Opinion of the Advocate General — ECLI:EU:C:2024:897
Date: 2024-10-17
Language of the case: German
Procedure: Reference for a preliminary ruling
Origin: Germany

Summary C-386/23 – 1 
Case C-386/23 
Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged: 
26 June 2023 
Referring court: 
Bundesgerichtshof (Germany) 
Date of the decision to refer: 
1 June 2023 
Defendant and appellant in the appeal on a point of law: 
Novel Nutriology GmbH 
Applicant and respondent in the appeal on a point of law: 
Verband Sozialer Wettbewerb e.V. 
  
Subject matter of the main proceedings 
Action for an injunction prohibiting the advertising of a product containing plant 
or herbal substances with claims which the applicant considers to be 
impermissible health claims 
Subject matter and legal basis of the request 
Interpretation of EU law, Article 267 TFEU 
Question referred for a preliminary ruling 
May plant or herbal substances (‘botanicals’) be advertised with health claims 
(Article 10(1) of Regulation [EC] 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 (Art. 10(3) of Regulation [EC] 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 the Regulation (Article 10(1) 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-386/23 
 
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of the Regulation) 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 the 
Regulation (Article 10(3) of the Regulation), pending completion of the 
evaluation by the Authority and the examination by the Commission of the 
inclusion of the claims notified in respect of ‘botanicals’ in the Community lists 
referred to in Articles 13 and 14 of Regulation (EC) No 1924/2006? 
Provisions of European Union law relied on 
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 
Commission Regulation (EU) No 1047/2012 of 8 November 2012, in particular 
Articles 10 and 28 
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, in particular recitals 10 
and 11 
Commission Regulation (EU) No 536/2013 of 11 June 2013 amending Regulation 
(EU) No 432/2012, in particular recitals 4 and 5 
Provisions of national law relied on 
Gesetz gegen den unlauteren Wettbewerb (German Law against unfair 
competition), in particular Paragraphs 3, 3a, 8 and 12 
Succinct presentation of the facts and procedure in the main proceedings 
1 The applicant, the Verband Sozialer Wettbewerb e.V., is a registered association 
whose responsibilities include the protection of the commercial interests of its 
members. 
2 The defendant distributes the food supplement ‘o'gaenics Adapto-Genie ANTI-
STRESS-KOMPLEX’. It advertised that product on its website with the following 
claims about the substances ‘saffron extract’ and ‘melon juice extract’: 
‘1. mood-enhancing saffron extract. 
2. The saffron extract Safr'Inside in Adapto-Genie was tested on 50 
participants over a period of 30 days in an open study. With a dose of 30 mg of 
Safr'Inside per day, 77% of the subjects experienced an improvement in emotional 
balance, felt more optimistic and happier after only two weeks of use. 66% also 
felt more relaxed and dynamic. After 30 days, sleep quality improved in 11% of 
the subjects. 
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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.’ 
3 The applicant considers those claims to be impermissible health claims pursuant 
to Article 10 of Regulation No 1924/2006. In a letter dated 23 October 2019 it 
therefore requested that the defendant issue an undertaking to desist. The 
defendant failed to comply with that request. 
4 Thereupon, the applicant brought an action before the Landgericht (Regional 
Court, Germany) and claimed, inter alia, that the defendant should be prohibited 
from advertising the product ‘o'gaenics Adapto-Genie ANTI-STRESS-
KOMPLEX’ in the course of business with the above-mentioned claims. 
5 The Landgericht (Regional Court) upheld the action. The defendant’s appeal 
against that was unsuccessful. The defendant then brought an appeal on a point of 
law before the referring court. 
Succinct presentation of the reasoning in the request for a preliminary ruling 
6 According to the referring court, the key issue in the present case is whether 
Article 10(1) and (3) of Regulation No 1924/2006 are applicable when plant or 
herbal substances (‘botanicals’) are 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) as long as the evaluation by the 
Authority and the examination by the Commission on the inclusion of the claims 
notified for ‘botanicals’ in the Community lists pursuant to Article 13 and 14 of 
Regulation No 1924/2006 have not yet been completed (see paragraph 11 et seq. 
in that regard). If Article 10(1) and (3) of Regulation No 1924/2006 are not 
applicable, a breach of those provisions can be ruled out from the outset and the 
claims asserted are unmeritorious; if, on the other hand, Article 10(1) and (3) of 
Regulation No 1924/2006 are applicable, the claims asserted are justified on the 
merits because the claims complained of are in infringement of those provisions 
(see paragraph 22 et seq. in that regard). 
