ECLI:EU:C:2026:752

Texto completo

OPINION OF ADVOCATE GENERAL

ĆAPETA

delivered on 10 September 2026 (1)

Cases C‑38/25 P, C‑48/25 P, C‑54/25 P and C‑55/25 P

European Commission

Aloe Vera of Europe BV (C‑38/25 P)

Aboca SpA Soc. agr.,

Coswell SpA,

Associação portuguesa de suplementos alimentares (Apard) (C‑48/25 P)

Ortis SA (C‑54/25 P)

Syndicat national des compléments alimentaires (Synadiet),

Asociación Española de Fabricantes de Preparados alimenticios especiales, dietéticos y plantas medicinales (Afepadi),

Be-Sup Asbl,

Fitoform SAS,

Laboratoires Diététique et Santé SASU,

Laboratoires Forte Pharma S.A.M,

Laboratoires Ilapharm SAS,

Laboratoires Ineldea SAS,

Laboratoires Juva Santé SASU,

Laboratoire Pionneau SAS,

Laboratoires Super Diet SASU,

Laboratoires Vitarmonyl SARL,

La Source SARLU,

Les Trois Chênes SA,

Naturenvie SAS,

Noria Distribution SAS,

Pharmanager Ingrédients SAS,

Plantex SASU,

Santé Verte SAS,

Thera-Sana SASU,

Vitamins SAS,

V.S. Vecteur Santé Laboratoires (C‑55/25 P)

( Appeal – Consumer protection – Regulation (EC) No 1925/2006 – Article 8 – Substances prohibited, restricted or under EU scrutiny – Regulation (EU) 2021/468 – Prohibition on ‘preparations’ derived from the parts of plant species containing hydroxyanthracene derivatives – Conditions governing the procedure of prohibiting substances, restricting their use or placing them under EU scrutiny )

I. Introduction

1. If an ingredient comes with more caveats than culinary value, it is time to rethink the recipe.

2. Pursuant to Article 8 of Regulation (EC) No 1925/2006 (‘the Additions Regulation’), (2) the Commission is tasked, in essence, with identifying reasons for those caveats and determining whether and to what extent it is necessary to regulate and, if need be, prohibit the addition of particular substances and ingredients to foods in the light of public health considerations.

3. The present appeals concern four judgments of the General Court. (3) Therein, that court annulled Regulation (EU) 2021/468 (‘the contested regulation’) (4) in so far as it prohibited or placed under scrutiny on grounds of public health concerns the addition to foods of a number of substances and ‘preparations’ derived from plant species, including that of the Aloe, containing hydroxyanthracene derivatives (‘HADs’).

4. The European Commission has appealed against those judgments, arguing, in essence, that the General Court misinterpreted the requirements for, and the procedure underlying, Article 8 of the Additions Regulation.

II. Legal and factual background to the present appeals

A. The Additions Regulation

5. One of the basic functions of food is to provide nutrition for growth, development and maintenance of a healthy life. To that end, food must be safe. Accordingly, the EU legislature has put in place a comprehensive body of EU regulations concerning the nutritional and health value of foods as well as their presentation and advertising. (5)

6. One part of that framework is the Additions Regulation. That regulation explains that the addition of nutrients and other ingredients to foods or their use in the manufacture of foods is practised either voluntarily or compulsorily, and for different purposes. (6) Therefore, and with a view to facilitating the free movement of such foods within the internal market, that regulation seeks to harmonise divergent national rules concerning the addition of vitamins, minerals and other substances. (7)

7. However, the Additions Regulation also pursues a high level of consumer health protection. (8) To that end, it seeks to ensure that the substances added to foods are safe. (9)

8. The Explanatory Memorandum underlying the Additions Regulation places particular emphasis on that safety aspect where ‘substances or ingredients other than vitamins and minerals’ are added in an ‘“innovative” way’. Their use ‘is increasingly cause for concern … largely due to the absence of scientific data to demonstrate that their use in large quantities, often far in excess of the quantities in which these substances would be ingested with a normal diet, do not pose any risks to health’. (10)

9. Against that background, the Additions Regulation explains that while ‘a normal and varied diet contains many ingredients, which in turn contain many substances … the intake [of which] would not cause concern and does not need to be regulated’, (11) ‘there is a wide range of nutrients and other ingredients that might be used in food manufacturing, including, but not limited to, vitamins, minerals including trace elements, amino acids, essential fatty acids, fibre, various plants and herbal extracts’. (12) However, ‘some substances other than vitamins and minerals or ingredients containing them are added to foods as extracts or concentrates and may result in intakes that are significantly higher than those that could be ingested through eating an adequate and varied diet. The safety of such practices is in some cases seriously contested and the benefits are unclear [which is why] it is appropriate, in such cases, that food business operators, responsible for the safety of the foods they place on the market, assume the burden of proof in relation to their safety.’ (13)

10. To that end, the regulation provides for two separate frameworks.

11. The first framework governs the requirements for, restrictions on and conditions for the addition of vitamins and minerals to foods. It is contained in Articles 3 to 7 of the Additions Regulation. Those provisions establish a positive list of the types of vitamins and minerals which may be added to foods and the forms that those vitamins and minerals may take, (14) as well as certain restrictions (15) and requirements (16) relating to their addition to foods.

