Provisional text

OPINION OF ADVOCATE GENERAL

BIONDI

delivered on 29 January 2026 (1)

Case C‑721/24

Vista-Life Pharma SA

and

Vista-Life Pharma Belgium SCRL

Laboratoires S.M.B. SA

and

Brussels Reps Pharma SRL

(Request for a preliminary ruling from the cour d’appel de Bruxelles (Court of Appeal, Brussels, Belgium))

( Reference for a preliminary ruling – Regulation (EC) No 1924/2006 – Advertised food supplements – Reduction of disease risk claims – Specific conditions of use )

1. By the present reference for a preliminary ruling, the cour d’appel de Bruxelles (Court of Appeal, Brussels, Belgium) asks the Court to clarify the application of some of the provisions of Regulation (EC) No 1924/2006. (2) The referring court is asking the Court, on the one hand, to determine when references to frequency of intake and method of administration of food supplements may, by virtue of the way in which they are presented, relate to health; on the other, to clarify the scope and form of the informative message that is to accompany a reference to reduction of health risks, including where it is to be positioned in the context of labelling and advertising.

I. Legislative context

2. Regulation No 1924/2006 on nutrition and health claims made on foods defines, in Article 2(2)(1) and (5), relevant concepts for the purposes of the present reference as follows: ‘“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’; and ‘“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’.

3. Article 14(2) of the regulation provides:

‘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’.

4. For the definition of ‘labelling’, Article 2(1)(d) of Regulation No 1924/2006 refers to Article 1(3)(a) of Directive 2000/13/EC, (3) which has since been repealed and replaced by Article 2(2)(j) of Regulation (EU) No 1169/2011. (4) That article defines ‘labelling’ 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’.

5. Although the referring court has doubts solely as to the interpretation of Regulation No 1924/2006, it nevertheless appears necessary, in my view, to recall how that regulation has been implemented in Belgian law. In particular, Article VI.104 of the Code de droit économique (Code of Economic Law) (5) prohibits unfair commercial practices, with a view to protecting the professional interests of undertakings.

II. Main proceedings, questions referred for a preliminary ruling and proceedings before the Court

6. The parties in the main proceedings operate in the Belgian pharmaceutical and parapharmaceutical sector. Laboratoires S.M.B. SA and Brussels Reps Pharma SRL (together, ‘SMB’) produce and market medicinal products and food supplements. Vista-Life Pharma SA and Vista-Life Pharma Belgium SCRL (together, ‘Vista-Life’) also market food supplements, which include Vista-D3 and VistaSterol. SMB and Vista-Life are competitors in the food supplement marketing sector.

7. The dispute in the main proceedings concerns commercial statements relating to the abovementioned products. The advertising campaigns at issue were carried out in specialised journals intended for pharmacists and doctors.

8. ‘Vista-D3’ was advertised with the following claims: ‘stable plasma levels’, ‘Vista-D3 prevents an increase in the risk of mortality’, ‘Vista-D3 prevents the first-pass effect in the liver and enzymatic degradation in the gastrointestinal tract’, ‘daily better than single dose’, and, in references to the sublingual method of administration, ‘the best possible absorption for all patients’.

9. ‘VistaSterol’ was advertised with the claim ‘the solution for controlling cholesterol’.

10. In two different applications, of 9 June 2021 and of 9 December 2022, SMB started proceedings before the Tribunal de l’entreprise francophone de Bruxelles (Brussels Business Court (French-speaking), Belgium), challenging the compatibility of the abovementioned claims with Regulation No 1924/2006. In particular, SMB argued that those claims constituted ‘health claims’ within the meaning of Regulation No 1924/2006, infringing Article 10 of that regulation as well as Article VI.104 of the Code de droit économique (Code of Economic Law). As regards the claims concerning stable plasma levels and cholesterol levels, SMB argues that those are contrary to Article 14(2) of that regulation and of Article VI.104 of the Code de droit économique (Code of Economic Law).

11. In two rulings of 6 April 2022 and of 5 April 2023, the court of first instance found an infringement of Article 10 and of Article 14(2) of Regulation No 1924/2006 and of Article VI.104 of the Code de droit économique (Code of Economic Law) and ordered Vista-Life to discontinue the infringement.

12. Vista-Life lodged an appeal before the cour d’appel de Bruxelles (Court of Appeal, Brussels), which joined the cases.

