Judgment;Abstract — ECLI:EU:T:2024:806
Date: 2024-11-13
Language of the case: French
Court formation: Sixth Chamber, Extended Composition
Subject matter: Consumer protection;Approximation of laws
Procedure: Action for annulment - successful
Origin: Belgium;Spain;France

summary report on the meeting held with the General Food Law Section of the Standing Committee on the Food Chain and Animal Health (‘the PAFF Committee’). 10 On 5 October 2020, the Commission presented its revised draft regulation to the PAFF Committee. 11 On 5 November 2020, the PAFF Committee was consulted by written procedure in order to deliver an opinion on the draft regulation. Following the favourable opinion delivered by the PAFF Committee on 12 November 2020, the draft regulation was examined by the European Parliament and by the Council of the European Union. 12 On 18 March 2021, the Commission adopted the contested regulation, by which, by the first, second and fourth entries in Article 1(1), it added aloe-emodin, emodin, danthron and all preparations in which those substances are present, and, by the third entry, preparations from the leaf of Aloe species containing HADs, to Part A of Annex III to Regulation No 1925/2006. By the first, second and third entries in Article 1(2) of the contested regulation, it also added 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 to Part C of Annex III to Regulation No 1925/2006. 13 In that regard, in recital 7 of the contested regulation, the Commission stated that ‘[EFSA had] found that the [HADs] aloe-emodin and emodin and structurally related substance danthron [had] been shown to be genotoxic in vitro’, that ‘Aloe extracts [had] also been shown to be genotoxic in vitro most likely due to hydroxyanthracene derivatives present in the extract’, that ‘furthermore, aloe-emodin [had been] shown to be genotoxic in vivo’ and that ‘the whole leaf aloe extract and structural analogue danthron [had been] shown to be carcinogenic.’ 14 Recital 8 of the contested regulation is worded as follows: ‘Given that aloe-emodin and emodin may be present in the extracts, the [EFSA] concluded that [HADs] should be regarded as genotoxic and carcinogenic unless there are specific data to the contrary and that there is a safety concern for extracts containing [HADs] although uncertainty persists. The [EFSA] was unable to provide advice on a daily intake of [HADs] that does not give rise to concerns for human health.’ 15 In recital 9 of the contested regulation, the Commission also stated that, ‘considering 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. Therefore, aloe-emodin, emodin, danthron and aloe preparations containing [HADs] [had to] be included in Annex III, Part A of Regulation (EC) No 1925/2006.’ 16 In recital 10 of the contested regulation, the Commission added that ‘during manufacture, [HADs could] be removed from the botanical preparations through a series of filtering processes resulting in products that contain those substances only at trace levels as impurities.’ 17 Lastly, in recital 11 of the contested regulation, the Commission noted that as there was a possibility of harmful effects on health associated with the use of Rheum, Cassia and Rhamnus and their preparations in food, but scientific uncertainty persisted regarding whether such preparations contained the substances listed in Part A of Annex III to Regulation No 1925/2006, such substances had to be placed under EU scrutiny and, therefore, they had to be included in Part C of Annex III to Regulation No 1925/2006. Forms of order sought 18 The applicants, supported by the interveners, European Federation of Associations of Health Product Manufacturers (EHPM) and FederSalus – Italian Association of Health Products Manufacturers and Distributors, claim that the Court should: – annul the contested regulation; – order the Commission to pay the costs. 19 The Commission contends that the Court should: – dismiss the action; – order the applicants to pay the costs. Law Definition of the subject matter of the action 20 In the present proceedings, it is common ground between the parties that none of the applicant companies and none of the applicants’ member companies produces products containing danthron. 21 Consequently, according to their written submissions, the applicants must be regarded as seeking the annulment of the first, second and third entries in Article 1(1), and Article 1(2), of the contested regulation. Substance 22 The applicants put forward five pleas in law in support of their action. 