Provisional text
JUDGMENT OF THE COURT (Fifth Chamber)
17 September 2026 (*)
( Reference for a preliminary ruling – Consumer protection – Regulation (EC) No 1924/2006 – Nutrition and health claims made on foods – Article 2(2)(5) – Concept of ‘health claim’ – Food supplement – Statements relating to the frequency of intake and/or the route of administration – Article 14(2) – Reduction of disease risk claims – Applicable conditions – Advertising promoting a food supplement )
In Case C‑721/24,
REQUEST for a preliminary ruling under Article 267 TFEU from the cour d’appel de Bruxelles (Court of Appeal, Brussels, Belgium), made by decision of 4 October 2024, received at the Court on 22 October 2024, in the proceedings
Vista-Life Pharma SA,
Vista-Life Pharma Belgium SCRL
v
Laboratoires S.M.B. SA,
Brussels Reps Pharma SRL,
THE COURT (Fifth Chamber),
composed of M.L. Arastey Sahún, President of the Chamber, J. Passer, E. Regan (Rapporteur), D. Gratsias and B. Smulders, Judges,
Advocate General: A. Biondi,
Registrar: A. Calot Escobar,
having regard to the written procedure,
after considering the observations submitted on behalf of:
– Vista-Life Pharma SA, by L. De Meese and P. Maeyaert, avocats,
– Laboratoires S.M.B. SA and Brussels Reps Pharma SRL, by G. Sorreaux, avocat,
– the Belgian Government, by M. Jacobs, L. Jans and C. Pochet, acting as Agents,
– the European Commission, by S. Delaude and B. Rous Demiri, acting as Agents,
after hearing the Opinion of the Advocate General at the sitting on 29 January 2026,
gives the following
Judgment
1 This request for a preliminary ruling concerns the interpretation of Article 2(2)(1) and (5) and Article 14(2) of 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 corrigendum OJ 2007 L 12, p. 3), as amended by Regulation (EC) No 109/2008 of the European Parliament and of the Council of 15 January 2008 (OJ 2008 L 39, p. 14) (‘Regulation No 1924/2006’).
2 The request has been made in proceedings between Vista-Life Pharma SA and Vista-Life Pharma Belgium SCRL (together ‘Vista-Life’) and Laboratoires S.M.B. SA and Brussels Reps Pharma SRL concerning information in commercial advertising by Vista-Life for the promotion of two food supplements.
Legal context
European Union law
Directive 2002/46/EC
3 Article 2 of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ 2002 L 183, p. 51) provides:
‘For the purposes of this Directive:
(a) “food supplements” means foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities;
…’
Directive 2006/114/EC
4 Article 2 of Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising (OJ 2006 L 376, p. 21) provides:
‘For the purposes of this Directive:
(a) “advertising” means the making of a representation in any form in connection with a trade, business, craft or profession in order to promote the supply of goods or services, including immovable property, rights and obligations;
…’
Regulation No 1924/2006
5 Recitals 3, 23 and 28 of Regulation No 1924/2006 state:
‘(3) General labelling provisions are contained in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs [(OJ 2000 L 109, p. 29)]. Directive [2000/13] generally prohibits the use of information that would mislead the purchaser or attribute medicinal properties to food. This Regulation should complement the general principles in Directive [2000/13] and lay down specific provisions concerning the use of nutrition and health claims concerning foods to be delivered as such to the consumer.
…
(23) Health claims should only be authorised for use in the Community after a scientific assessment of the highest possible standard. In order to ensure harmonised scientific assessment of these claims, the European Food Safety Authority [(EFSA)] should carry out such assessments. Upon request the applicant should be able to have access to his file to check the state of the procedure.
…
(28) Diet is one of the many factors influencing the onset of certain human diseases. Other factors such as age, genetic predisposition, the level of physical activity, the consumption of tobacco and other drugs, environmental exposure and stress may all influence the onset of human diseases. Specific labelling requirements should therefore apply in respect of claims relating to the reduction of a disease risk.’
6 Article 1 of that regulation, entitled ‘Subject matter and scope’, provides, in paragraphs 1 and 2 thereof:
‘1. This Regulation harmonises the provisions laid down by law, regulation or administrative action in Member States which relate to nutrition and health claims in order to ensure the effective functioning of the internal market whilst providing a high level of consumer protection.
2. This Regulation shall apply to nutrition and health claims made in commercial communications, whether in the labelling, presentation or advertising of foods to be delivered as such to the final consumer.
…’
7 Article 2 of that regulation, entitled ‘Definitions’, provides:
‘1. For the purposes of this Regulation:
…
(b) the definition of “food supplement” set out in Directive [2002/46] shall apply;
…
(d) the definition of “labelling” set out in Article 1(3)(a) of Directive [2000/13] shall apply.
