Provisional text

delivered on 17 October 2024 (1)

Case C-386/23

Novel Nutriology GmbH

Verband Sozialer Wettbewerb eV

(Request for a preliminary ruling from the Bundesgerichtshof (Federal Court of Justice, Germany))

( Reference for a preliminary ruling – Consumer protection – Regulation (EC) No 1924/2006 – Nutrition and health claims made on foods – Article 10(1) and (3) – Specific conditions for health claims – Article 28(5) and (6) – Transitional measures – Advertising ‘botanical substances’ using health claims – Prolonged absence of an evaluation by the European Food Safety Authority (EFSA) and an examination by the European Commission of the inclusion of health claims relating to ‘botanical substances’ in the lists referred to in Articles 13 and 14 – Applicability of Regulation No 1924/2006 )

1.Article 10(1) of Regulation (EC) No 1924/2006 (2) on nutrition and health claims made on foods provides that health claims which, inter alia, are not included in the lists of authorised claims provided for in Articles 13 and 14 of that regulation are prohibited, and Article 10(3) of that regulation provides that reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being may be made only if accompanied by a specific health claim included in those lists.

2.Are health claims relating to botanical substances, used for advertising, permitted under Article 10(1) and (3) of that regulation where the European Commission has not yet taken a decision on the inclusion of such claims in the lists provided for in Articles 13 and 14? That is, in essence, the novel question referred by the Bundesgerichtshof (Federal Court of Justice, Germany).

3.The request for a preliminary ruling was made in proceedings between Verband Sozialer Wettbewerb eV (‘VSW’), a German association whose purpose, according to its articles of association, is to protect the commercial interests of its members, and Novel Nutriology GmbH, a limited liability company under German law, concerning an action for an injunction to prohibit the use of health claims relating to botanical substances which appear on that company’s website for the purpose of advertising a food supplement.

II. The legal framework

‘(9) There is a wide range of nutrients and other substances including, but not limited to, vitamins, minerals including trace elements, amino-acids, essential fatty acids, fibre, various plants and herbal extracts with a nutritional or physiological effect that might be present in a food and be the subject of a claim. Therefore, general principles applicable to all claims made on foods should be established in order to ensure a high level of consumer protection, give the consumer the necessary information to make choices in full knowledge of the facts, as well as creating equal conditions of competition for the food industry.

…

(14) There is a wide variety of claims currently used in the labelling and advertising of foods in some Member States relating to substances that have not been shown to be beneficial or for which at present there is not sufficient scientific agreement. It is necessary to ensure that the substances for which a claim is made have been shown to have a beneficial nutritional or physiological effect.

…

(16) It is important that claims on foods can be understood by the consumer and it is appropriate to protect all consumers from misleading claims. However, since the enactment of Council Directive 84/450/EEC of 10 September 1984 concerning misleading and comparative advertising, (3) the Court of Justice of the European Communities has found it necessary in adjudicating on advertising cases to examine the effect on a notional, typical consumer. In line with the principle of proportionality, and to enable the effective application of the protective measures contained in it, this Regulation takes as a benchmark the average consumer, who is reasonably well-informed and reasonably observant and circumspect, taking into account social, cultural and linguistic factors, as interpreted by the Court of Justice, but makes provision to prevent the exploitation of consumers whose characteristics make them particularly vulnerable to misleading claims. …

(17) Scientific substantiation should be the main aspect to be taken into account for the use of nutrition and health claims and the food business operators using claims should justify them. A claim should be scientifically substantiated by taking into account the totality of the available scientific data, and by weighing the evidence.

…

(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.

…

(35) Adequate transitional measures are necessary to enable food business operators to adapt to the requirements of this Regulation.’

5. Chapter I of that regulation, entitled ‘Subject matter, scope and definitions’, includes Articles 1 and 2 thereof. Article 1 of that regulation, entitled ‘Subject matter and scope’, states in paragraphs 1 and 2:

‘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.

…’

6. 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/EC [ (4) ] shall apply;

…

…

(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;

…’

‘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.

Without prejudice to Directives 2000/13/EC [ (5) ] and [84/450] the use of nutrition and health claims shall not:

(a) be false, ambiguous or misleading;

…

8. Article 6 of that regulation, entitled ‘Scientific substantiation for claims’, is worded as follows, in paragraphs 1 and 2 thereof:

‘1. Nutrition and health claims shall be based on and substantiated by generally accepted scientific evidence.

9. Chapter IV of that regulation, entitled ‘Health claims’, includes Articles 10 to 19 thereof. Article 10 of Regulation No 1924/2006, entitled ‘Specific conditions’, states in paragraphs 1 to 3:

‘1. Health claims shall be prohibited unless they comply with the general requirements in Chapter II and the specific requirements in this Chapter and are authorised in accordance with this Regulation and included in the lists of authorised claims provided for in Articles 13 and 14.

(a) a statement indicating the importance of a varied and balanced diet and a healthy lifestyle;

(b) the quantity of the food and pattern of consumption required to obtain the claimed beneficial effect;

(c) where appropriate, a statement addressed to persons who should avoid using the food; and

(d) an appropriate warning for products that are likely to present a health risk if consumed to excess.

3. Reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being may only be made if accompanied by a specific health claim included in the lists provided for in Article 13 or 14.’

