotoxicity. In addition, given that the exposure estimates, in particular in respect of the two genotoxic components present in the products at issue, were well above the reference TTC, EFSA considered that the risk to human health could not be regarded as low.

200 Thus, contrary to what the applicants submit, EFSA, in assessing the safety of the products at issue on the basis of the data relating to the exposure estimates provided by the applicant, assessed the risks to human health under the planned conditions of use.

201 In its opinions, EFSA, in concluding that the products at issue raised concerns for genotoxicity, therefore considered that the applicant had not sufficiently demonstrated that those products did not present any risks to human health, within the meaning of Article 4(1) of Regulation No 2065/2003.

202 Furthermore, the applicants submit that EFSA did not determine whether the products at issue presented risks to human health in the context of their intended use. They rely on a statement of 16 November 2023 by the Chair of the EFSA Working Group on Flavourings, during a questions and answers session, according to which ‘the chance that such harmful effects would occur as a result of consumption of foods flavoured with smoke flavourings has not been investigated by EFSA’.

203 It must be noted that that extract from the answer by the Chair of the EFSA Working Group on Flavourings is taken out of context and does not support the applicants’ argument.

204 Thus, in response to the question ‘What does EFSA’s advice on smoke flavourings mean for consumers?’, the Chair of the EFSA Working Group on Flavourings stated:

‘In general, there may be an elevated risk of harmful effects when consuming genotoxic substances. However, the likelihood of these effects emerging depends on various factors, including an individual’s genetics and dietary habits. The chance that such harmful effects would occur as a result of consumption of foods flavoured with smoke flavourings has not been investigated by EFSA. However, it is worth noting that EFSA takes a conservative approach to its assessments, meaning that we consider worst-case scenarios to estimate hazards and risks.

A balanced diet generally reduces the likelihood of exposure to food risks. Balancing the diet with a wide variety of foods, e.g. meat, fish, vegetables, could help consumers to reduce their intake of harmful substances.’

205 Thus, in his answer, the Chair of the EFSA Working Group on Flavourings merely stated that EFSA was not required to determine the likelihood of harmful effects on health arising in specific cases. That answer cannot be interpreted as meaning that EFSA stated that it had not carried out the risk assessment of the products at issue in the context of their intended use.

206 Accordingly, the applicants cannot validly claim that the Commission, in following EFSA’s opinions, based the contested acts on an incomplete risk assessment and on the existence of theoretical hazards.

207 Second, the applicants claim that, since the Commission is not bound by EFSA’s opinions, it should have taken into account the scientific evidence submitted in the applications for renewal in order to determine whether an identified risk would materialise in practice. The Commission should have weighed the findings in EFSA’s opinions in the light of the extremely remote possibility that the potential concerns would materialise in practice and should have concluded that the products at issue did not present risks to human health. They add that the Commission failed to take into account the evidence which they had provided showing that EFSA’s assessment was incorrect and that the estimated consumption values of the products at issue did not present risks to human health.

208 It must be noted that the applicants again claim that the methodology followed by EFSA in its opinions should have been disregarded in favour of the method of assessing the products at issue that they used in their applications for renewal. It is sufficient to note that it follows from the analysis of the second plea that they have not established that the methodology used by EFSA was manifestly incorrect. They cannot therefore validly maintain that the Commission should have departed from the conclusions set out in EFSA’s opinions or that it should have requested EFSA to complete its risk assessment.

209 In addition, it should be noted that the role devolved to the Commission as risk manager differs from EFSA’s role.

210 Article 3(12) of Regulation No 178/2002 defines risk management as ‘the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options’.

211 It follows from paragraph 68 above that it is not for the Commission itself to carry out the scientific risk assessment. While the Commission may depart from EFSA’s opinions, it cannot, by way of its own scientific assessment, supplement those opinions or call into question the conclusion reached in them.

212 Furthermore, contrary to what the applicants claim, it is not for the Commission to establish how the risks to human health identified in EFSA’s opinions materialise in practice. It is sufficient to recall that, under Regulation No 2065/2003, the refusal of an authorisation requires that it be demonstrated that the use of an SFPP presents a risk to health and not that it be established that that use has actual and concrete effects on the health of consumers.

213 Third, the applicants state that the Commission failed to consider whether ‘appropriate prevention and control measures’ could alleviate the concerns for genotoxicity.

214 First, it must be stated that the applicants have not explained which measures the Commission could have adopted. Second, the purpose of such measures that might be adopted in the context of risk management is not, in any event, to call into question EFSA’s scientific conclusions relating to the genotoxicity of the products at issue.