2. The following definitions shall also apply:
1) “claim” means any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics;
…
5) “health claim” means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health;
6) “reduction of disease risk claim” means any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease;
…’
8 In Article 3 of that regulation, entitled ‘General principles for all claims’, the first paragraph is worded as follows:
‘Nutrition and health claims may be used in the labelling, presentation and advertising of foods placed on the market in the Community only if they comply with the provisions of this Regulation.’
9 Article 4 of Regulation No 1924/2006, entitled ‘Conditions for the use of nutrition and health claims’, provides, in paragraph 2 thereof:
‘By way of derogation from paragraph 1, nutrition claims:
…
(b) shall be allowed, where a single nutrient exceeds the nutrient profile provided that a statement about the specific nutrient appears in close proximity to, on the same side and with the same prominence as the claim. This statement shall read as follows: “High … content”.’
10 Article 14 of that regulation, entitled ‘Reduction of disease risk claims and claims referring to children’s development and health’, is worded as follows:
‘1. Notwithstanding Article 2(1)(b) of Directive [2000/13], the following claims may be made where they have been authorised in accordance with the procedure laid down in Articles 15, 16, 17 and 19 of this Regulation for inclusion in a Community list of such permitted claims together with all the necessary conditions for the use of these claims:
(a) reduction of disease risk claims;
…
2. In addition to the general requirements laid down in this Regulation and the specific requirements of paragraph 1, for reduction of disease risk claims the labelling or, if no such labelling exists, the presentation or advertising shall also bear a statement indicating that the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect.’
Regulation (EU) No 1169/2011
11 Article 2 of 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), entitled ‘Definitions’, provides, in paragraph 2 thereof:
‘The following definitions shall also apply:
…
(c) “mandatory food information” means the particulars that are required to be provided to the final consumer by Union provisions;
…
(j) “labelling” means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a food and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such food;
…’
12 Article 7 of that regulation, entitled ‘Fair information practices’, provides, in paragraph 2 thereof:
‘Food information shall be accurate, clear and easy to understand for the consumer.’
13 Article 12 of that regulation, entitled ‘Availability and placement of mandatory food information’, provides, in paragraphs 1 and 2 thereof:
‘1. Mandatory food information shall be available and shall be easily accessible, in accordance with this Regulation, for all foods.
2. In the case of prepacked food, mandatory food information shall appear directly on the package or on a label attached thereto.’
14 Under Article 53 of the same regulation, entitled ‘Repeal’:
‘1. Directives 87/250/EEC, 90/496/EEC, 1999/10/EC, [2000/13], 2002/67/EC and 2008/5/EC and Regulation (EC) No 608/2004 are repealed as from 13 December 2014.
2. References to the repealed acts shall be construed as references to this Regulation.’
Implementing Decision 2013/63/EU
15 Point 2 of the Annex to Commission Implementing Decision 2013/63/EU of 24 January 2013 adopting guidelines for the implementation of specific conditions for health claims laid down in Article 10 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council (OJ 2013 L 22, p. 25), entitled ‘Mandatory information accompanying authorised health claims – Article 10(2)’, is worded as follows:
‘2.1. Distinction of three cases for the implementation of Article 10(2)
In order to comply with the Regulation, Article 10(2) requires two, or where appropriate, four pieces of mandatory information to be provided to the consumer when using a health claim. The information laid down in points (a) to (d) of Article 10(2) must be given in the labelling of the food, or in its presentation and advertising if no such labelling exists. This provision should be understood in the light of the objective of the legislator to ensure a high level of consumer protection by providing accurate and truthful information to help consumers make an informed choice.
“Labelling”, is defined in point (a) of Article 1(3) of Directive [2000/13] and point (j) of Article 2(2) of Regulation [No 1169/2011]. That definition states that “‘labelling’ means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a food and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such food”. In the Union law there is a definition of “advertising” …, but no definition of “presentation”, which should therefore be understood in the light of the explanation provided for in point (a) of Article 2(3) of Directive [2000/13] and point (b) of Article 7(4) of Regulation [No 1169/2011].
A health claim can be made on the “labelling” which can mean more than just the label, since it encompasses all the information to the consumer about the food which it accompanies or refers to. The distinction between “labelling” and “advertising” is that “labelling” is concerned with the delivery of the food to the final consumer, while “advertising” is about the promotion of the supply of food by the food business operator.
(a) In order to comply with Article 10(2), it is necessary to include the mandatory information in the labelling of the food for which the health claim is made.