10. Article 13 of that regulation, entitled ‘Health claims other than those referring to the reduction of disease risk and to children’s development and health’, provides in paragraphs 1 to 3:

‘1. Health claims describing or referring to:

(a) the role of a nutrient or other substance in growth, development and the functions of the body; or

(b) psychological and behavioural functions; or

…

which are indicated in the list provided for in paragraph 3 may be made without undergoing the procedures laid down in Articles 15 to 19, if they are:

(i) based on generally accepted scientific evidence; and

(ii) well understood by the average consumer.

3. After consulting [EFSA], the Commission shall adopt, in accordance with the regulatory procedure with scrutiny referred to in Article 25(3), a Community list, designed to amend non-essential elements of this Regulation by supplementing it, of permitted claims as referred to in paragraph 1 and all necessary conditions for the use of these claims by 31 January 2010 at the latest.’

11. Chapter V of that regulation, entitled ‘General and final provisions’, comprises Articles 20 to 29 thereof. Article 28 of that regulation, entitled ‘Transitional measures’, provides in paragraphs 5 and 6:

‘5. Health claims as referred to in Article 13(1)(a) may be made from the date of entry into force of this Regulation until the adoption of the list referred to in Article 13(3), under the responsibility of food business operators provided that they comply with this Regulation and with existing national provisions applicable to them, and without prejudice to the adoption of safeguard measures as referred to in Article 24.

6. Health claims other than those referred to in Articles 13(1)(a) and in Article 14(1)(a), which have been used in compliance with national provisions before the date of entry into force of this Regulation, shall be subject to the following:

(a) health claims which have been the subject of evaluation and authorisation in a Member State shall be authorised as follows:

(i) Member States shall communicate to the Commission, by 31 January 2008 at the latest, such claims accompanied by a report evaluating the scientific data in support of the claim;

(ii) after consulting [EFSA], the Commission shall, in accordance with the regulatory procedure with scrutiny referred to in Article 25(3), adopt a decision concerning the health claims authorised in this way and designed to amend non-essential elements of this Regulation by supplementing it.

Health claims not authorised under this procedure may continue to be used for six months following the adoption of the Decision;

(b) health claims which have not been the subject of evaluation and authorisation in a Member State: such claims may continue to be used provided an application is made pursuant to this Regulation before 19 January 2008; health claims not authorised under this procedure may continue to be used for six months after a decision is taken pursuant to Article 17(3).’

12. Under recitals 10 and 11 of Regulation (EU) No 432/2012: (6)

‘(10) The Commission has identified a number of claims submitted for evaluation, referring to effects of plant or herbal substances, commonly known as “botanical” substances, for which [EFSA] has yet to complete a scientific evaluation. In addition, there are a number of health claims for which either a further evaluation is required before the Commission is able to consider their inclusion or otherwise in the list of permitted claims, or which have been evaluated, but due to other legitimate factors consideration cannot be completed by the Commission at this time.

(11) Claims whose evaluation by [EFSA] or whose consideration by the Commission has not yet been completed will be published on the website of the Commission and may continue to be used pursuant to Article 28(5) and (6) of Regulation [No 1924/2006].’

3. Regulation (EU) No 536/2013

13.Recitals 4, 5 and 9 of Regulation (EU) No 536/2013 (7) state:

‘(4) The Commission has finalised its consideration of all health claims submitted for evaluation except for four categories of claims made on specific groups of food or one of their constituents. Those categories include claims on plant or herbal substances, commonly known as “botanical substances”, claims on specific foodstuffs, namely foods for use in very low calorie diets and foods with reduced lactose content, claims on caffeine and a claim on carbohydrates.

(5) As regards botanical substances, Member States and stakeholders expressed concerns as regards the difference in consideration given to the evidence based on “traditional use” on the one hand under Regulation [No 1924/2006] in relation to health claims and on the other hand under Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (8) concerning the use as traditional herbal medicinal products. Since the Commission considers that these concerns are relevant and require further reflection and consultation, a decision on claims relating to botanical substances should only be taken once those steps have been completed.

…

(9) In order to ensure transparency and legal security for all interested parties, claims the consideration of which has not yet been completed will remain published on the website of the Commission and may continue to be used pursuant to paragraphs 5 and 6 of Article 28 of Regulation [No 1924/2006].’

14.Paragraph 3 of the Gesetz gegen den unlauteren Wettbewerb (Law on unfair competition) of 3 July 2004, (9) in the version applicable to the dispute in the main proceedings (‘the UWG’), entitled ‘Prohibition of unfair commercial practices’, provides:

‘(1) Unfair commercial practices shall be prohibited.

(2) Commercial practices addressed to or reaching consumers are unfair where they do not meet the level of diligence required of undertakings and are likely to materially distort the economic behaviour of consumers.

…’

15.Paragraph 3a of that law, entitled ‘Infringement of the law’, provides:

‘A person shall be considered to be acting unfairly where he or she infringes a statutory provision that is also intended to regulate market behaviour in the interests of market participants and the infringement is liable to have a significantly adverse effect on the interests of consumers, other market participants or competitors.’