23 The first plea is divided into three parts. The first part alleges infringement of Article 8(1) and (2)(a)(i) of Regulation No 1925/2006 and manifest error of assessment, in so far as there is no scientific certainty as to the existence of a harmful effect allowing the inclusion of certain substances and preparations in Part A of Annex III to that regulation. The second part alleges infringement of the same provision, in so far as it does not allow ‘preparations’ to be included in Part C of Annex III to that regulation. The third part also alleges infringement of the same provision and of Article 6 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), in so far as the rules on risk assessment for EFSA and risk management for the Commission have not been complied with. 24 The second plea alleges misuse of power, in so far as the ground of public health relied on to justify the adoption of the contested regulation does not reflect the reality of the situation and in so far as the regulation should have applied only to food supplements with doses higher than those present in common foods. 25 The third plea alleges manifest errors of assessment, in so far as the 2017 scientific opinion and the contested regulation were adopted without having regard to the risk assessment methodologies that should be followed and without considering a threshold for the purpose of prohibiting the substances and preparations in question. 26 The fourth plea alleges that the contested regulation infringes the general principle of legal certainty, in so far as the term ‘preparations’ is undefined and vague and in so far as the relationship between Article 1(1) and (2) of that regulation is vitiated by legal uncertainty. 27 The fifth plea alleges infringement of the principle of proportionality, in so far as the inclusion of the substances at issue in Part A of Annex III to Regulation No 1925/2006, without a threshold having been set, is not necessary to achieve the objective of protecting public health. 28 In the first place, the Court deems it appropriate to examine the arguments put forward by the applicants in the context of the second part of the first plea, alleging that Article 8(2)(b) of Regulation No 1925/2006 does not allow ‘preparations’ to be included in the list in Part C of Annex III to that regulation. In the second place, the Court will examine the applicants’ arguments put forward in the context of the second, third and fifth pleas, alleging that a risk threshold has not been established for prohibiting the addition to foods or the use in the manufacture of foods of some of the substances and preparations in question, in accordance with Article 8(1) and (2)(a)(i) of that regulation. The plea in law and arguments alleging that Article 8 of Regulation No 1925/2006 do not allow ‘preparations’ to be included in the list in Part C of Annex III to the regulation 29 In the second part of the first plea, the applicants submit that, under Article 8(2)(b) of Regulation No 1925/2006, only ‘substances’ other than vitamins or minerals are liable to be placed under EU scrutiny on the basis of that provision. However, Article 1(2) of the contested regulation does not refer to ‘substances’ but to ‘preparations’, which are semantically different from each other. 30 Therefore, the Commission could not have relied on Article 8(2) of Regulation No 1925/2006 in adopting Article 1(2) of the contested regulation. 31 The Commission argues that the concept of ‘preparations’ was defined in EFSA’s ‘Guidance on Safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements’ of 10 September 2009 (‘the 2009 EFSA Guidance’), according to which ‘this terminology includes all preparations obtained from botanicals by various processes (e.g. pressing, squeezing, extraction, fractionation, distillation, concentration, drying up and fermentation).’ It adds that the term ‘substance’ comes from the Latin ‘substantia’, which means ‘food’, and that this commonly accepted meaning is consistent with the context and objectives of Article 8 of Regulation No 1925/2006, aimed at protecting consumer health. 32 The Commission further clarifies that, although the word ‘ingredient’ in Article 8(2)(a)(i) of Regulation No 1925/2006 is not included in Article 8(2)(b) of that regulation, that was not a conscious decision on the part of the legislature, which could not have sought to prohibit the Commission from including ingredients, or preparations, in Part C of Annex III to that regulation. 33 The Court recalls that Article 8(1) of Regulation No 1925/2006 provides that the procedure for prohibition, restriction or placement under EU scrutiny is to 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 of that substance 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. 34 In addition, under Article 8(2) of Regulation No 1925/2006, the Commission may, on its own initiative or on the basis of information provided by Member States, take a decision, following in each case an assessment of available information by EFSA, to include, if necessary, the substance or ingredient in question in Annex III to that regulation. On that basis, Article 8(2)(a) and (b) of Regulation No 1925/2006 states 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.’ 