(b) Where no “labelling” exists, the mandatory information shall be given in the “advertising” and “presentation” of the food for which the health claim is made. For example, where a health claim is used in a generic advertising for a food (e.g. olive oil, dairy, meat, etc.) which does not link it to a specific product which would have “labelling”, then the mandatory information must also be given in the “advertising” and “presentation” of that food.
Article 12 of Regulation [No 1169/2011] establishes a principle that the consumer should always have the mandatory information when making a decision about a purchase of a food. …
…’
Belgian law
Code of Economic Law
16 Article VI.104 of the code de droit économique (Code of Economic Law) (Moniteur belge of 29 March 2013, p. 19975), as amended by the loi du 21 décembre 2013, portant insertion du titre VI ‘Pratiques du marché et protection du consommateur’ dans le code de droit économique et portant insertion des définitions propres au livre VI, et des dispositions d’application de la loi propres au livre VI, dans les livres Ier et XV du code de droit économique (Law of 21 December 2013 inserting Title VI ‘Market practices and consumer protection’ in the Code of Economic Law and inserting definitions specific to Book VI, and provisions implementing the law that are specific to Book VI, in Books I and XV of the Code of Economic Law) (Moniteur belge of 30 December 2013, p. 103506) (‘the Code of Economic Law’), provides:
‘Any act contrary to honest market practice by which an undertaking adversely affects or may adversely affect the professional interests of one or more other undertakings shall be prohibited.’
Royal Decree of 30 May 2021
17 Article 9 of the Arrêté royal du 30 mai 2021 concernant la mise dans le commerce de nutriments et de denrées alimentaires auxquelles des nutriments ont été ajoutés (Royal Decree of 30 May 2021 concerning the placing on the market of nutrients and foodstuffs to which nutrients have been added) (Moniteur belge of 11 June 2021, p. 61519) provides:
‘In the labelling, presentation and advertising of the foodstuffs referred to in Article 3, it shall be prohibited to:
1° attribute to the product the property of preventing, treating or curing a disease and referring to similar properties;
…’
The dispute in the main proceedings and the questions referred for a preliminary ruling
18 Laboratoires S.M.B. and Brussels Reps Pharma, the respondents in the main proceedings, are companies governed by Belgian law that are active in the pharmaceutical and parapharmaceutical sectors. They produce and market, inter alia, food supplements.
19 Vista-Life also markets food supplements and competes, in those sectors, with the respondents in the main proceedings. Those supplements include, in particular, two products named ‘Vista-D3’ and ‘VistaSterol’, respectively.
20 By a letter dated 18 March 2021, the respondents in the main proceedings gave Vista-Life formal notice to cease publishing two advertisements relating to the food supplement Vista-D3 which appeared in two periodicals aimed at health professionals in February 2021, on the ground that they presented a daily dose of that food supplement as resulting in ‘stable plasma levels’, constituting a health claim that was not authorised under Regulation No 1924/2006.
21 By a letter of 25 March 2021, Vista-Life denied having infringed that regulation, arguing that that statement did not constitute a health claim within the meaning of that regulation.
22 In April 2021, Vista-Life had a further advertisement published in a periodical for health professionals; it related to the food supplement VistaSterol and included the statement, ‘the solution for controlling cholesterol’. It was also indicated in that advertisement that that food supplement contained plant sterols.
23 On 9 June 2021, the respondents in the main proceedings brought an action for an injunction before the tribunal de l’entreprise francophone de Bruxelles (Brussels Business Court (French-speaking), Belgium) seeking, inter alia, (i) a declaration that the health claims ‘stable plasma levels’ and ‘the solution for controlling cholesterol’ used by Vista-Life in respect of its products Vista-D3 and VistaSterol infringed Article 10 and Article 14(2) of Regulation No 1924/2006 as well as Article VI.104 of the Code of Economic Law, and (ii) an order that Vista-Life cease that infringement, on pain of periodic penalty payments.
24 By a judgment of 6 April 2022, the tribunal de l’entreprise francophone de Bruxelles (Brussels Business Court (French-speaking)) upheld that action.
25 In the period from October to December 2022, Vista-Life had four new advertisements relating to the food supplement Vista-D3 published in three periodicals for health professionals. The advertisements suggested that taking that food supplement would help to prevent an increase in the risk of mortality and/or contained, inter alia, statements that taking vitamin D on a daily basis is preferable to taking a larger dose all at once (‘daily better than single dose’) and that the sublingual administration of the Vista-D3 product ‘is a preferred route of administration which offers a number of advantages over peroral administration: more rapid absorption helps in avoiding the first-pass effect in the liver and enzymatic degradation in the gastrointestinal tract’.