12. The second framework deals with the addition of substances other than vitamins and minerals. It is that framework, provided for in Article 8 of the Additions Regulation, which is of interest to the present appeals.

13. Article 8(1) of that regulation explains that the procedure to be followed in that article ‘shall be followed where a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, is added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts … greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.’ (17)

14. In other words, Article 8(1) foresees that the procedure therein is triggered in three situations: (i) where foods fortified with substances other than vitamins and minerals are ingested at levels that ‘greatly exceed’ normal consumption conditions; (ii) where such ingestion occurs and where there is a possibility that the amounts ingested would pose a potential food safety risk to consumers; or (iii) where, irrespective of the level of ingestion, there is a possibility that ingesting that substance would pose a potential food safety risk to consumers.

15. Where one of those situations occurs, Article 8(2) of the Additions Regulation empowers the Commission to ask the European Food Safety Authority (EFSA) for an assessment ‘of available information’ relating to the addition of those other substances to foods or their use in the manufacture of foods, and if need be, include the substance in Annex III thereto. That annex is composed of Parts A (‘Prohibited substances’), B (‘Restricted substances’) and C (‘Substances under [EU] scrutiny’). The requirements for including the substance or ingredient in Annex III are described in Article 8(2)(a) and (b) of the regulation as follows:

‘(a) if a harmful effect on health has been identified, the substance and/or the ingredient containing the substance shall:

(i) be placed in Annex III, Part A, and its addition to foods or its use in the manufacture of foods shall be prohibited; or

(ii) be placed in Annex III, Part B, and its addition to foods or its use in the manufacture of foods shall only be allowed under the conditions specified therein;

(b) if the possibility of harmful effects on health is identified but scientific uncertainty persists, the substance shall be placed in Annex III, Part C.’

16. The Commission may initiate the above procedure on its own initiative or on the basis of information provided by the Member States. (18)

B. Events leading to the contested regulation

17. HADs are a class of chemical substances with different and heterogeneous structures. (19) They are widely used in food supplements and herbal medicinal products for their laxative effect. (20)

18. According to the General Court, HADs naturally occur in different botanical species, including certain species of Aloe as well as certain fruits and vegetables. (21)

19. In the species of Aloe, (22) HADs are ‘primarily found in the aloe latex, the exudate found in between the inner leaf, i.e. the clear, central parenchymatous tissues of the aloe leaf, and the rind’. (23)

20. On 29 June 2016, acting on its own initiative following concerns raised by the Member States, the Commission initiated the procedure laid down in Article 8 of the Additions Regulation by asking EFSA to evaluate the available information on the safety of the use of HADs from all food sources. It also asked EFSA to recommend a daily intake of HADs that does not give rise to concerns about possible harmful effects on health for the general population and, as appropriate, for vulnerable subgroups of the population. (24)

21. On 22 November 2017, EFSA adopted the 2017 EFSA Opinion, titled ‘Safety of [HADs] for use in food’. On the basis of all available data, EFSA concluded that HADs ‘should be considered as genotoxic and carcinogenic’ in nature, (25) and that it ‘was unable to provide advice on a daily intake of [HADs] that does not give rise to concerns about harmful effects to health’. (26)

22. Indeed, according to the case file, EFSA takes the position that it is unable to set a safe daily intake of HADs given that, once concern for genotoxicity exists, there is no level below which exposure to genotoxic substances can be considered safe, since even the lowest exposure represents a risk. (27) Accordingly, ‘establishing health-based guidance values is not considered appropriate’. (28)

23. In the light of EFSA’s opinion, the Commission adopted the contested regulation on 18 March 2021.

24. Therein, the Commission, in relevant part, explains that EFSA ‘found that the [HADs] aloe-emodin and emodin and structurally related substance danthron have been shown to be genotoxic in vitro. Aloe extracts have also been shown to be genotoxic in vitro most likely due to [HADs] present in the extract. Furthermore, aloe-emodin was shown to be genotoxic in vivo. The whole leaf aloe extract and structural analogue danthron were shown to be carcinogenic.’ (29) The Commission thus concluded that given ‘the severe harmful effects on health associated with the use of aloe-emodin, emodin, danthron and aloe extracts containing [HADs] in food, and that no daily intake of [HADs] that does not give rise to concerns for human health could be set, such substances should be prohibited’. (30) Moreover, ‘as there is a possibility of harmful effects on health associated with the use of Rheum, Cassia and Rhamnus and their preparations in food, but scientific uncertainty persists about whether such preparations contain the substances listed in Annex III, Part A of [the Additions Regulation], such substances should be placed under Union scrutiny and therefore, should be included in Part C of Annex III’ to that regulation. (31)

25. Accordingly, under Article 1(1) of the contested regulation, the Commission amends Annex III to the Additions Regulation as follows: in Part A, it adds ‘aloe-emodin and all preparations in which this substance is present’, ‘emodin and all preparations in which this substance is present’, preparations from the leaf of Aloe species containing [HADs]’ and ‘danthron and all preparations in which this substance is present’.

26. Similarly, under Article 1(2) of the contested regulation, the Commission adds to Part C of the Additions Regulation, ‘preparations from the root or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids containing [HADs]’, ‘preparations from the leaf or fruit of Cassia senna L. containing [HADs]’ and ‘preparations from the bark of Rhamnus frangula L. or Rhamnus purshiana DC. containing [HADs]’.