III. The main proceedings, the question referred for a preliminary ruling and the procedure before the Court

16.Novel Nutriology markets the food supplement ‘o’gænics Adapto-Genie ANTI-STRESS-KOMPLEX’ (‘the product concerned’). It advertised the product on its website with the following claims about the components ‘saffron extract’ and ‘melon juice extract’ (‘the claims at issue’):

‘1. Mood-enhancing saffron extract.

3. Melon juice extract with superoxide dismutase activity has been shown in studies to reduce feelings of stress and fatigue after four weeks. It also reduced irritability and fatigue by 63%, leading to a significant improvement in quality of life.’

17.According to VSW, the health claims at issue are prohibited under Article 10 of Regulation No 1924/2006. By letter of 23 October 2019, VSW gave Novel Nutriology formal notice to issue an undertaking to refrain from using those claims. Novel Nutriology did not respond to that formal notice.

18.VSW brought an action before the Landgericht Hamburg (Regional Court, Hamburg, Germany) seeking an order prohibiting Novel Nutriology, subject to a penalty payment, from advertising the product concerned in the course of business with the claims at issue. (10) That court upheld the action. Novel Nutriology brought an appeal against that judgment before the Oberlandesgericht Hamburg (Higher Regional Court, Hamburg, Germany), which dismissed that appeal.

19.Novel Nutriology brought an appeal on a point of law against the judgment of the appeal court before the Bundesgerichtshof (Federal Court of Justice), the referring court, which observes that, according to its case-law, the fact that the lists of authorised claims provided for in Articles 13 and 14 of Regulation No 1924/2006 have not yet been drawn up in full does not, in principle, preclude the application of Article 10(1) and (3) of that regulation. However, the question which remains unresolved is whether Article 10(1) and (3) of that regulation is applicable when botanical substances are advertised with health claims or with reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being pending completion of the evaluation by EFSA and the examination by the Commission of the inclusion in the lists provided for in Articles 13 and 14 of that regulation. That is a decisive factor for the purposes of ruling on the case in the main proceedings, in so far as, according to that court, if Article 10(1) and (3) of Regulation No 1924/2006 is applicable, VSW’s claims are well founded, since the health claims at issue infringe those provisions.

20.In that regard, the referring court states that, according to a first interpretation, (12) Article 10(3) of that regulation is not applicable in a case such as that in the main proceedings. The EU legislature has provided for only a limited prohibition of general, non-specific health claims. It follows that general health-related claims are prohibited only if they are not accompanied by specific claims included in the lists provided for in Article 13 or 14 of that regulation, which presupposes that those lists have been drawn up. Otherwise, contrary to the intention of the EU legislature, which is also clearly expressed in the transitional provisions of Article 28 of Regulation No 1924/2006, that regulation would initially contain stricter provisions than those which would subsequently become applicable. As a result of the suspension of the evaluation of claims relating to ‘botanical substances’ by EFSA and the Commission, it is impossible for a food business operator to obtain a decision on specific health claims and, consequently, to be able to accompany a reference to general health by such health claims. The mere fact of not drawing up the lists referred to in Article 13 or 14 of Regulation No 1924/2006 and not dealing with applications for inclusion of herbal substances in the lists thus creates a legal situation which does not correspond to the intention of the EU legislature. The principle that that regulation is inapplicable as long as the Commission remains inactive also concerns situations in which a person against whom an action for an injunction has been brought has not made an application for the inclusion of specific claims in the lists, given that such an application would have no chance of success in the foreseeable future due to the suspension of the evaluation of claims relating to botanical substances.

21.According to a second interpretation, described by the referring court as ‘predominant’, (13) Article 10(3) of Regulation No 1924/2006 must be applied to botanical substances where a general, non-specific reference within the meaning of that provision is accompanied by a specific health claim which has been put ‘on hold’ and may continue to be used subject to the conditions laid down in Article 28(5) and (6) of that regulation. That interpretation is supported by the fact that the wording of Article 10(1) and (3) of that regulation does not make a distinction according to whether or not the claims relate to ‘botanical substances’.

22.Furthermore, the purpose of Article 10(1) and (3) appears to preclude advertising using non-specific health claims relating to ‘botanical substances’ from being fully exempted from the restrictions laid down by those provisions in the absence of a full scientific assessment of the specific health claims that must accompany them. There is a risk that consumers will not be able to distinguish between food supplements and plant-based medicinal products, and that, contrary to the intention of the EU legislature, the use of food supplements with untested health claims may continue to pose a health risk to patients. (14) Moreover, in recital 11 of Regulation No 432/2012 and recital 9 of Regulation No 536/2013, the Commission stated that claims whose examination has not yet been completed will remain published on the Commission’s website and may continue to be used in accordance with Article 28(5) and (6) of Regulation No 1924/2006, which could be sufficient for the purposes of taking into account the legitimate interests of advertising companies in being able to use health claims for ‘botanical substances’.

23.Lastly, the referring court states that Novel Nutriology did not make an application under Article 28(6)(b) of that regulation before 19 January 2008. In that regard, the appeal court found, without it being challenged in the appeal on a point of law, that that undertaking did not make an application concerning melon juice extract, and that the application it made for saffron extract was dated 13 January 2009.

