Judgment;Summary — ECLI:EU:C:2022:831
Date: 2022-10-27
Language of the case: German
Court formation: Second Chamber
Subject matter: Agriculture and Fisheries;Foodstuffs
Procedure: Reference for a preliminary ruling
Origin: Germany

Translation C-418/21 – 1 
Case C-418/21 
Request for a preliminary ruling 
Date lodged: 
9 July 2021 
Referring court: 
Oberlandesgericht Düsseldorf (Germany) 
Date of the decision to refer: 
28 June 2021 
Defendant and appellant: 
Orthomol pharmazeutische Vertriebs GmbH 
Applicant and respondent: 
Verband Sozialer Wettbewerb e. V. 
  
[…] 
OBERLANDESGERICHT DÜSSELDORF (HIGHER REGIONAL COURT, 
DÜSSELDORF) 
ORDER 
In the case of 
Orthomol pharmazeutische Vertriebs GmbH […] 
[…] Langenfeld, 
defendant and appellant, 
– […] 
v 
Verband Sozialer Wettbewerb e. V., […] Berlin, 
applicant and respondent, 
EN 
REQUEST FOR A PRELIMINARY RULING OF 28. 6. 2021 – CASE C-418/21 
 
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– […] 
the 20th Civil Chamber of the Higher Regional Court, Düsseldorf made, on 
28 June 2021, the following 
o r d e r: 
I. 
The proceedings are stayed. 
II. 
The Higher Regional Court, Düsseldorf refers the following questions on the 
interpretation of Regulation (EU) No 609/2013 of the European Parliament 
and of the Council of 12 June 2013 on food intended for infants and young 
children, food for special medical purposes, and total diet replacement for 
weight control and repealing Council Directive 92/52/EEC, Commission 
Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 
2009/39/EC of the European Parliament and of the Council and Commission 
Regulations (EC) No 41/2009 and (EC) No 953/2009 […] (OJ 2013 L 185, 
p. 35) (‘the FSG Regulation’) and in relation to Commission Delegated 
Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation 
(EU) No 609/2013 of the European Parliament and of the Council as regards 
the specific compositional and information requirements for food for special 
medical purposes (OJ 2016 L 25, p. 30) (‘the Delegated Regulation’) to the 
Court of Justice of the European Union 
for a preliminary ruling: 
1. 
Under what circumstances are there other medical nutrient requirements 
pursuant to the second alternative in Article 2(2)(g) of the FSG Regulation, 
namely: 
do they require – in addition to the limited, impaired or disturbed capacity to 
take, digest, absorb, metabolise or excrete ordinary food, as referred to in the 
first alternative – that there is an increased nutrient requirement brought 
about by illness, which is to be covered by the food, 
or is it sufficient if the patient […] generally benefits from the intake of that 
food because substances contained therein counteract the disorder or 
alleviate its symptoms? 
2. 
ORTHOMOL 
 
3 
In the event that the first question is answered in accordance with the latter 
alternative: 
Does ‘generally accepted scientific data’ within the meaning of Article 2(2) 
of the Delegated Regulation in any event presuppose a randomised, placebo-
controlled double-blind study which, although not related to the product in 
question itself, at least provides starting points for the claimed effects? 
G r o u n d s: 
1 The applicant is a registered association, one of the statutory duties of which is to 
protect the commercial interests of its members, in particular compliance with the 
rules of fair competition. It has standing to bring proceedings under German law. 
2 The defendant is a pharmaceutical company and markets, in particular, foodstuffs 
in the form of food supplements and products which it regards as food for special 
medical purposes. 
3 By the present action, the applicant challenges the marketing and advertising of 
‘Orthomol Immun’ and ‘Orthomol AMD extra’ as food for special medical 
purposes. It takes the view that those products do not meet the requirements for 
classification as ‘food for special medical purposes’. It submits that such 
foodstuffs must be distinguished from medicinal products. ‘Orthomol Immun’ is 
intended to be used for cases of nutritionally acquired immunodeficiency – a 
disease – and, according to the defendant, to strengthen the immune system. 
‘Orthomol AMD’ is intended to be used to counter the progression of a disease, 
namely age-related macular degeneration. They are not diseases which lead to a 
limited, impaired or disturbed capacity to take, digest, absorb, metabolise or 
excrete ordinary food or certain nutrients contained therein, or metabolites. The 
second alternative in Article 2(1)(g) of the FSG Regulation (‘patients … with 
other medically determined nutrient requirements’) concerns only diseases or 
conditions that lead to special energy and nutrient requirements on the part of the 
patient, such as mucoviscidosis (increased salt and calorie requirements), cancer 
cachexia (higher quantities of nutrients) or severe wounds/burns/pressure necrosis 
(increased requirement for proteins and glutamine), but does not concern 
substances that serve to treat the disease or condition itself. 
4 The defendant contended that the second alternative in Article 2(1)(g) of the FSG 
Regulation must be interpreted broadly. According to the defendant, it also 
concerns foodstuffs that contain substances that can be used to compensate for the 
consequences of a disease or to prevent the progression of the disease. ‘Orthomol 
Immun’ strengthens the immune system; in that respect, there is a study on the 
‘Dietary efficacy of a micronutrient combination in patients with recurrent upper 
respiratory tract infections’ in patients susceptible to infections. The defendant 
submits that ‘Orthomol AMD Extra’ slows down the progression of age-related 
macular degeneration; this is proven by studies. 
REQUEST FOR A PRELIMINARY RULING OF 28. 6. 2021 – CASE C-418/21 
 