C. Procedure before the General Court

27. Between 10 April and 27 May 2021, Aloe Vera of Europe BV (in Case T‑189/21), Ortis (in Case T‑271/21), Syndicat national des compléments alimentaires (Synadiet) and Others (in Case T‑274/21), and Aboca, Coswell and Apard (in Case T‑302/21), all producers or representatives of producers which market products containing substances derived from plant species containing HADs, brought actions requesting the annulment of the contested regulation.

28. On 13 November 2024, the General Court handed down the judgments under appeal, by which it upheld the pleas of the applicants at first instance in so far as they alleged infringement of the requirements provided for in Article 8(1) and (2) of the Additions Regulation. It did not assess any other pleas put forward by those parties.

29. In respect of its judgments in T‑302/21, in T‑271/21 and in T‑274/21, the General Court found that Article 8 of the Additions Regulation did not allow ‘preparations’ to be included in the lists in Parts A and C of Annex III thereto. (32) In addition to that finding, in respect of its judgments in T‑189/21, in T‑302/21, in T‑271/21 and in T‑274/21, the General Court also found that the Commission erroneously failed to establish a risk threshold for prohibiting the addition to foods, or the use in the manufacture of foods, of substances containing HADs, in accordance with Article 8(1) and (2) of the Additions Regulation. (33)

30. Consequently, the General Court annulled the contested regulation in its relevant parts.

D. Procedure before the Court of Justice

31. By its four appeals, the Commission requests the Court of Justice to set aside the judgments under appeal, to give final judgment in each case by dismissing the applications pursuant to Article 61 of the Statute of the Court of Justice of the European Union or, in the alternative, to refer the cases back to the General Court for consideration of the pleas not already assessed, and to order the applicants at first instance to pay the costs or to reserve the costs in the event that the case is referred back to the General Court.

32. The Commission is supported in that action by EFSA, which has been granted leave to intervene in each of the appeals. (34)

33. No hearing was held.

III. Analysis

34. My Opinion is structured as follows. I will begin with the argument that the General Court erred in holding that Article 8 of the Additions Regulation does not permit ‘preparations’ of substances other than vitamins and minerals to be included in the lists of Annex III to that regulation (Section A). Thereafter, I will turn to the argument that the conditions underlying Article 8(1) and (2) of that regulation should not be read cumulatively, such that the Commission should have set a risk threshold for the addition of substances containing HADs to foods or their use in the manufacture of foods (Section B). Lastly, my analysis will turn to the argument alleging a failure to state reasons and the General Court exceeding its powers of review (Section C).

A. Ground of appeal relating to the inclusion of ‘preparations’ containing substances other than vitamins and minerals in Annex III to the Additions Regulation

35. By its first ground of appeal in Cases C‑48/25 P, C‑54/25 P and C‑55/25 P, the Commission challenges the General Court’s finding that the concept of ‘preparations’ is not covered by the scope of Article 8 of the Additions Regulation. In its judgments in Cases T‑302/21, T‑271/21 and T‑274/21, that court found that Article 8 of the Additions Regulation refers solely to the concepts of ‘substances’, ‘ingredients’ and ‘ingredient containing [that] substance’. Thus, it observed, under Article 8(2)(a)(i) of the Additions Regulation, only the addition to, or use in the manufacture of, foods of a ‘substance’ or ‘an ingredient containing [that] substance’ could be prohibited by inclusion in Part A of Annex III to that regulation. However, the General Court considered that the concept of ‘preparations’ goes beyond the scope of either of those concepts. Similarly, it observed that given that Article 8(2)(b) of that regulation refers only to ‘substances’ and not to ‘ingredients’, its scope must be more limited than Article 8(2(a)(i) thereof. Accordingly, only ‘substances’ for which the possibility of harmful effects on health has been identified but for which uncertainty exists may be added to Part C of Annex III. On the basis of those interpretations, the General Court found that the concept of ‘preparations’ is not covered by either of the concepts of ‘substances’ or ‘ingredients’, that it cannot be substituted for either of those concepts and that, accordingly, the Commission was not able to rely on those provisions in order to adopt the amendments to Parts A and C of that regulation by means of Article 1(1) and Article 1(2) of the contested regulation.

36. The Commission, supported by EFSA, challenges that finding. Those parties argue that, in concluding that the concept of ‘preparations’ is broader than the scope of Article 8(2) of the Additions Regulation, that is to say, that it is not covered by the concept of ‘substances’ or ‘ingredients’, the General Court erred in law. That court’s reasoning is not consistent with the wording, the context and the objective of the procedure laid down in Article 8 thereof, nor is it capable of safeguarding the effectiveness of the regulation as a whole.

37. The respondents dispute that line of argument and support the General Court’s reasoning.

38. I agree with the Commission and EFSA.

39. The wording of Article 8(1) of the Additions Regulation emphasises that it seeks to cover those circumstances in which ‘a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, is added to foods or used in [their] manufacture’.

40. It is first and foremost by reference to a literal reading of that provision that the General Court considered that the procedure provided for therein does not apply to the addition of ‘preparations’ of substances containing HADs.