25.In those circumstances, the Bundesgerichtshof (Federal Court of Justice) decided to stay the proceedings and to refer the following question to the Court of Justice for a preliminary ruling:

26.‘May plant or herbal substances (“[botanical substances]”) be advertised with health claims (Article 10(1) of Regulation No 1924/2006) or with references to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being (Article 10(3) of Regulation No 1924/2006) without those claims being authorised under that regulation and included in the list of authorised claims pursuant to Articles 13 and 14 of [that regulation] (Article 10(1) of [Regulation No 1924/2006]) or without those references being accompanied by a specific health claim contained in one of the lists referred to in Articles 13 or 14 of [that regulation] (Article 10(3) of [Regulation No 1924/2006]), pending completion of the evaluation by [EFSA] and the examination by the Commission of the inclusion of the claims notified in respect of “[botanical substances]” in the Community lists referred to in Articles 13 and 14 of Regulation No 1924/2006?’

Novel Nutriology, VSW, the Greek and Italian Governments and the Commission submitted written observations. VSW, the Greek and French Governments and the Commission also presented oral argument at the hearing held on 20 June 2024. (15)

27.By its question, the referring court asks, in essence, whether Regulation No 1924/2006 must be interpreted as precluding ‘botanical substances’ from being advertised with specific health claims, within the meaning of Article 10(1) of that regulation, or with reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being, for the purposes of Article 10(3) of that regulation, without those specific health claims being included in the lists of authorised health claims referred to in Articles 13 and 14 of that regulation, or without that reference being accompanied by a specific health claim included in those lists, pending completion of the examination by the Commission of the inclusion of the health claims relating to botanical substances in those lists.

28.As a preliminary point, it should be recalled that Article 10 of Regulation No 1924/2006, which is contained in Chapter IV of that regulation, provides, in its paragraph 1, that health claims are to be prohibited unless they comply with the general requirements in Chapter II and the specific requirements in Chapter IV and are authorised in accordance with that regulation and included in the lists of authorised claims provided for in Articles 13 and 14 of that regulation. (16) Thus, Article 10(1) of Regulation No 1924/2006 lays down a prohibition in principle of health claims, with the exception of those included in the lists of authorised claims provided for in Article 13 or 14 of that regulation. (17)

29.Furthermore, under Article 10(3) of Regulation No 1924/2006, reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being may be made only if accompanied by a specific health claim included in the lists provided for in Article 13 or 14 of that regulation. According to the case-law of the Court, that provision thus introduces a distinction between two categories of health claims, namely, on the one hand, the ‘specific’ health claim included in the lists in question in accordance with the principle laid down in Article 10(1) of that regulation and, on the other hand, the ‘general’ health claim constituting a reference to those general, non-specific benefits which must be accompanied by a health claim appearing on those same lists. (18)

30.The Court has also held that Article 10(3) of Regulation No 1924/2006, which establishes a derogation from the principle laid down in Article 10(1) of that regulation, according to which health claims are prohibited, with the exception of those appearing in the lists of authorised claims referred to in that regulation, must therefore be interpreted strictly, and that it follows that a ‘general’ health claim within the meaning of that article must satisfy the evidential requirements laid down by that regulation. (19)

However, it is sufficient, for that purpose, that references to general, non-specific benefits of a nutrient or food for overall good health and health-related well-being be accompanied by specific health claims that are supported by generally accepted scientific evidence which has been verified and authorised, provided that the latter claims are included in the lists provided for in Article 13 or Article 14 of that regulation.

In turn, Article 28 of Regulation No 1924/2006 lays down transitional measures the objective of which, as is stated in recital 35 of that regulation, is to enable food business operators to adapt to the requirements of that regulation. In relation to health claims, the relevant transitional measures are set out in Article 28(5) and (6) of that regulation. In that regard, it is apparent from recitals 10 and 11 of Regulation No 432/2012 that the health claims that remain on hold – due, inter alia, to the fact that EFSA has not completed its scientific evaluation of them – may still be used in accordance with the transitional measures provided for in Article 28(5) and (6) of Regulation No 1924/2006.

According to the Court’s case-law, while the permitted health claims and the health claims on hold which are subject to the transitional regime could, in principle, be used in the marketing of food, those two categories of health claims are subject to different requirements and do not benefit from the same conditions. Whereas Article 17(5) of Regulation No 1924/2006 authorises, in principle, any food business operator to use the permitted health claims, included in the single definitive list for the European Union, the health claims on hold which are subject to the transitional regime must, inter alia, pursuant to Article 28(5) and (6) of that regulation, comply with that regulation and also the applicable national provisions.

That means, in particular, first, that in accordance with the second paragraph of Article 3, point (a), and Article 6(1) of that regulation, all health claims must not be false, ambiguous or misleading and must be based on generally accepted scientific evidence. Second, the health claims on hold must also meet, in each Member State, the requirements of its own national regime.

Again in accordance with the case-law of the Court, such a transitional situation, prolonged indefinitely beyond the period that ended, pursuant to Article 13(3) of Regulation No 1924/2006, at the latest on 31 January 2010, does not meet the requirements of that regulation, formulated in recital 23 thereof, according to which, in order to ensure a scientific assessment of the health claims that is harmonised and of the highest possible standard, such assessments should be carried out by EFSA.