26 By a letter of 23 November 2022, the respondents in the main proceedings sent formal notice to Vista-Life to cease using the statements contained in those advertisements, which, in their view, constituted health claims that were prohibited by Regulation No 1924/2006 and that infringed the Royal Decree of 30 May 2021 concerning the placing on the market of nutrients and foodstuffs to which nutrients have been added, Regulation No 1169/2011 and the Code of Economic Law.
27 By a letter of 2 December 2022, Vista-Life disputed the assertions thus made by the respondents in the main proceedings and refused to comply with that formal notice.
28 On 9 December 2022, the respondents in the main proceedings brought an action for an injunction before the tribunal de l’entreprise francophone de Bruxelles (Brussels Business Court (French-speaking)), seeking, inter alia, a declaration that the health claims referred to in paragraph 25 of the present judgment infringed Article 10 of Regulation No 1924/2006 and, accordingly, Article VI.104 of the Code of Economic Law, and an order that Vista-Life be required to cease using those claims and any similar claims, on pain of periodic penalty payments.
29 By a judgment of 5 April 2023, the tribunal de l’entreprise francophone de Bruxelles (Brussels Business Court (French-speaking)), inter alia, declared that the claim that Vista-D3 helps to prevent an increase in the risk of mortality, the claim that Vista-D3 helps in avoiding the first-pass effect in the liver and enzymatic degradation in the gastrointestinal tract and the claim ‘daily better than single dose’ constituted unauthorised health claims which, therefore, infringed Article 10 of Regulation No 1924/2006 and Article VI.104 of the Code of Economic Law. It also ordered Vista-Life to cease using those claims and any similar claims, on pain of periodic penalty payments.
30 Vista-Life lodged an appeal against the judgments of the tribunal de l’entreprise francophone de Bruxelles (Brussels Business Court (French-speaking)) of 6 April 2022 and 5 April 2023 before the cour d’appel de Bruxelles (Court of Appeal, Brussels, Belgium), which is the referring court and which joined the two cases.
31 In its request for a preliminary ruling, the referring court finds, first, that the respondents in the main proceedings and Vista-Life disagree as to whether the statements ‘stable plasma levels’, ‘Vista-D3 helps in avoiding the first-pass effect in the liver and enzymatic degradation in the gastrointestinal tract’ and ‘daily better than single dose’ constitute health claims within the meaning of Article 2(2)(5) of Regulation No 1924/2006.
32 In that regard, the referring court notes, first, that it is undisputed that those statements are not included in the lists of authorised health claims under Regulation No 1924/2006.
33 Second, it considers that, in the light of the definition of ‘health claim’ in Article 2(2)(5) of Regulation No 1924/2006, it is necessary to verify whether those statements state, suggest or imply that a relationship exists between the food supplement Vista-D3 and health.
34 In the present case, the referring court finds that the statements referred to in paragraph 31 of the present judgment suggest that there is a link between the frequency of intake and route of administration of the Vista-D3 product and its assimilation by the body, which it is claimed is more effective.
35 Nevertheless, the referring court observes that the general definition of ‘claim’ in Article 2(2)(1) of Regulation No 1924/2006 does not specify what is meant by ‘particular characteristics’ and that the definition of ‘health claim’ in Article 2(2)(5) of that regulation does not indicate whether the words ‘food or one of its constituents’ cover characteristics related to the frequency of intake or route of administration of the food concerned.
36 As regards, second, the statement ‘the solution for controlling cholesterol’, relating to the food supplement VistaSterol, the referring court notes that Vista-Life and the respondents in the main proceedings agree that that statement qualifies as a ‘health claim’ and, more specifically, as a reduction of disease risk claim, within the meaning of Article 2(2)(6) of Regulation No 1924/2006.
37 However, they disagree on whether or not that claim complies with Article 14(2) of that regulation.
38 In that regard, the referring court finds that the advertising concerned does not contain the statement included in that provision, that the disease to which the claim in question is referring – namely, in this case, cardiovascular disease – has multiple risk factors and that altering one of these risk factors – namely, in this case, the intake of plant sterols – may or may not have a beneficial effect.
39 It observes, however, that the packaging and leaflet of the food supplement VistaSterol and the Vista-Life website do contain a statement that high cholesterol is a risk factor for cardiovascular disease.
40 In those circumstances, the cour d’appel de Bruxelles (Court of Appeal, Brussels) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:
‘(1) Is Article 2(2)(1) and (5) of Regulation No 1924/2006 to be interpreted as meaning that the expressions “particular characteristics” and “a food category, a food or one of its constituents” cover statements relating to the frequency of intake and/or the route of administration of the foodstuff?