215 Accordingly, the first complaint must be rejected.

The second complaint, alleging that the Commission failed to take into account the direct repercussions of the contested acts on public health objectives

216 The applicants submit that the Commission must ensure a high level of protection of human health in accordance with Article 1 of Regulation No 2065/2003 and Article 168 TFEU. The Commission had the choice of renewing the authorisations of the products at issue by considering that the purely hypothetical risks identified by EFSA were reconcilable with a high level of protection of human health, or of inducing the market to return to the conventional smoking process, the significant negative impact of which on public health is greater than that of SFPPs. The applicants submit that recital 6 of Regulation No 2065/2003 recognises that SFPPs are generally considered to pose less health problems than the conventional smoking process.

217 First of all, it must be noted that the applicants again wrongly claim that the risks identified by EFSA were purely hypothetical.

218 Next, recital 6 of Regulation No 2065/2003 states that ‘because smoke flavourings are produced from smoke which is subjected to fractionation and purification processes, the use of smoke flavourings is generally considered to be of less health concern than the traditional smoking process’.

219 Although the purification process used for the production of smoke flavourings makes it possible to eliminate some of the harmful smoke components such as PAHs, that does not mean that smoke flavourings cannot contain substances presenting risks to human health or that they should be authorised without their composition being assessed before they are placed on the market.

220 Lastly, the applicants have not established that Implementing Decisions 2024/2066, 2024/2078 and 2024/2079 refusing the renewal of the authorisations of the products at issue result in an increase in the return to the traditional smoking process, especially since SFPPs are added to a whole range of foods for which the traditional smoking process is not used.

221 In that regard, the applicants cannot validly maintain that the fact that the Commission requested EFSA to assess the safety of traditionally smoked products constitutes recognition that the contested acts will lead to an increase in the use of the traditional smoking process.

222 In addition, the applicants cannot interpret the transitional periods provided for in Implementing Regulation 2024/2067 as an acknowledgement by the Commission of the fact that the products at issue do not present risks to human health.

223 Recital 7 of Implementing Regulation 2024/2067 states:

‘However, in light of [EFSA’s] concerns linked to [the eight SFPPs for which the authorisation of renewal was refused], but also of the fact that [SFPPs] are used extensively in a wide range of food products and that all the authorised uses of [SFPPs] imparting a “smoked” flavour or, in some cases, used as an alternative to a traditional smoking process have expired or are not renewed, appropriate measures, adapted to the different types of uses of [SFPPs], should be introduced in order to allow food business operators to find alternatives.’

224 It follows that the objective of the transitional periods is to allow producers of SFPPs to replace them with new products which do not present risks to health.

225 In any event, even if the contested acts resulted in an increase in the use of the traditional smoking process for certain products, that cannot mean that the objective of protecting human health required the Commission to renew the authorisations of the products at issue; it has not been established that the latter do not present any risks to health.

226 Therefore, contrary to what the applicants submit, the objective of protecting human health that is laid down in Article 1 of Regulation No 2065/2003 and in Article 168 TFEU did not mean that the Commission should have authorised the renewal of the authorisations of the products at issue.

227 The second complaint must, therefore, be rejected.

The third complaint, alleging that the Commission failed to take into account the other factors relevant to risk management

228 The applicants submit that, pursuant to Article 9(1) of Regulation No 2065/2003, the Commission, in the context of its risk management decision, should have taken into consideration other factors, such as the negative economic or ecological impacts of the non-renewal of SFPPs and the return to the traditional smoking process.

229 Article 9(1) of Regulation No 2065/2003 provides that the Commission, when preparing a draft measure, is to take into account, inter alia, the requirements of Article 4(1) of that regulation and other legitimate factors relevant to the matter under consideration.

230 It is apparent from Implementing Regulation 2024/2067 that the Commission took into account the economic factors linked to the refusal to renew the authorisations of the products at issue. Thus, it provided for a transitional period during which those products could continue to be placed on the market, in order to enable the food business operators to find alternatives. In recitals 8 and 9 of Implementing Regulation 2024/2067, the Commission states that that period is intended to enable manufacturers to adjust their production processes and food recipes.

231 However, since the negative economic and ecological impacts of a return to the traditional smoking process do not result from the refusal to renew the authorisations of the products at issue, the applicants cannot complain that the Commission did not take those impacts into account.

232 In addition, the applicants have not explained why such impacts, if they were to be taken into consideration by the Commission in the context of risk management, could lead to a situation where the risks to human health associated with the products at issue are ignored and justify the renewal of the authorisations of those products.