However, the Court has stated that neither Article 10, nor Article 28(5), nor any other provision of Regulation No 1924/2006 stipulates that Article 10(2) of that regulation is to apply only after the lists of authorised claims referred to in Article 13 thereof have been adopted. It has also held that the fact that the list of authorised claims referred to in Article 13 of Regulation No 1924/2006 has not yet been adopted does not justify the release of a food business operator from its obligation to give the consumer the information stipulated in Article 10(2) of that regulation.

Indeed, under the transitional measure laid down in Article 28(5) of Regulation No 1924/2006, an operator which has taken the decision to make a health claim should, under its own responsibility, know the effects on health of the foodstuff concerned and thus already have the information required by Article 10(2) of that regulation.

In the present case, it should be noted, first, that Regulation No 1924/2006 concerns health claims on ‘foods’ and, in particular, under Article 2(1)(b) thereof, on ‘food supplements’ as defined by Directive 2002/46.

In the present case, it is not disputed that the product concerned constitutes such a food supplement. In addition, according to recital 9 of Regulation No 1924/2006, that regulation covers ‘various plants and herbal extracts’. To that effect, as is confirmed by recitals 10 and 11 of Regulation No 432/2012, recitals 4 and 5 of Regulation No 536/2013 and the case-law of the Court, Regulation No 1924/2006 includes within its scope ‘botanical substances’, which include saffron extract and melon juice extract.

Second, according to the referring court, the claims at issue constitute health claims within the meaning of point 5 of Article 2(2) of Regulation No 1924/2006, which is also not disputed. In its order for reference, that court stated that while the appeal court held that the claims at issue fell within the scope of Article 10(3) of that regulation, the referring court itself left open the question whether it is Article 10(1) or Article 10(3) of that regulation which is applicable to those claims. In that regard, it is for the referring court to determine to which of those categories the claims at issue relate. In any event, I note that Article 10(1) and Article 10(3) do not differentiate according to whether or not such claims relate to botanical substances.

The case in the main proceedings arises from the prolonged absence of an evaluation by EFSA and an examination by the Commission as regards the inclusion of botanical substances in the lists of authorised claims provided for in Articles 13 and 14 of Regulation No 1924/2006, even though Article 10(1) and (3) of that regulation requires, inter alia, that in order to be authorised, health claims must be included in those lists. While the absence of an evaluation and an examination for such a long period appears open to criticism and may form the subject matter of an action for failure to act against the Commission, the question raised by the referring court is whether a food business operator may use health claims relating to botanical substances to advertise its products pending the inclusion of such claims in those lists.

As set out in the first paragraph of Article 3 of Regulation No 1924/2006, 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. According to a first interpretation, set out by the referring court, Article 10 of Regulation No 1924/2006 is not applicable to health claims relating to botanical substances until the evaluation by EFSA and the examination by the Commission of the inclusion of such health claims in the lists of authorised claims provided for in Articles 13 and 14 of that regulation have been completed.

However, according to a second interpretation, also mentioned by the referring court, as is apparent from the case-law cited in point 33 of this Opinion, no provision of Regulation No 1924/2006 stipulates that Article 10(2) of that regulation, concerning information requirements, is to apply only after the lists of authorised claims provided for in that regulation have been adopted. Similarly, it is clear from the unequivocal wording of Article 10(1) and (3) of that regulation that health claims are to be prohibited if, inter alia, they are not included in the lists of authorised claims provided for in Articles 13 and 14 of that regulation. Thus, the authorisation of a health claim implies that the lists provided for in those articles have been adopted and published. If health claims relating to botanical substances are not included in those lists, Article 10 of Regulation No 1924/2006 is applicable and those claims are, in principle, prohibited.

That interpretation is supported by the objectives pursued by Regulation No 1924/2006. As the Court has pointed out, Article 1(1) of that regulation states that the purpose of that regulation is to ensure the effective functioning of the internal market while providing a high level of consumer protection. In that regard, health protection is among the principal aims of the regulation, and to that end, consumers should be given the necessary information to make a choice in full knowledge of the facts. In that context, recital 16 of that regulation states that it is important that claims on foods be understood by the consumer and that all consumers should be protected against misleading claims, specifying that that regulation takes as a benchmark, inter alia, the average consumer, who is reasonably well informed and reasonably observant and circumspect, taking into account social, cultural and linguistic factors.

In general, given the positive image conferred on foods bearing health claims, consumers are liable to be influenced in their consumption choices. The use of such claims must therefore be strictly regulated, in particular by being based on and substantiated by generally accepted scientific evidence, as provided for in Article 6(1) of Regulation No 1924/2006. That finding appears to be particularly valid for claims relating to botanical substances in so far as the plant origin of a foodstuff may be associated, in the minds of consumers, with a product that is beneficial to their health.

According to the case-law of the Court, the use of the expression ‘generally accepted scientific evidence’ means that such evidence should not be limited to beliefs, hearsay derived from popular wisdom, or the observations or experiences of persons outside the scientific community, and that, on the contrary, the use of such an expression means that health claims should be based on objective and scientific evidence and that, in particular, there should be sufficient scientific agreement as to the benefits of the substances to which the health claims relate, as stated in recital 14 of Regulation No 1924/2006. The Court has stated that, in addition, as required in recital 17 of that regulation, health claims must be ‘scientifically substantiated by taking into account the totality of the available scientific data and by weighing the evidence’. A finding that Article 10(1) and (3) of that regulation is not applicable to health claims relating to botanical substances would be tantamount to permitting the use of claims which have not been scientifically proven and may mislead consumers and put their health at risk.