(2) Is Article 14(2) of Regulation No 1924/2006 to be interpreted as requiring the labelling or, if no such labelling exists, the presentation or advertising to reproduce verbatim the statement indicating that the disease to which the claim is referring “has multiple risk factors and … altering one of these risk factors may or may not have a beneficial effect”?
(3) Is Article 14(2) of Regulation No 1924/2006 to be interpreted as requiring that advertising which contains the reduction of disease risk claim must include the statement indicating that “the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect” where that statement appears on the packaging, leaflet and/or website of the product?’
Consideration of the questions referred
The first question
41 By its first question, the referring court asks, in essence, whether Article 2(2)(5) of Regulation No 1924/2006 must be interpreted as meaning that statements relating to the frequency of intake and/or the method of administration of a food supplement fall within the concept of ‘health claim’ within the meaning of that provision.
42 It should be noted at the outset that, under Article 1(2) of Regulation No 1924/2006, that regulation is to apply to nutrition and health claims made in commercial communications relating to foods to be delivered as such to the final consumer, including, as is apparent from Article 2(1)(b) of that regulation, read in conjunction with Article 2(a) of Directive 2002/46, food supplements.
43 In accordance with the first paragraph of Article 3 of Regulation No 1924/2006, such health claims may be used in the labelling, presentation and advertising of foods placed on the EU market only if they comply with the provisions of that regulation.
44 Those provisions lay down a series of requirements that govern the use, in the European Union, of health claims concerning foods, including the requirement referred to in recital 23 of that regulation, according to which such use should only be authorised after a scientific assessment of the highest possible standard which, in order to ensure a harmonised assessment, must be carried out by EFSA (see, to that effect, judgment of 30 April 2025, Novel Nutriology, C‑386/23, EU:C:2025:304, paragraph 65 and the case-law cited).
45 In that regard, it should be noted, first, that Article 2(2)(1) of Regulation No 1924/2006 defines ‘claim’ in broad terms as ‘any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics’.
46 It follows from the use of the verbs ‘suggests or implies’ that classification as a ‘claim’, within the meaning of that provision, does not require that the message or representation covered by that term expressly states that a food has certain particular characteristics. It is sufficient that that message or representation may give the average consumer who is reasonably well-informed and reasonably observant and circumspect the impression that the food has those characteristics (see, by analogy, judgment of 18 July 2013, Green – Swan Pharmaceuticals CR, C‑299/12, EU:C:2013:501, paragraph 24).
47 In addition, as the Advocate General stated, in essence, in point 26 of his Opinion, the reference to the ‘particular characteristics’ of a food should not be construed, contrary to Vista-Life’s contention in its written observations, as being limited to the intrinsic properties of that food, such as its composition or content. It also covers the way in which that food is intended to be consumed, where this is presented as being relevant to the characteristics attributed to that food.
48 Consequently, statements relating to the frequency of intake of a food supplement, such as ‘daily better than single dose’, or to the method of its administration, such as ‘sublingual’, are capable of attributing particular characteristics, within the meaning of Article 2(2)(1) of Regulation No 1924/2006, to that food supplement.
49 Second, Article 2(2)(5) of Regulation No 1924/2006 defines ‘health claim’ as ‘any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health’.
50 As the Court has previously held, the starting-point for the definition of a ‘health claim’ within the meaning of that provision is the relationship that must exist between a food or one of its constituents and health; that definition provides no information as to whether that relationship must be direct or indirect, or as to its intensity or duration, so that the term ‘relationship’ must be understood in a broad sense (judgment of 18 July 2013, Green – Swan Pharmaceuticals CR, C‑299/12, EU:C:2013:501, paragraph 22 and the case-law cited).
51 Consequently, the concept of ‘health claim’ covers not only a relationship implying an improvement in health as a result of the consumption of a food, but also any relationship which implies the absence or reduction of effects that are adverse to health and which would otherwise accompany or follow such consumption (see, to that effect, judgment of 6 September 2012, Deutsches Weintor, C‑544/10, EU:C:2012:526, paragraph 35).
52 Thus, statements relating to the frequency of intake or method of administration of a food supplement, such as those referred to in paragraph 48 of the present judgment, can, where presented as being relevant to the attainment of a beneficial effect on health or to the absence or reduction of an effect that is adverse to health that might result from a different frequency of intake or another method of administration, fall within the concept of ‘health claim’ within the meaning of Article 2(2)(5) of Regulation No 1924/2006.
53 However, as is apparent from the definition recalled in paragraph 50 of the present judgment, where those statements are limited to providing consumers with purely practical information on how the product in question is to be consumed, without any explicit or implicit reference to an effect on health, they are not covered by that concept.