233 It follows that the third complaint must be rejected, as must, therefore, the third plea in its entirety.

The first plea in law, alleging that the Commission and EFSA erred in law by failing to examine whether the products at issue presented risks to human health

234 The applicants claim that EFSA, as risk assessor, and the Commission, as risk manager, failed to determine whether the products at issue presented risks to human health in their intended use, in breach of Article 4(1), Article 8(1) and Article 9(1) of Regulation No 2065/2003.

235 The applicants submit that EFSA limited its assessment to the first stage of the risk assessment and to specific components, without examining whether the concerns for genotoxicity of those components resulted in risks to human health that were presented by the products at issue in their intended use. In their view, the Commission erred in law by referring only to EFSA’s findings.

236 First, it must be noted that, contrary to what the applicants claim, it was for neither EFSA nor the Commission to establish that the products at issue presented risks to human health in their intended use.

237 Second, even if, as the appellants submit, that plea is based on errors of law that differ from those raised in the second and third pleas, it is sufficient to note that the first plea relies on the same arguments as those raised in the second and third pleas. In that regard, it must be noted that, in the reply, the applicants refer expressly to the arguments which they put forward in the context of the second and third pleas.

238 The applicants’ arguments that EFSA did not carry out a full risk analysis have already been rejected in the analysis of the second plea. Similarly, the arguments that the Commission made errors of law in its risk assessment have already been rejected in the analysis of the third plea.

239 Accordingly, for the same reasons as those set out in the examination of the second and third pleas, the first plea must be rejected.

The fourth plea in law, alleging breach of the principle of proportionality

240 The applicants submit that the Commission, by adopting the contested acts, acted in breach of the principle of proportionality enshrined in Article 5(4) TEU. The contested acts are, in the applicants’ view, neither appropriate nor necessary to achieve the objective laid down in Article 1 of Regulation No 2065/2003, namely to ensure a high level of protection of human health, nor are they proportionate to that objective.

241 As a preliminary point, it should be recalled that Article 4(1) of Regulation No 2065/2003 provides that the authorisation of an SFPP may be subject to specific conditions of use. Article 9(4) of that regulation, applicable to the renewal of an authorisation, also provides that the authorisation holder or any other food business operator using the authorised SFPP must comply with any condition or restriction attached to such authorisation.

242 Thus, by providing for the renewal of authorisation of a SFPP subject to conditions and restrictions, those provisions expressly incorporate the principle of proportionality, which is one of the general principles of EU law. That principle requires that acts of the EU institutions should not exceed the limits of what is appropriate and necessary for the achievement of the legitimate objectives pursued by the legislation in question, it being understood that, where there is a choice between several appropriate measures, the least restrictive should be used and that the inconvenience caused must not be disproportionate to the aims pursued (see, by analogy, judgments of 6 May 2021, Bayer CropScience and Bayer v Commission, C‑499/18 P, EU:C:2021:367, paragraph 166 and the case-law cited, and of 22 June 2023, Arysta LifeScience Great Britain v Commission, C‑259/22 P, not published, EU:C:2023:513, paragraph 129).

243 Furthermore, it must be acknowledged that the Commission has a wide discretion when it adopts risk management measures. That procedure entails political choices on its part and complex assessments. The validity of a measure adopted in that area can be affected only if the measure is manifestly inappropriate (see judgments of 9 June 2016, Pesce and Others, C‑78/16 and C‑79/16, EU:C:2016:428, paragraph 49 and the case-law cited, and of 9 February 2022, Taminco and Arysta LifeScience Great Britain v Commission, T‑740/18, EU:T:2022:61, paragraph 166 and the case-law cited).

244 It should also be recalled that, according to Article 1 of Regulation No 2065/2003, the latter lays down a procedure at EU level for the evaluation and authorisation of SFPPs with the objective of ensuring the effective functioning of the internal market in relation to SFPPs, whilst providing the basis for securing a high level of protection for human health.

245 Given the exclusive nature of the safety criteria enshrined in the EU system for harmonising the authorisation of SFPPs, it is solely in the light of those criteria that the proportionality of a measure authorising, renewing or refusing an authorisation must be assessed. It follows that the relevant interests in the context of the review of proportionality are the same as those related to the protection of public health, taken into consideration in the application of the relevant legislation (see, by analogy, judgment of 15 May 2024, Fresenius Kabi Austria and Others v Commission, T‑416/22, EU:T:2024:316, paragraph 208 and the case-law cited).

246 Thus, as the Commission submits, the objective of Regulation No 2065/2003, in the light of which the principle of proportionality must be assessed, is to ensure a high level of protection for human health as regards the issuing of authorisations for SFPPs.