In its written observations, Novel Nutriology submits that prohibiting food business operators from using health claims relating to botanical substances constitutes a disproportionate interference with their fundamental rights, in particular the freedom to conduct a business and the freedom of expression, enshrined, respectively, in Articles 16 and 11 of the Charter. In that regard, it should be recalled that, according to the Court’s settled case-law, fundamental rights do not appear as unfettered prerogatives, but may be restricted, provided that the restrictions in fact correspond to objectives of public interest pursued by the measure in question and that they do not constitute, in the light of the objectives pursued, a disproportionate and intolerable interference which impairs the very substance of the rights guaranteed.

Article 16 of the Charter protects the freedom to pursue an economic or commercial activity, the freedom to use, within the limits of its liability for its own acts, the economic, technical and financial resources at an undertaking’s disposal and the freedom of contract. However, it is important to note that food business operators which market botanical substances are not deprived of their freedom to pursue a commercial activity and are perfectly able to continue selling their products. Regulation No 1924/2006 does not prohibit the marketing of botanical substances, but merely prohibits advertising those substances using health claims which, in the absence of any examination by the Commission, are not scientifically proven. In those circumstances, such a prohibition does not impair the very substance of the freedom to conduct a business.

Furthermore, under Article 11 of the Charter, the right to freedom of expression includes freedom to hold opinions and to receive and impart information and ideas without interference by public authority and regardless of frontiers. Again, although a food business operator which markets botanical substances may not, for the purposes of Regulation No 1924/2006, use health claims which have not yet been evaluated by EFSA and examined by the Commission, that does not mean that it is deprived of the right to advertise its products by means other than such claims. In addition, it should be recalled that, under Article 35 of the Charter, a high level of human health protection is to be ensured in the definition and implementation of all EU policies and activities and that, according to Article 38 of the Charter, EU policies are to ensure a high level of consumer protection. Consequently, the application of Article 10(1) and (3) of Regulation No 1924/2006 to health claims relating to botanical substances appears to ensure a fair balance is struck between the fundamental rights which must be reconciled.

Moreover, Regulation No 1924/2006 has not imposed a complete and absolute prohibition on the use of health claims relating to botanical substances. According to the case-law of the Court, since the Commission has not yet defined its position on the applications for entry of the health claims at issue in the lists provided for in Article 13 of Regulation No 1924/2006, those claims are subject to the transitional arrangements laid down in Article 28(5) and (6) of that regulation, which makes it possible to guarantee transparency and legal certainty for all interested parties. Article 28(5) refers to the health claims provided for in Article 13(1)(a) of that regulation, namely health claims describing or referring to the role of a nutrient or other substance in growth, development and the functions of the body. Article 28(6) concerns in particular the claims mentioned in Article 13(1)(b) of that regulation, which relate to psychological and behavioural functions.

In the present case, it is apparent from the order for reference that the referring court favours the interpretation that the functions advertised by the claims at issue are not physiological functions within the meaning of Article 13(1)(a) of Regulation No 1924/2006, but rather psychological functions within the meaning of Article 13(1)(b) of that regulation, because all the functions advertised have in common that they concern the emotions. It is for the referring court to make the final assessment in that regard in order to decide the case in the main proceedings.

Should the referring court consider, following that final assessment, that the claims at issue ultimately fall within the scope of Article 28(5) of Regulation No 1924/2006, I would note that, under that provision, the health claims provided for in Article 13(1)(a) can be made from the date of entry into force of that regulation until the adoption of the list referred to in Article 13(3), under the responsibility of food business operators, provided that they comply with Regulation No 1924/2006 and with existing national provisions applicable to them, and without prejudice to the adoption of the safeguard measures referred to in Article 24. Thus, it follows from the wording of Article 28(5) of that regulation that a food business operator could, under its own responsibility and in accordance with the conditions laid down, make health claims during the period between the entry into force of that regulation and the adoption of the list referred to in Article 13 of Regulation No 1924/2006.

Accordingly, under the transitional arrangements provided for in Article 28(5) of Regulation No 1924/2006, the burden of proof and standard of proof in respect of the health claims referred to in Article 13(1)(a) of that regulation are governed by that regulation, which requires the food business operator concerned to be able to justify, by means of generally accepted scientific evidence, the claims which it uses. Those claims must be based on objective evidence which has sufficient scientific agreement. If those conditions are met, operators may continue to use health claims relating to botanical substances so long as the list referred to in Article 13 of Regulation No 1924/2006 has not been adopted in respect of those substances.

48.Article 28(6) of Regulation No 1924/2006 concerns, inter alia, claims which have been used in compliance with national provisions before the date of entry into force of that regulation. Since the order for reference does not contain any information about that use, it is for the referring court to ascertain whether that precondition is satisfied in the present case.