41. I can understand the General Court’s frustration with that terminology. The word ‘preparations’ is not contained in Article 8 of the Additions Regulation, nor is it used in the remainder of that regulation. Depending on how that word is interpreted, its use may be read as going beyond the scope of that regulation. Why the Commission nonetheless considered it necessary to use that terminology in the operative part of an implementing regulation, and therefore risk being misunderstood as to the scope of its intended regulation, is not explained in the case file.

42. The Commission and EFSA have not provided a convincing explanation in that regard. For example, the fact that EFSA, in a 2009 guidance document (35) not related to the present proceedings, uses the concept of ‘preparations’ instead of ‘substances’ or ‘ingredients’ to provide further nuance to its analyses (which it is perfectly entitled to do) is certainly useful to understand the context in which that term is employed. However, it cannot possibly influence the scope of, or the terminology used by, a higher-ranking act of EU law.

43. At the same time, one need not overlook the fact that all acts of the EU institutions enjoy a general presumption of validity. (36) That means that those acts must be interpreted, as far as possible, in such a way as to respect that presumption. To my mind, that also implies that the mere use of a word in the operative part of an implementing act that is not otherwise used in the basic act is, in itself, not capable of overturning that presumption.

44. That is particularly so where, as in the present proceedings, the Commission and EFSA have argued both before the General Court and before the Court of Justice that the concept of ‘preparations’, as used in the contested regulation, should be understood to cover all those products used as inputs in a manufacturing process that contain the substance for which harmful effects have been identified.

45. In other words, both the Commission and EFSA insist that, by means of the concept of ‘preparations’, the contested regulation sought to cover the indirect addition of a prohibited substance to foods or the manufacture thereof.

46. To those parties, such a reading is not precluded by the scope or purpose of Article 8 of the Additions Regulation. They highlight that the General Court’s literal reading of that provision fails to take account of not only other literal elements contained in that provision, such as the expressions ‘added to foods’ and ‘used in the manufacture of foods’, but also the fact that, depending on how the concept of ‘ingredients’ is interpreted, it is capable of encompassing the various forms of indirect addition to foods or use in the manufacture of foods of substances for which harmful effects have been identified.

47. In my view, an interpretation according to which the concept of ‘ingredients’ is understood as the various forms and ways of indirectly adding a harmful substance to foods would indeed best preserve the function of Article 8 of the Additions Regulation.

48. As I have explained, the objective of that regulation is to lay down a framework to control the ‘wide range of nutrients and other ingredients that might be used in food manufacturing’, (37) the voluntary addition of which could provide a cause for concern for consumers’ health. (38)

49. Article 8 of the Additions Regulation does so in relation to substances other than vitamins and minerals. (39)

50. To achieve that aim, it should matter little whether said substance is in its pure form or is obtained from prior processes to be included, directly or indirectly, as a ‘preparation’, mixture or ingredient, provided it is voluntarily added to foods or used in the manufacture of foods.

51. Indeed, as EFSA explains, what matters is the fact that a harmful substance is added, irrespective of the way in which that addition occurs. After all, the success and failure of the framework provided for in Article 8 of that regulation lies in the ability of the Commission to regulate that addition as regards potentially harmful substances.

52. Accordingly, Article 8 of the Additions Regulation must be capable of covering the various forms such a substance may take as well as the diverse ways in which that substance may be added to foods or used in the production of foods.

53. A different interpretation, such as that adopted by the General Court, could lead to a situation in which the Commission could, in effect, regulate the direct addition of, say, aloe-emodin, emodin or danthron to foods, but not their indirect addition through their prior inclusion in a preparation before their addition to foods or used in the manufacture thereof. I cannot see how that would be logical or in line with the objective of protecting the consumer from harmful additions to foods.

54. Moreover, that interpretation would deprive the word ‘ingredient’, as used in Article 8 of the Additions Regulation, of its practical effect within that provision.

55. Therefore, whether a substance is added directly to foods or used in their manufacture, or first combined with other substances before being added to foods or used in their manufacture, the procedure provided for in Article 8 of the regulation must be capable of covering it.

56. The same logic must necessarily extend to Article 8(2)(b) of the Additions Regulation.

57. It is true, as the respondents and the judgments under appeal highlight, that that provision refers only to the concept of ‘substances’ and not also to that of ‘ingredients’. It is on that basis that it has been argued that Article 8(2)(b) of the Additions Regulation solely allows substances that are directly added to foods or used in their manufacture to be placed under EU scrutiny. However, as I have explained, in view of the objective pursued by the framework of Article 8 of the Additions Regulation as a whole, it would be illogical to limit that process accordingly and to exclude the possibility of placing under scrutiny the indirect addition of substances for which possible harmful effects on health have been identified but where scientific uncertainty persists.

58. A contrary reading also makes no sense if viewed contextually within Article 8 itself: under the urgency procedure of paragraph 5 thereof, the Commission may transfer a ‘substance’ from Part C of Annex III to Part A or B. Accordingly, for such a transfer to be possible for ‘ingredients’ on imperative grounds of urgency, Part C must be capable of harbouring ‘ingredients’ also. That means that Article 8(2)(b) of that regulation must be interpreted as extending to the placing of ‘ingredients’ in Part C of Annex III to that regulation. Therefore, and irrespective of the fact that the respondents’ line of argument is not novel, (40) it is in any event not capable of precluding the Commission from regulating the addition to foods of substances that may be harmful to human health.