54 That interpretation is, moreover, consistent with the objectives of Regulation No 1924/2006 which, first, seeks, as stated in Article 1(1) thereof, to ensure the effective functioning of the internal market while providing a high level of consumer protection, in particular against misleading claims, by facilitating the consumer’s choice by placing safe and adequately labelled products on the market. Second, health protection is among the principal aims of that regulation (see, to that effect, judgment of 30 April 2025, Novel Nutriology, C‑386/23, EU:C:2025:304, paragraph 63 and the case-law cited).
55 In order to fulfil the objectives of ensuring a high level of consumer protection and protection of human health, consumers should, in particular, be given the necessary information to make a choice in full knowledge of the facts (judgment of 30 April 2025, Novel Nutriology, C‑386/23, EU:C:2025:304, paragraph 64 and the case-law cited).
56 However, an interpretation that would exclude from the concept of ‘health claim’, within the meaning of Article 2(2)(5) of Regulation No 1924/2006, statements relating to the frequency of intake or to the method of administration of a food supplement that are not limited to purely practical information would run counter to those objectives. Indeed, such an interpretation would enable economic operators to use such statements even though they are liable to suggest to consumers the presence of a beneficial effect on health or the absence or reduction of an effect that is adverse to health, and to do so without having to meet the requirements laid down by that regulation, including the requirement referred to in paragraph 44 of the present judgment, that the use of health claims should only be authorised after a scientific assessment of the highest possible standard.
57 In the light of the foregoing considerations, the answer to the first question is that Article 2(2)(5) of Regulation No 1924/2006 must be interpreted as meaning that statements relating to the frequency of intake and/or the method of administration of a food supplement fall within the concept of ‘health claim’ within the meaning of that provision where those practical matters are presented as being linked to a beneficial effect on health or to the absence or reduction of an effect that is adverse to health.
The second question
58 By its second question, the referring court asks, in essence, whether Article 14(2) of Regulation No 1924/2006 must be interpreted as requiring the labelling of the food supplement concerned or, if no such labelling exists, the presentation or advertising relating to that food supplement to reproduce verbatim the statement set out in that provision that ‘the disease to which the claim is referring has multiple risk factors and … altering one of these risk factors may or may not have a beneficial effect’?
59 As is apparent from its heading, Article 14 of that regulation governs, inter alia, reduction of disease risk claims.
60 The concept of ‘reduction of disease risk claim’ is defined in Article 2(2)(6) of that regulation as ‘any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease’.
61 In accordance with Article 14(2) of Regulation No 1924/2006, in addition to the general requirements laid down in that regulation and the specific requirements laid down in paragraph 1 of that article, for reduction of disease risk claims the labelling or, if no such labelling exists, the presentation or advertising of a food is also to bear a statement indicating that the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect.
62 First, it should be noted that the wording of Article 14(2) does not evoke a requirement to reproduce verbatim the words that follow the expression ‘a statement indicating’, that statement being required, in particular, as is apparent from its wording, to be linked to the disease to which the relevant claim is referring.
63 Moreover, as the Advocate General noted, in essence, in point 32 of his Opinion, in other provisions of Regulation No 1924/2006 the EU legislature expressly provided for the mandatory use of a specific form of words. That is the case, in particular, in Article 4(2)(b) of that regulation, as well as in certain sections of the Annex to that regulation, which provide that certain nutrition claims must be accompanied by a statement the wording of which is prescribed verbatim.
64 Second, as is recalled in paragraphs 54 and 55 of the present judgment, since the protection of health is among the principal objectives of Regulation No 1924/2006, consumers should be given the necessary information to make a choice in full knowledge of the facts.
65 In order for that objective to be achieved, it is also necessary, as is clear from recital 3 of that regulation, to protect consumers from information that may mislead them by attributing medicinal properties to food that it does not have.
66 Article 14(2) of that regulation falls squarely within the framework of that objective.
67 Indeed, as the Advocate General noted, in essence, in point 33 of his Opinion, the statement prescribed in that provision is intended to make the scope of the reduction of disease risk claim clear and to prevent that claim from being perceived as a therapeutic promise. It thus helps to prevent any risk of the consumer being misled, by recalling, in accordance with recital 28 of Regulation No 1924/2006, that diet is one of the many factors influencing the onset of certain human diseases and that other factors may all influence the onset of such diseases.
68 In order to support the aim of ensuring the protection of human health, where a reduction of disease risk claim, within the meaning of Article 2(2)(6) of that regulation, is used in a commercial communication, it is sufficient for that claim to be accompanied by a statement which, without necessarily reproducing verbatim the words used in Article 14(2) of that regulation, informs consumers in an accurate, clear and easily understandable manner, first, that the disease to which the claim is referring has multiple risk factors and, second, that altering one of those factors may or may not have a beneficial effect.