13. It was in those circumstances that 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?’

14. The parties to the main proceedings, the Belgian Government and the European Commission presented their written observations.

III. Analysis

A. Preliminary observations

15. Regulation No 1924/2006 establishes a fully harmonised and directly applicable framework that safeguards the provision of correct information to consumers and ensures a level playing field for competition. (6)

16. Member States are responsible for monitoring and enforcement; the Commission, together with the European Food Safety Authority (EFSA), is responsible for updating the lists of authorised claims, and for providing guidance on and coordinating the implementation of that regulation, in line with the objectives pursued by the EU legislator, such as ensuring the effective functioning of the internal market and providing a high level of consumer protection. (7) In addition to consumer protection, the protection of health is among the principal aims of Regulation No 1924/2006. (8)

17. As the Court has stated, in order to fulfil those objectives, consumers should be given the necessary information to make a choice in full knowledge of the facts. (9)

18. The general principle of Regulation No 1924/2006 is that health claims made on foods are to be prohibited unless they comply with the regulation, are authorised by the Commission and are included in the list of authorised claims. (10)

19. Risk to health is also the rationale for the special rules on health claims and on reduction of disease risk claims. Where the commercial communications contain nutritional or health claims, those claims come within the scope of the regulation. The Court has adopted a broad and functional interpretation of the concept of ‘health claim’ which covers not only the improvement in health, but also the absence or reduction of adverse effects associated with the consumption of the food, as well as short-term effects, such as those arising from one-off consumption, and the effects of repeated consumption. (11)

20. In the judgment in Deutsches Weintor, the Court classified the expression ‘easily digestible’ (referring to a wine) as a health claim, noting that the message suggested an absence of harmful effects on the digestive system; that confirms that claims of positive health effects ‘despite’ potentially harmful consumption also come within the definition of a ‘health claim’. (12) In other words, the emphasis is placed on the overall impression on the consumer and the persuasive effect of the message. (13)

21. Consumer and health protection must also be reconciled with freedom to conduct a business. (14) That balancing exercise does not prevent health claims from being subject to certain conditions so that the consumer is placed in a position to make an informed choice. (15)

22. In carrying out that balancing exercise, the Court relies on the ‘average consumer, who is reasonably well-informed and reasonably observant and circumspect’. (16)

23. The aim of the statement referred to in Article 14(2) of Regulation No 1924/2006 (17) is to place the risk reduction claim in a realistic context, highlighting (i) the existence of multiple causes of the disease in question and (ii) the possibility that removing only one of those causes will have no beneficial effects. The above is consistent with health protection as pursued by the regulation. (18)

24. In the digital environment, where consumers regularly seek information and make purchases online, it is necessary to ensure that the relevant rules are effective. Advertising must not present a health claim separately from the precaution provided for in Regulation No 1924/2006: where the health claim appears on a website, but the precautionary warning appears on labelling, there could be a clear reference to the place where that claim appears in full, in order to ensure that it is immediately accessible. (19)

25. It is for the national courts and authorities to ensure the effectiveness of the regulation while maintaining its full enforcement. At the same time, the Commission is required to update lists of claims, maintain operational guidance and coordinate enforcement, in the interests of certainty for undertakings and the protection of consumers.

B. The first question for preliminary ruling: frequency and method of administration

26. Regulation No 1924/2006 adopts a broad and functional interpretation of the concepts of ‘claim’ and ‘health claims’. Those concepts cover any message which states, suggests or implies that a relationship exists between the food or one of its constituents and health. The reference to the ‘particular characteristics’ of the food is not limited to its intrinsic properties (composition, content and ingredients); it also includes elements which, as presented to the consumer, characterise the way in which the product is intended to be taken and give rise to the expectation of a benefit. From that perspective, references to the frequency of intake (for example, ‘daily better than single dose’) and/or the method of administration (for example, ‘sublingual’, on the basis that it would ensure ‘stable plasma levels’ or ‘better absorption’) may constitute a ‘claim’ within the meaning of Article 2(2)(1) and (5), where they imply a beneficial health effect.