59. Applied to the circumstances of the present proceedings, that means that nothing in the Additions Regulation speaks against interpreting the concepts of ‘substances’ and ‘ingredients’, as contained in Article 8 thereof, as referring to the indirect addition of substances other than vitamins and minerals to foods or use of those substances in the manufacture of foods as ‘preparations’. Therefore, the General Court erred when it interpreted that provision as not extending to such a scenario and when it annulled the relevant parts of the contested regulation inter alia on that basis.

60. On the basis of the above, I propose that the Court uphold the Commission’s first ground of appeal in Cases C‑48/25 P, C‑54/25 P and C‑55/25 P as well founded.

B. Grounds of appeal relating to the conditions underlying Article 8(1) and (2) of the Additions Regulation

61. In the judgments under appeal, the General Court interpreted Article 8(1) and (2) of the Addition Regulation as laying down two cumulative conditions for the Commission to be capable of prohibiting the addition to foods or the use in the manufacture of foods of a substance or ingredient: first, that their addition results in the ingestion of amounts of the substance in question greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers (Article 8(1)); and, second, that a harmful effect on health has been identified (Article 8(2)). On that basis, and considering that the Commission did not provide a threshold concerning the amounts of HADs in a balanced and varied diet, as it would have been required to do under Article 8(1) of that regulation, the General Court annulled the relevant parts of the contested regulation. (41)

62. By its first ground of appeal in Case C‑38/25 P and its second ground of appeal in Cases C‑48/25 P, C‑54/25 P and C‑55/25 P, the Commission contests those findings. Supported by EFSA, it argues, in essence, that it is only the condition relating to the identification of an adverse health effect, provided for in Article 8(2)(a) of that regulation, that must be satisfied in order to prohibit the addition of a substance to foods or its use in the manufacture thereof, either directly or through ingredients containing it. (42)

63. The respondents challenge that line of argument and support the General Court’s reasoning.

64. I agree with the Commission and EFSA.

65. As explained in point 14 of the present Opinion, Article 8(1) of the Addition Regulation lays down three risk scenarios in which the Commission is empowered to initiate the procedure of placing certain substances and/or ingredients in Annex III: first, where ingestion beyond a normal and balanced diet occurs; second, where such ingestion occurs and there exists a potential risk to consumers; or, third, where, irrespective of the level of ingestion, the addition of said substances or ingredients presents a potential risk to consumers.

66. Those conditions are clearly antecedent to and separate from the decision-making process that takes place under Article 8(2) of the Additions Regulation to regulate the risk thus identified. That decision-making process is only commenced after the Commission finds, either on the basis of concerns raised by the Member States or on its own initiative, that one or more of the risks laid down in Article 8(1) of the Additions Regulation may be found to exist.

67. Indeed, it appears clear to me that Article 8 of the Additions Regulation is structured in two distinct steps: the step of identifying a risk (under Article 8(1) of that regulation) and the step of deciding how to manage that risk (under Article 8(2) thereof).

68. For this second step – the risk management stage – the Commission must decide between the policy choices set by the EU legislature as to how to deal with the substance or ingredient at issue.

69. At this point in time, the risk identification scenarios provided for in Article 8(1) of the Addition Regulation are irrelevant.

70. Indeed, as Article 8(2) thereof notes, at this point in time, depending on the assessment made by EFSA, the Commission may, if a harmful effect is found, place the substance or ingredient in Part A and thereby prohibit its use outright (under Article 8(2)(a)(i)) or place it in Part B and allow its addition, subject to conditions (under Article 8(2)(a)(ii)); or if a harmful effect is identified but scientific uncertainty persists, place the substance or ingredient in Part C, allow its use and subject it to scrutiny (under Article 8(2)(b)). In other words, the Commission must decide on the specific actions to take by reference to the scientifically established likelihood of harmful effects.

71. In the context of the present proceedings, I understand that the Commission initiated the procedure provided for in Article 8(1) of the Additions Regulation purely on the basis of the risk of an ingestion of substances containing HADs presenting a health risk to consumers. In view of the assessment provided by EFSA finding that such risks exist for certain substances, (43) the Commission then followed the policy choice provided for in Article 8(2)(a)(i) of the Additions Regulation.

72. As is clear from the text of that provision, if the Commission takes a decision pursuant to Article 8(2)(a)(i), it must prohibit the substance or ingredient outright, and therefore does not have discretion to set a consumption threshold for that particular kind of substance (even if that were possible for genotoxic substances). (44) Had it been given such discretion, the EU legislature would have indicated that to be the case, as it did under Article 8(2)(a)(ii) thereof. (45)

73. Therefore, it is clear that the General Court erred in finding that Article 8(2) of the Additions Regulation must be read alongside Article 8(1) thereof, with the result that there are two conditions which the Commission must satisfy before listing a substance in Annex III to that regulation.

74. Contrary to what the respondents observe, the above interpretation does not deprive Article 8(1) of the Additions Regulation of its function. To my mind, those parties confuse the two distinct concepts of risk assessment and risk management.