247 In the first place, the applicants submit that the contested acts are neither appropriate nor necessary to achieve the objective of protecting human health that is pursued by Regulation No 2065/2003, given that the products at issue do not present risks to human health.

248 In that regard, it should be noted that the applicants rely on arguments that have already been rejected in the context of the examination of the second and third pleas.

249 The applicants also submit that the contested acts are not appropriate for attaining the objective of protecting human health that is pursued by Regulation No 2065/2003, since they will lead to an increase in the use of the traditional smoking process which presents a higher risk to health than SFPPs.

250 As regards the proportionality of the contested acts in the light of the objective of protecting human health that is pursued by Regulation No 2065/2003, the renewal of the authorisations of the products at issue is subject to the condition, laid down in Article 4(1) of that regulation, that they do not present risks to human health. In accordance with the case-law cited in paragraph 245 above, the risks to health arising from the use of products smoked in a traditional manner, which do not fall within the scope of Regulation No 2065/2003, are irrelevant.

251 In the second place, the applicants claim that the contested acts are disproportionate in that they go beyond what is necessary to achieve the objective of protecting human health. They submit that, even if the products at issue presented risks to human health, the Commission did not consider other measures that are less onerous than the refusals to renew the authorisations. The marketing authorisations could, they argue, be subject to revised conditions of use, namely lowering the maximum limits of use of SFPPs or limiting the categories of food in which SFPPs are authorised.

252 It must be noted that the applicants have merely asserted that it was possible to consider renewing the authorisations of the products at issue by imposing conditions, without establishing that those conditions would have made it possible to ensure that the use of those products did not present risks to human health.

253 In any event, as regards the possibility of lowering the maximum limits of use of SFPPs, it must be borne in mind that, in its opinions, EFSA stated that the exposure estimates for the genotoxic components were at least a factor of 10 400 for SF‑002, 64 for SF‑005 and 3 800 for SF‑006 above the reference TTC. Thus, as the Commission submits, it would not have been possible to reduce exposure to those components to a level below that value so that a renewal of the authorisations would have satisfied the requirements set out in Article 4(1) of Regulation No 2065/2003.

254 Furthermore, it must be stated, as the Commission has submitted, that that solution had not been proposed to it by Kerry. In its letter to the Commission of 26 January 2024, Kerry considered, as an alternative measure, the reduction or removal, in its products, of specific components raising concerns for genotoxicity.

255 As regards the possibility of limiting the categories of foods for which SFPPs are authorised, it is sufficient to note that the applicants have not specified which foods or explained why they should be authorised even though they contain SFPPs, and therefore it has not been established that they do not present any risks to human health.

256 The fourth plea must, therefore, be rejected.

The sixth plea in law, alleging infringement of the right to be heard

257 The applicants claim that EFSA, during the risk assessment phase, and the Commission, during the risk management phase, infringed Kerry’s right to be heard.

258 Under Article 41(2)(a) of the Charter, the right to good administration includes the right of every person to be heard, before any individual measure which would affect him or her adversely is taken.

259 As follows from its very wording, that provision is of general application. Accordingly, the right to be heard must be observed in all proceedings which are liable to culminate in a measure adversely affecting a person, even where the applicable legislation does not expressly provide for such a procedural requirement. Furthermore, that right guarantees every person the opportunity to make known his or her views effectively during an administrative procedure and before the adoption of any decision liable to affect his or her interests adversely (see judgment of 18 June 2020, Commission v RQ, C‑831/18 P, EU:C:2020:481, paragraph 67 and the case-law cited).

260 The right to be heard in an administrative procedure taken against a specific person is a corollary of the rights of the defence, which must be observed even in the absence of any rules governing the procedure in question (see judgment of 17 March 2021, FMC v Commission, T‑719/17, EU:T:2021:143, paragraph 183 and the case-law cited).

261 In the first place, the applicants submit that EFSA infringed Kerry’s right to be heard by refusing to engage in a scientific discussion with it and by failing to take into account its observations on the methodology and the scientific assessment. Following its applications for renewal, Kerry provided additional data, at EFSA’s request, on 10 and 27 February 2023. According to the applicants, EFSA did not take into account the evidence provided by Kerry, in particular the genotoxicity studies in respect of the mixture.

262 In the present case, it should be noted that the applications for renewal of the authorisations of the products at issue were lodged by Kerry. Under Article 7(3) of Regulation No 2065/2003, the dossier must contain, inter alia, the information necessary for the scientific evaluation of the products at issue and a reasoned statement affirming that the product complies with the first indent of Article 4(1) of that regulation.