35 Thus, under Article 8(2)(a)(i) of Regulation No 1925/2006, the purpose of inclusion in Part A of Annex III to that regulation is to prohibit the addition of a ‘substance’ or an ‘ingredient containing [that] substance’ to foods, or its use in the manufacture of foods, where a harmful effect on health has been identified. 36 Inclusion in Part C of Annex III to Regulation No 1925/2006, the purpose of which is to place a substance under EU scrutiny, is reserved for ‘substances’ where the possibility of harmful effects on health has been identified but scientific uncertainty persists, in accordance with Article 8(2)(b) of that regulation. 37 The procedure referred to in Article 8 of Regulation No 1925/2006 is thus applied if 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. 38 In the light of the parties’ arguments, the Court will examine whether the concept of ‘preparations’ in Article 1(2) of the contested regulation may correspond to the concept of ‘substance’ other than vitamins or minerals, or to that of ‘ingredient containing a substance’ other than vitamins or minerals, within the meaning of Article 8(1) and (2)(a)(i) and (b) of Regulation No 1925/2006. 39 The Court finds that the concepts of ‘substance’ and ‘ingredient containing a substance’ in Article 8(1) of Regulation No 1925/2006, the concepts of ‘substance and/or ingredient containing the substance’ in Article 8(2)(a)(i) of that regulation, the concept of ‘substance’ in Article 8(2)(b) of that regulation and the concept of ‘preparations’ in the contested regulation are not expressly defined in those regulations. 40 According to the settled case-law of the Court of Justice, the meaning and scope of terms for which EU law provides no definition must be determined by reference to their usual meaning in everyday language, while account is also taken of the context in which they occur and the purposes of the rules of which they form part (judgments of 9 November 2016, Davitas, C‑448/14, EU:C:2016:839, paragraph 26, and of 26 October 2017, The English Bridge Union, C‑90/16, EU:C:2017:814, paragraph 18). 41 In that regard, the General Court notes that the concept of ‘substance other than vitamins or minerals’, used in Article 8 of Regulation No 1925/2006, constitutes the concrete expression of the concept of ‘other substance’ defined in Article 2(2) of that regulation as ‘a substance other than a vitamin or a mineral that has a nutritional or physiological effect’. The concept of ‘other substance’ is therefore defined in a residual manner by the exclusion of vitamins or minerals, which are the subject of specific provisions in the same regulation, and by the sole indication that they have a nutritional or physiological effect. 42 The concept of ‘ingredient’ in Regulation No 1925/2006 is presented immediately by reference to the ‘substance’ which it contains. Thus, only ingredients containing the substance in question are referred to in Article 8(1) and (2)(a)(i) of that regulation. In other words, it is the harmful effect of the substance as such which results in the unsafe nature of the ingredient containing it and, therefore, the possible prohibition of its addition to foods or its use in the manufacture of foods, in accordance with Article 8(2)(a)(i) of that regulation. 43 Recital 1 of Regulation No 1925/2006 further states that ‘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’. It follows from this that vitamins, minerals including trace elements, amino acids, essential fatty acids, fibre, various plants and herbal extracts are examples of what may constitute a nutrient or an ingredient as provided for in that regulation. 44 As regards the concept of ‘preparations’, as the Commission rightly stated, it was defined in a footnote to the 2009 EFSA Guidance as including ‘all preparations obtained from botanicals by various processes (e.g. pressing, squeezing, extraction, fractionation, distillation, concentration, drying up and fermentation)’. 45 However, as expressly stated in the 2009 EFSA Guidance, those guidelines are intended only to define a general framework for the scientific assessment of the safety of botanicals and botanical preparations intended for use in food supplements. Although guidance documents of EU authorities may indeed serve as a basis for interpreting an act of EU law, such documents are not legally binding for that purpose (see, to that effect, judgment of 5 May 2022, Association France Nature Environnement (Temporary impacts on surface water), C‑525/20, EU:C:2022:350, paragraph 31). Therefore, a definition of the concept of ‘preparations’ drawn from the 2009 EFSA Guidance is not binding on the Courts of the European Union, since they alone have jurisdiction to provide a binding interpretation of EU law. 46 The Court also notes that the definition of ‘preparations’ contained in the 2009 EFSA Guidance is circular and merely sets out a list of various processes enabling a preparation of a given plant to be obtained, citing in a non-exhaustive manner examples of those processes, such as pressing, squeezing, extraction, fractionation, distillation, concentration, drying up and fermentation. It does not, by contrast, allow for a precise interpretation of what is meant by ‘preparations’. 