69 It must be noted that that requirement for accurate, clear and easily understandable information is confirmed by Article 7(2) of Regulation No 1169/2011, which forms part of the framework of a systemic interpretation of the provisions of Regulation No 1924/2006.
70 Indeed, it should be recalled that, as is apparent from recital 3 of Regulation No 1924/2006, that regulation should complement the general principles in Directive 2000/13. Since that directive has been repealed and replaced by Regulation No 1169/2011, which introduced new rules replacing those of that directive, Regulation No 1924/2006 must be understood in the light of Regulation No 1169/2011.
71 Under the heading ‘Fair information practices’, Article 7 of Regulation No 1169/2011 provides, in paragraph 2 thereof, that food information must be accurate, clear and easy to understand for the consumer.
72 In the present case, it appears, subject to verification by the referring court, that, in the case of the claim ‘the solution for controlling cholesterol’, the statement ‘high cholesterol is a risk factor in the development of cardiovascular disease’ is not capable of conveying to the average consumer who is reasonably well-informed and reasonably observant and circumspect, in a manner that is accurate, clear and easy to understand, the information required by Article 14(2) of Regulation No 1924/2006.
73 In the light of the above, the answer to the second question is that Article 14(2) of Regulation No 1924/2006 must be interpreted as not requiring the labelling of the food supplement concerned or, if no such labelling exists, the presentation or advertising relating to that food supplement to reproduce verbatim the statement set out in that provision that ‘the disease to which the claim is referring has multiple risk factors and … altering one of these risk factors may or may not have a beneficial effect’, provided that that labelling, presentation or advertising contains a statement informing the consumer of those two points in a manner that is accurate, clear and easy to understand.
The third question
74 It should be noted as a preliminary point that, according to settled case-law, in the procedure laid down by Article 267 TFEU providing for cooperation between national courts and the Court of Justice, it is for the latter to provide the national court with an answer which will be of use to it and enable it to decide the case before it. To that end, the Court should, where necessary, reformulate the questions referred to it (judgment of 26 March 2026 AVEPA, C‑294/25, EU:C:2026:254, paragraph 22 and the case-law cited).
75 In the present case, it is apparent from the request for a preliminary ruling that the dispute in the main proceedings concerns advertisements to promote food supplements that were published in periodicals for health professionals. The analysis must therefore be limited to written advertising only.
76 Accordingly, in order to provide an answer that will be of use to the referring court, it must be held that, by its third question, the referring court asks, in essence, whether Article 14(2) of Regulation No 1924/2006 must be interpreted as requiring written advertising which is aimed at promoting a food supplement and which includes a reduction of disease risk claim also to contain a statement indicating that the disease to which that claim is referring has multiple risk factors and that altering one of those risk factors may or may not have a beneficial effect, if that statement appears on the actual packaging, leaflet and website of that supplement?
77 In that regard, as noted in paragraph 61 of the present judgment, under Article 14(2), in addition to the general requirements laid down in that regulation and the specific requirements laid down in paragraph 1 of that article, for reduction of disease risk claims the labelling or, if no such labelling exists, the presentation or advertising of a food must also bear a statement indicating that the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect.
78 In accordance with the Court’s settled case-law, for the purpose of interpreting a provision of EU law, it is necessary to consider not only its wording but also the context in which it occurs and the objectives pursued by the rules of which it is part (judgment of 11 June 2020, ratiopharm, C‑786/18, EU:C:2020:459, paragraph 28 and the case-law cited).
79 As regards, in the first place, the wording of Article 14(2) of Regulation No 1924/2006, it should be noted that the use of the conjunction ‘or’ before the words ‘if no such labelling exists’ must be construed as meaning that the statement indicating that the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect must be included primarily in the labelling of the product concerned and, only if no such labelling exists, elsewhere, such as in the presentation of that product or the advertising relating to it.
80 In that regard, ‘labelling’ is defined in Article 2(1)(d) of Regulation No 1924/2006 by reference to Article 1(3)(a) of Directive 2000/13, since replaced by Article 2(2)(j) of Regulation No 1169/2011, as any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a food and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such food.
81 As is clear from Article 2(2)(j), any words or particulars relating to a food and placed on its packaging are covered by the concept of ‘labelling’ within the meaning of that provision.
82 In the present case, it is apparent from the request for a preliminary ruling that a statement that high cholesterol is a risk factor in the development of cardiovascular disease appears on the packaging and leaflet of the food supplement VistaSterol and, therefore, on its labelling, within the meaning of Article 2(2)(j).