263 Thus, Kerry had the opportunity to present the methodology which it had used and to express its view that the products at issue did not present any risks to human health.

264 In addition, it must be noted that, pursuant to Article 8(2) of Regulation No 2065/2003, EFSA requested additional information from Kerry. In response, on 10 and 27 February 2023, Kerry provided EFSA with additional data concerning, inter alia, the exposure assessment.

265 EFSA’s opinions were sent to Kerry and were published on 16 November 2023.

266 It is apparent from section 3 of EFSA’s opinions that EFSA carried out the assessment of the products at issue on the basis of the data provided by Kerry, in particular regarding the chemical composition of those products (section 3.1.2.4), their specifications (section 3.1.3), their stability and fate in food (section 3.1.4) and the exposure assessment (sections 3.3.2.1 and 3.3.2.2). EFSA, in section 3.4.2 of its opinions, which concerns the genotoxicity assessment of the primary product as a whole mixture, expressed its position on the various studies which had been submitted by Kerry. The assessments of the data provided by Kerry are set out in section 4, entitled ‘Discussion’, of EFSA’s opinions. Furthermore, section 6 of EFSA’s opinions, which concerns the documentation submitted to it, refers to the additional data provided by Kerry on 10 February and 22 June 2023 for products SF‑002 and SF‑005 and on 27 February 2023 for product SF‑006, as well as various studies submitted by it.

267 It follows that the applicants cannot validly claim that EFSA did not take into account Kerry’s observations or the studies sent to it by Kerry.

268 In the second place, the applicants submit that the Commission infringed Kerry’s right to be heard, first, by refusing to organise a meeting with its Chief Executive Officer (CEO) as requested by the latter in his letter of 1 December 2023; second, by failing to take into account the arguments put forward by Kerry at the meeting of 9 January 2024; and, third, by refusing to consider less onerous alternatives which Kerry had proposed in its letter of 26 January 2024.

269 It should be borne in mind that, by letters of 16 November 2023, the Commission informed Kerry of its intention to reject the applications for renewal of the authorisations of the products at issue. Subsequently, as the applicants acknowledge, Kerry had the opportunity to make its views known to the Commission both in writing and orally.

270 In that regard, on 22 November 2023, a meeting took place between Kerry’s representatives and the Commission’s Directorate-General (DG) for Health and Food Safety.

271 By email of 4 December 2023, Kerry’s CEO sent a letter dated 1 December 2023 to the Commissioner responsible for DG Health and Food Safety, in which he set out his observations on the Commission’s intention not to renew the authorisations of the products at issue and on EFSA’s opinions.

272 In the annex to the letter of 1 December 2023, Kerry explained the negative consequences that a return to the traditional smoking process would have for the health of consumers, for the environment and for the economy. Kerry also stated that the Commission’s intention was not proportionate to the risks identified in EFSA’s opinions and that EFSA had not taken into account the data which Kerry had sent to it. Kerry stated, inter alia, that the Commission was required to take into account the other available solutions and that EFSA had not taken into account the data which Kerry had produced concerning the assessment of the mixture.

273 By the email of 4 December 2023, Kerry’s CEO asked for a meeting to be held in order to discuss the Commission’s intention not to renew the authorisations of the products at issue. That request was made again by email of 18 December 2023.

274 On 9 January 2024, Kerry, together with other authorisation holders, attended a meeting of the Working Group on Flavourings, which operates under the Standing Committee on Plants, Animals, Food, and Feed of DG Health and Food Safety, at which Kerry presented its views on EFSA’s opinions and reiterated its concerns regarding the Commission’s intention not to renew the authorisations of the products at issue.

275 By letter of 26 January 2024 to the Commissioner responsible for DG Health and Food Safety, Kerry’s CEO submitted additional observations on the Commission’s intention not to renew the authorisations of the products at issue. Kerry explained how the non-renewal of the authorisations of the products at issue would cause significant disruption on the EU market and would disregard the significant investments made by Kerry and by other companies. Kerry proposed solutions that were less onerous than the prohibition planned by the Commission.

276 It follows that Kerry was heard by the Commission before the adoption of the contested acts and that it was thus able to submit its observations in good time, both in writing and at a hearing with the Commission’s services.

277 Moreover, since Kerry participated in the meeting of 9 January 2024 organised by the Commission’s services that were responsible for the dossier, the applicants cannot claim that the Commission refused to organise a meeting with Kerry as requested by the latter in its letter of 1 December 2023.