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5 The Landgericht (Regional Court) shared the view taken by the applicant and 
prohibited the defendant, in accordance with the form of order sought, from doing 
the following in the course of trade 
1. 
placing on the market and/or distributing the product ‘Orthomol Immun’ for 
the dietary management of nutrition-related immune deficiencies. 
2. 
advertising the product ‘Orthomol Immun’ as follows: 
2.1 
‘Common cold? Not for me thanks!’1; 
2.2 
‘Using nutritional science to support the immune system’; 
2.3 
‘Orthomol Immun is a dietary food for special medical purposes (balanced 
diet), Orthomol immune for the dietary management of nutrition-related 
immune deficiencies (e.g. recurrent respiratory infections)’; 
2.4 
‘Immunocompetent cells have an increased need for micronutrients 
compared to other body cells due to their increased metabolic turnover. In 
particular folic acid, vitamin B12, zinc and iron are involved in the growth 
of immune cells’; 
3. 
placing on the market and/or distributing the product ‘Orthomol AMD extra’ 
for the dietary management of advanced age-related macular degeneration; 
4. 
advertising the product ‘Orthomol AMD extra’ as follows: 
4.1 
‘Restricted? Losing sight of life? I have good support’; 
 
1 The German includes the verb ‘husten’ (to cough), thereby creating a pun.  
ORTHOMOL 
 
5 
4.2 
‘Using nutritional science to support advanced AMD’; 
4.3 
‘Orthomol AMD extra is a food for special medical purposes (balanced 
diet). It is suitable for the dietary management of patients with advanced 
age-related macular degeneration’; 
4.4 
Micronutrients for the dietary management of advanced macular 
degeneration; 
4.4.1 
‘The retina is characterised by high metabolic activity and light exposure. 
Here, for example, vitamin C, vitamin E and zinc, with their nutritional and 
physiological properties, make a significant contribution to the dietary 
treatment of advanced age-related macular degeneration’; 
4.4.2 
‘The carotenoids lutein and zeaxanthin are selectively enriched in the 
macula and their concentration is particularly high in the macula lutea. The 
composition of Orthomol AMD extra is carefully tailored to the nutritional 
needs of AMD patients’; 
in each case in so far as they occur as reproduced in a specific annex. 
6 The defendant’s appeal is directed against that decision. It takes the view that food 
does not have to serve nutritional purposes, at least not exclusively. It submits that 
the case-law to date is still applicable. It therefore requests that the court dismiss 
the action, altering the contested judgment. 
7 The applicant requests that the appeal be dismissed. It considers that the view 
taken by the Regional Court, which is also shared by other courts, is correct, and it 
argues that it is not sufficient that a nutrient being supplied has positive effects on 
the development of a disease in the sense that it helps to prevent, alleviate or cure 
it. 
The first question: 
8 The outcome of the dispute depends first of all on whether the contested products 
are a ‘food for special medical purposes’. Should this not be the case, as the 
applicant claims, the action would be well-founded from the outset. Under 
REQUEST FOR A PRELIMINARY RULING OF 28. 6. 2021 – CASE C-418/21 
 