A. General considerations 
7 Article 10(1) of Regulation No 1924/2006 provides that health claims are to be 
prohibited unless they comply with the general requirements in Chapter II and the 
specific requirements in that Chapter and are authorised in accordance with that 
Regulation and included in the lists of authorised claims provided for in 
Articles 13 and 14 of Regulation No 1924/2006. Article 10(3) of Regulation 
No 1924/2006 provides that reference to general, non-specific benefits of the 
nutrient or food for overall good health or health-related well-being may only be 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-386/23 
 
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made if accompanied by a specific health claim included in the lists provided for 
in Article 13 or 14 of Regulation No 1924/2006. 
8 Article 10(3) of Regulation No 1924/2006, as with Article 10(1) of Regulation 
No 1924/2006, requires a health claim; references to general, non-specific benefits 
of the nutrient or food for health in general or health-related well-being constitute 
a specific form of health claim. 
9 The contested claims ‘mood enhancing’, ‘improvement of emotional balance’, 
‘felt more optimistic and happy’, ‘felt … more relaxed and dynamic’, 
‘improved … sleep quality’, ‘feelings of stress and fatigue [decreased] …’, 
‘irritability and fatigue [were] reduced by 63%’ and ‘significant improvement in 
quality of life’ are health claims within the meaning of Article 1(2), points 1 and 
5, Article 10(1) and (3) of Regulation No 1924/2006. 
10 The distinction between Article 10(1) of Regulation No 1924/2006, on the one 
hand, and Article 10(3) of Regulation No 1924/2006, on the other, depends on 
whether the claim establishes a direct causal relationship between a food category, 
a food or one of its constituents and a function of the human organism, the 
scientific substantiation of which can be verified in an authorisation procedure (in 
which case it is a specific health claim within the meaning of Article 10(1) of 
Regulation No 1924/2006) or whether such verification is not possible (in which 
case it is a non-specific health claim within the meaning of Article 10(3) of 
Regulation No 1924/2006). 
B. Applicability of Article 10(1) and (3) of Regulation No 1924/2006 
11 The saffron and melon juice extracts in question are substances known as 
‘botanicals’. This term is commonly used to refer to plant or herbal substances 
(see recital 10 of Regulation No 432/2012; recital 4 of Regulation No 536/2013). 
The Commission of the European Union has not yet decided on the inclusion of 
health claims referring to ‘botanicals’ in the Community list of permitted claims 
within the meaning of Article 13(3) of Regulation No 1924/2006, but considers a 
further examination and consultation to be necessary (cf. recital 10 of Regulation 
No 432/2012; recitals 4 and 5 of Regulation No 536/2013). It is unclear whether 
Article 10(1) and (3) of Regulation No 1924/2006 is applicable to health claims 
on plant and herbal substances before the Authority’s evaluation and the 
Commission’s examination of the inclusion of the claims made regarding 
‘botanicals’ in the Community lists pursuant to Articles 13 and 14 of Regulation 
No 1924/2006 have been completed. 
12 However, the application of Article 10(3) of Regulation No 1924/2006 is in 
principle not precluded by the fact that the lists pursuant to Articles 13 and 14 of 
the Regulation have not yet been drawn up in full. The dissenting view is hardly 
compatible with the wording of Article 10(3) of Regulation No 1924/2006 or with 
the spirit and purpose of that provision. Moreover, it is precluded by the fact that 
additions are admissible in accordance with Article 13(5) of Regulation 
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No 1924/2006 (see Opinion of Advocate General Bobek in Case C-177/15, 
Nelsons, EU:C:2016:474, point 75 et seq.). The same applies to the application of 
Article 10(1) of Regulation No 1924/2006. 
13 However, it is uncertain whether Article 10(1) and (3) of Regulation 
No 1924/2006 applies to claims whose evaluation by the Authority or examination 
by the Commission is on hold and not yet finalised, such as claims referring to the 
effects of plant or herbal substances commonly referred to as ‘botanicals’ and 
certain other health claims on whose inclusion in the list of permitted claims the 
Commission has not yet taken a final decision. It is not possible to give a clear 
answer to that question. 