278 The fact that a new meeting was not organised following Kerry’s request in its letter of 26 January 2024 to the Commissioner responsible for DG Health and Food Safety cannot establish that its right to be heard was infringed, since it had already had the opportunity to submit its observations on several occasions and it has not explained what information it intended to submit other than the information contained in that letter.

279 Lastly, contrary to what the applicants claim, the fact that the Commission did not follow Kerry’s observations or that it did not consider the alternatives which Kerry had proposed does not mean that it did not take them into consideration.

280 In that regard, it should be noted that, according to the case-law, although, for there to be observance of the rights of the defence and the right to be heard, the EU institutions must enable the person concerned by the act adversely affecting him or her to make his or her views known effectively, those institutions cannot be required to accept them (see, to that effect, judgments of 30 June 2016, Jinan Meide Casting v Council, T‑424/13, EU:T:2016:378, paragraph 126, and of 27 September 2018, Ezz and Others v Council, T‑288/15, EU:T:2018:619, paragraph 330).

281 It follows that the applicants cannot validly claim that Kerry’s right to be heard was infringed by EFSA or by the Commission.

282 The sixth plea must, therefore, be rejected.

The seventh plea in law, alleging infringement of the obligation to state reasons and of the right to good administration

The first part, alleging infringement of the obligation to state reasons

283 The applicants claim that the Commission infringed the obligation to state reasons in so far as, in the contested acts, it did not set out the grounds enabling them to understand the reasons for the refusal to renew the authorisations of the products at issue. In Implementing Decisions 2024/2066, 2024/2078 and 2024/2079, the Commission did not, they argue, clearly state whether the products at issue presented a risk to human health, and it relied solely on EFSA’s opinions which also do not establish that risk.

284 It should be noted in that regard that the obligation to state reasons constitutes an essential procedural requirement which must be distinguished from the question whether the statement of reasons is well founded, which is a question of the substantive legality of the contested measure (see judgments of 30 January 2025, Frajese v Commission, C‑586/23 P, EU:C:2025:45, paragraph 35 and the case-law cited, and of 15 May 2024, Fresenius Kabi Austria and Others v Commission, T‑416/22, EU:T:2024:316, paragraph 53 and the case-law cited).

285 According to settled case-law, the statement of reasons required by the second paragraph of Article 296 TFEU must be appropriate to the nature of the measure at issue and must show clearly and unequivocally the reasoning of the institution which adopted the measure, so as to enable the persons concerned to ascertain the reasons for the measure and the competent court to exercise its review function. The requirement to state reasons must be assessed in the light of the circumstances of the case and it is not required that the statement of reasons specify all the relevant matters of fact and law, since the question whether the statement of reasons meets the requirements of the second paragraph of Article 296 TFEU must be assessed with regard not only to its wording but also to its context and to all the legal rules governing the matter in question (see judgments of 11 September 2025, Austria v Commission (Paks II nuclear power station), C‑59/23 P, EU:C:2025:686, paragraph 101 and the case-law cited, and of 15 May 2024, Fresenius Kabi Austria and Others v Commission, T‑416/22, EU:T:2024:316, paragraph 54 and the case-law cited).

286 The Commission is not required to adopt a position on all the arguments relied on before it by the parties concerned; rather, it is sufficient if it sets out the facts and legal considerations having decisive importance in the context of the decision (see judgments of 1 July 2008, Chronopost and La Poste v UFEX and Others, C‑341/06 P and C‑342/06 P, EU:C:2008:375, paragraph 96 and the case-law cited, and of 19 March 2025, LG Chem v Commission, T‑356/22, EU:T:2025:319, paragraph 263 (not published) and the case-law cited).

287 It should be recalled that, in recital 6 of Implementing Decisions 2024/2066, 2024/2078 and 2024/2079, the Commission stated that, in its opinions, EFSA had noted that the products at issue contained furan-2(5H)-one and benzene-1,2-diol and that the concern for genotoxicity of those substances had been identified in vivo upon oral administration. It noted that, in accordance with the statement on mixtures and given that the exposure estimates for those two components were above the reference TTC, EFSA had concluded that the products at issue raised concerns for genotoxicity. The Commission noted that EFSA had also concluded that four components of SF‑002 and of SF‑006 and five components of SF‑005 and the unidentified part of the products at issue raised a potential concern for genotoxicity.

288 In recital 7 of Implementing Decisions 2024/2066, 2024/2078 and 2024/2079, the Commission recalled that, in accordance with Article 4 of Regulation No 2065/2003, only smoke flavourings that do not present risks to human health may be authorised and placed on the market. It concluded that it was appropriate to refuse the renewal of the authorisation of the products at issue as SFPPs.