47 In any event, first, in the light of the wording of the provisions of the contested regulation and, in particular, of the first and second entries listed in Article 1(1) of that regulation, which refers to certain HADs as substances as well as preparations in which those substances are present, it must be held that the meaning to be given to the term ‘preparation’ is broader than that of ‘substance’. At the hearing, the Commission itself recognised that the concept of ‘preparations’ referred to ‘any changes made to a plant’ or ‘all changes that [could] be made to plants’. 48 It follows that a preparation containing a substance is a broader concept than that of ‘substance’, within the meaning of Regulation No 1925/2006, and therefore cannot be substituted for it. 49 On the other hand, although the Commission maintains that it may decide to place ‘ingredients’, within the meaning of Article 8 of Regulation No 1925/2006, under EU scrutiny and that these are confused with the concept of ‘preparations’, the Court notes that, at the hearing, the Commission stated that the definition of ‘ingredient’ in 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), could apply to Regulation No 1925/2006. 50 However, according to Article 2(2)(f) of Regulation (EU) No 1169/2011, an ingredient is defined as ‘any substance or product, including flavourings, food additives and food enzymes, and any constituent of a compound ingredient, used in the manufacture or preparation of a food and still present in the finished product, even if in an altered form’, whereas ‘residues shall not be considered as “ingredients”’. 51 It must therefore be concluded that a preparation, which may contain an ingredient, is a broader concept than that of ‘ingredient’, within the meaning of Regulation No 1925/2006, and cannot therefore be substituted for it. 52 Accordingly, irrespective of the question whether the legislature deliberately sought to draw a distinction between the placement under EU scrutiny of ‘substances’ and the prohibition on the addition to foods or the use in the manufacture of foods of ‘substances and/or ingredients containing them’, and without there being any need to establish an exact definition of those concepts in Article 8(1) and (2)(a)(i) and (b) of Regulation No 1925/2006, it is clear from the foregoing that, in the present case, the concept of ‘preparations’ in Article 1(2) of the contested regulation has a broader scope and meaning than that of ‘substances’ and, as the case may be, that of ‘ingredients’, and cannot be substituted for them, since it is capable of encompassing all types of processed food. 53 Since the concepts of ‘substance’, ‘ingredient’ and ‘ingredient containing a substance’ in Article 8 of Regulation No 1925/2006 thus evoke notions different from that conveyed by the concept of ‘preparations’ referred to in Article 1(2) of the contested regulation, the scope of a placement under EU scrutiny of the ‘preparations’ in question cannot be the same as that of substances or, as the case may be, ingredients. 54 As observed in paragraph 34 above, Article 8(2)(b) of Regulation No 1925/2006 only permits the inclusion in Part C of Annex III to that regulation of a ‘substance’. 55 Therefore, the Commission could not rely on Article 8(2)(b) of Regulation No 1925/2006 in adopting Article 1(2) of the contested regulation, aimed at placing under EU scrutiny ‘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., Rhamnus purshiana DC. containing [HADs]’. 56 The same would apply even if the EU legislature allowed the placement of ‘ingredients’ under EU scrutiny. 57 The applicants’ arguments alleging infringement of Article 8(2)(b) of Regulation No 1925/2006 must therefore be upheld and Article 1(2) of the contested regulation must be annulled. The plea in law and arguments alleging that a risk threshold has not been established for prohibiting the addition to foods or the use in the manufacture of foods of some of the substances and preparations in question, in accordance with Article 8(1) and (2)(a)(i) of Regulation No 1925/2006 58 In the second, third and fifth pleas, the applicants submit, inter alia, that the Commission should have relied on a comprehensive assessment of exposure, or the possibility of exposure, to the substances concerned as well as a characterisation of their risks. In the present case, however, EFSA did not assess quantitatively or qualitatively the likelihood of exposure to the substances and preparations in question. 59 The applicants add that the contested regulation should have applied only to food supplements containing HADs in doses higher than those of common foods and that, if HADs posed such a high risk that no threshold could be established, the European Medicines Agency (EMA) would not have authorised their presence in herbal medicinal products at doses considerably higher than the detection threshold set by the PAFF Committee at its meeting of 5 October 2020 on the draft regulation that led to the contested regulation. 