Status of the dispute 
– First view: Article 10(3) of Regulation No 1924/2006 is not applicable 
14 According to one view, Article 10(3) of Regulation No 1924/2006 is not 
applicable as long as the specific claims relating to ‘botanicals’ have not been 
evaluated by the Authority and examined by the Commission. One argument in 
support of that view is that the legislator considered a general ban on general, non-
specific health claims to be too far-reaching. It therefore enacted only a limited 
prohibition. Accordingly, general health-related claims are prohibited only if they 
are made without the addition of specific claims contained in a list pursuant to 
Article 13 or 14 of Regulation No 1924/2006. However, that limited prohibition 
requires those lists to be drawn up. Otherwise, contrary to the intention of the 
legislator, which is also clearly expressed in the transitional provisions of 
Article 28 of Regulation No 1924/2006, the Regulation would initially contain 
stricter provisions than it would eventually do. Due to the suspension of the 
evaluation of claims for ‘botanicals’ by the Authority and the Commission, it is 
currently impossible for the advertiser to obtain a decision on specific health 
claims; therefore, no such claims can be added to a non-specific claim within the 
meaning of Article 10(3) of Regulation No 1924/2006. The deliberate decision of 
the legislator not to impose a general ban on non-specific health claims but only to 
link them to the addition of listed specific claims would be reversed by the mere 
decision of the Commission to refrain from drawing up lists for an entire class of 
substances. If that were the case, merely by refraining from drawing up the lists 
and not dealing with applications for registration in respect of plant or herbal 
substances, the resulting legal position would be one that the legislator had not 
intended to enact. That is why the wording of Article 10(3) of Regulation 
No 1924/2006 alone could not be the decisive factor. Instead, it is to be assumed 
that the use of general health-related claims for ‘botanicals’ is not regulated by the 
Regulation as long as the Commission remains inactive. Those principles also 
apply even if the advertiser has not made an application for registration of specific 
claims. Such an application would have no chance of success in the foreseeable 
future because the treatment of health claims on ‘botanicals’ has been put ‘on 
hold’ by the competent bodies. 
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15 A further argument in favour of the inapplicability of the conditions for 
permissibility pursuant to Article 10(1) and (3) of Regulation No 1924/2006 could 
be that the Commission’s inaction over a number of years could be seen as a 
disproportionate restriction of the freedom of the undertakings concerned to 
conduct a business within the meaning of Article 16 of the Charter of 
Fundamental Rights of the European Union as well as unjustified unequal 
treatment compared to the advertising opportunities of competitors whose 
applications for the inclusion of health claims in the Community list concern 
substances that are being evaluated by the Authority and examined by the 
Commission. The Commission’s failure to act for a number of years could result 
in the conditions for permissibility under Article 10(1) and (3) of Regulation 
No 1924/2006 being maintained, which could be seen as a disproportionate 
interference with the legally protected interests of the undertakings concerned (see 
judgment of the Court of Justice of 23 November 2017, Bionorica and Diapharm 
v Commission, C-596/15 P and C-597/15 P, EU:C:2017:886, paragraph 91 et 
seq.). 
16 If one were to take that view, Article 10(1) and (3) of Regulation No 1924/2006 
are not applicable in the present case, and the contested use of the claims at issue 
here is not precluded by the fact that they are not authorised under that Regulation 
and included in the list of authorised claims pursuant to Article 13 and 14 of 
Regulation No 1924/2006 (Article 10(1) of Regulation No 1924/2006) or that they 
are not accompanied by specific health claims included in one of the lists provided 
for in Article 13 or 14 of Regulation No 1924/2006 (Article 10(3) of Regulation 
No 1924/2006). 
– Second view: Article 10(3) of Regulation No 1924/2006 is applicable 
17 By contrast, the predominant view is that Article 10(3) of Regulation 
No 1924/2006 must also be applied to ‘botanicals’, but with the proviso that its 
requirements are also met if a general, non-specific reference within the meaning 
of that provision is accompanied by a specific health claim which, according to 
the Commission, has been put ‘on hold’ and may continue to be used subject to 
the conditions of Article 28(5) and (6) of Regulation No 1924/2006. 
18 That view is supported by the fact that the wording of Article 10(1) and (3) of 
Regulation No 1924/2006 covers non-specific health claims without 
differentiating whether or not the claims refer to ‘botanicals’. 
19 Furthermore, the purpose of Article 10(1) and (3) of Regulation No 1924/2006 
would seem to militate against fully exempting advertising with non-specific 
health claims relating to ‘botanicals’ from the restrictions of those provisions 
without first completing a scientific evaluation of the specific health claims (to be 
attached). According to recital 23 of the Regulation, health claims should only be 
authorised for use in the Community after a scientific assessment of the highest 
possible standard which is to be carried out by the European Food Safety 
Authority in order to ensure consistency. It should be taken into account that there 
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is a risk that consumers will not be able to distinguish between food supplements 
and plant or herbal medicinal products in particular and that – contrary to the 
intention of the legislator – the use of food supplements with untested health 
claims may continue to pose a health risk to patients. 