27. The above is confirmed by a literal as well as a systematic and teleological interpretation: literal, because Article 2(2)(5) of Regulation No 1924/2006 expressly includes messages that ‘imply’ a health-food relationship; systematic, because as stated in recital 16 of Regulation No 1924/2006, the criterion of the average consumer is not a statistical criterion, instead it requires an evaluation of the typical reaction of consumers on a case-by-case basis; and teleological, because the objectives of providing effective protection prevent a benefit from being promised by way of incomplete messages or techniques which prevent the claim being subject to health claim checks. The case-law confirms that approach, according to which ‘health claim’ also means a message that does not promise a clinical improvement in the strict sense but suggests the absence or reduction of adverse effects and therefore attaches particular importance to the manner in which the consumer understands the message as a whole and decides accordingly. (20)

28. It follows that statements relating to the method of administration and the frequency of consumption are included within the definition of ‘health claim’ where, by virtue of their wording, graphic presentation, accompanying indications or images, they attribute to those methods a role in the attainment of a beneficial health effect (for example, ‘stable plasma levels’, ‘better absorption’ and ‘avoids the first-pass effect in the liver’). By contrast, instructions for use, with no persuasive health-related content (for example, ‘take with water’, ‘one tablet per day’), are excluded when not accompanied by any explicit or implicit reference to benefits or risks. The mere fact of mentioning the method of administration is not therefore decisive; rather it is its presentation as a reason for the benefit or reduction of risk that is relevant.

29. Lastly, that interpretation does not require excessive formalism by undertakings. The operator may provide neutral instructions for use; however, if the method of administration and frequency of intake are presented as a persuasive argument in terms of health, it comes within the scope of the requirements in Article 14(2) of Regulation No 1924/2006. It is for the national court to determine, in practice, whether the statements at issue respect the abovementioned criteria.

30. The answer to the first question is therefore that the frequency of intake and the method of administration, when presented as having a functional value in terms of health, constitute ‘particular characteristics’ which constitute ‘health claims’ within the meaning of Article 2(2)(1) and (5) of Regulation No 1924/2006.

C. The second question for preliminary ruling: the verbatim reproduction under Article 14(2) of Regulation No 1924/2006

31. Article 14(2) of Regulation No 1924/2006 does not require specific wording to be reproduced verbatim. It sets out, in essence, the content of the statement, which must indicate (i) the existence of multiple causes of the disease in question and (ii) the possibility that removing only one of those causes will have no beneficial effect. The literal wording indicates what must be conveyed to the consumer, not necessarily how it must be worded.

32. An analysis of other provisions of the same regulation also confirms that view. Where the legislature intends to impose standardised wording, it expressly states that this is the case. See, for example, Article 4(2)(b) (21) and the entries in the annex (22) to Regulation No 1924/2006, where, for certain nutrition claims, specific wording is required (for example, the obligation to add ‘contains naturally occurring sugars’ where sugars are naturally present alongside the claim ‘with no added sugars’). Article 14(2) does not operate in that way as it defines the purpose and content of the warning, not its exact wording.

33. The rationale is clear, namely to prevent the risk reduction claim from being perceived as a therapeutic promise. That result is obtained by accompanying it with a statement that makes its scope clear.

34. In the absence of such a requirement, a statement is compatible with Article 14(2) if it contains the essential elements required, namely that: (i) the disease has multiple factors; and (ii) altering only one of those factors may or may not have a beneficial effect.

35. The proposed interpretation avoids unnecessary rigidity thereby safeguarding clear information standards for the protection of health. (23)

36. In the present case, it arises from all the foregoing considerations that a statement conveying the substance of the message is in line with Article 14(2), as there is no need to reproduce the provision verbatim. It is for the referring court to ascertain, on the basis of the overall impression of the consumer, whether the wording used provides the necessary informative content in a clear and comprehensible manner.

D. The third question for preliminary ruling: the obligation to reproduce the statement in the advertising if it already appears on the packaging, leaflet and/or website

37. Article 14(2) of Regulation No 1924/2006 provides that, for reduction of disease risk claims, ‘the labelling or, if no such labelling exists, the presentation or advertising’ is to bear a warning statement.

38. A simple rule arises from that wording: the statement is necessary in advertising only ‘if no such labelling exists’. If labelling exists and is in compliance with Article 14(2), the obligation is discharged by that primary medium.

39. In other words: (i) if labelling exists, it must bear the warning statement; (ii) if labelling does not exist, the statement must appear in the presentation or advertising. The provision does not require automatic duplication of the statement on all advertising material.