289 Thus, it is clear from Implementing Decisions 2024/2066, 2024/2078 and 2024/2079 that the Commission refused to renew the authorisations of the products at issue on the ground that they did not satisfy the condition laid down in Article 4(1) of Regulation No 2065/2003. The Commission explicitly refers to the findings in EFSA’s opinions according to which the products at issue raised concerns for genotoxicity, in particular because they contained two substances identified as genotoxic, the exposure estimates of which were above the reference TTC. Thus, the applicants were in a position to understand why the Commission considered that it had not been sufficiently demonstrated that the products at issue did not present any risk to human health.

290 In that regard, it must be noted that, contrary to what the applicants claim, neither EFSA nor the Commission had to establish that the products at issue presented a risk to human health; they only had to find that it had not been demonstrated that those products did not present any such risk.

291 It should be noted that, although, by their line of argument, the applicants complain that the Commission inferred that there was a risk by relying solely on EFSA’s findings that the products at issue raised concerns for genotoxicity, that is a line of argument relating to the merits of Implementing Decisions 2024/2066, 2024/2078 and 2024/2079 which is raised in the context of the first and third pleas.

292 Furthermore, the applicants cannot complain that the Commission merely made a reference to one paragraph of EFSA’s findings. Since Implementing Decisions 2024/2066, 2024/2078 and 2024/2079 are consistent with EFSA’s opinions, the Commission was entitled merely to refer to the contents of EFSA’s findings. It should be borne in mind that the applicants were aware of EFSA’s opinions and were able to express their view on those opinions before Implementing Decisions 2024/2066, 2024/2078 and 2024/2079 were adopted.

293 It should also be noted, as regards the context in which Implementing Decisions 2024/2066, 2024/2078 and 2024/2079 were adopted, that Kerry was aware of the 2021 Guidance and the other EFSA cross-sectional guidance documents which Kerry had to take into account in its applications for renewal. The applicants were therefore in a position to have knowledge of the scientific reasoning followed by EFSA in its opinions, the merits of which, moreover, they have challenged in the context of the first and second pleas.

294 It follows that the applicants were in a position to have knowledge of the reasons for the refusals to renew the authorisations of the products at issue set out in Implementing Decisions 2024/2066, 2024/2078 and 2024/2079 and to challenge their merits.

295 Furthermore, contrary to what the applicants submit, it follows from the case-law cited in paragraph 286 above that the Commission was not required to respond to all the arguments raised by Kerry during the renewal procedure or to explain why risk management options were not considered.

296 Lastly, the applicants cannot validly claim that the Commission did not explain why Implementing Regulation 2024/2067 set out two different transitional periods. It is sufficient to note that those reasons are clear from recitals 8 and 9 of that implementing regulation.

297 In recitals 8 and 9 of Implementing Regulation 2024/2067, the Commission explains that foods to which SFPPs are added, when replacing the conventional smoking process, should be allowed to be placed on the market until 1 July 2029, in order to allow food business operators to adjust production processes. For other foods to which SFPPs are added, the transitional period is set to run until 1 July 2026 in order to allow for recipes to be adjusted.

298 The first part must, therefore, be rejected.

The second part, alleging infringement of the right to good administration

299 The applicants claim that the Commission infringed the right to good administration enshrined in Article 41 of the Charter by failing to examine carefully and impartially all the relevant aspects of the case.

300 It should be recalled that the institutions, bodies, offices and agencies of the European Union are required to respect the fundamental rights guaranteed by EU law, which include the right to good administration, enshrined in Article 41 of the Charter (see judgments of 21 October 2021, Parliament v UZ, C‑894/19 P, EU:C:2021:863, paragraph 51 and the case-law cited, and of 12 December 2024, DD v FRA, C‑680/22 P, EU:C:2024:1019, paragraph 28 and the case-law cited).

301 Article 41(1) of the Charter states that every person has the right to have his or her affairs handled impartially, fairly and within a reasonable time by the institutions and bodies of the European Union. Article 41(2) of the Charter provides that that right includes the right of every person to be heard, before any individual measure which would affect him or her adversely is taken; the right of every person to have access to his or her file, while respecting the legitimate interests of confidentiality and of professional and business secrecy; and the obligation of the administration to give reasons for its decisions.

302 According to the case-law, the administration is required, under the principle of good administration, to examine carefully and impartially all the relevant aspects of the case before it and to gather all the factual and legal information necessary to exercise its discretion, as well as ensure the proper conduct and effectiveness of the procedures that it implements (see judgment of 15 November 2023, PL v Commission, T‑790/21, EU:T:2023:724, paragraph 100 and the case-law cited; see also, to that effect, judgment of 8 June 2017, Schniga v CPVO, C‑625/15 P, EU:C:2017:435, paragraph 47 and the case-law cited).