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German law, the applicant could then have the distribution and advertising 
prohibited by a court. 
Such food is defined as follows in Article 2(2)(g) of the FSG Regulation: 
food specially processed or formulated and intended for the dietary management 
of patients …., to be used under medical supervision; it is intended for the 
exclusive or partial feeding of patients with a limited, impaired or disturbed 
capacity to take, digest, absorb, metabolise or excrete ordinary food or certain 
nutrients contained therein, or metabolites, or with other medically determined 
nutrient requirements, whose dietary management cannot be achieved by 
modification of the normal diet alone. 
9 That provision replaces the definitions in Article 1(2)(b) of Directive 1999/21 
foods for particular nutritional uses specially processed or formulated and 
intended for the dietary management of patients and to be used under medical 
supervision. They are intended for the exclusive or partial feeding of patients with 
a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or 
excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or 
with other medically determined nutrient requirements, whose dietary 
management cannot be achieved only by modification of the normal diet, by other 
foods for particular nutritional uses, or by a combination of the two. 
and in Article 1(2) of Directive 2009/39/EC 
foodstuffs which, owing to their special composition or manufacturing process, 
are clearly distinguishable from foodstuffs for normal consumption, which are 
suitable for their claimed nutritional purposes and which are marketed in such a 
way as to indicate such suitability. 
 The Bundesgerichtshof (Federal Court of Justice) (IZR 100/06 – judgment of 
4 December 2008 – Erfokol-Kapseln, paragraph 16 et seq.) interpreted those 
provisions as meaning that a particular nutritional purpose exists not only where 
there is a medically determined nutrient deficiency, but also where the nutrient 
intake is intended to counteract illnesses in other ways and the consumer can 
derive particular benefits from the controlled intake of certain nutrients (‘broad 
concept of nutrition’). Commentary on that case-law expresses the view that such 
foodstuffs have thereby been categorised as a ‘small medicinal product’. 
10 Recently, however, there has been discussion as to whether that case-law can 
continue to be applicable following the entry into force of the FSG Regulation 
and, at the latest, since the entry into force of the Delegated Regulation. The case-
law of the higher regional courts (most recently the Higher Regional Court, 
Frankfurt am Main – 6 U 38/20 – judgment of 16 July 2020; Higher Regional 
Court, Karlsruhe – 4 U 125/20 – judgment of 26 February 2021; Higher Regional 
Court, Schleswig – 6 U 6/20 – judgment of 25 March 2021; there is not yet any 
such case-law from the Court of Justice or the Federal Court of Justice) and the 
ORTHOMOL 
 
7 
published opinion of the authorities proceed on the assumption […] that a ‘narrow 
concept of nutrition’ now applies in any event. According to that opinion, under 
the law as it stands, foods for special medical purposes require that they are 
developed, intended and suitable for patients whose nutritional needs cannot be 
met by the consumption of ordinary food because of specific diseases, disorders or 
medical conditions. 
11 That view is derived, in particular, from recitals 10 et seq. of the FSG Regulation, 
recital 3 of the Delegated Regulation and the Commission Notice on the 
classification of Food for Special Medical Purposes (2017/C 401/01). The FSG 
Regulation was adopted precisely for the purpose of regulating the ‘uncontrolled 
proliferation’ that had arisen in Germany as a result of the case-law, and the 
resulting difficulties in establishing a distinction from medicinal products. 
12 Against that, however, it is contended in the legal literature that the wording of the 
provision has not changed significantly compared to that of the previous 
provisions. The category of persons ‘with other medically determined nutrient 
requirements’ continues to exist. 
13 The prevailing view (see paragraph 9) seems to the Chamber to stand to reason, 
especially against the background of the legislative history of the FSG Regulation. 
However, as this question arises in a large number of proceedings, the Chamber 
considers that it would be appropriate to obtain clarification from the Court. 
14 The question is also material to the resolution of the dispute […]. Nutrition-related 
immune deficiencies and age-related macular degeneration (AMD) are diseases. It 
is common ground that the foods in question do not fall within the scope of the 
first alternative in Article 2(2)(g) of the FSG Regulation. Nor do they serve to 
meet a patient’s increased nutrient requirements brought about by illness. 
The second question: 
15 The second question arises only if the Court answers the first question in 
accordance with the ‘broad concept of nutrition’ (paragraph 6). This is because, 
with regard to that eventuality, the parties are in dispute as to whether the 
documents submitted by the defendant in respect of the claimed effects of 
‘Orthomol Immun’ are sufficient. 
16 Article 2(2) of the Delegated Regulation provides that ‘food for special medical 
purposes shall be based on sound medical and nutritional principles’. 
17 With regard to the efficacy of ‘Orthomol Immun’, the defendant submits a 
placebo-controlled, randomised double-blind study on the ‘Dietary efficacy of a 
micronutrient combination in patients with recurrent upper respiratory tract 
infections’ […], a study on the ‘Effects of nutritional supplements on health’ […], 
a study on ‘Nutritional Formula Enhanced Immune Function and Reduced Days 
of Symptoms of Upper Respiratory Tract Infection in Seniors’ […] as well as 
REQUEST FOR A PRELIMINARY RULING OF 28. 6. 2021 – CASE C-418/21 
 
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studies on ‘Immunobiological effects of micronutrients’ […]. It follows from 
those studies that the addition of certain micronutrients strengthens the immune 
system in people with recurrent respiratory infections and thereby counteracts 
those infections. The applicant contends that those studies cover only patients with 
recurrent respiratory infections, particularly of the upper respiratory tract, and do 
not relate to the advertised range of applications in its entirety. In that respect, it 
must be stated that the studies do in fact relate only to that specific group of 
patients and that, for other patients, they contain at best only indications of 
positive effects.