40. In that regard, I recall that the Court has ruled in relation to Article 10(3) of Regulation No 1924/2006, which requires that a reference to a general and non-specific benefit must be ‘accompanied’ by a specific health claim. (24) In particular, the Court explained that where the specific health claims do not appear in their entirety on the same side of the packaging as the reference which they are intended to substantiate, the requirement for a direct visual link could be satisfied, exceptionally, by means of an explicit reference, such as an asterisk, where the latter ensures, in a manner that is clear and perfectly comprehensible to the consumer, that, in spatial terms, the content of the health claims and the reference match. (25) It is, in any case, for the national court to establish, in the light of all the circumstances of the case, whether the requirement for visual proximity is satisfied by the use of a linking asterisk. (26)

41. Applying, by analogy, that reasoning to Article 14(2) of Regulation No 1924/2006, it could be inferred that labelling, presentation or advertising can satisfy the requirements of Article 14(2) of Regulation No 1924/2006 by means of a reference to the statement required by that article reproduced elsewhere. It will however be for the national court to establish whether the reference to the statement is sufficient to ensure the full effectiveness of Article 14(2) of Regulation No 1924/2006.

42. As regards the concepts of packaging and leaflet in the present case, it should be noted that those terms undisputedly come within the definition of ‘labelling’ in Article 2(2)(j) of Regulation No 1169/2011.

43. As regards the website, Regulation No 1924/2006 was adopted at a time when electronic commerce was much less developed than today. As noted by the European Parliament, misleading claims occur in both online and offline sales of food. (27) The Parliament has explicitly invited the Commission to draft comprehensive guidelines for the enforcement of the regulation online. (28)

44. The digital channel has become a common channel not only for purchasing food supplements but also for pre-contractual information. (29)

45. In that context it must be established whether a website constitutes ‘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’ within the meaning of Article 2(2)(j) of Regulation No 1169/2011.

46. To that end, it is relevant to note the purpose of a website. If a website acts as an advertising platform for a product, it comes within the definition of ‘presentation’ or ‘advertising’ within the meaning of Article 14(2) of Regulation No 1924/2006. If it acts as a platform for the purchasing of products, it might be assumed that it acts instead as a ‘document’ or ‘notice’ which accompanies or refers to a food, coming within the definition of labelling for the purpose of Regulation No 1169/2011.

47. In the light of the foregoing, the application of the criteria laid out previously to websites depends on the function they perform: (a) where the site presents or promotes the product (product sheets, display pages or campaigns), it comes within the definition of presentation or advertising in Regulation No 1924/2006; (b) where the site is associated with distance selling (a purchase page) and conveys mandatory information prior to purchase, Article 14 of Regulation No 1169/2011 requires that such information is available on the medium used for distance selling: in that function, the page may be treated, specifically, as a ‘document’ or ‘notice’ accompanying the food supplements and, therefore, as labelling within the meaning of the broad definition in Regulation No 1169/2011.

48. The above would also avoid a general extension of the concept of labelling to the entire internet, ensuring that in distance sales channels the warning statement is available with a single click before the purchase.

49. There is therefore no reason to require the operator to duplicate the warning statement on every means of communication. Turning to the functional criterion, the warning statement should be placed where it fulfils its informative function and is easily accessible to a consumer deciding whether or not to make the purchase. In that regard, that may include the circumstance where a distance seller, in the case of the relevant webpage containing the warning statement, includes a reference (for example, by means of a link) to that sales page in its online advertising.

50. It is for the referring court to ascertain, in practice, whether the solution adopted by the operator ensures that the consumer takes note of the statement before deciding to make the purchase.

51. Article 14(2) of Regulation No 1924/2006 does not therefore, in principle, require the repetition of the statement in the advertising where it appears in a compliant manner on the labelling.

IV. Conclusion

52. In the light of the foregoing considerations, I propose that the Court answer the questions referred by the cour d’appel de Bruxelles (Court of Appeal, Brussels, Belgium) as follows:

(1) Article 2(2)(1) and (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

must be interpreted as meaning that the terms ‘particular characteristics’ and ‘a food category, a food or one of its constituents’ cover statements relating to the frequency of intake and/or the method of administration of a food.

(2) Article 14(2) of Regulation No 1924/2006

must be interpreted as meaning that it does not require that 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) Article 14(2) of Regulation No 1924/2006

must be interpreted as not 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.