75. Risk assessment, on the one hand, is a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation. (46) This process involves a complex scientific evaluation of the safety of a substance or biological agent based on all relevant scientific and technical data with a view to identifying and preventing emerging risks. At EU level, and for the purposes of the Additions Regulation, this task is performed by EFSA. Risk management, on the other hand, is a ‘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’. (47) It is only once the risk analysis is complete that the relevant authorities will be in a position to decide on the appropriate measures to achieve the desired level of protection. (48)

76. As I have explained, whereas Article 8(1) of the Additions Regulation may be understood as an element of risk assessment, Article 8(2) thereof clearly lays down the various options for managing a risk that has already been identified, assessed and characterised by EFSA. (49) In the present case, the Commission managed the risk identified by EFSA through the measure laid down in Article 8(2)(a)(i) of the Additions Regulation: placing the substance in question on List A of Annex III to that regulation and prohibiting its addition to foods or its use in the manufacture of foods. The review of that decision by the Commission is subject to the determination of a manifest error of assessment.

77. On the basis of the above, I propose that the Court uphold the Commission’s first ground of appeal in Case C‑38/25 P and the second ground of appeal in Cases C‑48/25 P, C‑54/25 P and C‑55/25 P as well founded.

C. Grounds of appeal relating to the General Court’s duty to state reasons and its powers of review

78. By its second ground of appeal in Case C‑38/25 P and its third ground of appeal in Cases C‑48/25 P, C‑54/25 P and C‑55/25 P, the Commission, supported by EFSA, argues that the General Court failed to state reasons (50) and that it exceeded its powers of judicial review. (51)

79. The respondents consider that the Commission’s arguments are inadmissible and that, in any event, the General Court neither failed to state reasons nor exercised an intensity of review beyond its powers.

80. I agree with the respondents.

81. As regards the claim that the General Court failed to state reasons, it should be recalled that one must distinguish between the existence of a statement of reasons, as required by Article 296 TFEU, and the question whether that reasoning is well founded. Only an argument relating to the existence of a statement of reasons can be subsumed under Article 296 TFEU. (52) It is clear, however, that the Commission does not allege that the judgments under appeal lack reasoning. Instead, it criticises the content of that reasoning in the statements at issue. Since that type of argument is not capable of being subsumed under Article 296 TFEU, the Commission’s line of argument must be rejected as inadmissible to that extent.

82. As regards the claim that the General Court exceeded its power of judicial review, first, and contrary to what the Commission argues, the General Court did not undertake a comprehensive review of the Commission’s factual determination relating to Article 8 of the Additions Regulation, and therefore exceeded its powers of review as regards scientific assessments. (53) Rather, that court reviewed the Commission’s interpretation of Article 8(1) and (2) of the Additions Regulation, in relation to which, as explained, it erroneously construed those provisions as laying down cumulative conditions. Since the EU Courts hold full jurisdiction to interpret the law, the Commission’s argument must be rejected as unfounded to that extent. Second, in so far as the Commission considers that the General Court substituted its reasoning for that of EFSA when concluding that ‘it is not apparent from the 2017 scientific opinion or from any material in the case file that the provisions of the contested regulation were adopted because the substances and preparations in question otherwise represented a potential risk to consumers’, (54) it is clear that that finding is a factual determination limited to what the General Court considered was contained in the case file. That statement does not constitute a scientific assessment. Accordingly, in seeking to challenge a factual determination by the General Court without raising its potential distortion, that argument, too, must be considered inadmissible.

83. On the basis of the above, I propose that the Court reject the Commission’s second ground of appeal in Case C‑38/25 P and its third ground of appeal in Cases C‑48/25 P, C‑54/25 P and C‑55/25 P as in part inadmissible and in part unfounded.

IV. Consequences

84. The first ground of appeal in Case C-38/25 P, and the first and second grounds of appeal in Cases C 48/25 P, C 54/25 P and C 55/25 P are well founded. Accordingly, the judgments under appeal should be set aside. However, since the General Court did not assess all the pleas in law raised at first instance, the Court of Justice is not in a position to give final judgment and must refer the underlying cases back to the General Court. (55)

V. Conclusion

85. I propose that the Court of Justice should:

– set aside the judgments of 13 November 2024, Aloe Vera of Europe v Commission (T‑189/21, EU:T:2024:802); of 13 November 2024, Aboca and Others v Commission (T‑302/21, EU:T:2024:808); of 13 November 2024, Ortis v Commission (T‑271/21, EU:T:2024:804); and of 13 November 2024, Synadiet and Others v Commission (T‑274/21, EU:T:2024:806);

– refer the case back to the General Court for the resolution of the remaining pleas in law; and

– order that the costs be reserved.

1 Original language: English.

2 Regulation of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ 2006 L 404, p. 26).

3 Judgments of 13 November 2024, Aloe Vera of Europe v Commission (T‑189/21, EU:T:2024:802) (‘Aloe Vera of Europe v Commission’); of 13 November 2024, Aboca and Others v Commission (T‑302/21, EU:T:2024:808) (‘Aboca and Others v Commission’); of 13 November 2024, Ortis v Commission (T‑271/21, EU:T:2024:804) (‘Ortis v Commission’); and of 13 November 2024, Synadiet and Others v Commission (T‑274/21, EU:T:2024:806) (‘Synadiet and Others v Commission’) (together, ‘the judgments under appeal’).