60 Therefore, by considering that the addition or use of HADs or the preparations in question was likely to result in the amounts consumed under normal conditions being greatly exceeded, without establishing a risk threshold in that regard, the Commission infringed Article 8 of Regulation No 1925/2006 and committed manifest errors of assessment. 61 The Commission maintains that the standard achieved by the scientific evidence meets the requirements under Article 8(2)(a)(i) of Regulation No 1925/2006 and that EFSA would have been unable to set a daily intake of HADs that does not give rise to concerns for human health. As for the fact that a substance posing risks might be prohibited in food but used in medicines, this is due to the different legal frameworks established by the relevant laws. 62 The Court recalls that, according to case-law, where the Commission is called upon to undertake complex technical or scientific assessments, it has a broad discretion. In such a situation, judicial review is confined to determining whether the relevant procedural rules have been complied with, whether the facts established by the Commission are correct and whether there has been a manifest error of appraisal of those facts or a misuse of powers. However, as regards the Commission’s conclusions which do not involve complex technical or scientific assessments, the Court has full jurisdiction to review them. Similarly, as regards questions of law, the Court can only carry out full judicial review (see, to that effect, judgment of 23 September 2020, Medac Gesellschaft für klinische Spezialpräparate v Commission, T‑549/19, EU:T:2020:444, paragraph 47 (not published and the case-law cited)). 63 In order to establish that an institution committed a manifest error in assessing complex facts such as to justify the annulment of that 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. The limits to the review by the Courts of the European Union do not, however, affect their 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 judgment of 11 February 2015, Spain v Commission, T‑204/11, EU:T:2015:91, paragraphs 32 and 33 and the case-law cited). 64 In addition, the discretion of the EU authorities, which implies limited judicial review of its exercise, does not concern only the nature and scope of the measures to be taken but also, to some extent, 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 that they took into consideration all the relevant factors and circumstances of the situation the act was intended to regulate (see judgment of 8 July 2010, Afton Chemical, C‑343/09, EU:C:2010:419, paragraphs 33 and 34 and the case-law cited; judgments of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 53, and of 11 May 2017, Deza v ECHA, T‑115/15, EU:T:2017:329, paragraph 164). 65 The questions of law in respect of which the Court is to carry out a comprehensive review include the interpretation to be given to legal provisions on the basis of objective factors and whether the conditions for the application of such a provision are satisfied (see, to that effect and by analogy, judgments of 11 July 1985, Remia and Others v Commission, 42/84, EU:C:1985:327, paragraph 34, and of 9 November 2022, Cambodia and CRF v Commission, T‑246/19, EU:T:2022:694, paragraph 45). 66 As recalled in paragraphs 33 and 34 above, Article 8 of Regulation No 1925/2006 sets out the procedure for including a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, in Annex III to that regulation, which contains lists of those substances whose addition to foods or use in the manufacture of foods is prohibited or subject to conditions or in respect of which there is scientific uncertainty. 67 It also follows from recital 2 of Regulation No 1925/2006 that that regulation aims to ‘regulate the addition of vitamins and minerals to foods and the use of certain other substances or ingredients containing substances other than vitamins or minerals that are added to foods or used in the manufacture of foods under conditions that 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’. 68 The Court notes that the procedure established by Article 8 of Regulation No 1925/2006 is characterised by the essential role assigned to a scientific assessment by EFSA of the effect of the addition of a substance, or an ingredient containing that substance, to foods or of its use in the manufacture of foods. Since the Commission is not in a position to carry out scientific assessments regarding the identification of their potential harmful effects 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. 