If that is the case, it is clear from Article 28(6)(a) of Regulation No 1924/2006 that if health claims have been the subject of evaluation and authorisation in a Member State, and that Member State has communicated those claims to the Commission by 31 January 2008 at the latest, claims which have not been authorised by the Commission under the indicated procedure (which is the case for claims relating to botanical substances) may continue to be used for six months after the adoption of the Commission decision. In so far as paragraph 6, unlike paragraph 5 of that article, makes no mention of the condition that claims must ‘comply’ with Regulation No 1924/2006, I consider, as does the Commission, that the continued use of a health claim relating to botanical substances is a matter for national law alone. Furthermore, under Article 28(6)(b) of that regulation, health claims which have not been the subject of evaluation and authorisation in a Member State may continue to be used provided that an application is made pursuant to that regulation before 19 January 2008, and health claims not authorised under that procedure may continue to be used for six months after a decision is taken pursuant to Article 17(3) of that regulation.

50.It is apparent from the order for reference that, in the case in the main proceedings, the health claims relating to the component ‘melon extract’ do not appear to have been communicated to the Commission in accordance with Article 28(6)(a) of Regulation No 1924/2006, and that no application under Article 28(6)(b) of that regulation was made in that regard before 19 January 2008. Therefore, subject to verification by the referring court, those claims do not appear, prima facie, to satisfy the conditions laid down in Article 28(6) of that regulation in order to continue to be used.

51.As regards the health claims relating to the component ‘saffron extract’, it is also apparent from the order for reference that those claims do not appear to have been communicated to the Commission in accordance with Article 28(6)(a) of Regulation No 1924/2006, and that an application under Article 28(6)(b) of that regulation was made on 13 January 2009, that is to say, after the deadline set by the latter provision, in order for those claims to continue to be used.

52.It is for the referring court to determine, taking into account all the circumstances of the case in the main proceedings, whether the conditions laid down in Article 28(5) or (6) of Regulation No 1924/2006 are satisfied as regards the claims at issue.

In the light of all the foregoing, I am of the opinion that Regulation No 1924/2006 must be interpreted as precluding ‘botanical substances’ from being advertised with specific health claims, for the purposes of Article 10(1) of that regulation, or with reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being, within the meaning of Article 10(3) of that regulation, without those specific health claims being included in the lists of authorised health claims provided for in Articles 13 and 14 of that regulation, or without that reference being accompanied by a specific health claim included in those lists, pending completion of the examination by the Commission of the inclusion of the health claims relating to botanical substances in those lists, except where those claims may continue to be used on a transitional basis and provided that the conditions laid down in Article 28(5) or (6) of that regulation are satisfied.

Conclusion

54.In the light of the foregoing considerations, I propose that the Court reply to the question referred for a preliminary ruling by the Bundesgerichtshof (Federal Court of Justice, Germany) as follows:

Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on food, as amended by Regulation (EC) No 109/2008 of the European Parliament and of the Council of 15 January 2008, must be interpreted as precluding ‘botanical substances’ from being advertised with specific health claims, for the purposes of Article 10(1) of that regulation, or with reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being, within the meaning of Article 10(3) of that regulation, without those specific health claims being included in the lists of authorised health claims provided for in Articles 13 and 14 of that regulation, or without that reference being accompanied by a specific health claim included in those lists, pending completion of the examination by the Commission of the inclusion of the health claims relating to botanical substances in those lists, except where those claims may continue to be used on a transitional basis and provided that the conditions laid down in Article 28(5) or (6) of that regulation are satisfied.

* * *

(1) Original language: French.

(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, 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’).

(3) Council Directive 84/450/EEC of 10 September 1984 relating to the approximation of the laws, regulations and administrative provisions of the Member States concerning misleading advertising (OJ 1984 L 250, p. 17).

(4) Directive 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).

(5) 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).

(6) Commission Regulation 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).

(7) Commission Regulation of 11 June 2013 amending Regulation (EU) No 432/2012 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 2013 L 160, p. 4).

(8) OJ 2001 L 311, p. 67.

(9) BGBl. 2004 I, p. 1414.

(10) VSW also requested the payment of a lump sum by way of reimbursement of the costs of giving formal notice in the amount of EUR 178.50, plus interest.

(11) Article 14 of Regulation No 1924/2006 concerns reduction of disease risk claims and claims referring to children’s development and health. That article does not appear to be relevant in the context of the case in main proceedings in so far as this case does not relate to children’s development and health.

(12) The referring court refers in that regard to a judgment of the Oberlandesgericht Karlsruhe (Higher Regional Court, Karlsruhe, Germany) of 27 February 2019 in Case 6 U 87/18.

(13) The referring court cites, inter alia, an order of the Oberlandesgericht Celle (Higher Regional Court, Celle, Germany) of 28 October 2020 in Case 13 U 44/20.

(14) In that regard, the referring court mentions, inter alia, a decision of the Bundesrat (Federal Council, Germany) of 12 February 2021, BR-Drucks. 36/21.

(15) I would like to pay my respects to Judge Marko Ilešič, who was the Judge-Rapporteur in this case and was present at this hearing, which was his last before his sudden and untimely death.

(16) As Advocate General Wathelet stated in his Opinion in Ehrmann (C‑609/12, EU:C:2013:746, point 87), Article 10(1) of Regulation No 1924/2006 sets out a series of conditions which, in the absence of any indication to the contrary, appear to be cumulative and of equal importance.