20 Moreover, the Commission has indicated in recital 9 of Regulation No 536/2013 
and in recital 11 of Regulation No 432/2012 that claims whose evaluation by the 
Authority or examination by the Commission has not yet been completed will be 
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. Thus, the 
legitimate interests of the advertising company in the use of health claims for 
‘botanicals’ could have been taken into account to a sufficient degree. 
21 If one were to take that view, Article 10(1) and (3) of Regulation No 1924/2006 
are applicable in the present case and preclude the contested use of the claims at 
issue here. 
C. Infringement of Article 10(1) and (3) of Regulation No 1924/2006 if 
applicable 
I. In the event that Article 10(1) of Regulation No 1924/2006 is applicable 
22 If the contested claims are to be classified as references to general, non-specific 
benefits of the nutrient or food for health in general or health-related well-being, 
they are in infringement of Article 10(3) of Regulation No 1924/2006 because 
they are not accompanied by a specific health claim, that is to say neither a claim 
included in one of the lists pursuant to Article 13 or 14 of Regulation 
No 1924/2006 nor a claim that has been put ‘on hold’ by the Commission and 
may continue to be used pursuant to Article 28(5) or (6) of Regulation 
No 1924/2006. 
II. In the event that Article 10(3) of Regulation No 1924/2006 is applicable 
23 If the contested claims are to be regarded as health claims within the meaning of 
Article 10(1) of Regulation No 1924/2006, they are in infringement of that 
provision for the very reason that they are neither authorised under that Regulation 
and included in the list of authorised claims pursuant to Articles 13 and 14 of 
Regulation No 1924/2006, nor are they claims that have been put ‘on hold’ by the 
Commission and allowed to continue to be used under Article 28(5) or (6) of 
Regulation No 1924/2006. 
24 Article 28(5) of Regulation No 1924/2006 provides that, so long as the list 
referred to in Article 13(3) of Regulation No 1924/2006 has not been adopted, the 
health claims provided for in Article 13(1)(a) of Regulation No 1924/2006 may be 
made under the responsibility of food business operators provided that they 
comply with that Regulation and with existing national provisions applicable to 
them. 
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25 According to Article 28(6)(b) of Regulation No 1924/2006, health claims not 
covered by Article 13(1)(a) of Regulation No 1924/2006 and Article 14 of 
Regulation No 1924/2006 (such as claims referring to psychological or 
behavioural functions pursuant to Article 13(1)(b) of Regulation No 1924/2006) 
and which were used in compliance with national law before the entry into force 
of that Regulation and have not been the subject of evaluation and authorisation in 
a Member State, may continue to be used for six months after a decision has been 
taken pursuant to Article 17(3) of Regulation No 1924/2006, provided that an 
application under that Regulation was submitted before 19 January 2008. 
26 The functions advertised 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 Regulation No 1924/2006. Thus, the 
transitional provision of Article 28(6) of Regulation No 1924/2006 is applicable. 
All the functions advertised in the present case have in common that they concern 
the emotional world. This does not count as a physiological function but rather as 
a psychological function. 
27 An application under the Regulation within the meaning of Article 28(6)(b) of 
Regulation No 1924/2006 can only mean an application under Article 13(5) in 
conjunction with Article 18(1) of Regulation No 1924/2006. According to that 
provision, any food business operator intending to use a health claim not included 
in the Community list of permitted claims referred to in Article 13(3) of 
Regulation No 1924/2006 may apply for the inclusion of the claim in that list. 
Pursuant to Article 18(4) of Regulation No 1924/2006, a decision on that 
application is to be taken by the Commission after obtaining the opinion of the 
Authority. The reference in Article 28(6)(b) of Regulation No 1924/2006 to 
Article 17(3) of Regulation No 1924/2006 is probably an error on the part of the 
legislator. 
28 In the present case, the defendant did not file an application before 19 January 
2008. The defendant did not file an application for melon juice extract at all and 
the application filed for saffron is dated 13 January 2009. 
29 It is irrelevant whether Article 28(6)(b) of Regulation No 1924/2006 must be 
interpreted as meaning that an application by a food business operator is not 
required if the claim is contained in the list provided by a Member State pursuant 
to Article 13(2) of Regulation No 1924/2006. The lower court found that there 
were no claims that were still to be examined.