69 Article 8(2) of Regulation No 1925/2006 must be read in conjunction with Article 8(1) of that regulation, with the result that the Commission may decide to prohibit or authorise under specified conditions the addition to foods or the use in the manufacture of foods of a substance other than vitamins or minerals, or of an ingredient containing that substance, or even to place a substance under EU scrutiny, subject to certain conditions, essentially where there is a risk or, as the case may be, a potential risk, in particular in the event of ingestion of amounts of the substance in question greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced or varied diet or that would otherwise represent a potential risk to consumers. 70 Thus, more specifically, under Article 8(2)(a)(i) of Regulation No 1925/2006, read in the light of Article 8(1) of that regulation, there are two conditions that must be satisfied in order to allow for prohibition of the addition to foods or the use in the manufacture of foods of a substance or ingredient containing it: first, it 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’ and, second, a ‘harmful effect on health has been identified’. 71 Such an interpretation is confirmed by a reading of recital 20 of Regulation No 1925/2006, in which a distinction is drawn between the ingestion of substances other than vitamins or minerals, or ingredients, under normal conditions, which must not be regulated, and the ingestion of such substances or ingredients containing them which are added to foods in the form of extracts or concentrates, and which may result in ‘intakes that are significantly higher than those that could be ingested through eating an adequate and varied diet’. 72 In the present case, the Commission relied on the 2017 scientific opinion, the conclusions of which set out in paragraph 6 above are reproduced in recitals 7 and 8 of the contested regulation, in order to include, inter alia, in Part A of Annex III to Regulation No 1925/2006, ‘aloe-emodin’ and ‘emodin’, and ‘all preparations in which [those] substance[s] [are] present’, on the basis of Article 8(2)(a)(i) of Regulation No 1925/2006, with the result that their addition to foods or their use in the manufacture of foods is prohibited. 73 As regards the first condition for prohibiting the addition of a substance or an ingredient containing it to foods or its use in the manufacture of foods, namely the ingestion of amounts greatly exceeding those reasonably expected to be ingested under normal conditions of consumption or that would otherwise represent a potential risk to consumers, the Court finds that, by the provisions of the contested regulation, all the substances and preparations in question are prohibited, irrespective of the amount of HADs which they contain. 74 In that regard, the Commission stated, in recitals 8 and 9 of the contested regulation, that EFSA had been unable to provide advice on a daily intake of HADs that does not give rise to concerns for human health, which is also apparent from the conclusion of the 2017 scientific opinion, as reproduced in paragraph 6 above. In Section 2.7.2 of the 2017 scientific opinion, entitled ‘Exposure via normal diet’, EFSA also stated that parts of plants containing HADs may be part of a normal diet, but that no data on the concentrations of HADs present in those parts of the plants consumed had been made available by interested parties following a call for data. 75 In addition, it is apparent from recital 10 of the contested regulation that, during manufacture, HADs can be removed from the botanical preparations through a series of filtering processes resulting in products that contain those substances only at trace levels as impurities. 76 Despite those considerations, the first, second and third entries in Article 1(1) of the contested regulation refer to ‘aloe-emodin’ and ‘emodin’, as well as ‘all preparations in which [those] substance[s] [are] present’, and all preparations from the leaf of Aloe species containing HADs, irrespective of the amount of HADs present therein. 77 The Commission therefore appears to have taken the view that the insufficiency of data relating to a daily intake that does not give rise to concern for health allowed it to assume that there was no level for safe use of HADs, with the result that it could prohibit them entirely. 78 However, that absence of a threshold is contrary to Article 8(2)(a)(i) of Regulation No 1925/2006, read in conjunction with Article 8(1) of that regulation, from which it is apparent, as stated in paragraph 69 above, that the prohibition procedure laid down therein presupposes that a harmful effect on health has been identified where substances other than vitamins or minerals, or ingredients containing them, are added to foods or used in their manufacture, resulting in ‘ingestion of amounts of [that] substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet’. 79 Moreover, 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. 80 Although Article 8(1) of Regulation No 1925/2006 confers on the Commission the power to include substances, other than vitamins or minerals, or ingredients containing such substances, in Annex III to that regulation, it must satisfy the conditions laid down in that provision. 