4 Commission Regulation of 18 March 2021 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives (OJ 2021 L 96, p. 6).

5 See notably Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ 2006 L 404, p. 9), and Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ 2011 L 304, p. 18).

6 See recitals 3 and 4 of the Additions Regulation. See further the Proposal for a regulation of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods, COM(2003) 671 final (‘the Additions Regulation Proposal’), p. 3.

7 See, to that effect, recitals 1, 2 and 22 of the Additions Regulation and Article 1(1) and Article 10 thereof. See also the Additions Regulation Proposal, p. 1.

8 See, to that effect, recitals 14 and 22 of the Additions Regulation and Article 1(1) thereof.

9 See recital 12 of the Additions Regulation.

10 See the Additions Regulation Proposal, point 21.

11 See recital 20 of the Additions Regulation.

12 See recital 1 of the Additions Regulation.

13 See recital 20 of the Additions Regulation. See also recital 2 of that regulation for similar language.

14 See Article 3(1) of the Additions Regulation, which lays down that ‘only vitamins and/or minerals listed in Annex I, in the forms listed in Annex II, may be added to foods, subject to the rules laid down in this Regulation.’

15 See Article 4 of the Additions Regulation, which provides for the product categories to which vitamins and minerals may not be added.

16 See Article 6 of the Additions Regulation, which provides for the conditions pursuant to which vitamins and minerals may be added to foods.

17 See Article 8(1) of the Additions Regulation (emphasis added). Similar language is contained in recital 2 thereof.

18 See Article 8(2) of the Additions Regulation.

19 See, to that effect, Aloe Vera of Europe v Commission, paragraph 4; Aboca and Others v Commission, paragraph 5; Ortis v Commission, paragraph 3; and Synadiet and Others v Commission, paragraph 3.

20 See Aloe Vera of Europe v Commission, paragraph 4; Aboca and Others v Commission, paragraph 5; Ortis v Commission, paragraph 3; and Synadiet and Others v Commission, paragraph 3.

21 See Aloe Vera of Europe v Commission, paragraph 4; Aboca and Others v Commission, paragraph 5; Ortis v Commission, paragraph 3; and Synadiet and Others v Commission, paragraph 3.

22 In its judgment in Aloe Vera of Europe v Commission, paragraph 3, the General Court explains that ‘Aloe vera is a species of Aloe the leaf of which is formed of three layers: the first is a thick outer green peel that protects the plant against harsh weather; the second is a middle layer of yellow rind containing [HADs]; and the third is a moist and transparent inner layer of gelatinous liquid that contains the plant’s nutrients …’

23 EFSA Panel on Food Additives and Nutrient Sources added to Food, ‘Safety of hydroxyanthracene derivatives for use in food’, EFSA Journal , Vol. 16, Issue 1, 5090, 2018. Available at: https://doi:10.2093/j.efsa.2018.5090 (‘the 2017 EFSA Opinion’), p. 19.

24 See, to that effect, Aloe Vera of Europe v Commission, paragraph 5; Aboca and Others v Commission, paragraph 6; Ortis v Commission, paragraph 4; and Synadiet and Others v Commission, paragraph 4.

25 See the 2017 EFSA Opinion, p. 1.

26 See the 2017 EFSA Opinion, p. 69.

27 See, to that effect, EFSA Scientific Committee, ‘Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment’, EFSA Journal, Vol. 9, Issue 9, 2379, 2011. Available at: https://doi:10.2903/j.efsa.2011.2379. See, in particular, p. 9, as well as Section 4.2 on exposure, pp. 23 to 25.

28 EFSA Scientific Committee, ‘Clarification of some aspects related to genotoxicity assessment’, EFSA Journal, Vol. 15, Issue 12, 5113, 2017, p. 1. Available at: https://doi.org/10.2903/j.efsa.2017.5113. See also pp. 14 and 15 in relation to establishing health-based guidance values for genotoxic substances.

29 Contested regulation, recital 7.

30 Contested regulation, recital 9.

31 Contested regulation, recital 11.

32 See Aboca and Others v Commission, paragraph 61; Ortis v Commission, paragraph 65; and Synadiet and Others v Commission, paragraph 57.

33 See, to that effect, Aloe Vera of Europe v Commission, paragraphs 66 and 67; Aboca and Others v Commission, paragraphs 90 and 91; Ortis v Commission, paragraphs 95 and 96; and Synadiet and Others v Commission, paragraphs 86 and 87.

34 It is also worth noting that the Italian Republic lodged an application to intervene in support of the submissions of the respondents in case C‑48/25 P. However, given that that application was lodged after the expiry of the time limit referred to in Article 190(2) of the Rules of Procedure of the Court of Justice but before the decision to open the oral part of the proceedings, by decision of the President of the Court of 23 May 2025, that party was authorised to submit its observations at an oral hearing, should one take place, pursuant to Article 194 of the Rules of Procedure.

35 EFSA Scientific Committee, ‘Guidance on safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements’, EFSA Journal, Vol. 7, Issue 9, 1249, 2009, p. 2. Available at: https://doi:10.2093/j.efsa.2009.1249.