83 So far as concerns, in the second place, the context of Article 14(2) of Regulation No 1924/2006, it should be noted that, for the purposes of Regulation No 1169/2011, Article 2(1)(g) of the latter regulation refers to the definition of the concept of ‘advertising’ in Article 2(a) of Directive 2006/114, according to which ‘the making of a representation in any form in connection with a trade, business, craft or profession in order to promote the supply of goods or services’ must be considered to be advertising.
84 It thus follows from Regulation No 1169/2011 that a distinction is drawn between the concepts of ‘labelling’ and ‘advertising’ in that regulation.
85 Furthermore, Article 12 of Regulation No 1169/2011, entitled ‘Availability and placement of mandatory food information’, provides, in paragraph 1 thereof, that mandatory food information – which includes, as follows from Article 2(2)(c) of that regulation, the information set out in Article 14(2) of Regulation No 1924/2006 – is to be available and easily accessible, in accordance with Regulation No 1169/2011, for all foods. Moreover, in paragraph 2, Article 12 of Regulation No 1169/2011 provides that, in the case of prepacked food, mandatory food information is to appear directly on the package or on a label attached thereto.
86 In that regard, Implementing Decision 2013/63, which was adopted by the European Commission within the framework of the implementing powers conferred on it by the EU legislature under Article 10(4) and Article 25 of Regulation No 1924/2006, provides, in the second subparagraph of point (b) in the third paragraph of point 2.1 of the Annex to that implementing decision, that ‘Article 12 of Regulation [No 1169/2011] establishes a principle that the consumer should always have the mandatory information when making a decision about a purchase of a food’.
87 Implementing Decision 2013/63 also states, in the third paragraph of point 2.1 of the Annex thereto, that ‘the distinction between “labelling” and “advertising” is that “labelling” is concerned with the delivery of the food to the final consumer, while “advertising” is about the promotion of the supply of food by the food business operator’.
88 Where a food has labelling which includes the mandatory information referred to in Article 14(2) of Regulation No 1924/2006, it is by means of that labelling that the consumer has that mandatory information when making a decision, the purpose of that labelling being precisely to inform the final consumer, as indicated in the preceding paragraph. In those circumstances, there is no requirement, for the purpose of achieving the objective pursued by Article 12 of Regulation No 1169/2011, that that mandatory information should also appear in the written advertising relating to that product.
89 So far as concerns, in the third place, the objective of Regulation No 1924/2006, as noted in paragraphs 54 and 64 of the present judgment, the protection of health is among the principal objectives of that regulation. To that end, consumers should be given the necessary information to make a choice in full knowledge of the facts.
90 However, provided that, as noted in paragraph 82 of the present judgment, the statement required by Article 14(2) of Regulation No 1924/2006 is included in the labelling of the product concerned, it is not necessary for that statement also to appear in the written advertising relating to that product, as the consumer concerned has all the necessary information to make an informed decision in full knowledge of the facts when making the purchase.
91 In the light of the foregoing, the answer to the third question is that Article 14(2) of Regulation No 1924/2006 must be interpreted as not requiring written advertising which is aimed at promoting a food supplement and which includes a reduction of disease risk claim also to contain a statement indicating that the disease to which that claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect, if that statement appears on the actual packaging of that supplement.
Costs
92 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.
On those grounds, the Court (Fifth Chamber) hereby rules:
1. Article 2(2)(5) of 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, as amended by Regulation (EC) No 109/2008 of the European Parliament and of the Council of 15 January 2008,
must be interpreted as meaning that statements relating to the frequency of intake and/or the method of administration of a food supplement fall within the concept of ‘health claim’ within the meaning of that provision where those practical matters are presented as being linked to a beneficial effect on health or to the absence or reduction of an effect that is adverse to health.
2. Article 14(2) of Regulation No 1924/2006, as amended by Regulation No 109/2008,
must be interpreted as not requiring the labelling of the food supplement concerned or, if no such labelling exists, the presentation or advertising relating to that food supplement to reproduce verbatim the statement set out in that provision that ‘the disease to which the claim is referring has multiple risk factors and … altering one of these risk factors may or may not have a beneficial effect’, provided that that labelling, presentation or advertising contains a statement informing the consumer of those two points in a manner that is accurate, clear and easy to understand.
3. Article 14(2) of Regulation No 1924/2006, as amended by Regulation No 109/2008,
must be interpreted as not requiring written advertising which is aimed at promoting a food supplement and which includes a reduction of disease risk claim also to contain a statement indicating that the disease to which that claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect, if that statement appears on the actual packaging of that supplement.
[Signatures]