1 Original language: Italian.

2 Regulation 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), as amended by Regulation (EC) No 107/2008 of the European Parliament and of the Council of 15 January 2008 amending Regulation (EC) No 1924/2006 on nutrition and health claims made on foods as regards the implementing powers conferred on the Commission (OJ 2008 L 39, p. 8), Regulation (EC) No 109/2008 of the European Parliament and of the Council of 15 January 2008 amending Regulation (EC) No 1924/2006 on nutrition and health claims made on foods (OJ 2008 L 39, p. 14), Commission Regulation (EU) No 116/2010 of 9 February 2010 amending Regulation No 1924/2006 with regard to the list of nutrition claims (OJ 2010 L 37, p. 16), 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 (OJ 2011 L 304, p. 18) and Commission Regulation (EU) No 1047/2012 of 8 November 2012 amending Regulation No 1924/2006 with regard to the list of nutrition claims (OJ 2012 L 310, p. 36) (‘Regulation No 1924/2006’).

3 Directive 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).

4 Regulation of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations 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, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ 2011 L 304, p. 18).

5 Moniteur belge of 29 March 2013, p. 19975, as amended by the Loi 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 I^er et XV du Code de droit économique (Law inserting Title VI ‘Market practices and consumer protection’ into the Code of Economic Law and inserting the definitions specific to Book VI and the provisions on the application of the law specific to Book VI into Books I and XV of the Code of Economic Law, of 21 December 2013) (Moniteur belge of 30 December 2013, p. 103506).

6 See recital 9 and Article 1(1) of Regulation No 1924/2006.

7 See recitals 31, 33, 34 and 36 and Article 1(1) and Article 20 of Regulation No 1924/2006.

8 Judgment of 30 April 2025, Novel Nutriology (C‑386/23, ‘the judgment in Novel Nutriology’, EU:C:2025:304, paragraph 63 and the case-law cited).

9 The judgment in Novel Nutriology, paragraph 64 and the case-law cited.

10 Article 10(1) of Regulation No 1924/2006. See also Commission Regulation (EC) No 983/2009 of 21 October 2009 on the authorisation and refusal of authorisation of certain health claims made on food and referring to the reduction of disease risk and to children’s development and health (OJ 2009 L 277, p. 3) and Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health (OJ 2012 L 136, p. 1).

11 Judgment of 6 September 2012, Deutsches Weintor (C‑544/10, ‘the judgment in Deutsches Weintor’, EU:C:2012:526, paragraphs 34 to 36).

12 Ibid., paragraph 35.

13 Ibid., paragraph 37.

14 Articles 15 and 16 of the Charter of Fundamental Rights of the European Union (OJ 2016 C 202, p. 389).

15 Opinion of Advocate General Rantos in Novel Nutriology (C‑386/23, EU:C:2024:897, point 43).

16 Recital 16 of Regulation No 1924/2006; and judgment of 30 January 2020, Dr. Willmar Schwabe (C‑524/18, EU:C:2020:60, paragraph 35).

17 Hereinafter referred to as ‘the warning statement’.

18 That aim is also recalled in the judgment in Deutsches Weintor, paragraph 45.

19 See point 37 onwards of the present Opinion.

20 The judgment in Deutsches Weintor, paragraph 35.

21 Article 4, entitled ‘Conditions for the use of nutrition and health claims’, states as follows in paragraph 2(b) thereof: ‘… This statement shall read as follows: “High (The name of the nutrient exceeding the nutrient profile) content”’.

22 The annex entitled ‘Nutrition claims and conditions applying to them’ reads as follows, in entry ‘WITH NO ADDED SUGAR’: ‘… If sugars are naturally present in the food, the following indication should also appear on the label: “CONTAINS NATURALLY OCCURRING SUGARS”’.

23 See also, by analogy, Opinion of Advocate General Hogan in Dr. Willmar Schwabe (C‑524/18, EU:C:2019:727, points 60 to 66).

24 Judgment of 30 January 2020, Dr. Willmar Schwabe (C‑524/18, EU:C:2020:60).

25 Ibid., paragraph 48.

26 Ibid., paragraph 49.

27 European Parliament resolution of 18 January 2024 on the implementation of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods (OJ C, C/2024/5729), point 1.

28 Ibid., point 23.

29 See, by analogy, judgment of 11 December 2003, Deutscher Apothekerverband (C‑322/01, EU:C:2003:664, paragraph 73).