36 See, ex multis, judgments of 13 February 1979, Granaria (101/78, EU:C:1979:38, paragraph 4), and of 27 January 2026, Commission v Hungary (Rescheduling of cannabis) (C‑271/23, EU:C:2026:45, paragraph 124 and the case-law cited).

37 See recital 1 of the Additions Regulation.

38 See, to that effect, recital 20 of the Additions Regulation. The Commission considers that the ‘unintentional’ presence of harmful substances in foods is governed by Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (OJ 1993 L 37, p. 1), pursuant to which the Commission may set maximum levels for contaminants in food.

39 As I have explained in point 11 of the present Opinion, the other procedure is that relating to the addition of vitamins and minerals.

40 See, to that effect, the Additions Regulation Proposal, which, in paragraph 21, notes that ‘sometimes [the use of certain other substances] and presentation in the labelling may lead to questions as to whether they should be treated as ingredients used in the manufacture of foods or whether they should be considered as “added”. Irrespective of the answer to this question, it would be opportune to regulate the safe use of such substances or ingredients, and where necessary prohibit their use, under this proposed Regulation.’

41 See, to that effect, Aloe Vera of Europe v Commission, paragraphs 51 and 59; Aboca and Others v Commission, paragraphs 75 and 83; Ortis v Commission, paragraphs 79 and 87; and Synadiet and Others v Commission, paragraphs 70 and 78.

42 While the respondents in Cases C‑54/25 P and C‑55/25 P claim that this ground of appeal is inadmissible on the ground that the Commission has raised it for the first time on appeal, it is clear that the Commission has merely put forward a line of argument arising from the judgments under appeal relating to the nature of the conditions underlying Article 8(1) and (2) of the Additions Regulation. Accordingly, that argument cannot succeed; see, by analogy, judgments of 29 November 2007, Stadtwerke Schwäbisch Hall and Others v Commission (C‑176/06 P, EU:C:2007:730, paragraph 17), and of 10 April 2014, Commission v Siemens Österreich and Others and Siemens Transmission & Distribution and Others v Commission (C‑231/11 P to C‑233/11 P, EU:C:2014:256, paragraphs 101 and 102).

43 That is to say, the substances listed in point 25 of the present Opinion.

44 As I explain in point 22 of the present Opinion, EFSA considers that there is simply no level below which the ingestion of genotoxic substances does not present harmful effects and a risk to human health. Accordingly, it takes the position that it cannot establish a threshold for genotoxic substances.

45 It should be recalled that, under that provision, the Commission must place the substance or the ingredient containing the substance at issue in Part B of Annex III and specify that its addition to foods or its use in the manufacture of foods is allowed only under certain conditions. However, even that provision does not mandate a consumption threshold below which the addition of that substance would not raise concerns for human health, even if the ‘additional requirements’ linked to entries in Part B of Annex III for the substances listed do provide for such a threshold. See, for example, Commission Regulation (EU) 2022/2340 of 30 November 2022 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards green tea extracts containing (-)-epigallocatechin-3-gallate (OJ 2022 L 310, p. 7).

46 See, in that regard, 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 [EFSA] and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1), which defines the concept of ‘risk assessment’ as ‘a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation’. See also, by analogy, my Opinion in Joined Cases France v Commission and Commission v CWS Powder Coatings and Others (C‑71/23 P and C‑82/23 P, EU:C:2025:65, points 75 and 76).

47 See Article 3(12) of Regulation No 178/2002. Emphasis added.

48 See also, by analogy, Communication from the Commission on the precautionary principle, COM(2000) 1 final of 2 February 2000, p. 15, which states that ‘when decision-makers become aware of a risk to the environment or human, animal or plant health that in the event of non-action may have serious consequences, the question of appropriate protective measures arise[s]. Decision-makers have to obtain, through a structured approach, a scientific evaluation, as complete as possible, of the risk to the environment, or health, in order to select the most appropriate course of action.’

49 As I have explained previously in the context of the classification of a substance as harmful to human health, when adopting risk management measures, the Commission enjoys little discretion beyond the measures laid down by the legislature. See my Opinion in Joined Cases France v Commission and Commission v CWS Powder Coatings and Others (C‑71/23 P and C‑82/23 P, EU:C:2025:65, point 78).

50 The Commission raises this argument in relation to the statements contained in Aloe Vera of Europe v Commission, paragraphs 58 and 60; Aboca and Others v Commission, paragraphs 82 and 84; Ortis v Commission, paragraphs 86 and 88; and Synadiet and Others v Commission, paragraphs 77 and 79.

51 The Commission raises this argument in relation to the statement contained in Aloe Vera of Europe v Commission, paragraph 60; Aboca and Others v Commission, paragraph 84; Ortis v Commission, paragraph 88; and Synadiet and Others v Commission, paragraph 79.

52 See, to that effect, judgments of 18 June 2015, Ipatau v Council (C‑535/14 P, EU:C:2015:407, paragraph 37 and the case-law cited), and of 10 September 2024, Commission v Ireland and Others (C‑465/20 P, EU:C:2024:724, paragraph 390 and the case-law cited).

53 See, for example, judgment 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).

54 See point 78 of the present Opinion.

55 See, to that effect, Article 61 of the Statute of the Court of Justice of the European Union.

Opinion of Advocate General Ćapeta delivered on 10 September 2026.###

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