303 In the first place, the applicants submit that the Commission acted in breach of the principle of good administration by failing to carry out a proper risk management, by failing to hear Kerry during the administrative procedure and by failing to state reasons for the contested acts.

304 It is sufficient to note that the applicants merely refer to the arguments raised in the context of the third and sixth pleas and in the first part of the seventh plea, which have already been rejected.

305 In the second place, the applicants claim that the administration’s negligence is also illustrated by the extremely short periods within which EFSA and the Commission carried out their assessments of the products at issue.

306 It must be noted that EFSA and the Commission complied with the time limits laid down in Regulation No 2065/2003. Thus, in accordance with Article 8(1) and (2) of Regulation No 2065/2003, EFSA adopted its opinions on 28 September 2023, within six months of Kerry’s submission of additional information. In accordance with Article 9(1) of Regulation No 2065/2003, the Commission adopted its draft measure, on 16 November 2023, within three months of receiving EFSA’s opinions.

307 Under Article 12 of Regulation No 2065/2003, the decision on the renewal of an authorisation must in principle be adopted one month before the date on which the authorisation expires, failing which the period of authorisation of the product is extended by six months. In the present case, the authorisations of the products at issue expired on 1 January 2024, and, on 31 July 2024, the Commission adopted its decisions refusing to renew those authorisations.

308 The applicants cannot therefore maintain that compliance with the time limits laid down in Regulation No 2065/2003 constitutes an infringement of the right to good administration.

309 In the reply, the applicants merely assert that compliance with deadlines does not automatically amount to good administration if the quality and thoroughness of the examination are compromised.

310 In that regard, it is sufficient to note that the applicants have not put forward any arguments other than those referred to in paragraph 303 above to establish that the Commission failed to examine carefully and impartially all the relevant aspects of the case.

311 It follows that the second part must be rejected, as must, therefore, the seventh plea in its entirety.

The request for measures of inquiry

312 The applicants, in the application and in the reply, requested the Court to adopt a measure of inquiry, under Article 88(1) of the Rules of Procedure, concerning the hearing of a witness in order to provide explanations on the scientific observations which the applicants submitted to EFSA and to enable the Court to assess the accuracy and scientific excellence of those observations.

313 As regards applications made by a party to a dispute for measures of organisation of procedure or measures of inquiry, the Court is the sole judge of any need to supplement the information available to it in respect of the cases before it (see judgment of 22 November 2023, Del Valle Ruíz and Others v SRB, T‑302/20, T‑303/20 and T‑307/20, EU:T:2023:735, paragraph 215 and the case-law cited).

314 It follows from the case-law that, even where a request for the examination of witnesses, made in the application, states precisely about what facts and for what reasons the witness or witnesses should be examined, it falls to the Court to assess the relevance of the application to the subject matter of the dispute and the need to examine the witnesses named (see judgment of 22 November 2023, Del Valle Ruíz and Others v SRB, T‑302/20, T‑303/20 and T‑307/20, EU:T:2023:735, paragraph 216 and the case-law cited).

315 In the present case, it must be noted that the elements in the file and the explanations provided during the hearing are sufficient to allow the Court to give a ruling, since it has been able to give a proper ruling on the basis of the forms of order sought, the pleas in law and the arguments put forward during the proceedings, and in the light of the documents lodged by the parties.

316 Accordingly, the applicants’ request for measures of inquiry must be rejected.

317 In the light of all the foregoing, the action must be dismissed in its entirety.

Costs

318 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 applicants have been unsuccessful, they must be ordered to bear their own costs and to pay those incurred by the Commission, in accordance with the form of order sought by the Commission.

319 In accordance with Article 138(1) of the Rules of Procedure, the institutions which have intervened in the proceedings are to bear their own costs. The Parliament and the Council shall therefore bear their own costs.

On those grounds,

THE GENERAL COURT (Fourth Chamber)

hereby:

1. Dismisses the action;

2. Orders Kerry Inc. and Kerry Ingredients (UK) Ltd to bear their own costs and to pay those incurred by the European Commission;

3. Orders the European Parliament and the Council of the European Union to bear their own costs.

De Baere

Svenningsen

Mac Eochaidh

Delivered in open court in Luxembourg on 11 November 2026

T. Henze

S. Papasavvas

Acting Registrar

President

* Language of the case: English.