81 The general prohibition on the addition to foods or the use in the manufacture of foods of substances and preparations containing certain substances, such as those referred to in the first, second and third entries in Article 1(1) of the contested regulation, irrespective of the amount of those substances present, does not comply with the conditions laid down in Article 8(2)(a)(i) of Regulation No 1925/2006, read in conjunction with Article 8(1) of that regulation. 82 It is true that it follows from recital 20 of Regulation No 1925/2006 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. However, pursuant to the same recital, it is only in cases where the addition of that substance as extracts or concentrates may result in intakes which are significantly higher than those that could be ingested through eating an adequate and varied diet that the burden of proof lies with the food business operators, as the Commission acknowledges, moreover, in paragraph 69 of the defence. 83 The Commission further acknowledges, in paragraph 24 of the defence, that food safety was examined in such a way as to ensure that food was safe when consumed regularly and by the entire population, and that ‘EFSA calculates for the various substances an “acceptable daily intake”, defined as the “estimated amount of a substance present in food … that can be consumed daily over an entire lifetime without representing a significant risk to health’”. 84 That conclusion is confirmed by Article 3(3) of Implementing Regulation No 307/2012, according to which, for the purposes of that regulation, those conditions that would result in the ingestion of amounts of a substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet are to occur under actual circumstances and are to be assessed on a case-by-case basis in comparison with the average intake of the concerned substance by the general adult population or other specified population group for which health concerns have been raised. 85 In the absence of data on the amount of the substance that can ‘be ingested through eating an adequate and varied diet’, within the meaning of recital 20 of Regulation No 1925/2006, or on the amounts which are ‘reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet’, within the meaning of Article 8(1) of that regulation, a food business operator is not in a position to make an appropriate comparison between, on the one hand, the amounts of a substance under normal conditions of consumption and, on the other hand, the amounts of that same substance under the conditions of use and addition as concentrates. 86 Consequently, the first, second and third entries in Article 1(1) of the contested regulation infringe Article 8(2)(a)(i) of Regulation No 1925/2006, read in conjunction with Article 8(1) of that regulation, in so far as they prohibit the HADs ‘aloe-emodin’ and ‘emodin’, and preparations in which those substances are present, as well as preparations from the leaf of Aloe species containing HADs, from being added to foods or used in the manufacture of foods, irrespective of the amount of HADs concerned. The applicants’ arguments in that regard must, therefore, be upheld. 87 It follows from all of the foregoing that the first, second and third entries in Article 1(1) of the contested regulation, and Article 1(2) of that regulation, must be annulled, without it being necessary for the Court to rule on the applicants’ other pleas and arguments. Costs 88 Under Article 134(1) of the Rules of Procedure of the General Court, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. 89 Since the Commission has been unsuccessful, and the applicants have applied for costs, the Commission must be ordered to bear its own costs and to pay those of the applicants. 90 Under Article 138(3) of the Rules of Procedure, the European Federation of Associations of Health Product Manufacturers (EHPM) and Federsalus – Italian Association of Health Products Manufacturers and Distributors are to bear their own costs. On those grounds, THE GENERAL COURT (Sixth Chamber, Extended Composition) hereby: 1. Annuls the first, second and third entries in Article 1(1), and Article 1(2), of Commission Regulation (EU) 2021/468 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; 2. Orders the European Commission to bear its own costs and to pay those incurred by the Syndicat national des compléments alimentaires (Synadiet) and the other applicants whose names are listed in the annex; 3. Orders the European Federation of Associations of Health Product Manufacturers (EHPM) and FederSalus – Italian Association of Health Products Manufacturers and Distributors to bear their own costs. Costeira Kancheva Öberg Zilgalvis Tichy-Fisslberger Delivered in open court in Luxembourg on 13 November 2024. [Signatures] * Language of the case: French. 1 The list of the other applicants is annexed only to the version sent to the parties.