(17) See judgment of 30 January 2020, Dr. Willmar Schwabe (C‑524/18, ‘judgment in Dr. Willmar Schwabe’, EU:C:2020:60, paragraph 37).

(18) See judgment in Dr. Willmar Schwabe (paragraph 38).

(19) See judgment in Dr. Willmar Schwabe (paragraphs 56 and 57).

(20) See judgment in Dr. Willmar Schwabe (paragraph 58).

(21) See judgment of 10 April 2014, Ehrmann (C‑609/12, ‘judgment in Ehrmann’, EU:C:2014:252, paragraph 31).

(22) See judgment of 23 November 2017, Bionorica and Diapharm v Commission (C‑596/15 P and C‑597/15 P, ‘judgment in Bionorica’, EU:C:2017:886, paragraph 87).

(23) See judgment in Bionorica (paragraph 88).

(24) See judgment in Bionorica (paragraph 89).

(25) See judgment in Bionorica (paragraph 91 and the case-law cited).

(26) See judgment in Ehrmann (paragraph 39).

(27) See judgment in Ehrmann (paragraph 42).

(28) See judgment in Ehrmann (paragraph 43).

(29) According to Article 2(a) of that directive ‘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’.

(30) See judgment in Bionorica (in particular paragraphs 56 and 57). See also judgment of 10 September 2020, Konsumentombudsmannen (C‑363/19, ‘judgment in Konsumentombudsmannen’, EU:C:2020:693, in particular paragraph 37).

(31) More specifically, recital 4 of Regulation No 536/2013 expressly refers to ‘plant or herbal substances, commonly known as “botanical substances”’.

(32) I note that, under Article 13(3) of Regulation No 1924/2006, the list referred to in that article should have been adopted by 31 January 2010 at the latest, which is still not the case as regards botanical substances.

(33) In the judgment in Bionorica, the Court found that the actions for failure to act brought by Bionorica and Diapharm should be dismissed for lack of interest in bringing proceedings.

34See points 20 and 21 of this Opinion.

35See point 22 of this Opinion.

36See, to that effect, the judgment in Ehrmann (paragraph 26). As stated by the Italian Government in its written observations, Article 10 of Regulation No 1924/2006 does not distinguish between the different reasons for non-inclusion in the lists provided for in Articles 13 and 14 of that regulation, namely, for example, whether the Commission’s examination of a claim following a scientific assessment has led to that non-inclusion, or whether the Commission has not yet carried out its examination of a general category of claims, as is the case for botanical substances.

37See, to that effect, the judgment in Dr. Willmar Schwabe (paragraph 35 and the case-law cited).

38See judgment in Konsumentombudsmannen (paragraphs 46 and 47).

39See judgment of 13 June 2024, C (Court-appointed administrators and liquidators) (C‑696/22, EU:C:2024:499, paragraph 111 and the case-law cited).

40See judgment of 27 June 2024, Gestore dei Servizi Energetici (C‑148/23, EU:C:2024:555, paragraph 62 and the case-law cited).

41See judgment of 12 January 2023, Migracijos departamentas (Reasons for persecution on the ground of political opinion) (C‑280/21, EU:C:2023:13, paragraph 29 and the case-law cited).

42See, to that effect, the judgment in Konsumentombudsmannen (paragraph 40 and the case-law cited). See also recital 11 of Regulation No 432/2012 and recital 9 of Regulation No 536/2013.

43In that regard, as concerns saffron, the Italian Government and the Commission stated, in their written observations, that there is a health claim under identification number 2038 relating to ‘Crocus Sativus L.’ – namely that it ‘Contributes to emotional balance; Helps to support the relaxation; Helps to maintain a positive mood’ – which is pending evaluation. They refer to an EFSA table (available in English only), in ‘Excel table’ format, entitled ‘Questions-on-hold-botanical-claims’, which can be viewed at the following web address: https://www.efsa.europa.eu/en/topics/topic/general-function-health-claims-under-article-13. As the referring court points out, the question whether the claims at issue correspond to that health claim may remain open at this stage of the main proceedings. In any event, such an assessment falls within the exclusive jurisdiction of the national court.

44By way of illustration, the Greek Government stated at the hearing that the Hellenic Republic had submitted to the Commission, before 31 January 2008, three health claims concerning Chios mastic, which appear in the EFSA database as claims which are ‘on hold’.

45It should be noted, as all the participants in the hearing did, that the deadlines of 19 and 31 January 2008 referred to in Article 28(6) of Regulation No 1924/2006 are not merely indicative dates corresponding to the actual start of the evaluation of health claims relating to botanical substances, but dates which are binding.

46In that context, as concerns saffron, the Italian Government and the Commission stated, in their written observations, that there is a health claim under identification number 2038 relating to ‘Crocus Sativus L.’ – namely that it ‘Contributes to emotional balance; Helps to support the relaxation; Helps to maintain a positive mood’ – which is pending evaluation. They refer to an EFSA table (available in English only), in ‘Excel table’ format, entitled ‘Questions-on-hold-botanical-claims’, which can be viewed at the following web address: https://www.efsa.europa.eu/en/topics/topic/general-function-health-claims-under-article-13. As the referring court points out, the question whether the claims at issue correspond to that health claim may remain open at this stage of the main proceedings. In any event, such an assessment falls within the exclusive jurisdiction of the national court.